[Federal Register Volume 87, Number 59 (Monday, March 28, 2022)]
[Notices]
[Pages 17295-17297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-21HI]


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 Red Carpet Entry (RCE) Program Implementation 
Project 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 20, 
2021 to obtain comments from the public and affected agencies. CDC 
received one comment related to the previous notice. This notice serves 
to allow an additional 30

[[Page 17296]]

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 instruments, call 
(404) 639-7570. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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

    Red Carpet Entry Program Implementation Project--New--National 
Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    This information collection involves original, implementation 
research on the Red Carpet Entry (RCE) program to link persons with HIV 
to care within 72 hours of their diagnosis or their return to care 
after being out of care. Originally developed and implemented in 
Washington, DC by Whitman Walker Health and the D.C. Department of 
Health's HIV/AIDS, Hepatitis, STD, and TB Administration, RCE has been 
shown to successfully and rapidly link people who tested HIV positive 
to an HIV care provider. Evaluations of RCE found that 70% of newly 
diagnosed people were linked to care within 72 hours of their HIV test. 
It was also shown to work for linking people who had fallen out of care 
with an HIV provider. An adapted version of RCE has also been shown to 
improve health outcomes among adolescents and youths in Kenya by 
quickly linking to care. The school-based program increased rates of 
linkage to care from 56.5% to 97.3% and three-month retention in care 
from 66.0% to 90.0%. Based on this, the CDC identified RCE as an 
evidence-informed structural intervention and included it in CDC's 
Compendium of Evidence-based Interventions (EBIs) and Best Practices 
for HIV Prevention.
    Having an evidence-informed intervention like RCE that can be 
disseminated to the broader HIV health care community is important for 
several reasons: (1) Antiretroviral therapy (ART) is the best way to 
manage HIV and reduce transmission; (2) ART initiation is only possible 
when someone enters health care and then is ultimately retained in 
care; and (3) There are few existing evidenced-based structural 
interventions to support this process. This bias in the field of HIV 
interventions stems from a focus on individual behavior change 
interventions to prevent HIV infection. However, as new and effective 
treatments have emerged that reduce the likelihood of HIV transmission, 
HIV clinics and other healthcare settings have emerged as key contexts 
for HIV prevention by making sure that persons with HIV (PWH) have 
immediate access to ART. Therefore, the field has slowly shifted to 
understanding how providers and health systems can be encouraged to 
support PWH to reduce HIV.
    This study will contribute to the field by creating tools to 
support clinics and healthcare settings that want to implement the RCE 
Program to link PWH to care. A toolkit will be created and tested via 
implementing RCE in two clinics, and lessons from the implementation of 
RCE will be used to update the toolkit. The final toolkit will be 
disseminated via CDC's website. Furthermore, because the study also 
evaluates the implementation strategies, outcomes, and context when RCE 
is being used, the study will be able to recommend what is needed to 
implement RCE with fidelity and success and incorporate these insights 
into the toolkit. Finally, because tracking costs are also a part of 
the evaluation, clinics and health systems that are examining potential 
RCE adoption will have material information about what is needed to put 
RCE into practice. An understanding of the actual costs can provide 
important justification for program planners.
    The results of this study will help CDC frame how best to 
disseminate the RCE Program to the broader HIV health care community. 
This is important because only federal agencies like CDC have the 
resources and infrastructure to broadly disseminate EBIs. Broad 
dissemination and uptake of EBIs like RCE can help move population 
rates of HIV suppression which would affect population transmission 
rates. Linkage to care, in an era of biomedical HIV prevention, is a 
prevention linchpin.
    CDC requests OMB approval for an estimated 125 burden hours. There 
are no costs to respondents other than their time to participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
RCE Clients...........................  Screener................             180               1            5/60
RCE Implementation Staff..............  Staff Survey--                         8               1           15/60
                                         Preparation Phase.
RCE Implementation Staff..............  Staff Survey--                         8               3           15/60
                                         Implementation Phase
                                         (months 1, 3, 5).
RCE Implementation Staff..............  Staff Survey--                         8               3           15/60
                                         Implementation Phase
                                         (months 2, 4, 6).
RCE Implementation Staff..............  Staff Interview Guide--                8               1               1
                                         Preparation Phase.

[[Page 17297]]

 
RCE Implementation Staff..............  Staff Interview Guide--                8               3           30/60
                                         Implementation Phase
                                         (months 1, 3, 5).
RCE Implementation Staff..............  Staff Interview Guide--                8               3           30/60
                                         Implementation Phase
                                         (mos 2, 4, 6).
Clinic Leadership.....................  Clinic Leadership                      2               1           30/60
                                         Interview Guide.
RCE Implementation Staff..............  Labor Cost Questionnaire               6               4           90/60
RCE Implementation Staff..............  Non-Labor Cost                         2               9           90/60
                                         Questionnaire.
RCE Implementation Staff..............  RCE Report Card.........               2               3           15/60
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-06435 Filed 3-25-22; 8:45 am]
BILLING CODE 4163-18-P