Memorandum of Understanding Between the Food and Drug Administration, and Duke University for the Cardiac Safety Research Consortium, 60732-60739 [06-8708]

Download as PDF 60732 Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices jlentini on PROD1PC65 with NOTICES Survey (FACES), the National Head Start Impact Study, Head Start’s Performance-Based Outcome System, and the ongoing evaluation of the Early Head Start program. DATES: October 27, 2006, 8:30 a.m.–5 p.m. Place: The Westin Embassy Row Hotel, 2100 Massachusetts Avenue, NW., Washington, DC 20008. Agenda: The Committee will continue the discussions begun at previous Committee meetings. SUPPLEMENTARY INFORMATION: This, the fourth meeting of the Committee, is open to the public. Persons wishing to bring written statements or papers focused on relevant, existing research with Head Start populations or on measures appropriate for low-income four- and five-year old children are welcome to do so. Individuals may e-mail such documents to Secretaryadvisory-hs@esi-dc.com or mail to: ESI, ATTN: Townley Knudson, Head Start Secretary’s Advisory Committee, 1150 Connecticut Avenue, NW., Suite 1100, Washington, DC 20036. Documents received shall be presented to the Committee. The Committee meeting records shall be kept at the Aerospace Center located at 901 D Street, SW., Washington, DC 20447. The Committee’s charter, past meeting agendas, meeting proceedings and materials related to this meeting can be found at: https://www.acf.hhs.gov/ programs/hsb/budget/AdvCmteSep05/ index.htm. An interpreter for the deaf and hardof-hearing, will be available upon advance request by contacting Secretaryadvisory-hs@esi-dc.com. Due to a clerical error at the Administration for Children and VerDate Aug<31>2005 16:16 Oct 13, 2006 Jkt 211001 Families, this meeting notice may be published less than 15 days prior to the meeting. Dated: October 10, 2006. Robert A. Sargis, Reports Clearance Officer. [FR Doc. 06–8671 Filed 10–13–06; 8:45 am] BILLING CODE 4184–01–M facilitate the development of safer and more effective cardiovascular therapies, diagnostic, and assessment tools. This collaboration between the Parties shall be known as the Cardiac Safety Research Consortium. The agreement became effective August 15, 2006. DATES: FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225–06–8404] Memorandum of Understanding Between the Food and Drug Administration, and Duke University for the Cardiac Safety Research Consortium 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 Duke University, on behalf of its Duke Clinical Research Institute (DCRI). FDA and Duke University agree to collaborate under the terms and conditions of this MOU, through steering committees and technical working groups, to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goals of identifying indicators of cardiovascular risk, predicting adverse cardiovascular events associated with therapeutic interventions, improving the clinical utility of biomarker technologies as diagnostic and assessment tolls that PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 For FDA: Wendy R. Sanhai, Office of the Commissioner (HF–18), Food and Drug Administration, 5600 Fishers Lane, 14B–45, Rockville, MD 20857, 301–827–7867, FAX: 301–443–9718, wendy.sanhai@fda.hhs.gov. For Duke Clinical Research Institute: Christopher H. Cabell, Department of Medicine, Duke University School of Medicine, DUMC Box 2705, Durham, NC 27705, 919–668– 8611, FAX: 919–668–7066, chris.cabell@duke.edu. For Duke: Office of Research Administration, Duke University Medical Center, 2424 Erwin Rd., suite 1103, Durham, NC 27705, 919–684–5175, FAX: 919–684– 6278. 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. SUPPLEMENTARY INFORMATION: Dated: October 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S E:\FR\FM\16OCN1.SGM 16OCN1 VerDate Aug<31>2005 16:16 Oct 13, 2006 Jkt 211001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\16OCN1.SGM 16OCN1 60733 EN16OC06.000</GPH> jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices 16:16 Oct 13, 2006 Jkt 211001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\16OCN1.SGM 16OCN1 EN16OC06.001</GPH> jlentini on PROD1PC65 with NOTICES 60734 VerDate Aug<31>2005 16:16 Oct 13, 2006 Jkt 211001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\16OCN1.SGM 16OCN1 60735 EN16OC06.002</GPH> jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices 16:16 Oct 13, 2006 Jkt 211001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 E:\FR\FM\16OCN1.SGM 16OCN1 EN16OC06.003</GPH> jlentini on PROD1PC65 with NOTICES 60736 VerDate Aug<31>2005 16:16 Oct 13, 2006 Jkt 211001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\16OCN1.SGM 16OCN1 60737 EN16OC06.004</GPH> jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices 16:16 Oct 13, 2006 Jkt 211001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\16OCN1.SGM 16OCN1 EN16OC06.005</GPH> jlentini on PROD1PC65 with NOTICES 60738 60739 [FR Doc. 06–8708 Filed 10–13–06; 8:45 am] BILLING CODE 4160–01–C VerDate Aug<31>2005 16:16 Oct 13, 2006 Jkt 211001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1 EN16OC06.006</GPH> jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices

Agencies

[Federal Register Volume 71, Number 199 (Monday, October 16, 2006)]
[Notices]
[Pages 60732-60739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-06-8404]


Memorandum of Understanding Between the Food and Drug 
Administration, and Duke University for the Cardiac Safety Research 
Consortium

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 Duke University, on 
behalf of its Duke Clinical Research Institute (DCRI). FDA and Duke 
University agree to collaborate under the terms and conditions of this 
MOU, through steering committees and technical working groups, to 
develop strategic plans, set priorities, and leverage resources and 
expertise from multiple sources, including the private sector, toward 
the goals of identifying indicators of cardiovascular risk, predicting 
adverse cardiovascular events associated with therapeutic 
interventions, improving the clinical utility of biomarker technologies 
as diagnostic and assessment tolls that facilitate the development of 
safer and more effective cardiovascular therapies, diagnostic, and 
assessment tools. This collaboration between the Parties shall be known 
as the Cardiac Safety Research Consortium.

DATES: The agreement became effective August 15, 2006.

FOR FURTHER INFORMATION CONTACT:
    For FDA: Wendy R. Sanhai, Office of the Commissioner (HF-18), Food 
and Drug Administration, 5600 Fishers Lane, 14B-45, Rockville, MD 
20857, 301-827-7867, FAX: 301-443-9718, wendy.sanhai@fda.hhs.gov.
    For Duke Clinical Research Institute: Christopher H. Cabell, 
Department of Medicine, Duke University School of Medicine, DUMC Box 
2705, Durham, NC 27705, 919-668-8611, FAX: 919-668-7066, 
chris.cabell@duke.edu.
    For Duke: Office of Research Administration, Duke University 
Medical Center, 2424 Erwin Rd., suite 1103, Durham, NC 27705, 919-684-
5175, FAX: 919-684-6278.

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: October 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 06-8708 Filed 10-13-06; 8:45 am]
BILLING CODE 4160-01-C
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