[Federal Register Volume 75, Number 42 (Thursday, March 4, 2010)]
[Notices]
[Pages 9905-9906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4553]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0223] (formerly 2006D-0383)


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.

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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the draft guidance entitled ``Guidance for Industry: Characterization 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

[[Page 9906]]

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 Sec.  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.
[FR Doc. 2010-4553 Filed 3-3-10; 8:45 am]
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