Federal Register / Vol. 72, No. 173 / Friday, September 7, 2007 / Notices 51449 

detailed description of the record 

contents they are seeking. 

CONTESTING RECORD PROCEDURE: 

Contact the official at the address 

specified under System Manager above, 

and identify the record and specify the 

information to be contested and 

corrective action sought with supporting 

justification to show how the record is 

inaccurate, incomplete, untimely, or 

irrelevant. 

RECORD SOURCE CATEGORIES: 

Information is obtained from 

departments, agencies, or 

instrumentalities of the United States or 

any State and from multistate financial 

institutions and insurers (or their 

agents). 

ITEMS EXEMPTED FROM CERTAIN PROVISIONS OF

THE ACT: 

None. 

[FR Doc. E7–17642 Filed 9–6–07; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–07–8405] 

Memorandum of Understanding 

Between the Food and Drug 

Administration and the University 

System of Maryland 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 

the University System of Maryland to 

establish terms of collaboration to 

support shared interests that can 

proceed through a variety of programs 

including collaborative research, public 

outreach, cooperative international 

initiatives, interdisciplinary training, 

and exchange of scientists and staff 

through sabbaticals, postdoctoral 

fellowships, and student internships. 

DATES: The agreement became effective 

July 12, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Mary I. Poos, Office of External 

Relations (HF–10), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–2825. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: August 29, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S 

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[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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