[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Notices]
[Pages 34359-34360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1998-D-0021 (formerly Docket No. 1998D-0514)]


Guidance for Industry on Abbreviated New Drug Applications: 
Impurities in Drug Substances; 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 ``ANDAs: Impurities in 
Drug Substances,'' which is a revision of a guidance for industry of 
the same name that published in November 1999. The guidance provides 
recommendations for applicants on what chemistry, manufacturing, and 
controls (CMC) information to include regarding the reporting, 
identification, and qualification of impurities in drug substances 
produced by chemical synthesis when submitting original abbreviated new 
drug applications (ANDAs); drug master files (DMFs), including type II 
DMFs; and ANDA supplements for changes in the synthesis or processing 
of a drug substance.

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

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Division of Drug Information (HFD-240), 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. Submit written comments on the 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.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

[[Page 34360]]


FOR FURTHER INFORMATION CONTACT:  Lawrence Yu, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9310.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised guidance for 
industry entitled ``ANDAs: Impurities in Drug Substances.'' The 
guidance provides revised recommendations on what CMC information to 
include regarding the reporting, identification, and qualification of 
impurities in drug substances produced by chemical synthesis when 
submitting: (1) Original ANDAs; (2) DMFs, including type II DMFs; and 
(3) ANDA supplements for changes in the synthesis or processing of a 
drug substance. The guidance also provides recommendations for 
establishing acceptance criteria for impurities in drug substances.
    In November 1999, FDA published the first version of this guidance. 
In 2003, the International Conference on Harmonisation made changes to 
recommendations on impurities in drug substances for new drug 
applications in the guidance for industry entitled ``Q3A Impurities in 
New Drug Substances'' (Revision 1) (Q3A(R)). As a result of these 
changes, FDA began an effort to revise this guidance for ANDAs. FDA has 
revised the guidance to update information on listing impurities, 
setting acceptance criteria, and qualifying impurities (thresholds and 
procedures) in ANDAs to make it consistent with Q3A(R).
    On January 31, 2005 (70 FR 4857), FDA announced the availability of 
the draft revision for public comment. The comment period closed on May 
2, 2005. A number of comments were received, which the agency 
considered carefully as it began the process of finalizing the 
guidance.
    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 impurities in drug substances for generic 
drugs. 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 an 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. Paperwork Reduction Act of 1995

    This 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 part 314 have been approved under 
OMB Control No. 0910-0001.

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: July 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16868 Filed 7-14-09; 8:45 am]
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