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)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 174 (September 7, 2018)
| Page Range | 45451-45452 | |
| FR Document | 2018-19379 |
[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] ----------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- 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
![Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45451
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden Total burden
Type of respondent Regulatory provision or form name responses per
respondents per response hours
respondent (in hours)
Importers ................................ 42 CFR 71.55 Dead Bodies, 42 CFR 71.32—Death certificates 20 1 1 20
Importer .................................. 42 CFR 71.56 (a)(2) African Rodents—Request for exemption .. 25 1 1 25
Importer .................................. 42 CFR 71.56(a)(iii) Appeal ......................................................... 2 1 1 2
Importer .................................. 42 CFR 71.32 Statements or documentation of non-infectious- 2,000 1 5/60 167
ness.
Total ................................ ....................................................................................................... ........................ ........................ ........................ 268,493
Jeffrey M. Zirger, (c) Enhance the quality, utility, and through this study will be used to
Acting Chief, Information Collection Review clarity of the information to be evaluate whether the TLC intervention
Office, Office of Scientific Integrity, Office collected; is an effective HIV-prevention strategy
of the Associate Director for Science, Office (d) Minimize the burden of the by assessing whether exposure to TLC
of the Director, Centers for Disease Control collection of information on those who services results in improvements in
and Prevention.
are to respond, including, through the participants’ health and HIV prevention
[FR Doc. 2018–19381 Filed 9–6–18; 8:45 am] behaviors. The trial will assess whether
use of appropriate automated,
BILLING CODE 4163–18–P electronic, mechanical, or other intervention participants’ behaviors
technological collection techniques or significantly change from baseline to 4-
other forms of information technology, and 8-month follow-up periods.
DEPARTMENT OF HEALTH AND This study will be carried out in
e.g., permitting electronic submission of
HUMAN SERVICES Chicago, Illinois, where the TLC
responses; and
Centers for Disease Control and (e) Assess information collection program is located. The study
Prevention costs. population will include 150 HIV-
To request additional information on negative adult transgender women
[30Day–18–18CI] the proposed project or to obtain a copy living in the Chicago metropolitan area.
of the information collection plan and Participants will be at least 18 years of
Agency Forms Undergoing Paperwork age; self-identify as transgender,
instruments, call (404) 639–7570 or
Reduction Act Review transsexual, women and/or female who
send an email to omb@cdc.gov. Direct
In accordance with the Paperwork written comments and/or suggestions was assigned male sex at birth; and have
Reduction Act of 1995, the Centers for regarding the items contained in this a self-reported history of sex with men
Disease Control and Prevention (CDC) notice to the Attention: CDC Desk in the past four months. The study
has submitted the information Officer, Office of Management and population will also include 10 TLC
collection request titled ‘‘Evaluation of Budget, 725 17th Street NW, staff members. Staff members will be
TransLife Center (TLC): A Locally- Washington, DC 20503 or by fax to (202) adults, involved in the delivery of TLC
Developed Combination Prevention 395–5806. Provide written comments intervention services. Participation in
Intervention for Transgender Women at within 30 days of notice publication. this study is voluntary.
High Risk of HIV Infection’’ to the Office We anticipate enrollment of a diverse
Proposed Project sample of transgender women
of Management and Budget (OMB) for
review and approval. CDC previously Evaluation of TransLife Center (TLC): comprised mainly of racial/ethnic
published a ‘‘Proposed Data Collection A Locally-Developed Combination minority participants under 35 years of
Submitted for Public Comment and Prevention Intervention for Transgender age, consistent with the current TLC
Recommendations’’ notice on January Women at High Risk of HIV Infection— program and the epidemiology of HIV
30, 2018 to obtain comments from the New—National Center for HIV/AIDS, infection among transgender women.
public and affected agencies. CDC Viral Hepatitis, STD and TB Prevention Intervention participants will be
received one (1) comment related to the (NCHHSTP), Centers for Disease Control recruited to the study through a
previous notice. This notice serves to and Prevention (CDC). combination of approaches, including
allow an additional 30 days for public traditional print advertisement, referral,
Background and Brief Description
and affected agency comments. in-person outreach, and through word of
CDC will accept all comments for this The National Center for HIV/AIDS, mouth. TLC staff members will be
proposed information collection project. Viral Hepatitis, STD and TB Prevention randomly selected to participate in the
The Office of Management and Budget is requesting approval for 24 months of evaluation.
is particularly interested in comments data collection entitled, ‘‘Evaluation of A computer-assisted quantitative
that: TransLife Center (TLC): A Locally- assessment will be used to collect
(a) Evaluate whether the proposed Developed Combination Prevention information for this study, which will
collection of information is necessary Intervention for Transgender Women at be delivered at the time of study
for the proper performance of the High Risk for HIV Infection.’’ The enrollment and again at 4-month and 8-
functions of the agency, including purpose of this study is to evaluate the month follow-ups. The assessment will
daltland on DSKBBV9HB2PROD with NOTICES
whether the information will have efficacy of TLC, which provides be used to measure changes in sexual
practical utility; combination (biomedical, behavioral risk behavior including condom use and
(b) Evaluate the accuracy of the and social/structural) HIV prevention pre-exposure prophylaxis (PrEP) care
agencies estimate of the burden of the and care services to adult transgender engagement. Intervention mediators,
proposed collection of information, women at high risk for HIV infection, in including gender affirmation, collective
including the validity of the a culturally specific and accessible self-esteem and social support, and
methodology and assumptions used; environment. The information collected intervention satisfaction will also be
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![45452 Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
measured. Participants will complete process through which the TLC minutes. The assessment will take 60
the assessment at baseline and again at intervention influences HIV risk minutes (one hour) to complete and will
4- and 8-month follow-ups after joining behavior, and the role of the be administered to 150 participants a
the TLC program. intervention in addressing social total of three times. The interview will
We will also examine intervention determinates of health (housing, take 60 minutes (one hour) to complete
experiences through semi-structured employment, legal issues, health care and will be administered to 30
interview with 20 of the 150 TLC access). participants (20 intervention
participants and 10 TLC staff members It is expected that 50% of transgender participants and 10 TLC staff) one time.
involved in the delivery of services women screened will meet study
through the TLC intervention. The eligibility. We expect the initial There are no costs to the respondents
audio-recorded interviews will capture screening to take approximately four other than their time. The total
participants and staff views about the minutes to complete and that providing estimated annualized burden hours are
TLC implementation process, the contact information will take four 255.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
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
Jeffrey M. Zirger, is particularly interested in comments Proposed Project
Acting Chief, Information Collection Review that: Network Epidemiology of Syphilis
Office, Office of Scientific Integrity, Office (a) Evaluate whether the proposed Transmission (NEST)—New—National
of the Associate Director for Science, Office collection of information is necessary
of the Director, Centers for Disease Control
Center for HIV/AIDS, Viral Hepatitis,
for the proper performance of the STD, and TB Prevention (NCHHSTP),
and Prevention.
functions of the agency, including Centers for Disease Control and
[FR Doc. 2018–19379 Filed 9–6–18; 8:45 am]
whether the information will have Prevention (CDC).
BILLING CODE 4163–18–P
practical utility;
Background and Brief Description
(b) Evaluate the accuracy of the
agencies estimate of the burden of the CDC, Division of STD Prevention
DEPARTMENT OF HEALTH AND (DSTDP), requests a 3-year approval for
HUMAN SERVICES proposed collection of information,
including the validity of the a new data collection entitled, Network
Centers for Disease Control and methodology and assumptions used; Epidemiology of Syphilis Transmission
Prevention (c) Enhance the quality, utility, and (NEST). Study participants’
clarity of the information to be sociodemographic, risk behavior, and
[30Day–18–18MY] collected; insurance coverage information will be
collected as part of study enrollment.
(d) Minimize the burden of the This study is funded by a cooperative
Agency Forms Undergoing Paperwork collection of information on those who
Reduction Act Review agreement between CDC and three study
are to respond, including, through the grantees, two universities (Ohio State
In accordance with the Paperwork use of appropriate automated, University and University of Illinois at
Reduction Act of 1995, the Centers for electronic, mechanical, or other Chicago) and one local health
Disease Control and Prevention (CDC) technological collection techniques or department (Baltimore City Health
has submitted the information other forms of information technology, Department) in collaboration with a
collection request titled Network e.g., permitting electronic submission of university (Johns Hopkins School of
Epidemiology of Syphilis Transmission responses; and Medicine). The recruitment of study
(NEST) to the Office of Management and (e) Assess information collection participants as well as the data
Budget (OMB) for review and approval. costs. collection activities will be carried out
CDC previously published a ‘‘Proposed To request additional information on at university-affiliated sites including
Data Collection Submitted for Public the proposed project or to obtain a copy local health departments, community
Comment and Recommendations’’ of the information collection plan and LGBT organizations, local STD clinics
notice on 03/05/2018 to obtain instruments, call (404) 639–7570 or and HIV/AIDS care facilities.
comments from the public and affected send an email to omb@cdc.gov. Direct The overall objective of NEST is to
agencies. CDC received 1 (one) comment written comments and/or suggestions support the establishment of cohorts of
daltland on DSKBBV9HB2PROD with NOTICES
related to the previous notice. This regarding the items contained in this MSM at high risk for syphilis and to
notice serves to allow an additional 30 notice to the Attention: CDC Desk prospectively collect behavioral, social,
days for public and affected agency Officer, Office of Management and and sexual network data, and biological
comments. Budget, 725 17th Street NW, specimens. Study participants will
CDC will accept all comments for this Washington, DC 20503 or by fax to (202) attend study visits every three months
proposed information collection project. 395–5806. Provide written comments for a period of up to 24 months. NEST
The Office of Management and Budget within 30 days of notice publication. is a multi-site study, with a target
VerDate Sep<11>2014 17:55 Sep 06, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1](https://thefederalregister.org/doc/83_FR_45625/page/2.svg)
Document Created: 2018-09-07 00:15:24
Document Modified: 2018-09-07 00:15:24
| 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 | |
| FR Citation | 83 FR 45451 |
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