[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]


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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.

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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/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

[[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: 
http://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. http://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: http://dx.doi.org/10.15585/mmwr.mm6933a1.

[FR Doc. 2022-02389 Filed 2-3-22; 8:45 am]
BILLING CODE 4150-28-P