[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
               Type of respondent                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           1,543
--------------------------------------------------------------------------------------------------------------------------------------------------------


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]
BILLING CODE 4163-18-P