[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Page 60292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23793]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1120]
Draft Guidance for Industry on Abbreviated New Drug Application
Submissions--Refuse-to-Receive Standards; 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availability of a draft guidance for industry entitled ``ANDA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--Refuse-to-Receive Standards.'' This guidance is intended
to assist applicants preparing to submit to FDA abbreviated new drug
applications (ANDAs) and related submissions (i.e., prior approval
supplements (PASs) for new strengths). The guidance contains details on
what should be included in these submissions and highlights serious
deficiencies that may cause FDA to refuse to receive the submission.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 31, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Johnny Young, Center for Drug
Evaluation and Research (HFD-613), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8677.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``ANDA Submissions--Refuse-to-Receive Standards.'' This
guidance is intended to assist applicants preparing to submit to FDA
ANDAs and PASs to ANDAs for which the applicant is seeking approval of
a new strength of the drug product. The guidance contains details on
what should be included in an ANDA and highlights serious deficiencies
that may cause FDA to refuse to receive an ANDA. A refuse-to-receive
decision indicates that FDA has determined that an ANDA is incomplete
on its face, usually because of omissions.
With the enactment of the Generic Drug User Fee Act on July 9, 2012
(Pub. L. 112-144, Title III), FDA's Office of Generic Drugs (OGD) was
tasked with a number of activities, including developing enhanced
refusal to receive standards for ANDAs and related submissions. Recent
data underscore the need for improvement in the quality of original
ANDA submissions. Between 2009 and 2012, OGD refused to receive 497
ANDAs, primarily because the submissions contained serious
deficiencies. FDA evaluates each incoming ANDA individually to
determine whether its format and content meet threshold criteria to
permit a substantive review and can thus be received by FDA. The Agency
cannot receive an ANDA unless it contains the information required
under section 505(j) of the Federal Food, Drug, and Cosmetic Act and
related regulations (e.g., 21 CFR 314.101(b)(1)). This guidance
explains in some detail the kind of omissions that can lead to a
refuse-to-receive determination. The guidance is intended to assist
applicants preparing ANDAs and related submissions to help improve the
quality of those submissions and ensure that their format and content
meet the threshold criteria for FDA receipt and review.
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 refusing to
receive ANDAs and related 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. Paperwork Reduction Act of 1995
This 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 collection of information in 21 CFR part 314 for ANDA and
related submissions has 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.
IV. 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 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23793 Filed 9-30-13; 8:45 am]
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