[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guidance announced in this notice finalizes the draft guidance entitled 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