[Federal Register Volume 70, Number 19 (Monday, January 31, 2005)]
[Notices]
[Page 4857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1752]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-0514]


Draft Guidance for Industry on Abbreviated New Drug Applications: 
Impurities in Drug Substances; 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availability of a draft guidance for industry entitled ``ANDAs: 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 Substances; Chemistry, Manufacturing, and Controls 
Information.'' This draft guidance provides recommendations on what 
chemistry, manufacturing, and controls information to include regarding 
the reporting, identification, and qualification of impurities in drug 
substances produced by chemical synthesis when submitting documentation 
for an abbreviated new drug application (ANDA), drug master file (DMF), 
or a supplement to support changes in drug substance synthesis or 
process.

DATES: Submit written or electronic comments on the draft guidance May 
2, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.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: Scott Furness, Center for Drug 
Evaluation and Research (HFD-640), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5849.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 3, 1999, FDA published in the Federal Register (64 FR 
67917) the guidance for industry entitled ``ANDA's: Impurities in Drug 
Substances.'' The guidance provided recommendations for including 
information in ANDAs and supporting DMFs on the content and 
qualification of impurities in drug substances produced by chemical 
syntheses.
    FDA is announcing the availability of a draft guidance for industry 
entitled ``ANDAs: Impurities in Drug Substances,'' which revises the 
December 3, 1999, guidance. The guidance is being revised to update 
information on listing of impurities, setting acceptance criteria, and 
qualifying impurities in conformance with the revision of the guidance 
for industry entitled ``Q3A Impurities in New Drug Substances'' 
(Q3A(R), published in February 2003). The 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 
Q3A(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 Nos. 0910-0001 and 0910-0032.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents 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 on the draft guidance. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. The draft 
guidance and received comments are available for public examination 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 
http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: January 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1752 Filed 1-28-05; 8:45 am]
BILLING CODE 4160-01-S