80 FR 27316 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 92 (May 13, 2015)

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a new information collection request entitled, ``Understanding Barriers and Facilitators to HIV prevention for Men Who Have Sex with Men (MSM)'' to conduct qualitative research with most at risk HIV-negative MSM. The research is intended to understand issues surrounding HIV risk for MSM, identify influences of high risk behaviors and to investigate risk management and resiliency among HIV-negative MSM.

[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27316-27318]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-15-15AGK; Docket No. CDC-2015-0032]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention, CDC, Department of 
Health and Human Services, HHS.

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a new information 
collection request entitled, ``Understanding Barriers and Facilitators 
to HIV prevention for Men Who Have Sex with Men (MSM)'' to conduct 
qualitative research with most at risk HIV-negative MSM. The research 
is intended to understand issues surrounding HIV risk for MSM, identify 
influences of high risk behaviors and to investigate risk management 
and resiliency among HIV-negative MSM.

DATES: Written comments must be received on or before July 13, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0032 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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)

[[Page 27317]]

ways to enhance the quality, utility, and clarity of the information to 
be collected; (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; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information.

Proposed Project

    Understanding Barriers and Facilitators to HIV prevention for Men 
Who Have Sex with Men (MSM) (Pulse Study)--New--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention (NCHHSTP)/Division of HIV/AIDS Prevention (DHAP) is 
requesting approval for one year of a data collection entitled, 
``Understanding Barriers and Facilitators to HIV prevention for Men Who 
Have Sex with Men (MSM).'' The purpose of this study is to conduct 
primarily qualitative research with most at risk HIV-negative MSM. 
There are four goals to this study: (1) Understand issues surrounding 
HIV risk for MSM; (2) learn more about how gay community or peer norms, 
and community identification influence risk behaviors; (3) understand 
individual HIV risk management, such as having an HIV-positive partner 
with suppressed viral load, barriers and facilitators for use of 
biomedical interventions (i.e., pre-exposure prophylaxis (PrEP), non-
occupational post-exposure prophylaxis (nPEP); and (4) understand 
factors that promote resiliency among HIV-negative MSM.
    The present research will be conducted in the top five Southern 
metropolitan areas in the United States with the highest HIV diagnoses 
for MSM--Atlanta, Georgia; Jackson, Mississippi; Miami, Florida; and 
New Orleans and Baton Rouge, Louisiana. These cities rank among those 
in the South with the highest prevalence and incidence of HIV and 
sexually transmitted infections (STIs) among black/African American and 
Hispanic/Latino MSM.
    The study population will consist of black/African-American and 
Hispanic/Latino (1) male adolescents who are attracted to men and 
report they are HIV negative or have not been tested and (2) adult MSM 
who are recently tested and verified as HIV-negative.
    All study participants will be 13 years of age or older. 
Participants will be recruited in the selected cities through referrals 
from Health Departments, clinics and other HIV testing centers. In 
addition, we will recruit via word-of-mouth referrals or flyers given 
out by community-based, advocacy, faith-based, and service-providing 
agencies.
    Primarily, we will use a qualitative research design and will 
include a brief quantitative survey to reduce participant burden where 
possible (for example, when we do not need to know an in-depth answer 
for socio-demographics, HIV testing history, housing status, health 
insurance status). The first portion of the interview instrument 
consists of brief structured questions to characterize the respondents. 
The second portion of the instrument consists of open-ended in-depth 
qualitative questions. This research design was chosen based on the 
exploratory nature of our study purpose.
    All data collection tools will be pre-tested and interviews 
conducted by trained personnel. The data collection will take place at 
a time and place that is convenient to the respondent. Locations will 
be private. Data collection may be audio-recorded and transcribed with 
the consent of the respondent.
    We anticipate that consent forms and screener forms to take five 
minutes to complete each. We anticipate 50 percent of HIV-negative MSM 
screened will be eligible for the study. The brief structured survey 
(15 minutes) and in-depth interview (45 minutes) for HIV-negative MSM 
are expected to take a total of 60 minutes (1 hour) total. We will 
complete interviews for 105 black/African-American and 45 Hispanic/
Latino HIV-negative MSM at greatest risk for HIV in high prevalence 
cities in the U.S. South. We anticipate screening 300 potential 
respondents. The total number of burden hours are 192.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
General Public--Adults........  HIV-negative MSM             210               1            5/60              18
                                 Screener--Engli
                                 sh.
General Public--Adults........  HIV-negative MSM              90               1            5/60               8
                                 Screener--Spani
                                 sh.
General Public--Adults........  HIV-negative MSM             105               1            1/60               2
                                 Contact
                                 Information
                                 Form--English.
General Public--Adults........  HIV-negative MSM              45               1            1/60               1
                                 Contact
                                 Information
                                 Form--Spanish.
General Public--Adults........  HIV-negative MSM              95               1            5/60               8
                                 Consent Form--
                                 English.
General Public--Adults........  HIV-negative MSM              35               1            5/60               3
                                 Consent Form--
                                 Spanish.
General Public--Adults........  HIV-negative MSM              10               1            3/60               1
                                 Assent for
                                 Minors Form--
                                 English.
General Public--Adults........  HIV-negative MSM              10               1            3/60               1
                                 Assent for
                                 Minors Form--
                                 Spanish.

[[Page 27318]]

 
General Public--Adults........  HIV-negative MSM             105               1               1             105
                                 In-Depth
                                 Interview
                                 Guide--English.
General Public--Adults........  HIV-negative In-              45               1               1              45
                                 Depth Interview
                                 Guide--Spanish.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             192
----------------------------------------------------------------------------------------------------------------


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. 2015-11512 Filed 5-12-15; 8:45 am]
 BILLING CODE 4163-18-P