57112 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 

Dated: September 26, 2008. 

Jeffrey Shuren, 

Asssociate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23120 Filed 9–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0043] 

[FDA No. 225–08–8004] 

Memorandum of Agreement Between 

the Food and Drug Administration, the 

National Cancer Institute, a Part of the 

National Institutes of Health, and the 

CRIX International Association 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration FDA) is providing 

notice of a memorandum of agreement 

(MOA) between FDA, the National 

Cancer Institute (NCI) and CRIX 

International Association. The purpose 

of the MOA is to establish a publicprivate partnership to pilot the use of a 

nonprofit organization to manage the 

production instance of the Federal 

Investigator Registry of Biomedical 

Information Research Data (FIREBIRD) 

system as a vehicle for secure, rapid and 

efficient electronic exchange of clinical 

investigator credentialing information 

among clinical investigators at trial 

sites, sponsors (including NCI), and 

FDA; and to continue the development 

of FIREBIRD to fulfill the requirements 

of FDA and sponsors (including the 

NCI). 

DATES: The agreement became effective 

August 28, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Randy Levin, Director for Health and 

Regulatory Data Standards (HF–18), 

Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 301–827–7784; 

George Komatsoulis, Chief Operating 

Officer, Center for Bioinformatics, 

National Cancer Institute, 8800 

Rockville Pike, Bethesda, MD 

20892–8505, 301–451–2881; and 

James L. Bland, Project Officer, CRIX 

International Association, 1195 

Freedom Dr., Reston, VA 20190, 

703–577–8788. 

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 MOA. 

Dated: September 24, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

BILLING CODE 4160–01–S 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57113 


jlentini on PROD1PC65 with NOTICESEN01OC08.003</GPH> 
57114 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 


jlentini on PROD1PC65 with NOTICESEN01OC08.004</GPH> 
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57115 


jlentini on PROD1PC65 with NOTICESEN01OC08.005</GPH> 
57116 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 


jlentini on PROD1PC65 with NOTICESEN01OC08.006</GPH> 
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57117 


jlentini on PROD1PC65 with NOTICESEN01OC08.007</GPH> 
57118 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 


jlentini on PROD1PC65 with NOTICESEN01OC08.008</GPH> 
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57119 


jlentini on PROD1PC65 with NOTICESEN01OC08.009</GPH> 
57120 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 


jlentini on PROD1PC65 with NOTICESEN01OC08.010</GPH> 
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57121 


jlentini on PROD1PC65 with NOTICESEN01OC08.011</GPH> 
57122 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 

[FR Doc. E8–22992 Filed 9–30–08; 8:45 am] 

BILLING CODE 4160–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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 


jlentini on PROD1PC65 with NOTICESEN01OC08.012</GPH>