83 FR 4207 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 83, Issue 20 (January 30, 2018)

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort 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 the proposed information collection project entitled ``Evaluation of TransLife Center (TLC): A Locally-Developed Combination Prevention Intervention for Transgender Women at High Risk of HIV Infection.'' The collection is part of a research study designed to evaluate the efficacy of a locally developed and potentially effective intervention, TransLife Center (TLC), which provides combination HIV prevention services to adult transgender women at high risk for HIV infection.

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4207-4208]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-18CI; Docket No. CDC-2018-0009]


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 effort 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 the proposed 
information collection project entitled ``Evaluation of TransLife 
Center (TLC): A Locally-Developed Combination Prevention Intervention 
for Transgender Women at High Risk of HIV Infection.'' The collection 
is part of a research study designed to evaluate the efficacy of a 
locally developed and potentially effective intervention, TransLife 
Center (TLC), which provides combination HIV prevention services to 
adult transgender women at high risk for HIV infection.

DATES: CDC must receive written comments on or before April 2, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0009 by any of the following methods:
     Federal eRulemaking Portal: Regulations.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.
    Please note: Submit all Federal comments 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 Leroy A. Richardson, 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.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate 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. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Evaluation of TransLife Center (TLC): A Locally-Developed 
Combination Prevention Intervention for Transgender Women at High Risk 
for 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

    CDC seeks to request a two-year OMB approval to collect data 
related to a project entitled ``Evaluation of TransLife Center (TLC): A 
Locally-Developed Combination Prevention Intervention for Transgender 
Women at High Risk for HIV Infection.'' With this study, CDC

[[Page 4208]]

seeks 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 will help 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. In addition, CDC 
will assess whether intervention participants' behaviors significantly 
change from baseline to 4 and 8-month follow-up periods.
    CDC will conduct the study in the TLC program's home base of 
Chicago, Illinois. 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 whom had 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.
    CDC anticipates 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 
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 randomly selected to 
participate in the evaluation.
    CDC will use a quantitative assessment to collect information for 
this study. Researchers will deliver the assessment at the time of 
study enrollment and again at 4-month and 8-month follow-ups. CDC will 
use the assessment 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 measured. 
Participants will complete the assessment at baseline and again at 4- 
and 8-month follow-ups after joining the TLC program.
    CDC 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 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).
    CDC expects that 50% of transgender women screened will meet study 
eligibility and the initial screening to take approximately four 
minutes to complete. It will take respondents one minute to provide 
contact information. On three occasions, CDC will administer the 
assessment to 150 participants. The assessment will take 60 minutes (1 
hour) to complete. On a single occasion, CDC will administer the 
interview to 30 participants (20 intervention participants and 10 TLC 
staff). The interview will take 60 minutes (1 hour) to complete.
    There are no costs to the respondents other than their time. The 
total estimated annualized burden hours are 252.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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General Public--Adults........  Eligibility                  150               1            4/60              10
                                 Screener.
General Public--Adults........  Contact                       75               1            1/60               2
                                 Information.
General Public--Adults........  Assessment......              75               3             1.0             225
General Public--Adults........  Interview.......              15               1             1.0              15
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             252
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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. 2018-01743 Filed 1-29-18; 8:45 am]
 BILLING CODE 4163-18-P