Notice2023-26422
CDC Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children-United States, 2023
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 1, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability of the final CDC Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children--United States, 2023.
Full Text
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<title>Federal Register, Volume 88 Issue 230 (Friday, December 1, 2023)</title>
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[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 83944-83945]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26422]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2022-0116]
CDC Recommendations for Hepatitis C Testing Among Perinatally
Exposed Infants and Children--United States, 2023
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: General notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), within
the Department of Health and Human Services (HHS), announces the
availability of the final CDC Recommendations for Hepatitis C Testing
Among Perinatally Exposed Infants and Children--United States, 2023.
DATES: The final document was published as an MMWR Reports &
Recommendations on November 3, 2023.
ADDRESSES: The document may be found in the docket at
<a href="http://www.regulations.gov">www.regulations.gov</a>, Docket No. CDC-2022-0116 and at <a href="https://www.cdc.gov/mmwr/volumes/72/rr/rr7204a1.htm?s_cid=rr7204a1_w">https://www.cdc.gov/mmwr/volumes/72/rr/rr7204a1.htm?s_cid=rr7204a1_w</a>.
FOR FURTHER INFORMATION CONTACT: Lakshmi Panagiotakopoulos, 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#4602100e36292a2f253f0625222568212930"><span class="__cf_email__" data-cfemail="91d5c7d9e1fefdf8f2e8d1f2f5f2bff6fee7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In 2021, CDC determined that Recommendations
for Hepatitis C Testing Among Perinatally Exposed Infants and
Children--United States, 2023 constituted influential scientific
information (ISI) that will have a clear and substantial impact on
important public policies and private sector decisions. As such, the
recommendations underwent peer review as required by Part II Section D
of the HHS Information Quality Guidelines (<a href="https://aspe.hhs.gov/hhs-guidelines-ensuring-maximizing-disseminated-information">https://aspe.hhs.gov/hhs-guidelines-ensuring-maximizing-disseminated-information</a>). HHS developed
these guidelines in accordance with the OMB issued Guidelines for
Ensuring and Maximizing the Quality, Objectivity, Utility, and
Integrity of lnformation Disseminated by Federal Agencies, 67 FR 8452
(Feb. 22, 2002) and the Information Quality Act Public Law 106-554,
515(a) (2000). CDC elected to use specialists in the field who were not
involved in the development of the recommendations. CDC solicited
nominations for reviewers from the American Academy of Family
Physicians, American Academy of Pediatrics, American Association for
the Study of Liver Diseases, American College of Obstetricians and
Gynecologists, and the North American Society for Pediatric
Gastroenterology, Hepatology & Nutrition. Six clinicians with expertise
in hepatology, gastroenterology, internal medicine, infectious
diseases, and/or pediatrics provided structured peer reviews.
Specifically, CDC asked reviewers to focus their reviews on the
following criteria:
<bullet> Methodology (studies included in the evidence review, methods
used to assess the evidence, clarity of evidence findings,
identification of limitations or uncertainties)
<bullet> Recommendations (reviewer agreement with CDC's conclusions,
suggestions for clarifying recommendations)
<bullet> Potential impact and implementation (whether implementing
recommendations would improve health outcomes, any resources or tools
that would facilitate implementation)
<bullet> Other comments for CDC consideration
A list of peer reviewers and CDC's responses to peer review
comments are available at CDC's Viral Hepatitis Influential Scientific
Information web page at <a href="https://www.cdc.gov/hepatitis/policy/isireview/index.htm">https://www.cdc.gov/hepatitis/policy/isireview/index.htm</a>.
In addition, on November 22, 2022, CDC published a notice in the
Federal Register (87 FR 71330) to obtain public
[[Page 83945]]
comment on the draft recommendations for hepatitis B screening and
testing. The comment period closed on January 27, 2023. CDC received 22
comments pertaining to the draft recommendations document. Public
comments were received from the general public, health care providers,
advocacy groups, industry, medical professional associations,
thinktanks and a public health department.
Twelve of the comments expressed full support for the
recommendations. Two comments were critical of the approach and
recommended keeping the current recommendation of HCV antibody testing
at age >=18 months. CDC also received comments about: testing infants
and children when maternal HCV status is unknown; follow up after
receiving test results; testing siblings of perinatally infected
infants; stigma and harms of HCV testing; suggested scientific content
and implementation guidance; and editorial comments. CDC addressed
these comments by correcting, clarifying, or updating content in the
final recommendations. A summary of public comments and CDC's response
can be found in the Documents tab of the docket, as well as CDC Stacks
at <a href="https://stacks.cdc.gov/view/cdc/134020">https://stacks.cdc.gov/view/cdc/134020</a>.
Tiffany Brown,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2023-26422 Filed 11-30-23; 8:45 am]
BILLING CODE 4163-18-P
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