Document ID: FDA-2014-N-1168-0029
Agency: fda
Document Type: Notice
Title: Generic Drug User Fee Amendments of 2012; September 2014 Public Hearing on Policy Development; Reopening of Docket; Request for Comments
Posted Date: 2015-02-06T05:00Z

[Federal Register Volume 80, Number 25 (Friday, February 6, 2015)]
[Notices]
[Pages 6729-6731]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02401]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1168]

Generic Drug User Fee Amendments of 2012; September 2014 Public 
Hearing on Policy Development; Reopening of Docket; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
reopening of the docket to solicit public comment on certain topics 
related to implementation of the Generic Drug User Fee Amendments of 
2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the 
legislation. A public hearing in September 2014 provided an opportunity 
for public input on future

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policy priorities. FDA is seeking additional written comments from all 
interested parties, including, but not limited to, regulated industry, 
consumers, patients, caregivers, health care professionals, and patient 
groups.

DATES: Submit electronic or written comments by March 9, 2015.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Office of Generic 
Drugs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg 75, Rm. 1670, Silver 
Spring, MD 20993-0002, 240-402-7930, elizabeth.giaquinto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) (the Hatch-Waxman Amendments) amended the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act). The Hatch-Waxman 
Amendments created section 505(j) of the FD&C Act (21 U.S.C. 355(j)), 
which established the abbreviated new drug application (ANDA) approval 
pathway, which allows lower-priced generic versions of previously 
approved innovator drugs to be approved and marketed.
    On July 9, 2012, GDUFA was signed into law by the President to help 
speed the delivery of safe and effective generic drugs to the public 
and to reduce costs to industry. Under GDUFA, FDA agreed to certain 
obligations as laid out in the GDUFA Commitment Letter that accompanies 
the legislation.\1\ To support these obligations, FDA is developing 
numerous guidance documents. At the time of the September 2014 public 
hearing, FDA had developed the following draft guidances for industry: 
\2\

    \1\ See Generic Drug User Fee Act Program Performance Goals and 
Procedures (GDUFA Commitment Letter) for fiscal years 2013 through 
2017, available at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf).
    \2\ The draft guidance documents referenced in this document are 
available on the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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 ``ANDA Submissions--Content and Format of Abbreviated New Drug 
Applications''
 ``ANDA Submissions--Refuse to Receive for Lack of Proper 
Justification of Impurity Limits''
 ``ANDA Submissions--Amendments and Easily Correctable 
Deficiencies Under GDUFA''
 ``ANDA Submissions--Prior Approval Supplements Under GDUFA''
 ``Controlled Correspondence Related to Generic Drug 
Development''

II. Purpose and Scope of the September 2014 Public Hearing

A. GDUFA Implementation: Draft Guidance Documents

    The purpose of the public hearing was to: (1) Solicit public 
comment on the five draft guidance documents described in section I 
that FDA had issued to facilitate implementation of GDUFA and (2) 
recommend future policy priorities, including recommendations for 
additional guidance topics to facilitate GDUFA implementation. We 
continue to solicit comments from interested members of the public, 
including industry, consumers, patient groups, caregivers, and health 
care professionals, on the following topics related to GDUFA 
implementation guidances:
     Are there comments on the five guidances described in 
section I?
     Are there GDUFA implementation issues related to the five 
draft guidances described in section I that have not been addressed?
     What other GDUFA implementation topics need the 
development of guidance?
     Are there any topics or issues related to generic drug 
development other than those related to GDUFA implementation that need 
the development of guidance?

B. GDUFA Implementation Related to Generic Drug Exclusivity

    Another purpose of the hearing was to solicit feedback on issues 
that may arise in FDA's consideration of 180-day exclusivity provided 
for in section 505(j)(5)(B)(iv) of the FD&C Act.
    Timing of ANDA approval is directly affected by an applicant's 
eligibility for 180-day exclusivity, and thus FDA's consideration of 
any issues related to 180-day exclusivity is a component of approval 
actions. FDA decisions regarding 180-day exclusivity are fact-specific, 
and the facts that have the potential to determine eligibility for 
exclusivity may shift up to the time when an ANDA that is eligible for 
180-day exclusivity, or another ANDA referencing the same listed drug, 
is ready for approval.
    With the enactment of GDUFA, FDA will take actions on pending 
applications consistent with the timeframes agreed upon in the GDUFA 
Commitment Letter. During the hearing, we sought input on possible 
processes FDA might introduce under GDUFA for making determinations on 
180-day exclusivity, as described in the following questions:
     Should FDA's consideration of eligibility for 180-day 
exclusivity for a specific drug product be a public process, including 
consideration of whether a first applicant has forfeited its 
eligibility for exclusivity under section 505(j)(5)(D) of the FD&C Act? 
If a public process is advisable, would it be so in all instances, or 
is there a subset of circumstances in which the process should be 
public? Also, what administrative mechanisms would best facilitate such 
a process?
     Legal challenges to FDA's decisions on 180-day exclusivity 
often must be resolved on an expedited basis that can be inconvenient 
for the parties and the court. What legal or regulatory mechanisms, if 
any, are available to better facilitate FDA's determination of and 
orderly resolution of sponsors' challenges to 180-day exclusivity 
determinations?
     Are there other topics related to 180-day exclusivity on 
which you would like to comment?
     Are there topics related to 180-day exclusivity that would 
benefit from FDA guidance?
    We continue to seek comment on these topics. When submitting input 
on the questions provided in this notice, we encourage commenters to 
consider FDA's statutory and regulatory authorities, including any 
restrictions on FDA's authority to disclose certain information related 
to unapproved ANDAs.

C. GDUFA Implementation and Potential First Generics

    At the public hearing, we also sought comment on meeting the goals 
of the GDUFA Commitment Letter with regard to the ``first generics'' 
review prioritization category. Subsequent to that hearing, the Agency 
opened a separate, dedicated docket, Docket No. FDA-2014-N-1741, 
seeking comment on ``first generic'' criteria, as described in the 
Federal Register notice ``Proposed Criteria for `First Generic' 
Submissions for Purposes of Abbreviated New Drug Application Review 
Prioritization Under the Generic Drug User Fee Amendments; 
Establishment of a Public Docket.'' This

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docket opened on November 19, 2014, and closed on December 19, 2014. We 
are no longer seeking comment on the ``first generic'' review 
prioritization category at this time.

III. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02401 Filed 2-5-15; 8:45 am]
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