National Center on Minority Health and Health Disparities; Notice of Meeting, 51458-51459 [07-4365]

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 The guidance announced in this notice finalizes the draft guidance entitled ‘‘Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using SporeForming Microorganisms’’ dated February 2005.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 Federal Register / Vol. 72, No. 173 / Friday, September 7, 2007 / Notices 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. mstockstill on PROD1PC66 with NOTICES Dated: August 28, 2007. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–4365 Filed 9–6–07; 8:45am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed 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 the following 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 Institute of Allergy and Infectious Diseases Special Emphasis Panel Poxvirus Program Project. Date: October 4, 2007. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge 6700, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Conference Call). Contact Person: Ellen S. Buczko, PhD, Scientific Review Administrator, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/ NIAID, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892–7616, 301–451–2676, ebuczko1@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: August 29, 2007. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–4363 Filed 9–6–07; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. VerDate Aug<31>2005 18:34 Sep 06, 2007 Jkt 211001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 51459 The meetings 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 Institute of Mental Health Initial Review Group, Interventions Committee for Adult Mood and Anxiety Disorders. Date: October 9, 2007. Time: 8:30 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: St. Gregory Hotel, 2033 M Street, NW., Washington, DC 20036. Contact Person: David I. Sommers, PhD, Scientific Review Administrator, Division of Extramural Activities, National Institute of Mental Health, National Institutes of Health, 6001 Executive Blvd., Room 6154, MSC 9609, Bethesda, MD 20892–9606, 301–443–7861, dsommers@mail.nih.gov. Name of Committee: National Institute of Mental Health Initial Review Group, Interventions Committee for Disorders Involving Children and Their Families. Date: October 10–11, 2007. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Washington National Airport, 1489 Jefferson Davis Hwy, Arlington, VA 22202. Contact Person: Christopher S. Sarampote, PhD, Scientific Review Administrator, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6148, MSC 9608, Bethesda, MD 20892– 9608, 301–443–1959, csarampo@mail.nih.gov. Name of Committee: National Institute of Mental Health Initial Review Group, Mental Health Services in MH Specialty Settings. Date: October 10, 2007. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street, NW., Washington, DC 20037. Contact Person: Marina Broitman, PhD, Scientific Review Administrator, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6153, MSC 9608, Bethesda, MD 20892–9608, 301–402–8152, mbroitma@mail.nih.gov. Name of Committee: National Institute of Mental Health Initial Review Group, Mental Health Services in Non-Specialty Settings. Date: October 10-11, 2007. Time: 4 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\07SEN1.SGM 07SEN1

Agencies

[Federal Register Volume 72, Number 173 (Friday, September 7, 2007)]
[Notices]
[Pages 51458-51459]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-4365]


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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

[[Page 51459]]

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]
BILLING CODE 4140-01-M

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