[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Draft Guidance for Industry on Drug Substance; Chemistry, 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availability of a draft guidance for industry entitled ``Drug 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draft guidance provides recommendations on the chemistry, 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draft guidance is structured to facilitate the preparation of 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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://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access to the draft guidance document.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:
    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://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: December 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-259 Filed 1-6-04; 8:45 am]

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