[Federal Register Volume 68, Number 172 (Friday, September 5, 2003)]
[Notices]
[Pages 52776-52777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22577]


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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 The draft guidance document provides recommendations to 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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://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://www.fda.gov/cber/guidelines.htm,  http://www.fda.gov/ohrms/dockets/default.htm,  http://www.fda.gov/cder/guidance/index.htm, or  
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