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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 [www.gpo.gov]
[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.
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     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 https://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to https://www.regulations.gov.

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: 
[email protected]. 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 regulations.gov 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:
     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.
     Are CDC's proposed recommendations for HIV screening in 
clinical settings clearly written? If not, what changes do you propose 
to make it clearer?
     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.
     How should CDC disseminate the final recommendations to 
effectively reach end users such as healthcare providers in clinical 
settings?
     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 https://www.regulations.gov. 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 https://www.cdc.gov/hiv/guidelines/testing.html. The final 
recommendations will also be posted to docket CDC-2024-0100 at 
www.regulations.gov.

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

[[Page 95794]]

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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