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###### Department of Health and Human Services

###### Centers for Disease Control and Prevention

          - [Docket No. CDC-2024-0100]

# AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

# ACTION:

Notice.

# 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:                         *nchhstppolicy@cdc.gov.*                         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                           ( print 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]

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