[Federal Register Volume 87, Number 64 (Monday, April 4, 2022)]
[Notices]
[Pages 19516-19517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07050]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     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 http://regulations.gov, 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 http://www.regulations.gov.

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: [email protected].

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:
     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.
     Are CDC's Proposed Updated Recommendations (see Supporting 
and Related Materials) clearly written? If not, what changes do you 
propose to make them clearer?
     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 https://www.regulations.gov. 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