[Federal Register: September 5, 2003 (Volume 68, Number 172)]
[Notices]
[Page 52776-52777]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se03-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0385]
Draft ``Guidance for Industry: Comparability Protocols--Protein
Drug Products and Biological Products--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 document entitled ``Guidance for Industry:
Comparability Protocols--Protein Drug Products and Biological
Products--Chemistry, Manufacturing, and Controls Information'' dated
September 2003. The draft guidance document provides recommendations to
applicants on preparing and using comparability protocols for changes
in chemistry, manufacturing, and controls of products in approved
marketing applications. The guidance applies to comparability protocols
that applicants would submit in biologics license applications (BLAs)
or supplements to these applications for therapeutic recombinant
deoxyribonucleic acid (DNA) derived protein products, naturally derived
protein products, plasma derivatives, vaccines, allergenics and
therapeutic DNA plasmids. The guidance also applies to 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 for protein
drug products, and certain peptides that are not sufficiently
characterizable (i.e., complex mixture of small peptides).
DATES: Submit written or electronic comments on the draft guidance by
December 4, 2003, to ensure their adequate consideration in preparation
of the final guidance. 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448; or 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 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 the office in processing your requests. The draft guidance may
also be obtained by mail by calling the CBER Voice Information System
at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
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.
FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210; or Stephen K.
[[Page 52777]]
Moore, Center for Drug Evaluation and Research (HFD-510), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6430;
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 document entitled
``Guidance for Industry: Comparability Protocols--Protein Drug Products
and Biological Products--Chemistry, Manufacturing, and Controls
Information'' dated September 2003. The draft document applies to
comparability protocols that would be submitted in BLAs, or supplements
to these applications, for therapeutic recombinant DNA derived protein
products, naturally derived protein products, plasma derivatives,
vaccines and allergenics, therapeutic DNA plasmids and NDAs, ANDAs and
investigational new drugs (INDs) for protein drug products, and not
sufficiently characterizable peptide products (e.g., complex mixture of
small peptides).
The draft guidance does not pertain to comparability protocols for
human blood and blood components intended for transfusion and for
further manufacture, somatic cell therapy, and gene therapy vectors
(except therapeutic DNA plasmids). It also does not pertain to vaccines
for veterinary use because these are regulated by the U.S. Department
of Agriculture.
The 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 the guidance was approved under OMB
control numbers 0910-0001, 0910-0032, and 0910-0338.
The 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 this topic.
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
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. Submit
written or electronic comments to ensure adequate consideration in
preparation of the final guidance. Submit a single copy of electronic
comments or two paper copies of any mailed comments, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in the brackets in the heading of this
document. A copy of 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 draft guidance
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
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://www.fda.gov/cvm/guidance/published.htm.
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm/guidance/published.htm.
Dated: August 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-22577 Filed 9-3-03; 10:00 am]
BILLING CODE 4160-01-S