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[Federal Register Volume 90, Number 5 (Wednesday, January 8, 2025)]
[Notices]
[Pages 1497-1499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00204]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2025-0002]

Establishing a Road Map for Accelerated Diagnosis and Treatment 
of HCV Infection in the United States

AGENCY: Centers for Disease Control and Prevention, Health, and Human 
Services (HHS).

ACTION: Notice of public meeting and request for comment.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) announces 
a two-day convening hosted and facilitated by the Association of Public 
Health Laboratories (APHL) to discuss hepatitis C diagnostics. Leaders 
from public health, laboratory, medical, academic, and industry sectors 
will have the opportunity to provide individual input, without building 
a consensus, on accelerating the diagnosis of current hepatitis C virus 
(HCV)

[[Page 1498]]

infection. Members of the public with interest and expertise in 
diagnosing HCV infection are also invited to provide individual input. 
Specifically, the convening will focus on how to leverage the following 
hepatitis C diagnostic methods: same-day diagnosis and treatment, and 
viral-first testing. The goal of the convening will be for each person 
to give their individual input, and not to build consensus. No 
discussions, recommendations, or advice to CDC will occur or be 
provided at the meeting. Day 1 will focus on the utility of point-of-
care (POC) testing for accelerating same-day HCV diagnosis and rapid 
treatment i.nitiation. Day 2 will focus on the utility of viral-first 
testing strategies for accelerating HCV diagnosis and treatment 
initiation in the United States. Following the meeting, APHL will 
prepare a meeting report summarizing the discussion and public comment 
received through regulations.gov, developed and documented as 
individual input to ensure thorough and complete input from partners. 
CDC and APHL will disseminate the APHL-prepared report as a reference 
for partners and industry to follow in developing and implementing 
future hepatitis C testing strategies. The final report will be added 
to docket CDC-2025-0002 once it is available.

DATES: Written comments must be received on or before February 19, 
2025.
    Times: February 11-12, 2025, 1:00-5:00 p.m. EST.
    Place: Virtual Meeting.
    To register for this virtual meeting on the public line (listen-
only access), please use the following link: https://webster.eventsair.com/hepatitis-2025-meeting/hcvattendee.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0002 by either of the methods listed below. Do not submit comments by 
email. CDC does not accept comments by email.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Office of Policy and Communications, Division of 
Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, 
and TB Prevention, Centers for Disease Control and Prevention, 1600 
Clifton Road, MS US12-3 Atlanta, GA 30329-4018.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Maxwell R. Rowshandel, Office of 
Policy and Communications, Division of Viral Hepatitis, National Center 
for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for 
Disease Control and Prevention, 1600 Clifton Road, MS US12-3 Atlanta, 
GA 30329-4018, phone: 1 (202) 245-0627, email: [email protected].

SUPPLEMENTARY INFORMATION: CDC announces a convening to discuss 
hepatitis C diagnostics. Interested parties are invited to provide 
public comment on regulations.gov in Docket CDC-2025-0002 on or before 
February 19, 2025.

Background

    More than 2.4 million adults in the United States are estimated to 
have hepatitis C virus (HCV) infection [Eric H, Hepatology 2024]. New 
infections continue to increase, primarily in association with 
injection drug use; nearly 67,400 cases of acute hepatitis C are 
estimated to have occurred in 2022 [CDC 2022 VH Surv Rpt]. More than 
half of new infections progress to chronic infection [Seo S, Clin 
Gastro Hepatol 2020]. Without treatment, HCV infection can lead to 
advanced liver disease, liver cancer, and death [Liang TF, Ann Intern 
Med 2000]. Since 2013, safe and effective treatment has been available 
that cures more than 95% of all treated persons, prevents future health 
complications, stops further transmission, and allows for the 
possibility of hepatitis C elimination [Falade-Nwulia O, Ann Intern Med 
2017].
    Testing is the first step to accessing life-saving treatment; 
however, about one-third of people with hepatitis C in the United 
States are unaware of their infection [Lewis KC, CID 2024]. The Centers 
for Disease Control and Prevention (CDC) recommends hepatitis C 
screening for all adults at least once, all pregnant persons during 
every pregnancy, and all persons with risk for HCV infection, including 
periodic testing if risk persists [Schillie S, MMWR Recomm Rep 2020]. 
Current testing guidance for clinicians and laboratorians begins with a 
hepatitis C antibody (anti-HCV) test followed, when reactive, by a 
nucleic acid test (NAT) to detect HCV RNA to diagnose current infection 
[CDC MMWR 2013]. Updated operational guidance was provided to ensure 
completion of the two-step approach using specimens collected during a 
single patient encounter. (Cartwright EJ, MMWR 2023)
    A limitation of the antibody-first hepatitis C testing approach is 
that it takes an average of 7 to 8 weeks after HCV infection to develop 
a reactive HCV antibody (Abdel-Hamid M, Clin Micro 2002). Therefore, 
the current testing sequence fails to diagnose HCV infection in the 
window-phase/early acute phase, within the first 6 months following 
infection, and among immunocompromised people who may have delayed 
seroconversion. Fortunately, advancements in the diagnostic and 
regulatory landscape have created an opportunity to improve hepatitis C 
testing. Currently, there are two tests for viral markers that identify 
current HCV infection: (1) real-time (RT) polymerase chain reaction 
(PCR) testing of HCV ribonucleic acid (RNA) detects virus within 1 to 2 
weeks of infection (Gowda C, Clin Infect Dis 2020); and (2) HCV core 
antigen (HCVcAg) testing, currently approved outside of the United 
States, that uses an immunoassay to detect HCV core antigen within 2 to 
3 weeks of infection (Sepulveda-Crespo D, Rev Med Virol 2023). Such 
virologic tests have become faster to perform and more accessible in a 
variety of care settings including closer to the point-of-care.
    With CDC support, the Association of Public Health Laboratories 
(APHL) held a 2-day convening of key stakeholders and subject matter 
experts in October 2021 to identify high-priority diagnostic tools 
needed to advance diagnosis of current HCV infection and linkage to 
treatment in a range of clinical and nonclinical settings. The 
published meeting report called for the US Food and Drug Administration 
(FDA) to reclassify HCV diagnostic tests from class III to class II, 
supported the availability of an FDA-cleared rapid CLIA-waived point-
of-care (POC) HCV viral detection test, and encouraged CDC to review 
and update recommendations for HCV testing to identify current HCV 
infection, including testing sequences that detect HCV viral markers in 
the first step. (https://www.aphl.org/aboutAPHL/publications/Documents/ID-HCV-2021-Meeting-Report.pdf).
    Subsequent to the APHL-led meeting:
    [ssquf] In November 2021, the FDA reclassified hepatitis C 
diagnostic tests from class III devices to class II devices with 
special controls (510k), providing a new, lower-barrier opportunity for 
manufacturers to introduce new hepatitis C diagnostic tools for FDA 
review, including tests that were available at that time outside of the 
United States, such as a nucleic acid test (NAT) for HCV RNA detection 
in a POC format and an assay for HCVcAg.

[[Page 1499]]

    [ssquf] In January 2024, CDC affirmed existing viral-first testing 
recommendations among people with recent HCV exposure (https://
www.cdc.gov/hepatitis-c/hcp/diagnosis-testing/
#:~:text=HCV%20RNA%20testing%20for,a%20syringe%20service%20program);
    [ssquf] In January 2024, CDC began the process of updating HCV 
testing guidance for clinicians and laboratorians, including evaluating 
testing strategies for the general population that include tests for 
viral markers in the first testing step (e.g., ``viral-first''); and
    [ssquf] In June 2024, the FDA authorized an HCV RNA CLIA-waived 
near point-of-care test for the diagnosis of current HCV infection.

Public Participation and Public Comment

    Public engagement will entail listen-only observation of 
information shared on day 1 and day 2. If members of the public have 
input on the questions asked during the meeting, those public comments 
can be collected through regulations.gov using Docket CDC-2025-0002 on 
or before February 19, 2025, and will be included in the final meeting 
report. Written comments must be submitted on or before February 19, 
2025.
    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.

Noah Aleshire,
Chief Regulatory Officer, Centers for Disease Control and Prevention.
[FR Doc. 2025-00204 Filed 1-7-25; 8:45 am]
BILLING CODE 4163-18-P
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