[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40111-40112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16235]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0902]


Draft Guidance for Industry on Abbreviated New Drug Application 
Submissions; Amendments and Easily Correctable Deficiencies Under the 
Generic Drug User Fee Amendments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 40112]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``ANDA 
Submissions--Amendments and Easily Correctable Deficiencies Under 
GDUFA.'' The guidance document is intended to assist applicants in 
preparing to submit to FDA amendments to abbreviated new drug 
applications (ANDAs) or prior approval supplements (PASs) under the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act), by explaining how 
the Generic Drug User Fee Amendments of 2012 (GDUFA) performance metric 
goals apply to these submissions. When finalized, this guidance will 
replace the December 2001 guidance for industry entitled ``Major, 
Minor, and Telephone Amendments to Abbreviated New Drug Applications'' 
in consideration of the new amendment review tier system and 
performance goals under GDUFA.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 9, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, Food and Drug Administration, 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access to the draft guidance document.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: Elizabeth Giaquinto, 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, [email protected] 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, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``ANDA Submissions--Amendments and Easily Correctable 
Deficiencies Under GDUFA.'' On July 9, 2012, GDUFA (Pub. L. 112-144, 
Title III) was signed into law by the President to speed the delivery 
of safe and effective generic drugs to the public and reduce costs to 
industry. Under GDUFA, FDA agreed to certain performance goals and 
procedures for the review of amendments submitted to original ANDAs and 
PASs filed on or after October 1, 2014.
    This draft guidance describes how FDA intends to classify major 
amendments, minor amendments, and easily correctable deficiencies 
(ECDs). Specifically, the draft guidance defines the types of 
amendments and describes the GDUFA performance metric goals for the 
amendment tiers, the process for submitting amendments, and dispute 
resolution procedures regarding amendment classifications.
    In accordance with the Commitment Letter, the GDUFA performance 
metrics described in the draft guidance only apply to amendments to 
original ANDAs and PASs submitted on or after October 1, 2014, and do 
not apply to amendments submitted on or after October 1, 2014, that 
amend original ANDAs or PASs submitted before October 1, 2014.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
another draft guidance entitled ``ANDA Submissions--Prior Approval 
Supplements Under GDUFA,'' which describes FDA's performance metric 
goals and clarifies how FDA will handle a PAS and amendments to a PAS 
for an ANDA.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency 02BC;s current thinking on ``ANDA 
Submissions--Amendments and Easily Correctable Deficiencies Under 
GDUFA.'' 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. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 in 21 CFR 314.96 have been approved under 
OMB control number 0910-0001.

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.

III. 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/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16235 Filed 7-10-14; 8:45 am]
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