03-22577. 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.

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 The draft guidance document provides recommendations to applicants on preparing and using comparability protocols for changes in chemistry, manufacturing, and controls of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Submit written or electronic comments on the draft guidance by December 4, 2003, to ensure their adequate consideration in preparation of the final guidance.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Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug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 The draft guidance may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800.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. 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.