Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 6611 

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 

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. 

Form name Number of 

respondents 1

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Baseline Pre-Transplant Essential Data (TED) ................... 200 48 9,600 2 0.70 6,720 

Disease Classification .......................................................... 200 48 9,600 3 0.43 4,160 

Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................ 200 45 9,000 1.00 9,000 

100-day Post-TED ............................................................... 200 48 9,600 0.88 8,448 

6 month Post-TED ............................................................... 200 43 8,600 0.85 7,310 

1 year Post-TED .................................................................. 200 40 8,000 0.65 5,200 

2 year Post-TED .................................................................. 200 34 6,800 0.65 4,420 

3+ years Post-TED .............................................................. 200 172 34,400 4 0.52 17,773 

Total .............................................................................. 200 ........................ 95,600 ........................ 63,031 

1The total of 200 is the number of centers completing the form; the same group will complete all of the forms. 

2The decimal is rounded up, and the actual number is .683333333. 

3The decimal is rounded down, and the actual number is .433333333. 

4The decimal is rounded up, and the actual number is .516667. 

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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2022–02318 Filed 2–3–22; 8:45 am] 

BILLING CODE 4165–15–P 

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 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 


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 

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 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 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 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. 

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 

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. 

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, 


lotter on DSK11XQN23PROD with NOTICES1