Notice2024-28294
Draft CDC's Recommendations for HIV Screening in Clinical Settings
Primary source
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Published
December 3, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention in the Department of Health and Human Services announces the opening of a docket to obtain comment on the draft Recommendations for HIV Screening in Clinical Settings, that update portions of CDC's "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings," published in 2006.
Full Text
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<title>Federal Register, Volume 89 Issue 232 (Tuesday, December 3, 2024)</title>
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[Federal Register Volume 89, Number 232 (Tuesday, December 3, 2024)]
[Notices]
[Pages 95793-95794]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28294]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2024-0100]
Draft CDC's Recommendations for HIV Screening in Clinical
Settings
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Centers for Disease Control and Prevention in the
Department of Health and Human Services announces the opening of a
docket to obtain comment on the draft Recommendations for HIV Screening
in Clinical Settings, that update portions of CDC's ``Revised
Recommendations for HIV Testing of Adults, Adolescents, and Pregnant
Women in Health-Care Settings,'' published in 2006.
DATES: Written comments must be received on or before January 2, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0100 by either of the methods listed below. Do not submit comments by
email. CDC does not accept comments by email.
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> Mail: National Center for HIV, Viral Hepatitis, STD, and
TB Prevention, CDC, 1600 Clifton Road NE, Mailstop U.S. 8-6, Atlanta,
GA 30329-4027.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to <a href="https://regulations.gov">https://regulations.gov</a>, including any personal
information provided. For access to the docket to read background
documents or comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Cecily Campbell, National Center for
HIV, Viral Hepatitis, STD, and TB Prevention, CDC, 1600 Clifton Road
NE, Mailstop U.S. 8-6, Atlanta, GA 30329-4027, Email:
<a href="/cdn-cgi/l/email-protection#abc5c8c3c3d8dfdbdbc4c7c2c8d2ebc8cfc885ccc4dd"><span class="__cf_email__" data-cfemail="fc929f94948f888c8c9390959f85bc9f989fd29b938a">[email protected]</span></a>. Office phone: 404-639-0485.
SUPPLEMENTARY INFORMATION: CDC is requesting public comment on the
draft ``Recommendations for HIV Screening in Clinical Settings,'' which
is available on <a href="http://regulations.gov">regulations.gov</a> in Docket CDC-2024-0100. These
recommendations modify the ages for HIV screening including eliminating
an upper age limit, encourage providers to use clinical decision
support tools such as automated HIV test laboratory orders to implement
HIV screening, provide considerations for healthcare populations on
which to conduct HIV screening, recommend anyone who requests a test
should be tested, and emphasize the use of a general consent process as
used for other routine tests. CDC describes the methods and supporting
evidence in the recommendations. The recommendations' objectives are to
diagnose and link patients with undiagnosed infection to clinical care;
relink persons with previously diagnosed HIV to clinical care; diagnose
HIV infection earlier; and reduce HIV transmission in the United
States.
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data. In addition, CDC
invites comments specifically on the following questions proposed in
this document:
<bullet> Does the evidence presented support the proposed
recommendations for HIV screening in clinical settings, including the
benefits and harms of HIV screening? If not, please state the reason
why and, if available, provide additional evidence for consideration.
<bullet> Are CDC's proposed recommendations for HIV screening in
clinical settings clearly written? If not, what changes do you propose
to make it clearer?
<bullet> If implemented as currently drafted, do you believe these
recommendations would improve HIV screening in clinical settings,
improve diagnoses and linking patients with undiagnosed infection to
clinical care; relinking persons with previously diagnosed HIV to
clinical care; diagnosing HIV infection earlier; and reducing HIV
transmission in the United States? If not, please provide an
explanation and supporting data or evidence.
<bullet> How should CDC disseminate the final recommendations to
effectively reach end users such as healthcare providers in clinical
settings?
<bullet> After the recommendations are finalized, CDC is planning
to publish an implementation guide for healthcare providers to
supplement the updated recommendations. What should the implementation
guide include?
Please note that comments received, including attachments and other
supporting materials, are part of the public record and are subject to
public disclosure. Comments will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Therefore, do not include any information in your
comment or supporting materials that you consider confidential or
inappropriate for public disclosure. If you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be on public display. CDC will
review all submissions and may choose to redact, or withhold,
submissions containing private or proprietary information such as
Social Security numbers, medical information, inappropriate language,
or duplicate/near duplicate examples of a mass-mail campaign. Do not
submit comments by email. CDC does not accept comment by email.
After the comments received on the draft are considered and
addressed, the final recommendations will be published on CDC's website
at <a href="https://www.cdc.gov/hiv/guidelines/testing.html">https://www.cdc.gov/hiv/guidelines/testing.html</a>. The final
recommendations will also be posted to docket CDC-2024-0100 at
<a href="http://www.regulations.gov">www.regulations.gov</a>.
Background
Human immunodeficiency virus (HIV) is a virus that attacks the
body's immune system. The only way a person can know their HIV status
is by getting tested (CDC, 2024a). While there is no
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cure, people with HIV who get on and stay on effective HIV treatment
can live long, healthy lives and protect their partners (CDC, 2024a).
While the number of persons living with HIV in the United States
has slightly increased from an estimated 1.1 million people at the end
of 2006 to 1.2 million people in 2022, the estimated HIV incidence has
decreased from 48,600 in 2006 to 31,800 in 2022 (Campsmith, Rhodes,
Hall, & Green, 2008; CDC, 2024b; Prejean et al., 2011). There are now
better HIV assays for more accurate diagnosis, improved antiretroviral
treatment, pre-exposure prophylaxis, post-exposure prophylaxis, and
self-testing, which taken together improve the prevention, diagnosis,
and treatment of HIV infections.
In 2006, the CDC published ``Revised Recommendations for HIV
Testing of Adults, Adolescents, and Pregnant Women in Health-Care
Settings,'' (hereafter referred to as 2006 HIV Testing
Recommendations). These guidelines transformed the HIV testing paradigm
in the United States by recommending routine, voluntary HIV screening
among all adults and adolescents between 13-64 years of age unless
prevalence of undiagnosed HIV infection in their patients has been
documented to be less than 0.1%. In addition, it was recommended that
repeat screening of persons not likely to be at high risk for HIV
should be performed based on clinical judgment.
The 2006 HIV Testing Recommendations aimed to normalize HIV
screening. To update the evidence, CDC conducted an in-depth systematic
review and analysis of other data sources using rigorous methods for
guidelines development. CDC obtained input from the public prior to
starting the update process and from internal and external experts at
different points in the process. CDC seeks to engage a diverse range of
perspectives to inform the development of the recommendations, improve
their credibility, and increase the transparency of the process.
CDC invites written comments by the public (any interested persons
or organizations) on the draft HIV screening guideline. These
recommendations will also undergo peer review.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease Control and Prevention.
[FR Doc. 2024-28294 Filed 12-2-24; 8:45 am]
BILLING CODE 4163-18-P
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