Notice2022-02318
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
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
February 4, 2022
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 24 (Friday, February 4, 2022)</title>
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[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6610-6611]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="/cdn-cgi/l/email-protection#d5a5b4a5b0a7a2baa7be95bda7a6b4fbb2baa3"><span class="__cf_email__" data-cfemail="354554455047425a475e755d4746541b525a43">[email protected]</span></a> 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]
BILLING CODE 4165-15-P
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