[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Notices]
[Pages 55813-55814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1292]


Draft Guidance for Industry on Abbreviated New Drug Application 
Submissions--Refuse To Receive for Lack of Proper Justification of 
Impurity Limits; 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availability of a draft guidance for industry entitled ``ANDA 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 for Lack of Proper Justification of 
Impurity Limits.'' This draft guidance is intended to assist applicants 
preparing to submit

[[Page 55814]]

to FDA abbreviated new drug applications (ANDAs) and related 
submissions (i.e., prior approval supplements) for which the applicant 
is seeking approval of a new strength of the drug product. The draft 
guidance highlights deficiencies about impurity information that may 
cause FDA to refuse to receive an ANDA.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 17, 2014.

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: Elizabeth Giaquinto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-
402-7930.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``ANDA Submissions--Refuse to Receive Lack of Proper 
Justification of Impurity Limits.'' This draft 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 draft guidance highlights serious 
deficiencies in impurity information that may cause FDA to refuse to 
receive an ANDA. Specifically, these deficiencies include: (1) Failing 
to justify proposed limits for specified identified impurities in drug 
substances and drug products that are above qualification thresholds; 
(2) failing to justify proposed limits for specified unidentified 
impurities that are above identification thresholds; and (3) proposing 
limits for unspecified impurities (e.g., any unknown impurity) above 
identification thresholds.
    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 
criteria 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)). FDA issued the draft guidance for industry ``ANDA 
Submissions--Refuse-to-Receive Standards'' to explain in some detail 
the kind of omissions that can lead to a refuse-to-receive 
determination. This guidance is being issued concurrently with the 
final version of the guidance for industry, ``ANDA Submissions--Refuse 
to Receive Standards.'' FDA intends to develop additional guidance 
documents further clarifying the enhanced refusal to receive standards.
    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 ``ANDA 
Submissions--Refuse to Receive for Lack of Proper Justification for 
Impurity Limits.'' 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 draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in 21 CFR 314.94 have been approved under 
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 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22110 Filed 9-16-14; 8:45 am]
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