Memorandum of Understanding Between the Office of the Assistant Secretary of Defense (Health Affairs), the Veterans Health Administration, and the U.S. Food and Drug Administration, 76658-76668 [E8-29952]

Download as PDF 76658 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES V. Electronic Access Memorandum of Understanding Between the Office of the Assistant Secretary of Defense (Health Affairs), the Veterans Health Administration, and the U.S. Food and Drug Administration Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/cvm or http:// www.regulations.gov. Dated: December 11, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–29953 Filed 12–16–08; 8:45 am] pwalker on PROD1PC71 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 Food and Drug Administration [Docket No. FDA–2008–N–0043] [FDA No. 225–08–8003] 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 the Office of the Assistant Secretary of Defense (Health Affairs), the Veterans Health Administration, and the U.S. Food and Drug Administration. The purpose of the MOU is to enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of the collaboration are to explore ways to: Further enhance information sharing efforts through PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 more efficient and robust interagency activities; promote efficient utilization of tools and expertise for product risk identification, validation and analysis; and build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, and utilization of drugs, biologics, and medical devices, as well as the safety and utilization of foods. The MOU is available on FDA’s Web site at www.fda.gov/oc/mous/domestic/ domesticmous.htm. DATES: The agreement became effective November 25, 2008. FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4324, Silver Spring, MD 20993, 301–796–4830. 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: December 11, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. E:\FR\FM\17DEN1.SGM 17DEN1 VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\17DEN1.SGM 17DEN1 76659 EN17DE08.000</GPH> pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\17DEN1.SGM 17DEN1 EN17DE08.001</GPH> pwalker on PROD1PC71 with NOTICES 76660 VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\17DEN1.SGM 17DEN1 76661 EN17DE08.002</GPH> pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\17DEN1.SGM 17DEN1 EN17DE08.003</GPH> pwalker on PROD1PC71 with NOTICES 76662 VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\17DEN1.SGM 17DEN1 76663 EN17DE08.004</GPH> pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\17DEN1.SGM 17DEN1 EN17DE08.005</GPH> pwalker on PROD1PC71 with NOTICES 76664 VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\17DEN1.SGM 17DEN1 76665 EN17DE08.006</GPH> pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\17DEN1.SGM 17DEN1 EN17DE08.007</GPH> pwalker on PROD1PC71 with NOTICES 76666 VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\17DEN1.SGM 17DEN1 76667 EN17DE08.008</GPH> pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices 76668 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices [FR Doc. E8–29952 Filed 12–16–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; The Effectiveness of the NIH Curriculum Supplements Programs and Career Resources Summary: Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, Office of Science Policy, Office of Science Education, National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on September 23, 2008 (Volume 73, Number 185, page 54840) and allowed 60-days for public comment. One comment was received. The purpose of this notice is to allow 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number. Proposed Collection Title: The Effectiveness of the NIH Curriculum Supplements Programs and Career Resources. Information Collection Request: Reinstatement. Need and Use of Information Collection: The survey will attempt to assess customer demographics and their satisfaction with the NIH curriculum supplements in presenting science in a more engaging and interactive way. The supplements help K–12 educators teach science by featuring the latest NIH research and utilized research-based instructional methods. A typical supplement contains two weeks of student activities on the science behind a health topic, such as cancer, sleep or Type of respondent: Survey title Number of respondents obesity. Web-based simulations, animations and experiments enhance the ‘‘pencil and paper’’ activities. In addition to developing and distributing the supplements, OSE conducts professional workshops to help teachers successfully implement these lessons with their students. Since January 2000, over 6,000 teachers have attended an OSE workshop. OSE also develops a series of videos, Women Are Scientists, that aim to excite middle school students on careers in the health sciences. Assessing the effectiveness of the NIH curriculum supplements, teacher workshops, and career resources is critical to determining if OSE is successfully fulfilling its mission. OSE has the database infrastructure in place to easily collect data from supplement and career video requesters and workshop attendees. At present, we do not have clearance to contact our customers to determine how NIH resources are meeting their educational needs. Burden Table Frequency of response Average time per response (hours) Hour burden per year (hours) Supplement requestor ..................................................................................... Career video requestor .................................................................................... Workshop Teacher: initial survey .................................................................... Workshop Teacher: in-depth survey ................................................................ 16,000 1,500 2,000 200 1 1 1 1 0.17 0.17 0.17 0.5 910 85 117 34 Totals ........................................................................................................ 19,700 a a 1,146 pwalker on PROD1PC71 with NOTICES a N/A. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) ways to enhance the quality, utility, and clarity of the information to be collected; and (3) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 fax to 202–395–6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. David Vannier, National Institutes of Health, Office of Science Education, 6100 Executive Boulevard, Suite 3E01, Bethesda, MD 20892, or call 301–496– 8741, or e-mail your request including your address to vannierd@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: December 4, 2008. David Vannier, Office of Science Education, National Institutes of Health. [FR Doc. E8–29815 Filed 12–16–08; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; 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 confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. E:\FR\FM\17DEN1.SGM 17DEN1

Agencies

[Federal Register Volume 73, Number 243 (Wednesday, December 17, 2008)]
[Notices]
[Pages 76658-76668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0043]
[FDA No. 225-08-8003]


Memorandum of Understanding Between the Office of the Assistant 
Secretary of Defense (Health Affairs), the Veterans Health 
Administration, and the U.S. 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 the Office of the Assistant 
Secretary of Defense (Health Affairs), the Veterans Health 
Administration, and the U.S. Food and Drug Administration. The purpose 
of the MOU is to enhance knowledge and efficiency by providing for the 
sharing of information and expertise between the Federal partners. The 
goals of the collaboration are to explore ways to: Further enhance 
information sharing efforts through more efficient and robust 
interagency activities; promote efficient utilization of tools and 
expertise for product risk identification, validation and analysis; and 
build infrastructure and processes that meet the common needs for 
evaluating the safety, efficacy, and utilization of drugs, biologics, 
and medical devices, as well as the safety and utilization of foods. 
The MOU is available on FDA's Web site at www.fda.gov/oc/mous/domestic/
domesticmous.htm.

DATES: The agreement became effective November 25, 2008.

FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4324, 
Silver Spring, MD 20993, 301-796-4830.

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: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.

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[FR Doc. E8-29952 Filed 12-16-08; 8:45 am]
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