[Federal Register: February 25, 2003 (Volume 68, Number 37)]
[Notices]
[Page 8772-8773]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe03-62]
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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Draft Guidance for Industry on Comparability Protocols--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availability of a draft guidance for industry entitled ``Comparability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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Training and Communications, Division of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 Submit written comments on the draft guidance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
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draft guidance document.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.
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]
BILLING CODE 4160-01-S