10-26-11 FDA HHS Comments Notice Bar Code Final Rule

8/3/2019 10-26-11 FDA HHS Comments Notice Bar Code Final Rule

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66235Federal Register / Vol. 76, No. 207/ Wednesday, October 26, 2011/ Proposed Rules

295 CFR 1320.11.3044 U.S.C. 3507(d).315 U.S.C. 601612.

3213 CFR 121.201.33 Id. n.22.

believes that the applicable entitiesshould be required to find that there isno adverse impact to the Bulk-PowerSystem from the exception and that it isconsidered in wide-area coordinationand operations. Further, we believe thatany exception should be subject tofurther review by the Regional Entity,NERC, and the Commission. This does

not necessarily mean that the RegionalEntity, NERC, or the Commissionshould have to approve the exception,

but that any of the three could lateraudit its implementation.

30. In conclusion, while theCommission provides three options forrevising footnote b in this Notice ofProposed Rulemaking, we seekcomments on the feasibility of theoptions and on ways in which theoptions might be improved. In addition,we seek comment on whether there areother ways for NERC to solve theconcerns outlined above in an equally

effective and efficient manner.III. Information Collection Statement

31. The Office of Management andBudget (OMB) regulations require thatOMB approve certain reporting andrecordkeeping (collections ofinformation) imposed by an agency.29The information contained here is alsosubject to review under section 3507(d)of the Paperwork Reduction Act of1995.30

32. As stated above, the subject of thisNOPR is NERCs proposed modificationto Table 1, footnote b applicable infour TPL Reliability Standards. ThisNOPR proposes to remand the footnoteb modification to NERC. By remandingfootnote b the applicable ReliabilityStandards and any informationcollection requirements are unchanged.Therefore, the Commission will submitthis NOPR to OMB for informationalpurposes only.

33. Interested persons may obtaininformation on the reportingrequirements by contacting thefollowing: Federal Energy RegulatoryCommission, 888 First Street, NE.Washington, DC 20426 [Attention: EllenBrown, Office of the Executive Director,

e-mail: [email protected], phone:(202) 5028663, orfax: (202) 2730873].

IV. Regulatory Flexibility Act

34. The Regulatory Flexibility Act of1980 (RFA) 31 generally requires adescription and analysis of final rulesthat will have significant economicimpact on a substantial number of smallentities. The RFA mandates

consideration of regulatory alternativesthat accomplish the stated objectives ofa proposed rule and that minimize anysignificant economic impact on asubstantial number of small entities.The Small Business Administrations(SBA) Office of Size Standards developsthe numerical definition of a small

business.32 The SBA has established a

size standard for electric utilities,stating that a firm is small if, includingits affiliates, it is primarily engaged inthe transmission, generation and/ordistribution of electric energy for saleand its total electric output for thepreceding twelve months did not exceedfour million megawatt hours.33 The RFAis not implicated by this NOPR becausethe Commission is remanding footnote

b and not proposing any modificationsto the existing burden or reportingrequirements. With no changes to theReliability Standards as approved, theCommission certifies that this NOPR

will not have a significant economicimpact on a substantial number of smallentities.

V. Comment Procedures

35. The Commission invites interestedpersons to submit comments on thematters and issues proposed in thisnotice to be adopted, including anyrelated matters or alternative proposalsthat commenters may wish to discuss.Comments are due 60 days frompublication in the Federal Register.Comments must refer to Docket No.RM1118000, and must include thecommenters name, the organization

they represent, if applicable, and theiraddress in their comments.

36. The Commission encouragescomments to be filed electronically viathe eFiling link on the CommissionsWeb site at http://www.ferc.gov.TheCommission accepts most standardword processing formats. Documentscreated electronically using wordprocessing software should be filed innative applications or print-to-PDFformat and not in a scanned format.Commenters filing electronically do notneed to make a paper filing.

37. Commenters that are not able to

file comments electronically must sendan original of their comments to:Federal Energy Regulatory Commission,Secretary of the Commission, 888 FirstStreet, NE., Washington, DC 20426.

38. All comments will be placed inthe Commissions public files and may

be viewed, printed, or downloadedremotely as described in the DocumentAvailability section below. Commenterson this proposal are not required to

serve copies of their comments on othercommenters.

VI. Document Availability

39. In addition to publishing the fulltext of this document in the FederalRegister, the Commission provides allinterested persons an opportunity toview and/or print the contents of this

document via the Internet throughFERCs Home Page (http://www.ferc.gov)and in FERCs Public Reference Roomduring normal business hours (8:30 a.m.to 5 p.m. Eastern time) at 888 FirstStreet, NE., Room 2A, Washington, DC20426.

40. From FERCs Home Page on theInternet, this information is available oneLibrary. The full text of this documentis available on eLibrary in PDF andMicrosoft Word format for viewing,printing, and/or downloading. To accessthis document in eLibrary, type thedocket number excluding the last three

digits of this document in the docketnumber field.41. User assistance is available for

eLibrary and the FERCs Web site duringnormal business hours from FERCOnline Support at (202) 5026652 (tollfree at 18662083676) or e-mail at

[email protected],or thePublic Reference Room at (202) 5028371, TTY (202) 5028659. E-mail thePublic Reference Room at

[email protected].

By direction of the Commission.Commissioner Spitzer is not participating.

Nathaniel J. Davis, Sr.,

Deputy Secretary.[FR Doc. 201127624 Filed 102511; 8:45 am]

BILLING CODE 671701P

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 610

[Docket No. FDA2011N0719]

Bar Code Technologies for Drugs andBiological Products; Retrospective

Review Under Executive Order 13563;Request for Comments

AGENCY: Food and Drug Administration,HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and DrugAdministration (FDA) is announcing areview of the Bar Code Final Rule,under Executive Order 13563,Improving Regulation and RegulatoryReview. The Bar Code Final Rule,which was published in 2004, requires

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1Department of Health and Human Services,Plan for Retrospective Review of Existing Rules, pp. 2122 (August 22, 2011).

certain human drug products andbiological products to have a bar code.Information submitted can help FDA toreassess the costs and benefits of therule and to identify any relevantchanges in technology that haveoccurred since it went into effect. FDAis establishing a public docket to receiveinformation relevant to reassessing the

Bar Code Rule. This is an opportunityfor interested persons to shareinformation, research, and ideas on theneed, maturity, and acceptability ofalternative identification technologiesfor the identification, including theunique identification, of drugs and

biological products. FDA will use theinformation received to assess whetherthe Bar Code Final Rule is achieving itsintended benefits as effectively aspossible or should be modified.DATES: FDA will accept both initialcomments and reply comments inresponse to this notice. Initial comments

must be received on or before January 9,2012 and reply comments on or beforeFebruary 23, 2012. (See theComments section of this documentfor more information.)ADDRESSES: Submit electroniccomments to http://www.regulations.gov.Submit writtencomments to the Division of DocketsManagement (HFA305), Food and DrugAdministration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852. Allcomments should be identified with thedocket number found in brackets in theheading of this document.FOR FURTHER INFORMATION CONTACT

:Benjamin A. Chacko, Center forBiologics Evaluation and Research(HFM17), Food and DrugAdministration, 1401 Rockville Pike,suite 200N, Rockville, MD 208521448,3018276210.SUPPLEMENTARY INFORMATION: OnFebruary 2, 2011, President BarackObama issued Executive Order (E.O.)13563, Improving Regulation andRegulatory Review (76 FR 3821). Oneof the provisions in the new Executiveorder is the affirmation of retrospectivereviews of existing significant

regulations. As one step inimplementing the new Executive order,FDA published a notice in the FederalRegister on April 27, 2011 (76 FR23520), entitled Periodic Review ofExisting Regulations; RetrospectiveReview Under E.O. 13563. In thatdocument, FDA announced that it isconducting a review of its existingregulations to determine, in part,whether they can be made moreeffective in light of current public healthneeds and to take advantage of andsupport advances in innovation that

have occurred since those regulationstook effect. Under E.O. 13563, andunder the Department of Health andHuman Services Plan for RetrospectiveReview of Existing Rules, FDA willconsider strengthening, complementing,or modernizing rules where necessary orappropriate.

As FDA conducts its retrospective

review of regulations, the Agency willtake into account the following factors: 1

Whether an action will have apositive impact on innovation in an areaof public health, safety, or delivery of oraccess to care;

Whether the public health benefitsof an action have been realized;

Whether the public or regulatedcommunity view modification orrevocation of a regulation as importantand have offered useful comments andsuggestions for change;

Whether the impact andeffectiveness of a regulation has

changed or been superseded by changesin conditions or advances in scientificor technological information;

Whether there are significant,unresolved issues with implementationor enforcement; and

How long the regulation has been ineffect and whether it has been subject toprior reviews.

The first rule FDA is reviewing underE.O. 13563 is the Bar Code Final Rule.The Agency plans to reassess its costsand benefits and to determine if the BarCode Final Rule should be modified totake into account changes in technologythat have occurred since the rule wentinto effect in 2004.

I. Background

In the Federal Register of March 14,2003 (68 FR 12500), FDA published aproposed rule (Bar Code Proposed Rule)that would require certain human drugproduct labels and biological productlabels to have a linear bar code thatwould contain, at a minimum, thedrugs National Drug Code (NDC)number. In the Federal Register ofFebruary 26, 2004 (69 FR 9120), theAgency finalized the proposed rule( 201.25 and 610.67 (21 CFR 201.25

and 610.67)). As discussed in thepreamble to the Bar Code ProposedRule, the rule was intended to helpreduce the number of medication errorsthat occur in hospitals and other healthcare settings (68 FR 12500 at 12501through 12502). FDA envisioned that

bar codes would be part of a system,along with bar code scanners andcomputerized databases, that would

enable health care professionals tocheck whether they are giving the rightdrug (in the right dose and via the rightroute of administration) to the rightpatient at the right time (Id. at 12501).

The events that led FDA to proposerequiring bar codes are described in thepreamble to the Bar Code ProposedRule. In brief, medication errors are

known to be a serious public healthproblem and can occur at several pointsfrom the time a health care providerprescribes the drug to a patient to thetime when the patient receives the drug.The use of bar codes on drug productswas expected to significantly reducemedication errors. Bar codes also cancomplement other efforts to reducemedication errors, such as computerphysician order entry (CPOE) systems(where a physician enters orderselectronically into a computer instead ofwriting the order on paper, andsubsequently the order can be checked

against the patients electronic recordsfor possible drug interactions,overdoses, and patient allergies) andretail pharmacy-based computersystems that use a bar-coded NDCnumber to verify that a consumersprescription is being dispensed with thecorrect drug. FDA refers readers to thepreamble to the Bar Code Proposed Ruleshould they wish to obtain details onthe events, recommendations, meetings,and literature that shaped the proposedrule.

In the preamble to the Bar CodeProposed Rule, the Agency discussed indetail the challenge of requiring the use

of linear bar codes, which, whileenabling hospitals to buy scanningequipment with the confidence thattheir purchased equipment would not

be rendered obsolete by newtechnology, could affect futuretechnological innovation (68 FR 12500at 12508 through 12510). Commentsreceived related to a public meeting on

bar coding, presented an array ofdiffering opinions on the issue ofwhether to require a specific technology(68 FR 12500 at 12508). Given thecomplexity of the issues, FDA requestedin the Bar Code Proposed Rule comment

concerning alternatives that couldreplace or be used in conjunction withthe linear bar code such as anothersymbol, standard, or technology (Id. at12510 and 12529).

In response to the Bar Code ProposedRule, FDA received comments includingthose opposing the use of linear barcodes or asking the Agency to considerother technologies or to eliminate anyreference to linear bar codes in the finalrule. Such comments primarily arguedthat selecting a symbology or standardwould inhibit technological innovation.

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2The National Childhood Vaccine Injury Act of1986 (Pub. L. 99660) (42 U.S.C. 300aa25(a))requires health care providers to report certainadverse events related to identified childhoodvaccines to the Vaccine Adverse Event ReportingSystem (42 U.S.C. 300aa25(b)). Although healthcare providers are encouraged to report adverseevents related to other drugs and biologicalproducts to FDA, they are not required to do so.

3 Guidance for Industry: Bar Code LabelRequirementsQuestions and Answers datedAugust 2011 (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdf).

4 Guidance for Industry: Standards for Securingthe Drug Supply ChainStandardized NumericalIdentification for Prescription Drug Packages datedMarch 2010 (http://www.fda.gov/downloads/RegulatoryInformation/Guidance/UCM206075.pdf).

Comments opposed to a linear bar coderequirement generally advocated thefollowing alternatives: (1) Two-dimensional symbologies, (2) theEuropean Article Number/UniformCode Council (EAN/UCC) systemgenerally, (3) radio frequencyidentification (RFID) chips, or (4) nostandard or symbology at all (69 FR

9120 at 9136).Ultimately, FDA determined that,

based on data and public comment, alinear bar code requirement wasappropriate (Id. at 9137 through 9138).In the preamble to the Bar Code FinalRule, the Agency addressed commentsconcerning alternatives to the linear barcode and stated that, while it believedthat linear bar codes were anestablished, cost-effective, widely usedand easily recognized technology, it alsoacknowledged that linear bar codes haveseveral disadvantages. For example,linear bar codes may take up more label

space than alternative technologies andmay encode less data compared to othertechnologies. Thus, if more data need to

be encoded on the packaging or labelingfor any other reason (such as to allowtracking and tracing of drug productsthrough the drug distribution system), alinear bar code might prove too limiting(Id. at 9137). FDA also stated that,although it had decided to preserve thelinear bar code requirement, it wouldconsider revising the rule toaccommodate newer technologies asthey become more mature andestablished (Id. at 9137 through 9138).

Since FDA issued the Bar Code FinalRule, advances in alternativetechnologies have occurred. In addition,it has become increasingly clear fromindustry, health care providers, andother FDA initiatives, that certain FDA-regulated products present unique barcoding concerns. For example, theAgency has since learned that certainvaccines present unique challenges inthe bar coding context, particularly withrespect to compliance withrecordkeeping and mandatory adverseevent reporting requirements that arespecific to the administration ofchildhood vaccines.2

In recognition of these challenges, inthe Federal Register of August 11, 2011(76 FR 49772), FDA announced theavailability of a final guidancedocument entitled Guidance for

Industry: Bar Code LabelRequirementsQuestions andAnswers3. This guidance amendedand superseded the final guidance of thesame title dated October 2006, byincorporating a revised response toquestion 12 (Q12), which pertains to theuse of alternate coding technologies forvaccines. The Agency explained in the

Federal Register notice announcing thefinal guidance that it believesalternative technology such as two-dimensional symbology has advanced,allowing the Agency to reconsider theuse of such technology. Accordingly, itwill now consider requests from vaccinemanufacturers who request to usealternate coding technologies, such astwo-dimensional symbology, thatencode lot number and expiration dateinformation, for an exemption under 201.25(d)(1)(ii) to the linear bar coderequirement. FDA limited the scope ofits revised response to Q12 to vaccines

because of the mandatory reportingconcerns specific to these products asdescribed in the guidance.

FDA recognizes, however, that sincealternative technologies continue toadvance, it may now be feasible forthese technologies to address otherstakeholder coding needs in othercontexts and for other products. Forexample, under section 505D of theFederal Food, Drug, and Cosmetic Act(the FD&C Act) (21 U.S.C. 355e), FDA isdeveloping standards for identification,validation, authentication, and trackingand tracing of prescription drugs. Thegoal of this initiative is to implement a

system to further ensure patient safetyand to improve the security of the drugsupply chain against counterfeit,diverted, subpotent, substandard,adulterated, misbranded, or expireddrugs. In March 2010, FDA issued aguidance that discusses a standard foruniquely identifying prescription drugpackages using a StandardizedNumerical Identifier (SNI).4 In theguidance, the Agency did not specifythe means of incorporating the SNI ontothe package. However, the guidancerecognizes that the SNI is a flexiblestandard that can be encoded into a

variety of machine-readable forms ofdata carriers, such as two-dimensionalbar codes, alternate coding systems, andRFID. Thus, the guidance leaves options

open while technologies for securing thesupply chain continue to be identified,and standards making use of SNI aredeveloped. Similarly, while FDArecognizes that the underlying primarygoals of the Bar Code Final Rule andsection 505D of the FD&C Act aredifferent, the Agency wants to leaveoptions open with respect to how the

same technology may be used for bothpurposes.

FDA is announcing the establishmentof a public docket to provide anopportunity for interested persons toshare information, research, and ideason the effectiveness of the currentregulation and the need, maturity, andacceptability of alternative technologiesfor the identification, including theunique identification, of drugs and

biological products. FDA will use theinformation received to assess codingtechnologies in relation to current barcode requirements and other initiatives.

II. Request for Comments andInformation

FDA is requesting comments andsupporting information on (1) bar codelabeling standards for drugs and

biological products and (2) theidentification of current alternativetechnologies for use by industry andothers.

To facilitate this discussion, FDA setsforth some questions in the followingparagraphs. These questions, which arenot meant to be exhaustive, areprovided to stimulate public comments

that will help FDA evaluate the BarCode Final Rule and theaccommodation of alternativetechnologies to the linear bar coderequirement (201.25). The public isencouraged to address these and/orother related questions.

The Agency encourages responses tothe following questions about the costsand benefits of any alternative to thelinear bar code. FDA also encouragesyou to provide as much detail andcontext as possible in your responses.Furthermore, the Agency specificallyinvites small businesses to provideinformation about the potential impactof alternatives to the linear bar code.

1. Is there a need for alternativetechnologies to the linear bar code?Does the current linear bar coderequirement meet the current needs ofthe health care industry and health careproviders?

2. How has product codingtechnology changed since FDA issuedthe Bar Code Final Rule on February 26,2004? Please provide information aboutthe maturity, degree of adoption, cost,and ease of use of coding technologies

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidance/UCM206075.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidance/UCM206075.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidance/UCM206075.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidance/UCM206075.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidance/UCM206075.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdf


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that may be considered as alternativesor in addition to the linear bar code.

3. What factors other than those listedin question 2 should FDA take intoaccount in considering technologiesalternative to or in addition to the linear

bar code?4. What technologies or coding

systems warrant FDAs consideration as

alternatives to the linear bar code? Inyour response, the Agency particularlyinvites comments on the followingissues for each technology identified:

A. What is the current state ofdevelopment and availability of thealternative technology?

B. Would adoption of this technologyas an alternative to the linear bar codefurther reduce medication errors inhospitals and health care settings?Please provide supporting data, ifavailable.

C. Would adoption of this alternativetechnology advance public health

protections? If so, how? If supportingdata exist, please provide thisinformation.

5. Does the adoption of thisalternative technology haveimplications for other FDA orDepartment of Health and HumanServices initiatives (e.g., SNI)?

6. Have you used the linear bar codefor authentication or tracking andtracing of prescription drugs?

A. If so, how?B. Please describe any successes or

challenges that you have encountered inadopting linear bar code technology forthis purpose.

C. If not, which if any alternativetechnologies could reduce medicationerrors while also serving otherfunctions?

7. For hospitals and other health-carefacilities that have adopted bar codetechnologies using linear bar codes:

A. What difficulties did youencounter in adopting the technology?

B. How have productivity andoperating costs changed?

C. What differences have you seen inmedical outcomes?

D. What problems have youexperienced with the technology?

8. For hospitals and other health-carefacilities that have adopted alternativetechnologies or non-linear coding:

A. What difficulties did youencounter in adopting the technology?

B. How have productivity andoperating costs changed?

C. What differences have you seen inmedical outcomes?

D. What problems have youexperienced with the technology?

9. For hospitals and other health-carefacilities that have not adopted bar codetechnologies using linear bar codes:

A. Do you plan to adopt thetechnology within the next 12 months?

B. If you do not plan to adopt thetechnology, please explain whatfactor(s) most influenced the decisionnot to adopt it.

10. How would technology adoptionhave proceeded since 2004 had the BarCode Final Rule not gone into effect?

11. What are hospitals and otherhealth-care facilities forecasts fortechnology adoption once incentives inthe Economic Stimulus Act of 2008(Pub. L. 110185) are no longer ineffect?

12. Would there be an economicimpact on those parties who may not besubject to the bar code requirement butwho nonetheless may use or adopt orhave adopted bar code technology (e.g.,hospitals, clinics, public healthagencies, and health care providers)?Please use the following questions toguide your responses.

A. Current practices. Describe yourcurrent practice(s) at your institutionwith respect to those products that arerequired to be labeled with a bar codeunder 201.25 and 610.67. Have youencountered any barriers to your abilityto use technology at your institution?

B. Using an alternative to the linearbar code. If an alternative to the linear

bar code could be placed on the label ofat least some of your products, whatimpact, if any, would that have on yourcurrent practice(s)? How would youchange your practices, if at all?

C. Expenses. What unplannedexpenses, if any, would you incur, if an

alternative to the linear bar code couldbe placed on the label of at least someof your products? If you could foreseeusing an alternative to the linear barcode, would you modify operations inyour facility, and if so, how?

D. Adverse event reporting andrecalls. Have you encounteredchallenges/successes in drugidentification or reporting with respectto products that contain a bar code ontheir labels? If so, please describe them.Would an alternative to the linear barcode have an impact on your recallmanagement or adverse event reporting,

and if so, how?13. Are there other parties whoseeconomic interests we should consider?

III. Comments

Interested persons may submit to theDivision of Dockets Management (seeADDRESSES) either electronic or writtencomments regarding this document. It isonly necessary to send one set ofcomments. It is no longer necessary tosend two copies of mailed comments.Identify comments with the docketnumber found in brackets in the

heading of this document. Receivedcomments may be seen in the Divisionof Dockets Management between 9 a.m.and 4 p.m., Monday through Friday.

Please allow sufficient time for mailedcomments to be timely received by thedue dates in the event of delivery delay.Comments must be received by these

dates to be considered. We request thatcomments be identified clearly as aninitial comment or a replycomment. Initial comments may addressany issue raised in this notice. Initialcomments will be made availableelectronically, online at http://www.regulations.gov,or for public inspectionin the Division of Dockets Management(see ADDRESSES). To allow sufficientopportunity for interested persons toprepare and submit any replycomments, late-filed initial commentswill not be considered. Reply commentsmust address only matters raised in

initial comments and must not be usedto present new arguments, contentions,or factual material that is not responsiveto the initial comments. To beconsidered, reply comments mustidentify which initial comments theyare replying to, and which specificissues(s) are being addressed. We willnot consider comments received duringthe reply comment period that do notidentify the specific issue(s) raisedduring the initial comment period onwhich the reply comment is based. It isthe Agencys intent to comply withExecutive Order 13563 as quickly aspossible, so we will not look favorablyon requests for extensions of thecomment period.

Comments previously submitted tothe Division of Dockets Management forthe following docket will also beconsidered by FDA and do not need to

be resubmitted: Draft Guidance forIndustry: Bar Code Label Requirements(Question 12 Update) (75 FR 54347September 2010; Docket No. FDA2010D0426).

Dated: October 21, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 201127657 Filed 102511; 8:45 am]

BILLING CODE 416001P

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