[Federal Register Volume 68, Number 37 (Tuesday, February 25, 2003)]
[Notices]
[Pages 8772-8773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0061]


Draft Guidance for Industry on Comparability Protocols--
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availability of a draft guidance for industry entitled ``Comparability 
Protocols--Chemistry, Manufacturing, and Controls Information.'' This 
draft document provides recommendations to applicants on preparing and 
using comparability protocols for postapproval changes in chemistry, 
manufacturing, and controls (CMC) information.

DATES: Submit written or electronic comments on the draft guidance by 
June 25, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Training and Communications, Division of 
Communications Management, Division of Drug Information (HFD-240), 
Center for Drug Evaluation and Research, 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 or to the Communications Staff (HFV-12), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit phone requests to 800-
835-4709 or 301-827-1800. Submit written comments on the draft guidance 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draft guidance document.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: Stephen Moore, Center for Drug 
Evaluation and Research (HFD-510), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-6430, or Christopher 
Joneckis, Center for Biologics Evaluation and Research (HFM-1), Food 
and Drug Administration, 8800 Rockville Pike, Rockville, 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 ``Comparability Protocols--Chemistry, Manufacturing, and 
Controls Information.'' This draft guidance applies to comparability 
protocols that would be submitted in new drug applications (NDAs), 
abbreviated new drug applications (ANDAs), new animal drug applications 
(NADAs), abbreviated new animal drug applications (ANADAs), or 
supplements to these applications, except for applications for protein 
products. Well-characterized synthetic peptides submitted in these 
applications are included within the scope of this guidance. This draft 
guidance also applies to comparability protocols submitted in drug 
master files (DMFs) and veterinary master files (VMFs) that are 
referenced in these applications. A separate guidance will address 
comparability protocols for proteins as well as for peptide products 
outside the scope of this guidance that are submitted in these 
applications. This separate guidance will also address comparability 
protocols for products submitted in biologics license applications 
(BLAs).
    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 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 agency's current thinking on ``Comparability Protocols; 
Chemistry, Manufacturing, and Controls Information''. 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

[[Page 8773]]

ADDRESSES) written or electronic comments on the draft guidance. 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. The draft guidance and received comments are available for 
public examination 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 draft guidance 
at http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/cvm/guidance/published.htm.

    Dated: February 19, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4311 Filed 2-20-03; 8:45 am]
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