[Federal Register Volume 73, Number 232 (Tuesday, December 2, 2008)]
[Notices]
[Pages 73332-73333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28552]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-09-09AG]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    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 Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 or 
send comments to Maryam Daneshvar, Acting CDC Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA

[[Page 73333]]

30333 or send an e-mail to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    An Assessment of the Acceptability of Pre-exposure Prophylaxis 
(PrEP) Among Inner City Persons At Risk for HIV/AIDS--New--National 
Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    New HIV infections, both in the U.S. and globally are continuing at 
an unacceptably rapid rate and are rising in some sites and sub-
populations. Despite the many behavioral interventions available, it is 
necessary to develop additional highly effective prevention modalities, 
including biomedical ones if we are to significantly reduce the number 
of new HIV infections. Pre-exposure prophylaxis (PrEP) is currently 
under intense investigation as a potential biomedical intervention for 
the prevention of HIV acquisition. Clinical trials are underway in 
populations at high risk of acquiring HIV in Asia (injection drug 
users), Africa (heterosexuals and discordant couples), Latin America 
(men who have sex with men [MSM]), and among MSM in the United States. 
Based on the high efficacy shown with antiretroviral prophylaxis for 
the prevention of HIV transmission to infants during pregnancy, birth, 
and breastfeeding; and on the protection against vaginal or rectal 
exposure prophylaxis studies with non-human primates, it is likely that 
one of more of these human trials will show efficacy.
    The purpose of the proposed study is to conduct a preliminary 
assessment of attitudes about, preferences for programmatic 
introduction of, and anticipated changes in risk behaviors resulting 
from PrEP among young adults in neighborhoods and social networks where 
risk behaviors are likely to lead to HIV exposure. An early 
understanding of the perspective of intended users is critical to 
planning for possible use of PrEP.
    Investigators at Georgia State University, in collaboration with 
NCHHSTP, will conduct 20 focus groups in the first year, and 50 
ethnographic individual interviews in the second year, with a largely 
African-American population of young adults, ages 18-24. Study 
participants will be recruited from the 10 zipcodes in Atlanta, GA with 
the highest HIV/STD prevalence. The focus group and interview guides 
will cover six major areas: (1) Healthcare access and use; (2) risk 
perception in their social network; (3) knowledge and understanding of 
HIV transmission; (4) positive and negative attitudes toward a clinic-
based HIV prevention program that involves daily doses of an 
antiretroviral with periodic HIV testing and risk counseling; (5) 
preferences for the design of such a program (e.g., where would it best 
be located); (6) whether they anticipate any changes in their risk 
behavior if engaged in such a program. In the second year, rapid HIV 
testing will be offered to individual interview participants, with 
referrals for prevention or treatment services as indicated by test 
results.
    There is no cost to respondents other than their time.

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                                                                     Number of    Average burden
            Types of data collection                 Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Focus Group Participants........................             160               1               2             320
Ethnographic Interviews.........................              50               1               2             100
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             420
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    Dated: November 21, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E8-28552 Filed 12-1-08; 8:45 am]
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