[Federal Register: February 24, 2005 (Volume 70, Number 36)]
[Notices]               
[Page 9084]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe05-80]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0528]

 
Draft Guidance for Industry: Manufacturing Biological Drug 
Substances, Intermediates, or Products 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 draft document entitled ``Guidance for Industry: 
Manufacturing Biological Drug Substances, Intermediates, or Products 
Using Spore-Forming Microorganisms'' dated February 2005. The draft 
document is intended to provide guidance to manufacturers using spore-
forming microorganisms in the production of certain biological 
products. The draft guidance document provides recommendations to 
industry in response to changes made to the requirements for spore-
forming microorganisms to allow greater flexibility in manufacturing.

DATES: Submit written or electronic comments on the draft guidance by 
May 25, 2005, to ensure their adequate consideration in preparation of 
the final guidance. General comments 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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, 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 The draft guidance may also be 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 the CBER Voice Information System 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electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.


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 draft document entitled 
``Guidance for Industry: Manufacturing Biological Drug Substances, 
Intermediates, or Products Using Spore-Forming Microorganisms'' dated 
February 2005. The draft document is intended to provide guidance to 
manufacturers using spore-forming microorganisms in the production of 
certain biological products. The draft 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.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency'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 requirement of the applicable 
statutes and regulations.

II. Comments

    The 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 
written or electronic comments to ensure adequate consideration in 
preparation of the final 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 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.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
    Dated: February 16, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-3593 Filed 2-23-05; 8:45 am]

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