``Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms''; Availability, 51458 [E7-17709]

Download as PDF 51458 Federal Register / Vol. 72, No. 173 / Friday, September 7, 2007 / Notices [FR Doc. 07–4404 Filed 9–6–07; 8:45 am] BILLING CODE 4160–01–C 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 SporeForming Microorganisms’’; 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: 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 The guidance announced in this notice finalizes the draft guidance entitled ‘‘Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using SporeForming Microorganisms’’ dated February 2005. DATES: Submit written or electronic comments on agency guidances at any time. 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 mstockstill on PROD1PC66 with NOTICES ADDRESSES: VerDate Aug<31>2005 18:34 Sep 06, 2007 Jkt 211001 electronic comments to either https:// www.fda.gov/dockets.ecomments or https://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). PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 https:// www.fda.gov/cber/guidelines.htm or https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center on Minority Health and Health Disparities; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Council on Minority Health and Health Disparities. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial E:\FR\FM\07SEN1.SGM 07SEN1

Agencies

[Federal Register Volume 72, Number 173 (Friday, September 7, 2007)]
[Notices]
[Page 51458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17709]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
https://www.fda.gov/dockets.ecomments or https://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 https://www.fda.gov/cber/guidelines.htm or https://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

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