[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70190-70192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0913]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to <a href="/cdn-cgi/l/email-protection#e38c8e81a3808780cd848c95"><span class="__cf_email__" data-cfemail="751a1817351611165b121a03">[email protected]</span></a>. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

[[Page 70191]]

Proposed Project

    Evaluating Locally-Developed HIV Prevention Interventions for 
African-American MSM in Los Angeles (OMB No. 0920-0913, expires 01/15/
2015)--[Extension]--National Center for HIV/AIDS, Viral Hepatitis, STD, 
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Data on HIV cases reported in 33 U.S. states with HIV reporting 
indicate the burden of HIV/AIDS is most concentrated in the African 
American population compared to other racial/ethnic groups. Of the 
49,704 African American males diagnosed with HIV between 2001 and 2004, 
54% of these cases were among men who have sex with men (MSM). In Los 
Angeles County (LAC), the proportion of HIV/AIDS cases among African 
American males attributable to male-to-male sexual transmission is even 
greater (75%). In the absence of an effective vaccine, behavioral 
interventions represent one of the few methods for reducing high HIV 
incidence among African American MSM (AAMSM). Unfortunately, in the 
third decade of the epidemic, very few of the available HIV-prevention 
interventions for African American populations have been designed 
specifically for MSM. In fact, until very recently none of CDC's 
evidence-based, HIV-prevention interventions had been specifically 
tested for efficacy in reducing HIV transmission among MSM of color. 
Given the conspicuous absence of (1) evidence-based HIV interventions 
and (2) outcome evaluations of existing AAMSM interventions, our 
collaborative team intends to address a glaring research gap by 
implementing a best-practices model of comprehensive program 
evaluation.
    As of November 7, 2014, 888 men were screened using the eligibility 
screener, 711 were eligible, and 520 men were consented, enrolled, and 
completed the baseline assessment. There are a total of 227 men who 
completed 3-month follow-up and 193 men who completed 6-month follow-
up. Each enrolled participant completed a client satisfaction survey 
for each of the three intervention sessions they attended. Finally, 
twenty-two men consented for and completed qualitative interviews. 
There were unanticipated delays in getting our initial OMB approval and 
delays in enrollment which prevented the study from reaching the 
desired sample size of 528 and completing data collection within the 
original 3-year timeframe. When the current information collection 
request (ICR) expires on January 31st, 2015, we will need to enroll, 
consent, and baseline approximately 10 more participants. To reach 
these additional 10 participants, we anticipate having to screen 
approximately more 20 men. During this extended period, an additional 
185 men will complete the 3-month assessment, 225 men will complete the 
6-month follow-up questionnaires, and 14 men will consent for and 
complete the success case study qualitative interviews. We anticipate 
that all data collection activities will be completed by the end of 
2015.
    The purpose of this project is to test in a real world setting the 
efficacy of an HIV transmission prevention intervention for reducing 
sexual risk among African American men who have sex with men in Los 
Angeles County. The intervention is a 3-session, group-level 
intervention that will provide participants with the information, 
motivation, and skills necessary to reduce their risk of transmitting 
or acquiring HIV. The intervention is being evaluated using baseline, 3 
month and 6 month follow up assessments. This project is also 
conducting in-depth qualitative interviews with a total of 36 men in 
order to assess the experiences with the intervention, elicit 
recommendations for improving the intervention, and to better 
understand the factors that put young African American MSM at risk for 
HIV.
    CDC is requesting approval for a 1-year clearance to complete data 
collection. The data collection system involves screenings, limited 
locator information, contact information, baseline questionnaire, 
client satisfaction surveys, 3-month follow-up questionnaire, 6-month 
follow-up questionnaire, and case study interviews. An estimated 20 men 
will be screened for eligibility in order to enroll 10 additional men 
to reach the desired sample size of 528. The baseline and follow up 
questionnaires contain questions about participants' socio-demographic 
information, health and healthcare, sexual activity, substance use, and 
other psychosocial issues. The duration of each baseline, 3-month, and 
6-month questionnaires are estimated to be 60 minutes; the Success Case 
Study interviews 90 minutes; Outreach Recruitment Assessment 5 minutes; 
limited locator information form 5 minutes; participant contact 
information form 10 minutes; each client satisfaction survey 5 minutes.
    There is no cost to participants other than their time. The total 
estimated annual burden hours are 459.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per  per respondent
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Prospective Participant...............  Outreach Recruitment                  20               1            5/60
                                         Assessment (screener).
Prospective Participant...............  Limited Locator Form....              20               1            5/60
Enrolled Participant..................  RCT Informed Consent                  10               1           10/60
                                         Form.
Enrolled Participant..................  Participant Contact                   10               1           10/60
                                         Information Form.
Enrolled Participant..................  Baseline Questionnaire..              10               1               1
Enrolled Participant..................  Client Satisfaction                   30               3            5/60
                                         Survey.
Enrolled Participant..................  3 month follow up                    185               1               1
                                         Questionnaire.
Enrolled Participant..................  6 month follow up                    225               1               1
                                         Questionnaire.
Enrolled Participant..................  Success Case Study                    14               1           10/60
                                         Informed Consent Form.
Enrolled Participant..................  Success Case Study                    14               1             1.5
                                         Interview.
----------------------------------------------------------------------------------------------------------------



[[Page 70192]]

Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-27851 Filed 11-24-14; 8:45 am]
BILLING CODE 4163-18-P


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