[Federal Register Volume 70, Number 166 (Monday, August 29, 2005)]
[Notices]
[Page 51077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17150]



[[Page 51077]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0312]


Draft Guidance for Industry on Abbreviated New Drug Applications: 
Impurities in Drug Products; Chemistry, Manufacturing, and Controls 
Information; 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availability of a draft guidance for industry entitled ``ANDAs: 
Impurities in Drug Products; Chemistry, Manufacturing, and Controls 
Information.'' This draft guidance provides recommendations on what 
chemistry, manufacturing, and controls information sponsors should 
include regarding reporting, identification, qualification, and setting 
acceptance criteria for impurities that are classified as degradation 
products in drug products when submitting an abbreviated new drug 
application (ANDA) or supplement to support changes in drug substance 
synthesis or process, formulation of the drug product, the 
manufacturing process, or components of the container/closure system.

DATES: Submit written or electronic comments on the draft guidance by 
November 28, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Devinder Gill, Center for Drug 
Evaluation and Research (HFD-630), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5845.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 5, 1999 (64 FR 516), FDA 
published the draft guidance for industry on ``ANDAs: Impurities in 
Drug Products.'' The draft guidance provided recommendations for 
including information in ANDAs and ANDA supplements about the 
reporting, identification, qualification of, and setting acceptance 
criteria for degradation products in drug products that are 
manufactured from drug substances produced by chemical synthesis.
    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``ANDAs: Impurities in Drug Products,'' which revises 
the January 5, 1999, draft guidance. The draft guidance is being 
revised to update information on listing of degradation products, 
setting acceptance criteria, and qualifying degradation products in 
conformance with our current thinking and the revision of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH) guidance for 
industry on ``Q3B(R) Impurities in New Drug Products,'' published in 
November 2003. The draft guidance is also being revised to remove 
sections of the guidance containing recommendations that are no longer 
needed because they are addressed in the more recent Q3B(R).
    This draft guidance contains information collection provisions 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 this draft guidance was approved under OMB 
Control No. 0910-0001.
    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 these 
topics. 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 to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17150 Filed 8-26-05; 8:45 am]
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