[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Notices]
[Page 55813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22068]



[[Page 55813]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1120]


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 guidance for industry entitled ``ANDA Submissions--
Refuse-to-Receive Standards.'' It finalizes the draft guidance with the 
same name that published on October 1, 2013. 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 for new strengths). The guidance represents the FDA's 
current thinking regarding the types of serious deficiencies that may 
cause FDA to refuse-to-receive the submission.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 
guidance document.
    Submit electronic comments on the 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: Benjamin Chacko, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993-0002, 240-
402-7924.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``ANDA Submissions--Refuse-to-Receive Standards.'' This 
guidance is intended to assist applicants preparing to submit to FDA 
ANDAs, and prior approval supplements to ANDAs, for which the applicant 
is seeking approval of a new strength of the drug product. The guidance 
highlights deficiencies that may cause FDA to refuse-to-receive an 
ANDA. A refuse-to-receive decision indicates that FDA determined that 
an ANDA is not sufficiently complete to permit a substantive review.
    Under the provisions of the Generic Drug User Fee Amendments of 
2012, the Office of Generic Drugs (OGD) is tasked with a number of 
activities, including the development of ``enhanced refusal to receive 
standards for ANDAs and other related submissions by the end of year 1 
of the program. . . .'' 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 
standards to permit a substantive review and thus can 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 (21 U.S.C. 355(j)) 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 are sufficiently complete to permit a 
substantive review.
    This guidance finalizes the draft guidance published in the Federal 
Register on October 1, 2013 (78 FR 60292). Comments on the draft 
guidance were considered while finalizing this guidance. Specifically, 
certain changes from the draft guidance include clarifying the 
definitions of ``major'' and ``minor'' deficiencies, clarifying the 
remedy process and period for minor deficiencies, and providing a non-
exhaustive list of minor deficiencies. This guidance is being issued 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The guidance represents the Agency's current thinking on 
``ANDA Submissions--Refuse-to-Receive Standards.'' 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.

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 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22068 Filed 9-16-14; 8:45 am]
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