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Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

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Page 1: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

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Page 2: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J.

0925-0001 (Rev. 03/16) Page Continuation Format Page

HIGH PLAINS INTERMOUNTAIN CENTER FOR AGRICULTURAL HEALTH AND SAFETY (HICAHS) U54 OH008085

TABLE OF CONTENTS

Page Face Page……………………………………………………………………………………………………………... 1 Table of Contents ……………………………………………………………....…………………………………… 2

BUDGET AND PROGRESS REPORT INFORMATION

Overall for Center

Budget Overview for Next Budget Period - Year 14…………………………………...……………….……. 5

IRB Approval for Center…………………………………………..…………………………………………….. 7

Center Administration

Detailed Budget for Next Budget Period - Year 14………….……………..………………………….…….. 8

Budget Justification ......…………….…………….…………….……………..………………………….…….. 9

Detailed Budget for Next Budget Period - UTHealth, Consortium - Year 14..…………………………….. 13

Budget Justification - UTHealth, Consortium…………………………………………………………………. 14

Progress Report Summary - Year 13………….…………......……………..……….………………….…….. 15

IRB Approval for Center Administration and Emerging Issues…………………..……………….………… 21

Checklist - UTHealth, Consortium.…………………………….……………..………………………….…….. 23

Checklist - CSU…………………………………………………………………………………………….……. 24

Emerging Issues

Detailed Budget for Next Budget Period - Year 14………….……………..………………………….…….. 25

Budget Justification ......…………….…………….…………….……………..………………………….…….. 26

Progress Report Summary - Year 13…….…….…………......……………..………………………….…….. 27

Checklist.......…..…………………….…………….…………….……………..………………………….…….. 28

Evaluation Program

Detailed Budget for Next Budget Period - Year 14………….……………..………………………….…….. 29

Budget Justification ......…………….…………….…………….……………..………………………….…….. 30

Progress Report Summary - Year 13…….…….…………......……………..………………………….…….. 33

2

Page 3: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J.

0925-0001 (Rev. 03/16) Page Continuation Format Page

Inclusion Enrollment Report…………………………………………………………………………………….. 34

Human Subject Certificate Renewals………………………………………………………………………….. 35

IRB Approvals…...………….…………......………………………………....…….…………………….…….. 37

Checklist.......…..…………………….…………….…………….……………..………………………….…….. 39

Development of Engineering Controls to Reduce Foldable ROPS Overturn Fatalities Type: Intervention (R1) Dr. Paul Ayers, University of Tennessee

Detailed Budget for Next Budget Period - Year 14………….……………..………………………….…….. 40

Budget Justification ......…………….…………….…………….……………..………………………….…….. 41

Progress Report Summary - Year 13…..….………..……......……………..………………………….…….. 43

Checklist.......…..…………………….…………….…………….……………..………………………….…….. 47

Occupational Safety Management and Leadership on Large-Herd Dairy Farms Type: Intervention (R2).

Detailed Budget for Next Budget Period - CSU - Year 14....................................................................... 48

Budget Justification - CSU…….…………….………..……….……………..……………………….….…….. 49

Detailed Budget for Next Budget Period - UTHealth, Consortium - Year 14…....………………………… 51

Budget Justification - UTHealth, Consortium………….……………………………………………………… 52

Progress Report Summary - CSU/UTHealth - Year 13…......……………..………………………….…….. 55

Inclusion Enrollment Report…………………………………………………………………………………….. 57

Human Subject Renewal Certificates………….…………......……………..………………………….…….. 58

IRB Approvals…...………….…………......……………..………………………………………………..…….. 64

Checklist - UTHealth, Consortium…………….…………….………………..………………………….…….. 65

Checklist - CSU………………………………………………………..………………………………………… 66

Agricultural Safety Education Initiative Type: Translation (R3) Dr. Michael Pate, Utah State University

Detailed Budget for Next Budget Period - USU - Year 14………….……..………….……………….…….. 67

Budget Justification - USU……….…………….…………….……………..……………...…………….…….. 68

Detailed Budget for Next Budget Period - MSU, Consortium - Year 14………….………………….…….. 72

Budget Justification - MSU, Consortium………………………………………..……………………….…….. 73

Checklist - MSU, Consortium…………………………………………………………………………………… 76

Detailed Budget for Next Budget Period - ISU, Consortium - Year 14…...………………………….…….. 77

Budget Justification - ISU, Consortium………….…………….……………..………………………….…….. 78

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Page 4: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J.

0925-0001 (Rev. 03/16) Page Continuation Format Page

Checklist - ISU, Consortium…………………………………………………………………………………….. 80

Progress Report Summary - Year 13………….…………......……………..….……………………….…….. 81

Inclusion Enrollment Reports.…………………………………………..……………………………………… 83

Checklist.......…..…………………….…………….…………….……………..………………………….…….. 87

Pilot/Feasibility Program

Detailed Budget for Next Budget Period - Year 14………….……………..………………………….…….. 88

Budget Justification ......…………….…………….…………….……………..………………………….…….. 89

Progress Report Summary - Year 13………….…………......……………..………………………….…….. 91

IRB Approval for Pilot/Feasibility Program……………………………………………………………………. 93

IRB Approval for Pilot Projects funded………….………….....……………..………………………….…….. 94

Checklist.......…..…………………….…………….…………….……………..………………………….…….. 96

Outreach Program

Detailed Budget for Next Budget Period - Year 14………….……………..………………………….…….. 97

Budget Justification ......…………….…………….…………….……………..………………………….…….. 98

Progress Report Summary - Year 13….……….…………......……………..………………………….…….. 102

Inclusion Enrollment Report……………………………………………………………………………………. 107

Human Subject Certificate Renewals………….…………......……………..………………………….…….. 108

Checklist.......…..…………………….…………….…………….……………..………………………….…….. 110

Checklist CSU Overall………………………………………….…………………………...…………………….… 111

Checklist Overall (Detailed Spreadsheet)…………………….……………….………………………………… 112

Other Support for Key Personnel…………………………………………………….…………………………… 113

All Personnel Report………………….………………………………………..………………………………….… 124

Component Budget Matrix…………………………………………………………………………………………. 126

FTE Table……………………………………………………………………………………………………………… 127

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Page 5: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): CSU - Overall

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT

Cal. Mnths

Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Center Administrative 77,836 22,608 100,444

Emerging Issues 0 0 0

Evaluation 66,812 15,689 82,501

R1 - Ayers - UTENN 36,252 7,023 43,275

R2 - Douphrate - UTHealth 16,179 4,546 20,725

R3 - Pate - USU 38,485 15,176 53,661

Pilot/Feasibility 12,042 3,383 15,425

Outreach 121,245 27,068 148,313

SUBTOTALS 368,851 95,493 464,344 CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

Center Admin - $1,120 R1-Ayers-UTENN - $6,280 R3-Pate-USU - $2,553 Outreach - $1,597 Evaluation - $2,060

13,610 TRAVEL

Center Admin - $26,918 Pilot/Feas. - $3,000 R1-Ayers-UTENN - $6,000 R2-Douphrate-UTHealth - $5,000 R3-Pate-USU - $6,545 Outreach - $16,540 Evaluation - $6,353 70,356 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

Center Admin - $5,459 Emerging Issues - $50,000 Pilots/Feas. - $51,575 R3-Pate-USU - $10,655 Outreach - $33,550 Evaluation - $9,086 160,325

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ 708,635

CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS - UTHealth-$10,428 + $145,633;MSU/ISU-$58,740 214,801

CONSORTIUM/CONTRACTUAL COSTS FACILITIES/ADMINISTRATIVE COSTS - UTHealth-$5,631 + $78,642; UTENN - $24,445; USU/MSU/ISU-$27,846 136,564

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ 1,060,000 PHS 2590 (Rev. 03/16) Page Form Page 2 5

Page 6: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): CSU - Overall

Reynolds, Stephen J.

BUDGET JUSTIFICATION

GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. (Please see justification for each core/project on the individual budget justifications.)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget.

PHS 2590 (Rev. 03/16) Page Form Page 3 6

Page 7: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Animal Care and Use · Human Research · Institutional Biosafety 208 University Services Building

Research Integrity & Compliance Review Office

Office of Vice President for Research 208 University Services Building

Fort Collins, CO 80523-2011 970-491-1553

FAX 970-491-2293 M E M O R A N D U M To: Stephen J. Reynolds, Ph.D. From: IRB Coordinator, Research Integrity & Compliance Review Office ([email protected]) Re: 118 Determination: High Plains Intermountain Center for Agricultural Health and Safety 2016-

2021 Funding Source: HHS-CDC Centers for Disease Control Grant #: PASS: #125248; IRB protocol to be submitted by May 2017 The above-referenced project has been administratively reviewed on August 11, 2016 and the IRB has determined that this project is an overall umbrella grant that does not include human subjects, but will include individual projects that will involve human subjects:

1) Appears to be approvable in concept but lacks sufficient details to make an approval determination because of its early design stage. For example, insufficient information is available to make risk/benefits assessments. It appears at this point to meet the requirements of 45 CFR 46.118, “Application and proposal lacking definite plans for involvement of human subjects.” The regulations allow awards for such projects to be made prior to review and approval by an IRB, but no human subjects may be involved until the review and approval has taken place.

Before humans are involved as participants, please submit your protocol to the CSU IRB for review or (in collaborative research with other institutions) work with the CSU IRB and IRB at your collaborator’s institution to establish an Institutional Authorization Agreement (IAA). For information regarding the protocol-review process, forms, and access to the electronic system see: http://ricro.colostate.edu/IRB/IRB.htm.

Colorado State University, through its IRB, is charged with prospective approval of activities meeting the federal definitions of human subject and research. CSU has certified to the federal government that each proposal for research covered by our federal assurance has been reviewed and approved by the IRB. That review must ascertain a variety of things, including that the risk is minimized and appropriate, and that participants be fully informed and that their participation is voluntary (these are detailed in the federal regulations).

If the federal human research protection requirements are circumvented, this could jeopardize the research funding at CSU, and an accumulation of such violations could cause the institution to lose its privilege to review human research protocols. Data collected prior to obtaining IRB approval cannot be used for research purposes or for publication. Federal regulations do not allow the IRB to retrospectively approve data collected without IRB approval.

Please contact me at 491-1553 or by email at [email protected] if you have questions.

Date of correspondence: 8/11/2016 7

Page 8: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): PE Core - Center Administration

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Reynolds, Stephen PD/PI 1.35 .45 27,765 7,802 35,567

Stallones, Lorann Deputy Director 0.90 0.30 18,510 5,201 23,711

Schaeffer, Joshua Co-Investigator 0.60 5,560 1,562 7,122

Petersen, Kathy Acctg Tech IV 1.20 5,082 2,165 7,247

TBN Admin Asst 5.58 20,919 5,878 26,797

SUBTOTALS 77,836 22,608 100,444 CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

Computer data storage; Printing/copying supplies

1,120 TRAVEL

Domestic travel - $17,918; International travel - $9,000 26,918 INPATIENT CARE COSTS OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

Official Function costs for External Advisory Board and Dairy Advisory Board; Long distance and conference telephone calling 5,459

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ 133,941 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS 10,428 CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS 5,631

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ 150,000 PHS 2590 (Rev. 03/16) Page Form Page 2 8

Page 9: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): PE Core - Center Administration

Reynolds, Stephen J.

BUDGET JUSTIFICATION

GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. Personnel - ($100,444) Reynolds, Stephen, PhD, Center Director, Annual Salary - $185,100; 1.35 academic person-months, 0.45 summer person-months (15% effort) in Year 14. Dr. Reynolds has served as Director of the High Plains Intermountain Center for Agricultural Health and Safety since 2003. In that role he is involved in rural and agricultural health research, education, outreach, and policy on a regional, national, and international level. He has more than 30 years of experience in research and teaching, and is internationally recognized for his work on bioaerosols, particularly endotoxins and their relationship to lung disease among agricultural workers. He has extensive experience working with community-based partners. In his roles as Chair of ACGIH (2010) and AIHA’s International Affairs Committee he has experience in leading occupational health programs on an international level. Over the past 14 years he has worked closely with the dairy industry to comprehensively address occupational health risk. In 2011 he led the establishment of the International Dairy Research Consortium to foster sharing of knowledge and best practices. He also served as Chair of the NIOSH AgFF Center Directors from 2011 through 2014. As HICAHS Director, he will provide overall vision, leadership, and management of the HICAHS Center, fostering and facilitating continued partnerships with researchers and AgFF constituents to successfully address their most pressing occupational health needs. He will coordinate closely with the HICAHS Leadership Team (Stallones, Douphrate, Quijano, Cassidy, Rosecrance, Schaeffer, Magzamen, Pate, Ayers) and HICAHS External Advisory Board on a regular basis to ensure effective progress and success of all components of the Center. (continued on next page)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget. Currently the unobligated balance of remaining budget is approximately 28.9%. Approval for carry forward from year 12 was just received. Carry forward funds were encumbered to: support data analysis and publication of papers from microbiome and other HICAHS projects; website consultation; and travel for External Advisory Board (scheduled for May 2017). These efforts are currently in progress. A delay occurred partly due to the maternity leave and subsequent reduction in effort of key personnel in the Administrative, Emerging Issues, Evaluation Core (Ms. Cassidy). Hiring a replacement for Administrative tasks is currently in process. Funds (including international travel) will be expended before the end of the year 13 period (September 14, 2017).

PHS 2590 (Rev. 03/16) Page Form Page 3 9

Page 10: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Center Administration

0925-0001 (Rev. 03/16) Page Continuation Format Page

Budget Justification - continued *Colorado State University, Department of Environmental & Radiological Health Sciences, agrees to a cost sharefor the portion of Dr. Stephen Reynolds salary which exceeds the NIH salary cap in Year 14.

Stallones, Lorann, PhD, Center Deputy Director, Annual Salary - $185,100; 0.90 academic person-months; 0.30 summer person-months (10% effort) in Year 14. Dr. Stallones has been the Deputy Director of the High Intermountain Plains Center for Agriculture Safety and Health between 2010 and 2016. She has provided leadership for the HICAHS programs and participated in Advisory Board meetings and other leadership meetings. Prior to joining the HICAHS team she directed a CDC funded injury control research center and has conducted research on agricultural injuries and disease prevention for over 30 years. Further she has worked extensively to understand community-based needs and interests in order to improve the reach of scientific results to prevent injuries and improve and the well-being of communities focusing largely on agricultural workers, families and communities affected by agricultural production. Her major responsibilities related to the administration core will be to serve on committees, continue to provide leadership to the direction of HICAHS and to support the Director.

*Colorado State University, Colorado School of Public Health/Graduate School, agrees to a cost share for theportion of Dr. Lorann Stallones salary which exceeds the NIH salary cap in Year 14.

Schaeffer, Joshua, Ph.D., Co-Investigator, Annual Salary - $111,200; 0.60 calendar months (5% effort) in Year 14. Dr. Schaeffer is an Assistant Professor in Environmental and Radiological Health Sciences at Colorado StateUniversity (CSU). He is also a Co-Principal Investigator on a HICAHS research project, and an member of theInternational Dairy Research Consortium. His primary research efforts are directed towards understandingemerging trends in exposure patterns of biological aerosols in the agricultural setting and investigating the roleintrinsic and extrinsic factors play in respiratory disease. He is developing interventions and solutions thateffectively reduce exposures. In the past two years he has helped secure six new grants as either principal orco-principal investigator. His research on bioaerosols and antimicrobial resistant bacteria has garneredsignificant attention from other researchers and industry leaders nationally and internationally, which hasfostered both intra- and inter-departmental collaborations at CSU as well as with other universities (e.g.,University of Wyoming, Saskatchewan, Edith Cowan and Johns Hopkins) and industry partnerships (e.g.,Immunetics). Using novel sampling and analytical methods to advance bioaerosol sciences, he is keenly awareof the importance of coordinating research efforts and integrating research findings into translation and outreachactivities. Dr. Schaeffer is co-chair of the Marijuana Occupational Health Sub-Committee at the ColoradoDepartment of Public Health and Environment, which is developing and disseminating best practices andproviding assistance to marijuana-related industries (e.g., grow operations, dispensaries, and retail). In thisHICAHS proposal, he is a Co-PI on the research project “Antimicrobial Resistant Bacteria: Exposures and Healthof Dairy and Beef Workers.” With his interdisciplinary background in biochemistry, toxicology, and industrialhygiene, he has the training, experience, and expertise necessary to successfully fulfill the role of HICAHSResearch Core Lead. He will provide leadership and vision to coordinate and expand HICAHS researchinteractions and impact, with a special emphasis on translating research to practice and communicating with ourstakeholders in a meaningful and effective manner.

Petersen, Kathy, Accounting Technician IV, Annual Salary - $50,820; 1.20 calendar months (10% effort) in Year 14. Since the HICAHS Center is a major center in an academic setting which necessitates financial oversight,as well as additional duties to Ms. Petersen established job description, we are requesting additionaladministrative support for her role in managing the accounting aspects of the Center. She will be responsible forpreparation of budgets and related documents, including coordinating sub-contracts for HICAHS and relatedgrant proposals, accounting and monitoring of awarded budgets on a regular/monthly basis, assistance withpreparation and submission of annual and final financial reports to NIOSH, directly coordinating with the CSUOffice of Sponsored Programs.

To-Be-Named, Administrative Assistant, Annual Salary - $44,987; 5.58 calendar months, (46.5% effort) in Year 14. The Administrative Assistant will support the Director in his functions. She/he will also: Serve as a liaison forcommunications between staff, advisory board members, and grant recipients; Develop relationships and lead

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Center Administration

0925-0001 (Rev. 03/16) Page Continuation Format Page

communications with the International Dairy Research Consortium, and HICAHS Advisory Board; Promote achievement of group goals by creating “Action Items” after each national call, writing detailed meeting minutes, and following up with assignments; Facilitate and document internal communications regarding Center decisions and accomplishments on an as-needed basis; Maintains email list serves for all HICAHS groups. He/she will also: Store information on HICAHS grant applications, reports, projects and activities in a share drive accessible to all staff members; Utilize Google Alerts to become notified about new HICAHS publications; Store and update citation information for HICAHS publications in EndNote, according to the HICAHS EndNote guide; and Generate reports on publications for NIOSH reports or upon request. Additional duties will include: Evaluation, Assist Dr. Quijano with maintaining the evaluation database and/or EndNote library which includes center products and contacts. Board Development & Conference Planning. Organize Internal, and External Advisory Board meetings; organize IDRC meetings; serve as liaison between HICAHS researchers and regional constituents; Plan the agenda for annual meetings with board members and other meetings as needed; Document center meetings, workshops, and conferences. Grant and Report Preparation (in coordination with Ms. Petersen and HICAHS Faculty): Help prepare reports for the National Institute for Occupational Safety and Health, Colorado State University, and other stakeholders as needed. Responsibilities include developing plan and timeline for creating reports, communicating with all project directors about their responsibilities, developing graphics and figures to enhance the report, writing sections of the report, light editing, and ensuring that the report meets requirements. Anticipated reports: Annual Report (currently due every September 30) & Progress Report.

Fringe benefits are assessed at the rate of 28.1% in Year 14 for the Center Director, Center Deputy Director, Co-Investigator, and Administrative Assistant; 42.6% in Year 14 for the Accounting Technician IV.

Materials and Supplies - ($1,120) Support is requested for materials and supplies including computer storage/accessories and other printing supplies (printing cartridges, paper, etc.) as needed.

Domestic Travel - ($17,918) Travel for the Center Director, Deputy Director, and/or Associate Director to participate in two NIOSH Ag Centers Directors meetings is required for each year.

Expense Category # People # Units Unit Cost $ Requested

Airfare 3 1 round trip $449/ticket $1,347 Ground Transportation 3 4 days $50/day $ 600 Per Diem 3 4 days $43.90/day $ 527 Lodging 3 3 nights $165/night $1,485

Total request for travel (per trip for 3 travelers) x 2 trips $3,959

To optimize our resources the second meeting will be scheduled to coincide with a major related scientific AgFF meeting such as the International Society for Agricultural Safety and Health (ISASH).

Travel funds are also needed for members of the HICAHS External Advisory Board to travel to Colorado State University for the annual meeting. Members represent Colorado, Montana, N Dakota, S Dakota, Wyoming, and Utah. All travel will be in accordance with the State of Colorado Travel Guidelines observed by Colorado State University. Travel costs are estimated as outlined below.

Expense Category # People # Units Unit Cost $ Requested

Airfare 9 1 round trip $500/ticket $4,500 Ground Transportation 9 1 round trip (DIA) $100 x 4 units $ 400 Per Diem 9 3 days $38.88/day $1,050 Lodging 9 3 nights $150/night $4,050

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Page 12: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Center Administration

0925-0001 (Rev. 03/16) Page Continuation Format Page

Total request for travel to CSU $10,000

International Travel - ($9,000) International travel funds are requested for the Director, Deputy and/or Associate Director to participate in one meeting to continue and grow our productive collaboration among researchers involved in dairy worker health and safety. The plan is for this consortium to meet in conjunction with an international agricultural health and safety conference to further maximize our resources. It is estimated each traveller will have a travel allowance of $3,000 as outlined below.

Expense Category # People # Units Unit Cost $ Requested

Airfare - International 3 1 round trip $1,550/ticket $4,650 Ground Transportation 3 4 days $75/day $ 900 Per Diem 3 4 days $100/day $1,200 Lodging 3 3 nights $250/night $2,250

Total request for travel to International Dairy Research Consortium $9,000

Other Direct Costs - ($5,459) We will need funds for hosted hospitality meetings and working lunches and dinners with potential and current community partners, and for meetings of the HICAHS External Advisory Board. We also anticipate other costs associated with long distance phone and video-conferencing to effectively manage this center. We also anticipate costs for graphic design work to support Outreach efforts.

Consortiums - ($16,059) Dr. David Douphrate is the Associate Director for HICAHS. He is an Assistant Professor in the Department of Epidemiology, Human Genetics and Environmental Sciences at The University of Texas School of Public Health, San Antonio Regional Campus. Since 2003, he has played an instrumental role in the High Plains and Intermountain Center for Agricultural Health and Safety (HICAHS). He has served as PI of two multi-year research projects, provided expertise and experience in a multitude of outreach projects, facilitated the development and administration of the International Dairy Research Consortium (IDRC), and represented HICAHS at numerous conferences (national and international) involving both academic and producer audiences. His producer engagement efforts have enabled the development and strengthening of a robust HICAHS Dairy stakeholder network comprised of owners, managers, workers, producer associations and other industry stakeholders. This stakeholder network will ensure continued HICAHS success in serving the health and safety needs of farming and livestock producers throughout the region as well as nationally. He has a long history of working with Drs. Reynolds and Stallones on multiple research projects as well as HICAHS strategic planning. He has the expertise, leadership, administrative experience and motivation necessary to help the HICAHS leadership team in fulfilling the center mission. He will continue to strengthen the stakeholder network through partnerships, provide strategic planning to more effectively serve stakeholder needs, represent HICAHS at various agricultural forums, and expand IDRC activities and products.

Indirect Costs - ($48,739) Indirect rate is calculated at Modified Total Direct Costs of 34% in Year 14.

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Page 13: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Program Director/Principal Investigator (Last, First, Middle): PE Core - Douphrate (UTHealth)

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Douphrate, David PD/PI 0.96 8,276 2,152 10,428

SUBTOTALS 8,276 2,152 10,428 CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

TRAVEL

INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS 10,428 CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS 5,631

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ PHS 2590 (Rev. 03/16) Page Form Page 2 13

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Program Director/Principal Investigator (Last, First, Middle): PE Core - Douphrate (UTHealth)

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. Personnel - ($10,428) Douphrate, David I., Ph.D., MPT, MBA, CPE, CSP, Project Director and Subcontract Principal Investigator, Annual Salary - $103,454; 0.96 calendar months (8.0% effort) in Year 14. Dr. Douphrate will serve as HICAHS Associate Director. He will support the Center Director and Deputy Director in leadership and management of the Center. His primary responsibility will be building and fostering partnerships with industry, other AgFF Centers, and other Center stakeholders. He will lead and coordinate research and outreach efforts in the dairy sector. He will also facilitate the continued expansion of the International Dairy Research Consortium (IDRC) and coordinate its planned activities.

Indirect Costs - ($5,631) Indirect rate is calculated at Modified Total Direct Costs of 54% in Year 14

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget. N/A

PHS 2590 (Rev. 03/16) Page Form Page 3 14

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Center Administration

PHS 2590 (Rev. 03/16) Page Form Page 5

PROGRESS REPORT SUMMARY GRANT NUMBER U54OH008085 PERIOD COVERED BY THIS REPORT

PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR Stephen J. Reynolds

FROM 09/15/2016

THROUGH 09/14/2017

APPLICANT ORGANIZATION Colorado State University - High Plains Intermountain Center for Agriculture Health & Safety (HICAHS) TITLE OF PROJECT (Repeat title shown in Item 1 on first page) Administration, Planning and Evaluation Core

A. Human Subjects (Complete Item 6 on the Face Page)

Involvement of Human Subjects No Change Since Previous Submission Change B. Vertebrate Animals (Complete Item 7 on the Face Page)

Use of Vertebrate Animals No Change Since Previous Submission Change

C. Select Agent Research No Change Since Previous Submission Change

D. Multiple PD/PI Leadership Plan No Change Since Previous Submission Change

E. Human Embryonic Stem Cell Line(s) Used No Change Since Previous Submission Change

SEE PHS 2590 INSTRUCTIONS.

WOMEN AND MINORITY INCLUSION: See PHS 398 Instructions. Use Inclusion Enrollment Report Format Page and, if necessary, Targeted/Planned Enrollment Format Page.

A. Specific AimsNo specific aims have been modified.

Component 1. Administration and Planning (A&P) 1) Provide vision, leadership, strategic planning, and management;2) Ensure transdisciplinary coordination and synergy through the structure and functions of the Internal

Advisory Board and External Advisory Board, and through continued engagement of HICAHS researchersand staff;

3) Coordinate and facilitate innovative, high impact-programs in Outreach and Research.4) Continue to foster and enhance the HICAHS Dairy Health and Safety Network and the HICAHS

International Dairy Consortium.

Component 2. Emerging Issues (EI) 1) To provide leadership and resources for Projects addressing high priority emerging issues in Public Health

Service Region VIII in a timely manner.

Component 3. Evaluation 1) Use a novel logic model to evaluate the quality, effectiveness, and impact of the HICAHS Agricultural

Center over the next five years.2) Collect evaluation data from research participants, advisory board members, and constituents to provide

feedback and assess regional needs.3) Provide feedback and guidance to each HICAHS project and program, based upon evaluation metrics

related to specific aims, outputs, outcomes, potential long-term goals, and impacts.4) Evaluate and document Center-wide collaborations with multiple entities, including NIOSH and other

NIOSH Agricultural Centers, as well as partnerships to accomplish Center goals.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Center Administration

0925-0001 (Rev. 03/16) Page Continuation Format Page

B. Studies and ResultsAll activities have been initiated and are ongoing.

A&P Aim 1. The Internal Advisory Committee meets every two weeks. Minutes are recorded and shared with all HICAHS staff. The 12 people who compose the Internal Committee include the Core Directors, Program Leads and Principal Investigators and bring skills that significantly broaden and strengthen the administrative team. Other communications occur more frequently by telephone and email. A&P Aims 2, 3, and 4. Each of the Internal Advisory Committee members facilitates communication between the administrative team, and staff and investigators within their respective programs and projects. As a group, the Internal Advisory Committee is responsible for interdisciplinary coordination and integration of projects and programs within HICAHS and with HICAHS external partners. The Internal Advisory Committee is also responsible for implementing and coordinating all programs with the Evaluation Program and Outreach/Translation initiatives and assists in identifying and prioritizing Emerging Issues. Please see Emerging Issues and Evaluation Components of this Core, as well as the Outreach Core for more detail. A&P Aim 4. Also please see below for more information regarding dairy industry r2p building on our domestic and international dairy initiatives.

EI Aim 1. Approval for carry forward from year 12 was just received; carry forward funds were encumbered for two emerging issues project – one with the University of Wyoming and one with the US Dairy Education & Training Consortium (USDETC). The University of Wyoming project focuses on “Assessing Worker Perceptions of Health and Safety Risk in Beetle-Killed Forests” – i.e. are the risks different than healthy forests. The goal is to generate hypotheses regarding risk-behavior for design of intervention strategies. The project with USDETC builds on our successful work with Dr. Robert Hagevoort at the New Mexico State University to develop and deliver training for dairy workers incorporating human and cow health. Funds were awarded to develop dairy stockmanship vignettes for a novel mobile employee training tool. Funds from carryforward have also been committed to Dr. Schaeffer (CSU) to build on research concerning bioaerosol exposures and lung disease experienced by dairy workers.

The Evaluation Program initiated conversations with all project PIs and program leads regarding data collection timelines and methods as well as appropriate and specific metrics for each project. Discussions with the information and technology group at Colorado State were initiated to enhance the existing database to manage the following: a) accept mobile phone entries of activities and products, b) to document and store qualitative data, c) to upload data from a template, d) to document progress on specific aims, e) to store products associate with projects and programs, f) compatibility with NIOSH data collection requirements. Conversations and initial data collection variables have been identified by the Evaluation Lead and the Geospatial Information Systems team for the Agricultural Education Project. Dr. Quijano has participated in the Evaluators, Coordinators, and Outreach (ECO) calls and has attended Agricultural Director Conference calls. Since Dr. Quijano was on medical leave in the fall of 2016, some proposed positions were not filled. However, hiring is underway for an administrative assistant to assist Dr. Quijano on regular and timely data collection from project PIs and program leads and a Research Associate I position will be filled in the upcoming months to manage the database and provide input on data management and analyses.

C. Significance

The HICAHS region encompasses twenty percent of the U.S. landmass consisting of Colorado, Wyoming, Montana, Utah, North Dakota, South Dakota, and 27 Tribal Nations. Building on a substantial record of accomplishments in research, intervention, education and outreach HICAHS is an innovative interdisciplinary Center that has leveraged expertise and resources among partners to promote a healthy agricultural and forestry/logging population in PHS Region VIII and beyond for over 20 years. A major focus of our Center involves Industrialized Large Animal Production (Dairy, Beef Cattle), while being responsive to other unique and diverse needs of the region, including developing capacity to address health and safety issues related to row crops, logging and forestry. As with many agricultural commodities, there are a high percentage of “vulnerable” Latino workers employed in agriculture within the HICAHS region. The Administration, Planning, and Evaluation Core is organized to facilitate collaboration throughout the region, and utilizes an innovative approach to foster synergy among the multiple projects and partners that constitute this Center.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Center Administration

0925-0001 (Rev. 03/16) Page Continuation Format Page

The HICAHS approach to emerging issues is grounded on engaging and listening to stakeholders, soliciting their feedback, and responding to their needs with sound and relevant programs and partnerships. This application utilizes a health-focused approach to the prevention and reduction of work hazards among high risk industries in agriculture and forestry. Further there is an emphasis on vulnerable populations within the workforce.

The HICAHS approach to evaluation is based on obtaining stakeholder feedback, and reporting results to the research community, eXtension, and the agricultural community at large, ensuring projects and programs are relevant to stakeholders. Surveys will be developed to solicit feedback from the Center’s External Advisory Board members and from project specific review panels and constituents. In this way, PIs will have additional information regarding perception of project impact from relevant stakeholders in a timely manner. A survey will administered to the HICAHS newsletter recipients to provide an opportunity for all constituents and community members to provide feedback. Feedback and Google Analytics reports are also available on HICAHS videos that are on the U.S. Agricultural Safety and Health Centers YouTube channel. The Geospatial Information Systems technology will provide a unique understanding of the breadth and depth of projects’ influence. Success Stories from individual constituents will also provide perception of impact for associated projects/programs.

D. Plans

A delay in some activities occurred due to the maternity leave and subsequent reduction in effort of Key Personnel in the Administrative, Emerging Issues, Evaluation Core (Ms. Cassidy). Hiring a replacement for Administrative tasks is currently in process.

A HICAHS Advisory Board meeting is being scheduled for this summer. The current HICAHS Center (2016 – 2021) builds on our successful integrative, partner-based model and extends it beyond the dairy industry. Our Advisory Board meeting with focus on using our Center’s systematic evaluation process and producer / stakeholder feedback to continue to successfully manage current projects and to foster our new and growing health and safety initiatives in cattle feedlots, logging, and other sectors. HICAHS will continue to foster the development and adoption of occupational health and safety (OHS) management programs for the US Dairy industry. The International Dairy Research Consortium leadership (Reynolds, Lundqvist, Douphrate, and Lunner-Kolstrup) will continue to spearhead a new global initiative to document occupational health and safety management needs, as well as global best practices on dairy farms.

Remaining funds for emerging issues grants have not been committed at this point. A delay in soliciting and processing emerging issues proposals occurred due to the maternity leave and subsequent reduction in effort of key personnel in the Administrative, Emerging Issues, Evaluation Core (Ms. Cassidy). Hiring a replacement for Administrative tasks is currently in process. Identifying additional emerging issues in the region will be a key activity at our upcoming External Advisory Board meeting (Spring 2017). Funds will be expended before the end of the year 13 period (September 14, 2017).

A key activity for obtaining feedback on specific projects and programs and future directions will occur at our upcoming Advisory Board meeting. An Advisory Board survey will be constructed and administered at the upcoming meeting. Survey results will be distributed to project PIs and program leads to communicate feedback from constituents and possible new directions for project improvements or emerging issues. The Geospatial Information Systems project will collect additional data elements from the HICAHS Agricultural Education Project over time to determine impact through the spread of the educational product. The Pilot Projects Program is slated to be uploaded into the Geospatial Information Systems Program to track spread of programs and document leveraged projects.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Center Administration

0925-0001 (Rev. 03/16) Page Continuation Format Page

E. Outputs, Outcomes, and Research to Practice (r2p)

Journal Articles 1. Nonnenmann MW, Gimeno DRP, Levin J, Douphrate D, Boggaram V, Schaffer J, Gallagher M, Hornick

M, Reynolds, S. (2016) Pulmonary function and airway inflammation among dairy parlor workers afterexposure to inhalable aerosols. American Journal of Industrial Medicine. Article DOI:10.1002/ajim.22680

2. David Douphrate, David Gimeno, PhD; Matthew W Nonnenmann, PhD; Robert Hagevoort, PhD;Stephen J Reynolds, PhD; Anabel Rodriguez, BS; Nathan B Fethke, PhD. Effects of milking unitdesign on upper extremity muscle activity during attachment among U.S. large-herd parlor workers. doi:10.1016/j.apergo.2016..08.008 003-6870/ Applied Ergonomics 2016

3. Schwatka NV, Atherly A, Dally MJ, Reynolds SJ et al. Health Risk Factors as Predictors of Worker’sCompensation Claim Occurance and Cost. Occup Environ Med Published Online First: 16/08/16doi:10.1136/oemed- 2015-103334.

4. Menger L, Pezzutti F, Tellechea T, Stallones L, Rosecrance J, Roman-Muniz IM. Perceptions of healthand safety among immigrant Latino/a dairy workers in the US. Frontiers in Public Health. 2016; 4:106.Doi:10.3389/fpubh.2016.00106.

5. Taghavi S, Mokarami H, Ahmadi O, Stallones L, Abbaspour A, Marioryad H. Assessing the risk factorsfor developing work-related musculoskeletal disorders during dairy farming. International Journal ofOccupational and Environmental Medicine. (accepted 2016).

6. Lagerstrom E, Magzamen S, Stallones L, Gilkey D, Rosecrance J. Understanding the risk factorpatterns in ATV fatalities: A recursive partitioning approach. Journal of Safety Research. 2016. 59:23-31. doi: 10.1016/j.jsr2016.10.004.

7. Menger L, Rosecrance J, Stallones L, Roman-Muniz N. Training Immigrant Dairy Workers: A Review ofBest Practices. Frontiers in Public Health. December 23, 2016 doi: 10.3389/fpubh.2016.00282.

Presentations, Conferences, Meetings, and Courses 8. Presentation accepted for July 2017. This project received supplementary funding from the HICAHS

Emerging Issues funds. J.C. Chandler, J.W. Schaeffer, M. Davidson, S.L. Magzamen, A. Pérez-Méndez, S.J. Reynolds, L.D. Goodridge, J. Volckens, A.B. Franklin, S.A. Shriner, and B. Bisha. AMethod for the Improved Detection of Aerosolized Influenza Viruses Using Impingers That IncorporateAnion Exchange Resin. 2017 International Association for Food Protection Annual Meeting. 9-12 July,2017. Tampa, FL.

9. Dr. Quijano is a collaborating author with Dr. Michael Pate on an abstract for the upcoming ISASHconference representing the evaluation for the HICAHS Agricultural Safety Education Initiative Project.

10. 2/6/17 Risk assessment course in Ternopol State Medical University in Ukraine, in March 2017.Andrey Korchevskiy, PhD, CIH, Director of Research & Development, Chemistry & Industrial Hygiene,Inc. Wheat Ridge, CO. Dr. Reynolds provided PPT presentations on organic dusts and agriculture forhis use. Will follow up to explore collaborations.

11. 2/15/17 Dr. Reynolds presentation and discussion to OHS faculty at Edith Cowen University,Joondalup, Western Australia. MAP ERC and HICAHS overviews. ~ 20 faculty and students. Dr.Reynolds is Adjunct Professor at ECU.

12. 2/22/17 Dr. Quijano and Ms. Cassidy represented HICAHS at the Governor’s Agricultural Forum onColorado Agriculture

13. 3/1/17 Drs. Hagevoort and Douphrate presentation entitled “Challenges surrounding training thenext generation” at the Western Dairy Management Conference in Reno, NV.

14. The next HICAHS Advisory Board meeting scheduled for May 2017

HICAHS Consultations 15. 2/14/17 AgriBeef, Boise, ID. Dr. Reynolds reviewed article and email regarding legislation in WA re

Beef industry/cattle feedlots and possible exemption from EPA Clean Air Act. Spoke with Jayne Davis,18

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Center Administration

0925-0001 (Rev. 03/16) Page Continuation Format Page

Director Corporate and Regulatory Affairs to provide opinion and discuss. Also suggested additional contacts.

16. 2/17/17 LDS Church, Risk Management, Salt Lake City, UT. Dr. Reynolds consulted with ClarkEvans regarding guidelines and standards for organic dust exposures, sample interpretation, andexposure profiles for agricultural workers.

Program Organizer 17. Paul Ayers and Allison Cassidy along with personnel at NYCAMH and other organizations have

participated in the National Tractor Safety Coalition (NTSC) and the National ROPS Rebate Program.Paul Ayers was part of the organizing committee for the NTSC. Allison Cassidy spoke to agriculturalproducers in Wyoming in August 2016 about the National ROPS Rebate Program.

Service 18. Cassidy, A. (2014 – present). Board Member for the Agrisafe Network. http://www.agrisafe.org/19. Cassidy, A. (2013 – present). Founder and Member of the NORA AgFF Outreach, Communications,

and Partnerships Working Group.20. Reynolds, S. J. (2013 – present). NORA Agriculture, Forestry & Fishing Sector Council.21. Reynolds, S. J. (2010 – present). Worksafe Colorado Advisory Board.22. Reynolds, S. J. (2011 – present). External Advisory Board Member of the Upper Midwest Agricultural

Safety and Health Center (Minneapolis, MN).23. Reynolds, S. J. (2010 – present). Colorado Department of Public Health and the Environment (CDPHE)

Occupational Health Surveillance Program.24. Reynolds, S. J. (2008 – present). International Member of the Canadian Centre for Health and Safety in

Agriculture (CCHSA).25. Reynolds, S.J., Cassidy, A. (2010-present). Wyoming Governor’s Taskforce/Wyoming-Colorado

Occupational Safety and Health Coalition26. Dr. Stallones is on the leadership team for the Farm and Health Safety (FReSH) Community of Practice

(CoP) which operates through the Cooperative Extension eXtension program.27. Drs. Stallones and Reynolds serve as Associate Editors for the Journal of Agromedicine and the

Journal of Agricultural Safety and Health.

Outcomes Aurora Organic Dairy (operations in CO and TX) has worked with HICAHS on implementing an OHS Management program for a number of years. Emily Prisco, the Director of Farm Resources who implements that program is currently pursuing an MPH in the Colorado School of Public Health. Dr. Reynolds is working with her to develop a Total Worker Health Program through an independent study, and collaborating with the new Rocky Mountain Center for Total Worker Health. This would be the first TWH program for Dairy that we are aware of.

The emerging issues award to the University of Wyoming has helped HICAHS succeed in fostering new relationships with the logging industry. See Outreach Report for related efforts with logging industry.

Research to Practice After 15 years of working with the dairy industry we are now seeing examples of research to practice, with dairy producers implementing integrated health and safety management into their business, hiring appropriate staff, and requesting HICAHS support for their efforts. An article about the Idaho Dairymen’s Association’s most recent steps can be found at the following link: http://www.capitalpress.com/Idaho/20161215/idaho-dairymen-to-add-worker-safety-emphasis. They are now asking Drs. Douphrate and Hagevoort for assistance with training employees on 500 dairy farms, and implementing a comprehensive safety management program on each farm operation. Several other producer organizations are also exploring similar efforts.

F. Project-Generated ResourcesNone.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Center Administration

0925-0001 (Rev. 03/16) Page Continuation Format Page

HUMAN SUBJECTS / IRB APPROVALS This project was reviewed by the Research Integrity & Compliance Review Office at Colorado State University and it was determined that this project meets the requirements of 45 CFR 46.118, “Application and proposal lacking definite plans for involvement of human subjects.” The regulations allow awards for such projects to be made prior to review and approval by an IRB, but no human subjects may be involved until the review and approval has taken place.

The Emerging Issues Proposal “Assessing Worker Perceptions of Health and Safety Risk in Beetle-killed Forests” was reviewed by the Institutional Review Board at the University of Wyoming. The approval letter can be found on the following page.

It is our intention to remain compliant with the human subjects’ requirements of our institution and to keep the Grants Management Specialist and the NIOSH Program Official informed of IRB approvals.

20

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Animal Care and Use · Human Research · Institutional Biosafety 208 University Services Building

Research Integrity & Compliance Review Office Office of Vice President for Research

208 University Services Building Fort Collins, CO 80523-2011

970-491-1553FAX 970-491-2293

M E M O R A N D U M

To: Stephen J. Reynolds, Ph.D.

From: IRB Coordinator, Research Integrity & Compliance Review Office ([email protected])

Re: 118 Determination: High Plains Intermountain Center for Agricultural Health and Safety 2016-2021 – Administration, Planning, and Evaluation Core

Funding Source: HHS-CDC Centers for Disease Control

Grant #: PASS: #125248; IRB protocol to be submitted by May 2017

The above-referenced project has been administratively reviewed on August 11, 2016 and the IRB has determined that the project listed above:

1) Appears to be approvable in concept but lacks sufficient details to make an approval determination becauseof its early design stage. For example, insufficient information is available to make risk/benefitsassessments. It appears at this point to meet the requirements of 45 CFR 46.118, “Application and proposallacking definite plans for involvement of human subjects.” The regulations allow awards for such projectsto be made prior to review and approval by an IRB, but no human subjects may be involved until thereview and approval has taken place.

Before humans are involved as participants, please submit your protocol to the CSU IRB for review or (incollaborative research with other institutions) work with the CSU IRB and IRB at your collaborator’sinstitution to establish an Institutional Authorization Agreement (IAA). For information regarding theprotocol-review process, forms, and access to the electronic system see:http://ricro.colostate.edu/IRB/IRB.htm.

Colorado State University, through its IRB, is charged with prospective approval of activities meeting the federal definitions of human subject and research. CSU has certified to the federal government that each proposal for research covered by our federal assurance has been reviewed and approved by the IRB. That review must ascertain a variety of things, including that the risk is minimized and appropriate, and that participants be fully informed and that their participation is voluntary (these are detailed in the federal regulations).

If the federal human research protection requirements are circumvented, this could jeopardize the research funding at CSU, and an accumulation of such violations could cause the institution to lose its privilege to review human research protocols.

Data collected prior to obtaining IRB approval cannot be used for research purposes or for publication. Federal regulations do not allow the IRB to retrospectively approve data collected without IRB approval.

Please contact me at 491-1553 or by email at [email protected] if you have questions.

Date of correspondence: 8/11/2016 21

kathyp
Highlight
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Vice President for Research & Economic Development

1000 E. University Avenue, Department 3355 • Room 305/308, Old Main • Laramie, WY 82071

(307) 766-5353 • (307) 766-5320 • fax (307) 766-2608 • www.uwyo.edu/research

September 23, 2016

Dr. Trevor Durbin

Post- Doctoral Researcher

Anthropology

University of Wyoming

Protocol #20160923TD1305

Re: IRB Proposal “Assessing Worker Perceptions of Health and Safety Risk in Beetle-killed

Forests”

Dear Drs. Durbin and Strauss:

The proposal referenced above qualifies for exempt review and is approved as one that would not

involve more than minimal risk to participants. Our exempt review and approval will be reported to the

IRB at their next convened meeting October 20, 2016.

Any significant change(s) in the research/project protocol(s) from what was approved should be

submitted to the IRB (Protocol Update Form) for review and approval prior to initiating any change. Per

recent policy and compliance requirements, any investigator with an active research protocol may be

contacted by the recently convened Data Safety Monitoring Board (DSMB) for periodic review. The

DSMB’s charge (sections 7.3 and 7.4 of the IRB Policy and Procedures Manual) is to review active

human subject(s) projects to assure that the procedures, data management, and protection of human

participants follow approved protocols. Further information and the forms referenced above may be

accessed at the “Human Subjects” link on the Office of Research and Economic Development website:

http://www.uwyo.edu/research/human-subjects/index.html.

You may proceed with the project/research and we wish you luck in the endeavor. Please feel

free to call me if you have any questions.

Sincerely,

Colette Kuhfuss Colette Kuhfuss

IRB Coordinator

On behalf of the Chairman,

Institutional Review Board

Dr. Sarah Strauss

Professor

Anthropology

University of Wyoming

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Program Director/Principal Investigator (Last, first, middle): PE Core - Douphrate (UTHealth)

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 07/07/2014 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 10,428 x Rate applied 54 % = F&A costs $ 5,631 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 23

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Program Director/Principal Investigator (Last, first, middle): PE Core - Center Administration

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 06/30/2016 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 143,350 x Rate applied 34 % = F&A costs $ 48,739 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 24

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Program Director/Principal Investigator (Last, First, Middle): PE Core - Emerging Issues Program

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Reynolds, Stephen PD/PI 0 0 0

SUBTOTALS CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

TRAVEL

INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

Emerging Issues to address priorities identified 50,000

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ 50,000 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS

CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ 50,000 PHS 2590 (Rev. 03/16) Page Form Page 2 25

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Program Director/Principal Investigator (Last, First, Middle): PE Core - Emerging Issues Program

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary.

Other Direct Costs - ($50,000)

All funds for emerging issues will be used to address the priorities identified by HICAHS constituents including producers, Extension, HICAHS Advisory Board Members, and other Agricultural and Forestry partners in the High Plains Intermountain Region. Projects and use of funds may vary depending on the need. Recent past examples include: rapid response to developing and communicating information on appropriate PPE and work practices for bird flu, and Ebola virus in the High Plains Intermountain region and nationally; development and delivery of OSHA training for Dairy producers.

Emerging issues will be prioritized and selected by the HICAHS Leadership Team. They will be managed and evaluated through the Administrative Planning and Evaluation Core, in coordination with the Outreach Translation and Research Cores.

Indirect Costs - ($26,000)

Indirect rate is calculated at Modified Total Direct Costs of 52% in Year 14.

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget. Approval for carry forward from year 12 was just received; carry forward funds were encumbered for two emerging issues project – one with the University of Wyoming and one with the US Dairy Education & Training Consortium. Remaining funds for emerging issues grants have not been committed at this point. A delay in soliciting and processing emerging issues proposals occurred due to the maternity leave and subsequent reduction in effort of key personnel in the Administrative, Emerging Issues, Evaluation Core (Ms. Cassidy). Hiring a replacement for Administrative tasks is currently in process. Funds will be expended before the end of the year 13 period (September 14, 2017).

PHS 2590 (Rev. 03/16) Page Form Page 3 26

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Program Director/Principal Investigator (Last, First, Middle): PE Core - Emerging Issues Program

Reynolds, Stephen J.

PROGRESS REPORT SUMMARY GRANT NUMBER U54OH008085 PERIOD COVERED BY THIS REPORT

PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR Dr. Stephen J. Reynolds

FROM 09/15/2016

THROUGH 09/14/2017

APPLICANT ORGANIZATION Colorado State University - High Plains Intermountain Center for Agriculture Health & Safety (HICAHS) TITLE OF PROJECT (Repeat title shown in Item 1 on first page) Planning and Evaluation Core - Emerging Issues Program

A. Human Subjects (Complete Item 6 on the Face Page)

Involvement of Human Subjects No Change Since Previous Submission Change B. Vertebrate Animals (Complete Item 7 on the Face Page)

Use of Vertebrate Animals No Change Since Previous Submission Change

C. Select Agent Research No Change Since Previous Submission Change

D. Multiple PD/PI Leadership Plan No Change Since Previous Submission Change

E. Human Embryonic Stem Cell Line(s) Used No Change Since Previous Submission Change

SEE PHS 2590 INSTRUCTIONS.

WOMEN AND MINORITY INCLUSION: See PHS 398 Instructions. Use Inclusion Enrollment Report Format Page and, if necessary, Targeted/Planned Enrollment Format Page.

See Center Administration Progress Report for Emerging Issues

PHS 2590 (Rev. 03/16) Page Form Page 5 27

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Program Director/Principal Investigator (Last, first, middle): PE Core - Emerging Issues Program

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 06/30/2016 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 50,000 x Rate applied 52 % = F&A costs $ 26,000 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 28

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Program Director/Principal Investigator (Last, First, Middle): PE Core - Evaluation Program

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Quijano, Louise PD/PI 1.71 0.57 19,123 5,374 24,497

TBN Res Assoc I 6.00 22,250 6,252 28,502

TBN Admin Asst 2.10 7,907 2,222 10,129

TBN GRA 4.50 17,532 1,841 19,373

SUBTOTALS 66,812 15,689 82,501 CONSULTANT COSTS

Please note that we will have no consulting costs in Year 14. We are moving the budget of $9,800 into Personnel for the Admin Assistant to help on this section. EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

Project-specific computer for data entry and Center project activities; Printing/copying supplies

2,060 TRAVEL

Domestic travel - $3,090; International travel - $3,263 6,353 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

In-state tuition for GRA - 1 semester = $5,401; CHHS IT Group - $1,685 GIS Centroid Support - $2,000 9,086

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ 100,000 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS

CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ 100,000 PHS 2590 (Rev. 03/16) Page Form Page 2 29

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Program Director/Principal Investigator (Last, First, Middle): PE Core - Evaluation Program

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary.

Personnel - ($82,501)

Quijano, Louise, Ph.D., Lead – Evaluation Program, Annual Salary - $100,647; 1.71 academic person-months, 0.57 summer person-months (19% effort) in Year 14. Dr. Quijano will provide administrative leadership to all aspects of the evaluation program. She has multiple years of experience conducting applied and evaluation research as well as leading programs as a PI and Co-PI. Dr. Quijano has served as Co-PI for the HICAHS evaluation team for the last five years. Dr. Quijano will work closely with all evaluation personnel and consultants to insure timely accomplishment of all proposed aspects of the evaluation proposal. She will oversee the budget, provide leadership to the evaluation team, and serve as the primary interface with all HICAHS proposed projects/programs and Advisory Boards, communicating evaluation outcomes and processes to Center administration and documenting improvements made. A key role for Dr. Quijano will be to facilitate collaborative relationships with all HICAHS project PIs and partners in order to integrate stakeholder feedback within the Center on an ongoing basis. Quijano will also represent the HICAHS evaluation team in meetings with NIOSH and other agricultural center directors and evaluators and will supervise all staff and students on the evaluation team.

(continued on next page)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget. Dr. Quijano was on medical leave for the period 9/15/16 to 12/15/16 and therefore, no salary was charged to the grant for her during that time. In addition, the Research Associate I was not hired during that same time period. Dr. Quijano is back from leave and the hiring process for the Research Associate I is currently underway. The Graduate Research Assistant will also be hired during this latter part of the year. An administrative assistant hire is underway to assist with the data collection from all Investigators and project managers and to track and record pilot study for Evaluation.

PHS 2590 (Rev. 03/16) Page Form Page 3 30

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Evaluation Program

0925-0001 (Rev. 03/16) Page Continuation Format Page

Budget Justification - continued

To-Be-Named, Research Associate I, Annual Salary - $44,500; 6.0 calendar months (50% effort) in Year 14. The Research Associate will work closely with Dr. Quijano, project PIs and program leads to insure timely and accurate data collection and entry for the purpose of reporting findings to Center personnel, constituents, and NIOSH. The Research Associate will collect all products and contacts from project/program personnel for storage in the evaluation database, providing timely retrieval of materials for the Outreach Core staff as needed. The Research Associate will conduct key informant interviews, administer surveys, and analyze data for reporting purposes under the supervision of Dr. Quijano. In addition, the Research Associate will provide data on selected projects (Agricultural Safety Education translation project and Outreach Core) to the Geospatial Centroid at CSU (see description below) to enable GIS mapping and story mapping.

To-Be-Named, Administrative Assistant, Annual Salary - $44,987; 2.10 calendar months (17.57 effort) in Year 14. The Administrative Assistant will assist Dr. Quijano with obtaining data from project PIs and program leadsfor the purpose of evaluation. Quarterly reports from each project/program will be collected for monitoringprogress on specific aims and objectives. The administrative assistant also be responsible for communicatingevaluation deadlines and results to project PIs and program leads. Specifically, the administrative assistant willcollect data, monitor results, and track project leveraged for all pilot projects funded through HICAHS.

To-Be-Named, Graduate Research Assistant, Annual Salary - $46,752; 4.5 calendar months, (37.5% effort) in Year 14. A PhD student in the School of Social Work will be hired to assist the PI and Research Associate with all aspects of data collection and entry. In particular, this position will assist the PI and Research Associate with development of instruments including the following: key informant interviews, research participant surveys, health and safety product requests, and process evaluations. The student will be involved in all aspects of evaluation research including instrument development and administration, data collection and analysis, and reporting.

Fringe benefits area assessed at the rates of 28.1% in Year 14 for the PI, Research Associate I and Administrative Assistant; 10.5% in Year 14 for the Graduate Research Assistant.

Materials and Supplies - ($2,060) Funding is requested for a laptop to be used by the Graduate Research Assistant for data entry and Center project activities. Funds are also requested for printing/copying supplies.

Domestic Travel - ($3,090) Travel for the Evaluation program Lead is required to participate in one NIOSH Ag Centers Directors/ Evaluator meeting (1 person trip). In addition, the dollars are requested to allow the Evaluation program lead (and Research Associate or student) to travel to regional and National AFF health and safety meetings to present. (2 persons trip)

Expense Category # People # Units Unit Cost $ Requested

Airfare 1 1 round trip $375/ticket $ 375 Ground Transportation 1 4 days $30/day $ 120 Per Diem 1 4 days $40/day $ 160 Lodging 1 3 nights $125/night $ 375

Total request for travel (per trip) x 3 persons trips $1,030

International Travel - ($3,263) Travel is requested for the Evaluation program Lead to attend one International Dairy Research Consortium to collect data on international collaborations and their impact on regional and national health and safety solutions.

31

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. PE Core - Evaluation Program

0925-0001 (Rev. 03/16) Page Continuation Format Page

Expense Category # People # Units Unit Cost $ Requested

Airfare - International 1 1 round trip $1,553/ticket $1,553 Ground Transportation 1 4 days $95/day $ 380 Per Diem 1 4 days $120/day $ 480 Lodging 1 3 nights $250/night $ 750 Shuttle - FC, CO to DIA 1 1 round trip $100 trip $ 100

Total request for travel to International Dairy Research Consortium $3,263

Other Direct Costs - ($9,086) In-state tuition is being request for the Graduate Research Assistant (1 semester per year) - $5,199

College of Health and Human Sciences Information Technology Group - $1,887 The CHHSIT Group will assist the Evaluation program to enhance the database platform and user interface. The database will be configured by projects and programs funded within the current cycle and will be enhanced to store all data from prior cycles, in the event certain projects or products are selected for translation or outreach.

Geospatial Centroid-Geographic Information Systems (GIS) - $2,000 The Geospatial Centroid will provide the Evaluation team with a dedicated student who will work solely to provide geographic information to the HICAHS to document regional reach and impact of selected projects. This student will be under the supervision of Dr. Quijano and a GIS expert in the Geospatial Centroid unit at CSU.

Indirect Costs - ($32,164) Indirect rate is calculated at Modified Total Direct Costs of 34% in Year 14.

32

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Program Director/Principal Investigator (Last, First, Middle): PE Core - Evaluation Program

Reynolds, Stephen J.

PROGRESS REPORT SUMMARY GRANT NUMBER U54OH008085 PERIOD COVERED BY THIS REPORT

PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR Dr. Louise Quijano

FROM 09/15/2016

THROUGH 09/14/2017

APPLICANT ORGANIZATION Colorado State University - High Plains Intermountain Center for Agriculture Health & Safety (HICAHS) TITLE OF PROJECT (Repeat title shown in Item 1 on first page) Planning and Evaluation Core - Evaluation Program

A. Human Subjects (Complete Item 6 on the Face Page)

Involvement of Human Subjects No Change Since Previous Submission Change B. Vertebrate Animals (Complete Item 7 on the Face Page)

Use of Vertebrate Animals No Change Since Previous Submission Change

C. Select Agent Research No Change Since Previous Submission Change

D. Multiple PD/PI Leadership Plan No Change Since Previous Submission Change

E. Human Embryonic Stem Cell Line(s) Used No Change Since Previous Submission Change

SEE PHS 2590 INSTRUCTIONS.

WOMEN AND MINORITY INCLUSION: See PHS 398 Instructions. Use Inclusion Enrollment Report Format Page and, if necessary, Targeted/Planned Enrollment Format Page.

See Center Administration Progress Report for Evaluation

PHS 2590 (Rev. 03/16) Page Form Page 5 33

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PHS Inclusion Enrollment Report OMB Number: 0925-0001 and 0925-0002 Expiration Date: 10/31/2018This report format should NOT be used for collecting data from study participants.

*Study Title(must beunique):

Evaluation

Comments:

* Delayed Onset Study? Yes No

If study is not delayed onset, the following selections are required:

Enrollment Type Planned Cumulative (Actual)

Using an Existing Dataset or Resource Yes No

Enrollment Location Domestic Foreign

Clinical Trial Yes No NIH-Defined Phase III Clinical Trial Yes No

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female MaleUnknown/

Not Reported

Hispanic or Latino

Female MaleUnknown/

Not Reported

Unknown/Not Reported Ethnicity

Female MaleUnknown/

Not Reported

Total

American Indian/ Alaska Native

Asian

Native Hawaiian or Other Pacific IslanderBlack or African American

White

More than One Race

Unknown or Not Reported

Total

To ensure proper performance, please save frequently.

Report 1 of 1 34

Page 35: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 1 OF 2

COURSEWORK REQUIREMENTS*

* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details.See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.

• Name: Louise Quijano (ID: 1966104)• Institution Affiliation: Colorado State University (ID: 309)• Institution Email: [email protected]• Institution Unit: Social Work• Phone: 970-491-7448

• Curriculum Group: Human Research• Course Learner Group: Group 2.SOCIAL / HUMANISTIC / BEHAVIORAL RESEARCH• Stage: Stage 3 - Refresher Course• Description: This course is suitable for Graduate Students, Faculty and Staff conducting SOCIAL / HUMANISTIC /

BEHAVIORAL RESEARCH with human subjects.

• Record ID: 20822707• Completion Date: 15-Feb-2017• Expiration Date: 15-Feb-2020• Minimum Passing: 80• Reported Score*: 100

REQUIRED AND ELECTIVE MODULES ONLY DATE COMPLETED SCORESBE Refresher 1 – Defining Research with Human Subjects (ID: 15029)  14-Feb-2017 2/2 (100%) SBE Refresher 1 – Privacy and Confidentiality (ID: 15035)  14-Feb-2017 2/2 (100%) SBE Refresher 1 – Assessing Risk (ID: 15034)  14-Feb-2017 2/2 (100%) SBE Refresher 1 – Research with Children (ID: 15036)  14-Feb-2017 2/2 (100%) SBE Refresher 1 – International Research (ID: 15028)  14-Feb-2017 2/2 (100%) Biomed Refresher 1 - Instructions (ID: 960)  14-Feb-2017 No Quiz SBE Refresher 1 – History and Ethical Principles (ID: 936)  14-Feb-2017 2/2 (100%) SBE Refresher 1 – Federal Regulations for Protecting Research Subjects (ID: 937)  14-Feb-2017 2/2 (100%) SBE Refresher 1 – Informed Consent (ID: 938)  14-Feb-2017 2/2 (100%) SBE Refresher 1 – Research with Prisoners (ID: 939)  14-Feb-2017 2/2 (100%) SBE Refresher 1 – Research in Educational Settings (ID: 940)  15-Feb-2017 2/2 (100%) SBE Refresher 1 – Instructions (ID: 943)  15-Feb-2017 No Quiz 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: www.citiprogram.org/verify/?k11af0f7a-7d2b-44cf-942f-92a559b2e68b-20822707

Collaborative Institutional Training Initiative (CITI Program)Email: [email protected]: 888-529-5929Web: https://www.citiprogram.org

35

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COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 2 OF 2

COURSEWORK TRANSCRIPT**

** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of thecourse. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.

• Name: Louise Quijano (ID: 1966104)• Institution Affiliation: Colorado State University (ID: 309)• Institution Email: [email protected]• Institution Unit: Social Work• Phone: 970-491-7448

• Curriculum Group: Human Research• Course Learner Group: Group 2.SOCIAL / HUMANISTIC / BEHAVIORAL RESEARCH• Stage: Stage 3 - Refresher Course• Description: This course is suitable for Graduate Students, Faculty and Staff conducting SOCIAL / HUMANISTIC /

BEHAVIORAL RESEARCH with human subjects.

• Record ID: 20822707• Report Date: 15-Feb-2017• Current Score**: 100

REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST RECENT SCORESBE Refresher 1 – History and Ethical Principles (ID: 936) 14-Feb-2017 2/2 (100%) Biomed Refresher 1 - Instructions (ID: 960) 14-Feb-2017 No Quiz SBE Refresher 1 – Federal Regulations for Protecting Research Subjects (ID: 937) 14-Feb-2017 2/2 (100%) SBE Refresher 1 – Informed Consent (ID: 938) 14-Feb-2017 2/2 (100%) SBE Refresher 1 – Research with Prisoners (ID: 939) 14-Feb-2017 2/2 (100%) SBE Refresher 1 – Research in Educational Settings (ID: 940) 15-Feb-2017 2/2 (100%) SBE Refresher 1 – Instructions (ID: 943) 15-Feb-2017 No Quiz SBE Refresher 1 – International Research (ID: 15028) 14-Feb-2017 2/2 (100%) SBE Refresher 1 – Defining Research with Human Subjects (ID: 15029) 14-Feb-2017 2/2 (100%) SBE Refresher 1 – Assessing Risk (ID: 15034) 14-Feb-2017 2/2 (100%) SBE Refresher 1 – Privacy and Confidentiality (ID: 15035) 14-Feb-2017 2/2 (100%) SBE Refresher 1 – Research with Children (ID: 15036) 14-Feb-2017 2/2 (100%) 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: www.citiprogram.org/verify/?k11af0f7a-7d2b-44cf-942f-92a559b2e68b-20822707

Collaborative Institutional Training Initiative (CITI Program)Email: [email protected]: 888-529-5929Web: https://www.citiprogram.org

36

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NOTICE OF APPROVAL FOR HUMAN RESEARCH

DATE:

TO:

FROM:

PROTOCOL TITLE:

FUNDING SOURCE:

PROTOCOL NUMBER:

APPROVAL PERIOD:

Research Integrity & Compliance Review Office

Office of the Vice President for Research

321 General Services Building - Campus Delivery 2011 eprotocol

TEL: (970) 491-1553

FAX: (970) 491-2293

37

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Approval Period:

Review Type:

IRB Number:

Funding:

Research Integrity & Compliance Review Office

Office of the Vice President for Research

321 General Services Building - Campus Delivery 2011 eprotocol

TEL: (970) 491-1553

FAX: (970) 491-2293

38

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Program Director/Principal Investigator (Last, first, middle): PE Core - Evaluation Program

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 06/30/2016 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 94,599 x Rate applied 34 % = F&A costs $ 32,164 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 39

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Program Director/Principal Investigator (Last, First, Middle): RC/Intervention1 - Ayers (UT)

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Ayers, Paul PD/PI 2.06 26,503 8,772 35,275

TBN Student Hourly 3.0 8,000 0 8,000

SUBTOTALS 34,503 8,772 43,275 CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

Supplies needed to develop the force/angle measurement system.

6,280 TRAVEL

Domestic Travel - $3,000; International Travel - $3,000 6,000 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ 55,555 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS

CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ 55,555 PHS 2590 (Rev. 03/16) Page Form Page 2 40

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Program Director/Principal Investigator (Last, First, Middle): RC/Intervention1 - Ayers (UT)

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary.

Personnel - ($43,275)

Ayers, Paul D., Ph.D., Principal Investigator, Annual Salary - $154,087; 2.06 calendar months (17.2% effort) in Year14. Dr. Ayers is the supervisor of the project and is responsible for completing the objectives and submitting the final reports.

To-Be-Named, Student Hourly, Annual Salary - $32,000; 3.0 calendar months (25% effort - 520 hours) in Year 14. He/she will assist in preparing the force/angle measurement system, and designing and testing foldable ROPS lift assist.

Fringe rates are assessed at 33.1% in Year 14 for the Principal Investigator; 0% for the Student Hourly in Year 14.

Materials and Supplies - ($6,280)

Supplies are needed to develop the force/angle measurement system for foldable ROPS, and constructing and testing foldable ROPS lift assist. In Year 14 the force analysis measurement system for the foldable ROPS lift assist designs will be designed and constructed. This will measure the force at the operator seat.

(continued next page) CURRENT BUDGET PERIOD FROM

09/15/2016 THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget. N/A

PHS 2590 (Rev. 03/16) Page Form Page 3 41

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Intervention1 - Ayers (UT)

0925-0001 (Rev. 03/16) Page Continuation Format Page

BUDGET JUSTIFICATION - continued

Domestic Travel - ($3,000) Travel for the PI and other personnel to pick up supplies, conduct foldable ROPS testing and attend ASABE and ISO ROPS research conferences and committee meetings.

Expense Category # People # Units Unit Cost $ Requested

Airfare 1 1 round trip $350/ticket $350 Ground Transportation 1 1 round trip $80 $ 80 Airport Parking 1 4 days $10/day $ 40 Per Diem 1 3 days $50/day $150 Lodging 1 2 nights $100/night $200 Conference Registration 1 1 conference $440 $440

Total for 1 person 1 conference (attendance at 2 conferences) $1,260 Mileage (in-state) 1 1,000 miles $480 ($.48/mile) $480

Total request for travel $3,000

International Travel - ($3,000) It is anticipated the ISO research conference will be held internationally in Year 14 so we are requesting International Travel as outlined below.

Expense Category # People # Units Unit Cost $ Requested

Airfare - International 1 1 round trip $1,600/ticket $1,600 Ground Transportation 1 4 days $50/day $ 200 Airport Parking 1 4 days $10/day $ 40 Per Diem 1 4 days $50/day $ 200 Lodging 1 3 nights $200/night $ 600 Conference Registration 1 1 conference $360 $ 360

Total for 1 person trip $3,000

Indirect Costs - ($24,445) Indirect rate is calculated at Modified Total Direct Costs of 44% in Year 14.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Intervention1 - Ayers (UT)

PHS 2590 (Rev. 03/16) Page Form Page 5

PROGRESS REPORT SUMMARY GRANT NUMBER U54OH008085 PERIOD COVERED BY THIS REPORT

PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR Paul Ayers, University of Tennessee

FROM 09/15/2016

THROUGH 09/14/2017

APPLICANT ORGANIZATION Colorado State University - High Plains Intermountain Center for Agriculture Health & Safety (HICAHS) TITLE OF PROJECT (Repeat title shown in Item 1 on first page) Development of Engineering Controls to Reduce Foldable ROPS Overturn Fatalities

A. Human Subjects (Complete Item 6 on the Face Page)

Involvement of Human Subjects No Change Since Previous Submission Change B. Vertebrate Animals (Complete Item 7 on the Face Page)

Use of Vertebrate Animals No Change Since Previous Submission Change

C. Select Agent Research No Change Since Previous Submission Change

D. Multiple PD/PI Leadership Plan No Change Since Previous Submission Change

E. Human Embryonic Stem Cell Line(s) Used No Change Since Previous Submission Change

SEE PHS 2590 INSTRUCTIONS.

WOMEN AND MINORITY INCLUSION: See PHS 398 Instructions. Use Inclusion Enrollment Report Format Page and, if necessary, Targeted/Planned Enrollment Format Page.

A. Specific Aims

The specific goal of this project is to develop and test new and retrofit mechanical lift assists for foldable ROPS that can be operated from the tractor seat and meets ergonomic standards, and generate guidelines for implementing these engineering controls on various size tractors/ROPS combinations. To meet this goal the following specific tasks are identified.

1) Develop and test a sensor to measure the actuation forces and angles for foldable ROPS.

2) Determine the actuation forces and angles on foldable ROPS of various sizes and compare to theoreticalvalues to define both the theoretical and frictional forces.

3) Based on the actuation forces and location of the foldable ROPS with respect to the seat reference point,design and develop new and retrofit mechanical lift assist mechanisms operable from the tractor seat forvarious size ROPS.

4) Evaluate the mechanical lift assist to determine the forces and movement required by the operator to meetappropriate ergonomic standards.

5) Generate guidelines that can be used to aid the development of mechanical lift assists for foldable ROPS.

B. Studies and Results

A sensor to measure foldable ROPS actuation forces and angles was developed, constructed and calibrated. It was used to measure the ROPS actuation forces (both raising and lowering) for 12 tractors of various sizes. The ROPS friction was determined and ranged from near 0% to nearly 100% of the theoretical actuation forces. The influence of lubricant on the actuation forces was determined and lowered the forces in only the ROPS that exhibited high friction. A model defining the relationship of foldable ROPS actuation forces as a function of ROPS size/weight was developed and validated.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Intervention1 - Ayers (UT)

0925-0001 (Rev. 03/16) Page Continuation Format Page

The influence of friction is in the process of being added to the model. A protocol design of a lever-operated ROPS lift assist operable from the tractor seat was developed. It utilizes a pivot bolt extension to avoid compromising the ROPS integrity. A progress report has been provided to the project advisory committee.

C. Significance

A methodology has been developed to accurately determine the actuation forces of foldable ROPS and to quantify the influence of friction. A simple lift assist design was developed that shows promise of reducing actuation forces, meeting the required ergonomic requirements, and not compromising the ROPS integrity.

D. Plans

The plans for the next year include

1) the construction and testing of a lift assist operated from the tractor seat to reduce ROPS actuation force forone tractor/ROPS size design,

2) the development of the necessary sensors to measure the operator lift assist force requirements to assureergonomic compliance, and

3) modification of the lift assist design protocol and expand for different size foldable ROPS.

No modifications are made from the original proposal.

E. Outputs, Outcomes, and Research to Practice (r2p)

1. Ayers, P., F. Khorsandi, X. Wang, and G. Araujo. 2017. ROPS designs to protect operators duringtractor rollovers. Under review for Journal of Terramechanics, Special Issue.

2. Martin, L. and P. Ayers. 2017. Evaluation of operator clearance protection by folded ROPS. Accepted inrevision by The Journal of Undergraduate Research.

3. Khorsandi, F., P. Ayers, and T. Truster. 2017. Developing and evaluating a finite element model forpredicting the Roll-Over Protective Structure (ROPS) nonlinear behavior under SAE J2194 Static Test.Online in Biosystems Engineering.

4. Ayers, P, and V. Rondelli. 2016. Tractor ROPS and stability research: Introduction to this special issue.Journal for Agricultural Safety and Health 22(4): 213-214.

5. Ayers, P., F. Khorsandi, Y. John, and G. Whitaker. 2016. Development and evaluation of a computer-based ROPS design program. Journal for Agricultural Safety and Health 22(4): 247-260.

6. Khorsandi, F., P. Ayers, D. Jackson, and J. Wilkerson. 2016. Effect of speed on foldable ROPSactuation forces. Journal for Agricultural Safety and Health 22(4): 285-298.

F. Project-Generated Resources

There are no project generated resources (i.e. data, models) available to be shared at this point with other researchers.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Intervention1 - Ayers (UT)

0925-0001 (Rev. 03/16) Page Continuation Format Page

Figures of lift assist prototype.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Intervention1 - Ayers (UT)

0925-0001 (Rev. 03/16) Page Continuation Format Page

Figure of foldable ROPS actuation forces with and without coil spring assistance.

HUMAN SUBJECTS / IRB APPROVALS Not applicable. This project does not involve human subjects.

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Program Director/Principal Investigator (Last, first, middle): RC/Intervention1 - Ayers (UT)

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 10/21/2014 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 55,555 x Rate applied 44 % = F&A costs $ 24,445 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 47

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Program Director/Principal Investigator (Last, First, Middle): RC/Intervention2 - Douphrate (UTHealth) CSU

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Reynolds, Stephen PD/PI 0.27 0.09 5,553 1,560 7,113

Roman-Muniz, Noa Co-Investigator 0.88 0.29 10,626 2,986 13,612

SUBTOTALS 16,179 4,546 20,725 CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

TRAVEL

Travel to diary sties; travel support to present at conferences 5,000 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ 25,725 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS 145,633 CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS 78,642

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ 250,000 PHS 2590 (Rev. 03/16) Page Form Page 2 48

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Program Director/Principal Investigator (Last, First, Middle): RC/Intervention2 - Douphrate (UTHealth) CSU

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. Personnel - ($20,725) Reynolds, Stephen, Ph.D., Principal Investigator, Annual Salary - $185,100, 0.27 academic person-months, 0.09 summer person-months (3% effort) in Year 14. Salary support is requested for Dr. Reynolds to provide expertise in the development, delivery and evaluation of safety leadership and management training intervention. Dr. Reynolds will assist in the dissemination of study findings through manuscript development and conference presentations.

*Colorado State University, Department of Environmental & Radiological Health Sciences, agrees to a costshare for the portion of Dr. Stephen Reynolds salary which exceeds the NIH salary cap.

Roman-Muniz, Noa, Ph.D., Co-Investigator, Annual Salary - $108,873; 0.88 academic person-months, 0.29 summer person-months (9.76% effort) in Year 14. Dr. Roman-Muniz will facilitate the recruitment of Northeastern Colorado dairy farms and supervisors for inclusion in the study. She will provide his expertise in development and delivery of training content, as well as provide safety coaching of dairy supervisors participating in the intervention group of the study. She will also assist in the dissemination of study findings through manuscript development and conference presentations.

Fringe benefits area assessed at the rate of 28.1% for Year 14 for the Principal Investigator and Co-Investigator.

(continued on next page)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget. N/A

PHS 2590 (Rev. 03/16) Page Form Page 3 49

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Intervention2 - Douphrate (UTHealth) CSU

0925-0001 (Rev. 03/16) Page Continuation Format Page

Budget Justification - continued

Domestic Travel - ($5,000) Travel support is requested for Dr. Roman-Muniz for dairy visits for dairy recruitment, and provide safety coaching of dairy supervisors participating in the intervention group of the study. Dr. Roman-Muniz serves on multiple dairy producer conference planning boards and travel support is requested to support her travel to the planning and actual conferences to present the project and recruit dairy producers.

Expense Category # People # Units Unit Cost $ Requested

Airfare 1 1 round trip $540/ticket $540 Ground Transportation 1 1 round trip $100 $100 Airport Parking 1 4 days $15/day $ 60 Per Diem 1 3 days $75/day $225 Lodging 1 2 nights $150/night $300 Conference Registration 1 1 conference $675 $675

Total for 1 person 1 conference (attendance at 2 conferences) $1,900 Mileage (in-state) 1 2,500 miles $1,200 ($.48/mile) $1,200

Total request for travel $5,000

Consortium - ($224,275) Dr. Douphrate will serve as Project Director and Subcontract Principal Investigator at UTHealth and as Project Director for the proposed project entitled Occupational Safety Management and Leadership on Large-herd Dairy Farms. He will oversee and coordinate all project activities and be responsible for the recruitment of subjects and dairies; data collection; data entry; data analysis; and, the preparation of presentations, reports and manuscripts. Dr. Douphrate will also coordinate the International Dairy Research Consortium, a product in the current HICAHS funding cycle. UTHealth budget and budget justification are included on the following pages.

Indirect Costs - ($13,377) Indirect rate is calculated at Modified Total Direct Costs of 52% in Year 14.

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Program Director/Principal Investigator (Last, First, Middle): RC/Intervention2 - Douphrate (UTHealth)

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Douphrate, David PD/PI 3.60 31,036 8,069 39,105

Gimeno, David Co-Investigator 1.20 10,843 2,819 13,662

Pompeii, Lisa Co-Investigator 0.96 9,544 2,481 12,025

TBN GRA 6.00 20,000 5,200 25,200

SUBTOTALS 71,423 18,569 89,992 CONSULTANT COSTS

Kines - $5,000; Hagevoort - $5,000; Mendoca - $7,000

17,000 EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

iPad touches - $11,250

11,250 TRAVEL Domestic travel - $17,831; International travel - $3,500 21,331 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

Participant incentives - $4,060; Life Data subscription - $2,000 6,060

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS 145,633 CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS 78,642

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ PHS 2590 (Rev. 03/16) Page Form Page 2 51

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Program Director/Principal Investigator (Last, First, Middle): RC/Intervention2 - Douphrate (UTHealth)

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. Personnel - ($89,992)

Douphrate, David I., Ph.D., MPT, MBA, CPE, CSP, Project Director and Subcontract Principal Investigator, Annual Salary - $103,454; 3.60 calendar months (30% effort) in Year 14. Dr. Douphrate will serve as Subcontract Principal Investigator at UTHealth and as Project Director for the proposed project entitled Occupational Safety Management and Leadership on Large-herd Dairy Farms. He will oversee and coordinate all project activities and be responsible for the recruitment of subjects and dairies; data collection; data entry; data analysis; and, the preparation of presentations, reports and manuscripts. Dr. Douphrate will also coordinate the International Dairy Research Consortium, a product in the current HICAHS funding cycle.

Gimeno, David, Ph.D., Co-Investigator, Annual Salary - $108,430; 1.20 calendar months (10% effort) in Year 14. Dr. Gimeno will serve as a Co-Investigator, lending his research expertise in social and cultural determinants of occupational injuries and illnesses, working with large complex databases, and conducting multilevel statistical models in comparative epidemiological studies. For the proposed project, Dr. Gimeno’s primary responsibilities will be developing, guiding and implementing the data management and data analysis plan. He will work collaboratively with Dr. Douphrate in the dissemination of study findings through conference presentations, manuscript development and annual report preparation. He will also provide English-Spanish translation support for data collection activities.

(continued on next page)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget. N/A

PHS 2590 (Rev. 03/16) Page Form Page 3 52

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0925-0001 (Rev. 03/16) Page Continuation Format Page

Budget Justification - continued Pompeii, Lisa, Ph.D., Co-Investigator, Annual Salary - $119,301; 0.96 calendar months (8%) effort in Year 14. Dr. Pompeii will provide her expertise particularly in the first year of the study when training content will be developed for deployment on mobile devices, as well as development of data collection methodologies. She will facilitate dairy owner and supervisor focus groups to identify training needs and delivery methodology. In the remaining years of the study, she will guide the dissemination of training videos on mobile platforms using Articulate software, as well as work with Dr. Douphrate in the dissemination of study findings through manuscript development and conference presentations.

To-Be-Named, Graduate Research Assistant #1, Annual Salary - $40,000; 6.00 calendar months (50% effort) in Year 14. Salary support is requested for a Graduate Research Assistant at the UTHealth SPH San Antonio Campus for data collection equipment maintenance, field data collection, and poster and manuscript preparation.

Fringe rates are assessed at 26% in Year 14 for the Principal Investigator, Co-Investigator, and the Graduate Research Assistant.

Consultant Costs - ($17,000) Kines, Pete, Ph.D. - Dr. Kines (Senior Scientific Researcher, National Institute of Occupational Health Division of Safety Research, Denmark) will serve as a consultant for this study. He will provide valuable expertise and experience in the development of intervention tools that are adapted to a small business safety culture. Dr. Kines has a great deal of experience in international research collaborations, as well as in the development of tablet (e.g. iPad) app’s for practical use by businesses in their daily occupational health and safety processes. We request $250/day for 20 days - $5,000 in Year 14 to compensate Dr. Kines for his time on this project.

Hagevoort, Robert. Ph.D. - Dr. Hagevoort (Associate Professor and Extension Dairy Specialist, Extension Animal Sciences and Natural Resources Department, College of Consumer and Environmental Sciences at New Mexico State University) will serve as a consultant for the study. Dr. Hagevoort will assist in the recruitment of Texas-New Mexico dairy farms and supervisors for inclusion in the study. He will provide his expertise in development and delivery of training content, as well as provide safety coaching of dairy supervisors participating in the intervention group of the study. We are requesting $250/day for 20 days - $5,000 in Year 14 to compensate Dr. Hagevoort for his time and travel on this project.

Mendoca, Luis, Ph.D. - Dr. Mendoca (Assistant Professor, Dairy Extension Specialist, Department of Animal Sciences and Industry, Kansas State University) will serve as a consultant for this study. Dr. Mendoca will facilitate the recruitment of Western Kansas dairy farms and supervisors for inclusion in the study. He will provide his expertise in development and delivery of training content, as well as provide safety coaching of dairy supervisors participating in the intervention group of the study Due to Dr. Mendoca being headquartered in Manhatten, KS and incurring higher travel costs, we are requesting $200/day for 35 days - $7,000 in Year 14 to compensate Dr. Mendoca for his time and travel on this project.

Domestic Travel - $17,831 Data collection activities will address Specific Aims 1, 2 and 3. Intervention training will begin in all three regions (Texas-New Mexico, Colorado and Kansas). Dr. Douphrate and GRA will travel to each region to recruit dairy supervisors, and initiate and conclude training interventions. Group safety climate, leadership and safety behavior assessments will commence on each participating dairy.

Expense Category # People # Units Unit Cost $ Requested

Airfare 1 1 round trip $437/ticket $437 Ground Transportation 1 3 days $45/day $135 Per Diem 1 3 days $50/day $150 Lodging 1 2 nights $89/night $178

Total for 1 person trip $900 Total request for travel (17 person trips projected in Year 14) $15,300

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0925-0001 (Rev. 03/16) Page Continuation Format Page

Dr. Douphrate will also travel to one HICAHS Advisory Board Meeting (location TBD). Expense Category # People # Units Unit Cost $ Requested

Airfare 1 1 round trip $500/ticket $500 Ground Transportation 1 2 days $45/day $ 90 Per Diem 1 2 days $50/day $100 Lodging 1 1 nights $110/night $110

Total for 1 person trip to HICAHS Advisory Board Meeting $800

Travel support and conference registration fees are requested for presentation of project at academic or industry producer conferences. Conference venue and location are TBD.

Expense Category # People # Units Unit Cost $ Requested

Airfare 1 1 round trip $500/ticket $ 500 Ground Transportation 1 3 days $45/day $ 135 Per Diem 1 3 days $50/day $ 150 Lodging 1 2 nights $150/night $ 300 Conference Registration 1 1 conference $631 $ 646

Total for 1 person trip to 1 conference $1,731

International Travel - ($3,500) Funds are requested for international travel for one meeting to continue and grow our productive collaboration among researchers involved in dairy worker health and safety. The plan is for this consortium to meet in conjunction with an annual international agricultural health and safety conference to further maximize our resources. Platform presentation of findings will be planned for these conferences.

Expense Category # People # Units Unit Cost $ Requested

Airfare - International 1 1 round trip $2,200/ticket $2,200 Ground Transportation 1 5 days $50/day $ 250 Per Diem 1 5 days $50/day $ 250 Lodging 1 4 nights $200/night $ 800

Total for 1 person trip $3,500

Materials and Supplies - ($11,250) Mobile Devices and Data Collection - In Year 14, we will acquire 50 iPod touches ($197 each x 50 = $9,850 total) for mobile survey administration. IPod touches will be used by dairy supervisors to report their daily safety leadership and management practices utilizing a customized app written with Life Data software. This data collection will support both Specific Aims 1 and 2. Each device will have Wi-Fi capability only (3G/4G network capability will not be needed). We will also purchase protective cases ($28 each x 50 = $1,400) for each device.

Other Direct Costs - ($6,060) Worker Incentives – We will pay a $10 incentive to each dairy worker choosing to participate in the group safety climate, leadership, safety behavior assessment. We expect to recruit a minimum of five workers per supervisor enrolled in the study (intervention and control group to complete the assessment before and after the training intervention - $10 x 406 = $4,060 Life Data Subscription - We request $2,000/year to cover a Life Data Subscription. This subscription will enable the development of the daily SLAMP application which will be downloaded to each iPod touch. Additionally, the subscription will enable daily data collection and real time monitoring of supervisor SLAMP activities which is necessary for supervisor coaching and eventual analysis of training effectiveness.

Indirect Costs - ($78,642) Indirect rate is calculated at Modified Total Direct Costs of 54% in Year 14.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Intervention2 - Douphrate (UTHealth) CSU

PHS 2590 (Rev. 03/16) Page Form Page 5

PROGRESS REPORT SUMMARY GRANT NUMBER U54OH008085 PERIOD COVERED BY THIS REPORT

PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR Stephen J. Reynolds, David Douphrate

FROM 09/15/2016

THROUGH 09/14/2017

APPLICANT ORGANIZATION Colorado State University - High Plains Intermountain Center for Agriculture Health & Safety (HICAHS) TITLE OF PROJECT (Repeat title shown in Item 1 on first page) Occupational Safety Management and Leadership on Large-Herd Dairy Farms

A. Human Subjects (Complete Item 6 on the Face Page)

Involvement of Human Subjects No Change Since Previous Submission Change B. Vertebrate Animals (Complete Item 7 on the Face Page)

Use of Vertebrate Animals No Change Since Previous Submission Change

C. Select Agent Research No Change Since Previous Submission Change

D. Multiple PD/PI Leadership Plan No Change Since Previous Submission Change

E. Human Embryonic Stem Cell Line(s) Used No Change Since Previous Submission Change

SEE PHS 2590 INSTRUCTIONS.

WOMEN AND MINORITY INCLUSION: See PHS 398 Instructions. Use Inclusion Enrollment Report Format Page and, if necessary, Targeted/Planned Enrollment Format Page.

A. Specific Aims

No specific aims have been modified.

1) Develop and implement integrated safety management and leadership training intervention for large-herddairy front-line supervisors. Status: Ongoing without modification.

2) Evaluate the effects of the safety leadership and management training intervention.a) Evaluate the effects of the intervention on front-line supervisor safety leadership and management daily

practices. Status: To begin in Year 2, without modification.b) Evaluate the effects of the intervention on group safety climate and behavior among workers. Status:

To begin in Year 2, without modification.

B. Studies and Results

In the first few months of the project, the project was awarded institutional human subjects approval, and after a delay, all consultant agreements have been established. The research team has begun the development process of the training content and curriculum. The project has been presented at multiple dairy industry conferences and was overwhelmingly received by producers and other industry stakeholders. Drs. Douphrate and Pompeii will be traveling in March 2017 to New Mexico, Colorado and Kansas to meet with dairy producers and managers to solicit input and guidance on the content and delivery of the safety management and leadership training curriculum. Extension research personnel have begun the process of recruiting dairies for participation in their respective states, and planning their inclusion in the subsequent years of the project. Support research personnel have been identified and are in the process of being hired into the project.

C. SignificanceThe U.S. dairy industry has shifted towards a large-herd, mass-production model due to economies of scale.This shift has led to a higher risk of fatalities, injuries and work-related musculoskeletal disorders (MSDs) dueto task specialization, increased work demands and hazards. Additionally, dairy owners are increasinglydependent on front-line supervisors to effectively manage a larger workforce comprised primarily of low-

55

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Intervention2 - Douphrate (UTHealth) CSU

0925-0001 (Rev. 03/16) Page Continuation Format Page

literacy, non-English speaking workers with minimal to no experience of working on large-herd farms. Owners are increasingly seeking supervisors who demonstrate effective management and leadership skills, especially in relation to worker health and safety. Much research effort has been put into developing safety management systems for large enterprises, whereas there is a lack of development, implementation and evaluation of safety management systems for small enterprises, especially dairy farming operations. Despite increasing herd sizes with increasing numbers of hired workers, over 95% of dairy farms in the U.S. remain private, family-owned operations. This study builds on extensive HICAHS dairy research and outreach over the past 14 years, and responds to these findings with the development of an integrated safety management strategy that will be operationalized on modern, large-herd U.S. dairy farms. The long-term goal of the project is to reduce or eliminate injuries and fatalities among a vulnerable workforce on dairy farms. This project employs novel and innovative longitudinal data collection and analysis methods which have not been utilized in occupational safety research in agricultural settings.

D. PlansThe remainder of the first year of the project will focus on the development of the training intervention contentas well as mechanism of delivery. Additionally, the mobile data collection methodology will be developed.Research extension personnel will continue to recruit dairies and planning for their participation in thesubsequent years of the project (Years 2-5). The training intervention will commence in Year 2 with trainingeffectiveness assessment data collection.

E. Outputs, Outcomes, and Research to Practice (r2p)

Outputs Conference presentations 1. Hagevoort R. Dairy safety management: current issues, challenges & solutions. Oregon Dairy Farmers

Convention 2017. Salem, OR. February 20th, 2017.2. Hagevoort R, Douphrate, D, Naerebout R,, Brose J, and White J. Challenges surrounding training the next

generation. Panel presentation. Western Dairy Management Conference. Reno, NV. February 28-March2, 2017Peppermill, Reno, NV.

3. Hagevoort R. Where most dairymen go wrong. Gibby Group Roundtable. Twin Falls, ID. March 8-9th,2017.

Outcomes: none

Research to Practice: none

F. Project-Generated Resourcesnone

HUMAN SUBJECTS / IRB APPROVALS This project was reviewed by the Research Integrity & Compliance Review Office at Colorado State University and it was determined that this project meets the requirements of 45 CFR 46.118, “Application and proposal lacking definite plans for involvement of human subjects.” The regulations allow awards for such projects to be made prior to review and approval by an IRB, but no human subjects may be involved until the review and approval has taken place. The first year of the project involves training intervention development without human subject recruitment. IRB approval will be obtained prior to human subject recruitment and inclusion in the project which will begin in the second year. We will remain compliant with the human subjects’ requirements of our institutions and to keep the Grants Management Specialist and the NIOSH Program Official informed of IRB approvals.

An Inclusion Enrollment Report can be found on the following page.

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PHS Inclusion Enrollment Report OMB Number: 0925-0001 and 0925-0002 Expiration Date: 10/31/2018This report format should NOT be used for collecting data from study participants.

*Study Title(must beunique):

Occupational Safety Management and Leadership on Large-Herd Dairy Farms

Comments:

* Delayed Onset Study? Yes No

If study is not delayed onset, the following selections are required:

Enrollment Type Planned Cumulative (Actual)

Using an Existing Dataset or Resource Yes No

Enrollment Location Domestic Foreign

Clinical Trial Yes No NIH-Defined Phase III Clinical Trial Yes No

Project is only six months into the first year of the study. First year is dedicated to training intervention development with no subject enrollment.

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female MaleUnknown/

Not Reported

Hispanic or Latino

Female MaleUnknown/

Not Reported

Unknown/Not Reported Ethnicity

Female MaleUnknown/

Not Reported

Total

American Indian/ Alaska Native 0

Asian 0

Native Hawaiian or Other Pacific Islander 0

Black or African American 0

White 0

More than One Race 0

Unknown or Not Reported 0

Total 0

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Report 1 of 1 57

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COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 1 OF 2

COURSEWORK REQUIREMENTS*

* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details.See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.

• Name: David Douphrate (ID: 437817)• Email: [email protected]• Institution Affiliation: University of Texas Health Science Center at Houston (ID: 661)• Institution Unit: UTSPH San Antonio• Phone: 210-562-5505

• Curriculum Group: Human Research• Course Learner Group: Group 1 Biomedical Researcher and Key Personnel• Stage: Stage 1 - Basic Course

• Report ID: 21625586• Completion Date: 07-Dec-2016• Expiration Date: 07-Dec-2019• Minimum Passing: 80• Reported Score*: 96

REQUIRED AND ELECTIVE MODULES ONLY DATE COMPLETED SCOREAvoiding Group Harms - U.S. Research Perspectives (ID: 14080)  07-Dec-2016 3/3 (100%) Belmont Report and CITI Course Introduction (ID: 1127)  07-Dec-2016 3/3 (100%) History and Ethics of Human Subjects Research (ID: 498)  07-Dec-2016 7/7 (100%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2)  07-Dec-2016 5/5 (100%) Informed Consent (ID: 3)  07-Dec-2016 5/5 (100%) Records-Based Research (ID: 5)  07-Dec-2016 3/3 (100%) Genetic Research in Human Populations (ID: 6)  07-Dec-2016 4/5 (80%) Vulnerable Subjects - Research Involving Children (ID: 9)  07-Dec-2016 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10)  07-Dec-2016 3/3 (100%) FDA-Regulated Research (ID: 12)  07-Dec-2016 5/5 (100%) Research and HIPAA Privacy Protections (ID: 14)  07-Dec-2016 4/5 (80%) Conflicts of Interest in Research Involving Human Subjects (ID: 488)  07-Dec-2016 5/5 (100%) University of Texas Health Science Center at Houston (ID: 1000)  07-Dec-2016 No Quiz 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: https://www.citiprogram.org/verify/?34bcab53-a84e-465d-ac4b-83676d30ebf9

CITI ProgramEmail: [email protected]: 888-529-5929Web: https://www.citiprogram.org

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COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 2 OF 2

COURSEWORK TRANSCRIPT**

** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of thecourse. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.

• Name: David Douphrate (ID: 437817)• Email: [email protected]• Institution Affiliation: University of Texas Health Science Center at Houston (ID: 661)• Institution Unit: UTSPH San Antonio• Phone: 210-562-5505

• Curriculum Group: Human Research• Course Learner Group: Group 1 Biomedical Researcher and Key Personnel• Stage: Stage 1 - Basic Course

• Report ID: 21625586• Report Date: 07-Dec-2016• Current Score**: 98

REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST RECENT SCOREHistory and Ethics of Human Subjects Research (ID: 498) 07-Dec-2016 7/7 (100%) Introduction (ID: 757) 17-Jan-2007 No Quiz Informed Consent (ID: 3) 07-Dec-2016 5/5 (100%) History and Ethical Principles - SBE (ID: 490) 18-Jan-2007 5/5 (100%) Defining Research with Human Subjects - SBE (ID: 491) 18-Jan-2007 5/5 (100%) Belmont Report and CITI Course Introduction (ID: 1127) 07-Dec-2016 3/3 (100%) Records-Based Research (ID: 5) 07-Dec-2016 3/3 (100%) The Federal Regulations - SBE (ID: 502) 18-Jan-2007 6/6 (100%) Genetic Research in Human Populations (ID: 6) 07-Dec-2016 4/5 (80%) Assessing Risk - SBE (ID: 503) 18-Jan-2007 5/5 (100%) Informed Consent - SBE (ID: 504) 18-Jan-2007 5/5 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 07-Dec-2016 3/3 (100%) Privacy and Confidentiality - SBE (ID: 505) 18-Jan-2007 5/5 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 07-Dec-2016 3/3 (100%) Research with Prisoners - SBE (ID: 506) 18-Jan-2007 5/5 (100%) Group Harms: Research With Culturally or Medically Vulnerable Groups (ID: 11) 17-Jan-2011 3/3 (100%) Research with Children - SBE (ID: 507) 18-Jan-2007 5/5 (100%) FDA-Regulated Research (ID: 12) 07-Dec-2016 5/5 (100%) Research in Public Elementary and Secondary Schools - SBE (ID: 508) 18-Jan-2007 5/5 (100%) International Research - SBE (ID: 509) 18-Jan-2007 5/5 (100%) Internet-Based Research - SBE (ID: 510) 18-Jan-2007 4/4 (100%) Research and HIPAA Privacy Protections (ID: 14) 07-Dec-2016 4/5 (80%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 07-Dec-2016 5/5 (100%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 07-Dec-2016 3/3 (100%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 07-Dec-2016 5/5 (100%) University of Texas Health Science Center at Houston (ID: 1000) 07-Dec-2016 No Quiz 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: https://www.citiprogram.org/verify/?34bcab53-a84e-465d-ac4b-83676d30ebf9

Collaborative Institutional Training Initiative (CITI Program)Email: [email protected]: 888-529-5929Web: https://www.citiprogram.org

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COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 1 OF 2

COURSEWORK REQUIREMENTS*

* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details.See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.

• Name: David Gimeno Ruiz de Porras (ID: 1163411)• Institution Affiliation: University of Texas Health Science Center at Houston (ID: 661)• Phone: 2105625500

• Curriculum Group: Human Research• Course Learner Group: Group 1 Biomedical Researcher and Key Personnel• Stage: Stage 3 - Refresher Course

• Report ID: 21047121• Completion Date: 06-Dec-2016• Expiration Date: 06-Dec-2019• Minimum Passing: 80• Reported Score*: 100

REQUIRED AND ELECTIVE MODULES ONLY DATE COMPLETED SCOREBiomed Refresher 2 - Instructions (ID: 764)  05-Dec-2016 No Quiz Biomed Refresher 2 – History and Ethical Principles (ID: 511)  06-Dec-2016 3/3 (100%) Biomed Refresher 2 – Regulations and Process (ID: 512)  05-Dec-2016 2/2 (100%) Biomed Refresher 2 – Informed Consent (ID: 514)  05-Dec-2016 3/3 (100%) Biomed Refresher 2 – SBR Methodologies in Biomedical Research (ID: 515)  05-Dec-2016 4/4 (100%) Biomed Refresher 2 – Genetics Research (ID: 518)  05-Dec-2016 2/2 (100%) Biomed Refresher 2 – Records-Based Research (ID: 516)  06-Dec-2016 3/3 (100%) Biomed Refresher 2 - Populations in Research Requiring Additional Considerations and/or Protections (ID: 519)  05-Dec-2016 1/1 (100%) Biomed Refresher 2 – Vulnerable Subjects – Prisoners (ID: 520)  05-Dec-2016 2/2 (100%) Biomed Refresher 2 – Vulnerable Subjects – Children (ID: 521)  06-Dec-2016 3/3 (100%) Biomed Refresher 2 – Vulnerable Subjects – Pregnant Women, Human Fetuses, Neonates (ID: 522)  06-Dec-2016 2/2 (100%) Biomed Refresher 2 – FDA-Regulated Research (ID: 524)  06-Dec-2016 3/3 (100%) Biomed Refresher 2 – HIPAA and Human Subjects Research (ID: 526)  06-Dec-2016 5/5 (100%) Biomed Refresher 2 – Conflicts of Interest in Research Involving Human Subjects (ID: 681)  06-Dec-2016 3/3 (100%) How to Complete the CITI Refresher Course and Receive a Completion Report (ID: 922)  06-Dec-2016 No Quiz 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: https://www.citiprogram.org/verify/?a0648b32-a832-4add-8470-ff2807de9743

CITI ProgramEmail: [email protected]: 888-529-5929Web: https://www.citiprogram.org

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COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 2 OF 2

COURSEWORK TRANSCRIPT**

** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of thecourse. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.

• Name: David Gimeno Ruiz de Porras (ID: 1163411)• Institution Affiliation: University of Texas Health Science Center at Houston (ID: 661)• Phone: 2105625500

• Curriculum Group: Human Research• Course Learner Group: Group 1 Biomedical Researcher and Key Personnel• Stage: Stage 3 - Refresher Course

• Report ID: 21047121• Report Date: 06-Dec-2016• Current Score**: 100

REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST RECENT SCOREBiomed Refresher 2 - Instructions (ID: 764) 05-Dec-2016 No Quiz Biomed Refresher 2 – History and Ethical Principles (ID: 511) 06-Dec-2016 3/3 (100%) Biomed Refresher 2 – Regulations and Process (ID: 512) 05-Dec-2016 2/2 (100%) Biomed Refresher 2 – Informed Consent (ID: 514) 05-Dec-2016 3/3 (100%) Biomed Refresher 2 – SBR Methodologies in Biomedical Research (ID: 515) 05-Dec-2016 4/4 (100%) Biomed Refresher 2 – Records-Based Research (ID: 516) 06-Dec-2016 3/3 (100%) Biomed Refresher 2 – Genetics Research (ID: 518) 05-Dec-2016 2/2 (100%) Biomed Refresher 2 - Populations in Research Requiring Additional Considerations and/or Protections (ID: 519) 05-Dec-2016 1/1 (100%) Biomed Refresher 2 – Vulnerable Subjects – Prisoners (ID: 520) 05-Dec-2016 2/2 (100%) Biomed Refresher 2 – Vulnerable Subjects – Children (ID: 521) 06-Dec-2016 3/3 (100%) Biomed Refresher 2 – Vulnerable Subjects – Pregnant Women, Human Fetuses, Neonates (ID: 522) 06-Dec-2016 2/2 (100%) Biomed Refresher 2 – FDA-Regulated Research (ID: 524) 06-Dec-2016 3/3 (100%) Biomed Refresher 2 – HIPAA and Human Subjects Research (ID: 526) 06-Dec-2016 5/5 (100%) Biomed Refresher 2 – Conflicts of Interest in Research Involving Human Subjects (ID: 681) 06-Dec-2016 3/3 (100%) How to Complete the CITI Refresher Course and Receive a Completion Report (ID: 922) 06-Dec-2016 No Quiz Biomed Refresher 2 – Vulnerable Subjects – Pregnant Women, Human Fetuses, Neonates (ID: 552) 17-Mar-2009 1/1 (100%) 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: https://www.citiprogram.org/verify/?a0648b32-a832-4add-8470-ff2807de9743

Collaborative Institutional Training Initiative (CITI Program)Email: [email protected]: 888-529-5929Web: https://www.citiprogram.org

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COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 1 OF 2

COURSEWORK REQUIREMENTS*

* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details.See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.

• Name: David Gimeno Ruiz de Porras (ID: 1163411)• Institution Affiliation: University of Texas Health Science Center at Houston (ID: 661)• Phone: 2105625500

• Curriculum Group: Human Research• Course Learner Group: Group 2 Social and Behavioral Researchers and Key Personnel• Stage: Stage 4 - Refresher Course

• Report ID: 21047120• Completion Date: 06-Dec-2016• Expiration Date: 06-Dec-2019• Minimum Passing: 80• Reported Score*: 95

REQUIRED AND ELECTIVE MODULES ONLY DATE COMPLETED SCORESBE Refresher 1 – Instructions (ID: 943)  06-Dec-2016 No Quiz SBE Refresher 1 – History and Ethical Principles (ID: 936)  06-Dec-2016 2/2 (100%) SBE Refresher 1 – Federal Regulations for Protecting Research Subjects (ID: 937)  06-Dec-2016 2/2 (100%) SBE Refresher 1 – Informed Consent (ID: 938)  06-Dec-2016 2/2 (100%) SBE Refresher 1 – Defining Research with Human Subjects (ID: 15029)  06-Dec-2016 2/2 (100%) SBE Refresher 1 – Privacy and Confidentiality (ID: 15035)  06-Dec-2016 2/2 (100%) SBE Refresher 1 – Assessing Risk (ID: 15034)  06-Dec-2016 2/2 (100%) SBE Refresher 1 – Research with Prisoners (ID: 939)  06-Dec-2016 2/2 (100%) SBE Refresher 1 – Research with Children (ID: 15036)  06-Dec-2016 2/2 (100%) SBE Refresher 1 – Research in Educational Settings (ID: 940)  06-Dec-2016 2/2 (100%) SBE Refresher 1 – International Research (ID: 15028)  06-Dec-2016 1/2 (50%) 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: https://www.citiprogram.org/verify/?cde8cbc3-a9da-4855-aa19-2ff967bbd9fd

CITI ProgramEmail: [email protected]: 888-529-5929Web: https://www.citiprogram.org

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COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 2 OF 2

COURSEWORK TRANSCRIPT**

** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of thecourse. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.

• Name: David Gimeno Ruiz de Porras (ID: 1163411)• Institution Affiliation: University of Texas Health Science Center at Houston (ID: 661)• Phone: 2105625500

• Curriculum Group: Human Research• Course Learner Group: Group 2 Social and Behavioral Researchers and Key Personnel• Stage: Stage 4 - Refresher Course

• Report ID: 21047120• Report Date: 06-Dec-2016• Current Score**: 100

REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST RECENT SCORESBE Refresher 1 – History and Ethical Principles (ID: 936) 06-Dec-2016 2/2 (100%) SBE Refresher 1 – Federal Regulations for Protecting Research Subjects (ID: 937) 06-Dec-2016 2/2 (100%) SBE Refresher 1 – Informed Consent (ID: 938) 06-Dec-2016 2/2 (100%) SBE Refresher 1 – Research with Prisoners (ID: 939) 06-Dec-2016 2/2 (100%) SBE Refresher 1 – Research in Educational Settings (ID: 940) 06-Dec-2016 2/2 (100%) SBE Refresher 1 – Instructions (ID: 943) 06-Dec-2016 No Quiz SBE Refresher 1 – International Research (ID: 15028) 06-Dec-2016 2/2 (100%) SBE Refresher 1 – Defining Research with Human Subjects (ID: 15029) 06-Dec-2016 2/2 (100%) SBE Refresher 1 – Assessing Risk (ID: 15034) 06-Dec-2016 2/2 (100%) SBE Refresher 1 – Privacy and Confidentiality (ID: 15035) 06-Dec-2016 2/2 (100%) SBE Refresher 1 – Research with Children (ID: 15036) 06-Dec-2016 2/2 (100%) 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: https://www.citiprogram.org/verify/?cde8cbc3-a9da-4855-aa19-2ff967bbd9fd

Collaborative Institutional Training Initiative (CITI Program)Email: [email protected]: 888-529-5929Web: https://www.citiprogram.org

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Dr. David Douphrate UT-H - SPH - San Antonio Regional Campus

NOTICE OF APPROVAL TO BEGIN RESEARCH July 12, 2016

HSC-SPH-16-0559 - Occupational Safety Management and Leadership on Large-Herd Dairy Farms

Number of Subjects Approved: Preparation Only

PROVISIONS: This approval relates to the research to be conducted under the above referenced title and/or to any associated materials considered by the Committee for the Protection of Human Subjects, e.g. study documents, informed consent, etc. Year 1 –Preparation only.

APPROVED: By Expedited Review and Approval

REVIEW DATE: 07/09/2016

APPROVAL DATE: 07/12/2016

EXPIRATION DATE: 06/30/2017

CHAIRPERSON: L. Maximilian Buja, MD

Subject to any provisions noted above, you may now begin this research.

CHANGES: The principal investigator (PI) must receive approval from the CPHS before initiating any changes, including those required by the sponsor, which would affect human subjects, e.g. changes in methods or procedures, numbers or kinds of human subjects, or revisions to the informed consent document or procedures. The addition of co-investigators must also receive approval from the CPHS. ALL PROTOCOL REVISIONS MUST BE SUBMITTED TO THE SPONSOR OF THE RESEARCH.

INFORMED CONSENT DETERMINATION: Not applicable

HEALTH INSURANCE PORTABILITY and ACCOUNTABILITY ACT (HIPAA):

Exempt from HIPAA:

UNANTICIPATED RISK OR HARM, OR ADVERSE DRUG REACTIONS: The PI will immediately inform the CPHS of any unanticipated problems involving risks to subjects or others, of any serious harm to subjects, and of any adverse drug reactions.

RECORDS: The PI will maintain adequate records, including signed consent and HIPAA documents if required, in a manner that ensures subject confidentiality.

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Program Director/Principal Investigator (Last, first, middle): RC/Intervention2 - Douphrate (UTHealth)

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 07/07/2014 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 145,633 x Rate applied 54 % = F&A costs $ 78,642 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 65

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Program Director/Principal Investigator (Last, first, middle): RC/Intervention2 - Douphrate (UTHealth) CSU

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 06/30/2016 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 25,725 x Rate applied 52 % = F&A costs $ 13,377 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 66

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Program Director/Principal Investigator (Last, First, Middle): RC/Translation - Pate (USU)

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Pate, Michael PD/PI 2.50 22,331 10,049 32,380

Lawver, Rebecca G. Co-Investigator 1.00 8,677 3,904 12,581

TBN Project Asst 1.50 5,788 463 6,251

Miller, Rhonda Evaluator 0.12 1,131 509 1,640

Dai, Xin Statistician 0.12 558 251 809

SUBTOTALS 38,485 15,176 53,661 CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

Project-specific laptops, software, software updates

2,553 TRAVEL

Travel for data collection and teacher trainings 6,545 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

Stipend for teacher participation - $50 x 50 teachers - $2,500; Safety workshop materials and official functions, printing, web advertisement, postage - $8,155 10,655

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ 73,414 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS 58,740 CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS 18,244

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ 150,398 PHS 2590 (Rev. 03/16) Page Form Page 2 67

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Program Director/Principal Investigator (Last, First, Middle): RC/Translation - Pate (USU)

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. Personnel - ($53,661) Pate, Michael, Ph.D., Principal Investigator, Annual Salary - $107,360; 2.5 calendar months (20.8% effort) in Year 14. Dr. Pate will oversee the scientific and administration aspects of the proposed Agricultural Safety Initiative and will be the primary contact with co-investigators in Montana, South Dakota and Utah. Dr. Pate will be responsible for the overall development, operation, and supervision of the Agricultural Safety Education initiative. Dr. Pate will provide leadership for establishing training programs with the on-site co-investigators. Dr. Pate will provide expertise in agricultural equipment hazard assessment and injury prevention programming. Dr. Pate will oversee project management activities of the project. Dr. Pate will lead collaborative efforts with co-investigators and external evaluation consultants to assess the community-engagement program. Dr. Pate will be responsible for human subject research review, evaluation of the project and preparation of progress reports. Dr. Pate will serve as liason between project sites and the center administration core.

Lawver, Rebecca, PhD, Co-Investigator, Annual Salary - $104,165; 1.0 calendar months (8.33% effort) in Year 14. Dr. Lawver will assist Dr. Pate in the technical aspects of the teacher training program with Utah teachers. Dr. Lawver will assist with data collection and training teachers. Dr. Lawver will be responsible for serving as a liaison with the Utah FFA association and Utah secondary agricultural education teachers. Dr. Lawver will provide expertise in teacher education and will oversee marketing and promotion of the teacher training program.

(continued on next page)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget.

PHS 2590 (Rev. 03/16) Page Form Page 3 68

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Translation - Pate (USU)

0925-0001 (Rev. 03/16) Page Continuation Format Page

Budget Justification - continued

To-Be-Named, Project Assistant, BS, Annual Salary - $46,304; 1.5 calendar months (12.5% effort) in Year 14. A project assistant will perform logistical management of teacher training seminars and data collection of community FFA safety programs in Utah. This individual will be responsible for scheduling, training site organization, preparation of communications with teachers, and working closely with Dr. Lawver and Dr. Pate performing data collection tasks on intermediate behavioral and environmental health outcomes. This individual will have substantial experience working with high school agricultural education teachers and FFA students.

Miller, Rhonda, Ph.D., Evaluation Specialist, Annual Salary - $113,100; 0.12 calendar months (1.0% effort) in Year 14. Dr. Miller will serve as an evaluation expert for quality assurance, timely performance assessment of activities, process and formative evaluation reviews, and impact assessments. Dr. Miller, Associate Professor, will serve as the project’s internal specialist to assist in evaluation of project activities and assess impacts. Dr. Miller will coordinate with Montana State University’s external evaluation expert Dr. Alyx Shultz throughout the project period.

Dai, Xin, Ph.D., Statistician, Annual Salary - $55,800; 0.12 calendar months (1.0% effort) in Year 14. Dr. Dai will serve as an expert in multivariate statistics such as generalized linear modelling (GLM). Dr. Dai, Statistician for the Utah Agricultural Experiment station, will serve as the project’s internal specialist to assist in statistical analysis and research design. Dr. Dai will coordinate with Montana State University’s external evaluation expert Dr. Alyx Shultz throughout the project period.

Fringe benefits are assessed at the rates of 45.00% in Year 14 for the Principal Investigator, Co-Investigator, Evaluation Specialist and Statistician; 8.00% in Year 14 for the Project Assistant.

Materials and Supplies - ($2,553) This project will require extensive geospatial data authoring, document preparation, multimedia presentation development, record keeping, maintenance of data bases, and data analysis. During Year 14, two laptop computers will be purchased (AMD Dual-Core A6-5350M APU with Radeon HD 8450 Graphics (2.9 GHz, 1 MB cache), 4 GB 1600 MHz DDR3 SDRAM (1 x 4 GB), 500 GB 7200 rpm SATA. These laptops will be used to conduct on-site field observations and record keeping during data collection. Software for data entry will also be purchased for the laptops. Software update and drivers for the previously purchased computers will also be needed to maintain the computers compatibility.

Domestic Travel - ($6,545) Drs. Pate and Lawver will travel in Utah in order to provide training, data collection and meet with high school agricultural education teachers during Year 14. The project assistant will travel in Utah ($3,545) in order to assist in training and data collection. Dr. Pate will travel out-of-state ($3,000) to coordinate with each co-investigators in South Dakota and Montana. These funds will cover mileage, per diem, flights and lodging for each of the trips. This travel is necessary to ensure training of teachers in assessment of agricultural equipment hazards and implementation of the community FFA safety program.

Out-of-State Travel Estimates - Expense Category # People # Units Unit Cost $ Requested

Airfare 1 1 roundtrip $450/ticket $ 450 Per Diem 1 3 days $50/day $ 150 Lodging 1 2 nights $80/night $ 160 Ground Transportation 1 3 days $80/day $ 240

Total for Out-of-State Travel per trip (3 trips in Year 14) $1,000

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Translation - Pate (USU)

0925-0001 (Rev. 03/16) Page Continuation Format Page

In-state Travel Estimates - Expense Category # People # Units Unit Cost $ Requested

Mileage (In-state) 1 3,970 miles $0.50/mile $1,985 Per Diem 1 12 days $50/day $ 600 Lodging 1 12 nights $80/night $ 960

Total for In-state Travel $3,545

Other Direct Costs - ($10,655) During Year 14, the purchase of snacks (fruit, cheeses, cookies, muffins, and crackers) and light refreshments (sodas, milk, juices, coffee, and bottled water) are estimated at $1,000 for teacher workshops (50 teachers x $20) in Utah. Also, in Year 14 an estimated $500 (50 teachers x $10) for electronic files of workshop presentations will be provided to teachers using USB flash-drives. Data collection forms and reports for the community FFA safety program will be stored and provided to teachers on the USB flash-drive. Website promotions will be developed and used to encourage teacher attendance. During the training seminars, safety equipment and communication tools such as agricultural machinery warning messages will be provided to teachers. Printed workshop materials for equipment, ATV, and machinery hazards will be provided to participating teachers. SMV stickers/signs along with PTO and other entanglement warning labels, and ATV safety training documents will be distributed to teachers. Safety tool boxes will be provided as an incentive to participants to store the safety and communication tools to use when conducting student work-site visits. Agricultural machinery and vehicle hazard risk assessment documents will be provided to teachers for professional use with their students. During Year 14, a stipend of $50 per teacher (50 teachers) will be provided as an additional incentive to return to subsequent training seminars with completed documentation of local National FFA chapter community safety programs and supervised agricultural experience risk assessments to be reviewed and discussed with the principal investigator and co-investigator. This $50 incentive will be directed to be used by the teacher’s local National FFA chapter programs for increasing agricultural safety in the rural and agricultural communities.

Postage for shipping materials to Consortiums in Year 14 will also be needed.

Consortium/Contractual - ($58,740) A subcontract will be made with Montana State University to complete project work with Montana agriculture teachers and students. Dr. Dustin Perry, Assistant Professor Agricultural Education, will lead project activities in Montana. Dr. Perry will serve as the co-investigator and fulfill responsibilities for coordinating all project activities within Montana in collaboration with Dr. Michael Pate. Montana State University is the premier and sole institution for agricultural education teacher training. Dr. Perry will be responsible for Montana teacher trainings, establishing the community FFA safety program, data collection on project activities, capacity-building with secondary education teachers.

A subcontract will be made with Iowa State University to complete project work with South Dakota agriculture teachers and students. Dr. Scott Smalley will lead project activities in South Dakota. Dr. Smalley will serve as the co-investigator and fulfill responsibilities for coordinating all project activities within South Dakota in collaboration with Dr. Michael Pate. Dr. Smalley will be responsible for South Dakota teacher trainings, establishing the community FFA safety program, data collection on project activities, capacity-building with secondary education teachers.

Consortiums Indirect Costs - ($18,244) Indirect rate is calculated at the Modified Total Direct Costs of 46% in Year 14 for Iowa State University. Indirect rate is calculated at the Modified Total Direct Costs of 34.5% in Year 14 for Montana State University.

70

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Translation - Pate (USU)

0925-0001 (Rev. 03/16) Page Continuation Format Page

Indirect Costs - ($9,602) Indirect rate is calculated at Modified Total Direct Costs of 15.3% in Year 14 for Utah State University. Indirects will not be charged on the Iowa State University and Montana State University subcontracts by Utah State University as the $25K for each subcontract limitation was met in Year 13 of the project.

71

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Program Director/Principal Investigator (Last, First, Middle): RC/Translation - Pate (USU - sub MSU)

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Perry, Dustin Co-Investigator 1.00 6,867 2,541 9,408

TBN Project Asst 0.20 780 70 850

SUBTOTALS 7,647 2,611 10,258 CONSULTANT COSTS

External Evaluation Expert ($5,408) & Secondary Education Program Specailist ($1,648)

7,056 EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

Safety Workshop Material, Printing, and supplies

5,944 TRAVEL

Domestic Travel for data collection and teacher trainings 2,730 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category) Participant incentives for teachers @ $50 x 50 participants - $2,500 Official Function expenses for workshops @ $20.60 x 50 participants - $1,030 3,530

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS 29,518 CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS 8,966

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ PHS 2590 (Rev. 03/16) Page Form Page 2 72

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Program Director/Principal Investigator (Last, First, Middle): RC/Translation - Pate (USU - sub MSU)

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. Personnel - ($10,258)

Perry, Dustin, PhD, Co-Investigator, Annual Salary - $82,437; 1.0 calendar months (8.33% effort) in Year 14. Dr. Perry will serve as the co-investigator and fulfill responsibilities for coordinating all project activities within Montana in collaboration with Dr. Michael Pate. Dr. Perry will provide leadership for planning and hosting a safety workshop for secondary agricultural education teachers in Montana. The USU principal investigator will coordinate training activities with Dr. Perry. Dr. Perry will assist in data collection working with teachers and students, serving as a liaison with the Montana FFA association. Dr. Perry will coordinate and conduct data collection with USU PI using approved methods to document effectiveness of the training and community FFA safety programs.

To-Be-Named, Project Assistant, Annual Salary - $46,706; 0.20 calendar months (1.67% effort) in Year 14. An hourly employee will assist with creating registration forms, marketing material, and educational workshop material. The material this emplouyee creates will be utlitized in Years 15 through 17.

Fringe benefits are assesed at the rate of 37.0% for the Co-Investigatgor and 9.0% for the Project Assistant in Year 14.

(continued on next page)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget.

PHS 2590 (Rev. 03/16) Page Form Page 3 73

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Translation - Pate (USU - sub MSU)

0925-0001 (Rev. 03/16) Page Continuation Format Page

Budget Justification - continued

Consultant Costs - ($7,056) Shultz, Alyx, Ph.D. - Dr. Shultz will assist in assessing the effectiveness of the program, data collection techniques, and assist with statistical analysis. She is an expert in statistical methods and analyses as well as an experienced agricultural educator. The combination of these two backgrounds makes her an asset for evaluating outcomes of this project. Dr. Shultz will travel from Kentucky for five days of consulting.

Expense Category # People # Units Unit Cost $ Requested

Travel - Air mileage 1 3,300 miles $1.16/mile $3,828 Per Diem 1 5 days $26/day $ 130 Consulting Fee 1 5 days $290/day $1,450

Total for Consultant Services $5,408

A current Montana secondary education program consultant will be contracted for assisting in the facilitation of project outcomes, preparing project materials, and collecting data. This individual will assist in the logistical management of teacher training seminars and data collection of community FFA safety programs in Montana. This individual will be responsible for scheduling, training site organization, preparation of communications with teachers, and working closely with Dr. Perry performing data collection tasks on intermediate behavioral and environmental health outcomes as well as documentation of community FFA safety programs. This individual will have substantial experience working with high school agricultural education teachers and FFA students.

Summary of Secondary Education Consultant Services - Affiliation Montana Office of Public Instruction Expense Category # People # Units Unit Cost $ Requested

Travel 1 800 miles $.50/mile $ 400 Per Diem 1 8 days $23/day $ 184 Consulting Fee 1 8 days $133/day $1,064

Total for Consultant Services $1,648

Materials and Supplies - ($5,944) An estimated $500 (50 teachers x $10) for electronic files of workshop presentations will be provided to teachers using USB flash-drives. Data collection forms and reports for the community FFA safety program will be stored and provided to teachers on the USB flash-drive. During the training seminars, safety equipment and communication tools such as agricultural machinery warning messages will be provided to teachers. Printed workshop materials for equipment, ATV, and machinery hazards will be provided to participating teachers. SMV stickers/signs along with PTO and other entanglement warning labels, and ATV safety training documents will be distributed to teachers. Safety tool boxes will be provided as an incentive to participants to store the safety and communication tools to use when conducting student work-site visits. Agricultural machinery and vehicle hazard risk assessment documents will be provided to teachers for professional use with their students.

Domestic Travel - ($2,730) Dr. Perry will travel in order to provide training, data collection and meet with high school agricultural education teachers in Year 14. This amount is requested to cover Dr. Perry’s per-diem, mileage, and lodging costs for seven days of activities related directly to the facilitation of the project workshops and data collection. This travel is necessary to ensure training of teachers in assessment of agricultural equipment hazards and implementation of the community FFA safety program.

Expense Category # People # Units Unit Cost $ Requested

Travel 1 3,393 miles $0.59/mile $2,002 Per Diem 1 7 days $24/day $ 168 Lodging 1 7 nights $80/night $ 560

Total for travel $2,730 74

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Translation - Pate (USU - sub MSU)

0925-0001 (Rev. 03/16) Page Continuation Format Page

Other Direct Costs - ($3,530) The purchase of snacks (fruit, cheeses, cookies, muffins, and crackers) and light refreshments (sodas, milk, juices, coffee, and bottled water) are estimated at $1,030 for teacher workshops (50 teachers x $20.60) in Montana. A stipend of $50 per teacher (50 teachers x $50 = $2,500) will be provided as an additional incentive to return to subsequent training seminars with completed documentation of local National FFA chapter community safety programs and supervised agricultural experience risk assessments to be reviewed and discussed with the principal investigator and co-investigator. This $50 incentive will be directed to be used by the teacher’s local National FFA chapter programs for increasing agricultural safety in the rural and agricultural communities.

Indirect Costs - ($8,966) Indirect rate is calculated at Modified Total Direct Costs of 34.5% in Year 14.

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Program Director/Principal Investigator (Last, first, middle): RC/Translation - Pate (USU - sub MSU)

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 09/17/2015 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 25,988 x Rate applied 34.5 % = F&A costs $ 8,966 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.): 34.5% On-campus other sponsored activities using modified total direct cost base. All ‘Other Expenses’ costs are exempt from the institutions F & A costs.

PHS 2590 (Rev. 03/16) Page Form Page 6 76

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Program Director/Principal Investigator (Last, First, Middle): RC/Translation - Pate (USU - sub ISU)

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Smalley, Scott W. Co-Investigator 1.00 7,484 1,122 8,606

TBN Project Asst. 4.32 9,270 93 9,363

SUBTOTALS 16,754 1,215 17,969 CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

TRAVEL

Domestic travel 2,200 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

Participant incentives for teachers @ $50 x 50 participants = $2,500 Official Function expenses for workshops @ $20 x 50 participants - $1,000 Safety Workshop Material, printing, web advertisement - $5,553 9,053 SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS 29,222 CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS 9,278

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ PHS 2590 (Rev. 03/16) Page Form Page 2 77

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Program Director/Principal Investigator (Last, First, Middle): RC/Translation - Pate (USU - sub ISU)

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. Personnel - ($17,969) Smalley, Scott, Ph.D., Co-Investigator, Annual Salary - $89,844; 1.0 calendar months (8.33% effort) in Year 14. Dr. Smalley will plan and host a safety workshop for secondary agricultural education teachers in South Dakota. The USU principal investigator will coordinate training activities with Dr. Smalley. Dr. Smalley will assist in data collection working with teachers and students, serving as a liaison with the South Dakota FFA association. Dr. Smalley will coordinate and conduct data collection with USU PI using approved methods to document effectiveness of the training and community FFA safety programs.

To-Be-Named, Project Assistant, BS, Annual Salary - $25,750; 4.32 calendar months (750 hours - 36% effort) in Year 14. A project assistant will provide logistical management of teacher training seminars and data collection of community FFA safety programs in South Dakota. This individual will be responsible for scheduling, training site organization, preparation of communications with teachers, and working closely with Dr. Smalley performing data collection tasks on intermediate behavioral and environmental health outcomes as well as documentation of community FFA safety programs. This individual will have substantial experience working with high school agricultural education teachers and FFA students.

Fringe benefits are assessed at the rate of 15.0% in Year 14 for the Co-investigator; 1.0% for Years 01 through 05 for the Project Assistant.

(continued on next page)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget.

PHS 2590 (Rev. 03/16) Page Form Page 3 78

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Translation - Pate (USU - sub ISU)

0925-0001 (Rev. 03/16) Page Continuation Format Page

Budget Justification - continued

Domestic Travel - ($2,200) Dr. Smalley and the project assistant will travel in South Dakota in order to provide training, data collection and meet with high school agricultural education teachers. These funds will cover airfare, per diem, and hotels for each of the trips. This travel is necessary to ensure training of teachers in assessment of agricultural equipment hazards and implementation of the community FFA safety program.

Expense Category # People # Units Unit Cost $ Requested

Airfare 2 1 round trip $300 $ 600 Per Diem 2 3 days $30/day $ 180 Lodging 2 2 nights $80/night $ 320

Total travel for each 2 persons trip (2 trips in Year 14) $1,100

Other Direct Costs - ($9,053) The purchase of snacks (fruit, cheeses, cookies, muffins, and crackers) and light refreshments (sodas, milk, juices, coffee, and bottled water) are estimated at $1,000 for teacher workshops (50 teachers x $20) in South Dakota professional use with their students. In Year 14, a stipend of $50 per teacher (50 teachers x $50 = $2,500) will be provided as an additional incentive to return to subsequent training seminars with completed documentation of local National FFA chapter community safety programs and supervised agricultural experience risk assessments to be reviewed and discussed with the principal investigator and co-investigator. This $50 incentive will be directed to be used by the teacher’s local National FFA chapter programs for increasing agricultural safety in the rural and agricultural communities.

Indirect Costs - ($9,278) Indirect rate is calculated at Modified Total Direct Costs of 46% in Year 14.

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Program Director/Principal Investigator (Last, first, middle): RC/Translation - Pate (USU - sub ISU)

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 20,169 x Rate applied 46 % = F&A costs $ 9,278 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 80

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Translation - Pate (USU)

PHS 2590 (Rev. 03/16) Page Form Page 5

PROGRESS REPORT SUMMARY GRANT NUMBER U54OH008085 PERIOD COVERED BY THIS REPORT

PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR Michael Pate, Utah State University

FROM 09/15/2016

THROUGH 09/14/2017

APPLICANT ORGANIZATION Colorado State University - High Plains Intermountain Center for Agriculture Health & Safety (HICAHS) TITLE OF PROJECT (Repeat title shown in Item 1 on first page) Agricultural Safety Education Initiative

A. Human Subjects (Complete Item 6 on the Face Page)

Involvement of Human Subjects No Change Since Previous Submission Change B. Vertebrate Animals (Complete Item 7 on the Face Page)

Use of Vertebrate Animals No Change Since Previous Submission Change

C. Select Agent Research No Change Since Previous Submission Change

D. Multiple PD/PI Leadership Plan No Change Since Previous Submission Change

E. Human Embryonic Stem Cell Line(s) Used No Change Since Previous Submission Change

SEE PHS 2590 INSTRUCTIONS.

WOMEN AND MINORITY INCLUSION: See PHS 398 Instructions. Use Inclusion Enrollment Report Format Page and, if necessary, Targeted/Planned Enrollment Format Page.

A. Specific Aims1) Determine the effectiveness of utilizing an evidence based agricultural machinery safety curriculum to

provide “Train the Teacher” programming to secondary agricultural teachers.2) Assess performance of safety procedures related to agricultural machinery using teacher-led supervised

agricultural experiences (SAE).3) Measure local community adoption of agricultural machinery safety procedures and develop a model for

translation using an FFA Award structure (SAE Proficiency Awards) to diffuse student safety educationgains.

B. Studies and ResultsPlanning meeting have been conducted with the PI and Co-I’s. The project staff continues preparations effortsto conduct training seminars for teachers in Montana, Utah, and South Dakota. To date no results are availableas training seminars are scheduled to occur June and July 2017. The project team anticipates reporting resultsof the summer training seminar pre-test by September 2017.

C. SignificanceThe work proposed here will assess the effectiveness of a training program for agriculture teachers to identifyagricultural machinery and vehicle hazards and to encourage corrective actions to protect young workers fromthose hazards. This study is one important step in the continuum of research to determine effectiveprogramming to reduce interactions of youth with agricultural machinery and vehicle hazards. There is asignificant need to train teachers in protecting and shaping our future leaders in agriculture.

D. PlansDuring June and July 2017, a 10-hour summer teacher training seminar is scheduled with agriculture teachersin Montana, South Dakota, and Utah. Training will include demonstrations on technical safety procedures andhazard risk assessment protocols. Safety materials and supplies will be provided to participating teachers.These will include guards, warning labels, SMV emblems, personal protective equipment, and supervisorsafety tool boxes. These materials will be used by teachers to train their high school students. All teachers willcomplete pre- and post-tests to determine their existing knowledge and knowledge gain of agricultural safetypractices and hazard recognition associated with machinery and vehicles.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. RC/Translation - Pate (USU)

0925-0001 (Rev. 03/16) Page Continuation Format Page

E. Outputs, Outcomes, and Research to Practice (r2p)A presentation is set for the annual International Society for Agricultural Safety and Health conference.

F. Project-Generated ResourcesTraining seminar lessons are being generated for distribution with teacher educators in surrounding states.

HUMAN SUBJECTS / IRB APPROVALS This project was reviewed by the Institutional Review Board at Utah State University and human subjects approval was obtained until August 2017. This IRB approval has not been renewed or revised since the last Notice of Award, so no copy is provided here. An application to continue the human subjects approval will be initiated three months prior to expiration.

It is our intention to remain compliant with the human subjects’ requirements of our institution and to keep the Grants Management Specialist and the NIOSH Program Official informed of IRB approvals.

82

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PHS Inclusion Enrollment Report OMB Number: 0925-0001 and 0925-0002 Expiration Date: 10/31/2018This report format should NOT be used for collecting data from study participants.

*Study Title(must beunique):

Agricultural Safety Education Initiative

Comments:

* Delayed Onset Study? Yes No

If study is not delayed onset, the following selections are required:

Enrollment Type Planned Cumulative (Actual)

Using an Existing Dataset or Resource Yes No

Enrollment Location Domestic Foreign

Clinical Trial Yes No NIH-Defined Phase III Clinical Trial Yes No

Teacher enrollment from Montana, South Dakota, and Utah

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female MaleUnknown/

Not Reported

Hispanic or Latino

Female MaleUnknown/

Not Reported

Unknown/Not Reported Ethnicity

Female MaleUnknown/

Not Reported

Total

American Indian/ Alaska Native 2

Asian 0

Native Hawaiian or Other Pacific Islander 0

Black or African American 1

White 100

More than One Race 0

Unknown or Not Reported

Total 103

2

0

0

2

187

0

191

0

0

0

0

2

0

2

0

0

0

0

4

0

4

4

0

0

3

293

0

300

To ensure proper performance, please save frequently.

Report 1 of 4 83

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PHS Inclusion Enrollment Report

*Study Title(must beunique):

Agricultural Safety Education Initiative

Comments:

* Delayed Onset Study? Yes No

If study is not delayed onset, the following selections are required:

Enrollment Type Planned Cumulative (Actual)

Using an Existing Dataset or Resource Yes No

Enrollment Location Domestic Foreign

Clinical Trial Yes No NIH-Defined Phase III Clinical Trial Yes No

Pre/Post test student Enrollment from Montana, South Dakota, and Utah

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female MaleUnknown/

Not Reported

Hispanic or Latino

Female MaleUnknown/

Not Reported

Unknown/Not Reported Ethnicity

Female MaleUnknown/

Not Reported

Total

American Indian/ Alaska Native 1

Asian 0

Native Hawaiian or Other Pacific Islander 0

Black or African American 1

White 21

More than One Race 0

Unknown or Not Reported

Total 23

1

0

0

2

20

0

23

0

0

0

0

2

0

2

0

0

0

0

2

0

2

2

0

0

3

45

0

50

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Report 2 of 4

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PHS Inclusion Enrollment Report

*Study Title(must beunique):

Agricultural Safety Education Initiative

Comments:

* Delayed Onset Study? Yes No

If study is not delayed onset, the following selections are required:

Enrollment Type Planned Cumulative (Actual)

Using an Existing Dataset or Resource Yes No

Enrollment Location Domestic Foreign

Clinical Trial Yes No NIH-Defined Phase III Clinical Trial Yes No

SAE observations of students from Montana, South Dakota, and Utah

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female MaleUnknown/

Not Reported

Hispanic or Latino

Female MaleUnknown/

Not Reported

Unknown/Not Reported Ethnicity

Female MaleUnknown/

Not Reported

Total

American Indian/ Alaska Native 1

Asian 0

Native Hawaiian or Other Pacific Islander 0

Black or African American 0

White 4

More than One Race 0

Unknown or Not Reported

Total 5

1

0

0

0

4

0

5

0

0

0

0

1

0

1

0

0

0

0

1

0

1

2

0

0

0

10

0

12

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Report 3 of 4

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PHS Inclusion Enrollment Report

*Study Title(must beunique):

Agricultural Safety Education Initiative

Comments:

* Delayed Onset Study? Yes No

If study is not delayed onset, the following selections are required:

Enrollment Type Planned Cumulative (Actual)

Using an Existing Dataset or Resource Yes No

Enrollment Location Domestic Foreign

Clinical Trial Yes No NIH-Defined Phase III Clinical Trial Yes No

Supervised agricultural experience reports from Montana, South Dakota, and Utah

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female MaleUnknown/

Not Reported

Hispanic or Latino

Female MaleUnknown/

Not Reported

Unknown/Not Reported Ethnicity

Female MaleUnknown/

Not Reported

Total

American Indian/ Alaska Native 2

Asian 0

Native Hawaiian or Other Pacific Islander 0

Black or African American 1

White 100

More than One Race 0

Unknown or Not Reported

Total 103

2

0

0

2

187

0

191

0

0

0

0

2

0

2

0

0

0

0

4

0

4

4

0

0

3

293

0

300

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Report 4 of 4

86

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Program Director/Principal Investigator (Last, first, middle): RC/Translation - Pate (USU)

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 05/12/2015 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 62,759 x Rate applied 15.3 % = F&A costs $ 9,602 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 87

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Program Director/Principal Investigator (Last, First, Middle): Research Core - Pilot/Feasibility Program

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Clark, Maggie PD/PI 0.45 0.15 5,703 1,602 7,305

TBN Admin Asst 1.69 6,339 1,781 8,120

SUBTOTALS 12,042 3,383 15,425 CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

TRAVEL

Travel to support previous pilot award recipients to HICAHS Research Day 3,000 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

Pilot/feasibility awards - $50,000; Room rental and official function expenses for HICAHS Research Day - $1,575 51,575

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ 70,000 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS

CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ 70,000 PHS 2590 (Rev. 03/16) Page Form Page 2 88

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Program Director/Principal Investigator (Last, First, Middle): Research Core - Pilot/Feasibility Program

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. Personnel - ($15,425)

Clark, Maggie L., PhD, Principal Investigator, Annual Salary - $114,060; 0.45 academic person-months, 0.15 summer person-months (5% effort) in Year 14. Dr. Clark will direct the pilot/feasibility projects program. Dr. Clark’s primary roles will be: to develop and distribute the annual RFP, to coordinate and facilitate the proposal review process, to communicate the outcomes and solicit feedback on the annual review to both the Internal and External HICAHS Advisory Boards, and to assist Dr. Reynolds with the direction of the Annual HICAHS Research Day agenda.

To-Be-Named, Administrative Assistant, $44,987; 1.69 calendar months (14.09% effort) in Year 14. The Administrative Assistant will support the pilot/feasibility projects program. Their primary roles will be: to support the distribution of the annual RFP, ensuring coverage across the region, to organize the distribution of relevant information (e.g., review guidelines and formats) to reviewers and coordinate the annual review meeting; to coordinate the participation of past pilot program awardees in the Annual HICAHS Research Day.

Fringe benefits area assessed at the rates of 28.1% in Year 14 for the PI and Administrative Assistant.

(continued on next page)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget. A delay in soliciting and processing pilot proposals, as well as a delay in organizing the HICAHS Research Day, occurred due to the maternity leave and subsequent reduction in effort of key personnel in the Pilot Program (this included the reduction in salary expenditure for this team member). Hiring a replacement for these tasks is currently in process. A further delay in processing one of the awarded pilot projects occurred due to a delay in obtaining human subjects research approval by the investigators of the specific pilot project. Funds will be expended before the end of the year 13 period (September 14, 2017).

PHS 2590 (Rev. 03/16) Page Form Page 3 89

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. Research Core - Pilot/Feasibility Program

0925-0001 (Rev. 03/16) Page Continuation Format Page

Budget Justification - continued

Domestic Travel - ($3,000) Travel support will be provided to previous pilot award recipients (awarded within the past 5 years) to present updated research findings at the annual HICAHS Research Day. We consider the travel for these pilot award recipients to be essential to the overarching goal of the pilot program, providing a way to increase engagement and collaboration of the pilot awardees with each other and with existing HICAHS investigators and stakeholders. The experience will provide further training and exposure to young investigator recipients as well as established recipients seeking a new direction in agricultural and forestry health and safety.

Expenses per traveler are based on the following estimates for 3 days of travel (2 out-of-state travelers and 2 in-state travelers). We anticipate inviting 2-4 past recipients in Year 14.

Expense Category # People # Units Unit Cost $ Requested

Airfare 2 2 round trip $500/ticket $1,000 Ground Transportation 2 1 round trip (DIA) $100 $200 Airport Parking 2 4 days $10/day $80 Mileage (in-state) 2 500 miles RT $240 ($.48/mile) $480 Per Diem 4 3 days $36.66/day $440 Lodging 4 2 nights $100/night $800

Total request for travel to CSU $3,000

Other Direct Costs - ($51,575) Pilot/feasibility project awards (2-3 new projects awarded per year): $50,000 per year in Year 14. The solicitation shall specify that applicant entities for these projects will be limited to indirect costs of 8%.

The Annual HICAHS Research Day will build research capacity by fostering collaborative partnerships with the pilot recipients and the HICAHS investigators, stakeholders, and students/trainees. Support for the Annual HICAHS Research Day will be provided to cover the following costs: Room rental fees for the on-campus meeting/conference ($70, room rental fee in Lory Student Center, Colorado State University; breakfast/lunch/refreshments provided to attendees for full-day meeting, approximately $1,505 in Year 14 depending on anticipated number of attendees ranging from 40-60, Lory Student Center Catering). $1,575

Indirect Costs - ($36,400) Indirect rate is calculated at Modified Total Direct Costs of 52% in Year 14.

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. Research Core - Pilot/Feasibility Program

PHS 2590 (Rev. 03/16) Page Form Page 5

PROGRESS REPORT SUMMARY GRANT NUMBER U54OH008085 PERIOD COVERED BY THIS REPORT

PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR Maggie L. Clark

FROM 09/15/2016

THROUGH 09/14/2017

APPLICANT ORGANIZATION Colorado State University - High Plains Intermountain Center for Agriculture Health & Safety (HICAHS) TITLE OF PROJECT (Repeat title shown in Item 1 on first page) Research Core - Pilot/Feasibility Program

A. Human Subjects (Complete Item 6 on the Face Page)

Involvement of Human Subjects No Change Since Previous Submission Change B. Vertebrate Animals (Complete Item 7 on the Face Page)

Use of Vertebrate Animals No Change Since Previous Submission Change

C. Select Agent Research No Change Since Previous Submission Change

D. Multiple PD/PI Leadership Plan No Change Since Previous Submission Change

E. Human Embryonic Stem Cell Line(s) Used No Change Since Previous Submission Change

SEE PHS 2590 INSTRUCTIONS.

WOMEN AND MINORITY INCLUSION: See PHS 398 Instructions. Use Inclusion Enrollment Report Format Page and, if necessary, Targeted/Planned Enrollment Format Page.

A. Specific AimsNo specific aims have been modified.

1) Develop new and creative research (basic, applied, translational) related to human health and safety inagriculture and forestry within Federal Region VIII.

2) Build research capacity related to human health and safety in agriculture and forestry in Federal RegionVIII.

3) Foster new, collaborative partnerships among the HICAHS researchers, private industry, and regional andfederal government agencies with stakeholder interests in human health and safety in agriculture andforestry.

B. Studies and Results

Ten proposals were received in response to the request for applications to the HICAHS Pilot Program and three were chosen for funding for the 2017 fiscal year.

Ryan Gan, M.P.H., Ph.D., a postdoctoral fellow in the Department of Environmental and Radiological Health Sciences at Colorado State University, received $11,880 for his project titled, “Characterizing smoke exposure and lung function in wildland firefighters.” The proposal aims to quantify the amount of smoke exposure to which firefighters are exposed during pile burning, measure lung function health outcomes, and compare these outcomes to firefighters who do not work on pile burning.

Christian L'Orange, Ph.D., PMP, a research scientist at the Center for Energy Development and Health at the Energy Institute at Colorado State University, received $20,000 for his project titled, “A novel, low-cost method for assessing personal aerosol exposures in real-time.” The objective of the proposed work is to develop a low-cost method for assessing aerosol exposure in real-time. The hypothesis is that aerosol concentration can be determined in near real-time by combining time-resolved differential pressure data with a measurement of filter mass accumulation.

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Tara Nordgren, Ph.D., Senior Research Associate in the Department of Internal Medicine at the University of Nebraska Medical Center, received $20,000 for her project, “Role of agricultural dust exposures on lung-resident mesenchymal stem/stromal cell function.” The specific aims are to (1) Define how extracts of agricultural dusts (DE) polarize lung-resident Mesenchymal stem/stromal cells activation status and (2) Determine the role of DE-mediated FGF10 signaling in mesenchymal-epithelial wound repair processes.

C. SignificanceNothing new to report.

D. PlansThe 2017 request for applications (RFA) will follow the same schedule as prior years, with the RFAdisseminated summer 2017 and an estimated project start date of 15 November.

E. Outputs, Outcomes, and Research to Practice (r2p)No outputs, outcomes, or r2p have been developed through grant number U54OH008085 (start date ofSeptember 15, 2016).

Pilot funding recipients from the previous grant have submitted journal articles on their research. A manuscript by Mark Guiberson (2015 Pilot Grant Recipient) was accepted by The American Journal of Audiology titled, “A Preliminary Study of a Spanish Graphic Novella Targeting Hearing Loss Prevention." Travis Sondgerath (2016 Pilot Grant Recipient) is preparing to submit a paper to the Journal of Agricultural Safety and Health titled, “Population-based cohort development of family farms in Colorado: A feasibility study.”

F. Project-Generated ResourcesNone

HUMAN SUBJECTS / IRB APPROVALS This project was reviewed by the Research Integrity & Compliance Review Office at Colorado State University and it was determined that this program does not meet the definition of research 45CFR46.102 (d), and would therefore not be under the IRB’s purview. Any activity sponsored by the program that includes human subjects research obtains IRB approval for that activity, but the program is not an activity that meets the federal definition of research.

The pilot project by Ryan Gan involves human subjects and received IRB approval until January 24, 2018. The notice of approval is on the following page.

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Research Integrity & Compliance Review Office Office of Vice President for Research

Fort Collins, CO 80523-2011 (970) 491-1553

FAX (970) 491-2293

Date: March 27, 2017

To: Stephen J. Reynolds, Ph.D. Maggie L. Clark, Ph.D.

From: Tammy Felton-Noyle, CIP, CCRP, IRB Coordinator

Re: High Plains Intermountain Center for Agricultural Health and Safety 2016-2021 – Pilot/Feasibility Program

After review of the information regarding the Pilot/Feasibility Program of HICAHS, it was determined that this program does not meet the definition of research 45CFR46.102(d), and would therefore not be under the IRB’s purview. Any activity sponsored by the program that includes human subjects research obtains IRB approval for that activity, but the program is not an activity that meets the federal definition of research.

§46.102(d) Research means a systematic investigation, including researchdevelopment, testing and evaluation, designed to develop or contributeto generalizable knowledge.

Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Thank you for submitting this information. If you have more projects that are similar, please contact us prior to submission. The IRB must determine whether a project needs to have IRB approval.

Animal Care & Use • Human Research • Institutional Biosafety 601 S. Howes Street, Suite #208     https://vprnet.research.colostate.edu/RICRO/irb/  

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NOTICE OF APPROVAL FOR HUMAN RESEARCH

DATE: February 08, 2017

TO: Gan, Ryan, Environmntl & Radiologicl Hlth

Magzamen, Sheryl, Environmntl & Radiologicl Hlth, Nickoloff, Jac

FROM: Swiss, Evelyn, CSU IRB 1

PROTOCOL TITLE: Characterizing smoke exposure and lung function in wildland firefighters.

FUNDING SOURCE: Funding - Grants/Contracts

PROTOCOL NUMBER: 16-7007H

APPROVAL PERIOD: Approval Date: January 25, 2017 Expiration Date: January 24, 2018

The CSU Institutional Review Board (IRB) for the protection of human subjects has reviewed the protocol entitled: Characterizing smoke exposure and lung function inwildland firefighters.. The project has been approved for the procedures and subjects described in the protocol. This protocol must be reviewed for renewal on a yearlybasis for as long as the research remains active. Should the protocol not be renewed before expiration, all activities must cease until the protocol has been re-reviewed.

Important Reminder: If you will consent your participants with a signed consent document, it is your responsibility to use the consent form that has been finalized anduploaded into the consent section of eProtocol by the IRB coordinators. Failure to use the finalized consent form available to you in eProtocol is a reportable protocolviolation.

If approval did not accompany a proposal when it was submitted to a sponsor, it is the PI's responsibility to provide the sponsor with the approval notice.

This approval is issued under Colorado State University's Federal Wide Assurance 00000647 with the Office for Human Research Protections (OHRP). If you have anyquestions regarding your obligations under CSU's Assurance, please do not hesitate to contact us.

Please direct any questions about the IRB's actions on this project to:

IRB Office - (970) 491-1553; [email protected] Swiss, Senior IRB Coordinator - (970) 491-1381; [email protected] Felton-Noyle, Assistant IRB Coordinator - (970) 491-1655; [email protected]

Swiss, Evelyn

Initial Approval has been granted to recruit wildland firefighters from The Nature Conservancy with the approved recruitment and consent procedures. Theabove-referenced research activity has been reviewed and approved by the Institutional Review Board under expedited review categories 2 and 7. Approveddocuments include: IBC submission documentation; Outcomes Questionnaire, dated 12/14/2016; Willingness to Participate in Future Studies, dated 12/14/2016;Baseline Information and Work History Questionnaire, dated 1/20/2017; Daily Work Activities Questionnaire, dated 1/20/2017; Consent form, dated 1/26/2017.

___________________________________________________________________________

Approval Period: January 25, 2017 through January 24, 2018

Review Type: EXPEDITED

Research Integrity & Compliance Review Office

Office of the Vice President for Research

321 General Services Building - Campus Delivery 2011 eprotocol

TEL: (970) 491-1553

FAX: (970) 491-2293

Page: 1

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IRB Number: 00010468

Funding: HICAHS

Research Integrity & Compliance Review Office

Office of the Vice President for Research

321 General Services Building - Campus Delivery 2011 eprotocol

TEL: (970) 491-1553

FAX: (970) 491-2293

Page: 2

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Program Director/Principal Investigator (Last, first, middle): Research Core - Pilot/Feasibility Program

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 06/30/2016 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 70,000 x Rate applied 52 % = F&A costs $ 36,400 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 96

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Program Director/Principal Investigator (Last, First, Middle): Outreach Core

Reynolds, Stephen J.

DETAILED BUDGET FOR NEXT BUDGET PERIOD – DIRECT COSTS ONLY

FROM 09/15/2017

THROUGH 09/14/2018

GRANT NUMBER U54OH008085

List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME ROLE ON PROJECT Cal.

Mnths Acad. Mnths

Summer Mnths

SALARY REQUESTED

FRINGE BENEFITS TOTALS

Stallones, Lorann PD/PI 0.90 0.30 18,510 5,201 23,711

Rosecrance, John Co-Investigator 1.44 .48 24,748 6,954 31,702

Gilkey, David Co-Investigator 0.45 0.15 6,316 1,775 8,091

Cassidy, Allison Outreach Coordinator 6.00 31,885 8,960 40,845

TBN GRA #1 4.98 19,893 2,089 21,982

TBN GRA #2 4.98 19,893 2,089 21,982

SUBTOTALS 121,245 27,068 148,313 CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

Materials for booth displays at conferences, data storage media, audio/video supplies, personal protective equipment

1,597 TRAVEL

Travel - Domestic - $12,246; Travel - International - $4,294 16,540 INPATIENT CARE COSTS

OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

Small Community Initiated Projects - $30,000; Video production costs, printing services, postage, software subscriptions, official function expenses for Outreach Advisory Board, conference fees, professional/membership dues - $3,550

33,550

SUBTOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD $ 200,000 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS

CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS

TOTAL DIRECT COSTS FOR NEXT BUDGET PERIOD (Item 8a, Face Page) $ 200,000 PHS 2590 (Rev. 03/16) Page Form Page 2 97

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Program Director/Principal Investigator (Last, First, Middle): Outreach Core

Reynolds, Stephen J.

BUDGET JUSTIFICATION GRANT NUMBER U54OH008085

Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended. Use continuation pages if necessary. Personnel - ($148,313)

Stallones, Lorann, M.P.H., Ph.D., Principal Investigator, Annual Salary - $185,100; 0.90 academic person-months; 0.30 summer person-months (10% effort) in Year 14. Dr. Stallones will serve as the overall director of all activities within the Outreach Core. She will also serve on the Farm & Ranch eXtension in Safety & Health (FReSH) leadership team. Dr. Stallones has over 30 years of experience studying agricultural safety and health. She has been involved in community based research and outreach regarding injury prevention and control in general and also among migrant and seasonal farm workers, farmers, farm families, and rural communities impacted by agricultural activities. She has served as the director of the HICAHS Outreach Core from 2010-2016.

*Colorado State University, Colorado School of Public Health/Graduate School, agrees to a cost share for the portion of Dr. Lorann Stallones salary which exceeds the NIH salary cap.

Rosecrance, John, Ph.D., Co-Investigator, Annual Salary - $154,675; 1.44 academic person-months, 0.48 summer person-months (16% effort) in Year 14. Dr. Rosecrance will serve as the primary leader for the work being conducted under specific aim 4, the translation outreach activities with community initiated projects. Professor Rosecrance has been involved in community-based research and outreach to end-users for more than 20 years primarily in the agricultural and construction sectors. He is the current principal investigator for the HICAHS program “Enhancing Translation and Dissemination through Agricultural Partnership.”

(continued next page)

CURRENT BUDGET PERIOD FROM 09/15/2016

THROUGH 09/14/2017

Explain any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget. Approval for carry forward from year 12 was just received; therefore, there has not been sufficient time to encumber the carry forward funds. These were for funding personnel and will be encumbered and spent before the end of the year 13 period (September 14, 2017).

Additionally, the funds for community initiated grants have not been committed at this point and will be expended before the end of the year 13 period (September 14, 2017).

PHS 2590 (Rev. 03/16) Page Form Page 3 98

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0925-0001 (Rev. 03/16) Page Continuation Format Page

Budget Justification - continued

On the proposed project, he will work closely with Drs. Stallones and Gilkey, as well as Allison Cassidy, to identify and assist community agricultural partners to conduct relevant community-initiated projects focused on the prevention injuries and deaths among agricultural workers throughout the HICAHS region. He will also assist in the evaluation of the translation and dissemination of these projects to end-users.

Gilkey, David, Ph.D., Co-Investigator, Annual Salary - $126,320; 0.45 academic person-months, 0.15 summer person-months (5% effort) in Year 14. Dr. Gilkey will work with Dr. Rosecrance to direct the activities within the translation outreach program (specific aim 4). Dr. Gilkey has worked with Dr. Rosecrance on several community projects aimed at enhancing health and safety for ag producers over the past six years. Dr. Gilkey also served as the Director of Continuing Education for the Mountain and Plains Education and Research Center from 2012-2015 and is the current Director of Diversity. His leadership in ATV safety has increased capacity to train Montana Ag producers in safe use practices on farms and ranches. Dr. Gilkey will maintain an active role in the translation outreach program recruiting and working with ag partners on community grants through the funding period.

Cassidy, Allison, M.P.H., Outreach Coordinator, Annual Salary - $63,770; 6.00 calendar months (50% effort) in Year 14. Ms. Cassidy will serve as the head of the outreach activities listed under specific aims 1-3. She will work with other NIOSH funded Agricultural Safety and Health Centers (“Ag Centers”) to implement evidence based programs to address injuries and illnesses. She will oversee activities for the Outreach Advisory Board, which will be comprised of a group of members from the HICAHS Advisory Board and will meet in conjunction with the HICAHS Advisory Board. Ms. Cassidy has worked collaboratively with the Ag Centers on a variety of projects over the last five years. She is a leader of the Ag Centers YouTube channel, a founder of the Evaluators, Coordinators, and Outreach (ECO) group, and an active participant in Ag Center “Awareness” events. She has strong relationships with each of the advisory board members, having led communications to the board on behalf of HICAHS and HICAHS Director Dr. Stephen Reynolds for the past five years.

To-Be-Named, Graduate Research Assistant #1 (GRA), Annual Salary - $47,936; 4.98 calendar months, (41.5% effort) in Year 14. The GRA will work with Drs. Rosecrance and Gilkey to implement activities related to specific aim 4, specifically the translation program working with community partners.

To-Be-Named, Graduate Research Assistant #2 (GRA), Annual Salary - $47,936; 4.98 calendar months, (41.5% effort) in Year 14. The GRA will work with Dr. Stallones to support activities related to specific aims 1-3.

Fringe benefits area assessed at the rates of 28.1% in Year 14 for the PI, Co-Investigators, and Outreach Coordinator; 10.5% in Year 14 for the Graduate Research Assistants.

Materials and Supplies - ($1,597) Materials and supplies are needed to create professional materials for booth displays at conferences (e.g., retractable stand-alone banners, table skirts), data storage media such as USB jump drives and high capacity hard drives, memory, audio/video supplies, and personal protective equipment for safe working procedures on farms and in forests (e.g., hearing protection, respirators, work boots, steel-toed shoes).

Domestic Travel - ($12,246) Travel is requested for attendance and participation at annual safety and health conferences and to work with community partners in forestry and agriculture.

Montana & South Dakota trips - total of 6 person trips Dr. Rosecrance and a GRA will travel to Montana and South Dakota twice to work with community partners in forestry and agriculture, respectively (4 person trips). An additional trip by the GRA to Montana is anticipated to work with the professional logging association on the development of a safety leadership curriculum (1 person trip). Dr. Gilkey will also travel to Montana to work with Extension specialist and agents on a community program related to ATV injury prevention (1 person trip).

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0925-0001 (Rev. 03/16) Page Continuation Format Page

Safety and Health Conferences - total of 6 person trips Travel is requested for attendance at the International Society for Agricultural Safety and Health annual conference (1 person trip), the annual meeting of the Agricultural Safety and Health Council of America (ASHCA) (1 person trip), DakotaFest (2 person trips), and the eXtension annual conference (1 person trip). We are also requesting travel and conference costs for Dr. Rosecrance to attend a national meeting to present the outreach activities (1 person trip).

Expense Category # People # Units Unit Cost $ Requested

Airfare 1 1 round trip $300/ticket $300 Ground Transportation 1 1 trip $200/trip $200 Per Diem 1 3 days $50/day $150 Lodging 1 2 nights $125/night $250

Total for 1 person trip $900 Total requested for travel (12 person trips projected in Year 14) $10,800

Local Travel - total of 3 person trips Lastly, we anticipate local travel in Colorado and Wyoming to work with other partners on the development of community-initiated projects, to providing trainings (i.e. OSHA 10-Hour Training and EPA WPS Training) and participation in/with local farm shows, agricultural groups, occupational safety and health professionals, and other HICAHS stakeholders.

Expense Category # People # Units Unit Cost $ Requested

Mileage (in-state) 1 vehicle 833 miles RT $400 ($.48/mile) $400 Per Diem 2 1 days $41/day $ 82

Total requested for 1 person trip $482 Total requested for travel (3 person trips projected in Year 14) $1,446

International Travel - ($4,294) Travel is requested in Year 14 for international travel funds to present the community-initiated project results during at least one international occupational health and safety meeting per year (e.g. the International Dairy Research Consortium conferences).

Expense Category # People # Units Unit Cost $ Requested

Airfare - International 2 1 round trip $1,322/ticket $2,644 Ground Transportation 2 4 days $37.50/day $ 300 Per Diem 2 4 days $75/day $ 600 Lodging 2 3 nights $125/night $ 750

Total travel requested for 2 person trip $4,294

Other Direct Costs - $33,550 The majority ($30,000/year) of Other Direct Costs will be used to support community-initiated safety projects for agricultural and forestry workers in the HICAHS region. Applications for community-initiated safety projects will be solicited from the HICAHS region. We anticipate that each project will range from $5,000 to $20,000 depending on the scope of work proposed. The solicitation shall specify that applicant entities for these projects will not be allowed indirect costs on these funds.

Video production costs, printing services, postage, conference fees, professional dues, membership dues, and software subscriptions (e.g. SurveyMonkey for survey administration, ConstantContact for newsletters) are requested. Support is also requested for official functions and conference room fees for the Outreach Advisory Board annual meeting. We are also requesting funds for official functions to encourage and incentivize members

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of agricultural and forestry organizations to participate in meetings to determine best practices for targeting and reaching end-users with the products developed in the community-initiated program. ($3,550)

Indirect Costs - $68,000 Indirect rate is calculated at Modified Total Direct Costs of 34% in Year 14.

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PHS 2590 (Rev. 03/16) Page Form Page 5

PROGRESS REPORT SUMMARY GRANT NUMBER U54OH008085 PERIOD COVERED BY THIS REPORT

PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR Lorann Stallones

FROM 09/15/2016

THROUGH 09/14/2017

APPLICANT ORGANIZATION Colorado State University - High Plains Intermountain Center for Agriculture Health & Safety (HICAHS) TITLE OF PROJECT (Repeat title shown in Item 1 on first page) Outreach Core

A. Human Subjects (Complete Item 6 on the Face Page)

Involvement of Human Subjects No Change Since Previous Submission Change B. Vertebrate Animals (Complete Item 7 on the Face Page)

Use of Vertebrate Animals No Change Since Previous Submission Change

C. Select Agent Research No Change Since Previous Submission Change

D. Multiple PD/PI Leadership Plan No Change Since Previous Submission Change

E. Human Embryonic Stem Cell Line(s) Used No Change Since Previous Submission Change

SEE PHS 2590 INSTRUCTIONS.

WOMEN AND MINORITY INCLUSION: See PHS 398 Instructions. Use Inclusion Enrollment Report Format Page and, if necessary, Targeted/Planned Enrollment Format Page.

The outreach efforts proposed build on a foundation of twenty-five years of outreach activities to agricultural stakeholders and end-users and on our previous community-initiated projects. HICAHS proposes to focus on opportunities to strengthen the effectiveness of our outreach activities and of the community-initiated activities among our community partners involved in agricultural and forestry (AgF) safety and health. The goal of the community-initiated program is to continue to enhance the translation, dissemination, and evaluation of the AgF safety and health activities of community organizations in the HICAHS region. Key facets include financial support to organizations involved in occupational safety activities through community-initiated small grants and methodological assistance to grant recipients in the conduct of their translation and dissemination efforts. Knowledge generated from community-initiated grants will be translated into user-specific media and disseminated to the targeted AgF communities. A participatory “Agricultural Extension Model” will serve as the framework of the proposed community-initiated project. Within this framework, theories work behavior (Campbell et al., 1993), planned behavior (Ajzen, 1991), the organization of work model (NORA Organization of Work Team, 2002), as well as social marketing principles will be incorporated to enhance effective translation and dissemination of AgF health and safety information. The HICAHS personnel will utilize a participatory approach with key agricultural partners (change agents and end-users) such as Extension specialists and agents, forestry, logging, and agricultural associations, insurance companies, and migrant health services, all of whom have direct access to end-users. A. Specific AimsNo specific aims have been modified. The following are the specific aims of the Outreach Core:

1) To design, implement and evaluate a communication plan.2) To work in partnership with other NIOSH funded Agricultural Safety and Health Centers on cross-site

initiatives to increase the use of evidence-based occupational safety and health programs.3) To conduct training programs for agricultural injury prevention.4) To augment regional agriculture and forestry safety and health education programs by providing

community-initiated small grants to regional partners involved in the prevention of agricultural andforestry occupational injuries, illnesses and deaths.

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0925-0001 (Rev. 03/16) Page Continuation Format Page

B. Studies and ResultsAim 1: A communication plan developed during the previous project period for HICAHS was modified and updated and is being used to guide the development of newsletters and press releases. Aim 2: HICAHS staff continue to participate in regular meetings with staff from other NIOSH funded Agricultural Safety and Health Centers. Ms. Cassidy worked with Amanda Wickman, Diane Kampa, and other Ag Center personnel to prepare for Ag Safety Awareness Week (March 5-11). A social media kit was developed, webinars created, and an “awareness campaign” was enacted for this event. Ms. Cassidy submitted an abstract (primary author) with Ellen Duysen and Amanda Wickman on the Ag Center “Awareness Campaigns” for the 2017 International Society for Agricultural Safety and Health (ISASH) Conference. She also requested space to set up an educational display about HICAHS research during ISASH. Aim 3: HICAHS staff have been in contact with Extension to assess needs for agriculture injury prevention training related to pesticide exposures among farm workers. Ms. Cassidy is creating a poster on worker protection standards which will fulfill one requirement for the new Worker Protection Standards. The new WPS standards went into effect in January. HICAHS staff continue to work with partners in the dairy industry to reduce injuries and improve production. Aim 4: HICAHS awarded a community-initiated small grant ($15,000) to the Montana Logging Association (MLA) to finalize the production and perform an immediate evaluation of a video-based training program on emergency first-aid. This community-based project is an extension of the former MLA project to develop a curriculum on critical logging safety issues. Working together, HICAHS and the MLA determined that the most effective way to disseminate consistent safety training messages to Montana loggers was through video modules at their annual spring safety training. The modular format of the videos allows content to be easily updated and refined over time. The focus of the video modules is on emergency first-aid. The MLA chose this topic because many of their members work in remote areas of the wilderness without trained first-responders nearby. Each module is situation-based and illustrates common emergency circumstances seen in the field. The 2017 MLA project provides resources for script development and narration, final editing, and implementation and evaluation (pre- post-test) of the training. HICAHS personnel continue to work with Extension Services in Montana and Wyoming on ATV safety specifically targeted to ranching and farming applications. A 6-module, interactive ATV safety training curriculum that was developed during the last 5-year grant program has been refined and developed for wide distribution. HICAHS is collaborating with the Continuing Education program of the Mountain and Plains Educational Research Center in Colorado to develop the ATV 2.0 program as a stand-alone web-based interactive training platform with pre and post-test questions. This program will be available online in summer 2017. C. SignificanceFor twenty years, the HICAHS has served the AgF population of Public Health Service Region VIII, which is largely defined by its unique and varied geography. The HICAHS region encompasses twenty percent of the U.S. landmass consisting of Colorado, Wyoming, Montana, Utah, North Dakota, South Dakota, and 27 Tribal Nations. The vast geography, limited water resources, high altitude plains and rugged mountains define the HICAHS region and have led to a culture of self-reliant independent farmers, ranchers, dairymen and loggers who are hard to reach with traditional safety education programs. The region is a significant producer of cattle (beef and dairy), row crops (corn, sugar beets, alfalfa, wheat) as well as timber. As with many agricultural commodities, there are a high percentage of “vulnerable” Latino workers employed in agriculture within the HICAHS region. D. PlansMs. Cassidy and HICAHS Evaluation Director Louise Quijano are designing a survey on communication channels for agricultural safety and health messages. The survey will be administered to the HICAHS Advisory Board. Ms. Cassidy’s role on the Outreach Program will be changed to “Co-Investigator” to reflect her role in the Outreach Program. She was listed as “Coordinator” on the grant submission to NIOSH, although she was heavily involved in the writing and development of the Outreach Program plan.

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E. Outputs, Outcomes, and Research to Practice (r2p)

Outputs: Journal Articles

1. Lagerstrom, E. Gilkey, D., Magzamen, S., Stallones, L., and Rosecrance, J. (2016). Understanding riskfactor patterns in ATV fatalities: A recursive partitioning approach. Journal of Safety Research, 59, 23-31.

Audiovisual Materials 2. The r2p ATV safety project with Montana Extension has led to the development of 6 high quality videos

which will be uploaded to the U.S. Agricultural Safety and Health Centers website:www.youtube.com/usagcenters.

Conferences and meetings hosted/organized by HICAHS 3. HICAHS will be holding a meeting with its Advisory Board later this year.

Conference presentations by HICAHS 4. Gilkey, D., Rosecrance, J., and Lagerstrom, E. (2016). ATV Safety Research and Outreach at

Colorado State University. ANB45 (1) Rollover Subcommittee, WDC - June 28th, 20165. Gilkey, D., Rosecrance, J., and Lagerstrom, E. (2016). ATV Safety Research and Outreach at

Colorado State University. Governor’s Ag Safety Coalition of Wyoming, Douglas, WY – August 5th,2016

6. 2/15/17 Dr. Reynolds presentation and discussion to OHS faculty at Edith Cowen University,Joondalup, Western Australia. MAP ERC and HICAHS overviews. ~ 20 faculty and students. Dr.Reynolds is Adjunct Professor at ECU.

7. 3/1/17 Drs. Hagevoort and Douphrate presentation entitled “Challenges surrounding training the next generation” at the Western Dairy Management Conference in Reno, NV.

Submitted Abstracts 8. Ms. Cassidy submitted an abstract on the Ag Center “Awareness Campaigns” for the 2017 International

Society for Agricultural Safety and Health (ISASH) Conference.9. Dr. Quijano is a collaborating author with Dr. Michael Pate on an abstract for the upcoming ISASH

conference representing the evaluation for the HICAHS Agricultural Safety Education Initiative Project.Courses

10. 2/6/17 Risk assessment course in Ternopol State Medical University in Ukraine, in March 2017. Andrey Korchevskiy, PhD, CIH, Director of Research & Development, Chemistry & Industrial Hygiene, Inc. Wheat Ridge, CO. Dr. Reynolds provided PPT presentations on organic dusts and agriculture for his use. Will follow up to explore collaborations.

Meetings 11. 2/22/17 Dr. Quijano and Ms. Cassidy represented HICAHS at the Governor’s Agricultural Forum on

Colorado Agriculture

Website development/updates 12. Ms. Cassidy continues to maintain the HICAHS website. www.hicahs.colostate.edu.

HICAHS Consultations 13. 2/14/17 AgriBeef, Boise, ID. Dr. Reynolds reviewed article and email regarding legislation in WA re

Beef industry/cattle feedlots and possible exemption from EPA Clean Air Act. Spoke with Jayne Davis,

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Director Corporate and Regulatory Affairs to provide opinion and discuss. Also suggested additional contacts.

14. 2/17/17 LDS Church, Risk Management, Salt Lake City, UT. Dr. Reynolds consulted with ClarkEvans regarding guidelines and standards for organic dust exposures, sample interpretation, andexposure profiles for agricultural workers.

Program Organizer 15. Paul Ayers and Allison Cassidy along with personnel at NYCAMH and other organizations have

participated in the National Tractor Safety Coalition (NTSC) and the National ROPS Rebate Program.Paul Ayers was part of the organizing committee for the NTSC. Allison Cassidy spoke to agriculturalproducers in Wyoming in August 2016 about the National ROPS Rebate Program.

Service 16. Cassidy, A. (2014 – present). Board Member for the Agrisafe Network. http://www.agrisafe.org. Ms.

Cassidy has served as a board member of the AgriSafe Network’s advisory board since June 2014.She participates in the conference calls held every other month and provides consultation on how topromote AgriSafe’s services. From June 2015-June 2016 she served as the Vice Chair and designed apolicy and procedure for the AgriSafe Director Annual Evaluation.

17. Cassidy, A. (2013 – present). Founder and Member of the NORA AgFF Outreach, Communications,and Partnerships Working Group.

18. Reynolds, S. J. (2013 – present). NORA Agriculture, Forestry & Fishing Sector Council.19. Reynolds, S. J. (2010 – present). Worksafe Colorado Advisory Board.20. Reynolds, S. J. (2011 – present). External Advisory Board Member of the Upper Midwest Agricultural

Safety and Health Center (Minneapolis, MN).21. Reynolds, S. J. (2010 – present). Colorado Department of Public Health and the Environment (CDPHE)

Occupational Health Surveillance Program.22. Reynolds, S. J. (2008 – present). International Member of the Canadian Centre for Health and Safety in

Agriculture (CCHSA).23. Reynolds, S.J., Cassidy, A. (2010-present). Wyoming Governor’s Taskforce/Wyoming-Colorado

Occupational Safety and Health Coalition24. Dr. Stallones is on the leadership team for the Farm and Health Safety (FReSH) Community of Practice

(CoP) which operates through the Cooperative Extension eXtension program.25. Drs. Stallones and Reynolds serve as Associate Editors for the Journal of Agromedicine and the

Journal of Agricultural Safety and Health.

Outcomes: none

Research to Practice: 26. Allison Cassidy continues to participate in the Evaluators, Coordinators, and Outreach (ECO) personnel

group, along with the “YouTube,” “Awareness,” “Evaluation” and other sub-groups. She maintains aleadership role in the YouTube group and for various other ECO projects.

27. We continue to work with the Farm and Ranch eXtension Safety and Health (FReSH), Community ofPractice (http://www.extension.org/farm_safety_and_health) which operates through the CooperativeExtension eXtension program. Dr. Stallones serves as the contact person for HICAHS and serves onthe Leadership Team for the FReSH Community of Practice.

F. Project-Generated ResourcesNone

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0925-0001 (Rev. 03/16) Page Continuation Format Page

HUMAN SUBJECTS / IRB APPROVALS This project was reviewed by the Research Integrity & Compliance Review Office at Colorado State University and it was determined that this project meets the requirements of 45 CFR 46.118, “Application and proposal lacking definite plans for involvement of human subjects.” The regulations allow awards for such projects to be made prior to review and approval by an IRB, but no human subjects may be involved until the review and approval has taken place.

There are no activities underway that require human subjects approval. It is our intention to remain compliant with the human subjects’ requirements of our institution and to keep the Grants Management Specialist and the NIOSH Program Official informed of IRB approvals.

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PHS Inclusion Enrollment Report OMB Number: 0925-0001 and 0925-0002 Expiration Date: 10/31/2018This report format should NOT be used for collecting data from study participants.

*Study Title (must be unique):

Evaluation of a Safety Training Program for Commercial Loggers

Comments:

* Delayed Onset Study? Yes No

If study is not delayed onset, the following selections are required:

Enrollment Type Planned Cumulative (Actual)

Using an Existing Dataset or Resource Yes No

Enrollment Location Domestic Foreign

Clinical Trial Yes No NIH-Defined Phase III Clinical Trial Yes No

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female MaleUnknown/

Not Reported

Hispanic or Latino

Female MaleUnknown/

Not Reported

Unknown/Not Reported Ethnicity

Female MaleUnknown/

Not Reported

Total

American Indian/ Alaska Native

Asian

Native Hawaiian or Other Pacific IslanderBlack or African American

White

More than One Race

Unknown or Not Reported

Total

To ensure proper performance, please save frequently.

Report 1 of 1

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COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 1 OF 2

COURSEWORK REQUIREMENTS*

* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details.See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.

• Name: John Rosecrance (ID: 633733)• Institution Affiliation: Colorado State University (ID: 309)• Institution Unit: Environmental and Radiological Health Sciences• Phone: 970-491-1405

• Curriculum Group: Human Research• Course Learner Group: Group 1.BIOMEDICAL RESEARCH• Stage: Stage 1 - Basic Course• Description: This course is suitable for Gradute Students, Faculty and staff conducting BIOMEDICAL RESEARCH

with human subjects.

• Record ID: 21264370• Completion Date: 28-Mar-2017• Expiration Date: 27-Mar-2020• Minimum Passing: 80• Reported Score*: 88

REQUIRED AND ELECTIVE MODULES ONLY DATE COMPLETED SCOREConsent Tools Used by Researchers (ID: 16944)  27-Mar-2017 4/5 (80%) Consent in the 21st Century (ID: 17060)  27-Mar-2017 4/5 (80%) Belmont Report and CITI Course Introduction (ID: 1127)  27-Mar-2017 3/3 (100%) History and Ethical Principles - SBE (ID: 490)  27-Mar-2017 5/5 (100%) Defining Research with Human Subjects - SBE (ID: 491)  27-Mar-2017 5/5 (100%) The Federal Regulations - SBE (ID: 502)  27-Mar-2017 5/5 (100%) Assessing Risk - SBE (ID: 503)  27-Mar-2017 5/5 (100%) Informed Consent - SBE (ID: 504)  27-Mar-2017 5/5 (100%) Privacy and Confidentiality - SBE (ID: 505)  27-Mar-2017 4/5 (80%) Research with Prisoners - SBE (ID: 506)  27-Mar-2017 4/5 (80%) Research with Children - SBE (ID: 507)  27-Mar-2017 4/5 (80%) Research in Public Elementary and Secondary Schools - SBE (ID: 508)  27-Mar-2017 4/5 (80%) International Research - SBE (ID: 509)  27-Mar-2017 4/5 (80%) Internet-Based Research - SBE (ID: 510)  27-Mar-2017 4/5 (80%) Unanticipated Problems and Reporting Requirements in Social and Behavioral Research (ID: 14928)  28-Mar-2017 4/5 (80%) Colorado State University (ID: 738)  28-Mar-2017 No Quiz 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: www.citiprogram.org/verify/?kb433cb8c-2570-47e0-bdad-d5f8a713c1bb-21264370

Collaborative Institutional Training Initiative (CITI Program)Email: [email protected]: 888-529-5929Web: https://www.citiprogram.org

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COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)COMPLETION REPORT - PART 2 OF 2

COURSEWORK TRANSCRIPT**

** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of thecourse. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.

• Name: John Rosecrance (ID: 633733)• Institution Affiliation: Colorado State University (ID: 309)• Institution Unit: Environmental and Radiological Health Sciences• Phone: 970-491-1405

• Curriculum Group: Human Research• Course Learner Group: Group 1.BIOMEDICAL RESEARCH• Stage: Stage 1 - Basic Course• Description: This course is suitable for Gradute Students, Faculty and staff conducting BIOMEDICAL RESEARCH

with human subjects.

• Record ID: 21264370• Report Date: 28-Mar-2017• Current Score**: 88

REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST RECENT SCOREHistory and Ethical Principles - SBE (ID: 490) 27-Mar-2017 5/5 (100%) Defining Research with Human Subjects - SBE (ID: 491) 27-Mar-2017 5/5 (100%) Belmont Report and CITI Course Introduction (ID: 1127) 27-Mar-2017 3/3 (100%) The Federal Regulations - SBE (ID: 502) 27-Mar-2017 5/5 (100%) Assessing Risk - SBE (ID: 503) 27-Mar-2017 5/5 (100%) Informed Consent - SBE (ID: 504) 27-Mar-2017 5/5 (100%) Privacy and Confidentiality - SBE (ID: 505) 27-Mar-2017 4/5 (80%) Research with Prisoners - SBE (ID: 506) 27-Mar-2017 4/5 (80%) Research with Children - SBE (ID: 507) 27-Mar-2017 4/5 (80%) Research in Public Elementary and Secondary Schools - SBE (ID: 508) 27-Mar-2017 4/5 (80%) International Research - SBE (ID: 509) 27-Mar-2017 4/5 (80%) Internet-Based Research - SBE (ID: 510) 27-Mar-2017 4/5 (80%) Unanticipated Problems and Reporting Requirements in Social and Behavioral Research (ID: 14928) 28-Mar-2017 4/5 (80%) Colorado State University (ID: 738) 28-Mar-2017 No Quiz Consent Tools Used by Researchers (ID: 16944) 27-Mar-2017 4/5 (80%) Consent in the 21st Century (ID: 17060) 27-Mar-2017 4/5 (80%) 

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institutionidentified above or have been a paid Independent Learner.

Verify at: www.citiprogram.org/verify/?kb433cb8c-2570-47e0-bdad-d5f8a713c1bb-21264370

Collaborative Institutional Training Initiative (CITI Program)Email: [email protected]: 888-529-5929Web: https://www.citiprogram.org

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Program Director/Principal Investigator (Last, first, middle): Outreach Core

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 06/30/2016 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $ 200,000 x Rate applied 34 % = F&A costs $ 68,000 Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain)

Explanation (Attach separate sheet, if necessary.):

PHS 2590 (Rev. 03/16) Page Form Page 6 110

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Program Director/Principal Investigator (Last, first, middle): CSU - Overall

Reynolds, Stephen J.

GRANT NUMBER

U54OH008085

CHECKLIST 1. PROGRAM INCOME (See instructions.)All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income isanticipated, use the format below to reflect the amount and source(s).

Budget Period Anticipated Amount Source(s)

2. ASSURANCES/CERTIFICATIONS (See instructions.)In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5).

3. FACILITIES AND ADMINSTRATIVE (F&A) COSTSIndicate the applicant organization’s most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS Agency Cost Advisory Office.

F&A costs will not be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

DHHS Agreement dated: 06/30/2016 No Facilities and Administrative Costs Requested.

No DHHS Agreement, but rate established with Date

CALCULATION*

Entire proposed budget period: Amount of base $

See attached spreadsheet

x Rate applied

See attached spreadsheet

% = F&A costs $ 224,680

Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b.

*Check appropriate box(es):

Salary and wages base Modified total direct cost base Other base (Explain)

Off-site, other special rate, or more than one rate involved (Explain) Explanation (Attach separate sheet, if necessary.): Please see attached spreadsheet for the amount of base and F&A rate for each budget.

PHS 2590 (Rev. 03/16) Page Form Page 6 111

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. CSU - Overall

0925-0001 (Rev. 03/16) Page Continuation Format Page

IDC from Checklists Indirect

Rate Amount of

Base Directs CSU

Indirects Consortium

Indirects Total Center Admin 34.0% $ 143,350 $ 150,000 $ 48,739 $ 198,739 Emerging Issues 52.0% $ 50,000 $ 50,000 $ 26,000 $ 76,000 Evaluation 34.0% $ 94,599 $ 100,000 $ 32,164 $ 132,164 Outreach 34.0% $ 200,000 $ 200,000 $ 68,000 $ 268,000 Pilots/Feasibility 52.0% $ 70,000 $ 70,000 $ 36,400 $ 106,400 Occ Safety Mgmt 52.0% $ 25,725 $ 250,000 $ 13,377 $ 78,642 $ 263,377 Agric Safety - Pate USU $ 160,000 $ - $ 9,602 $ 160,000 ROPS - Ayers UT $ 80,000 $ - $ 24,445 $ 80,000

Total $ 1,060,000 $ 224,680 $

112,689 $ 1,284,680

*CSU F&A limitation on the first $25K of a subcontract was met in Year 13 on the Pate & Ayers projects.

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0925-0001 (Rev. 03/16) Page Continuation Format Page

REYNOLDS, Stephen J.

ACTIVE 5T42OH009229 CDC/NIOSH (Newman UCDHSC) 07/01/11 - 06/30/20 2.39 academic Mountains and Plains Education Research Center $ 870,117 0.80 summer Graduate training support for occupational medicine, industrial hygiene, ergonomics, health physics, and occupational health psychology. Continuing Education and Outreach sections. Role: PI at CSU / Center Deputy Director– responsible for overall leadership and implementation, and Director of Industrial Hygiene Program.

5U01OH010840-03 09/01/14 - 08/31/17 0.87 academic CDC/NIOSH (Reynolds, Magzamen, Schaeffer - PI’s) $ 184,828 0.29 summer Design and evaluation of interventions to improve dairy worker respiratory health This project will better characterize bioaerosols to understand the implication of the presence of peptidoglycans and β-glucans. The overall goal is to identify and evaluate potential interventions to reduce exposure.

NIH/NIEHS (Clark, PI) 02/01/13 - 06/30/17 0.27 academic 5R00ES022269 $ 167,425 0.09 summer Community-based Participatory Research: A Tool to Advance Cookstove Interventions. The goal of this community-engaged project is to facilitate and accurately measure the adoption of culturally appropriate cleaner-burning cookstoves; an intervention study will evaluate the impact of the cookstove on subclinical indicators of cardiopulmonary health among Honduran women. Role: Co-Investigator

RD-83563501-0 03/02/15 - 03/01/19 0.30 academic EPA STAR $ 378,406 0.10 summer Sustainable Places, Health and Educational Research in Schools (SPHEReS) The objective of this study is to examine which combination of building features, materials, construction practices, and operations and maintenance practices are most effective in creating healthy indoor air quality resulting in optimal health and a safe learning environment.

R01 OH010662 (Volckens) 09/01/15 - 08/31/19 0.36 academic HHS-CDC $ 363,854 0.12 summer A New Paradigm for Workplace Air Sampling and Cost-Effective Exposure Assessment The objective of this research will develop technology that reduces the cost of workplace air monitoring by over an order of magnitude and the time sampling to hazard communication from weeks to hours.

PENDING CDC/NIOSH (Reynolds, Magzamen, Schaeffer, PIs) 09/15/17 – 09/14/21 0.93 academic

$ 290,000 0.31 summer Antimicrobial resistant bacteria: Exposures and health of dairy workers The goal of this study is to combine microbial exposure assessment and epidemiologic studies to understand the prevalence of antimicrobial resistant (AMR) bacterial in dairy environmental samples and dairy worker personal samples, and to elucidate the role of AMR bacterial in systemic inflammation and lung function in workers.

OVERLAP None

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0925-0001 (Rev. 03/16) Page Continuation Format Page

STALLONES, Lorann

ACTIVE P14AC00728 Stallones (PI) 08/15/15 – 12/31/19 0.37 academic National Parks Service $ 181,261 0.13 summer A Collaborative Approach to Promoting One Health in the NPS This is a program to provide training for graduate students in environmental and public health on health issues related to interactions between humans and wildlife in National Parks. There is also training provided to employees of National Parks through CSU.

5R00ES022269-05 (Clark, PI) 02/01/13 - 06/30/17 0.27 academic NIH/NIEHS $ 167,425 0.09 summer Community-Based Participatory Research: A Tool to Advance Cookstove Interventions The goal of this Career Development Award is to initiate an independent research program in air pollution epidemiology, exploring the dynamic relationship between environmental and social/behavior risk factors on cardiovascular disease.

PENDING None

OVERLAP None

DOUPHRATE, David I.

ACTIVE 5U01OH010815 (Casanova / Douphrate) 09/01/14 – 08/31/17 2.40 calendar CDC/NIOSH/UTHSC-Tyler $ 82,223 (UTSPH subcontract PI: Douphrate) Development of Safety Management and Leadership Training Program for Logging Contractors The long-term goal of the proposed project is to reduce or eliminate injuries and fatalities among a vulnerable workforce of logging workers. The objectives of this proposal are to describe safety management practices currently being used on logging cut sites, as well as examine the relationships between safety leadership, group safety climate, and worker safety behaviors. This study will engage logging contractors in a participatory approach to develop a survey instrument to assess safety management and leadership among contractors, and group safety culture and safety behaviors among workers. The administration of this instrument will generate data which will help develop a safety management and leadership training module for logging contractors.

2T42OH008421 (Symanski, PI) 07/01/15 – 06/30/20 1.20 calendar CDC/NIOSH $ 1,212,122 Southwest Center for Occupational and Environmental Health The purpose of the Southwest Center for Occupational and Environmental Health is to respond to the critical need for well-trained occupational and environmental health specialists by providing graduate-level academic and research training and continuing education in the occupational health disciplines, with an underlying foundation of a state-of -the-art research program.

SH-29638-16-60-F-48 (Douphrate) 09/30/16 – 09/29/17 1.20 calendar OSHA/Susan Harwood Training Grants $ 116,248 Safe Animal Handling Training for Large-Herd Dairy Workers Using an Innovative Mobile-Learning Platform This agricultural safety and health training program fosters the adoption of safe work practices including safe livestock handling by workers on large-herd dairy farms and addresses the variability of safety needs within and across dairy farms through the application of mobile-learning technologies.

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U54OH007541 (Levin) 09/30/16 - 09/29/21 1.67 calendar CDC/NIOSH/UTHSC-Tyler $ 92,721 (UTSPH subcontract PI: Douphrate) Southwest Center for Agricultural Health, Injury Prevention, & Education: Physical Exposures and Musculoskeletal Symptoms Among Logging Machine Operators This is a prospective study of the association between exposure to physical risk factors and musculoskeletal symptoms (MSS) in logging machine operators (LMO). Physical risk factors will be determined through the direct measurement of force (EMG), posture (inertial measurement units and video), repetition (EMG), and seated vibration. MSS will be reported by smart-phone for 150 LMO (30 LMO/year), 3 times/day for one week, 4 times each year.

U54OH007541 (Levin) 09/30/16 – 09/29/21 0.96 calendar CDC/NIOSH/UTHSC-Tyler $10,124 (UTSPH subcontract PI: Douphrate) Southwest Center for Agricultural Health, Injury Prevention, & Education The goal of this center is to support research, intervention, education and outreach efforts to reduce injuries and health problems for agricultural workers in the region including Arkansas, Louisiana, Oklahoma, New Mexico and Texas. Dr. Douphrate will serve as Deputy Director of the Center.

1U54OH007541 (Levin) 09/30/16 - 09/29/21 0.72 calendar $ 18,082

CDC/NIOSH/UTHSC-Tyler /Southeastern Louisiana Univ. (Carruth PI) (UTSPH subcontract PI: Douphrate) Southwest Center for Agricultural Health, Injury Prevention and Education: The Impact of Thermal Load on PFD Use Among Shrimp Fisherman The long-term goal of the proposed research is to create workplace improvements in commercial shrimp shrimping in the Gulf of Mexico. Aim #1: To increase the understanding of physiological responses to environmental heat and varying physical work among Vietnamese shrimp fishermen Specifically, thermal environment, heat stress symptoms, and physiological measures, with and without Personal Floatation Device use during the physically demanding work of harvesting shrimp in the Gulf of Mexico region, will be quantified and compared; Aim #2: Identify personal cooling equipment designs that are commercially available and have demonstrated comfort and workability; and, Aim #3: To design, launch and evaluate the effectiveness of a multimodal and culturally appropriate social marketing campaign to increase OSHA/NIOSH recommendations for heat stress reduction and Personal Floatation Device use.

U54OH007541 (Levin) 09/30/16 – 09/29/18 1.20 calendar CDC/NIOSH/UTHSC-Tyler (Casanova PI) $ 15,418 (UTSPH subcontract PI: Douphrate) Southwest Center for Agricultural Health, Injury Prevention, & Education: Occupational Exposures of Tree Planters in the Forestry Services Sector The primary objective of this project is to provide an evidence base for a research program that focuses on the occupational health and safety outcomes of tree planters in the forestry services sector. Using a participatory approach, this project will commence with an assessment of work place risks and exposures, using both direct measures and self-report with both manual and machine tree planters.

PENDING None

OVERLAP In the event of overlap UTHealth will work with the appropriate Program Officials to reduce Dr. Douphrate’s effort, as needed, on active projects to ensure that he won’t be overcommitted.

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AYERS, Paul D.

ACTIVE None

PENDING None

OVERLAP None

CASSIDY, Allison

ACTIVE None

PENDING None

OVERLAP None

CLARK, Maggie L.

ACTIVE: 5R00ES022269-05 (Clark, PI) 02/01/13 - 06/30/17 1.80 academic NIH/NIEHS $ 167,425 0.60 summer Community-Based Participatory Research: A Tool to Advance Cookstove Interventions The goal of this Career Development Award is to initiate an independent research program in air pollution epidemiology, exploring the dynamic relationship between environmental and social/behavior risk factors on cardiovascular disease.

5R01ES023688-03 (Peel/Volckens, PI) 08/15/14 - 05/31/19 0.38 academic HHS/NIH/NIEHS $ 403,469 0.12 summer Cookstove Air Pollution: Emission Profiles and Subclinical Effects of Exposure The objective of this research is to develop credible and representative laboratory data as a first step to test the improved stoves hypothesis and to improve our ability to address this massive threat to global health. Role: Co-Investigator - effort began in Year 02 of project.

T704766 (Emory Univ. Clasen) 09/22/16 - 06/30/21 1.35 academic HHS/NIH UM1 $ 105,000 0.45 summer Household air pollution and health: a multi-country LPG intervention trial The overall objective of the Biomarker Core is to provide a high-capacity, high-quality, and high-throughput analysis resource capable of measuring a wide range of HAP-related biomarkers in samples collected from sites participating in the Center’s clinical trial.

T702665 09/22/16 - 06/30/21 0.90 academic HHS/NIH/UM1 (Emory Univ. Clasen) $ 59,600 0.30 summer Household air pollution and health: a multi-country LPG intervention trial The overall objective of this clinical study is a multi-country LPG Intervention Trial to evaluate the air pollution exposure reductions and health benefits associated with a clean fuel cookstove intervention.

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PENDING None

OVERLAP None

GILKEY, David P.

ACTIVE 5T42OH009229-09 (Newman, UCDHSC) 07/01/11 - 06/30/20 0.52 academic CDC/NIOSH $ 80,203 0.17 summer Mountain and Plains Education Research Center The major goal of this project is graduate training support for occupational medicine, industrial hygiene, ergonomics, health physics, and occupational health psychology, continuing education and outreach. Role: Co-Investigator for Diversity

PENDING None

OVERLAP None

GIMENO, David

ACTIVE IL-29677-16-75-K-48 (Gimeno) 09/01/16 - 08/31/19 0.96 calendar DoD/ILAB/OELR/CEO $ 51,154 Working Conditions and Health in Central America This Project is funded by the United States Department of Labor (USDOL) Bureau of International Labor Affairs (ILAB), the Office of Economic and Labor Research (OELR) and the USDOL Chief Evaluation Office (CEO). The main aim of this project will be to conduct a household survey and focus groups on the prevalence, nature, and possible effects of certain labor rights practices in Central America, including the prevalence of work-related and gender-based violence.

R01OH010648 (Delclos / Gimeno) 08/01/14 - 07/31/18 1.80 calendar CDC/NIOSH $ 169,237 Asthma in Texas Healthcare Professionals II The purpose of the study is to repeat our assessment of asthma prevalence and associated risk factors among Texas healthcare workers (HCW) (nurses, physicians, respiratory therapists and occupational therapists) from 2003. The specific aims are to: (1) to estimate the prevalence rate of asthma risk factors and work-related asthma (WRA) in healthcare settings and compare these to rates obtained in the 2003 survey; (2) to measure associations between occupational exposures and WRA among Texas HCW and compare them to those obtained in 2003; and (3) to measure various indicators of socioeconomic impact of asthma in healthcare workers, comparing them among persons with WRA, non-work-related asthma in nonasthmatics.

T42OH008421 (Symanski) 07/01/15 - 06/30/20 1.20 calendar CDC/NIOSH $ 1,212,122 Southwest Center for Occupational and Environmental Health The UT ERC provides advanced degree training in occupational health and safety to meet the critical need for trained professionals in PHR 6. A full spectrum of degree programs, advanced research training, and continuing education courses help meet the needs of the Region for well-trained professionals to protect the health and safety of the nations' workforce.

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0925-0001 (Rev. 03/16) Page Continuation Format Page

U01OH010815 (Casanova / Douphrate) 09/01/14 - 08/31/17 1.20 calendar (UTSPH subcontract PI: Douphrate) $ 82,234 CDC / UTHSC-Tyler Development of Safety Management and Leadership Training Program for Logging Contractors The long-term goal of the proposed project is to reduce or eliminate injuries and fatalities among a vulnerable workforce of logging workers. The objectives of this proposal are to describe safety management practices currently being used on logging cut sites, as well as examine the relationships between safety leadership, group safety climate, and worker safety behaviors. This study will engage logging contractors in a participatory approach to develop a survey instrument to assess safety management and leadership among contractors, and group safety culture and safety behaviors among workers. The administration of this instrument will generate data which will help develop a safety management and leadership training module for logging contractors.

U54OH007541 (Levin) 09/30/16 - 09/29/21 2.40 calendar (UTSPH subcontract PI: Douphrate) $ 92,721 UTHSC-Tyler / CDC Southwest Center for Agricultural Health, Injury Prevention, & Education: Physical Exposures and Musculoskeletal Symptoms Among Logging Machine Operators This is a prospective study of the association between exposure to physical risk factors and musculoskeletal symptoms (MSS) in logging machine operators (LMO). Physical risk factors will be determined through the direct measurement of force (EMG), posture (inertial measurement units and video), repetition (EMG), and seated vibration. MSS will be reported by smart-phone for 150 LMO (30 LMO/year), 3 times/day for one week, 4 times each year.

1U54OH007541 (Levin) 09/30/16 - 09/29/21 0.72 calendar (UTSPH subcontract PI: Douphrate) $ 18,082 UTHSC-Tyler / SOUTHEASTERN LOUISIANS UNIV Southwest Center for Agricultural Health, Injury Prevention and Education: The Impact of Thermal Load on PFD Use Among Shrimp Fisherman The long-term goal of the proposed research is to create workplace improvements in commercial shrimp shrimping in the Gulf of Mexico. Aim #1: To increase the understanding of physiological responses to environmental heat and varying physical work among Vietnamese shrimp fishermen Specifically, thermal environment, heat stress symptoms, and physiological measures, with and without Personal Floatation Device use during the physically demanding work of harvesting shrimp in the Gulf of Mexico region, will be quantified and compared; Aim #2: Identify personal cooling equipment designs that are commercially available and have demonstrated comfort and workability; and, Aim #3: To design, launch and evaluate the effectiveness of a multimodal and culturally appropriate social marketing campaign to increase OSHA/NIOSH recommendations for heat stress reduction and Personal Floatation Device use.

PENDING None

OVERLAP None

LAWVER, Rebecca G.

ACTIVE Utah State Office of Education (Lawver, Co-I) 09/01/16 – 06/30/17 0.10 Calendar Agriculture Teacher Induction Program VIII $ 7,000 Project Goals include: The goal of this program is to provide continuing education and support for new agriculture teachers in Utah. Classroom visits and mentoring program provide opportunities for new teachers to interact and acclimate to the profession.

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0925-0001 (Rev. 03/16) Page Continuation Format Page

Utah State Office of Education (Lawver, PI) 09/01/16 – 06/30/17 0.10 Calendar New Teacher Academy IX $ 7,500 Project Goals Include: The goal of this program is to provide continuing education and support for provisionally certified Career and Technical Education Teachers in Utah. Thirty-two hours of instruction related to teaching pedagogy are delivered.

PENDING None

OVERLAP None

PATE, Michael L.

ACTIVE 2014-41590-22321 09/01/14 - 09/31/18 0.60 calendar USDA NIFA AgrAbility Grant $ 720,000 Utah AgrAbility Renewal Project. Project goals include: Evaluate educational resources for aging workers; provide a means for enhancing curriculums and farm safety and health educational opportunities for aging workers in formal and non-formal settings; and centralize access to curriculum, learning activities, and farm safety and health expertise and resources. Role: Co-Investigator

USDA NIFA Youth Farm Safety Education 09/01/16 - 08/31/17 0.88 calendar and Certification (YFSEC) Grant $ 300,000 Strengthening Safety in Agriculture for Youth Program Project goals include: Build upon and strengthen the activities and accomplishments of the Safety in Agriculture for Youth (SAY) project, as well as identify and address curricula and outreach gaps. Role: Co-Investigator

PENDING None

OVERLAP None

PERRY, Dustin K.

ACTIVE Farm Service Agency (Perry – Contract) 01/01/17 – 01/01/18 0.10 calendar

$ 6,667 A Generational Approach to Outreach Education for Montana Youth, Young Adults, Educators, and Urban Specialty Crop Growers on FSA Programs This project will aim to increase outreach, education and awareness of FSA programs, functions, and activities to Montana youth, young adults, educators, and urban specialty crop growers, distributors, and producers. The project team will assist FSA in reaching its goals by promoting financial safety, stewardship of the environment, and best production practices for current and future specialty crop growers, distributors, and producers. A series of outreach and educational workshops will be developed for each audience within the overall program to familiarize each generation with FSA loans that can support agricultural financial and production activities integral to enterprises. These workshops will be presented at 4-H and FFA meetings, MSU farm field days, MSU classrooms and farms, extension offices, farmers’ markets, and professional conferences. A unique, modern communication approach will include the development of a professional promotional video for FSA. Project

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leaders, Dr. Shannon Arnold, Dr. Mac Burgess, and Dr. Dustin Perry, will aim to provide the technical, educational, and financial expertise to build awareness and knowledge of FSA within each of these areas.

PENDING None

OVERLAP None

PETERSEN, Kathy M.

ACTIVE 5T42OH009229-09 CDC/NIOSH (Newman UCDHSC) 07/01/11 - 06/30/20 1.87 calendar Mountains and Plains Education Research Center $ 870,117 Graduate training support for occupational medicine, industrial hygiene, ergonomics, health physics, and occupational health psychology; other sections also include continuing education, diversity, and outreach. Role: Accounting Technician IV

PENDING None

OVERLAP None

POMPEII, Lisa

ACTIVE 5R01OH010648-03 (Delclos) 08/01/14 - 07/31/18 0.60 calendar CDC $ 169,237 Asthma in Texas Healthcare Professionals II One in 12 adults has asthma in the United States (ref), with an increase of 15% over the past decade (ref). Among adult asthmatics, it is estimated that 15% to 25% of cases are attributed to, or aggravated by, work-related factors. Work-related asthma (WRA) is defined as asthma that is exacerbated or induced de novo by inhalation exposures in the workplace. As a preventable occupational disease, WRA is associated with serious adverse health and socioeconomic consequences (ref). Among the 2.25 million Americans aged 15 to 65 years at risk for WRA, healthcare workers (HCWs) are at greater risk compared to other occupational groups (ref). This is compounded by a projected growth of 14.3% in the healthcare workforce between 2010 and 2020

R01OH011344 (Pompeii) 09/30/15 - 08/31/17 2.40 calendar NIH $ 394,454 The Associations of Mid- and Late-Life Physical Activity on Falls in a Large Prospective Study of Older Adults The major goals of this project are to determine associations between objective measures of physical activity and risk of falls and injurious falls (and whether these associations vary by sex, age, and race); to evaluate the impact of falls on subsequent physical activity levels; and to examine the association of trajectories of physical activity from mid- and late-lie with physical activity, physical function and fall risk in later life.

5U01OH010815-03 (Douphrate) 09/01/14 - 08/31/17 1.20 calendar UTHSC-Tyler / CDC $ 82,234 Development of Safety Management and Leadership Training Program for Logging Contractors The long-term goal of the proposed project is to reduce or eliminate injuries and fatalities among a vulnerable workforce of logging workers. The objectives of this proposal are to describe safety management practices currently being used on logging cut sites, as well as examine the relationships between safety leadership, group safety climate, and worker safety behaviors. This study will engage logging contractors in a participatory

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0925-0001 (Rev. 03/16) Page Continuation Format Page

approach to develop a survey instrument to assess safety management and leadership among contractors, and group safety culture and safety behaviors among workers. The administration of this instrument will generate data which will help develop a safety management and leadership training module for logging contractors.

5T42OH008421-10 (Symanski) 07/01/15 - 06/30/20 0.24 calendar CDC $ 1,212,122 Southwest Center for Occupational and Environmental Health The UT ERC provides advanced degree training in occupational health and safety to meet the critical need for trained professionals in PHR 6. A full spectrum of degree programs, advanced research training, and continuing education courses help meet the needs of the Region for well-trained professionals to protect the health and safety of the nations' workforce.

SH-29638-16-60-F-48 (Douphrate) 09/30/16 - 09/29/17 1.20 calendar DEPT. OF LABOR / OSHA $ 102,275 Dairy Farm Safety and Livestock Handling Training Occupational health and safety researchers from UTHealth propose a Capacity Building Development grant to foster the adoption of safe work practices by workers on large-herd dairy farms. This training program addresses the variability of safety needs within and across dairy farms through the application of mobile-learning technologies, as well as classroom-based and field-base live demonstration.

PENDING (Pompeii) 04/01/17 - 03/31/20 3.00 calendar CDC $ 300,709 Workplace Violence in Outpatient Physician Clinics Workplace violence (WPV) incurred by healthcare workers, including verbal abuse, physical threats, and physical assaults can have devastating effects on workers. WPV has been studied among hospital, yet no studies have examined the risk of WPV among the 2.5 million U.S. workers employed in outpatient physician clinics. In 2010, Bureau of Labor Statistics (BLS) estimated a rate of 0.9/10,000 WPV events in these clinics, which suggests the WPV risk is low. However, the majority (75%) of these clinics are exempt from OSHA reporting requirements due to their small size (<11 employees), suggesting that these estimates are not a reliable measure of what these workers may be experiencing. Studies outside the U.S. have reported concerning estimates for patient-perpetrated violence (Type II Violence) against clinic workers including verbal abuse (42%-99%), physical threats (27%-39%), and physical assaults (3%-27%). These estimates are on par with those reported for hospital workers, as well as some contributing factors such as patient drug seeking and mental illness. What is not similar is that these workers are managing violent patients in environments without the same level of protection available in hospitals, such as on-site security personnel, making them vulnerable for injury risk. These workers may also be vulnerable because they handle/exchange money and work in clinics in resource-poor neighborhoods – factors associated with crime-related violence (Type I Violence) in other industries. The small size of these establishments may also offer less protection to workers who experience other forms of violence, as well. We propose to study the scope of WPV (Types I through IV) among 2,600 workers in 182 physician clinics that are part of two healthcare systems in Houston, TX. We will employ a three-year cross-sectional study in which we will conduct clinic walk-though surveys, focus groups/key informant interviews, an online survey, and an assessment of clinic community characteristics to learn more about WPV and WPV management/prevention in these settings/ More specifically, we aim to: (1) Describe the risk of WPV among outpatient physician clinic workers and identify factors associated with WPV including worker, job tasks, clinic, clinic system, and community level characteristics; (2) Characterize WPV prevention practices and policies employed by outpatient physician clinics, including the WPV prevention resources provided by their clinic system owners; and

1R21OH011386-01 (Conway) 04/01/17 - 03/31/19 0.60 calendar CDC / NIOSH $ 107,157 Occupational Exposures to Long Work Hours: Thresholds of Effect and Influence of Exposure Patterns on Chronic Health Conditions

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0925-0001 (Rev. 03/16) Page Continuation Format Page

The proposed work employs innovative analytical methods establish in other fields to perform exposure-response modeling of long work hours and two common and costly adverse health outcomes: hypertension and diabetes.

OVERLAP None

QUIJANO, Louise M.

ACTIVE None

PENDING None

OVERLAP None

ROMAN-MUNIZ, Noa

ACTIVE None

PENDING None

OVERLAP None

ROSECRANCE, John C.

ACTIVE 5T42OH009229 (Newman, UCDHSC) 07/01/11 - 06/30/20 0.54 academic CDC/NIOSH $ 197,093 0.18 summer Mountain and Plains Education Research Center - Ergonomics The major goal of this project is graduate training support for occupational medicine, industrial hygiene, ergonomics, health physics, and occupational health psychology. Role: PI for Ergonomics

1554933 PO 1000780762 (Johnson, UCB) 09/01/14 - 08/31/19 0.72 academic University of Colorado Boulder (subcontract) $ 15,076 0.24 summer CDC/NIOSH Enhancing Safety Climate through Leadership The major goal of this proposed study is to identify and validate the effective leadership skills considered critical to safety in the construction industry. Role: Co-Investigator

PENDING None

OVERLAP None

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0925-0001 (Rev. 03/16) Page Continuation Format Page

SCHAEFFER, Joshua

ACTIVE 5U01OH010840 09/01/14 - 08/31/17 2.82 calendar CDC/NIOSH (Reynolds, Magzamen, Schaeffer - PI’s) $ 184,828 Design and evaluation of interventions to improve dairy Worker respiratory health This project will better characterize bioaerosols to understand the implication of the presence of peptidoglycans and β-glucans. The overall goal is to identify and evaluate potential interventions to reduce exposure.

RD-83563501-0 03/02/14 - 03/01/19 0.64 calendar EPA STAR (Cross, PI) $ 265,594 Sustainable Places, Health and Educational Research in Schools (SPHEReS) The objective of this study is to examine which combination of building features, materials, construction practices, and operations and maintenance practices are most effective in creating healthy indoor air quality resulting in optimal health and a safe learning environment. Role: Co-Investigator

PENDING CDC/NIOSH (Reynolds, Magzamen, Schaeffer) 09/15/17 – 09/14/21 3.60 calendar

$ 290,000 Antimicrobial resistant bacteria: Exposures and health of dairy workers The goal of this study is to combine microbial exposure assessment and epidemiologic studies to understand the prevalence of antimicrobial resistant (AMR) bacterial in dairy environmental samples and dairy worker personal samples, and to elucidate the role of AMR bacterial in systemic inflammation and lung function in workers.

OVERLAP None

SMALLEY, Scott W.

ACTIVE 2016-68004-24768 03/01/16 – 02/29/20 0.60 calendar USDA-CAP Grant $ 3,985,000 Back to the Future: Enhancing food security and farm production with integrated crop-livestock production systems. Project goals include: Developing an integrated crop-livestock production system with the development of educational curriculum, learning activities for agricultural education instructors. Role: Co-Investigator

PENDING NSF 01/01/18 - 12/31/22 1.0 calendar CNH-L $ 1,701,790 Development of Regionally-appropriate Biomass Feedstock Systems for Bioenergy, Industrial Chemicals, and Bio products Project goals include: To improve the economic and ecological sustainability of livestock production in the northern Great Plains.

OVERLAP None

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Program Director/Principal Investigator (Last, First, Middle): Reynolds, Stephen J. ALL PERSONNEL REPORT

Place this form at the end of the signed original copy of the application. Do not duplicate.

GRANT NUMBER

2U54OH008085-13

Always list the PD/PI(s). In addition, list all other personnel who participated in the project during the current budget period for at least one person month or more, regardless of the source of compensation (a person month equals approximately 160 hours or 8.3% of annualized effort). Use the following abbreviated categories for describing Role on Project:

• PD/PI* • Statistician• Co-Investigator • Graduate Student (research assistant)• Faculty • Non-student Research Assistant• Postdoctoral (scholar, fellow, or other • Undergraduate Student

postdoctoral position)* • High School Student• Technician • Consultant• Staff Scientist (doctoral level) • Other (please specify)

If personnel are supported by a Reentry or Diversity Supplement please indicate such after the Role on Project, using the following abbreviations: RS - Reentry Supplement; DS - Diversity Supplement. *Commons ID required for any personnel holding this Role on Project and for all individuals supported by a Reenty orDiversity Supplement. The Commons ID will be required in the future for all individuals with a graduate student, orundergraduate role. The Commons ID is strongly encouraged, but not required, for all other Project Personnel.Use Cal (calendar), Acad, or Summer to enter months devoted to project.

Commons ID* Name Degree(s)

SSN (last 4 digits) Role on Project

DoB (MM /YY) Cal Acad Summer

SJReynolds Reynolds, Stephen Ph.D. 9689 Center Director/PI 07/55 1.62 0.54

LORANNS Stallones, Lorann Ph.D. 2709 Deputy Director 05/52 1.80 0.60

DDOUPH7 Douphrate, David Ph.D. 6803 Associate Director 10/69 4.56

J.Arroyo_Vera Arroyo Vera, Jose Gustavo

BS 1590 GRA 12/93 6.0

pdayers Ayers, Paul Ph.D. 5992 PI - UTENN 06/56 2.06

A.Cassidy Cassidy, Allison MS 9829 Coordinator, Outreach

12/81 6.0

GIMENOD Gimeno, David Ph.D. 3728 Co-Investigator 11/73 1.20

A.Keeney Keeney, Adrianne MSW 7355 Student Hourly 04/84 4.50

T.King King, Taylor BA 0771 GRA 03/94 2.68

RLawver Lawver, Rebecca Ph.D. 7619 Co-Investigator 04/73 1.0

mlpate Pate, Michael Ph.D. 2989 PI - USU 08/82 2.50

DUSTINPERRY Perry, Dustin Ph.D. 4044 Co-Investigator 12/86 1.0

K.PETERSEN Petersen, Kathy 5513 Acctg Tech IV 12/54 1.20

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lpompeii Pompeii, Lisa Ph.D. 2123 Co-Investigator 10/65 1.20

L.QUIJANO Quijano, Louise Ph.D. 3963 PI - Evaluation 01/64 1.71 0.57

N.ROMAN-MUNIZ

Roman-Muniz, Noa Ph.D. 0557 Co-Investigator 07/76 0.90 0.30

MALROSE Rose, Malcolm MS 7331 Project Assistant 09/85 1.25

johnrosecrance Rosecrance, John Ph.D. 0824 Co-Investigator 01/58 1.44 0.48

Smalley1 Smalley, Scott Ph.D. 2442 Co-Investigator 09/82 1.0

C.Worrell Worrell, Cortney MS 0415 GRA 11/67 3.0

0925-0002 (Rev.03/16) Page Form Page 7 125

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Institution Name: COLORADO STATE UNIVERSITYAward Number: 2 U54 OH008085-14

Component TitlePlanning/Eval Core -

Center AdminPlanning/Eval Core -

Emerging IssuesPlanning/Eval Core -

Evaluation Outreach CorePilot/Feasibility

Program

Occ Safety Mgmt & Leadership on Large-

Herd Dairy FarmsAgric Safety Education

Initiative

Dev of Eng Controls to Reduce Foldable

ROPS OF

PI Reynolds, Stephen Reynolds, Stephen Quijano, Louise Stallones, Lorann Clark, Maggie Douphrate, David Pate, Michael Ayers, Paul

FWA # and expiration date 00000647 05/08/18 00000647 05/08/18 00000647 05/08/18 00000647 05/08/18 00000647 05/08/18

00000647(CSU) 05/08/18 000000667 (UTHSCH)

02/01/17 00003308 03/18/20 00006629 08/20/19

IRB Approval Date No Human Subjects No Human Subjects 02/15/17 CSUSubmitted 118 (IRB pending) No Human Subjects 07/12/16 (UTHealth) 8/26/16 (USU) No Human Subjects

Salaries & Wage $77,836 $0 $66,812 $121,245 $12,042 $16,179 $38,485 $34,503 $367,102Fringe Benefits $22,608 $0 $15,689 $27,068 $3,383 $4,546 $15,176 $8,772 $97,242 Personnel Costs $100,444 $0 $82,501 $148,313 $15,425 $20,725 $53,661 $43,275 $464,344Consultant Services $0 $0 $0 $0 $0 $0 $0 $0 $0

Service 1 $0 $0 $0 $0 $0 $0 $0 $0 $0Service 2 $0 $0 $0 $0 $0 $0 $0 $0 $0

Misc Service $0 $0 $0 $0 $0 $0 $0 $0 $0Equipment $0 $0 $0 $0 $0 $0 $0 $0 $0Supplies $1,120 $0 $2,060 $1,597 $0 $0 $2,553 $6,280 $13,610Travel Costs - Domestic $17,918 $0 $3,090 $12,246 $3,000 $5,000 $6,545 $6,000 $53,799Travel Costs - International $9,000 $0 $3,263 $4,294 $16,557Other Costs $5,459 $50,000 $9,086 $33,550 $51,575 $0 $10,655 $0 $160,325Consortium / Contractual Costs $16,059 $0 $0 $0 $0 $224,275 $86,586 $24,445 $351,365

Contract 1 $10,428 $0 $0 $0 $0 $145,633 $38,484 $0Contract 2 $0 $0 $0 $0 $0 $0 $38,500 $0

Misc Contract - Consortium F&A $5,631 $0 $0 $0 $0 $78,642 $9,602 $24,445 Total Direct Costs $150,000 $50,000 $100,000 $200,000 $70,000 $250,000 $160,000 $80,000 $1,060,000FA Cost Rate (as a percentage) 34% 52% 34% 34% 52% 52% ---FA Cost Base $143,350 $50,000 $94,599 $200,000 $70,000 $25,725 $583,674 Total FA Costs $48,739 $26,000 $32,164 $68,000 $36,400 $13,377 $0 $0 $224,680 Grand Total $198,739 $76,000 $132,164 $268,000 $106,400 $263,377 $160,000 $80,000 $1,284,680

Grand Totals

Planning & Evaluation Core - $406,903

Page 127: Program Director/Principal Investigator (Last, First, Middlecsu-cvmbs.colostate.edu/Documents/hicahs-2017-progress-report.pdf · Reynolds, Stephen, PhD, Center Director, Annual Salary

Center Director:__Dr. Stephen Reynolds____ Applicant Institution:___Colorado Sate University__

PAR-15-303 Table 2 January 2017

P&E Core Outreach Core

Reynolds, Stephen Center Director/PI1.35 acad; 0.45 summer

Stallones, Lorann Deputy Director0.90 acad; 0.30 summer

Douphrate, David Assoc. Director 3.60 cal

Petersen, Kathy Accty Tech IV 1.20 cal

Quijano, Louise PI - Evaluation1.71 acad; 0.57 summer

Keeney, AdrianneStudent Hourly - Evaluation 4.50 cal

Worrell, Cortney GRA - Evaluation 3.00 cal

Ayers, Paul PI - UTENN 2.06 cal

Martin, Luke Student Hourly 2.00 cal

Douphrate, David PI - UTHealth 0.96 cal

Gimeno, David Co-Investigator 1.20 cal

Pompeii, Lisa Co-Investigator 1.20 cal

Reynolds, Stephen Co-Investigator0.27 acad; 0.09 summer

Roman-Muniz, Noa Co-Investigator

Pate, Michael PI - USU 2.50 cal

Lawver, Rebecca Co-Investigator

Malcolm, Rose Project Asst 1.25 cal

Perry, Dustin PI - Consortium 1.00 cal

Smalley, Scott PI - Consortium 1.00 cal

Clark, Maggie PI0.45 acad; 0.15 summer

Stallones, Lorann PI - Outreach0.90 acad; 0.30 summer

Rosecrance, John Co-Investigator1.44 acad; 0.48 summer

Cassidy, Allison Coordinator 6.00 cal

Arroyo Vera, Jose Gustavo GRA 6.00 cal

King, Taylor GRA 2.68 cal

Personnel

Colorado State University - U54OH008085-13Investigators, Key Personnel and Significant Contributors

Outreach

Research Core

Role ROPS - Ayers

(UTENN)

Project #5

Project #6

Project #7

Ag Safety - Pate (USU)

OccSM - Douphrate (UTHealth)

Pilots Project #8Name

*List all investigators, key personnel and significant contributors. For each individual, report the calendar/academic/summer months devoted to the corresponding core/project/program area. Please replace "Project #" w/ an abbreviated research project title. Pilot/Feasibility programs fall under the Research Core.

Planning and

Evaluation

127