[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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the draft guidance entitled ``Guidance for Industry: Characterization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]
BILLING CODE 4160-01-S