[Federal Register Volume 86, Number 159 (Friday, August 20, 2021)]
[Notices]
[Pages 46852-46854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17863]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21HI; Docket No. CDC-2021-0086]


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 Red Carpet Entry (RCE) Program 
Implementation Project. This study will prepare for, implement, and 
evaluate an implementation model of linkage and reengagement to HIV 
care via a toolkit.

DATES: CDC must receive written comments on or before October 19, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0086 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    <bullet> 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: 404-639-7118; Email: 
<a href="/cdn-cgi/l/email-protection#95faf8f7d5f6f1f6bbf2fae3"><span class="__cf_email__" data-cfemail="3956545b795a5d5a175e564f">[email protected]</span></a>.

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

[[Page 46853]]

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;
    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; and
    5. Assess information collection costs.

Proposed Project

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

Background and Brief Description

    This project 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 DC Department of Health's HIV/AIDS, Hepatitis, 
STD, and TB Administration, Red Carpet Entry (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. 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 approval for an estimated 125 annual 
burden hours. There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                          Number of      Average
                                                            Number of     responses    burden per   Total burden
        Type of respondents               Form name        respondents       per      response (in      hours
                                                                         respondent      hours)
----------------------------------------------------------------------------------------------------------------
RCE Clients.......................  Screener............           180             1          5/60            15
RCE Implementation Staff..........  Staff Survey--                   8             1         15/60             2
                                     Preparation Phase.
RCE Implementation Staff..........  Staff Survey--                   8             3         15/60             6
                                     Implementation
                                     Phase (months
                                     1,3,5).
RCE Implementation Staff..........  Staff Survey--                   8             3         15/60             6
                                     Implementation
                                     Phase (months
                                     2,4,6).
RCE Implementation Staff..........  Staff Interview                  8             1             1             8
                                     Guide--Preparation
                                     Phase.
RCE Implementation Staff..........  Staff Interview                  8             3         30/60            12
                                     Guide-Implementatio
                                     n Phase (months
                                     1,3,5).
RCE Implementation Staff..........  Staff Interview                  8             3         30/60            12
                                     Guide-Implementatio
                                     n Phase (months
                                     2,4,6).
Clinic Leadership.................  Clinic Leadership                2             1         30/60             1
                                     Interview Guide.
                                    Labor Cost                       6             4           1.5            36
                                     Questionnaire.
                                    Non-Labor Cost                   2             9           1.5            27
                                     Questionnaire.
                                                         -------------------------------------------------------
    Total.........................  ....................  ............  ............  ............           125
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[[Page 46854]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-17863 Filed 8-19-21; 8:45 am]
BILLING CODE 4163-18-P


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