Notice2025-14397
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; 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
July 30, 2025
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the Paperwork Reduction Act of 1995, HRSA 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 90 Issue 144 (Wednesday, July 30, 2025)</title>
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[Federal Register Volume 90, Number 144 (Wednesday, July 30, 2025)]
[Notices]
[Pages 35913-35914]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14397]
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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
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 Paperwork Reduction Act of 1995, HRSA
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 August 29,
2025.
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 HRSA
Information Collection Clearance Officer, at <a href="/cdn-cgi/l/email-protection#0d7d6c7d687f7a627f664d657f7e6c236a627b"><span class="__cf_email__" data-cfemail="037362736671746c7168436b7170622d646c75">[email protected]</span></a> or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
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), a component of the
C.W. Bill Young Cell Transplantation Program (Program), which
necessitates certain electronic record-keeping and reporting
requirements to perform functions related to hematopoietic stem cell
transplantation (HCT) under contract to HHS. Data are collected from
transplant centers by the Center for International Blood and Marrow
Transplant Research. They are used for ongoing analysis of transplant
outcomes to improve treatment and survival for patients who may benefit
from cellular therapies.
The proposed revisions to this ICR reflect the most up-to-date
medical evidence while also reducing the burden on hematopoietic stem
cell transplantation facilities. Revisions fall into several
categories: consolidating questions, implementing interactive requests
(such as electronic check boxes, ``check all that apply,'' and pull-
down menus) to reduce data entry time, adding necessary information
fields, clarifying information requests, and removing items that are no
longer clinically significant.
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
[[Page 35914]]
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.
A 60-day notice published in the Federal Register on May 16, 2025,
vol. 90, No. 94; pp. 21049-51. There were no public comments.
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 of HHS with an annual
report of transplant center-specific survival data.
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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Average
Number of Number of Total burden per Total
Form name \1\ respondents \2\ responses per responses response burden
respondent \3\ (in hours) hours \4\
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Pre-Transplant Information Collection... 182.00 53.80 \5\ 9,788.00 \6\ 2.24 21,902.61
Transplant Procedure and Product 182.00 53.80 \7\ 9,788.00 \8\ 0.75 7356.66
Information............................
Post-Transplant Periodic Information 182.00 418.90 \9\ \10\ 0.57 43,810.53
Collection based on Predetermined 76,232.00
Schedule...............................
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Total............................... 182.00 .............. 95,808.00 ........... 73,069.80
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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 182 as of April 14, 2025. 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 numbers in this column have been rounded to the nearest hundredth and do not sum precisely due to
rounding adjustments throughout the table.
\5\ Total responses for Pre-Transplant Information Collection equals the estimated number of new transplant
patients in 2024.
\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 2.2377.
\7\ Transplant Procedure and Product Information equals estimated number of new transplant patients in 2024.
\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 0.7516.
\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, cause of death, and
subsequent procedures. This number is rounded to the nearest hundredth. The actual burden estimate is 0.5747.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-14397 Filed 7-29-25; 8:45 am]
BILLING CODE 4165-15-P
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