83 FR 45451 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 83, Issue 174 (September 7, 2018)

[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45451-45452]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19379]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-18CI]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ``Evaluation of TransLife Center (TLC): A 
Locally-Developed Combination Prevention Intervention for Transgender 
Women at High Risk of HIV Infection'' to the Office of Management and 
Budget (OMB) for review and approval. CDC previously published a 
``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on January 30, 2018 to obtain comments from 
the public and affected agencies. CDC received one (1) comment related 
to the previous notice. This notice serves to allow an additional 30 
days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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 [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Evaluation of TransLife Center (TLC): A Locally-Developed 
Combination Prevention Intervention for Transgender Women at High Risk 
of HIV Infection--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 is requesting approval for 24 months of data collection 
entitled, ``Evaluation of TransLife Center (TLC): A Locally-Developed 
Combination Prevention Intervention for Transgender Women at High Risk 
for HIV Infection.'' The purpose of this study is to evaluate the 
efficacy of TLC, which provides combination (biomedical, behavioral and 
social/structural) HIV prevention and care services to adult 
transgender women at high risk for HIV infection, in a culturally 
specific and accessible environment. The information collected through 
this study will be used to evaluate whether the TLC intervention is an 
effective HIV-prevention strategy by assessing whether exposure to TLC 
services results in improvements in participants' health and HIV 
prevention behaviors. The trial will assess whether intervention 
participants' behaviors significantly change from baseline to 4- and 8-
month follow-up periods.
    This study will be carried out in Chicago, Illinois, where the TLC 
program is located. The study population will include 150 HIV-negative 
adult transgender women living in the Chicago metropolitan area. 
Participants will be at least 18 years of age; self-identify as 
transgender, transsexual, women and/or female who was assigned male sex 
at birth; and have a self-reported history of sex with men in the past 
four months. The study population will also include 10 TLC staff 
members. Staff members will be adults, involved in the delivery of TLC 
intervention services. Participation in this study is voluntary.
    We anticipate enrollment of a diverse sample of transgender women 
comprised mainly of racial/ethnic minority participants under 35 years 
of age, consistent with the current TLC program and the epidemiology of 
HIV infection among transgender women. Intervention participants will 
be recruited to the study through a combination of approaches, 
including traditional print advertisement, referral, in-person 
outreach, and through word of mouth. TLC staff members will be randomly 
selected to participate in the evaluation.
    A computer-assisted quantitative assessment will be used to collect 
information for this study, which will be delivered at the time of 
study enrollment and again at 4-month and 8-month follow-ups. The 
assessment will be used to measure changes in sexual risk behavior 
including condom use and pre-exposure prophylaxis (PrEP) care 
engagement. Intervention mediators, including gender affirmation, 
collective self-esteem and social support, and intervention 
satisfaction will also be

[[Page 45452]]

measured. Participants will complete the assessment at baseline and 
again at 4- and 8-month follow-ups after joining the TLC program.
    We will also examine intervention experiences through semi-
structured interview with 20 of the 150 TLC participants and 10 TLC 
staff members involved in the delivery of services through the TLC 
intervention. The audio-recorded interviews will capture participants 
and staff views about the TLC implementation process, the process 
through which the TLC intervention influences HIV risk behavior, and 
the role of the intervention in addressing social determinates of 
health (housing, employment, legal issues, health care access).
    It is expected that 50% of transgender women screened will meet 
study eligibility. We expect the initial screening to take 
approximately four minutes to complete and that providing contact 
information will take four minutes. The assessment will take 60 minutes 
(one hour) to complete and will be administered to 150 participants a 
total of three times. The interview will take 60 minutes (one hour) to 
complete and will be administered to 30 participants (20 intervention 
participants and 10 TLC staff) one time.
    There are no costs to the respondents other than their time. The 
total estimated annualized burden hours are 255.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
General Public-Adults.................  Eligibility Screener....             150               1            4/60
                                        Contact Information.....              75               1            4/60
                                        Baseline Assessment.....              75               1               1
                                        Follow Up Assessment....              75               2               1
                                        Participant Interview...              10               1               1
                                        Staff Interview.........               5               1               1
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Jeffrey M. Zirger,
Acting 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. 2018-19379 Filed 9-6-18; 8:45 am]
 BILLING CODE 4163-18-P