6610 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 

Dated: January 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02359 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; The Stem Cell Therapeutic 

Outcomes Database, OMB No. 0915– 

0310—Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this Notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than March 7, 2022. 

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. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Samantha Miller, the acting HRSA 

Information Collection Clearance Officer 

at paperwork@hrsa.gov or call (301) 

443–9094. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

The Stem Cell Therapeutic Outcomes 

Database OMB No. 0915–0310— 

Extension. 

Abstract: Given the rapid evolution of 

COVID–19 and its impact on those with 

compromised immune systems, it is 

imperative for the transplant 

community to continue collecting 

COVID–19 related data. Having access 

to COVID–19 vaccination status on 

blood stem cell recipients and 

understanding immune responses will 

assist with making informed decisions 

regarding direct clinical care. This will 

also inform critical policy decisions. 

The Stem Cell Therapeutic and 

Research Act of 2005, Public Law (Pub. 

L.) 109–129, as amended, provides for 

the collection and maintenance of 

human blood stem cells for the 

treatment of patients and research. It 

also maintains a scientific database of 

information relating to patients who 

have been recipients of a stem cell 

therapeutics product (e.g., bone marrow, 

cord blood, or other such product) from 

a donor. 

Given the rapid evolution of the 

COVID–19 public health emergency and 

its impact on immunocompromised 

patients, availability of new vaccines, 

and continual changes in vaccination 

recommendations, HRSA wants to 

leverage the required data collection 

platform of the Stem Cell Therapeutic 

Outcomes Database to obtain vaccine 

information for all US allogeneic 

hematopoietic stem cell transplant 

recipients. 

A 60-day notice published in the 

Federal Register, 86 FR 67478 

(November 26, 2021). There were no 

public comments. 

Need and Proposed Use of the 

Information: To collect COVID–19 

vaccine data, HRSA is requesting an 

extension of OMB’s approval of both the 

Pre-Transplant Essential Data (Pre-TED) 

Form 2400 and Post-Transplant 

Essential Data (Post-TED) Form 2450. 

Collecting these data will help 

clinicians and policymakers to 

understand the landscape of vaccination 

among immunocompromised patients 

before and after a blood stem cell 

transplant. 

This information will be used to 

analyze outcomes based on vaccine 

manufacturer/type, doses received 

(including potential boosters), timing, 

and inform future vaccination strategies. 

Information currently collected 

regarding COVID–19 infections has 

already been used in research studies. 

Data collected prior to a patient 

receiving a blood stem cell transplant 

will be used to characterize frequencies 

of vaccination, and the level of 

protection afforded during and after 

transplant based on the incidence of 

COVID infection. Post-transplant, this 

information can be used to assess 

vaccination rates and timing in blood 

stem cell recipients, characterize 

emerging vaccination strategies (which 

may include ‘‘boosters’’), describe 

possible short and long-term side effects 


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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 


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