Notices. Notice
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/register/2007/09/07/07-4365A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 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 The guidance announced in this notice finalizes the draft guidance entitled “Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms” dated February 2005.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 *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 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 property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Advisory Council on Minority Health and Health Disparities. *Date:* September 18, 2007. *Closed:* 8:30 a.m. to 9:30 a.m. *Agenda:* To review and evaluate grant applications. *Place:* Bethesda North Marriott Hotel, 5701 Marinelli Road, Bethesda, MD 20852. *Open:* 9:30 a.m. to 5 p.m. *Agenda:* The agenda will include Opening Remarks, Administrative Matters, Director's Report, NCMHD Health Disparities Update, Scientific Programs Highlights, and other business of the Council. *Place:* Bethesda North Marriott Hotel, 5701 Marinelli Road, Bethesda, MD 20852. *Contact Person:* Donna Brooks, Asst. Director for Administration, National Center on Minority Health and Health Disparities, National Institutes of Health, 6707 Democracy Blvd., Suite 800, Bethesda, MD 20892, 301-435-2135, *brooksd@ncmhd.nih.gov* . This meeting is being published less than 15 days prior to the meeting due to timing limitations imposed by administrative matters. Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Dated: August 28, 2007. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-4365 Filed 9-6-07; 8:45am]
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