[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Pages 71330-71332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25421]


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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; Request for Comment 
and Notice of Informational Webinar

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), in the 
Department of Health and Human Services (HHS), announces the opening of 
a docket to obtain comment on proposed new recommendations for 
perinatal hepatitis C virus (HCV) infection testing to identify infants 
who may go on to develop chronic hepatitis C. Recommendations include: 
HCV testing of all perinatally exposed infants at age 2-6 months with a 
Nucleic Acid Test (NAT) for detection of HCV ribonucleic acid (RNA); 
and referral of infants with detectable HCV RNA to a healthcare 
provider with expertise in pediatric hepatitis C management. CDC

[[Page 71331]]

also announces an Informational Webinar to explain the public comment 
process.

DATES: Written comments must be received on or before January 27, 2023.
    The Informational Webinar will be held December 6, 2022 from 3-4 
p.m. EST.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0116 by either of the methods listed below.
     Federal eRulemaking Portal: https://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-2022-0116.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to https://www.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 https://www.regulations.gov.
    Registration for Informational Webinar: You can register for the 
webinar at https://www.zoomgov.com/webinar/register/WN_tDK5btj3QpGcmDzKVjvDbw. CDC will not accept public comment during 
this webinar.

FOR FURTHER INFORMATION CONTACT: Lakshmi Panagiotakopoulos, 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: 

Background

    Hepatitis C virus (HCV) infection is the most commonly reported 
blood-borne infection in the United States, causing substantial liver 
damage and death.\1\ During 2017-2020, there were an estimated 2.2 
million non-institutionalized adults in the United States living with 
hepatitis C.\2\ Percutaneous exposure (e.g., injection drug use or 
blood transfusion) is the most efficient mode of HCV transmission, and 
injection drug use is the primary risk factor for infection.\3\ 
National surveillance data reveal a steady increase in HCV infections 
in the United States from 2010 through 2020, with rates of acute 
infections more than quadrupling among reproductive aged persons during 
this time, corresponding with increases in injection drug use.\4\ 
Approximately 7 percent of perinatally exposed children (i.e., those 
coming into contact with the virus during pregnancy or delivery) will 
acquire perinatal HCV infection.\5\ Curative direct-acting antiviral 
(DAA) drugs are an FDA-approved treatment, currently approved for use 
beginning at 3 years of age. However, many perinatally infected 
children are not tested or linked to care.6 7 8 9
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    \1\ Centers for Disease Control and Prevention. Viral Hepatitis 
Surveillance Report--United States, 2020. https://www.cdc.gov/hepatitis/statistics/2020surveillance/index.htm. Published September 
2022. See also Hofmeister, M.G., Rosenthal, E.M., Barker, L.K., 
Rosenberg, E.S., Barranco, M.A., Hall, E.W., Edlin, B.R., Mermin, 
J., Ward, J.W. and Ryerson, A.B. (2019), Estimating Prevalence of 
Hepatitis C Virus Infection in the United States, 2013-2016. 
Hepatology, 69: 1020-1031. https://doi.org/10.1002/hep.30297 
Rosenberg ES, Rosenthal EM, Hall EW, Barker L, Hofmeister MG, 
Sullivan PS, Dietz P, Mermin J, Ryerson AB. Prevalence of Hepatitis 
C Virus Infection in US States and the District of Columbia, 2013 to 
2016. JAMA Netw Open. 2018 Dec 7;1(8):e186371. doi: 10.1001/
jamanetworkopen.2018.6371. PMID: 30646319; PMCID: PMC6324373.
    \2\ Thompson WW, Symum H, Sandul A, et al. Vital Signs: 
Hepatitis C Treatment Among Insured Adults--United States, 2019-
2020. MMWR Morb Mortal Wkly Rep 2022;71:1011-1017. DOI: http://dx.doi.org/10.15585/mmwr.mm7132e1.
    \3\ Centers for Disease Control and Prevention. Viral Hepatitis 
Surveillance Report--United States, 2020. https://www.cdc.gov/hepatitis/statistics/2020surveillance/index.htm. Published September 
2022.
    \4\ Centers for Disease Control and Prevention. Viral Hepatitis 
Surveillance Report--United States, 2020. https://www.cdc.gov/hepatitis/statistics/2020surveillance/index.htm. Published September 
2022.
    \5\ Benova, L., et al., Vertical transmission of hepatitis C 
virus: systematic review and meta-analysis. Clin Infect Dis, 2014. 
59(6): p. 765-73.
    \6\ Towers, C.V. and K.B. Fortner, Infant follow-up postdelivery 
from a hepatitis C viral load positive mother. J Matern Fetal 
Neonatal Med, 2019. 32(19): p. 3303-3305.
    \7\ Lopata, S.M., et al., Hepatitis C Testing Among Perinatally 
Exposed Infants. Pediatrics, 2020. 145(3).
    \8\ Hojat, L.S., et al., Using Preventive Health Alerts in the 
Electronic Health Record Improves Hepatitis C Virus Testing Among 
Infants Perinatally Exposed to Hepatitis C. Pediatr Infect Dis J, 
2020. 39(10): p. 920-924.
    \9\ Kuncio, D.E., et al., Failure to Test and Identify 
Perinatally Infected Children Born to Hepatitis C Virus-Infected 
Women. Clin Infect Dis, 2016. 62(8): p. 980-5.
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    The World Health Organization (WHO)'s global health sector 
strategies \10\ for eliminating viral hepatitis include diagnosing at 
least 90% of people living with hepatitis C by 2030. In support of this 
goal, CDC conducted a systematic review of the literature to develop 
recommendations for testing perinatally exposed infants and children 
for hepatitis C. Among children born to women with HCV infection, well-
child visits in the first 6 months of life are the most frequently 
attended and provide an opportunity to test in a patient group that is 
often lost to follow-up. Although treatment is not currently approved 
for infants and children under 3 years of age, it is important to test 
exposed infants as close to birth as possible and record a diagnosis in 
the medical record. HCV-infected infants and children are usually 
asymptomatic, and it is important to diagnose and treat HCV infection 
before liver damage occurs. Prior studies have estimated that, in the 
United States, the total annual burden of HCV infection was about 10 
billion U.S. dollars in 2017.\11\ Proper identification of perinatally 
infected children, referral to care for evaluation and monitoring, and 
curative DAA treatment are critical to achieving the goal of hepatitis 
C elimination.
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    \10\ Global health sector strategies on, respectively, HIV, 
viral hepatitis and sexually transmitted infections for the period 
2022-2030. Geneva: World Health Organization; 2022. License: CC BY-
NC-SA 3.0 IGO. Available at: https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/strategies/global-health-sector-strategies.
    \11\ Stepanova M, Younossi ZM. Economic Burden of Hepatitis C 
Infection. Clin Liver Dis. 2017 Aug;21(3):579-594. doi: 10.1016/
j.cld.2017.03.012. Epub 2017 Apr 22. PMID: 28689595.
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    As described in the recommendation document found in the Supporting 
and Related Materials tab of the docket, these recommendations 
supplement ``CDC Recommendations for Hepatitis C Screening Among 
Adults--United States, 2020,'' which includes screening during each 
pregnancy, by recommending the timing and type of HCV test for infants 
and children born to persons determined to have HCV infection in 
pregnancy. In addition, this recommendation replaces a prior 
recommendation for testing perinatally exposed infants and children 
included in a CDC guideline from 1998,\12\ as HCV epidemiology and 
methods of testing infants and children for HCV infection have evolved.
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    \12\ Recommendations for prevention and control of hepatitis C 
virus (HCV) infection and HCV-related chronic disease. Centers for 
Disease Control and Prevention. MMWR Recomm Rep. 1998 Oct 16;47(RR-
19):1-39. PMID: 9790221.
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Public Participation

    Interested persons or organizations are invited to participate by 
submitting written views, recommendations, and data related to any of 
the proposed 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 Supporting and Related Materials tab), 
does the evidence support the proposed recommendations for testing

[[Page 71332]]

perinatally exposed infants and children for HCV infection? If not, 
please state the reason why and, if available, provide additional 
evidence for consideration.
     Are CDC's proposed recommendations (see Supporting and 
Related Materials tab) clearly written? If not, please provide changes 
to make them clearer.
     If implemented as currently drafted, do you believe the 
proposed recommendations would result in increased identification and 
treatment of perinatal HCV infections and reduction in associated 
health and financial consequences in the United States (e.g., 
healthcare costs to treat complications of chronic hepatitis C)? 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 or 
near duplicate examples of a mass-mail campaign.
    Informational Webinar: CDC will host an Informational Webinar on 
December 6, 2022 from 3:00-4:00 p.m. EST to explain the public comment 
process. CDC will not accept public comment on the Draft 
Recommendations during the webinar.

    Dated: November 17, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-25421 Filed 11-21-22; 8:45 am]
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