[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
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
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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.
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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