# 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.
**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 *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 HRSA Information Collection Clearance Officer, at *[email protected]* 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 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.
| Form name | Number of | Number of | Total | Average | Total |
| --- | --- | --- | --- | --- | --- |
| Pre-Transplant Information Collection | 182.00 | 53.80 | 9,788.00 | 2.24 | 21,902.61 |
| Transplant Procedure and Product Information | 182.00 | 53.80 | 9,788.00 | 0.75 | 7356.66 |
| Post-Transplant Periodic Information Collection based on Predetermined Schedule | 182.00 | 418.90 | 76,232.00 | 0.57 | 43,810.53 |
| Total | 182.00 | | 95,808.00 | | 73,069.80 |
Maria G. Button,
Director, Executive Secretariat.