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finalizes the draft guidance entitled 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. 

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 

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Federal Register / Vol. 72, No. 173 / Friday, September 7, 2007 / Notices 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 

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. 

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. 

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