[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Draft Guidance for Industry on Abbreviated New Drug Application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availability of a draft guidance for industry entitled ``ANDA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 This draft guidance is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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 9, 2014.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug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Submit electronic comments on the draft guidance to http://www.regulations.gov.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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