Notice2021-25786
Agency Information Collection Activities: Proposed Collection: Public Comment Request; The Stem Cell Therapeutic Outcomes Database, OMB No. 0915-0310-Extension
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 26, 2021
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 225 (Friday, November 26, 2021)</title>
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[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Notices]
[Pages 67478-67479]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#9bebfaebfee9ecf4e9f0dbf3e9e8fab5fcf4ed"><span class="__cf_email__" data-cfemail="2656475643545149544d664e54554708414950">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#daaabbaabfa8adb5a8b19ab2a8a9bbf4bdb5ac"><span class="__cf_email__" data-cfemail="a1d1c0d1c4d3d6ced3cae1c9d3d2c08fc6ced7">[email protected]</span></a> 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]
BILLING CODE 4165-15-P
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