2010-4553. Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a document entitled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications,” dated February 2010. The guidance document provides recommendations to manufacturers of viral vaccines for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use. The guidance announced in this notice finalizes the draft guidance entitled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral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, and replaces the information specific to viral vaccines for the prevention and treatment of infectious diseases that the agency provided in the 1993 document entitled “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.”

DATES:

Submit electronic or written comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development (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 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 guidance document.

Submit electronic or written comments on the guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Paul E. Levine, 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 document entitled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications,” dated February 2010. The guidance document provides manufacturers of viral vaccines with recommendations for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use. The recommendations in the guidance may be used to support a Biologics License Application or an application for an Investigational New Drug.

In the Federal Register of September 29, 2006 (71 FR 57547), FDA announced the availability of the draft guidance 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. FDA received numerous comments on the draft guidance and those comments were considered as the guidance was finalized. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated September 2006, and replaces information specific to viral vaccines for the prevention and treatment of infectious diseases contained in the 1993 document entitled “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.” The guidance 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) guidance documents entitled “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).

For the production of biological products not covered under this guidance, we recommend that you refer to the “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals,” dated 1993.

The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA'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. Paperwork Reduction Act

The 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 the guidance refers are covered by 21 CFR part 601 (BLAs (biologics license application)) and part 312 (INDs (investigational new drugs)), 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 Number 0910-0116; those in 21 CFR 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

Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) elecronic or written comments regarding the 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 brackets in the heading of this document. A copy of the 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 guidance at either http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm, http://www.fda.gov/​cber/​guidelines.htm or http://www.regulations.gov.

Dated: March 1, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.