Request for Information: Regarding a Revision to U.S. Public Health Service Guideline: Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection, 6611-6613 [2022-02389]
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6611
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices
of vaccines, and analyze the incidence
of COVID–19 infection based on
different vaccination approaches. This
information may guide future
vaccination strategies or COVID
treatments. The vaccination status of
recipients may also be useful for risk
adjustment in the annual transplant
center-specific analysis. For example,
CDC advisors could potentially use
COVID–19 vaccination data on blood
stem cell transplant recipients to make
informed decisions regarding whether to
issue any recommendations for this
medically vulnerable population. The
data collected under this extension
request could help answer these and
other questions.
The additional COVID–19 vaccine
questions capture basic information on
vaccination status, vaccine
manufacturer/type, dose(s) given, and
date(s) received. Patients who need a
blood stem cell transplant are typically
aware of their COVID–19 risk and
vaccination status, and the information
is also found on the vaccine cards
carried by most recipients. Questions
about vaccination status will likely
become universal at transplant center
intake for the next 12 months or more.
For these reasons, HRSA believes the
data will be readily available to data
professionals working at transplant
centers via the medical record. To
reduce burden, an ‘‘unknown’’ option
has been included for scenarios where
the data cannot be located, and a ‘‘date
estimated’’ checkbox has been included
when the exact date of vaccination is
not known. Although these questions
are anticipated to be asked over the next
12 months and then removed, other
COVID–19 related questions may be
requested for inclusion on these forms
in the future given the rapid evolution
of COVID–19 and its impact on
immunocompromised patients,
availability of new vaccines, and
Number of
respondents 1
Form name
Number of
responses per
respondent
continual changes in vaccination
recommendations.
Likely Respondents: Transplant
Centers.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Baseline Pre-Transplant Essential Data (TED) ...................
Disease Classification ..........................................................
Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................
100-day Post-TED ...............................................................
6 month Post-TED ...............................................................
1 year Post-TED ..................................................................
2 year Post-TED ..................................................................
3+ years Post-TED ..............................................................
200
200
48
48
9,600
9,600
2 0.70
3 0.43
6,720
4,160
200
200
200
200
200
200
45
48
43
40
34
172
9,000
9,600
8,600
8,000
6,800
34,400
1.00
0.88
0.85
0.65
0.65
4 0.52
9,000
8,448
7,310
5,200
4,420
17,773
Total ..............................................................................
200
........................
95,600
........................
63,031
1 The
total of 200 is the number of centers completing the form; the same group will complete all of the forms.
decimal is rounded up, and the actual number is .683333333.
decimal is rounded down, and the actual number is .433333333.
4 The decimal is rounded up, and the actual number is .516667.
2 The
3 The
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
lotter on DSK11XQN23PROD with NOTICES1
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–02318 Filed 2–3–22; 8:45 am]
BILLING CODE 4165–15–P
VerDate Sep<11>2014
18:50 Feb 03, 2022
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information: Regarding a
Revision to U.S. Public Health Service
Guideline: Assessing Solid Organ
Donors and Monitoring Transplant
Recipients for Human
Immunodeficiency Virus, Hepatitis B
Virus, and Hepatitis C Virus Infection
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Request for information.
AGENCY:
The Office of the Assistant
Secretary for Health in the Department
of Health and Human Services (HHS)
seeks public comment regarding a
proposed revision to the 2020 PHS
Guideline Assessing Solid Organ Donors
SUMMARY:
Jkt 256001
PO 00000
Frm 00129
Fmt 4703
Sfmt 4703
and Monitoring Transplant Recipients
for Human Immunodeficiency Virus,
Hepatitis B Virus, and Hepatitis C Virus
Infection (1). The Organ Procurement
and Transplantation Network (OPTN)
implemented a policy change related to
organ transplant candidate assessment
and testing on March 1, 2021, to align
OPTN policy with the new Guideline
recommendations (2). Previous PHS
Guideline recommendations did not
include a specific timeframe during
which pre-transplant testing for HIV,
HBV, and HCV infections among organ
transplant candidates should occur. In
order to more accurately assess pretransplant infection status and to enable
the investigation of possible solid organ
donor transmission of infection, the
2020 Guideline specified that pretransplant HIV, HBV, and HCV testing
of transplant candidates should occur
during hospital admission for transplant
E:\FR\FM\04FEN1.SGM
04FEN1
lotter on DSK11XQN23PROD with NOTICES1
6612
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices
surgery but prior to the implantation of
the organ. In May 2021, HHS reviewed
communications from members of the
public to the OPTN, outlining concerns
that the additional amount of blood
drawn for infectious disease testing
(when added to the relatively large
amount of blood required for immediate
preoperative laboratory testing) during
the admission for transplantation poses
potential risks for some pediatric organ
transplant candidates. Potential risks
due to blood volume loss include those
related to preoperative low body weight
(and low blood volume), anemia, or
exacerbation of underlying co-morbid
conditions. HHS conducted a review of
the most recent HIV, HBV, and HCV
surveillance data in the United States as
stratified by age group. Additionally,
HHS engaged with relevant stakeholders
during May–November 2021, to
understand implications of policy
changes on organ transplantation and
organ utilization. In December 2021,
findings from these analyses were
presented to the Advisory Committee on
Blood and Tissue Safety and
Availability (ACBTSA). The committee
considered whether a revision to the
Guideline recommendation pertaining
to pre-transplant testing of candidates
≤10 years of age is warranted. Based on
feedback from the ACBTSA and
analyses specified above, HHS is
proposing changes pertinent to the
timing of pre-transplant testing for
candidates ≤10 years of age. HHS is
asking respondents to review the
proposed revision to the current
Guideline (listed in the Supplementary
Information section of this notice) and
provide assessments on updating the
Guideline, whether this change is
achievable in the clinical setting, or if
there are potential barriers to
implementation. In addition, impact on
organ allocation and utilization should
be considered. Other comments
pertinent to this proposed revision are
welcome.
DATES: To be assured consideration,
comments must be received at the
address provided below no later than
5:00 p.m. ET on March 7, 2022.
ADDRESSES: Electronic responses are
strongly preferred and may be addressed
to ACBTSA@hhs.gov. Please include in
the subject line of the email: ACBTSA–
RFI.
FOR FURTHER INFORMATION CONTACT: Mr.
James Berger, Designated Federal
Official, Office of Infectious Disease and
HIV/AIDS Policy, 202–795–7608.
SUPPLEMENTARY INFORMATION:
Background: Since the emergence of the
human immunodeficiency virus (HIV)
epidemic in the 1980s, the U.S. Public
VerDate Sep<11>2014
18:50 Feb 03, 2022
Jkt 256001
Health Service (PHS) has made
recommendations to reduce the risk of
HIV transmission associated with organ
transplantation (3, 4). Historically,
recommendations included identifying
risk factors among organ donors
associated with HIV infection to
minimize risk of potential transmission
to recipients. Recommendations also
included laboratory screening of donors
using anti-HIV antibody testing, with
additional testing recommendations
added as technologies such as nucleic
acid testing (NAT) were developed. In
2013, based on donor-derived
transmission events and reports of poor
recipient outcomes from hepatitis B
virus (HBV) and hepatitis C virus (HCV)
transmission, the PHS released a revised
guideline. The 2013 Guideline added
organ donor screening
recommendations for HBV (hepatitis B
surface antigen [HBsAg] and total
antibody to hepatitis B core antigen
[total anti-HBc]) and HCV (antibody to
hepatitis C [anti-HCV] and HCV RNA by
NAT), in addition to HIV, to reduce the
risk of unintended transmission through
transplantation (5). This revised
Guideline was enhanced by
recommending specific recipient
informed consent and post-transplant
recipient monitoring for evidence of
possible disease transmission.
In 2020, the Guideline was updated to
reflect changes in the epidemiology of
HIV, HBV, and HCV infections,
advances in testing, and the widespread
availability of highly effective (for HIV
and HBV) and curative (for HCV)
treatment. In addition to several other
updated recommendations, the 2020
Guideline specified that all transplant
candidates should be tested prior to
surgery for HIV, HBV, and HCV
infections, with testing to occur during
hospital admission for transplant but
before transplantation (1). This
recommendation was implemented in
order to more accurately assess pretransplant infection status and to enable
the investigation of whether infectious
disease transmission may have occurred
through transplantation. Based on the
feedback from members of the public
that this requirement for repeat
screening at the time of transplantation
might pose potential harm to some
pediatric patients due to blood volume
loss, HHS (including CDC and HRSA)
conducted additional analyses of
surveillance data. Additionally, CDC
and HRSA also participated in a work
group convened by the OPTN and
which included members of the OPTN
Disease Transmission Advisory
Committee and Pediatric Committee.
CDC surveillance data for the years
2015–2019 pertaining to incident HIV
PO 00000
Frm 00130
Fmt 4703
Sfmt 4703
infections among pediatric populations
in the United States were reviewed.
Briefly, 524 children <13 years of age in
the United States and 6 U.S. territories
and freely associated states received a
new diagnosis of HIV infection from
2015–2019. Overall, 181 (35%) of these
524 children received their diagnosis of
HIV infection between 0–5 months of
age; an additional 23 (4%) were
diagnosed between 6–11 months of age.
With effective perinatal elimination
efforts, prevalence and incidence of HIV
infection in children <13 years of age in
the United States have been steadily
decreasing (6). Children <13 years of age
are among the lowest risk group for new
HIV infections in the United States.
Estimated prevalence of HIV infection
in children <13 years of age in the
United States is <2,000; incidence in
this age group is <100 cases per year,
and most of these are perinatally
acquired (6). With perinatal testing and
clinical follow-up of exposed children,
it is unlikely that a transplant candidate
≤10 years of age would have an
undiagnosed HIV infection at the time
of organ transplantation.
CDC surveillance data for 2019
pertaining to incident HBV and HCV
infections among pediatric populations
in the United States were also reviewed.
Incident HBV and HCV infections are
similarly low among children in the
United States. The rate of acute HBV
infection in persons <20 years in the
United States was 0.0 per 100,000
population as of 2019 (7). Additionally,
more than 90% of 2-year-olds and
adolescents in the United States have
been vaccinated against HBV (8, 9). The
rate of acute HCV infection in persons
<20 years in the United States was 0.1
per 100,000 population as of 2019 (7).
Perinatal exposure is the most common
mode of transmission for HCV infection
in children.
In December 2021, HHS convened the
Advisory Committee on Blood and
Tissue Safety and Availability
(ACBTSA) to receive expert input on
whether, and if so, how, the current
PHS Guideline recommendation
pertaining to pre-transplant testing of
pediatric candidates should be revised
(https://www.hhs.gov/oidp/advisorycommittee/blood-tissue-safetyavailability/meetings/2021-12-01/
index.html). Additionally, HHS
solicited input from this committee on
the specific question as to whether
available data support exempting solid
organ transplant candidates who are ≤10
years of age at the time of transplant
(and who have received postnatal
infectious disease testing) from the
recommendation for HIV, HBV, and
HCV testing during hospital admission
E:\FR\FM\04FEN1.SGM
04FEN1
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices
for transplant but prior to anastomosis
of the first organ. The committee voted
unanimously in favor of the change.
Potential revision to the 2020
Guideline: HHS has reviewed the
ACBTSA recommendations and other
available information and is considering
the following revision to current
recommendations in the 2020
Guideline.
Exempt solid organ transplant
candidates who are ≤10 years of age at
the time of transplant (and who have
received postnatal infectious disease
testing) from the recommendation for
HIV, hepatitis B virus, and hepatitis C
virus testing during the hospital
admission for transplant but prior to
anastomosis of the first organ.
HHS is not considering changes to
any other 2020 Guideline
recommendations. We seek informed
feedback regarding this proposed
change to the recommendations in the
2020 Guideline.
lotter on DSK11XQN23PROD with NOTICES1
Dated: January 25, 2022.
James J. Berger,
Designated Federal Officer, Advisory
Committee on Blood and Tissue Safety and
Availability, Office of Infectious Disease and
HIV/AIDS Policy.
Footnotes
1. Jones JM, Kracalik I, Levi ME, et al.
Assessing Solid Organ Donors and
Monitoring Transplant Recipients
for Human Immunodeficiency
Virus, Hepatitis B Virus, and
Hepatitis C Virus Infection—U.S.
Public Health Service Guideline,
2020. MMWR Recomm Rep
2020;69(No. RR–4):1–16. DOI:
https://dx.doi.org/10.15585/
mmwr.rr6904a1.
2. OPTN Policy 15.2: Candidate PreTransplant Infectious Disease
Reporting and Testing
Requirements. Available: https://
optn.transplant.hrsa.gov/media/
eavh5bf3/optn-policies-effective-asof-dec-6-2021-e-signature.pdf.
3. CDC. Guidelines for preventing
transmission of human
immunodeficiency virus through
transplantation of human tissue and
organs. Centers for Disease Control
and Prevention. MMWR
Recommendations and reports:
Morbidity and mortality weekly
report Recommendations and
reports/Centers for Disease Control.
1994;43(RR–8):1–17.
4. CDC. Testing donors of organs,
tissues, and semen for antibody to
human T-lymphotropic virus type
III/lymphadenopathy-associated
virus. MMWR Morbidity and
mortality weekly report.
1985;34(20):294.
VerDate Sep<11>2014
18:50 Feb 03, 2022
Jkt 256001
5. Seem DL, Lee I, Umscheid CA,
Kuehnert MJ. PHS guideline for
reducing human immunodeficiency
virus, hepatitis B virus, and
hepatitis C virus transmission
through organ transplantation.
Public health reports (Washington,
DC: 1974). 2013;128(4):247–343.
6. Centers for Disease Control and
Prevention. HIV Surveillance
Report, 2019; vol.32. https://
www.cdc.gov/hiv/library/reports/
hiv-surveillance.html. Published
May 2021.
7. Centers for Disease Control and
Prevention. 2019 Viral Hepatitis
Surveillance Report. https://
www.cdc.gov/hepatitis/statistics/
SurveillanceRpts.htm. Published
July 2021.
8. FastStats—Immunization (cdc.gov):
https://www.cdc.gov/nchs/fastats/
immunize.htm.
9. Elam-Evans LD, Yankey D, Singleton
JA, et al. National, Regional, State,
and Selected Local Area
Vaccination Coverage Among
Adolescents Aged 13–17 Years—
United States, 2019. MMWR Morb
Mortal Wkly Rep 2020;69:1109–
1116. DOI: https://dx.doi.org/
10.15585/mmwr.mm6933a1.
[FR Doc. 2022–02389 Filed 2–3–22; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Aging Systems and Geriatrics Study
Section.
Date: March 3–4, 2022.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
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Sfmt 4703
6613
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Inese Z. Beitins, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6152,
MSC 7892, Bethesda, MD 20892, 301–435–
1034, beitinsi@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Organization and Delivery of Health Services
Study Section.
Date: March 3–4, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Catherine Hadeler
Maulsby, MPH, Ph.D., Scientific Review
Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, (301) 435–1266,
maulsbych@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–20–
117: Maximizing Investigators’ Research
Award (MIRA) for Early Stage Investigators
(R35—Clinical Trial Optional).
Date: March 8–9, 2022.
Time: 9:00 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Anita Szajek, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, 301–827–6276,
anita.szajek@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Drug Discovery Involving the
Nervous System.
Date: March 8–9, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Lai Yee Leung, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1011D,
Bethesda, MD 20892, (301) 435–1042,
leungl2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Biomaterials, Delivery, and
Nanotechnology.
Date: March 10–11, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: David Filpula, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6181,
E:\FR\FM\04FEN1.SGM
04FEN1
]]>Agencies
[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6611-6613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02389]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information: Regarding a Revision to U.S. Public
Health Service Guideline: Assessing Solid Organ Donors and Monitoring
Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B
Virus, and Hepatitis C Virus Infection
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: The Office of the Assistant Secretary for Health in the
Department of Health and Human Services (HHS) seeks public comment
regarding a proposed revision to the 2020 PHS Guideline Assessing Solid
Organ Donors and Monitoring Transplant Recipients for Human
Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus
Infection (1). The Organ Procurement and Transplantation Network (OPTN)
implemented a policy change related to organ transplant candidate
assessment and testing on March 1, 2021, to align OPTN policy with the
new Guideline recommendations (2). Previous PHS Guideline
recommendations did not include a specific timeframe during which pre-
transplant testing for HIV, HBV, and HCV infections among organ
transplant candidates should occur. In order to more accurately assess
pre-transplant infection status and to enable the investigation of
possible solid organ donor transmission of infection, the 2020
Guideline specified that pre-transplant HIV, HBV, and HCV testing of
transplant candidates should occur during hospital admission for
transplant
[[Page 6612]]
surgery but prior to the implantation of the organ. In May 2021, HHS
reviewed communications from members of the public to the OPTN,
outlining concerns that the additional amount of blood drawn for
infectious disease testing (when added to the relatively large amount
of blood required for immediate preoperative laboratory testing) during
the admission for transplantation poses potential risks for some
pediatric organ transplant candidates. Potential risks due to blood
volume loss include those related to preoperative low body weight (and
low blood volume), anemia, or exacerbation of underlying co-morbid
conditions. HHS conducted a review of the most recent HIV, HBV, and HCV
surveillance data in the United States as stratified by age group.
Additionally, HHS engaged with relevant stakeholders during May-
November 2021, to understand implications of policy changes on organ
transplantation and organ utilization. In December 2021, findings from
these analyses were presented to the Advisory Committee on Blood and
Tissue Safety and Availability (ACBTSA). The committee considered
whether a revision to the Guideline recommendation pertaining to pre-
transplant testing of candidates <=10 years of age is warranted. Based
on feedback from the ACBTSA and analyses specified above, HHS is
proposing changes pertinent to the timing of pre-transplant testing for
candidates <=10 years of age. HHS is asking respondents to review the
proposed revision to the current Guideline (listed in the Supplementary
Information section of this notice) and provide assessments on updating
the Guideline, whether this change is achievable in the clinical
setting, or if there are potential barriers to implementation. In
addition, impact on organ allocation and utilization should be
considered. Other comments pertinent to this proposed revision are
welcome.
DATES: To be assured consideration, comments must be received at the
address provided below no later than 5:00 p.m. ET on March 7, 2022.
ADDRESSES: Electronic responses are strongly preferred and may be
addressed to [email protected]. Please include in the subject line of the
email: ACBTSA-RFI.
FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal
Official, Office of Infectious Disease and HIV/AIDS Policy, 202-795-
7608.
SUPPLEMENTARY INFORMATION: Background: Since the emergence of the human
immunodeficiency virus (HIV) epidemic in the 1980s, the U.S. Public
Health Service (PHS) has made recommendations to reduce the risk of HIV
transmission associated with organ transplantation (3, 4).
Historically, recommendations included identifying risk factors among
organ donors associated with HIV infection to minimize risk of
potential transmission to recipients. Recommendations also included
laboratory screening of donors using anti-HIV antibody testing, with
additional testing recommendations added as technologies such as
nucleic acid testing (NAT) were developed. In 2013, based on donor-
derived transmission events and reports of poor recipient outcomes from
hepatitis B virus (HBV) and hepatitis C virus (HCV) transmission, the
PHS released a revised guideline. The 2013 Guideline added organ donor
screening recommendations for HBV (hepatitis B surface antigen [HBsAg]
and total antibody to hepatitis B core antigen [total anti-HBc]) and
HCV (antibody to hepatitis C [anti-HCV] and HCV RNA by NAT), in
addition to HIV, to reduce the risk of unintended transmission through
transplantation (5). This revised Guideline was enhanced by
recommending specific recipient informed consent and post-transplant
recipient monitoring for evidence of possible disease transmission.
In 2020, the Guideline was updated to reflect changes in the
epidemiology of HIV, HBV, and HCV infections, advances in testing, and
the widespread availability of highly effective (for HIV and HBV) and
curative (for HCV) treatment. In addition to several other updated
recommendations, the 2020 Guideline specified that all transplant
candidates should be tested prior to surgery for HIV, HBV, and HCV
infections, with testing to occur during hospital admission for
transplant but before transplantation (1). This recommendation was
implemented in order to more accurately assess pre-transplant infection
status and to enable the investigation of whether infectious disease
transmission may have occurred through transplantation. Based on the
feedback from members of the public that this requirement for repeat
screening at the time of transplantation might pose potential harm to
some pediatric patients due to blood volume loss, HHS (including CDC
and HRSA) conducted additional analyses of surveillance data.
Additionally, CDC and HRSA also participated in a work group convened
by the OPTN and which included members of the OPTN Disease Transmission
Advisory Committee and Pediatric Committee.
CDC surveillance data for the years 2015-2019 pertaining to
incident HIV infections among pediatric populations in the United
States were reviewed. Briefly, 524 children <13 years of age in the
United States and 6 U.S. territories and freely associated states
received a new diagnosis of HIV infection from 2015-2019. Overall, 181
(35%) of these 524 children received their diagnosis of HIV infection
between 0-5 months of age; an additional 23 (4%) were diagnosed between
6-11 months of age. With effective perinatal elimination efforts,
prevalence and incidence of HIV infection in children <13 years of age
in the United States have been steadily decreasing (6). Children <13
years of age are among the lowest risk group for new HIV infections in
the United States. Estimated prevalence of HIV infection in children
<13 years of age in the United States is <2,000; incidence in this age
group is <100 cases per year, and most of these are perinatally
acquired (6). With perinatal testing and clinical follow-up of exposed
children, it is unlikely that a transplant candidate <=10 years of age
would have an undiagnosed HIV infection at the time of organ
transplantation.
CDC surveillance data for 2019 pertaining to incident HBV and HCV
infections among pediatric populations in the United States were also
reviewed. Incident HBV and HCV infections are similarly low among
children in the United States. The rate of acute HBV infection in
persons <20 years in the United States was 0.0 per 100,000 population
as of 2019 (7). Additionally, more than 90% of 2-year-olds and
adolescents in the United States have been vaccinated against HBV (8,
9). The rate of acute HCV infection in persons <20 years in the United
States was 0.1 per 100,000 population as of 2019 (7). Perinatal
exposure is the most common mode of transmission for HCV infection in
children.
In December 2021, HHS convened the Advisory Committee on Blood and
Tissue Safety and Availability (ACBTSA) to receive expert input on
whether, and if so, how, the current PHS Guideline recommendation
pertaining to pre-transplant testing of pediatric candidates should be
revised (https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meetings/2021-12-01/). Additionally, HHS
solicited input from this committee on the specific question as to
whether available data support exempting solid organ transplant
candidates who are <=10 years of age at the time of transplant (and who
have received postnatal infectious disease testing) from the
recommendation for HIV, HBV, and HCV testing during hospital admission
[[Page 6613]]
for transplant but prior to anastomosis of the first organ. The
committee voted unanimously in favor of the change.
Potential revision to the 2020 Guideline: HHS has reviewed the
ACBTSA recommendations and other available information and is
considering the following revision to current recommendations in the
2020 Guideline.
Exempt solid organ transplant candidates who are <=10 years of age
at the time of transplant (and who have received postnatal infectious
disease testing) from the recommendation for HIV, hepatitis B virus,
and hepatitis C virus testing during the hospital admission for
transplant but prior to anastomosis of the first organ.
HHS is not considering changes to any other 2020 Guideline
recommendations. We seek informed feedback regarding this proposed
change to the recommendations in the 2020 Guideline.
Dated: January 25, 2022.
James J. Berger,
Designated Federal Officer, Advisory Committee on Blood and Tissue
Safety and Availability, Office of Infectious Disease and HIV/AIDS
Policy.
Footnotes
1. Jones JM, Kracalik I, Levi ME, et al. Assessing Solid Organ Donors
and Monitoring Transplant Recipients for Human Immunodeficiency Virus,
Hepatitis B Virus, and Hepatitis C Virus Infection--U.S. Public Health
Service Guideline, 2020. MMWR Recomm Rep 2020;69(No. RR-4):1-16. DOI:
https://dx.doi.org/10.15585/mmwr.rr6904a1.
2. OPTN Policy 15.2: Candidate Pre-Transplant Infectious Disease
Reporting and Testing Requirements. Available: https://optn.transplant.hrsa.gov/media/eavh5bf3/optn-policies-effective-as-of-dec-6-2021-e-signature.pdf.
3. CDC. Guidelines for preventing transmission of human
immunodeficiency virus through transplantation of human tissue and
organs. Centers for Disease Control and Prevention. MMWR
Recommendations and reports: Morbidity and mortality weekly report
Recommendations and reports/Centers for Disease Control. 1994;43(RR-
8):1-17.
4. CDC. Testing donors of organs, tissues, and semen for antibody to
human T-lymphotropic virus type III/lymphadenopathy-associated virus.
MMWR Morbidity and mortality weekly report. 1985;34(20):294.
5. Seem DL, Lee I, Umscheid CA, Kuehnert MJ. PHS guideline for reducing
human immunodeficiency virus, hepatitis B virus, and hepatitis C virus
transmission through organ transplantation. Public health reports
(Washington, DC: 1974). 2013;128(4):247-343.
6. Centers for Disease Control and Prevention. HIV Surveillance Report,
2019; vol.32. https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published May 2021.
7. Centers for Disease Control and Prevention. 2019 Viral Hepatitis
Surveillance Report. https://www.cdc.gov/hepatitis/statistics/SurveillanceRpts.htm. Published July 2021.
8. FastStats--Immunization (cdc.gov): https://www.cdc.gov/nchs/fastats/immunize.htm.
9. Elam-Evans LD, Yankey D, Singleton JA, et al. National, Regional,
State, and Selected Local Area Vaccination Coverage Among Adolescents
Aged 13-17 Years--United States, 2019. MMWR Morb Mortal Wkly Rep
2020;69:1109-1116. DOI: https://dx.doi.org/10.15585/mmwr.mm6933a1.
[FR Doc. 2022-02389 Filed 2-3-22; 8:45 am]
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