Notice2021-17863
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 20, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 159 (Friday, August 20, 2021)</title>
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[Federal Register Volume 86, Number 159 (Friday, August 20, 2021)]
[Notices]
[Pages 46852-46854]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="http://Regulations.gov">Regulations.gov</a>. 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 <a href="http://Regulations.gov">Regulations.gov</a>.
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
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Number of Average
Number of responses burden per Total burden
Type of respondents Form name respondents per response (in hours
respondent hours)
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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.
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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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