[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Notices]
[Pages 67478-67479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
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.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects of the Paperwork Reduction 
Act of 1995, HRSA announces plans to submit an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the 
public regarding the burden estimate, below, or any other aspect of the 
ICR.

DATES: Comments on this ICR should be received no later than January 
25, 2022.

ADDRESSES: Submit your comments to [email protected] or by mail to the 
HRSA Information Collection Clearance Officer, Room 14N136B, 5600 
Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call Samantha Miller, 
the acting HRSA Information Collection Clearance Officer at (301) 443-
9094.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information collection request title 
for reference.
    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 
(P.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 U.S. allogeneic hematopoietic stem cell transplant recipients.
    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 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.
    HRSA will use this information 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.
    HRSA will use data collected prior to a patient receiving a blood 
stem cell transplant to characterize frequencies of vaccination and 
level of protection afforded during and after transplant based on 
incidence of COVID infection. Post-transplant, this information can be 
used to assess vaccination rates and

[[Page 67479]]

timing in blood stem cell recipients, characterize emerging vaccination 
strategies (which may include boosters), describe possible short and 
long-term side effects 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. Vaccination status of recipients may also be useful for 
risk adjustment in the annual transplant center specific analysis. For 
example, Centers for Disease Control and Prevention 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 during the intake process at transplant centers 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, it is possible that 
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.

                                     Total Estimated Annualized Burden Hours
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                                     Number of       Number of                    Average burden
            Form name               respondents    responses per       Total       per response    Total burden
                                        \1\         respondent       responses      (in hours)         hours
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Baseline Pre-Transplant                      200              48           9,600        \2\ 0.70           6,720
 Essential Data (TED)...........
Disease Classification..........             200              48           9,600        \3\ 0.43           4,160
Product Form (includes Infusion,             200              45           9,000            1.00           9,000
 HLA, and Infectious Disease
 Marker inserts)................
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
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    Total.......................             200  ..............          95,600  ..............          63,031
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\1>\ The total of 200 is the number of centers completing the form; the same group will complete all of the
  forms.
\2\ The decimal is rounded down, and the actual number is .683333333.
\3\ The decimal is rounded down, and the actual number is .433333333.
\4\ The 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. 2021-25786 Filed 11-24-21; 8:45 am]
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