[Federal Register Volume 72, Number 173 (Friday, September 7, 2007)]
[Notices]
[Page 51458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-17709]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0528]
``Guidance for Industry: Manufacturing Biological Intermediates
and Biological Drug Substances Using Spore-Forming Microorganisms'';
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:
Manufacturing Biological Intermediates and Biological Drug Substances
Using Spore-Forming Microorganisms'' dated September 2007. The guidance
document is intended to provide guidance to manufacturers using spore-
forming microorganisms in the production of certain biological
products. The guidance document provides recommendations to industry in
response to changes made to the requirements for spore-forming
microorganisms to allow greater flexibility in manufacturing. The
guidance announced in this notice finalizes the draft guidance entitled
``Guidance for Industry: Manufacturing Biological Drug Substances,
Intermediates, or Products Using Spore-Forming Microorganisms'' dated
February 2005.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the 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 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 written comments on the 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 either
http://www.fda.gov/dockets.ecomments or http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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: Manufacturing Biological Intermediates and
Biological Drug Substances Using Spore-Forming Microorganisms'' dated
September 2007. The document provides guidance to manufacturers using
spore-forming microorganisms in the production of certain biological
products. The guidance document provides recommendations to industry in
response to changes made to the requirements for spore-forming
microorganisms to allow greater flexibility in manufacturing.
In the Federal Register of December 30, 2003, FDA published the
direct final rule entitled ``Revision of the Requirements for Spore-
Forming Microorganisms'' (68 FR 75116) and the accompanying proposed
rule entitled ``Revision of the Requirements for Spore-Forming
Microorganisms; Companion to Direct Final Rule'' (68 FR 75179) to
modify the regulatory requirements for the manufacturing of biological
products with spore-formers to allow greater manufacturing flexibility.
The modifications were intended to provide alternatives to the then-
existing requirements for separate, dedicated facilities and equipment
for work with spore-forming microorganisms. In the Federal Register of
May 14, 2004 (69 FR 26768), FDA published the ``Revision of the
Requirements for Spore-Forming Microorganisms; Confirmation of
Effective Date'' confirming the effective date of June 1, 2004, for the
direct final rule.
In the Federal Register of February 24, 2005 (70 FR 9084), FDA
announced the availability of the draft guidance dated February 2005.
FDA received a few 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 February 2005.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the 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. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this 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 may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: August 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-17709 Filed 9-6-07; 8:45 am]
BILLING CODE 4160-01-S