FR_FedGuidanceCA

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48894 Federal Register / Vol. 65, No. 155/ Thursday, August 10, 2000/ Rules and Regulations

good cause exists for making someSIAPs effective in less than 30 days.

Conclusion

The FAA has determined that thisregulation only involves an established

body of technical regulations for whichfrequent and routine amendments arenecessary to keep them operationally

current. It, therefore—(1) is not a‘‘significant regulatory action’’ underExecutive Order 12866; (2) is not a‘‘significant rule’’ under DOTRegulatory Policies and Procedures (44FR 11034; February 26, 1979); and (3)does not warrant preparation of aregulatory evaluation as the anticipatedimpact is so minimal. For the samereason, the FAA certifies that thisamendment will not have a significanteconomic impact on a substantialnumber of small entities under thecriteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

Air Traffic Control, Airports,Navigation (Air).

Issued in Washington, DC on August 4,2000.

L. Nicholas Lacey,

Director, Flight Standards Service.

Adoption of the Amendment

Accordingly, pursuant to theauthority delegated to me, part 97 of theFederal Aviation Regulations (14 CFRpart 97) is amended by establishing,amending, suspending, or revokingStandard Instrument Approach

Procedures, effective at 0901 UTC onthe dates specified, as follows:

PART 97—STANDARD INSTRUMENTAPPROACH PROCEDURES

1. The authority citation for part 97 isrevised to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,40120, 44701; and 14 CFR 11.49(b)(2).

2. Part 97 is amended to read asfollows:

§§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33,and 97.35 [Amended]

By amending: §97.23 VOR, VOR/

DME, VOR or TACAN, and VOR/DMEor TACAN; §97.25 LOC, LOC/DME,LDA, LDA/DME, SDF, SDF/DME;§ 97.27 NDB, NDB/DME; § 97.29 ILS,ILS/DME, ISMLS, MLS, MLS/DME,MLS/RNAV; §97.31 RADAR SIAPs;§ 97.33 RNAV SIAPs; and §97.35COPTER SIAPs, identified as follows:

* * * Effective October 5, 2000

Walnut Ridge, AR, Walnut Ridge Regional,VOR–A, Amdt 16

Walnut Ridge, AR, Walnut Ridge Regional,VOR/DME RWY 22, Amtd 13

Walnut Ridge, AR, Walnut Ridge Regional,LOC RWY 18, Amdt 3

Walnut Ridge, AR, Walnut Ridge Regional,NDB RWY 18, Amdt 4

Jacksonville, FL, Cecil Field , VOR RWY 9R,Orig

Alton/St. Louis, IL, St. Louis Regional, NDBOR GPS RWY 29, Amdt 10B

Carbondale/Murphysboro, IL, SouthernIllinois, NDB OR GPS RWY 18L, Amdt 12C

Champaign-Urbana, IL, University of Illinois-Willard, NDB OR GPS RWY 32L, Amdt10B

Danville, IL, Vermilion County, VOR/DMEOR GPS RWY 3, Amdt 11B

Effingham, IL, Effingham County Memorial,LOC RWY 29, Amdt 1B

Galesburg, IL, Galesburg Muni, VOR OR GPSRWY 21, Amdt 6B

Macomb, IL, Macomb Muni, NDB OR GPSRWY 27, Amdt 2D

Pekin, IL, Pekin Muni, VOR/DME RNAV ORGPS RWY 9, Amdt 5A

Peoria, IL, Greater Peoria Regional, NDB ORGPS RWY 31, Amdt 14A

South Bend, IN, South Bend Regional, VOROR GPS RWY 18, Amdt 7B

South Bend, IN, South Bend Regional, NDBOR GPS RWY 27L, Amdt 28C

Hays, KS, Hays Regional, RNAV RWY 34,Orig

Frenchville, ME, Northern AroostockRegional, NDB RWY 32, Amdt 6

Frenchville, ME, Northern AroostockRegional, RNAV RWY 14, Orig

Frenchville, ME, Northern AroostockRegional, RNAV RWY 32, Orig

College Park, MD, College Park, RNAV RWY15, Orig

College Park, MD, College Park, VOR/DMERNAV RWY 15, Amdt 3

Gaithersburg, MD, Montgomery CountyAirpark, VOR RWY 14, Amdt 3

Gaithersburg, MD, Montgomery County

Airpark, NDB RWY 14, Amdt 1Gaithersburg, MD, Montgomery County

Airpark, RNAV RWY 14, OrigGaithersburg, MD, Montgomery County

Airpark, VOR/DME RNAV RWY 14, Amdt4, CANCELLED

Stevensville, MD, Bay Bridge, VOR/DMERWY 29, Amdt 1

Stevensville, MD, Bay Bridge, RNAV RWY11, Orig

Stevensville, MD, Bay Bridge, GPS RWY 11,Orig, CANCELLED

Stevensville, MD, Bay Bridge, RNAV RWY29, Orig

Westminster, MD, Carroll County Reg/Jack B.Poage Field, VOR–A, Amdt 1

Westminster, MD, Carroll County Reg/Jack B.

Poage Field, VOR RWY 34, Amdt 4Westminster, MD, Carroll County Reg/Jack B.

Poage Field, RNAV RWY 16, OrigWestminster, MD, Carroll County Reg/Jack B.

Poage Field, RNAV RWY 34, OrigWestminster, MD, Clearview Airpark, VOR–

A, Amdt 4Westminster, MD, Clearview Airpark, RNAV

RWY 14, OrigChillicothe, OH, Ross County, VOR RWY 23,

Amdt 3BColumbus, OH, Bolton Field, NDB OR GPS

RWY 4, Amdt 6BColumbus, OH, Rickenbacker Intl, NDB OR

GPS RWY 23L, Orig-A

Findlay, OH, Findlay, GPS RWY 18, Amdt1A

Fremont, OH, Sandusky County Regional,GPS RWY 6, Orig-A

Fremont, OH, Sandusky County Regional,GPS RWY 24, Orig-A

Lancaster, OH, Fairfield County, LOC RWY28, Amdt 1A

Lancaster, OH, Fairfield County, NDB ORGPS RWY 28, Amdt 8A

Lancaster, OH, Fairfield County, VOR/DMERNAV OR GPS RWY 10, Amdt 10A

Lima, OH, Lima Allen County, VOR OR GPSRWY 27, Amdt 14B

Marion, OH, Marion Muni, GPS RWY 24,Orig-A

Mount Vernon, OH, Knox County, VOR/DMERNAV OR GPS RWY 28, Amdt 2B

Springfield, OH, Springfield-Beckley Muni,NDB OR GPS RWY 24, Amdt 16A

Wapakoneta, OH, Neil Armstrong, LOC RWY26, Amdt 3C

Wapakoneta, OH, Neil Armstrong, VOR/DMERNAV OR GPS RWY 26, Amdt 5C

Springfield, TN, Springfield-RobertsonCounty, LOC RWY 4, Orig

Springfield, TN, Springfield-Robertson

County, NDB RWY 4, OrigCorsicana, TX, C. David Campbell Field-

Corsicana Muni, VOR/DME–A, Amdt 1Corsicana, TX, C. David Campbell Field-

Corsicana Muni, VOR/DME–B, Amdt 1Corsicana, TX, C. David Campbell Field-

Corsicana Muni, NDB RWY 14, Amdt 4Corsicana, TX, C. David Campbell Field-

Corsicana Muni, NDB RWY 32, Amdt 3Corsicana, TX, C. David Campbell Field-

Corsicana Muni, RNAV RWY 14, OrigCorsicana, TX, C. David Campbell Field-

Corsicana Muni, RNAV RWY 32, OrigCharlotte Amalie, VI, Cyril E King, GPS RWY

10, Orig, CANCELLEDCharlotte Amalie, VI, Cyril E King, RNAV

RWY 10, Orig

[FR Doc. 00–20275 Filed 8–9–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF COMMERCE

National Institute of Standards andTechnology

15 CFR Part 287

[Docket No. 981222315–0219–02]

RIN 0693–AB49

Guidance on Federal Conformity

Assessment Activities

AGENCY: National Institute of Standardsand Technology (NIST), Commerce.

ACTION: Final policy guidance.

SUMMARY: This document contains finalpolicy guidance on Federal agency useof conformity assessment activities. Theprovisions are solely intended to beused as guidance for agencies in theirconformity assessment activities and donot preempt the agencies’ authority andresponsibility to make regulatory

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48895Federal Register / Vol. 65, No. 155/ Thursday, August 10, 2000/ Rules and Regulations

procurement decisions authorized bystatute or required to meetprogrammatic objectives andrequirements.

DATES: This guidance becomes effectiveAugust 10, 2000.FOR FURTHER INFORMATION CONTACT: Dr.Belinda Collins, Director, Office of

Standards Services, National Institute of Standards and Technology, Building820, MS 2100, Room 282, Gaithersburg,MD 20899. Phone: (301) 975–4000.SUPPLEMENTARY INFORMATION:

Background

This guidance outlines Federalagencies’ responsibility for evaluatingthe efficacy and efficiency of theirconformity assessment activities. Eachagency is responsible for coordinatingits conformity assessment activities withthose of other appropriate governmentagencies and with those of the privatesector to make more productive use of the increasingly limited Federalresources available for the conduct of conformity assessment activities and toreduce unnecessary duplication.

This guidance applies to all agencies,which set policy for, manage, operate, oruse conformity assessment activitiesand results, both domestic andinternational, except for activitiescarried out pursuant to treaties.‘‘Agency’’ means any Executive BranchDepartment, independent commission,

board, bureau, office, agency,government-owned or controlledcorporation, or other establishment of

the Federal government. It also includesany regulatory commission or board,except for independent regulatorycommissions subject to separatestatutory requirements regarding policysetting, management, operation, and useof conformity assessment activities. Itdoes not include the legislative orjudicial branches of the Federalgovernment.

History of the Guidance

In February 1996, The NationalTechnology Transfer and AdvancementAct (NTAA) of 1995 was enacted by

Congress. Section 12 of the Act directedNIST to coordinate conformityassessment activities of Federal, stateand local entities with private sectortechnical standards activities andconformity assessment activities withthe goal of eliminating any unnecessaryduplication of conformity assessmentactivities. The Office of Managementand Budget (OMB) Circular A–119,revised February 19, 1998 directed theSecretary of Commerce to issueguidance to the agencies to ensureeffective coordination of Federal

conformity assessment activities. TheDirector of the National Institute of Standards and Technology (NIST),United States Department of Commerce,published proposed guidance in theFederal Register on Federal conformityassessment activities on November 3,1999 (64 FR 59691 (1999)). Closing datefor comments was January 18, 2000.

Summary of Public Comments Received by the Agency in Response to theNovember 3, 1999 Request for PublicComments, and the Agency’s Responseto the Comments

NIST received comments from ninecommentors, including: one nationalstandards coordinating and conformityassessment accreditation body, onegovernment agency, one internationalcompany, one laboratory accreditation

body, one certification body, oneconsulting organization, and three tradeassociations in response to its request.

In addition, in September 1999, the U.S.General Accounting Office (GAO)published a report, entitled ‘‘GAO/GGD–99–170—CertificationRequirements: New Guidance ShouldEncourage Transparency in AgencyDecisionmaking,’’ which contained arecommendation for including a sectionin the guidance on the issue of transparency in agency certificationdecisionmaking. The 51 comments aswell as the GAO recommendation wereconsidered in finalizing the guidance.The following summarizes thecomments received and the agency’sresponse to the comments.

General Comments

One national standards coordinatingand conformity assessmentaccreditation body commented that theguidance should task only NIST withsubstantive objectives and identify theapproach and procedures foraccomplishing them.

Response: In OMB Circular A–119,OMB stated that ‘‘(t)o ensure effectivecoordination, the Secretary of Commerce must issue guidance to theagencies.’’ This guidance is a responseto that mandate. The suggested

approach would not be consistent withOMB’s mandate.One laboratory accreditation body

commented the proposed rule should bewithdrawn and that the guidance beissued as an annex to OMB Circular A–119.

Response: This document is intendedto serve as guidance for Federal agenciesin implementing their responsibilitiesunder the NTTAA, and is not a rule.The guidance was issued at thedirection of OMB, which chose not toinclude conformity assessment in OMB

Circular A–119. This comment has beenforwarded to OMB for considerationduring the next revision of the Circular.

One government agency commentedthat while the examples in the guidancewere helpful in describing how theguidance may be implemented, theyshould remain examples in the finalversion of the guidance.

Response: NIST agrees with thiscomment.

One government agency commentedthat Federal regulatory programs thatengage in conformity assessment mustapply a high degree of scrutiny toensure that requirements are met.Therefore, it may be very difficult torely on the work of private sectororganizations, which understandablyperform their activities for other motivesand perhaps to a lesser degree of scrutiny. The guidance should presentthe option that private sectororganizations rely on the conformityassessment activities of a Federalagency. This option would also promotethe objectives under the proposedSection 287.1.

Response: Elimination of unnecessaryduplication and complexity inconformity assessment activities can beaccomplished by relying on privatesector conformity assessment programsand activities. However, reduction induplication and complexity can also beaccomplished by Federal agencyreliance on other governmentalconformity assessment activities, byreliance on supplier’s declaration of conformity, or by encouraging the

private sector to rely on governmentalactivities. The NTTAA does not indicatea preference for any specific approach.The determination of which approach

best meets agency objectives is theresponsibility of the agency.

Comments on Section 287.1

One national standards coordinatingand conformity assessmentaccreditation body commented thatSection 287.1 should provide moreinformation on the evaluationprocedures to be used to evaluate theefficacy and efficiency of Federal

conformity assessment activities.Response: The variety of conformityassessment activities conducted bydifferent Federal agencies precludesdevelopment of specific evaluationtechniques that would apply to allagencies. Guidance on how to measurecertain aspects of performance(regulatory burden, cost-benefit issues,etc.,) is available from the Office of Management and Budget (OMB) andfrom other sources within the Federalgovernment, but this guidance mustusually be tailored to reflect the type of





activities a given agency undertakes.NIST believes that evaluations of onlyone aspect of program performance can

be misleading. Evaluations of programperformance/effectiveness shouldconsider all programmatic aspects,including an agency’s legislativemandates, program objectives andresource availability.

One laboratory accreditation bodycommented that the second and thirdsentences of Section 287.1 should bereplaced by: ‘‘Each agency should seekways in which it can use existingconformity assessment activities of theprivate sector instead of creating ormaintaining their own activities.’’

Response: The purpose and scope, ascurrently written in Section 287.1, bestreflects the intent stated in the Act,which is to eliminate ‘‘unnecessaryduplication and complexity in thedevelopment and promulgation of conformity assessment requirementsand measures.’’ This can beaccomplished in a number of ways.Using the results of private sectorconformity assessment activities is onlyone method.

One laboratory accreditation bodycommented that the last sentence of Section 287.1 should be revised to citethe role of the U.S. Trade Representative(USTR) in overseeing theimplementation of the U.S. tradeobligations including commitmentsunder the World Trade Organization(WTO) Agreement on Technical Barriersto Trade (TBT).

Response: The guidance is not

intended to address U.S. obligations orthe USTR’s role in implementing theWTO Agreement or in other tradeagreements. This guidance addressesonly matters covered in the NTTAA.The Federal government’s obligationsunder the World Trade OrganizationAgreement and other trade agreementsare addressed elsewhere.

One consulting organizationcommented that NIST should state itsposition on who is responsible foraccreditation in the United States.

Response: Accreditation activities can be conducted by either the public and/

or the private sector. The appropriatesector to be assigned responsibility foraccreditation should be determined on acase-by-case basis. The need foraccreditation also needs to bedetermined on a case-by-case basis.There is no one-size-fits-all solution tothis issue.

One certification body commentedthat the Interagency Committee onStandards Policy (ICSP) should beopened to regular participation andattendance by private sector standardsdevelopers and organizations providing

conformity assessment services tofacilitate cooperation and confidence

between the government and privatesector conformity assessmentorganizations.

Response: The ICSP has invited anumber of standards developers andconformity assessment organizations topresent information and viewpoints on

topics of interest to the ICSP. However,the ICSP is an interagency committee.Membership is restricted to the Federaldepartments and agencies listed in itscharter.

One certification body commentedthat the promotion of accreditation and/or recognition organizations that havenot demonstrated added value to themarketplace should be discouraged.

Response: NIST agrees with thiscomment. Agencies are responsible formeeting programmatic objectives in acost-effective manner. However, it is theresponsibility of each agency to

determine which approach best meetsits needs.One certification body commented

that no single mechanism can meet theneeds of all suppliers or acceptanceauthorities around the globe. Newmechanisms that facilitate trade,provide regulatory confidence andprotect public safety should beconsidered as they are developed andproven effective to meet the needs of supplier and acceptance authorities.

Response: NIST agrees with thiscomment. However, it remains theresponsibility of each agency todetermine which mechanisms are

appropriate for application within itsprograms.

One trade association commented thatthe following objectives should beincluded in the proposed guidance:

• Eliminate the cost to government of conducting (developing) its ownconformity assessment activities andthereby decrease the cost of goodsprocured and the burden of complyingwith agency regulation;

• Provide incentives andopportunities (to whom) to establishconformity assessment programs thatserve national needs;

•

Encourage long term growth of U.S.enterprises and promote efficiency andeconomic competition throughharmonization of conformity assessmentactivities; and

• Further the policy of reliance uponthe private sector to supply thegovernment need for goods and services.

Response: While the statements listedabove are a partial list of potential

benefits from implementation of theguidance, the objective of the guidancewas clearly and succinctly defined inthe NTAAA—to eliminate ‘‘unnecessary

duplication and complexity in thedevelopment and promulgation of conformity assessment requirementsand measures.’’


One national standards coordinatingand conformity assessmentaccreditation body commented that the

definition of recognition is too narrowin section 287.2 and is inconsistent withthe way it is used in the example insection 287.4.

Response: While the definition for theterm ‘‘recognition’’ in Section 287.2 isappropriate; the term has been changedin the example.

One national standards coordinatingand conformity assessmentaccreditation body and one tradeassociation commented that thedefinitions in the InternationalOrganization for Standardization/International ElectrotechnicalCommission (ISO/IEC) Guide 2 should

be cited without modification.Response: The definitions in section

287.2 were based on ISO/IEC Guide 2, but the definitions have been modifiedto better address the nature of Federalgovernment conformity assessmentactivities. Definitions were considerednecessary because agencies do not useconsistent terminology in theirregulatory and procurement conformityassessment programs. This inconsistentuse of terminology could createpotential confusion for agencies readingthe guidance. NIST decided to defineonly those terms which were considered

to be necessary to understand theguidance.

One laboratory accreditation bodycommented that the World TradeOrganization (WTO) Agreement onTechnical Barriers to Trade (TBT)definition of conformity assessmentshould be referenced and ‘‘mandatoryadministrative procedures’’ should not

be excluded from the definition.Response: ISO/IEC Guide definitions

have been used in accordance with theNTTAA’s requirements that preference

be given to the use of voluntaryconsensus standards. There is also no

evidence in the Act or legislative historythat Congress intended to includemandatory administrative procedures.

The Occupational Safety and HealthAdministration (OSHA) commented thatsome of the key definitions in the noticedo not correctly depict the OccupationalSafety and Health Administration’s(OSHA’s) National Recognized TestingLaboratory (NRTL) Program. OSHArecognizes a testing/certification bodyunder the NRTL Program, not anaccreditation body. In addition, theagency commented that OSHA’s





recognition does not mean that anorganization is ‘‘competent’’ in testingor in certification to the extent that‘‘competent’’ means adept, proficient ora similar term. To obtain recognition, anorganization must demonstrate that itmeets the requirements in 29 CFR1910.7, but this regulation does notinclude requirements for proficiency or

other criteria to judge ‘‘competence.’’Response: NIST agrees that agencies

do not use standardized terminology intheir conformity assessment activities.In defining key terms, NIST intended tolet the reader know what is meant bythat term within the context of theguidance. NIST recognizes that the sameterm may be used by different agenciesto mean very different types of activities. A footnote will be added tothe definition for ‘‘accreditation’’ toaccommodate OSHA’s activities.

OSHA also commented that thedefinition of conformity assessment

describes requirements as beingapplicable to ‘‘products, services, andsystems,’’ but not to ‘‘organizations’’and requested that the word‘‘organizations’’ be added.

Response: The word ‘‘organizations’’has been added.

One international company, onelaboratory accreditation body, and onetrade association commented that theguidance should identify supplier’sdeclaration as an appropriate option foragencies to consider in their conformityassessment policies, taking into accountthe appropriate balance of risks and

benefits of first party (supplier), secondparty, and third party conformityassessment for specific products andservices. The same trade associationrecommended that NIST amend thedefinition in the proposed Section 287.2as follows: In the definition of conformity assessment, add ‘‘suppliersdeclaration of conformity’’ after‘‘inspection’’ and add a definition for‘‘supplier’s declaration of conformity.’’

Response: The guidance now includesreference to first, second and third partyconformity assessment activities andprocedures. The definition of

conformity assessment has beenamended to include ‘‘supplier’sdeclaration of conformity.’’ A definitionof ‘‘supplier’s declaration of conformity’’ has also been included.However, the guidance does not intendto suggest that any one method oractivity is preferable. It is theresponsibility of each agency to selectthe conformity assessment activities andprocedures, which will best meet itslegislative mandates and programmaticobjectives in the most cost-effective andefficient manner.


One national standards coordinatingand conformity assessmentaccreditation body commented thatNIST should be charged in section 287.3with ensuring that other agencies areaware of their obligation to adoptpolicies needed to accomplish the

purpose of this guidance.Response: While NIST is charged withcoordinating conformity assessmentactivities, agencies remain responsiblefor their own conformity assessmentactivities, including the adoption of anypolicies that agencies feel are needed tooperate in accordance with theirstatutory mandates. NIST is availableand willing to assist agencies in carryingout this responsibility and to provideguidance as needed.

One national standards coordinatingand conformity assessmentaccreditation body and one tradeassociation commented that some

attention should be given in section287.3 to NIST’s obligations beyond theFederal level, especially to itsobligations at the state level.

Response: NIST partially agrees withthis comment. The language in the Actis unclear as to what Congress intendedNIST to do with regard to stateconformity assessment activities.However, in the Congressional HouseRecord of 2/27/96 for The NationalTechnology Transfer and AdvancementAct (NTTAA), Representative Morellastated that: ‘‘Section 12 StandardsConformity. Restates existing authorities

for the National Institute of Standardsand Technology (NIST) activities instandards and conformity assessment.Requires NIST to coordinate amongFederal agencies, survey existing stateand Federal practices, and report backto Congress on recommendations forimprovements in these activities.’’ NISTis undertaking studies of existing stateconformity assessment practices, subjectto resource limitations. NIST also plansto undertake additional activities withthe states as resources become available.Any activities undertaken by NIST will

be conducted in a manner that respects

state sovereignty issues. NIST has addedthe following statement to the guidance:‘‘To the extent that resources areavailable, NIST will developinformation on existing state conformityassessment practices; and, upon request

by a state government agency, will workwith that agency to reduce duplicationand complexity in state conformityassessment activities.’’

One laboratory accreditation bodycommented that a new clause should beadded to section 287.3 so that NISTwould also ‘‘encourage government

participation and use of private sector,conformity assessment activities to themaximum extent practical.’’

Response: NIST disagrees. NIST isobligated to assist other Federalagencies in reducing duplication andcomplexity in their conformityassessment activities. The use of privatesector conformity assessment activities

is only one of a number of methods thatcan be used by an agency to accomplishthis goal. It remains the responsibility of the agency to determine which methodis most appropriate for its specificapplications.


One national standards coordinatingand conformity assessmentaccreditation body commented that theexample in section 287.4, which usesthe term ‘‘recognition,’’ does notsupport the use of the qualifier‘‘mutual.’’

Response: The agency agrees with thiscomment. The qualifier ‘‘mutual’’ has

been removed and the term‘‘recognition’’ has been replaced.

One national standards coordinatingand conformity assessmentaccreditation body and one laboratoryaccreditation body commented that alist of references, containing thedocuments of the organizations cited insection 287.4 should be inserted in thissection or that NIST should provide alist of specific conformity assessmentguides and standards, perhaps as aseparate document.

Response: NIST believes that a bettersolution is to address an agency’s needfor a list of applicable standards on acase-by-case basis. NIST’s NationalCenter for Standards and CertificationInformation (NCSCI) assists agencies toidentify possible conformity assessmentstandards/guides, which may be of interest for a specific application. Theorganizations listed in the guidance areexamples, and are not intended torepresent a comprehensive list of organizations that develop standardsand guidance in the conformityassessment area. A specific list could

omit standards of potential interest toagencies in conformity assessmentrelated areas or from other organizationsnot included as examples. In addition,such a list would rapidly becomeoutdated as ISO guides and standards inthe conformity assessment area arerevised, reissued, or removed. Lastly,standards that appear on such a listmight be presumed by some to have a‘‘special blessing’’ by NIST, whichcould create misunderstanding.Agencies can contact NCSCI for a list of standards in their area of interest.





One national standards coordinatingand conformity assessmentaccreditation body commented thatsection 287.4 should be rewritten toaddress the policies and procedures thatshould be adopted by agencies throughthe mechanism of the InteragencyCommittee on Standards Policy (ICSP).The development of a policy on

conformity assessment might bestipulated that would address the rolesof supplier’s declaration, third parties,and accreditors.

Response: As noted in section287.3(a), NIST will assist ‘‘the ICSP indeveloping policies and guidance onconformity assessment issues.’’ AgencyStandards Executives serving on theICSP are responsible for determiningwhich policies and procedures the ICSPshould develop, which might be usefulfor consideration within their agencies.However, the individual agency isresponsible for the final selection and

implementation of the policies andprocedures needed by the agency toimplement the goals of the NTTAA.

One national standards coordinatingand conformity assessmentaccreditation body commented that theICSP Agency Standards Executives’suitability for serving as change agentswith respect to the conformityassessment activities of the Federalgovernment should be reconsidered.

Response: The selection of the ICSPAgency Standards Executives is theresponsibility of the Agency, as noted insection 287.4(n). The agency isresponsible for selecting an individual

who is capable of carrying out theguidance in OMB Circular A–119 aswell as the guidance in this document.If needed, the Agency is free to assignadditional personnel to assist theAgency Standards Executive in carryingout these responsibilities.

One international companycommented that the examples listed insection 287.4(g) are limited to laboratoryissues and organizations that are closeto the Federal process. It would beappropriate to list some otherorganizations such as the AmericanNational Standards Institute (ANSI) or

the International Organization forStandardization’s (ISO) Committee onConformity Assessment (CASCO) toindicate the broader direction that isintended.

Response: The examples cited have been included in the guidance.

One international companycommented that organizations, such asthe American National StandardsInstitute (ANSI) or the InternationalOrganization for Standardization’s (ISO)Committee on Conformity Assessment(CASCO) be listed in section 287.4(j) to

indicate the broader direction that isintended.

Response: Section 287.4(j) does notlist examples. Participation in thedevelopment of any private sectorconformity assessment standards(consistent with the mission andobjectives of the agency) would beincluded in this section. ANSI does not

develop standards, so it would not beincluded in this section. ISO is a privatesector organization, which developsconformity assessment standards, soparticipation in ISO CASCO is includedin this section.

One laboratory accreditation bodycommented that in section 287.4(c),agencies need to consider ways to usenot only conformity assessment resultsof others (both domestic and foreign),

but the conformity assessment activitiesthemselves as a replacement for theirown activities.

Response: This comment addressesmatters beyond the scope of thisguidance. Regulatory and procurementobligations of Federal agencies have

been authorized by Congress, and suchactivities/systems cannot be replaced byprivate sector activities/systems withoutcongressional approval or legislativechange.

One laboratory accreditation bodycommented that the examples insections 287.4(e) and (h) are weak asthey only suggest an agency mightsupplement (not replace) its ownactivities with outside conformityassessment activities mainlyadministered by other government

agencies.Response: In section 287.4(e), NIST

will include the example of the FederalCommunications Commission’s FCCTelecommunications Certification Body(TCB) program, which allowsdesignated private entities to issuetelecommunications equipmentapprovals for specified regulatoryrequirements in essentially the samemanner as the FCC. FCC has alsoreplaced requirements for premarketingapproval with supplier’s declaration of conformity for certain types of equipment.

One laboratory accreditation bodycommented that in section 287.4(f), it isnot clear why ‘‘mutual recognition’’ isnecessary or desirable between agencieswhen one-way recognition may also beappropriate.

Response: This section has beenreworded.

One laboratory accreditation bodycommented that section 287.4(g) shoulddelete any reference to the NationalEnvironmental Laboratory AccreditationConference (NELAC) because NELACspecifically prohibits private sector

laboratory accreditation bodies from being part of NELAC by suggesting thataccreditation is an inherent governmentfunction. This is contrary to the intentof the NTTAA, which encourages use of private sector conformity assessmentactivities.

Response: The purpose of the NTTAAis to eliminate unnecessary duplication

and complexity in conformityassessment activities. While this can bedone by relying on private sectorconformity assessment programs andactivities, it can also be accomplished

by relying on other governmentalactivities, by relying on a supplier’sdeclaration of conformity, or byencouraging the private sector to rely ongovernmental activities. While agenciesshould consider alternative approachesin their rulemaking and procurementactivities, the determination of whichapproach best meets agency objectives isthe responsibility of the agency.

One laboratory accreditation body andone trade association commented thatsections 287.4(i) should cite the USTR’srole in trade policy. The same tradeassociation commented that sections287.4(j) should also cite the USTR’srole.

Response: While NIST recognizes theimportant role that the USTR has indeveloping trade related policies, aswell as the responsibilities placed onFederal agencies as a result of tradeagreements, such as the WTOAgreement, these roles andresponsibilities are defined in otherlegislation and related documents. This

guidance addresses only matterscovered in the NTTAA.

One laboratory accreditation bodycommented that there is no need forseparate government recognitionsystems if equivalent systems exist inthe private sector that provideequivalent recognition. Governmentrecognition systems would add costwithout adding value and would createunnecessary duplication andcomplexity, the opposite intent of theNTTAA.

Response: In trade agreements, theneed for government recognition of

conformity assessment bodies isdetermined not only by the U.S.Government, but also by the othercountries signatory to such anagreement. Since some governments donot deem the use of private sectorsystems to be adequate proof of competence in the absence of governmental recognition, suchrecognition becomes a requirementunder the terms of the specificagreement. For domestic regulatory andprocurement issues, it is theresponsibility of each Federal agency to





determine whether use of a privatesector system can adequately address allof its programmatic objectives and anyrelevant legislative mandates in a cost-effective manner.

One trade association commented thatwhile the reference to the NationalCooperation for LaboratoryAccreditation (NACLA) and the

National Environmental LaboratoryAccreditation Conference (NELAC) insection 287.4(g) begins to address theissue of duplication of accreditations fortesting programs, the proposed guidanceshould also provide direction related toother forms of conformity assessment,such as certification and registration.

Response: The organizations listed insection 287.4(g) are intended to serveonly as examples of activities in whichagencies should consider participation.The activities of ANSI have been addedto the list of examples to better illustratethe broad range of activities whereFederal participation is encouraged.

One trade association commented thatthe wording in section 287.4(c) shouldstrongly encourage the use of privatesector conformity assessment programsin lieu of the development of government programs. The same tradeassociation commented that Section287.4(e) include a requirement thatNIST provide a centralized coordinatingfunction in the determination of acceptable private sector conformityassessment practices. To allocate theresponsibility to each agency onlycontinues the duplication of accreditation and approval processes.

NIST should advocate the use of privatesector accreditation bodies that complywith national and international criteriaas the tool to be used for determinationof acceptance. The same tradeassociation also commented that insection 287.4(f), mutual recognition of private sector procedures should berecommended for all agencies.

Response: The purpose of the NTTAAis to eliminate unnecessary duplicationand complexity in conformityassessment activities. While this can bedone by relying on private sectorconformity assessment programs and

activities, it can also be accomplished by relying on other governmentalactivities, by relying on a supplier’sdeclaration of conformity, or byencouraging the private sector to rely ongovernmental activities. While agenciesshould consider alternative approachesin their rulemaking and procurementactivities, the determination of whichapproach best meets agency objectives isthe responsibility of the agency.

One trade association commented thatin section 287.4(j), agencies should beencouraged to participate in the

development of private sectorconformity assessment procedures andprograms as well as the development of standards. RESPONSE: NIST partiallyagrees with this comment. Theresponsibility for participation inconformity assessment programs andactivities, as distinct from standardsdevelopment, is covered in section

287.4(g). The examples in this sectionwill be expanded to includeparticipation in ANSI’s conformityassessment related activities to betterillustrate the intention of this section.

GAO Recommendation: GAOrecommended that the guidance includea section that ‘‘specifically addresses thetransparency of agencies’ certificationdecisionmaking.’’ GAO recommendedthat the guidance ‘‘should encourageagencies to publicly explain whyparticular certification decisions weremade or how certification decisions inthe future will be made.’’

Response: A new item has been addedto section 287.4 of the guidance toaddress this issue.


One national standards coordinatingand conformity assessmentaccreditation body commented thatsection 287.5 places responsibility for

both standards and conformityassessment with one representative fromeach agency and noted that a significantmajority of persons with majorresponsibilities for standards have noresponsibility or knowledge of conformity assessment.

Response: NIST partially disagreeswith this comment. The Office of Management and Budget (OMB) A–119indicates that more than one StandardsExecutive was not contemplated byOMB. That is, the Circular speaks of ‘‘a’’Standards Executive (14(c)) and ‘‘the’’Standards Executive (14(d)), etc. NISTand OMB believe that having only oneStandards Executive would facilitate

better coordination and communicationfor both standards and their relatedconformity assessment activities.However, both also recognize that

because responsibility for an agency’s

conformity assessment activities maycut across organizational boundaries, itmay be necessary to assign additionalagency personnel to carry out these newresponsibilities. The agency mustensure that these responsibilities arecoordinated and should carefully defineeach staff member’s responsibilities toensure that the duties defined underthis guidance and under OMB CircularA–119 are effectively carried out.

One laboratory accreditation bodycommented that section 287.5 shouldcontain reporting requirements for the

annual agency reports to NIST andOMB, including whether each agencygave consideration to the use of relevantprivate sector, conformity assessmentactivities and the reason for not usingthem—similar to agencies’ reportingunder OMB Circular A–119. NIST itself should be required to make similarreports justifying it own conformity

assessment activities.Response: Mandatory agency

reporting requirements regardingconformity assessment activities werenot specified in the NTTAA. Conformityassessment reporting requirements forall agencies, including NIST, remainvoluntary.

One government agency commentedthat the guidance states that each agency‘‘should coordinate its * * * activities’’to make ‘‘more productive use of * * *limited Federal resources * * *.’’However, the ‘‘responsibilities’’ underthe proposed Section 2987.5 and the

actual coordination could demandresources that may more than offset anygains expected from the coordination.

Response: The guidance does notrecommend that agencies undertakeactivities where the costs involved arelikely to exceed the benefits realized.While coordination is often beneficialand should always be considered, theagencies themselves are responsible forthe final decision as to the appropriatelevel of coordination and commitmentof resources to the agency’s conformityassessment activities.

One trade association commented thata new responsibility should be added to

this section— ‘‘To use private sectorconformity assessment program resultsin all agency assessment programs.’’

Response: The goal of the guidance,which is spelled out in the NTTAA, can

be accomplished in a number of ways.It is the responsibility of each agency todetermine which option or set of procedures is most appropriate for itsapplication.

Purpose of This Guidance

This guidance outlines Federalagencies’ responsibility for evaluationthe efficacy and efficiency of their

conformity assessment activities. Eachagency is responsible for coordinatingits conformity assessment activities withthose of other appropriate governmentagencies and with those of private sectorto make more productive use of theincreasingly limited Federal resourcesavailable for the conduct of conformityassessment activities and to reduceunnecessary duplication.

Applicability of This Guidance

This guidance applies to all agencies,which set policy for, manage, operate, or





1Definitions of accreditation, certification,conformity assessment, inspection, supplier’sdeclaration of conformity, registration and testingare based on the International Organization forStandardization (ISO)/InternationalElectrotechnical Commission (IEC), Guide 2 (1996).In certain industrial sectors, it is recognized thatorganizations other than ISO or IEC may issuedefinitions relevant to conformity assessment, suchas the Codex Alimentarius Commission withrespect to the food industry sector.

2For some agencies, accreditation may mean thata body or person meets requirements defined in aspecific section(s) of the CFR. The referencedsection(s) may include only limited requirementsfor demonstration of technical competency.

use conformity assessment activitiesand results, both domestic andinternational, except for activitiescarried out pursuant to treaties.‘‘Agency’’ means any Executive BranchDepartment, independent commission,

board, bureau, office, agency,government-owned or controlledcorporation, or other establishment of

the Federal government. It also includesany regulatory commission or board,except for independent regulatorycommissions subject to separatestatutory requirements regarding policysetting, management, operation, and useof conformity assessment activities. Itdoes not include the legislative orjudicial branches of the Federalgovernment.

Rulemaking Requirements

Under 5 U.S.C. 553(b)(A), thisguidance is not subject to the notice andcomment requirements of theAdministrative Procedure Act.Furthermore, pursuant to 5 U.S.C.553(d)(2), this guidance is not subject tothe delayed effective date requirementof the Act. The Director has chosen topublish this document for commentonly to obtain input from persons whomay be affected by the guidance.

PRA Clearance

This policy statement does notcontain a collection of information forpurposes of the Paperwork ReductionAct.

Executive Order 12866

It has been determined that this actionis significant for purposes of ExecutiveOrder 12866.

Regulatory Flexibility Act

This action is exempt from theanalytical requirements of theRegulatory Flexibility Act becausenotice and comment are not required forthis action by section 553 of theAdministrative Procedure Act or anyother law.

List of Subjects in 15 CFR Part 287

Conformity assessment, Procurement,Reporting and recordkeepingrequirements.

Dated: August 4, 2000.

Karen H. Brown,

Deputy Director.

For the reasons set forth in thepreamble, Part 287 is added tosubchapter J of chapter II in Title 15 of the Code of Federal Regulations (CFR) toread as follows:

PART 287—GUIDANCE ON FEDERALCONFORMITY ASSESSMENT

Sec.287.1 Purpose and scope of this guidance.287.2 Definitions.287.3 Responsibilities of the National

Institute of Standards and Technology.287.4 Responsibilities of Federal agencies.287.5 Responsibilities of an Agency

Standards Executive.Authority: Sec. 12, Pub. L. 104–113, 110

Stat. 782 (15 U.S.C. 272).

§ 287.1 Purpose and scope of thisguidance.

(a) This part provides guidance foreach Federal agency to use in evaluatingthe efficacy and efficiency of itsconformity assessment activities. Eachagency should coordinate its conformityassessment activities with those of otherappropriate government agencies andwith those of the private sector toreduce unnecessary duplication. Thisguidance is intended to help Federalagencies improve the management andcoordination of their own conformityassessment activities with respect toother government entities and theprivate sector. This will help ensuremore productive use of the increasinglylimited Federal resources available toconduct conformity assessmentactivities. This will also support the roleof the U.S. Government in pursuinginternational trade and other relatednegotiations and agreements withforeign countries and U.S. industry inpursuing agreements with foreignnational and international private sector

organizations.(b) This guidance applies to allagencies, which set policy for, manage,operate, or use conformity assessmentactivities and results, both domestic andinternational, except for activitiescarried out pursuant to treaties.

(c) This guidance does not preemptthe agencies’ authority andresponsibility to make regulatory orprocurement decisions authorized bystatute or required to meetprogrammatic objectives andrequirements. These decision-makingactivities include: determining the level

of acceptable regulatory or procurementrisk; setting the level of protection; balancing risk, cost and availability of technology (where statutes permit) inestablishing regulatory and procurementobjectives; and determining orimplementing procurement orregulatory requirements necessary tomeet programmatic or regulatoryobjectives. Each agency retains broaddiscretion in its selection and use of regulatory and procurement conformityassessment practices and may elect notto use or recognize alternative

conformity assessment practices if theagency deems them to be inappropriate,inadequate, or inconsistent withstatutory criteria or programmaticobjectives and requirements. Nothingcontained herein shall give any partyany claim or cause of action against theFederal government or any agencythereof. Each agency remains

responsible for representation of theagency’s views on conformityassessment in matters under itsjurisdiction. Each agency also remainsthe primary point of contact forinformation on the agency’s regulatoryand procurement conformity assessmentactions.

§287.2 Definitions.1

Accreditation means a procedure usedto provide formal notice that a body orperson is competent to carry out specifictasks. These tasks include: sampling andtesting; inspection; certification; andregistration.2

Agency means any Executive BranchDepartment, independent commission,

board, bureau, office, agency,government-owned or controlledcorporation, or other establishment of the Federal government. It also includesany regulatory commission or board,except for independent regulatorycommission subject to separate statutoryrequirements regarding policy setting,management, operation, and use of conformity assessment activities. It doesnot include the legislative or judicial

branches of the Federal government.Agency Standards Executive means

an official designated by an agency as itsrepresentative on the InteragencyCommittee for Standards Policy (ICSP)and delegated the responsibility foragency implementation of OMB CircularA–119 and the guidance in this part.

Certification means a procedure usedto provide written assurance that aproduct, process, service, or person’squalifications conforms to specifiedrequirements.

Conformity assessment means anyactivity concerned with determiningdirectly or indirectly that requirementsare fulfilled. Requirements for products,





services, systems, and organizations arethose defined by law or regulation or byan agency in a procurement action.Conformity assessment includes:sampling and testing; inspection;supplier’s declaration of conformity;certification; and quality andenvironmental management systemassessment and registration. It also

includes accreditation and recognition.Conformity assessment does not includemandatory administrative procedures(such as registration notification) forgranting permission for a good orservice to be produced, marketed, orused for a stated purpose or understated conditions. Conformityassessment activities may be conducted

by the supplier (first party) or by the buyer (second party) either directly or by another party on the supplier’s or buyer’s behalf, or by a body not underthe control or influence of either the

buyer or the seller (third party).

Inspection is defines ad theevaluation by observation and judgmentaccompanied as appropriate bymeasurement, testing or gauging of theconformity of a product, process orservice to specified requirements.

NIST means the National Institute of Standards and Technology, an agencywithin the United States Department of Commerce.

Recognition means a procedure usedto provide formal notice that anaccreditation body is competent to carryout specific tasks. These tasks include:the accreditation of testing laboratoriesand inspection, certification, and

registration bodies. A governmentalrecognition system is a set of one ormore procedures used by a Federalagency to provide recognition.

Registration means a procedure usedto give written assurance that a systemconforms to specified requirements.Such systems include those establishedfor the management of product, processor service quality and environmentalperformance.

Sampling means the selection of oneor more specimens of a product,process, or service for the purpose of evaluating the conformity of the

product, process or service to specifiedrequirements.Supplier’s declaration of conformity

means a procedure by which a suppliergives written assurance that a product,process, service or organizationconforms to specified requirements.

Testing means the action of carryingout one or more technical operations(tests) that determine one or morecharacteristics or performance of a givenproduct, material, equipment, organism,person’s qualifications, physicalphenomenon, process, or service

according to a specified technicalprocedure (test method).

§ 287.3 Responsibilities of the NationalInstitute of Standards and Technology.

(a) Work with agencies through theInteragency Committee on StandardsPolicy (ICSP) to coordinate Federal,state and local conformity assessment

activities with private sector conformityassessment activities. NIST chairs theICSP; assists the ICSP in developing andpublishing policies and guidance onconformity assessment related issues;collects and disseminates informationon Federal, state and private sectorconformity assessment activities; andincreases public awareness of theimportance of conformity assessmentand nature and extent of national andinternational conformity assessmentactivities.

(b) Encourage participation in theICSP by all affected agencies and ensurethat all agency views on conformity

assessment are considered.(c) To the extent that resources are

available, develop information on stateconformity assessment practices; and,upon request by a state governmentagency, work with that state agency toreduce duplication and complexity instate conformity assessment activities.

(d) Review within three years fromAugust 10, 2000, the effectiveness of thefinal guidance and recommendmodifications to the Secretary asneeded.

§ 287.4 Responsibilities of Federalagencies.

Each agency should:(a) Implement the policies contained

in the guidance in this part.(b) Provide a rationale for its use of

specified conformity assessmentprocedures and processes in rulemakingand procurement actions to the extentfeasible. Further, when notice andcomment rulemaking is otherwiserequired, each agency should providethe opportunity for public comment onthe rationale for the agency’s conformityassessment decision.

(c) Use the results of othergovernmental agency and private sector

organization conformity assessmentactivities to enhance the safety andefficacy of proposed new conformityassessment requirements and measures.An example of this would be to collectand review information on similaractivities conducted by other Federal,state and international organizationsand agencies and private sectororganizations to determine if the resultsof these activities can be used toimprove the effectiveness of a proposedFederal agency conformity assessmentactivity.

(d) Use relevant guides or standardsfor conformity assessment practicespublished by domestic and internationalstandardizing bodies as appropriate inmeeting regulatory and procurementobjectives. Guides and standards forsampling, testing, inspection,certification, quality and environmentalmanagement systems, management

system registration and accreditation areissued by organizations which include,

but are not limited to, the AmericanNational Standards Institute, theInternational Organization forStandardization (ISO), the InternationalElectrotechnical Commission (IEC), theInternational TelecommunicationsUnion (ITU) and the Organization forEconomic Cooperation andDevelopment (OECD), the World HealthOrganization (WHO), and the CodexAlimentarius Commission. Each agencyretains responsibility for determiningwhich, if any, of these documents are

relevant to its needs.(e) Identify appropriate private sector

conformity assessment practices andprograms and consider the results of such practices and/or programs asappropriate in existing regulatory andprocurement actions. Responsibility forthe determination of appropriatenessrests with each agency. Examples: anagency could use the results of privatesector or other governmental conformityassessment activities to scheduleprocurement type audits moreeffectively. This could allow agencies toreduce the number and extent of audits

conducted at companies which areperforming in accordance with contractspecifications and which are underreview by a third party or anotheragency and to concentrate agency auditefforts on companies which have shownproblems in conforming to contractspecifications. Another example is theFederal Communications Commission’s(FCC) Telecommunication CertificationBody (TCB) program, which allowsdesignated private entities to issuetelecommunications equipmentapprovals for specified regulatoryrequirements. In addition, under Part15, FCC premarketing approvalrequirements for certain types of equipment have been replaced withsuppliers declaration of conformity tothe regulations, provided test resultssupporting the declaration are obtainedfrom an accredited testing lab.

(f) Consider using the results of otheragencies’ conformity assessmentprocedures. Example: An agency coulduse the results of another agency’sinspection/audit of a supplier toeliminate or reduce the scope of its owninspection/audit of that supplier.





(g) Participate in efforts designed toimprove coordination amonggovernmental and private sectorconformity assessment activities. Theseefforts include, but are not limited to,the National Cooperation for LaboratoryAccreditation (NACLA) organization,the National Environmental LaboratoryAccreditation (NELAC), the

International Organizations forStandardization’s (ISO) Committee onConformity Assessment (CASCO),conformity assessment related activitiesof the American National StandardsInstitute (ANSI), and ICSP workinggroups dealing with conformityassessment issues.

(h) Work with other agencies to avoidunnecessary duplication andcomplexity in Federal conformityassessment activities. Examples: Anagency can participate in anotheragency’s conformity assessmentactivities by conducting joint

procurement audits/inspections of suppliers that sell to both agencies. Anagency can share conformity assessmentinformation with other agencies. Anagency can use conformity assessmentinformation provided by other agenciesto the extent appropriate to improve theeffectiveness and efficiency in its ownconformity assessment activities.Conformity assessment information mayinclude: Conformity assessmentprocedures and results, technical dataon the operation of conformityassessment programs, processingmethods and requirements forapplications, fees, facility site data,

complaint review procedures, andconfidentiality procedures.

(i) Encourage domestic andinternational recognition of U.S.conformity assessment results bysupporting the work of the U.S.Government in international trade andrelated negotiations with foreigncountries and U.S. industry in pursuingagreements with foreign national andinternational private sectororganizations and any resultingactivities/requirements resulting fromthose negotiations/agreements.

(j) Participate in the development of

private sector conformity assessmentstandards to ensure that Federalviewpoints are represented.

(k) Work with other agencies toharmonize Federal requirements forquality and environmental managementsystems for use in procurement andregulation, including provisions whichwill allow the use of one quality orenvironmental management system persupplier facility in the Federalprocurement process and the sharingand usage of audit results and relatedinformation as appropriate.

(l) Work with other ICSP members,NIST, and the private sector to developnational infrastructures for coordinatingand harmonizing U.S. conformityassessment needs, practices andrequirements in support of the efforts of the U.S. Government and U.S. industryto increase international market accessfor U.S. products.

(m) Work with other ICSP members,NIST, and the private sector asnecessary and appropriate to establishcriteria for the development andimplementation of governmentalrecognition systems to meet governmentrecognition requirements imposed byother nations and regional groups tosupport the efforts of the U.S.Government to facilitate internationalmarket access for U.S. products.

(n) Assign an Agency StandardExecutive responsibility forcoordinating the agency-wideimplementation of the guidance in this

part.§ 287.5 Responsibilities of an AgencyStandards Executive.

In addition to carrying out the dutiesdescribed in OMB Circular A–119related to standards activities, anAgency Standards Executive should:

(a) Promote the following goals:(1) Effective use of agency conformity

assessment related resources andparticipation in conformity assessmentrelated activities of agency interest.

(2) Development and dissemination of agency technical and policy positions.

(3) Development of agency positions

on conformity assessment related issuesthat are in the public interest.

(b) Ensure that agency participation inconformity assessment related activitiesis consistent with agency missions,authorities, priorities, and budget.

(c) Cooperate with NIST in carryingout agency responsibilities under theguidance in this part.

(d) Consult with NIST, as necessary,in the development and issuance of internal agency procedures andguidance implementing the policies inthis part.

(e) Establish an ongoing process for

reviewing his/her agency’s existingconformity assessment activities andidentifying areas where efficiencies can

be achieved through coordination withother agency and private sectorconformity assessment activities.

(f) Work with other parts of his/heragency to develop and implementimprovements in agency conformityassessment related activities.

(g) Report to NIST, on a voluntary basis, on agency conformity assessmentactivities for inclusion in the annualreport to the Office of Management and

Budget (OMB) on the agency’simplementation of OMB Circular A–119.[FR Doc. 00–20262 Filed 8–9–00; 8:45 am]

BILLING CODE 3510–13–M

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 310, and 344

[Docket No. 77N–334S]

RIN 091O–AA01

Topical Otic Drug Products for Over-the-Counter Human Use; Products forDrying Water-Clogged Ears;Amendment of Monograph; Lift ofPartial Stay of Effective Date

AGENCY: Food and Drug Administration,HHS.ACTION: Final rule; lift of partial stay of effective date.

SUMMARY: The Food and DrugAdministration (FDA) is issuing a finalrule amending the monograph for over-the-counter (OTC) topical otic drugproducts (the regulation that establishesconditions under which these drugproducts are generally recognized assafe and effective and not misbranded).The amendment adds conditions formarketing topical otic drug products fordrying water-clogged ears and includeslabeling in the new OTC drug format.

The agency is amending its finalregulations for OTC drug labelingrequirements to include the newflammability warning for topical oticdrug products for drying water-cloggedears. The agency is also lifting a partialstay of the effective date of certainprovisions of the regulations for topicalotic drug products for the drying of water clogged ears. This final rule ispart of the ongoing review of OTC drugproducts conducted by FDA.DATES:

Effective Date: This rule is effectiveMay 17, 2002. The stay of §310.545(a)(15)(ii) for topical otic drug productsfor the drying of water-clogged ears thatpublished at 60 FR 42436 on August 16,1995, and effective June 22, 1995, islifted effective September 11, 2000.

Compliance Date: The compliancedate for products with annual sales lessthat $25,000 is May 17, 2003. Thecompliance date for all other OTC drugproducts is May 17, 2002.FOR FURTHER INFORMATION CONTACT:Gerald M. Rachanow, Center for DrugEvaluation and Research (HFD–560),Food and Drug Administration, 5600


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