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]
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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
https://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may obtain the draft guidance at either
https://www.fda.gov/cvm or https://
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]
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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
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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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76668
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[FR Doc. E8–29952 Filed 12–16–08; 8:45 am]
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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
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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
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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]
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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.
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]]>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]
-----------------------------------------------------------------------
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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