[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40059-40060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17291]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-19-1178; Docket No. CDC-2019-0065]
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.
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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 the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Comprehensive HIV Prevention and
Care for Men Who Have Sex with Men of Color. This study is designed to
support state and local health departments to develop and implement
demonstration projects for provision of comprehensive human
immunodeficiency virus (HIV) prevention and care services for men who
have sex with men (MSM) of color by creating a collaborative with
community based organizations (CBOs), clinics and other health care
providers, and behavioral health and social services providers in their
jurisdiction.
DATES: CDC must receive written comments on or before October 15, 2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0065 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all 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 Jeffrey M. Zirger, 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].
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 the 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
Comprehensive HIV Prevention and Care for Men Who Have Sex With Men
of Color (OMB Control No. 0920-1178, Exp. 4/30/2020)--Extension--
National
[[Page 40060]]
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.
Achieving these outcomes requires that men utilize a broad variety
of HIV prevention and care services. The continuum of HIV prevention
services includes HIV testing, offering HIV-negative men at risk for
acquiring HIV infection biomedical interventions such as preexposure
prophylaxis (PrEP) or postexposure prophylaxis (PEP), prescribing the
medications needed for PrEP or PEP, adhering to these medications as
prescribed, returning for follow-up visits to support adherence, and
monitoring potential medication side effects. Lab-based Antigen/
Antibody HIV testing is recommended because it is the most sensitive
HIV diagnostic test, allowing acute HIV infection to be diagnosed, and
allowing health departments to prioritize initiation of treatment early
in the course of infection to improve long-term health outcomes and
prevent secondary HIV transmission. State and local health departments
are authorized to provide HIV testing, prevention, and care services,
and are essential partners in carrying out Thrive's programmatic goals.
The continuum of HIV care services includes HIV testing and notifying
HIV-positive men of their results, linking HIV-positive men to their
initial HIV clinic visit, prescribing antiretroviral medications to
treat HIV infection, adhering to antiretroviral medications, being
retained or re-engaged in care, and achieving HIV viral suppression.
These services will be provided by a community collaborative led by
the health department, which consists of several partners: Community-
based organizations (CBOs), healthcare providers, behavioral healthcare
providers, and social service providers. But, because of the fragmented
nature of U.S. healthcare system, and the independent management and
diverse funding streams and administration of each collaborative
member, the health departments will need to work cooperatively with CDC
to form and sustain this collaborative and to provide technical
assistance and support for them to deliver high quality HIV prevention
and care services to men who require them. CDC needs to understand
facilitators and barriers to developing and sustaining a community
collaborative to guide the technical assistance it provides to the
collaborative so it can optimally deliver all of the required HIV
prevention and care services to all men who require them.
Because many of the service providers in the collaborative are not
part of the health department organizational structure or co-located
within a health department facility or clinic, the health departments
will support navigators to help MSM of color to utilize all of the
services. In order to provide technical assistance to ensure effective
navigation models, CDC must understand the characteristics of the
various models; how they integrate service utilization within the
collaborative structure, and the number of men who they assist in
utilizing services. CDC requests approval for 1,543 annual burden
hours. There are no other costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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THRIVE Partners................................ Monitoring and Evaluation Data Elements 80 2 9 1,440
on HIV Prevention and Care Services.
Qualitative Interview: Collaborative 80 1 40/60 53
Process Evaluation.
Collaborative Assessment Tool.......... 80 1 20/60 27
THRIVE Awardees................................ Monitoring and Evaluation Data Elements 7 2 1 14
on HIV Prevention and Care Services.
Qualitative Interview: Collaborative 7 1 40/60 5
Process Evaluation.
Collaborative Assessment Tool.......... 7 1 20/60 2
Funding Allocation Report.............. 7 1 20/60 2
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Total...................................... ....................................... .............. .............. .............. 1,543
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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. 2019-17291 Filed 8-12-19; 8:45 am]
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