Notice2025-08703
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Stem Cell Therapeutic Outcomes Database
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
May 16, 2025
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 90 Issue 94 (Friday, May 16, 2025)</title>
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[Federal Register Volume 90, Number 94 (Friday, May 16, 2025)]
[Notices]
[Pages 21049-21051]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08703]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: The Stem
Cell Therapeutic Outcomes Database
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
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 July 15,
2025.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#93e3f2e3f6e1e4fce1f8d3fbe1e0f2bdf4fce5"><span class="__cf_email__" data-cfemail="abdbcadbced9dcc4d9c0ebc3d9d8ca85ccc4dd">[email protected]</span></a> or mail the HRSA
Information Collection Clearance Officer, Room 14NWH04, 5600 Fishers
Lane, Rockville, Maryland 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#d7a7b6a7b2a5a0b8a5bc97bfa5a4b6f9b0b8a1"><span class="__cf_email__" data-cfemail="2f5f4e5f4a5d58405d446f475d5c4e01484059">[email protected]</span></a> or call Samantha Miller,
the HRSA
[[Page 21050]]
Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: The Stem Cell Therapeutic
Outcomes Database, OMB No. 0915-0310--Revision.
Abstract: The Stem Cell Therapeutic and Research Act of 2005 (Pub.
L. 109-129, December 20, 2005), as amended and codified in Section 379A
of the Public Health Service Act (42 U.S.C. 247l), provides for the
collection and maintenance of human blood stem cells for the treatment
of patients and research. The Public Health Service Act requires the
Secretary of HHS to contract for the establishment and maintenance of
information related to patients who have received stem cell therapeutic
products and to do so using an electronic format. HRSA has established
the Stem Cell Therapeutic Outcomes Database (SCTOD), one component of
the C.W. Bill Young Cell Transplantation Program (Program) which
necessitates certain electronic record keeping and reporting
requirements to perform the functions related to hematopoietic stem
cell transplantation (HCT) under contract to HHS. Data is collected
from transplant centers by the Center for International Blood and
Marrow Transplant Research and is used for ongoing analysis of
transplant outcomes to improve the treatment, survival, and quality of
life for patients who may benefit from cellular therapies.
Over time, there is an expected increase in the information
reported as the number of transplants performed annually increases and
survivorship after transplantation improves. Similarly, because of the
ongoing rapid evolution in transplant indications, methods to establish
diagnoses, disease prognostic factors, treatments provided before HCT,
methods to determine donor matching, and transplantation techniques,
the Program anticipates incremental changes in the information
collected by the SCTOD after OMB approval to reflect current clinical
care, facilitate statistical modeling throughout the approval period to
fulfill Program requirements, keep pace with changes in the field, and
to enhance the ability to collect information in an automated fashion
from respondent source systems, such as electronic health records.
Interim updates to the information collected about disease indications,
disease definitions, and disease prognostic factors will be triggered
by the publication of peer-reviewed scientific articles or public
reference materials of updated criteria by organizations such as the
World Health Organization, national or international scientific
consensus panels (e.g., European LeukemiaNet, International Working
Group for Prognosis in MDS) or similar. The updates mentioned above are
anticipated to be reflected as changes in response options to existing
information collection and will represent non-substantive changes
without additional public notice. Such small incremental changes will
not significantly affect the burden.
Need and Proposed Use of the Information: Per statutory
responsibilities, the collection of information outlined in the ``Total
Estimated Annualized Burden Hours'' section below is needed to collect,
analyze, and publish stem cell transplantation-related data including
patient outcomes data and provide the Secretary with an annual report
of transplant center-specific survival data. The proposed revisions of
this information collection reflect the most up-to-date medical
evidence while simultaneously reducing the HCT facility burden.
Revisions fall into several categories: consolidating questions,
implementing interactive requests (electronic check boxes, check all
that apply, and pull-down menus) to reduce data entry time, adding
necessary information fields, adding clarity to information requests
and removing items no longer clinically significant (e.g., discontinued
or re-named medications).
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. The estimated total annual
burden hours for this submission is 52,469.66.
Total Estimated Annualized Burden Hours
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Number of Number of Average burden
Form name \1\ respondents responses per Total per response Total burden
\2\ respondent \3\ responses \4\ (in hours) hours
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Pre-Transplant Information 177.00 52.63 \5\ 9,315.51 \6\ 1.42 13,228.02
Collection....................
Transplant Procedure and 177.00 52.63 \7\ 9,315.51 \8\ 1.06 9,874.44
Product Information...........
Post-Transplant Periodic 177.00 319.07 \9\ 56,475.39 \10\ 0.52 29,367.20
Information Collection based
on Predetermined Schedule.....
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Total...................... 177.00 ............... 75,106.41 .............. 52,469.66
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\1\ This burden estimate table refers to data collections at different time periods consistent with approved
practice. The SCTOD contractor is working with respondents to reduce burden by submitting data using
interoperability standards. These data collections may include OMB-approved forms.
\2\ The total number of U.S. transplant centers that submit data to the SCTOD is 177 as of March 29, 2022. The
number of centers providing data may change intermittently based on opening or closure of centers.
\3\ The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of
Respondents and rounding to the nearest hundredth.
\4\ The total number of responses is less than previous calculations because of improvements in estimation.
Previous estimates assumed all years had the same number of transplants. This improved estimate includes
accurate transplant counts from prior years, which are often less than the current year leading to less follow-
up activity.
\5\ Total responses for Pre-Transplant Information Collection equals estimated number of new transplant patients
in 2021.
[[Page 21051]]
\6\ Pre-transplant Data includes baseline recipient data including patient demographics, pertinent medical
history, disease characteristics and status, co-morbidities, transplant data procedure characteristics,
including preparative regimen, and donor data. This number is rounded to the nearest hundredth. The actual
burden estimate for these data is 1.4175.
\7\ Transplant Procedure and Product Information equals estimated number of new transplant patients in 2021.
\8\ Transplant Procedure and Product Information includes Graft-vs-Host Disease prophylaxis, graft source, donor
type and degree of HLA matching and graft manipulation; graft characteristic data for cord blood units,
including infused cell dose; and product information. This number is rounded to the nearest hundredth. The
actual burden estimate for these data is 1.0616.
\9\ The number of responses for Post-Transplant Periodic Information Collection is based on a predetermined
schedule: 100 days after transplant, 6 months after transplant, 1 year after transplant, annually for 6 years
after transplant and then biennially thereafter. In any given year the number of responses is a function of
the number of transplants in that year, the number of transplants in previous years, and expected patient
survival between the time of transplant and any follow-up activity.
\10\ Post-Transplant Data Collection includes hematopoietic recovery and engraftment serious complications
including Graft-vs-Host Disease and second cancers, disease status, survival status, and cause of death; and
subsequent procedures. This number is rounded to the nearest hundredth. The actual burden estimate is 0.5247.
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. 2025-08703 Filed 5-15-25; 8:45 am]
BILLING CODE 4165-15-P
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