[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Draft Guidance for Industry on Abbreviated New Drug Application 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availability of a draft guidance for industry entitled ``ANDA 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 31, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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    FDA is announcing the availability of a draft guidance for industry 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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