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)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 20 (January 30, 2018)
| Page Range | 4207-4208 | |
| FR Document | 2018-01743 |
[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: omb@cdc.gov. 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 ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response Total burden respondents respondent (in hours) (in hours) ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- 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
![Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices 4207
ACTION: Notice. DEPARTMENT OF HEALTH AND Control and Prevention, 1600 Clifton
HUMAN SERVICES Road NE, MS–D74, Atlanta, Georgia
SUMMARY: The Gulf Coast Ecosystem 30329; phone: 404–639–7570; Email:
Restoration Council (Council) Centers for Disease Control and omb@cdc.gov.
announces the Notice of Funding Prevention SUPPLEMENTARY INFORMATION: Under the
Availability for the Council-Selected [60Day–18–18CI; Docket No. CDC–2018– Paperwork Reduction Act of 1995 (PRA)
Restoration Component 2017 Funded 0009] (44 U.S.C. 3501–3520), Federal agencies
Priorities List (FPL) for Comprehensive must obtain approval from the Office of
Commitment and Planning Support Proposed Data Collection Submitted Management and Budget (OMB) for each
under the Council-Selected Restoration for Public Comment and collection of information they conduct
Component of the Resources and Recommendations or sponsor. In addition, the PRA also
Ecosystems Sustainability, Tourist requires Federal agencies to provide a
AGENCY: Centers for Disease Control and 60-day notice in the Federal Register
Opportunities, and Revived Economies Prevention (CDC), Department of Health
of the Gulf Coast States Act of 2012 concerning each proposed collection of
and Human Services (HHS). information, including each new
(RESTORE Act). ACTION: Notice with comment period. proposed collection, each proposed
DATES: Applications will be accepted extension of existing collection of
until April 30, 2018. The Centers for Disease
SUMMARY:
information, and each reinstatement of
Control and Prevention (CDC), as part of
previously approved information
FOR FURTHER INFORMATION CONTACT: its continuing effort to reduce public
collection before submitting the
Kristin Smith, Council staff, telephone burden and maximize the utility of
collection to OMB for approval. To
number: 504–444–3558; or email government information, invites the
comply with this requirement, we are
grantsoffice@restorethegulf.gov. general public and other Federal
publishing this notice of a proposed
agencies to take this opportunity to
SUPPLEMENTARY INFORMATION: The data collection as described below.
comment on proposed and/or The OMB is particularly interested in
Council approved the Council-Selected continuing information collections, as
Restoration Component 2017 Funded comments that will help:
required by the Paperwork Reduction 1. Evaluate whether the proposed
Priorities List for Comprehensive Plan Act of 1995. This notice invites
Commitment and Planning Support collection of information is necessary
comment on the proposed information for the proper performance of the
(2017 CPS FPL or CPS FPL) on January collection project entitled ‘‘Evaluation
24, 2018, authorized under the Council- of TransLife Center (TLC): A Locally- functions of the agency, including
whether the information will have
Selected Restoration Component of the Developed Combination Prevention practical utility;
RESTORE Act (33 U.S.C. 1321(t)(2)). Intervention for Transgender Women at 2. Evaluate the accuracy of the
The Council has published a Notice of High Risk of HIV Infection.’’ The agency’s estimate of the burden of the
Funding Availability (NOFA) for collection is part of a research study proposed collection of information,
financial assistance available through designed to evaluate the efficacy of a including the validity of the
the CPS FPL, which provides guidance locally developed and potentially methodology and assumptions used;
to Council members on the steps effective intervention, TransLife Center 3. Enhance the quality, utility, and
necessary to submit applications for (TLC), which provides combination HIV clarity of the information to be
funding to enhance collaboration, prevention services to adult transgender collected; and
coordination, public engagement, and women at high risk for HIV infection. 4. Minimize the burden of the
use of best available science needed to DATES: CDC must receive written collection of information on those who
make efficient use of Gulf restoration comments on or before April 2, 2018. are to respond, including through the
funds resulting from the Deepwater ADDRESSES: You may submit comments, use of appropriate automated,
Horizon oil spill. The CPS FPL awards identified by Docket No. CDC–2018– electronic, mechanical, or other
will support the Council’s commitment 0009 by any of the following methods: technological collection techniques or
to a coordinated approach to ecosystem • Federal eRulemaking Portal: other forms of information technology,
restoration, as called for in the Regulations.gov. Follow the instructions e.g., permitting electronic submissions
Comprehensive Plan Update 2016: for submitting comments. of responses.
Restoring the Gulf Coast’s Ecosystem • Mail: Leroy A. Richardson, 5. Assess information collection costs.
and Economy. The CPS FPL was Information Collection Review Office, Proposed Project
finalized in September 2017 and was Centers for Disease Control and Evaluation of TransLife Center (TLC):
officially approved by the Council in the Prevention, 1600 Clifton Road NE, MS– A Locally-Developed Combination
January 24, 2018 vote. The full text of D74, Atlanta, Georgia 30329. Prevention Intervention for Transgender
the NOFA for the CPS FPL awards is Instructions: All submissions received Women at High Risk for HIV Infection—
available on the Council website at must include the agency name and New—National Center for HIV/AIDS,
https://www.restorethegulf.gov/sites/ Docket Number. Viral Hepatitis, STD, and TB Prevention
default/files/GO-RES_20180124_NOFA_ Please note: Submit all Federal (NCHHSTP), Centers for Disease Control
CPS.pdf. To locate the opportunity on comments through the Federal and Prevention (CDC).
www.grants.gov, enter Funding eRulemaking portal (regulations.gov) or
Opportunity Number GCC–FPL–18–001 by U.S. mail to the address listed above. Background and Brief Description
daltland on DSKBBV9HB2PROD with NOTICES
in the main search box. FOR FURTHER INFORMATION CONTACT: To CDC seeks to request a two-year OMB
request more information on the approval to collect data related to a
Keala J. Hughes, proposed project or to obtain a copy of project entitled ‘‘Evaluation of TransLife
Director of External Affairs & Tribal Relations, the information collection plan and Center (TLC): A Locally-Developed
Gulf Coast Ecosystem Restoration Council. instruments, contact Leroy A. Combination Prevention Intervention
[FR Doc. 2018–01702 Filed 1–29–18; 8:45 am] Richardson, Information Collection for Transgender Women at High Risk for
BILLING CODE 6560–58–P Review Office, Centers for Disease HIV Infection.’’ With this study, CDC
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![4208 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices
seeks to evaluate the efficacy of TLC, adults, involved in the delivery of TLC CDC will also examine intervention
which provides combination intervention services. experiences through semi-structured
(biomedical, behavioral and social/ CDC anticipates enrollment of a interview with 20 of the 150 TLC
structural) HIV prevention and care diverse sample of transgender women participants and 10 TLC staff members
services to adult transgender women at comprised mainly of racial/ethnic involved in the delivery of services
high risk for HIV infection, in a minority participants under 35 years of through the TLC intervention. The
culturally specific and accessible age, consistent with the current TLC interviews will capture participants and
environment. program and the epidemiology of HIV staff views about the TLC
implementation process, the process
The information collected will help infection among transgender women.
through which the TLC intervention
evaluate whether the TLC intervention Intervention participants recruited to
influences HIV risk behavior, and the
is an effective HIV-prevention strategy the study through a combination of
role of the intervention in addressing
by assessing whether exposure to TLC approaches, including traditional print
social determinates of health (housing,
services results in improvements in advertisement, referral, in-person
employment, legal issues, health care
participants’ health and HIV prevention outreach, and through word of mouth.
access).
behaviors. In addition, CDC will assess TLC staff members will randomly
CDC expects that 50% of transgender
whether intervention participants’ selected to participate in the evaluation.
women screened will meet study
behaviors significantly change from CDC will use a quantitative eligibility and the initial screening to
baseline to 4 and 8-month follow-up assessment to collect information for take approximately four minutes to
periods. this study. Researchers will deliver the complete. It will take respondents one
CDC will conduct the study in the assessment at the time of study minute to provide contact information.
TLC program’s home base of Chicago, enrollment and again at 4-month and 8- On three occasions, CDC will administer
Illinois. The study population will month follow-ups. CDC will use the the assessment to 150 participants. The
include 150 HIV-negative adult assessment to measure changes in assessment will take 60 minutes (1
transgender women living in the sexual risk behavior including condom hour) to complete. On a single occasion,
Chicago metropolitan area. Participants use and pre-exposure prophylaxis CDC will administer the interview to 30
will be at least 18 years of age; self- (PrEP) care engagement. Intervention participants (20 intervention
identify as transgender, transsexual, mediators, including gender affirmation, participants and 10 TLC staff). The
women and/or female whom had collective self-esteem and social interview will take 60 minutes (1 hour)
assigned male sex at birth; and have a support, and intervention satisfaction to complete.
self-reported history of sex with men in measured. Participants will complete There are no costs to the respondents
the past four months. The study the assessment at baseline and again at other than their time. The total
population will also include 10 TLC 4- and 8-month follow-ups after joining estimated annualized burden hours are
staff members. Staff members will be the TLC program. 252.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
General Public—Adults ..................... Eligibility Screener ............................ 150 1 4/60 10
General Public—Adults ..................... Contact Information .......................... 75 1 1/60 2
General Public—Adults ..................... Assessment ...................................... 75 3 1.0 225
General Public—Adults ..................... Interview ........................................... 15 1 1.0 15
Total ........................................... ........................................................... ........................ ........................ ........................ 252
Leroy A. Richardson, DEPARTMENT OF HEALTH AND part of the Mother and Infant Home
Chief, Information Collection Review Office, HUMAN SERVICES Visiting Program Evaluation Long-Term
Office of Scientific Integrity, Office of the Follow-Up project (MIHOPE–LT). The
Associate Director for Science, Office of the Administration for Children and purpose of MIHOPE–LT is to conduct
Director, Centers for Disease Control and Families follow-up studies that assess the long-
Prevention. term impact of the Maternal, Infant, and
[FR Doc. 2018–01743 Filed 1–29–18; 8:45 am] Proposed Information Collection
Early Childhood Home Visiting
Activity; Comment Request
BILLING CODE 4163–18–P (MIECHV) Program. The design of
Title: Mother and Infant Home MIHOPE–LT calls for multiple follow-
Visiting Program Evaluation (MIHOPE): up points including when the
Long-Term Follow-Up. participating children are in
OMB No.: 0970–0402. kindergarten, 3rd grade, early
daltland on DSKBBV9HB2PROD with NOTICES
Description: The Administration for adolescence, and late adolescence. This
Children and Families (ACF), in Federal Register Notice is specific to the
partnership with the Health Resources first follow-up study. Data collected
and Services Administration (HRSA), during the first follow-up study (when
both of the U.S. Department of Health the children from the MIHOPE sample
and Human Services (HHS), is are of kindergarten age) will include the
proposing a data collection activity as following: (1) A one-hour survey with
VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1](https://thefederalregister.org/doc/83_FR_4227/page/2.svg)
Document Created: 2018-10-26 10:13:07
Document Modified: 2018-10-26 10:13:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before April 2, 2018. | |
| 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] | |
| FR Citation | 83 FR 4207 |
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