[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Pages 68891-68892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27385]



Food and Drug Administration

[Docket No. FDA-2014-N-1741]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of public docket; request for comments.


SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the opening of a public docket and requesting comments on 
proposed criteria for ``first generic'' abbreviated new drug 
application (ANDA) submissions. The purpose is to facilitate FDA's 
establishment of review prioritization under the Generic Drug User Fee 
Amendments of 2012 (GDUFA). Establishing clear criteria for this review 
prioritization category will allow FDA to appropriately prioritize ANDA 
submissions and track them in a manner consistent with the review 
prioritization commitments FDA made under GDUFA. Clear criteria for 
this category will also lead to less industry confusion and more 
consistent identification of ``first generic'' submissions.

DATES: Submit either electronic or written comments by December 19, 

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments as follows:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written comments as follows:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions must include the Docket No. found in 
brackets in the heading of this document. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Maryll Toufanian, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1682, Silver Spring, MD 20993-0002, 240-


I. Background

    On July 9, 2012, GDUFA (Title III of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144)) was signed 
into law by the President. GDUFA is designed to speed the delivery of 
safe and effective generic drugs to the public and to reduce costs to 
industry. GDUFA is based on an agreement negotiated by FDA and 
representatives of the generic drug industry to address a growing 
number of regulatory challenges. An attendant

[[Page 68892]]

commitment letter enumerates the performance efficiencies, metric 
goals, and procedures to which FDA agreed for the GDUFA program 
(Commitment Letter).\1\ In a portion of the Commitment Letter relevant 
to this notice, FDA agreed to: (1) Expedite review of ANDAs in the year 
1 and year 2 cohorts (i.e., those ANDAs submitted in fiscal year (FY) 
2013 and FY2014, respectively) that are submitted on the first day that 
any valid paragraph IV application for the drug in question is 
submitted (first-to-file ANDA); (2) strive to review and act on all 
first-to-file ANDAs within 30 months of submission to avoid inadvertent 
forfeiture of 180-day exclusivity eligibility under section 
505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)(D)(i)(IV)); and (3) expedite review of ``first 
generic'' ANDAs for which there are no blocking patents or 

    \1\ http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.

    To help meet the goals in the Commitment Letter, FDA will 
prioritize ANDA reviews in conformance with the recently issued Manual 
of Policies and Procedures (MAPP) 5240.3 Rev. I: Prioritization of the 
Review of Original ANDAs, Amendments, and Supplements; and MAPP 5200.4: 
Criteria and Procedures for Managing the Review of Original ANDAs, 
Amendments and Supplements.\2\ These MAPPs contemplate FDA prioritizing 
its ANDA reviews in a manner consistent with the provisions of the 
Commitment Letter, which identify certain types of submissions, 
including ``first generic'' ANDA submissions, as representing public 
health priorities that will receive expedited review. The MAPPs also 
expressly describe prioritization of the ANDA types described 

    \2\ http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/.

    Subsequent to enactment of GDUFA, FDA has received informal 
comments on the Commitment Letter from several stakeholders that 
conveyed different understandings of the criteria for the ``first 
generic'' review prioritization category. For example, stakeholders 
have characterized a ``first generic'' as the first ANDA submitted, the 
first ANDA approved, the first ANDA marketed, all first-to-file ANDAs, 
and a company's ``top priority'' ANDA. Without clear criteria for this 
category, there is the potential for confusion and inconsistent review 
    On September 17, 2014, FDA's Office of Generic Drugs held a public 
hearing to solicit public comment on certain topics related to 
implementation of GDUFA.\3\ The hearing provided an opportunity for 
public input on future policy priorities. At that hearing, FDA 
solicited comment on the specific criteria FDA should apply to identify 
an ANDA as a ``first generic'' eligible for expedited review. FDA has 
considered comments provided at that hearing and submitted to the 
related public docket. Today, FDA is announcing proposed criteria for 
the review prioritization category of ``first generic'' ANDA 

    \3\ https://www.federalregister.gov/articles/2014/08/19/2014-19632/generic-drug-user-fee-amendments-of-2012-public-hearing-on-policy-development-request-for-comments#footnote-4.

II. Request for Comments and Supporting Information

    FDA is requesting comments and supporting information on the 
following criteria for a ``first generic'' ANDA for the purposes of 
review prioritization. A first generic application is any received ANDA 
\4\: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, 
or for which there are no blocking patents or exclusivities; and (2) 
for which there is no previously-approved ANDA for the drug product.

    \4\ FDA evaluates each submitted ANDA individually to determine 
whether the ANDA can be received. The receipt of an ANDA means that 
FDA made a threshold determination that the ANDA is sufficiently 
complete to permit a substantive review.

    FDA believes that these proposed criteria appropriately focus FDA's 
resources on approving as quickly as possible, new safe and effective 
generic drug products for patient use. The Agency also believes that 
these criteria are consistent with the broad scope of the Commitment 
Letter, and generally reflect industry intent. Finally, these criteria 
enable FDA to prioritize review of a pending ANDA when the date on 
which the ANDA can be approved alters due to changes in the patent or 
exclusivity landscape.
    We note that under these proposed criteria, ``first generic'' 
status is predicated largely on circumstances outside Agency control, 
and ones that may change while the ANDA is pending, for example, 
developments related to the disposition of related patent litigation. 
Accordingly, FDA also is seeking comments and supporting information on 
mechanisms the Agency could put in place to facilitate ANDA sponsor 
submission of such relevant information in a timely manner, in addition 
to that already required under the regulations.
    We also note that as a result of such developments, ANDA 
submissions that originally met the criteria for a ``first generic'' 
submission may no longer meet those criteria; for example, the validity 
of a patent may be upheld in litigation, thereby blocking approval 
until patent expiry.
    We thus are seeking comment on whether FDA should change the review 
prioritization for an ANDA that no longer meets the ``first generic'' 
criteria during its review.

III. 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: November 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-27385 Filed 11-18-14; 8:45 am]