[Federal Register Volume 77, Number 191 (Tuesday, October 2, 2012)]
[Notices]
[Pages 60124-60125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24325]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1010]


Draft Guidance for Industry on Initial Completeness Assessments 
for Type II Active Pharmaceutical Ingredient Drug Master Files Under 
the Generic Drug User Fee Amendments of 2012

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Initial Completeness Assessments for Type II API DMFs Under GDUFA.'' 
Under the Generic Drug User Fee Amendments of 2012 (GDUFA), holders of 
certain drug master files, namely, Type II active pharmaceutical 
ingredient (API) drug master files (DMFs) that are referenced in 
generic drug applications, or in amendments or prior approval 
supplements to these applications, will be required to undergo an 
initial completeness assessment in accordance with FDA criteria. This 
guidance is intended to clarify the criteria FDA will use in the 
initial completeness assessment.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 3, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Send 
one self-addressed adhesive label to assist the 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Jaewon Hong, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 1-866-405-5367 or 301-
796-6707.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 744B(a)(2)(D)(ii) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-42(a)(2)(D)(ii)) (FD&C Act), which was added by 
GDUFA, Title III, Food and Drug Administration Safety and Innovation 
Act (Pub. L. 112-144), states that, on or after October 1, 2012, a Type 
II API DMF will be deemed available for reference in an abbreviated new 
drug application (ANDA), ANDA amendment, or ANDA prior approval 
supplement (PAS), if the required fee has been paid and if the DMF has 
not failed an initial completeness assessment ``in accordance with 
criteria to be published by'' FDA. Any Type II API DMF intended for 
reference in a generic drug submission for which the fee is paid will 
undergo an initial completeness assessment. Section 744B(a)(2)(D)(iii) 
of the FD&C Act requires FDA to make publicly available on its Web site 
a list of DMF numbers that correspond to DMFs that have successfully 
undergone an initial completeness assessment in accordance with 
criteria to be published by FDA and are available for reference.

[[Page 60125]]

This list will thus contain DMF numbers for those DMFs for which the 
fee has been paid and which have successfully undergone the initial 
completeness assessment. Note that these provisions do not apply to 
Type II API DMFs that are not intended to be referenced in an ANDA, 
ANDA amendment, or ANDA PAS.
    Fee amounts and the due date for the fee will be announced in a 
separate Federal Register notice or notices.
    For DMFs that fail the initial completeness assessment, FDA will 
issue a letter notifying the holder of the DMF that the DMF is 
incomplete and identifying missing elements in the DMF that must be 
addressed. Once the DMF is amended, FDA will re-evaluate it for 
completeness. This draft guidance describes the criteria that FDA will 
use in its initial completeness assessment of Type II API DMFs to be 
referenced in generic drug submissions.
    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's current thinking on initial 
completeness assessments of Type II API DMFs to be referenced in 
generic drug submissions. 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. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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 or http://www.regulations.gov.

    Dated: September 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24325 Filed 10-1-12; 8:45 am]
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