
[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Pages 52931-52932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0938]


Draft Guidance for Industry on Abbreviated New Drug Applications: 
Stability Testing of Drug Substances and Products, Questions and 
Answers; 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availability of a draft guidance for industry entitled ``ANDAs: 
Stability Testing of Drug Substances and Products, Questions and 
Answers.'' This draft guidance clarifies stability testing 
recommendations for abbreviated new drug applications (ANDAs) by 
providing responses to public comments in a questions-and-answers 
format. This draft guidance addresses public comments regarding FDA's 
recommendation to generic drug manufacturers to follow International 
Conference on Hamonisation (ICH) stability guidances Q1A (R2) through 
Q1E.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 28, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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, 
Room 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Radhika Rajagopalan, Center for Drug 
Evaluation and Research (HFD-640), Food and Drug Administration, 7500 
Standish Pl., MPN2, Rm. 243, Rockville, MD 20855, 240-276-8546.

SUPPLEMENTARY INFORMATION: 

[[Page 52932]]

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``ANDAs: Stability Testing of Drug Substances and Products, 
Questions and Answers.'' Because of increases in the number and 
complexity of ANDAs and FDA's desire to standardize generic drug 
review, on September 25, 2012 (77 FR 58999), FDA published a draft and 
on June 20, 2013 (78 FR 37231), published a final guidance recommending 
the generic industry follow the approach in the ICH stability-related 
guidances: (1) ``Q1A(R2) Stability Testing of New Drug Substances and 
Products,'' November 2003; (2) ``Q1B Photostability Testing of New Drug 
Substances and Products,'' November 1996; (3) ``Q1C Stability Testing 
for New Dosage Forms,'' November 1996; (4) ``Q1D Bracketing and 
Matrixing Designs for Stability Testing of New Drug Substances and 
Products,'' January 2003; and (5) ``Q1E Evaluation of Stability Data,'' 
June 2004. These guidances can be found on the FDA Guidances (Drugs) 
Web site under International Conference on Harmonisation--Quality at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm. FDA also recommended that industry follow the 
ICH outlined definitions, glossaries, references, and attachments.
    While carefully considering the public comments on the September 
2012 draft guidance, we decided to publish a draft guidance in a 
questions-and-answers format. This draft guidance discusses stability 
testing relating to general questions, drug master files, drug product 
manufacturing and packaging, amendments to pending ANDA applications, 
and stability studies.
    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 ANDAs: 
Stability Testing of Drug Substances and Products, Questions and 
Answers. 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 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. The 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 parts 312 and 314 have been 
approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

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: August 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20893 Filed 8-26-13; 8:45 am]
BILLING CODE 4160-01-P


