E6-15963. Draft Guidance for Industry on Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases; 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: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases,” dated September 2006. This guidance provides recommendations to manufacturers of viral vaccines for the characterization and qualification of cell substrates and viral seeds used in the production of viral vaccines for human use. This draft guidance, when finalized, will replace the information specific to viral vaccines contained in the 1993 document, entitled “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.”

DATES:

Submit written or electronic comments on the draft guidance by December 28, 2006 to ensure their adequate consideration in preparation of the final guidance.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Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug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, suite 200N, Rockville, MD 20852-1448. 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 The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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:

Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448,301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft document entitled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases,” dated September 2006. This draft guidance provides manufacturers of viral vaccines with recommendations for the characterization and qualification of cell substrates and viral seeds used for the production of viral vaccines for human use. These recommendations may be used to support a Biologics License Application or an application for an Investigational New Drug.

This draft guidance, when finalized, is intended to replace the information specific to viral vaccines, but does not replace information on other biological products, contained in the 1993 document entitled, “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.” This draft guidance, when finalized, is also intended to supplement recommendations on the production of viral vaccines for the prevention and treatment of infectious diseases, provided in the International Conference on Harmonisation (ICH) documents entitled “Guidance for Industry: Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” dated September 1998 (63 FR 51074; September 24, 1998) and “Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products” (63 FR 50244; September 21, 1998).

The scope of this draft guidance document is limited to cell substrates of human and animal origins and does not cover characterization of unicellular organisms, such as bacteria or yeast. This draft guidance also applies to the characterization and qualification of viral seeds. This draft guidance does not supersede the general requirements for biologicals described in Title 21 Code of Federal Regulations (CFR), part 210, part 211, part 601, nor part 610.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This draft guidance, when finalized, will represent FDA's current thinking on the identified topic. It does not create nor 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. Paperwork Reduction Act

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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). Most of the collections of information to which this draft guidance refers are covered by parts 601 (on BLAs) and 21 CFR part 312 (on INDs), and were approved under OMB Control No. 0910-0338 and 0910-0014, respectively. For the remaining referenced collections of information, those in 21 CFR 640.3 and 640.63 have been approved under OMB control numbers 0910-0116; those in part 211, including § 211.160(b), have been approved under OMB control number 0910-0139; and those in 21 CFR part 58 have been approved under OMB Control No. 0910-0119.

III. Comments

This 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 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.

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/​cber/​guidelines.htm or http://www.fda.gov/​ohrms/​dockets/​default.htm.

Dated: September 22, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.