[Federal Register Volume 74, Number 237 (Friday, December 11, 2009)]
[Notices]
[Page 65778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29461]



[[Page 65778]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Evaluation of the 
NIAID HIV Vaccine Research Education Initiative

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of Allergy and Infectious 
Diseases (NIAID), the National Institutes of Health (NIH) has submitted 
to the Office of Management and Budget (OMB) a request to review and 
approve the information collection listed below. This proposed 
information collection was previously published in the Federal Register 
on October 16, 2009, pages 53259-53260 and allowed 60 days for public 
comment. Three public comments were received and responses were sent to 
each person. The purpose of this notice is to allow an additional 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 control number.
    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 
pre-exposure 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 preventive clinical 
trials. In the United States, 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.
    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 research-related 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 1,167 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      Hours per
                                                                of respondents      response       Total hours
----------------------------------------------------------------------------------------------------------------
Highly Impacted Population Surveys...........................           3,500          0.33333            1,167
----------------------------------------------------------------------------------------------------------------

    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) The 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) Ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) 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.
    For Further Information: 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, [email protected], or by 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 Katharine Kripke, Assistant Director, Vaccine 
Research Program, Division of AIDS, NIAID, NIH, 6700B Rockledge Dr., 
Bethesda, MD 20892-7628, or call non-toll-free number 301-402-0846, or 
e-mail your request, including your address to [email protected].
    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.

J.J. McGowan,
Executive Officer, NIAID,National Institutes of Health.
[FR Doc. E9-29461 Filed 12-10-09; 8:45 am]
BILLING CODE 4140-01-P