Establishing a Road Map for Accelerated Diagnosis and Treatment of HCV Infection in the United States, 1497-1499 [2025-00204]
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<![CDATA[
1497
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
National Program of Cancer Registries
Cancer Surveillance System (OMB
Control No. 0920–0469, Exp. 1/31/
2026)—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 2021, the most recent year for
which complete incidence information
is available, almost 620,000 people died
of cancer and more than 1.8 million
were diagnosed with cancer. It is
estimated that 17 million Americans are
currently alive with a history of cancer.
In the U.S., State/Territory-based central
cancer registries (CCR) are the only
method for systematically collecting and
reporting population-based information
about cancer incidence and outcomes
such as survival. These data are used to
measure the changing incidence and
burden of each cancer; identify
populations at increased or increasing
risk; target preventive measures; and
measure the success or failure of cancer
control efforts in the United States.
In 1992, Congress passed the Cancer
Registries Amendment Act which
established the National Program of
Cancer Registries (NPCR). The NPCR
provides support for State/Territorybased cancer registries that collect,
for state and national cancer control and
prevention. In addition, datasets can be
made available for secondary analysis.
Respondents are NPCR-supported
CCRs in 46 U.S. States, three Territories,
and the District of Columbia. Fifty CCRs
submit data elements specified for the
Standard NPCR CSS Report. Each CCR
is asked to transmit two data files to
CDC per year. The first NPCR CSS
Standard file, submitted in January, is a
preliminary report consisting of one
year of data for the most recent year of
available data. CDC evaluates the
preliminary data for completeness and
quality and provides a report back to the
CCR. The second NPCR CSS Standard
file, submitted in November, contains
cumulative cancer incidence data from
the first diagnosis year for which the
cancer registry collected data with the
assistance of NPCR funds (e.g., 1995)
through 12 months past the close of the
most recent diagnosis year (e.g., 2022).
The cumulative file is used for analysis
and reporting. The burden for each file
transmission is estimated at two hours
per response. Because cancer incidence
data are already collected and
aggregated at the state level, the
additional burden of reporting the
information to CDC is small.
All information is transmitted to CDC
electronically. Participation is required
as a condition of the cooperative
agreement with CDC. CDC requests
OMB approval for an estimated 200
annual burden hours. There are no costs
to respondents except their time.
manage, and analyze data about cancer
cases. The State/Territory-based cancer
registries report information to CDC
through the National Program of Cancer
Registries Cancer Surveillance System
(NPCR CSS), (OMB Control No. 0920–
0469). CDC plans to request OMB
approval to continue collecting this
information for three years. Data
definitions will be updated to reflect
changes in national standards for cancer
diagnosis and coding. No changes to the
total estimated annualized burden hours
or number of respondents are
anticipated.
The NPCR CSS allows CDC to collect,
aggregate, evaluate, and disseminate
cancer incidence data at the national
level. The NPCR CSS is the primary
source of information for the United
States Cancer Statistics (USCS), which
CDC has published annually since 2002.
The latest USCS report published in
2024 provided cancer statistics for 98%
of the U.S. population from all cancer
registries in the United States. Prior to
the publication of USCS, cancer
incidence data at the national level were
available for only 14% of the population
of the United States. The NPCR CSS also
allows CDC to monitor cancer trends
over time, describe geographic variation
in cancer incidence throughout the
country, and provide incidence data on
populations by race, ethnicity, and other
demographic and tumor characteristics
and data on rare cancers. These
activities and analyses further support
CDC’s planning and evaluation efforts
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Total burden
(in hours)
Form name
Central Cancer Registries in States,
Territories, and the District of Columbia.
Standard NPCR CSS Report ...........
50
2
2
200
Total ...........................................
...........................................................
........................
........................
........................
200
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
ACTION:
Centers for Disease Control and
Prevention
SUMMARY:
[Docket No. CDC–2025–0002]
BILLING CODE 4163–18–P
Establishing a Road Map for
Accelerated Diagnosis and Treatment
of HCV Infection in the United States
Centers for Disease Control and
Prevention, Health, and Human Services
(HHS).
AGENCY:
VerDate Sep<11>2014
17:50 Jan 07, 2025
Jkt 265001
Notice of public meeting and
request for comment.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2025–00163 Filed 1–7–25; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
Average
burden per
response
(in hours)
Type of respondents
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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)
E:\FR\FM\08JAN1.SGM
08JAN1
1498
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices
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.
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-2025meeting/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: https://
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 https://regulations.gov, including any
personal information provided. For
access to the docket to read background
lotter on DSK11XQN23PROD with NOTICES1
DATES:
VerDate Sep<11>2014
17:50 Jan 07, 2025
Jkt 265001
documents or comments received, go to
https://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:
dvhpolicy@cdc.gov.
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)
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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-2021Meeting-Report.pdf).
Subsequent to the APHL-led meeting:
D 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.
E:\FR\FM\08JAN1.SGM
08JAN1
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices
D In January 2024, CDC affirmed
existing viral-first testing
recommendations among people with
recent HCV exposure (https://
www.cdc.gov/hepatitis-c/hcp/diagnosistesting/#:∼:text=HCV%20RNA%20
testing%20for,a%20
syringe%20service%20program);
D 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
D In June 2024, the FDA authorized
an HCV RNA CLIA-waived near pointof-care test for the diagnosis of current
HCV infection.
lotter on DSK11XQN23PROD with NOTICES1
Public Participation and Public
Comment
Public engagement will entail listenonly 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
VerDate Sep<11>2014
17:50 Jan 07, 2025
Jkt 265001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–25–24FS]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Needle
Exchange Utilization Survey (NEXUS)’’
to the Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on May 28, 2024, to obtain
comments from the public and affected
agencies. CDC received one comment
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
1499
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Needle Exchange Utilization Survey
(NEXUS)—New—National Center for
HIV, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The opioid crisis in the U.S. has led
to steep increases in overdose, Hepatitis
C Virus (HCV) incidence, and HIV
clusters and outbreaks among people
who inject drugs (PWID). These
alarming trends indicate an urgent need
to strengthen interventions to prevent
morbidity and mortality and
transmission of infectious disease
among PWID. Syringe services programs
(SSPs) are evidence-based, highly
effective prevention programs that have
expanded in many areas in the United
States to respond to the increasing
needs of providing HIV and HCV
prevention and other health and social
services to PWID and their
communities. Due to an increase in HCV
and HIV related to injection drug use
(IDU), it is now critical to understand
current patterns of IDU for the
prevention of these infectious diseases
and other injection related harms. Data
to inform these prevention efforts are
needed nationally, particularly from
non-urban settings that have
experienced increases in IDU and where
current surveillance activities are nonexistent or limited.
The purpose of the Needle Exchange
Utilization Survey (NEXUS) is to
develop a surveillance system to
monitor drug use, prevention behaviors,
and the infectious disease consequences
of drug use in 6–15 select urban and
non-urban areas of the U.S. that the
opioid crisis has impacted. Such a
surveillance system is needed to inform
prevention efforts and policy. The
specific objectives of the project are to
assess the following among persons who
inject drugs who are recruited in SSPs
and their peers who use drugs through
peer-driven recruitment: (1) drug use
and sexual behaviors, injection risk
networks, receipt of prevention services,
and barriers to prevention and care; and
(2) the prevalence of HIV and HCV
infections.
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 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: 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
