[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6610-6611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02318]


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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.

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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 [email protected] 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

[[Page 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.

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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 up, 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. 2022-02318 Filed 2-3-22; 8:45 am]
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