citizen petition regulation amendments

8/3/2019 Citizen Petition Regulation Amendments

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25Federal Register / Vol. 77, No. 1 / Tuesday, January 3, 2012 / Proposed Rules

end of the Volcker Rule Proposalcomment period.

By the Commission.

Dated: December 23, 2011.

Kevin M. ONeill,

Deputy Secretary.

[FR Doc. 201133614 Filed 123011; 8:45 am]

BILLING CODE 801101P

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. FDA2011N0697]

Amendments to Regulations on CitizenPetitions, Petitions for Stay of Action,and Submission of Documents toDockets

AGENCY: Food and Drug Administration,HHS.

ACTION: Proposed rule.

SUMMARY: The Food and DrugAdministration (FDA) is proposing toamend certain regulations relating tocitizen petitions, petitions for stay ofaction, and the submission ofdocuments to the Agency. In particular,the proposed rule would establish newregulations to implement certainprovisions of the Federal Food, Drug,and Cosmetic Act (FD&C Act), whichconcern certain citizen petitions andpetitions for stay of action (PSAs) thatinvolve a request for FDA to take anyform of action relating to a pendingabbreviated new drug application(ANDA) or 505(b)(2) application. We aremaking these changes to implementprovisions of the Food and DrugAdministration Amendments Act of2007 (FDAAA).

DATES: Submit either electronic orwritten comments by April 2, 2012.Submit comments on informationcollection issues under the PaperworkReduction Act of 1995 by February 2,2012, (see section VI. PaperworkReduction Act of 1995 of thisdocument). See section II.E of thisdocument for the proposed effectivedate of a final rule based on thisproposed rule.

ADDRESSES: You may submit comments,identified by Docket No. FDA2011N0697, by any of the following methods;except that comments on informationcollection issues under the PaperworkReduction Act of 1995 must besubmitted to the Office of RegulatoryAffairs, Office of Management andBudget (OMB) (see the Paperwork

Reduction Act of 1995 section of thisdocument).

Electronic Submissions

Submit electronic comments in thefollowing way:

Federal eRulemaking Portal: http://www.regulations.gov.Follow theinstructions for submitting comments.

Written Submissions

Submit written submissions in thefollowing ways:

FAX: (301) 8276870. Mail/Hand delivery/Courier (for

paper, disk, or CDROM submissions):Division of Dockets Management (HFA305), Food and Drug Administration,5630 Fishers Lane, Rm. 1061, Rockville,MD 20852.

Instructions: All submissions receivedmust include the Agency name andDocket No. FDA2011N0697 for thisrulemaking. All comments received may

be posted without change to http://www.regulations.gov,including anypersonal information provided. Foradditional information on submittingcomments, see the Comments headingof the SUPPLEMENTARY INFORMATIONsection of this document.

Docket: For access to the docket toread background documents orcomments received, go to http://www.regulations.govand insert thedocket number(s), found in brackets inthe heading of this document, into theSearch box and follow the promptsand/or go to the Division of DocketsManagement, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852.FOR FURTHER INFORMATION CONTACT:

Nicole Mueller, Center for DrugEvaluation and Research, Food andDrug Administration, 10903 NewHampshire Ave., Bldg. 51, Rm. 6312,Silver Spring, MD 209930002, (301)7963601.

SUPPLEMENTARY INFORMATION:

I. Background

A. Enactment of Section 505(q)

On September 27, 2007, Congressenacted FDAAA (Pub. L. 11085).

Section 914 of title IX of FDAAA addednew section 505(q) to the FD&C Act (21U.S.C. 355(q)). Section 505(q) applies tocertain citizen petitions and PSAs(collectively referred to as petitions) thatrequest FDA to take any form of actionrelated to a pending applicationsubmitted under section 505(b)(2) or (j)of the FD&C Act (21 U.S.C. 355(b)(2) or(j)). An application submitted undersection 505(b)(2) of the FD&C Act is atype of new drug application (NDA)described in that subsection and isreferred to in this document as a

505(b)(2) application. An applicationsubmitted under section 505(j) is anANDA for a generic drug product.

Section 505(q) governs the manner inwhich FDA handles certain citizenpetitions and PSAs that ask the Agencyto take any form of action related topending 505(b)(2) applications orANDAs. Over the years, FDA has

received numerous petitions asking theAgency not to approve a particularANDA or 505(b)(2) application (orclasses of these applications concerninga particular drug product or activeingredient) unless certain criteria setforth in the petition are met. In manycases, the petitions have raisedscientific and/or legal issues relating tothe standards for approval of anapplication. Examples include: Petitionssuggesting a particular method fordetermining the bioequivalence of aproposed generic product to thereference listed drug (RLD) and

petitions maintaining that a proposedgeneric product does not contain thesame active ingredient as the RLD.When submitted early, such as when weare making decisions about the

bioequivalence requirements for ageneric drug product or before we havereceived the first ANDA or 505(b)(2)application for a drug product, apetition containing material informationcan assist us in establishing standardsfor these applications. However, whenpetitions are submitted late in thereview process for challengedapplications and do not raise validscientific and/or legal issues, they may

have the effect of improperly delayingthe approval of an application. Byenacting section 505(q), Congressindicated a desire to ensure thatpetitions not be used to improperlydelay approval of ANDAs and 505(b)(2)applications.

B. Provisions of Section 505(q) of theFD&C Act

Section 505(q)(1)(A) of the FD&C Actspecifies that FDA must not delayapproval of a pending ANDA or505(b)(2) application because of anyrequest to take any form of action

relating to the application, unless therequest is in writing and in a citizenpetition submitted under 10.30 (21CFR 10.30) or a PSA submitted under 10.35 (21 CFR 10.35), and the Agencydetermines, upon reviewing thepetition, that a delay is necessary toprotect the public health.

Section 505(q)(1)(F) of the FD&C Actgoverns the timeframe for final Agencyaction on a petition. Under thisprovision, FDA must take final Agencyaction on a petition not later than 180days after the date on which the petition

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is submitted. The 180-day period is notto be extended for any reason includingany determination made under section505(q)(1)(A) regarding delay of approvalof an application (i.e., that delay isnecessary to protect the public health),the submission of comments orsupplemental information, or theconsent of the petitioner. In addition,

FDA may deny a petition at any pointif it determines that a petition or asupplement to the petition wassubmitted with the primary purpose ofdelaying the approval of an applicationand the petition does not on its faceraise valid scientific or regulatory issues(section 505(q)(1)(E) of the FD&C Act).FDA may issue guidance to describe thefactors that will be used to determinewhether a petition is submitted with theprimary purpose of delaying theapproval of an application (section505(q)(1)(E) of the FD&C Act).

Section 505(q) of the FD&C Act also

includes certification and verificationrequirements for certain documents.Under section 505(q)(1)(H) of the FD&CAct, FDA may not consider a petitionfor review unless the petition is inwriting and signed and contains acertification that is specified in thatsection. In addition, we may not acceptfor review any supplementalinformation or comments on a petitionunless the submission is in writing andsigned and contains a specificverification (section 505(q)(1)(I) of theFD&C Act).

II. Description of the Proposed Rule

FDA is proposing to amend ourregulations on general administrativeprocedures in part 10 (21 CFR part 10)to implement section 505(q) of theFD&C Act. We are proposing to add new 10.31, which includes the followingprovisions:

Proposed 10.31(a) states that 10.31 would encompass all citizenpetitions and PSAs that request that theAgency take any action that could, iftaken, delay approval of an ANDA or505(b)(2) application (i.e., petitions andPSAs that are or may be subject tosection 505(q) of the FD&C Act).

Proposed 10.31(b) would clarifythe date of submission for petitionssubmitted under 10.31.

Proposed 10.31(c) and (d) wouldcodify the certification and verificationrequirements of section 505(q)(1)(H) and(I). Although the certification andverification requirements of section505(q)(1)(H) and (I) include that thedocument be signed, we have notproposed a regulation that explicitlystates that submissions under 10.31 or 10.35 must be signed because current 10.20 requires that all submissions

made to the Division of DocketsManagement be signed.

We are also proposing minor revisionsto 10.20 and 10.30 to conform withthe addition of proposed 10.31.

With respect to 10.35,administrative stay of action, we areproposing a revision to conform withthe implementation of section 505(q).

We are also proposing to add new 10.35(i) to clarify that a petitioner fora stay of action may supplement,amend, or withdraw a PSA, similar tothe provision for citizen petitions incurrent 10.30(g).

In addition to implementing theprovisions in section 505(q) of the FD&CAct, we are proposing minor technicalchanges to revise 10.30(e)(3) and10.35(e) to allow the Commissioner ofFood and Drugs (the Commissioner) todismiss petitions as moot.

A. Submission Date for a CitizenPetition Submitted Under Section 505(q)

of the FD&C ActProposed 10.31(b) would make clear

that for a petition that could be subjectto section 505(q) of the FD&C Act andsubmitted under proposed 10.31, thedate of submission is the date on whichthe petition is received by the Divisionof Dockets Management. Proposed 10.31(b) also states that the petitionmust be submitted in accordance with 10.20, 10.30, 10.31, and 10.35, theother relevant regulations regardingcitizen petitions and PSAs.

1. Current Regulations Regarding

Submission DatesWe are proposing 10.31(b) becauseunder current 10.20(e), the submissiondate for documents submitted to theDivision of Dockets Managementdepends on how the document issubmitted to FDA. Current 10.20(e)states that all submissions to theDivision of Dockets Management will beconsidered as submitted on the datethey are postmarked or, if delivered inperson during regular business hours,on the date on which they are delivered.The date considerations in current 10.20(e) apply unless a provision in

part 10, an applicable Federal Registernotice, or an order issued by anadministrative law judge specificallystates that the documents must bereceived by a specified date. Section10.20(e) provides as an example 10.33(g), which states that a petitionfor reconsideration will be consideredsubmitted on the date received.

Under current 10.20(e), whichapplies to all citizen petitions submittedto the Agency, the computation of timeto respond to a citizen petition woulddepend on the type of delivery service

by which a document is sent to theDivision of Dockets Managementregardless of the date on which it isactually received by the Division ofDockets Management. Therefore, it ispossible for two petitions to havedifferent submission dates even if theyare received by the Division of DocketsManagement on the same day. For

example, if Petition A is sent by U.S.mail, postmarked May 1, 2010, andreceived by the Division of DocketsManagement on May 5, 2010, thesubmission date for Petition A would beconsidered to be May 1, 2010 (the dateof postmark). If Petition B is sent bycourier and hand delivered to theDivision of Dockets Management onMay 5, 2010, the submission date forPetition B would be considered to beMay 5, 2010.

Other part 10 regulations also relate tosubmission dates:

Under 10.35(g), a PSA isconsidered submitted on the day it isreceived by the Division of DocketsManagement. Therefore, under thecurrent regulations, a documentssubmission date could be differentdepending on whether the document isa citizen petition or a PSA.

Under 10.30(e), FDA is required torespond to a citizen petition within 180days of receipt of the petition byapproving the petition, denying thepetition, or providing a tentativeresponse indicating why the Agency has

been unable to reach a decision; this180-day deadline is based on the date ofreceipt by the Division of Dockets

Management.2. Submission Date for PetitionsSubmitted Under Proposed 10.31

We believe that it is important to beclear regarding what date a petitionsubmitted under 10.31 will beconsidered to be submitted becausesection 505(q)(1)(F) of the FD&C Actimposes a strict deadline for FDA torespond to a petition. Under section505(q)(1)(F) of the FD&C Act, FDA musttake final Agency action on a petitionsubject to section 505(q) no later than180 days after the date on which the

petition is submitted. The 180-dayperiod is not to be extended for anyreason, including any determinationmade under section 505(q)(1)(A) of theFD&C Act regarding delay of approval ofan application, the submission ofcomments or supplemental information,or the consent of the petitioner.

Accordingly, proposed 10.31(b)would make clear that the date ofsubmission for all petitions subject to 10.31 and submitted in accordancewith 10.20, 10.30, 10.31, and 10.35 isthe date on which a petition is received



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1Although the existence of a pending application

generally is not made public by FDA, a potentialpetitioner may be aware of the existence of apending ANDA or 505(b)(2) application because of:(1) A paragraph IV patent notification, from theapplicant to the NDA holder and the patent owner,stating that the application has been submitted andexplaining the factual and legal bases for theapplicants opinion that the patent is invalid or willnot be infringed (see section 505(b)(2)(B) and(j)(2)(B) of the FD&C Act), (2) a publicannouncement by the applicant disclosing thesubmission of the application, or (3) the tentativeapproval of an ANDA or 505(b)(2) application madepublic by FDA or the applicant. In addition, FDAsWeb site identifies drug products for which theAgency has received an ANDA with a paragraph IVcertification.

about which the information firstbecame known to the party on whosebehalf the petition is submitted. Forexample, if the petitioner providesMay 2010 as the date in thecertification, we would consider thecertification to be deficient. The text ofthe certification provided in proposed 10.31(c) includes a qualification that

the petitioner learned of the informationon or about the following date;therefore, we believe the certificationwould accommodate instances in whicha petitioner may not know the exactdate on which it became aware of theinformation.

Similarly, under proposed 10.31(d),we are proposing that if the petitioneror commenter does not provide amonth, day, and year in the verification,FDA will consider the verification to bedeficient and will not review thesubmission.

7. Multiple Dates and Types ofInformation

FDA recognizes that a petition,supplement, or comment could be basedon more than one type of information.Proposed 10.31(c)(2) would require apetitioner to provide in the certificationan estimated relevant date for each typeof information if different types ofinformation became known over aperiod of time. The petitioner mustidentify the information associated withthe particular date. To the extent that apetitioner believes that additionalclarification is appropriate, the blank

space in the certification that proposed 10.31(c) designates for the date couldaccommodate additional informationthat the petitioner believes isappropriate to explain the date that ithas identified. This would be done byproviding, in each case in which morethan one type of information is reliedon, the date followed by anidentification of the informationassociated with that date in parentheses.Thus, for example, a petition mightinclude the following in the space forthe date:

September 21, 1995 (informationabout bioavailability issues with theinnovator drug);

November 12, 2009 (publication of adraft bioequivalence guidance for thedrug);

March 30, 2010 (information that anANDA had been submitted).

When adding additional information,the petitioner should ensure that thewords of the certification (except forinformation added in the blank spaceprovided) continue to exactly match thewords of the certification as provided byproposed 10.31(c).

Similarly, proposed 10.31(d) wouldrequire that the petitioner or commenterinclude in the verification each type ofinformation and supply the date eachtype of information became known. Theverification in proposed 10.31(d)includes a blank space that canaccommodate this information.

Under proposed 10.31(c) and (d), it

is the responsibility of the personsubmitting the petition, supplementalinformation, or comment to identifyeach type of information upon which itrelies and to supply a date with respectto each such type of information. Thefailure to provide any information reliedupon (and the date) in the certificationor verification may result in the failureof FDA to consider that information inits analysis of the petition and would,FDA believes, foreclose the petitioner orthe person submitting the supplementalinformation or comment from relyingupon such information in judicial

review of FDAs final decision.8. Petitions That Would Be Required ToInclude the 505(q) Certification

Proposed 10.31 would apply to allpetitions that request an action thatcould delay the approval of a possibleANDA or 505(b)(2) application(proposed 10.31(a)); therefore, all suchpetitions would be required to includethe certification proposed in 10.31(c).

Because section 505(q)(1)(A) of theFD&C Act specifically referencespending ANDA or 505(b)(2)applications, we interpret section 505(q)

to apply only to petitions for which, atthe time the petition is submitted, atleast one ANDA or 505(b)(2) applicationrelated to the subject matter of thepetition is pending. If there is no relatedANDA or 505(b)(2) application pendingat the time that the petition issubmitted, then we will not consider theprovisions of section 505(q) of the FD&CAct to apply to the petition. We believethis interpretation of section 505(q) ofthe FD&C Act is appropriate because ifno related ANDA or 505(b)(2)application is pending at the time thata petition is submitted, the references insection 505(q)(1)(A) to a pendingapplication and delay of approval by apetition would be inapplicable. Withrespect to the actual submission of thecertification and/or verification with apetition, we recognize that petitionersmay not be aware of the existence of apending ANDA or 505(b)(2) applicationand, therefore, may not know whetherto submit the appropriate certificationand/or verification under section 505(q)of the FD&C Act. Generally, theexistence of an ANDA or a 505(b)(2)application would not be public

information.1 Therefore, FDA hasrecommended that any petitionerchallenging the approvability of anANDA or a 505(b)(2) applicationinclude the statutory certification toavoid a situation in which a petitionthat is subject to section 505(q) of theFD&C Act is missing the certificationand therefore cannot be reviewed by

FDA under the statute. We have statedthat in situations where a petitionersubmits such a petition, we recommendthat the petitioner withdraw the originalpetition and resubmit a petition thatincludes the required certification undersection 505(q) of the FD&C Act.

We have also stated that although wemay contact a petitioner to notify himor her of a missing or deficientcertification, it is the responsibility ofthe petitioner to ensure that his or herpetition complies with the applicablerequirements of section 505(q) of theFD&C Act as well as all other applicable

statutory and regulatory requirements.Contacting petitioners who havesubmitted deficient petitions representsan administrative burden for theAgency. In addition, we are concernedthat our contacting such petitionerscould notify the petitioner and thepublic that an ANDA or 505(b)(2)application for a particular drug productis pending.

By including in proposed 10.31(a)all petitions that challenge theapprovability of a possible ANDA or505(b)(2) application, all such petitionswould be required to include thecertification in proposed 10.31(c).

Proposed 10.31(a) would eliminate theneed for FDA to contact a petitioner toadvise him or her that the petition mustinclude the 505(q) certification or avoida delay in dealing with the specificissues contained in a petition becausethe petitioner must withdraw andresubmit the petition. In addition, wepropose that any supplement orcomments to a petition that is subject toproposed 10.31 and that includes thecertification in 10.31(c) must includethe verification in 10.31(d).



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C. Dismiss Petition as Moot

Although the primary purpose of thisrule is to implement section 505(q) ofthe FD&C Act, we are proposing to addlanguage to 10.30(e) to allow theCommissioner to dismiss a petition asmoot. Because we are making changes to 10.30 to implement section 505(q) of

the FD&C Act, we believe it would beuseful to make this minor clarifyingchange to the regulations. This changeis technical in nature and would beapplicable to citizen petitions ingeneral, including those subject tosection 505(q) of the FD&C Act. Current 10.30(e) could be read to require thatthe Commissioner respond to a citizenpetition by either granting or denyingthe requests in the citizen petition, evenwhen circumstances have rendered therequests in the petition moot. Current 10.30(e) does not by its termscontemplate a situation in which a

petition can be dismissed as moot.Because changes in law, facts, or

circumstances occurring after a citizenpetition is submitted to the Agency canrender the requests contained in apetition moot, we propose to allow theCommissioner to dismiss a petition asmoot in these situations. An example ofa moot petition would be a petition thatrequests that the Agency remove aparticular drug from the market forsafety reasons when, at the time of theresponse, the drug has already beenremoved from the market. Anotherexample would be where a petitioner

requests a change to a regulation thathas been rescinded or withdrawn sincethe petition was submitted. In suchcircumstances, it would be appropriatefor the Commissioner to dismiss thepetition as moot rather than to grant ordeny the requests in the petition. Thisproposed change to our regulations isintended to clarify that, in addition toour authority to grant or deny a petitionunder our current regulations, theAgency can dismiss citizen petitions asmoot in certain circumstances.

When a citizen petition is dismissedas moot, FDA would respond to thepetitioner in writing just as we wouldwhen granting or denying a petition. We

believe, however, that the Agencysjustification for dismissing a petition asmoot could be brief in comparison to aresponse granting or denying a petition,and thus would require dedication offewer Agency resources. FDAs responsedismissing a citizen petition as moot,similar to a response granting ordenying a petition, would constitutefinal Agency action as to that citizenpetition.

D. Petitions for Stay of Action

We are proposing a conformingchange to 10.35(b) to clarify theapplicable regulations for PSAs that aresubject to section 505(q) of the FD&CAct. Section 10.35(b) currently statesthat a request for stay must besubmitted in accordance with 10.20

and in the following form no later than30 days after the date of the decisioninvolved. We propose to add languageto 10.35(b) to provide that petitions forstay subject to 10.31 must include thecertification provided in 10.31(c). Thisproposed revision would alertpetitioners for stays of action that may

be subject to section to 505(q) of theFD&C Act that they must also submitthe certification in 10.31(c).

Section 505(q)(1)(A) of the FD&C Actstates that FDA must not delay approvalof a pending ANDA or 505(b)(2)application because of any request to

take any form of action relating to theapplication unless the request is inwriting, is a citizen petition submittedunder 10.30 or a PSA submitted under 10.35, and FDA determines, uponreviewing the petition, that a delay isnecessary to protect the public health.Section 10.35(d) provides that filing aPSA, citizen petition, or other type ofpetition, or taking another type of actionas described in 10.35(d) will not stayor otherwise delay any administrativeaction by the Commissioner unless: (1)The Commissioner determines that astay or delay is in the public interest

and stays the action, (2) a statuterequires that the matter be stayed, or (3)a court orders that the matter be stayed.In other words, the mere filing of anypetition, including a petition undersection 505(q) of the FD&C Act, wouldnot stay or otherwise delayadministrative action by FDA. See TMJImplants, Inc. v. United States HHS, 584F.3d 1290, 1300 (10th Cir. 2009). Adelay of an administrative action couldonly occur if FDA chose to take actionin response to a particular submission.We are not proposing any changes to 10.35(d) to implement section505(q)(1)(A) of the FD&C Act because

we believe that the provisions of section505(q)(1)(A) of the FD&C Act regardingthe circumstances in which FDA wouldstay or delay an administrative action(e.g., approval of an ANDA or 505(b)(2))would be covered by the currentlanguage of 10.35(d).

As explained previously in thisdocument with respect to citizenpetitions under 10.30(e)(3), we areproposing to add a sentence to 10.35(e)to allow the Commissioner to dismiss apetition for stay of action as moot.

In addition, we are proposing to add 10.35(i), which would mirror 10.30(g) governing citizen petitionsand allow a petitioner who hassubmitted a PSA to supplement, amend,or withdraw a PSA without Agencyapproval and without prejudice, unlessthe PSA has been referred for a hearingunder 21 CFR parts 12, 13, 14, or 15.

Proposed 10.35(i) would apply to allPSAs, not just PSAs subject to section505(q) of the FD&C Act. We believe thatadding this provision to allow PSAs to

be amended, withdrawn, orsupplemented is permitted under theFD&C Act and is appropriate to allowpetitioners submitting PSAs the sameprocedural rights as petitionerssubmitting citizen petitions. Byamending this regulation, we areclarifying that it is permissible toamend, withdraw, or supplement a PSA

because the current regulations are notspecific on this point and our current

practice allows a PSA to be amended,withdrawn, or supplemented.Furthermore, under section 505(q)(1)(I)of the FD&C Act, the verificationstatement that applies to citizenpetitions and PSAs refers tosupplemental information. Therefore, indrafting this provision, Congressassumed it was possible to provide asupplement to a PSA.

E. Proposed Effective Date

FDA proposes that any final rule thatmay issue based on this proposal

become effective 60 days after its

publication in the Federal Register.FDA seeks public comment on itsproposed 60-day effective date for anyfinal rule that may issue based on thisproposed rule.

III. Legal Authority

This rule, if finalized, would amend 10.20, 10.30, and 10.35 and add new 10.31 in a manner consistent with theAgencys current understanding andapplication of these provisions. FDA isimplementing certain provisions ofFDAAA that govern petitions subject tosection 505(q) of the FD&C Act. FDA hasauthority to issue regulations for theefficient administration of theseprovisions under section 701(a) of theFD&C Act (21 U.S.C. 371(a)).

IV. Environmental Impact

FDA has determined under 21 CFR25.30(h) that this action is of a type thatdoes not individually or cumulativelyhave a significant effect on the humanenvironment. Therefore, neither anenvironmental assessment nor anenvironmental impact statement isrequired.



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V. Analysis of Impacts

FDA has examined the impacts of thefinal rule under Executive Order 12866,Executive Order 13563, the RegulatoryFlexibility Act (5 U.S.C. 601612), andthe Unfunded Mandates Reform Act of1995 (Pub. L. 1044). Executive Orders12866 and 13563 direct Agencies to

assess all costs and benefits of availableregulatory alternatives and, whenregulation is necessary, to selectregulatory approaches that maximizenet benefits (including potentialeconomic, environmental, public healthand safety, and other advantages;distributive impacts; and equity). TheAgency believes that this final rule isnot a significant regulatory action underExecutive Order 12866.

The Regulatory Flexibility Actrequires Agencies to analyze regulatoryoptions that would minimize anysignificant impact of a rule on smallentities. Because the annualized

compliance costs to individual industrymembers who submit a petition isestimated to be about $100, the Agencyproposes to certify that the final rulewill not have a significant economicimpact on a substantial number of smallentities.

Section 202(a) of the UnfundedMandates Reform Act of 1995 requiresthat Agencies prepare a writtenstatement, which includes anassessment of anticipated costs and

benefits, before proposing any rule thatincludes any Federal mandate that mayresult in the expenditure by State, local,

and tribal governments, in the aggregate,or by the private sector, of $100,000,000or more (adjusted annually for inflation)in any one year. The current thresholdafter adjustment for inflation is $136million, using the most current (2010)Implicit Price Deflator for the GrossDomestic Product. FDA does not expectany final rule to result in any 1-yearexpenditure that would meet or exceedthis amount.

A. Purpose of the Proposed Rule

Section 505(q) of the FD&C Actconcerns the manner in which FDA

handles certain citizen petitions andPSAs that request that the Agency takesome action related to a pending505(b)(2) application or 505(j)application (ANDA). Congress wasconcerned that some petitions mayimproperly delay the approval of anapplication if they are submitted late inthe review process and do not containvalid scientific, legal, or public healthissues. The provisions contained insection 505(q) of the FD&C Act are self-implementing, and FDA has operatedunder these requirements since FDAAA

became law in September 2007. Thisproposed rule would codify thecertification and verificationrequirements included in section 505(q)of the FD&C Act extend theserequirements to all petitions challengingthe approvability of possible ANDAsand 505(b)(2) applications, as well asthose submitting supplements and

comments to these petitions, clarify howFDA determines the date of submissionsfor citizen petitions and PSAs subject tosection 505(q), and clarify that apetitioner for a PSA may supplement,amend, or withdraw a PSA in a mannersimilar to that provided in theprovisions for citizen petitions. Inaddition, the proposed rule would allowthe Commissioner to dismiss a citizenpetition or PSA as moot in certaincircumstances.

B. Benefits of the Proposed Rule

Section 505(q) of the FD&C Act was

enacted in light of concerns that somecitizen petitions were submitted todelay the approval of ANDAs or505(b)(2) applications. With theenactment of FDAAA, FDA is requiredto take final action on a 505(q) petitionwithin 180 days of its receipt. Further,the law requires that an expandedcertification statement be included withpetitions, and a verification statement

be included with supplements andcomments to petitions. While theserequirements do not specificallypreclude anyone from submitting apetition that may delay approval of an

ANDA or 505(b)(2) application, therequirement that the person submittingthe document reveal the date on whichhe or she became aware of theinformation contained in the petition ispresumably intended to reduce this typeof behavior.

The requirements contained insection 505(q) of the FD&C Act have

been in effect for 3 years. FDA received21 505(q) petitions in fiscal year (FY)2008, 31 505(q) petitions in FY 2009,and 20 505(q) petitions in FY 2010.Over the same period, however, thenumber of ANDAs and 505(b)(2)applications whose approvals weredelayed decreased slightly, from 2 in FY2008 to 1 in FY 2009 and 1 in FY 2010.The sample size of only 3 years is toosmall to conclusively determinewhether the statute has caused areduction in the number of petitionsthat did not include valid scientific orlegal issues whose primary purpose wasto delay approval of an application. Theexistence of the statutory requirementthat FDA take final action within 180days of receipt of a 505(q) petition,consequently reducing delays of

approval, may have had this effect byitself.

By codifying the certification andverification statements (with a minortechnical change to the verificationlanguage), the proposed rule wouldreinforce the need for exact wording of

both the certification and verificationstatements. Further, the proposed rule

makes clear that each of these twostatements requires the identification ofa month, day, and year in the place ofthe date, as opposed to just a year or amonth and year. In addition, theproposed rule would clarify that eachindividual type of information requiresits own separate date. By providingadditional clarity on the statutoryrequirements, this proposed rule wouldlikely reduce the number of deficient505(q) petitions. FDA does not haveenough information to estimate thisreduction in deficient 505(q) petitions,

but believes it will result in lower

administrative costs for both industryand FDA.

C. Costs of the Proposed Rule

1. Industry Labor Costs

Companies involved inpharmaceutical research andmanufacturing would incur labor costsdue to the rule through theiradministrative review of the final ruleand determination of their complianceresponsibilities. All companies involvedin this would incur some labor costs,regardless of the frequency of theirsubmission of ANDAs or 505(b)(2)

applications or citizen petitions to FDA.Census data from 2007 list 763companies in its pharmaceuticalpreparation manufacturing category.FDA estimates that each company willexpend about 4 hours to review the finalrule and determine any changes it needsto make to its internal administrativepolicies due to this rule. Thepharmaceutical and medicinemanufacturing category of the NorthAmerican Industrial ClassificationSystem (NAICS) lists the hourly wagefor a manager in this category at about$54. A 35-percent adjustment to thisfigure for employee benefits results intotal hourly compensation costs of about$73. A one-time 4-hour review for eachcompany would result in compliancecosts of almost $300 per company, anda total of about $224,000 for theindustry. This equates to an annualizedcost (over 5 years at a 7-percentdiscount rate) of about $55,000 for theentire industry. These estimates mayoverstate true compliance costs forreview of the rule because companiesthat are unlikely to submit citizenpetitions on even an occasional basis



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may not expend as much labor as thosethat submit petitions more often. FDAinvites comment on the estimate of 4hours of labor to review the final ruleand make any adjustment to companypolicies.

Additional labor costs of the rulewould be incurred due to the newrequirement that all petitioners

challenging the approvability of apossible ANDA or 505(b)(2) applicationfor which an application is not currentlypending at FDA submit the appropriatecertification, as well as the requirementthat any supplements or comments tothese petitions include the verification.The implementation of the requirementsthat 505(q) petitions (concerning theapprovability of a pending ANDA or505(b)(2) application) use the newcertification language and thatsupplements and comments to thesepetitions use the verification language

began with the enactment of FDAAA in

September 2007 and are not the subjectof the proposed rule. FDA haspreviously estimated that the statutewould result in about 28 additionalcertifications with petitions and 25additional verifications withsupplements or comments to petitions.

FDA received a yearly average of 32petitions that challenged theapprovability of a possible ANDA or505(b)(2) application since the end of2007. This number represents a verysmall increase over the average for theprevious 4-year period. Of these 32petitions, on average only 25 were505(q) petitions. FDA uses the

difference between these two numbers,or about seven petitions per year, as its

estimate of the number of additionalpetitions that this proposed rule wouldrequire to comply with the 505(q)requirements for certification. FDAestimates that the additional timeneeded to prepare the certificationlanguage in the proposed rule at 30minutes. The majority of this timerepresents the additional effort of

determining the date on which theinformation or data included in thepetition became known to the personsubmitting the petition. FDA uses thesame pharmaceutical and medicinemanufacturing category of the NAICShourly wage for a manager (adjusted for

benefits) of $73 to calculate this cost. At30 minutes per petition, the marginalcost to prepare the additionalcertification language for 1 petition isestimated at $37. For the average ofseven additional petitions that wouldneed the additional language, the totalcost to industry is estimated at about

$250 annually.Additional labor costs would also be

incurred for the preparation ofcertifications for supplements andcomments to petitions that challenge theapprovability of ANDA applications and505(b)(2) applications for which there isno pending application at the time ofthe supplement or commentsubmission. FDA previously estimatedthat it would receive about 9verifications for every 10 certificationsin the implementation of the 505(q)provision. Using this ratio, FDAestimates that this proposed rule would

result in the submission of verificationsamounting to 90 percent of the

additional certifications that it receiveddue to this rule. Since FDA estimatedthat 7 additional certifications would besubmitted due to this rule, FDAestimates that 90 percent of thisnumber, or about 6 verifications, wouldalso be submitted as a result of this rule.At 30 minutes per petition and the sameadjusted wage rate of $73/hour, the

additional cost per verification isestimated at $37. The additional laborcosts for the 6 verifications would totalto about $220 per year.

The provision of the proposed rulethat would allow a petitioner who hassubmitted a PSA to supplement, amend,or withdraw a PSA without Agencyapproval would not impose anymarginal costs on industry members.These practices reflect FDAs currentpolicy. Similarly, the provision of thisproposed rule that clarifies how FDAdetermines the submission date fordocuments received by FDAs Division

of Docket Management is also notexpected to impose any costs onindustry members.

The total one-time costs plus annualcosts of this proposed rule are estimatedat about $224,000, with annualizedcosts (one-time costs annualized over 5years at a 7-percent discount rate plusannual costs) at about $55,000 for theentire industry (see table 1 of thisdocument). This estimate reflects a one-time $300 per company review cost foreach industry member (annualized over5 years at a 7-percent discount rate atabout $70), plus an additional $37 labor

cost per certification or verificationsubmitted.

TABLE 1INDUSTRY COMPLIANCE COSTS

Labor cost factors One-time costs Annual costsAnnualized

costs 1

Final Rule Review ............................................................................................................ $223,600 ............................ $55,000Certification Preparation .................................................................................................. ............................ $250 250Verification Preparation ................................................................................................... ............................ 200 200

Total Costs ............................................................................................................... ............................ ............................ 55,450

1Annualized costs represent one-time costs amortized over 5 years at a 7-percent discount rate plus annual costs. At a 3-percent discountrate, annualized costs are reduced by about $5,400.

2. Costs to the Government

The costs to government for oversightof this proposed rule would be low asa review of the language in anadditional seven certifications includedwith petitions and six verificationsincluded with supplements orcomments to petitions would onlyrequire 15 minutes for each. FDA

believes this cost would not besignificant, and emphasizes that theFDA personnel reviewing and

responding to citizen petitions spendthe vast majority of the time on thesubstantive issues included in thedocuments.

D. Small Business Impact

The Regulatory Flexibility Actrequires Agencies to analyze regulatoryoptions that would minimize anysignificant impact of a rule on smallentities. Because of the very low coststhat would be incurred by an individualcompany submitting a petition or

supplement or comment to a petition,FDA believes that the proposed rulewould not have a significant economicimpact on a substantial number of smallmanufacturing entities.

The companies that would be affectedby this proposed rule are classified intwo NAICS categories by the CensusBureau. The affected industries areNAICS 325412PharmaceuticalPreparation, and NAICS 325414Biological Products (except diagnostic).The Small Business Administration



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(SBA) defines small entities in thepharmaceutical preparation category asthose with less than 750 employees anddefines small entities in the biologicalproduct (except diagnostic) category asthose with less than 500 employees. Themost recent Census of Manufacturesdata that offer the level of detail forestablishments at or near the employee

size limits as defined by SBA is from2002. In both of these establishment sizecategories, large majorities of theestablishments meet the criteria as smallentities. Even taking into account thatmany of these establishments are partsof multi-establishment corporations,significant numbers of companieswould still qualify as small entities.Preliminary Census data from 2007,though less detailed, show thatsignificant numbers of establishmentscontinue to have fewer than 100employees across all of these categories.While FDA expects that most companies

submitting petitions that challenge theapprovability of an ANDA or 505(b)(2)application would be larger than theaverage-sized company in theirindustry, FDA concludes that asubstantial number of companies wouldstill qualify as small entities.

The cost analysis concluded that theannualized compliance cost of theproposed rule for a company thatsubmitted one additional certification asa result of the rule would be just over$100. Because FDA estimates that onlyabout seven additional certificationswill be submitted due to this rule, it isdoubtful that many firms will submit

more than one additional certification orverification annually to those alreadyrequired by section 505(q) of the FD&CAct. Using 2002 Census data, theaverage value of shipments forestablishments in these industries with1 to 4 employees ranged from $478,000to $824,000 according the Census ofManufactures. Assuming that suchsmall operations had to prepare evenone additional certification orverification each year, the costs of theproposed rule would represent, at most,0.02 percent of the annual value ofshipments. For establishments with 10

or more employees, the compliancecosts would represent 0.01 percent orless of the value of shipments. As statedpreviously, FDA concludes that thisproposed rule would not have asignificant economic impact on asubstantial number of small entities.

VI. Paperwork Reduction Act

This proposed rule containscollections of information that aresubject to review by OMB under thePaperwork Reduction Act of 1995 (thePRA) (44 U.S.C. 35013520).

Collection of information includesany request or requirement that personsobtain, maintain, retain, or reportinformation to the Agency, or discloseinformation to a third party or to thepublic (44 U.S.C. 3502(3) and 5 CFR1320.3(c)). The title, description, andrespondent description of theinformation collection are shown under

this section with an estimate of theannual reporting burden. Included inthe estimate is the time for reviewinginstructions, searching existing datasources, gathering and maintaining thedata needed, and completing andreviewing the collection of information.

FDA invites comments on thesetopics: (1) Whether the collection ofinformation is necessary for properperformance of FDAs functions,including whether the information willhave practical utility; (2) the accuracy ofFDAs estimate of the burden of theproposed collection of information,

including the validity of themethodology and assumptions used; (3)ways to enhance the quality, utility, andclarity of the information to becollected; and (4) ways to minimize the

burden of the collection of informationon respondents, including through theuse of automated collection techniques,when appropriate, and other forms ofinformation technology.

Title: Amendments to Regulations onCitizen Petitions, Petitions for Stay ofAction, and Submission of Documentsto Dockets.

Description of Respondents:Respondents to this collection of

information as it is related to citizenpetitions are individuals or households,State or local governments, not-for-profit institutions, and businesses orother for-profit institutions or groups.Respondents to this collection ofinformation as it is related to PSAs arepersons who choose to file a petition foran administrative stay of action.

Description: FDA is requesting publiccomment on estimates of annualsubmissions from these respondents, asrequired by section 505(q) of the FD&CAct and described in this proposed ruleunder 10.31(c) and (d). Section

10.31(c) of this proposed rule requiresthat citizen petitions and PSAs that aresubject to section 505(q) include acertification to be considered for review

by FDA. Section 10.31(d) requires thatsupplemental information or commentsto such citizen petitions and PSAsinclude a verification to be accepted forreview by FDA. This proposed rule setsforth the statutory language undersection 505(q) requiring the submissionof a certification and/or a verificationand the precise language of thecertification and verification. One of the

criteria for a citizen petition or PSA tobe subject to section 505(q) is that arelated ANDA or 505(b)(2) application ispending at the time the citizen petitionor petition for stay is submitted.Because petitioners or commenters maynot be aware of the existence of apending ANDA or 505(b)(2) application,this proposed rule requires that all

petitioners challenging theapprovability of a possible ANDA or505(b)(2) application include thecertification required in 10.31(c) ofthis proposed rule and that petitionersand commenters submittingsupplements or comments, respectively,to a citizen petition or PSA challengingthe approvability of a possible ANDA or505(b)(2) application include theverification required in section 10.31(d) of this proposed rule.

FDA currently has OMB approval forthe collection of information entitledGeneral Administrative Procedures:

Citizen Petitions; Petition forReconsideration or Stay of Action;Advisory Opinions (OMB controlnumber 09100183). This collection ofinformation includes, among otherthings: (1) The format and procedures

by which an interested person maysubmit to FDA, in accordance with 10.20, a citizen petition requesting theCommissioner to issue, amend, orrevoke a regulation or order, or to takeor refrain from taking any other form ofadministrative action (10.30(b)); (2) thesubmission of written comments on afiled citizen petition (10.30(d)); (3) thesubmission of a supplement or

amendment to or a letter to withdraw afiled citizen petition ( 10.30(g)); (4) theformat and procedures by which aninterested person may request, inaccordance with 10.20, theCommissioner to stay the effective dateof any administrative action (10.35(b));and (5) the submission of writtencomments on a filed petition foradministrative stay of action (10.35(c)).This information collection includescitizen petitions, PSAs, comments topetitions, supplements to citizenpetitions, and letters to withdraw acitizen petition, as described previously,

that are subject to section 505(q) of theFD&C Act and described in thisproposed regulation.

OMB recently approved (OMB controlnumber 09100679) the informationcollection in the guidance for industryentitled Citizen Petitions and Petitionsfor Stay of Action Subject to Section505(q) of the Federal Food, Drug, andCosmetic Act (see the informationcollection analysis at 75 FR 78249(December 15, 2010), and the documentannouncing the availability of theguidance at 76 FR 33309 (June 8, 2011)).



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certification requirement of 10.31. Thepetition must be in the following form:

* * * * *(c) A petition that appears to meet the

requirements of paragraph (b) of thissection, 10.20, and, if applicable, 10.31, will be filed by the Division ofDockets Management, stamped with thedate of filing, and assigned a docketnumber. * * *

(d) * * * The comments are tospecify the docket number of thepetition, include, if applicable, theverification under 10.31, and maysupport or oppose the petition in wholeor in part.* * *

(e) * * *(2) * * *(iii) Dismiss the petition as moot if at

any time the Commissioner determinesthat changes in law, facts, orcircumstances since the date on whichthe petition was submitted haverendered the petition moot; or

* * * * *(3) * * * If, at any time, the

Commissioner determines that changesin law, facts, or circumstances since thedate on which the petition wassubmitted have rendered the petitionmoot, the Commissioner may dismissthe petition as moot. * * *

* * * * *4. Section 10.31 is added to read as

follows:

10.31 Citizen petitions and petitions forstay of action related to an abbreviated newdrug application or a new drug application.

(a) Applicability. This section appliesto a citizen petition or petition for stayof action that meets all of the followingcriteria:

(1) The petition requests that theCommissioner take any form of actionthat could, if taken, delay approval of anabbreviated new drug application(ANDA) submitted under section 505(j)of the Federal Food, Drug, and CosmeticAct (21 U.S.C. 355(j)) or a new drugapplication submitted under section505(b)(2) (a 505(b)(2) application).

(2) The petition is submitted on orafter September 27, 2007.

(3) The petition is submitted inwriting and under 10.30 (for citizenpetitions) or 10.35 (for petitions forstay of action).

(b) Date of submission. A petitionsubject to this section and submitted inaccordance with 10.20, 10.30, 10.31,and 10.35 is regarded as submitted onthe date on which the petition isreceived by the Division of DocketsManagement.

(c) Certification. (1) FDA will notconsider for review a petition that issubject to this section unless the

petition is in writing and contains thefollowing certification: I certify that, tomy best knowledge and belief: (i) Thispetition includes all information andviews upon which the petition relies;(ii) this petition includes representativedata and/or information known to thepetitioner that are unfavorable to thepetition; and (iii) I have taken

reasonable steps to ensure that anyrepresentative data and/or informationthat are unfavorable to the petition weredisclosed to me. I further certify that theinformation upon which I have basedthe action requested herein first becameknown to the party on whose behalf thispetition is submitted on or about thefollowing date:________ [in the blankspace, provide the date on which suchinformation first became known to theperson submitting the petition]. If Ireceived or expect to receive payments,including cash and other forms ofconsideration, to file this information or

its contents, I received or expect toreceive those payments from thefollowing persons or organizations:________ [in the blank space, providethe names of such persons ororganizations]. I verify under penalty ofperjury that the foregoing is true andcorrect as of the date of the submissionof this petition.

(2) The certification in paragraph(c)(1) of this section must contain one ormore specific dates (month, day, andyear) in the blank space provided. Ifdifferent categories of information

became known at different times, thecertification must contain each

estimated relevant date. Theinformation associated with a particulardate must be identified.

(d) Verification. (1) FDA will notaccept for review any supplementalinformation or comments on a petitionthat is subject to this section unless thesupplemental information or commentsare in writing and contain the followingverification: I certify that, to my bestknowledge and belief: (i) I have notintentionally delayed submission of thisdocument or its contents; and (ii) theinformation upon which I have basedthe action requested herein first became

known to me on or aboutllllllll[in the blank space,provide the date on which suchinformation first became known to theperson submitting the document]. If Ireceived or expect to receive payments,including cash and other forms ofconsideration, to file this information orits contents, I received or expect toreceive those payments from thefollowing persons or organizations:llllllll[in the blank space,provide the names of such persons ororganizations]. I verify under penalty of

perjury that the foregoing is true andcorrect as of the date of the submissionof this document.

(2) The verification in paragraph(d)(1) of this section must contain oneor more specific dates (month, day, andyear) in the blank space provided. Ifdifferent categories of information

became known at different times, thecertification must contain eachestimated relevant date. Theinformation associated with a particulardate must be identified.

5. Section 10.35 is amended byrevising the third sentence of paragraph(b); by adding to paragraph (e) a newsentence after the second sentence; and

by adding paragraph (i) to read asfollows:

10.35 Administrative stay of action.

* * * * *

(b) * * * A request for stay must besubmitted in accordance with 10.20and in the following form (except thatstays subject to 10.31 must include thecertification provided in 10.31(c)) nolater than 30 days after the date of thedecision involved. * * *

* * * * *

(e) * * * If, at any time, theCommissioner determines that changesin law, facts, or circumstances since thedate on which the petition wassubmitted have rendered the petitionmoot, the Commissioner may dismissthe petition as moot. * * *

* * * * *

(i) A petitioner may supplement,amend, or withdraw a petition for stayof action in writing without Agencyapproval and without prejudice toresubmission at any time until theCommissioner rules on the petition,provided the resubmission is made inaccordance with paragraph (b) of thissection, unless the petition for stay ofaction has been referred for a hearingunder parts 12, 13, 14, or 15 of thischapter. After a ruling or referral, apetition for stay of action may be

supplemented, amended, or withdrawnonly with the approval of theCommissioner. The Commissioner mayapprove withdrawal, with or withoutprejudice against resubmission of thepetition for stay of action.

Dated: December 27, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 201133622 Filed 123011; 8:45 am]

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