[Federal Register Volume 68, Number 18 (Tuesday, January 28, 2003)]
[Notices]
[Pages 4219-4220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1919]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0526]


Draft Guidance for Industry on Drug Product: Chemistry, 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availability of a draft guidance for industry entitled ``Drug Product: 
Chemistry, Manufacturing, and Controls Information.'' This draft 
guidance provides recommendations on the chemistry, manufacturing, and 
controls (CMC) information for drug products that should be submitted 
in original new drug applications (NDAs) and abbreviated new drug 
applications (ANDAs). The draft guidance is structured to facilitate 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DATES: Submit written or electronic comments on the draft guidance by 
June 27, 2003. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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access to the draft guidance document.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: Upinder Atwal, Center for Drug 
Evaluation and Research (HFD-623), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20852, 301-827-5848, or Christopher 
Joneckis, Center for Biologics Evaluation and Research (HFM-1), Food 
and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892, 301-
435-5681.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Drug Product: Chemistry, Manufacturing, and Controls 
Information.'' This draft guidance addresses the information to be 
submitted in NDAs and ANDAs for drug products to ensure continued 
product quality (i.e., identity, strength, quality, purity, and 
potency). Recommendations are provided on the information that should 
be included for: (1) Description and composition of the drug product, 
(2) manufacture, (3) control of excipients, (4) control of drug 
products, (5) reference standards or materials, (6) container closure 
systems, and (7) stability. Information is also provided on the type of 
pharmaceutical development information that should be included in an 
NDA or ANDA. 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 Documentation for the Manufacture and Controls for Drug 
Products'' (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 number 0910-0001.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on CMC 
information for drug products.

[[Page 4220]]

 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 Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two hard copies of any written comments, except 
that individuals may submit one hard 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 Dockets Management 
Branch 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, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: January 27, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-1919 Filed 1-27-03; 8:45 am]
BILLING CODE 4160-01-S