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, 57112-57122 [E8-22992]

Download as PDF 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. jlentini on PROD1PC65 with NOTICES ACTION: Notice. VerDate Aug<31>2005 18:22 Sep 30, 2008 Jkt 214001 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). The agreement became effective August 28, 2008. FOR FURTHER INFORMATION CONTACT: Randy Levin, Director for Health and DATES: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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 E:\FR\FM\01OCN1.SGM 01OCN1 VerDate Aug<31>2005 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\01OCN1.SGM 01OCN1 57113 EN01OC08.003</GPH> jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\01OCN1.SGM 01OCN1 EN01OC08.004</GPH> jlentini on PROD1PC65 with NOTICES 57114 VerDate Aug<31>2005 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\01OCN1.SGM 01OCN1 57115 EN01OC08.005</GPH> jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\01OCN1.SGM 01OCN1 EN01OC08.006</GPH> jlentini on PROD1PC65 with NOTICES 57116 VerDate Aug<31>2005 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4725 E:\FR\FM\01OCN1.SGM 01OCN1 57117 EN01OC08.007</GPH> jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4725 E:\FR\FM\01OCN1.SGM 01OCN1 EN01OC08.008</GPH> jlentini on PROD1PC65 with NOTICES 57118 VerDate Aug<31>2005 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4725 E:\FR\FM\01OCN1.SGM 01OCN1 57119 EN01OC08.009</GPH> jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4725 E:\FR\FM\01OCN1.SGM 01OCN1 EN01OC08.010</GPH> jlentini on PROD1PC65 with NOTICES 57120 VerDate Aug<31>2005 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\01OCN1.SGM 01OCN1 57121 EN01OC08.011</GPH> jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57122 [FR Doc. E8–22992 Filed 9–30–08; 8:45 am] BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES jlentini on PROD1PC65 with NOTICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Aug<31>2005 18:22 Sep 30, 2008 Jkt 214001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 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 E:\FR\FM\01OCN1.SGM 01OCN1 EN01OC08.012</GPH> Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices

Agencies

[Federal Register Volume 73, Number 191 (Wednesday, October 1, 2008)]
[Notices]
[Pages 57112-57122]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22992]


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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 public-private 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.
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[FR Doc. E8-22992 Filed 9-30-08; 8:45 am]
BILLING CODE 4160-01-C

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