[Federal Register Volume 84, Number 229 (Wednesday, November 27, 2019)]
[Notices]
[Pages 65394-65396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-1178]


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 Comprehensive HIV Prevention and Care for Men 
Who Have Sex with Men of Color 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 August 13, 2019 to obtain comments from the public and 
affected agencies. CDC did not receive comments 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

[[Page 65395]]

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

    Comprehensive HIV Prevention and Care for Men Who Have Sex with Men 
of Color (OMB Contrtol No. 0920-1178, Exp. 4/30/2020)--Extension--
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 (US). Among MSM, those who are black and Hispanic 
comprise 64% of all new infections. Goals of the National HIV 
Prevention Strategy and the new initiative ``Ending the HIV Epidemic: A 
Plan for America'' include increasing the number of MSM of color living 
with HIV infection who achieve HIV viral suppression with 
antiretroviral treatment (ART), and decreasing the number of new HIV 
infections among MSM of color at risk of acquiring an HIV infection.
    Antiretroviral (ARV) medications for pre-exposure prophylaxis 
(PrEP) can be used for HIV prevention by MSM at substantial risk for 
HIV acquisition or by those with a possible HIV exposure in the past 72 
hours post-exposure prophylaxis (nPEP). The daily use of co-formulated 
tenofovir disoproxil fumarate and emtricitabine (marketed as Truvada) 
for PrEP has been proven to significantly reduce the risk of HIV 
acquisition among sexually active MSM. In July 2012, the US Food and 
Drug Administration (FDA) approved an HIV prevention indication for 
Truvada, and in May 2014 CDC published clinical practice guidelines for 
provision of PrEP. Given the high incidence of HIV among MSM of color, 
those who are sexually active are considered at risk for HIV 
acquisition and thus could benefit from prevention services such as 
routine and frequent HIV screening with lab-based fourth generation HIV 
tests, routine screening for STDs, assessment of PrEP eligibility, 
provision of PrEP (if at substantial risk for HIV acquisition), 
provision of nPEP (if a possible HIV exposure occurred in the past 72 
hours), and/or other risk reduction interventions.
    Among people living with HIV (PLWH), ARV treatment can suppress HIV 
viral load, which both improves health outcomes of individuals and 
reduces the risk of HIV transmission. Two studies, one that 
demonstrated the effectiveness of ARV treatment in preventing HIV 
transmission, and one that demonstrated improved health outcomes for 
individuals whose ARV treatment was initiated immediately, have led to 
increased public health focus on interventions and strategies designed 
to initiate ARV treatment, link, retain, and re-engage PLWH in HIV 
care, and to provide support for adherence to ARV medications.
    The purpose of this project is to support state and local health 
departments to develop and implement demonstration projects for 
provision of comprehensive HIV prevention and care services for MSM of 
color by creating a collaborative with CBOs, clinics and other health 
care providers, and behavioral health and social services providers in 
their jurisdiction. Behavioral health services include mental health 
and substance abuse treatment to enable MSM of color to utilize HIV 
prevention and care services; social services include services that 
promote access to housing, job counseling, and employment services to 
enable MSM of color to utilize HIV prevention and care services.
    Comprehensive models of HIV prevention and care for MSM of color 
will be developed and implemented by a collaborative that is led by the 
jurisdiction's health department and includes the following: Health 
care providers (e.g., federally qualified health centers (FQHCs), FQHC 
Look-Alikes, other clinics, or health care providers); HIV care 
providers (e.g., clinics funded through the Ryan White HIV/AIDS Program 
(RWHAP clinics), other HIV care clinics, or HIV care providers); 
behavioral health and social services providers (i.e., mental health 
and substance abuse services, housing programs, and job training or 
employment services); and community based organizations (CBOs). 
Principles of high impact prevention should guide the selection and 
implementation of activities and strategies to focus on MSM of color at 
substantial risk for HIV infection (i.e., eligible for prevention with 
PrEP), and those living with HIV. MSM of color who are at risk for HIV 
acquisition but not eligible for or decline PrEP will be provided risk 
reduction interventions, partner services if diagnosed with an STD, re-
testing for HIV and STDs in 3-6 months, and behavioral health and 
social services. The risk of HIV acquisition should be assessed at 
every encounter with an individual, and MSM of color at substantial 
risk of HIV acquisition should be offered PrEP when indicated by the 
risk assessment.
    There are a total of 24 required HIV prevention and care services 
that must be provided by the health department collaborative for this 
project, 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, ARV 
treatment, and partner services for those diagnosed with acute HIV 
infection; (6) Expedient linkage to care, ARV 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; and (13) 
Navigators to assist enrollment in a health plan.
    HIV care services include: (1) HIV primary care, including 
antiretroviral (ARV) 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; and (11) Navigators to assist 
enrollment in a health plan.
    CDC HIV program grantees will collect, enter or upload, and report 
agency-identifying information, budget data, information on HIV 
prevention and care services, and client demographic characteristics. 
The total annual burden hours are 1,534 hours. There are no other costs 
to respondents other than their time.

[[Page 65396]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondent                    Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
THRIVE Partners.......................  Monitoring and                        80               2               9
                                         Evaluation 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                         7               2               1
                                         Evaluation 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                     7               1           20/60
                                         Report.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-25746 Filed 11-26-19; 8:45 am]
BILLING CODE 4163-18-P