CDC Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children-United States, 2023; Request for Comment and Notice of Informational Webinar, 71330-71332 [2022-25421]
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Federal Register / Vol. 87, No. 224 / Tuesday, November 22, 2022 / Notices
Women of Reproductive Age (WRA)
about Folic Acid Fortification and
Supplementation—New—National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
proposed collection, each proposed
extension of an existing collection of
information, and each reinstatement of
a previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Background and Brief Description
A contemporary understanding of
cultural factors in the decision-making
process and how certain populations of
women obtain information is needed for
Hispanic/Latina women of reproductive
age (WRA) to increase their knowledge
and intake of folic acid to prevent
neural tube defects (NTD).
Previous research highlighted
important nuances in potential cultural
beliefs regarding folic acid. A study of
Spanish-speaking, Hispanic/Latina
women in the southwest United States
found no cultural barriers to
incorporating folic-acid rich foods into
their diets; however, focus groups of
Mexican-American women within the
study found several cultural barriers.
These included: misperception of the
term folic acid as an illegal substance
(as the word ‘‘acid’’ is sometimes used
to describe the drug LSD); the
importance of folic acid in preventing
NTDs since their healthcare providers
did not talk to them about folic acid; the
absence of folic acid in injectable form
at the pharmacy; and mistaken beliefs
that birth defects are not preventable
(resulting from an act of God). Other
Proposed Project
Assessing Knowledge, Attitudes, and
Practices (KAPs) of Hispanic/Latina
studies also present contradictory
findings suggesting that Spanishspeaking, Mexican-American women
have increased awareness of the
association between folate and birth
defects compared to English-speaking,
Mexican-American women. Although
several studies have examined beliefs
and best practices for promoting folic
acid consumption, more research is
needed to determine cultural factors in
the decision-making process around
folic acid intake for Hispanic/Latina
WRA.
The objective of this project is to
conduct formative research with
Hispanic/Latina WRA and leadership
from key organizations that serve
Hispanic/Latina populations to
understand the following: (1) knowledge
and awareness about folic acid and
fortified food for NTD prevention; (2)
practices around consumption of
fortified foods as well as traditional food
items that may or may not be fortified
and supplement use; and (3) appropriate
messages and dissemination channels to
improve folic acid intake from
supplements and folic acid fortified
foods among Hispanic/Latina WRA.
This information collection will
involve focus groups with Hispanic/
Latina WRA. CDC requests OMB
approval for an estimated 63 annual
burden hours. There are no costs to
respondents other than their time to
participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Hispanic/Latina Women of Reproductive Age (WRA) ....
Total .........................................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–25400 Filed 11–21–22; 8:45 am]
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Number of
respondents
Form name
Knowledge, Attitudes, and Practices
(KAPs) of Hispanic/Latina WRA:
Focus Group Moderator Guide.
..............................................................
1
63
........................
........................
........................
63
Centers for Disease Control and
Prevention
[Docket No. CDC–2022–0116]
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment.
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Total burden
(in hours)
1
CDC Recommendations for Hepatitis C
Testing Among Perinatally Exposed
Infants and Children—United States,
2023; Request for Comment and Notice
of Informational Webinar
VerDate Sep<11>2014
Average
burden
per response
(in hours)
63
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Number of
responses per
respondent
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
SUMMARY:
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Federal Register / Vol. 87, No. 224 / Tuesday, November 22, 2022 / Notices
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: DVHpolicy@
cdc.gov. Telephone: (404) 639–8000.
SUPPLEMENTARY INFORMATION:
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Background
Hepatitis C virus (HCV) infection is
the most commonly reported bloodborne infection in the United States,
causing substantial liver damage and
death.1 During 2017–2020, there were
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.
VerDate Sep<11>2014
17:48 Nov 21, 2022
Jkt 259001
an estimated 2.2 million noninstitutionalized 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
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
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: https://
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 metaanalysis. 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.
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.
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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. HCVinfected 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.
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.
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
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.
12 Recommendations for prevention and control
of hepatitis C virus (HCV) infection and HCVrelated 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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Federal Register / Vol. 87, No. 224 / Tuesday, November 22, 2022 / Notices
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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Annual
Report on Households Assisted by the
Low Income Home Energy Assistance
Program (OMB #0970–0060)
Office of Community Services
(OCS), Administration for Children and
Families (ACF), Department of Health
and Human Services (HHS).
ACTION: Request for public comment.
AGENCY:
OCS, Division of Energy
Assistance, is requesting a substantial
change of the Household Report Office
of Management and Budget (OMB)
#0970–0060, expiration May 31, 2025).
Grant recipients complete the
Household Report on an annual basis,
completing either the Long Form or the
Short Form version of the report.
Submission of the completed report is
one requirement for the Low Income
Home Energy Assistance Program
(LIHEAP) grant recipients applying for
Federal LIHEAP block grant funds. OCS
proposes substantive changes, including
the addition of reporting requirements
for assisted applicants and household
member demographic characteristics on
the Household Report Long Form and
Short Form, and the removal of
reporting requirements collecting counts
of applicant households by assistance
type and poverty interval on the
Household Report Long Form.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. One can find this particular
information collection by selecting
‘‘Currently under 30-day Review-Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: States, the District of
Columbia, and the Commonwealth of
Puerto Rico are required to complete the
SUMMARY:
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Household Report-Long Form on an
annual basis. The Long Form collects
the following information:
• Assisted households, by type of
LIHEAP assistance and funding source;
• Assisted households receiving bill
payment assistance, by funding source;
• Assisted households receiving any
type of LIHEAP assistance, by funding
source;
• Assisted households by poverty
interval, type of LIHEAP assistance, and
funding source;
• Assisted households, by type of
LIHEAP assistance and funding source,
having at least one vulnerable member
who is at least 60 years or older,
disabled, or 5 years old or younger;
• Assisted households receiving any
type of LIHEAP assistance or funding
source, having at least one member 60
years or older, disabled, or 5 years old
or younger.
Tribal grant recipients and other U.S.
territory grant recipients are required to
complete the Household Report-Short
Form on an annual basis. The Short
Form collects data only on the number
of households, by funding source,
receiving heating, cooling, energy crisis,
and/or weatherization benefits.
The information reported in the
Household Report Long Form and Short
Form is being collected for the
Department’s annual LIHEAP Report to
Congress. The data also provides
information about the need for LIHEAP
funds. Finally, the data are used in the
calculation of LIHEAP performance
measures under the Government
Performance and Results Act of 1993.
The data elements will allow the
accuracy of measuring LIHEAP targeting
performance and LIHEAP cost
efficiency.
ACF is proposing changes to the
Household Report Long Form and Short
Form beginning with FY 2023 reporting.
These changes include additional
reporting requirements for assisted
household and household member
demographic characteristics, and the
removal of reporting requirements
collecting counts of applicant
households by assistance type and
poverty interval on the Household
Report Long Form. The additional
reporting requirements include the
following:
1. Number of Households by Owner/
Renter Status (own, rent with utilities
billed separately, rent with utilities in
rental fee, other) [This is optional for FY
2023 reporting and required beginning
with FY 2024 reporting].
2. Number of Assisted Applicants by
Ethnicity. Grant recipients will report
on assisted applicants by ethnicity
according to standard census categories
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
---------------------------------------------------------------------------
\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: https://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.
---------------------------------------------------------------------------
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]
BILLING CODE 4163-18-P
