[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40112-40113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16236]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0901]


Draft Guidance for Industry on Abbreviated New Drug Application 
Submissions--Prior Approval Supplements Under the Generic Drug User Fee 
Amendments of 2012; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``ANDA 
Submissions--Prior Approval

[[Page 40113]]

Supplements Under GDUFA.'' The Generic Drug User Fee Amendments of 2012 
(GDUFA) enables FDA to assess user fees to fund critical and measurable 
improvements to FDA's generic drugs program. This draft guidance is 
intended to assist applicants preparing to submit to FDA prior approval 
supplements (PASs) and amendments to PASs for abbreviated new drug 
applications (ANDAs). It describes FDA's performance metric goals for 
PASs and clarifies how FDA will handle a PAS and amendments to a PAS 
for an ANDA subject to the GDUFA performance metric goals.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 9, 2014.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or 
the Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, 
rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

FOR FURTHER INFORMATION CONTACT: Benjamin Chacko, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993-0002, 240-
402-7924 or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``ANDA Submissions--Prior Approval Supplements Under GDUFA.'' 
On July 9, 2012, the President signed GDUFA (Pub. L. 112-144, Title 
III) into law. GDUFA is based on an agreement negotiated by FDA and 
representatives of the generic drug industry to address a growing 
number of regulatory challenges. GDUFA aims to ensure timely access to 
safe, high-quality, low-cost generic drugs. GDUFA enables FDA to assess 
user fees to fund critical and measurable improvements to FDA's generic 
drugs program and to bring greater predictability and timeliness to the 
review of generic drug applications.
    GDUFA requires that FDA and human generic drug manufacturers meet 
certain commitments. In the GDUFA Commitment Letter, FDA committed to 
review and act on a certain percentage of PASs within a specified time 
period from the date of submission for receipts in fiscal years (FY) 
2015-2017. The percentage of PASs that FDA has committed to review and 
act on varies for each fiscal year, and the deadlines for review depend 
on whether a PAS requires an inspection.
    This draft guidance describes the performance metric goals that FDA 
agreed to in the Commitment Letter and clarifies how FDA will review a 
PAS and amendments to a PAS for an ANDA subject to the GDUFA 
performance metric goals. The GDUFA performance metrics described in 
this draft guidance only apply to ANDA applicants that submit a PAS on 
or after October 1, 2014. These performance metrics do not apply to new 
drug applications (NDAs), biologics license applications (BLAs), 
supplements filed for NDAs or BLAs, or changes being effected (CBE) 
supplements and annual report filings to NDAs, BLAs, or ANDAs.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
another draft guidance entitled ``ANDA Submissions--Amendments and 
Easily Correctable Deficiencies Under GDUFA,'' which explains how the 
GDUFA performance metric goals apply to amendments made to ANDAs and to 
PASs.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance, when 
finalized, will represent the Agency's current thinking on how GDUFA 
relates to prior approval supplements for ANDAs. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information for supplements and amendments in 
21 CFR part 314 have been approved under OMB control number 0910-0001. 
The collection of information for manufacturer registration in 21 CFR 
part 207 has been approved under OMB control number 0910-0045. The 
collection of information for manufacturer compliance with current good 
manufacturing practices in 21 CFR part 211 has been approved under OMB 
control number 0910-0139.

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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidance/default.htm, or http://www.regulations.gov.

    Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16236 Filed 7-10-14; 8:45 am]
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