[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 83944-83945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
www.regulations.gov, Docket No. CDC-2022-0116 and at https://www.cdc.gov/mmwr/volumes/72/rr/rr7204a1.htm?s_cid=rr7204a1_w.

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: [email protected].

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 (https://aspe.hhs.gov/hhs-guidelines-ensuring-maximizing-disseminated-information). 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:

 Methodology (studies included in the evidence review, methods 
used to assess the evidence, clarity of evidence findings, 
identification of limitations or uncertainties)
 Recommendations (reviewer agreement with CDC's conclusions, 
suggestions for clarifying recommendations)
 Potential impact and implementation (whether implementing 
recommendations would improve health outcomes, any resources or tools 
that would facilitate implementation)
 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 https://www.cdc.gov/hepatitis/policy/isireview/index.htm.
    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 https://stacks.cdc.gov/view/cdc/134020.

Tiffany Brown,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2023-26422 Filed 11-30-23; 8:45 am]
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