[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57733-57734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23521]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2019-0094]
Recommendations for Hepatitis C Screening Among Adults--2019;
Request for Comment
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice and request for comment.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the Department of Health and Human Services announces the opening of a
public docket to obtain public comment on proposed new recommendations
for hepatitis C virus (HCV) infection screening for adults, including
pregnant women. The new recommendations are intended for U.S.
healthcare providers and will include supporting scientific evidence of
the effectiveness and
[[Page 57734]]
economic value of screening to diagnose current HCV infection among
adults and pregnant women in the United States.
DATES: Written comments must be received on or before December 27,
2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0094 by any 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-2019-0094.
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: CDR Sarah Schillie, MD, MPH, MBA,
Centers for Disease Control and Prevention, 1600 Clifton Road NE,
Mailstop U12-3, Atlanta, GA 30329. Email: [email protected]. Telephone:
(404) 639-8000.
SUPPLEMENTARY INFORMATION:
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:
Based on the evidence presented in the full
recommendations document (see the Supporting and Related Materials tab
in the docket), do you agree with CDC's proposed recommendations for
HCV infection screening? If not, please state the reason why and, if
available, provide additional evidence for consideration.
Are CDC's recommendations (see Supporting and Related
Materials) clear as written? If not, what changes do you propose to
make them clearer?
If implemented as proposed, do you believe these
recommendations would result in a reduction in HCV infections and
associated health and financial consequences in the United States? If
not, please provide an explanation.
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. CDC will
carefully consider all comments submitted in preparation of the final
recommendation and may revise as appropriate.
Background and Brief Description
Hepatitis C Virus (HCV) infection is the most commonly reported
blood-borne infection in the United States (CDC Viral Hepatitis
Surveillance, 2019; Rosenberg et al, 2018), and during 2013-2016 there
were an estimated 2.4 million people in the nation (or 1.0% of the U.S.
population) living with hepatitis C (Hofmeister et al, 2019).
Percutaneous exposure (e.g., injection drug use, blood transfusion) is
the most efficient mode of HCV transmission, and injection drug use is
the primary risk factor for infection (CDC Viral Hepatitis
Surveillance, 2017). National surveillance data reveal an increase in
reported cases of acute HCV infection every year from 2009 through
2017, the most recent year for which there is data. The highest rates
of acute cases are among persons aged 20-39 years (CDC Viral Hepatitis
Surveillance, 2017). As new HCV infections have risen among
reproductive aged adults, rates of HCV infection nearly doubled from
2009-2014 among women with live births (Patrick et al, 2017). In 2015,
0.38% of live births were delivered by HCV-infected women (Schillie et
al, 2018). Given the current rate and trends of HCV infections, CDC has
decided to augment the current guidelines to address the rise in HCV
infections among adults in the U.S.
As described in the recommendation document found in the Supporting
and Related Materials tab of the docket, these recommendations augment
previously published CDC recommendations for the identification of
hepatitis C in the United States (Smith et al, 2012; CDC HCV
Recommendations, 1998).
Dated: October 23, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-23521 Filed 10-25-19; 8:45 am]
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