[Federal Register: January 7, 2004 (Volume 69, Number 4)]
[Notices]
[Page 929-930]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ja04-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0571]
Draft Guidance for Industry on Drug Substance; Chemistry,
Manufacturing, and Controls Information; Availability
AGENCY: Food and Drug Administration.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Drug
Substance: Chemistry, Manufacturing, and Controls Information.'' This
draft guidance provides recommendations on the chemistry,
manufacturing, and controls (CMC) information for drug substances that
should be submitted to support original new drug applications (NDAs),
abbreviated new drug applications (ANDAs), new animal drug applications
(NADAs), and abbreviated new animal drug applications (ANADAs). The
draft guidance is structured to facilitate the preparation of
applications submitted in Common Technical Document (CTD) format.
DATES: Submit written or electronic comments on the draft guidance by
July 5, 2004. 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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, or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. 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on the draft guidance to the Division of Dockets Management (HFA-305),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access to the draft guidance document.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:
Steve Miller, Center for Drug Evaluation and Research (HFD-530),
Food and Drug Administration, 9201 Corporate Blvd., Rockville, MD
20850, 301-827-2392, or
Chris Joneckis, Center for Biologics Evaluation and Research (HFM-
1), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD
20892, 301-435-5681, or
Dennis Bensley, Center for Veterinary Medicine (HFV-143), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-
6956
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Drug Substance: Chemistry, Manufacturing, and Controls
Information.'' This draft guidance provides recommendations on the drug
substance information to be submitted in NDAs, ANDAs, NADAs, and ANADAs
to ensure continued drug substance and drug product quality (i.e., the
identity, strength, quality, purity, and potency). Recommendations are
provided on the information that should be included for: (1)
Nomenclature, structure, and general drug substance properties, (2)
manufacture, (3) characterization, (4) control of drug substance, (5)
reference standards or materials, (6) container closure system, and (7)
stability. The draft guidance is structured to facilitate the
preparation of applications submitted in CTD format. The draft
guidance, when finalized, will replace the guidance entitled
``Submitting Supporting Documentation in Drug Applications for the
Manufacture of Drug Substance'' (February 1987).
This 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 guidance was approved under OMB
control numbers 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
[[Page 930]]
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: December 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-259 Filed 1-6-04; 8:45 am]
BILLING CODE 4160-01-S