Memorandum of Understanding Between the National Cancer Institute and the Food and Drug Administration, 21271-21277 [07-2106]

Download as PDF Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices Dated: April 23, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–8137 Filed 4–27–07; 8:45 am] rwilkins on PROD1PC63 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 18:27 Apr 27, 2007 Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225–07–8001] Memorandum of Understanding Between the National Cancer Institute and the Food and Drug Administration 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 National Cancer Institute (NCI), part of the National Institutes of Health of the Department of Health and Human Services. The purpose of this MOU is to establish a formal collaboration between FDA and NCI regarding proteomics science and technology to accelerate proteomics technology development and application in clinical settings. FDA and NCI intend to collaborate in areas involving proteomics such as: Sample collection, preparation, storage and processing; bioinformatics and data analysis; discovery and validation of PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 biomarkers; and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development. DATES: The agreement became effective April 5, 2007. FOR FURTHER INFORMATION CONTACT: Francis Kalush, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276–0996, e-mail: francis.kalush@fda.hhs.gov. or Henry Rodriguez, Office of the Director, (MSC–2580), National Cancer Institute, 31 Center Dr., rm. 10A52, Bethesda, MD 20892, 301– 496–1550. 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: April 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S E:\FR\FM\30APN1.SGM 30APN1 EN30AP07.017</GPH> topics will be discussed: (1) The definition of quality, (2) mechanisms for implementing quality in clinical investigations, and (3) methods to improve the accuracy and reliability of collected data. As part of the Human Subject Protection/Bioresearch Monitoring Initiative (https:// www.fda.gov/ oc/ initiatives/ criticalpath/ ), this public workshop will help improve the safe conduct of clinical investigations and maximize efficiency in clinical investigations without compromising quality. 21271 VerDate Aug<31>2005 Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices 18:27 Apr 27, 2007 Jkt 211001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4725 E:\FR\FM\30APN1.SGM 30APN1 EN30AP07.018</GPH> rwilkins on PROD1PC63 with NOTICES 21272 VerDate Aug<31>2005 18:27 Apr 27, 2007 Jkt 211001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4725 E:\FR\FM\30APN1.SGM 30APN1 21273 EN30AP07.019</GPH> rwilkins on PROD1PC63 with NOTICES Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices VerDate Aug<31>2005 Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices 18:27 Apr 27, 2007 Jkt 211001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4725 E:\FR\FM\30APN1.SGM 30APN1 EN30AP07.020</GPH> rwilkins on PROD1PC63 with NOTICES 21274 VerDate Aug<31>2005 18:27 Apr 27, 2007 Jkt 211001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4725 E:\FR\FM\30APN1.SGM 30APN1 21275 EN30AP07.021</GPH> rwilkins on PROD1PC63 with NOTICES Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices VerDate Aug<31>2005 Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices 18:27 Apr 27, 2007 Jkt 211001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\30APN1.SGM 30APN1 EN30AP07.022</GPH> rwilkins on PROD1PC63 with NOTICES 21276 Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices 21277 [FR Doc. 07–2106 Filed 4–27–07; 8:45 am] VerDate Aug<31>2005 19:01 Apr 27, 2007 Jkt 211001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\30APN1.SGM 30APN1 EN30AP07.023</GPH> rwilkins on PROD1PC63 with NOTICES BILLING CODE 4160–01–C

Agencies

[Federal Register Volume 72, Number 82 (Monday, April 30, 2007)]
[Notices]
[Pages 21271-21277]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-07-8001]


Memorandum of Understanding Between the National Cancer Institute 
and the Food and Drug Administration

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 National Cancer 
Institute (NCI), part of the National Institutes of Health of the 
Department of Health and Human Services. The purpose of this MOU is to 
establish a formal collaboration between FDA and NCI regarding 
proteomics science and technology to accelerate proteomics technology 
development and application in clinical settings. FDA and NCI intend to 
collaborate in areas involving proteomics such as: Sample collection, 
preparation, storage and processing; bioinformatics and data analysis; 
discovery and validation of biomarkers; and surrogate biomarkers of 
cancer development and drug response, including standardization among 
technology platforms and assay standards development.

DATES: The agreement became effective April 5, 2007.

FOR FURTHER INFORMATION CONTACT:
Francis Kalush, Center for Devices and Radiological Health (HFZ-440), 
Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 
240-276-0996, e-mail: francis.kalush@fda.hhs.gov.
    or Henry Rodriguez, Office of the Director, (MSC-2580), National 
Cancer Institute, 31 Center Dr., rm. 10A52, Bethesda, MD 20892, 301-
496-1550.

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: April 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 07-2106 Filed 4-27-07; 8:45 am]
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