[Federal Register: January 31, 2005 (Volume 70, Number 19)]
[Notices]
[Page 4857]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31ja05-76]
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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Draft Guidance for Industry on Abbreviated New Drug Applications: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availability of a draft guidance for industry entitled ``ANDAs: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 This draft guidance provides recommendations on what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DATES: Submit written or electronic comments on the draft guidance May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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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access to the draft guidance document.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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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