Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level, 44855 [E9-20895]
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Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices
Dated: August 3, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–20967 Filed 8–28–09; 8:45 am]
BILLING CODE 4163–18–P
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: August 21, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20895 Filed 8–28–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
National Institutes of Health
[Docket No. FDA–2008–N–0565]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on Formal
Dispute Resolution; Appeals Above
the Division Level
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on Formal
Dispute Resolution; Appeals Above the
Division Level’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
Elizabeth.Berbakos@fda.hhs.gov, 301–
796–3792.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 28, 2009 (74
FR 19225), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0396. The
approval expires on August 31, 2012. A
copy of the supporting statement for this
information collection is available on
Proposed Collection; Comment
Request; Evaluation of the NIAID HIV
Vaccine Research Education Initiative
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Allergy and
Infectious Diseases (NIAID), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Evaluation
of the NIAID HIV Vaccine Research
Education Initiative, Highly Impacted
Population Survey. Type of Information
Collection Request: NEW. Need and Use
of Information Collection: Developing
measures that protect against HIV
infection is one of NIAID’s highest
priorities. Methods in development for
the prevention of HIV infection include:
HIV vaccines, microbicides, and preexposure prophylaxis (PrEP). Given the
daunting complexity of the HIV virus,
developing these methods will
ultimately require tens of thousands of
volunteers to participate in HIV
prevention clinical trials. In the U.S.,
minority participation in clinical trials
of HIV prevention technologies is
essential; nearly two-thirds of people
diagnosed with HIV in the United States
are African American or Hispanic/
Latino. Historically, recruitment of
racial/ethnic populations has been a
critical challenge for medical
researchers, and initiatives to increase
recruitment of these groups into cancer
and chronic disease trials have only
been partially successful.
44855
To address the need for volunteers in
HIV vaccine clinical trials, and enable
NIAID to fulfill its Congressional
mandate to prevent infectious diseases
like HIV/AIDS, NIAID created the
NIAID HIV Vaccine Research Education
Initiative (NHVREI). The goal of
NHVREI is to increase knowledge about
and support for HIV vaccine research
among U.S. populations most heavily
affected by HIV/AIDS—in particular,
African Americans, Hispanics/Latinos,
men who have sex with men (MSM),
women and youth, recognizing the
intersection of these groups.
A critical component of NHVREI is
outreach to members of these specific
highly impacted populations. With the
assistance of funded community-based
and national organizations, NHVREI is
designing, developing, and
disseminating HIV vaccine researchrelated messages to NHVREI target
audiences. These messages are delivered
through print (e.g., brochures, posters,
fact sheets, information kits), radio, TV,
and Internet resources. Print materials
are distributed through various NHVREI
program activities (e.g., trainings,
conferences, symposia) and other
NIAID-funded partners, governmental
and non-governmental organizations.
NIAID is conducting an evaluation of
the NHVREI program in order to assess
its impact and generate key findings
applicable toward the design of future
educational initiatives. Part of the
evaluation includes a population survey
to guide future NHVREI activities.
With this document, NIAID requests
clearance for the third part of the
evaluation, a survey of the general
population and members of the U.S.
populations most heavily impacted by
HIV/AIDS. The survey will be
conducted once in 2010. The total
number of respondent burden hours
will not exceed 1167 annually.
Frequency of Response: Once. Affected
Public: Individuals. Type of
Respondents: General U.S. population
with oversampling of subpopulations
highly impacted by HIV. The annual
reporting burden is shown in the table
below. There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
Total No. of
respondents
Highly Impacted Population Surveys ...........................................................................................
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
VerDate Nov<24>2008
14:57 Aug 28, 2009
Jkt 217001
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Hours per response
Total hours
3,500
0.33333
1,167
performance of the function of the
agency, including whether the
information will have practical utility;
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31AUN1
]]>Agencies
[Federal Register Volume 74, Number 167 (Monday, August 31, 2009)]
[Notices]
[Page 44855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20895]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0565]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry on Formal
Dispute Resolution; Appeals Above the Division Level
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry on Formal
Dispute Resolution; Appeals Above the Division Level'' has been
approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, Elizabeth.Berbakos@fda.hhs.gov, 301-
796-3792.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 28, 2009
(74 FR 19225), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0396.
The approval expires on August 31, 2012. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: August 21, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20895 Filed 8-28-09; 8:45 am]
BILLING CODE 4160-01-S
