Notice2022-07050
CDC Recommendations for Hepatitis B Screening and Testing-United States, 2022; Request for Comment
Primary source
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Published
April 4, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on proposed updated recommendations for hepatitis B virus (HBV) infection screening and testing (Proposed Updated Recommendations), including hepatitis B screening at least once in a lifetime for persons 18 years of age and older, using a three-test panel. The Proposed Updated Recommendations also expand existing risk-based testing recommendations to include the following populations, activities, exposures, or conditions associated with increased risk for HBV infection: Persons currently or formerly incarcerated in a jail, prison, or other detention setting; persons with a history of sexually transmitted infections or multiple sex partners; and persons with a history of hepatitis C virus infection. The Proposed Updated Recommendations are intended to inform the practices of and care by U.S. healthcare providers and are based on scientific evidence of the effectiveness and economic value of screening to diagnose current HBV infection among adults in the United States.
Full Text
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<title>Federal Register, Volume 87 Issue 64 (Monday, April 4, 2022)</title>
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[Federal Register Volume 87, Number 64 (Monday, April 4, 2022)]
[Notices]
[Pages 19516-19517]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07050]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2022-0044]
CDC Recommendations for Hepatitis B Screening and Testing--United
States, 2022; Request for Comment
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), announces the
opening of a docket to obtain comment on proposed updated
recommendations for hepatitis B virus (HBV) infection screening and
testing (Proposed Updated Recommendations), including hepatitis B
screening at least once in a lifetime for persons 18 years of age and
older, using a three-test panel. The Proposed Updated Recommendations
also expand existing risk-based testing recommendations to include the
following populations, activities, exposures, or conditions associated
with increased risk for HBV infection: Persons currently or formerly
incarcerated in a jail, prison, or other detention setting; persons
with a history of sexually transmitted infections or multiple sex
partners; and persons with a history of hepatitis C virus infection.
The Proposed Updated Recommendations are intended to inform the
practices of and care by U.S. healthcare providers and are based on
scientific evidence of the effectiveness and economic value of
screening to diagnose current HBV infection among adults in the United
States.
DATES: Written comments must be received on or before June 3, 2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0044, by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> Mail: Division of Viral Hepatitis, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, Mailstop U12-3, Atlanta,
GA 30329, Attn: Docket No. CDC-2022-0044.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to <a href="http://regulations.gov">http://regulations.gov</a>, including any personal
information provided. Do not submit comments by email; CDC does not
accept comments by email. For access to the docket to read background
documents or comments received, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Erin Conners, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, Mailstop U12-3, Atlanta,
GA 30329; Telephone: 404-639-8000; Email: <a href="/cdn-cgi/l/email-protection#5410021c243b383d372d143730377a333b22"><span class="__cf_email__" data-cfemail="6d293b251d0201040e142d0e090e430a021b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data related to any of
the Proposed Updated Recommendations or supporting evidence. In
addition, CDC invites comments specifically on the following questions:
<bullet> Based on the evidence presented in the full
recommendations document (see the Supporting and Related Materials tab
in the docket), does the evidence support the Proposed Updated
Recommendations for HBV infection screening and testing? If not, please
state the reason why and, if available, provide additional evidence for
consideration.
<bullet> Are CDC's Proposed Updated Recommendations (see Supporting
and Related Materials) clearly written? If not, what changes do you
propose to make them clearer?
<bullet> If implemented as currently drafted, do you believe the
Proposed Updated Recommendations would result in a reduction in HBV
infections and associated health and financial consequences (e.g.,
patient and healthcare costs to treat chronic hepatitis B) in the
United States? If not, please provide an explanation and supporting
data or evidence.
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
[[Page 19517]]
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 comments by email.
Background and Brief Description
Hepatitis B virus (HBV) is transmitted via blood or sexual contact.
Persons with chronic HBV infection are at increased risk for cirrhosis
and liver cancer and require medical care (Schillie et al., 2018).
National health survey data indicate that about 880,000 people were
living with HBV infection in the United States during 2013-2018, with
modeled data putting that estimate at 1.89 million (Roberts, Ly, et
al., 2021; Wong et al., 2021). Testing is the first step in accessing
treatment, but an estimated two-thirds of people living with hepatitis
B in the United States during 2013-2018 were unaware of their HBV
infection (Kim et al., 2013). Despite the availability of highly
effective hepatitis B vaccines that can prevent development of
subsequent acute and chronic liver disease, 70 percent of adults in the
United States self-reported they were unvaccinated as of 2018 (Lu et
al., 2021). National surveillance data reveal that during 2011-2019,
rates of reported acute hepatitis B steadily increased among persons
aged 40-49 and 50-59 years (CDC Viral Hepatitis Surveillance, 2021).
Among the acute HBV cases reported to CDC in 2019, injection drug use
was the most common risk factor (CDC Viral Hepatitis Surveillance,
2021). Rates of newly reported chronic hepatitis B were highest among
persons aged 30-49 years, Asian/Pacific Islander persons, and Black/
African American persons in 2019 (CDC Viral Hepatitis Surveillance,
2021). Providing a framework to reach the World Health Organization
(WHO) viral hepatitis elimination goals, the Viral Hepatitis National
Strategic Plan for the United States calls for an increase in the
proportion of people with HBV infection who are aware of their
infection from a baseline of 32 percent during 2013-2016 to 90 percent
by 2030 (Department of Health and Human Services, 2020). In support of
this goal, CDC used current evidence to update its previous 2008
recommendations for testing and management for people with chronic
hepatitis B in the United States.
As described in the recommendation document found in the Supporting
and Related Materials tab of the docket, these recommendations
supplement previously published CDC recommendations for testing and
identifying persons with chronic HBV infection in the United States
published in 2008 (Weinbaum et al., 2008). They do so by adding
hepatitis B screening at least once in a lifetime for persons aged 18
years of age and older and specifying the use of the three-test panel
during screening to identify persons who: (1) Have a current HBV
infection, (2) have resolved infection and who may be susceptible to
reactivation, (3) are susceptible and need vaccination, or (4) are
vaccinated.
Dated: March 30, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-07050 Filed 4-1-22; 8:45 am]
BILLING CODE 4163-18-P
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