[Federal Register Volume 71, Number 189 (Friday, September 29, 2006)]
[Notices]
[Pages 57547-57548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0383]


Draft Guidance for Industry on Characterization and Qualification 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.

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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 This draft guidance, when finalized, will replace the 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DATES: Submit written or electronic comments on the draft guidance by 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

[[Page 57548]]

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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may 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to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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 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

    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 orhttp://www.fda.gov/ohrms/dockets/default.htm.

    Dated: September 22, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-15963 Filed 9-28-06; 8:45 am]
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