[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85962-85963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-16ET]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Comprehensive HIV Prevention and Care for Men Who Have Sex with Men 
of Color (THRIVE)--New--National Center for HIV/AIDS, Viral Hepatitis, 
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    Approximately 40,000 people in the United States are newly infected 
with HIV each year. Gay, bisexual, and other men who have sex with men 
(MSM) remain the population most affected by HIV infection in the 
United States. Among MSM, those who are black and Hispanic comprise 64% 
of all new infections. Goals of the National HIV Prevention Strategy 
include increasing the number of MSM of color living with HIV infection 
who achieve HIV viral suppression with antiretroviral treatment, and 
decreasing the number of new HIV infections among MSM of color at risk 
of acquiring an HIV infection. Achieving these outcomes requires that 
men utilize a broad variety of HIV prevention and care services.
    In 2015, CDC developed a cooperative agreement program to promote 
use and adoption of Targeted Highly-Effective Interventions to Reverse 
the HIV Epidemic (THRIVE). Awardees are seven state and local health 
departments that are developing and implementing demonstration projects 
to provide comprehensive HIV prevention and care services for MSM of 
color. Each THRIVE awardee is creating a collaborative with community-
based organizations, health care, behavioral health, and social 
services providers in its jurisdiction to strengthen referrals and 
coordination of HIV testing, prevention, and treatment services. 
Overall, approximately 80 partner organizations are participating in 
THRIVE collaboratives.
    Each THRIVE collaborative is required to address a total of 24 HIV 
prevention and care services, including 13 HIV prevention services for 
MSM of color at substantial risk for HIV infection and 11 HIV care 
services for MSM of color living with HIV infection. HIV prevention 
services include: 1. HIV testing that uses lab-based 4th generation HIV 
tests; 2. Assessment of indications for pre-exposure prophylaxis (PrEP) 
and non-occupational post-exposure prophylaxis (nPEP); 3. Provision of 
PrEP and nPEP; 4. Adherence interventions for PrEP and nPEP; 5. 
Immediate linkage to care, antiretoriviral treatment, and partner 
services for those diagnosed with acute HIV infection; 6. Expedient 
linkage to care, antiretoriviral treatment, and partner services for 
those diagnosed with established HIV infection; 7. STD screening and 
treatment; 8. Partner services for patients with STDs; 9. Behavioral 
risk-reduction interventions; 10. Screening for behavioral health and 
social services needs; 11. Linkage to behavioral health and social 
services; 12. Navigators to assist utilizing HIV prevention and 
behavioral health and social services; 13. Navigators to assist 
enrollment in a health plan.
    HIV care services include: 1. HIV primary care, including 
antiretroviral treatment; 2. Retention interventions; 3. Re-engagement 
interventions; 4. Adherence interventions; 5. STD screening and 
treatment; 6. Partner services; 7. Behavioral risk reduction 
interventions; 8. Screening patients for behavioral health and social 
services needs; 9. Linkage to behavioral health and social services; 
10. Navigators to assist linking to care and accessing behavioral 
health and social services; 11. Navigators to assist enrollment in a 
health plan.
    CDC requests OMB approval to collect the information needed to 
monitor and assess the demonstration projects. In general, information 
collection will be conducted in 2 steps: THRIVE

[[Page 85963]]

collaborative partners will report information to their respective 
health department (THRIVE awardee), and THRIVE awardees will provide 
reports to CDC. The monitoring and evaluation plan is based on semi-
annual reports of Monitoring and Evaluation (M&E) Variables, comprised 
primarily of de-identified or coded client-level data on demographics 
and services received. The M&E files will be transmitted 
electronically. Recognizing that THRIVE awardees and partners vary in 
terms of existing infrastructure, CDC has established guidelines and 
specifications for M&E content, but is permitting a flexible approach 
to electronic reporting. A similar approach will be applied to 
electronic transmission of the annual Funding Allocation Report (FAR). 
The FAR is only required for THRIVE awardees.
    Information collection also includes an Annual Collaborative 
Process and Outcome Evaluation based on semi-structured interviews and 
completion of a questionnaire called the Annual Collaborative 
Assessment Tool. These information collections will allow CDC to assess 
how successful THRIVE awardees have been in creating, engaging, and 
sustaining collaborative partnerships and to understand how these 
partnerships contributed to achieving the goals of the project. Both 
tools will be submitted to CDC electronically on an annual basis.
    CDC will use findings to provide technical assistance to THRIVE 
awardees and to develop recommendations for the coordination of 
comprehensive HIV testing, prevention, and treatment services for MSM 
of color.
    OMB approval is requested for three years. Participation is 
required as a condition of THRIVE funding and there are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 1,543.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
         Type of respondent                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
THRIVE Partners....................  Monitoring and Evaluation                80               2               9
                                      Data Elements on HIV
                                      Prevention and Care
                                      Services.
                                     Qualitative Interview:                   80               1           40/60
                                      Collaborative Process
                                      Evaluation.
                                     Collaborative Assessment                 80               1           20/60
                                      Tool.
THRIVE Awardees....................  Monitoring and Evaluation                 7               2               1
                                      Data Elements on HIV
                                      Prevention and Care
                                      Services.
                                     Qualitative Interview:                    7               1           40/60
                                      Collaborative Process
                                      Evaluation.
                                     Collaborative Assessment                  7               1           20/60
                                      Tool.
                                     Funding Allocation Report..               7               1           20/60
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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. 2016-28588 Filed 11-28-16; 8:45 am]
 BILLING CODE 4163-18-P