[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Draft Guidance for Industry on Initial Completeness Assessments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announcing the availability of a draft guidance for industry entitled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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 3, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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