OMB control number

Stem Cell Therapeutic Outcomes Database

OMB 0915-0310 ยท HHS/HSA.

OMB 0915-0310

The Stem Cell Therapeutic and Research Act of 2005 (Public Law 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 latest form for Stem Cell Therapeutic Outcomes Database expires 2028-09-30 and is listed under ICR 202507-0915-003.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form Post-Transplant Pe Post-Transplant Periodic Information Collection based on Predetermined ScheduleForm
Form Post-Transplant Pe Post-Transplant Periodic Information Collection based on Predetermined ScheduleForm
Form Transplant Procedu Transplant Procedure and Product InformationForm
Form Transplant Procedu Transplant Procedure and Product InformationForm
Form Pre-Transplant Inf Pre-Transplant Information CollectionForm
Form Pre-Transplant Inf Pre-Transplant Information CollectionForm
CIBMTR-HIPAA Ltr PHA Letter 2008Mar26.pdfSupplementary Document
CIBMTR-HIPAA Ltr PHA Letter 2008Mar26.pdf Supplementary Document
Appendices Final_ 10July2025.pdfSupplementary Document
Appendices Final_ 10July2025.pdf Supplementary Document
07102025 - Supporting Statement A - 051620255001 - CLEAN.docxSupporting Statement A
07102025 - Supporting Statement A - 051620255001 - CLEAN.docxSupporting Statement A
Post-Transplant Periodic Information Collection based on Predetermined Schedule Instruction
Post-Transplant Periodic Information Collection based on Predetermined Schedule Form
Post-Transplant Periodic Information Collection based on Predetermined Schedule Form
Transplant Procedure and Product Information Instruction
Transplant Procedure and Product Information Form
Transplant Procedure and Product Information Form
Pre-Transplant Information Collection Instruction
Pre-Transplant Information Collection Form
Pre-Transplant Information Collection Form

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202507-0915-003 Revision of a currently approved collection 2025-07-30
202407-0915-001 No material or nonsubstantive change to a currently approved collection 2024-07-25 Approved without change
202405-0915-001 No material or nonsubstantive change to a currently approved collection 2024-05-15 Approved without change
202404-0915-001 No material or nonsubstantive change to a currently approved collection 2024-04-08 Approved without change
202402-0915-001 No material or nonsubstantive change to a currently approved collection 2024-02-06 Approved without change
202309-0915-005 No material or nonsubstantive change to a currently approved collection 2023-09-20 Approved without change
202302-0915-002 No material or nonsubstantive change to a currently approved collection 2023-02-10 Approved without change
202207-0915-001 Revision of a currently approved collection 2022-07-14 Approved without change
202202-0915-001 Extension without change of a currently approved collection 2022-02-10 Approved with change
202109-0915-001 Revision of a currently approved collection 2021-09-07 Approved without change
202103-0915-003 No material or nonsubstantive change to a currently approved collection 2021-03-29 Withdrawn and continue
202011-0915-003 No material or nonsubstantive change to a currently approved collection 2020-11-30 Approved without change
202007-0915-002 No material or nonsubstantive change to a currently approved collection 2020-07-28 Approved without change
202007-0915-001 Extension without change of a currently approved collection 2020-07-27 Withdrawn and continue
202004-0915-001 No material or nonsubstantive change to a currently approved collection 2020-04-07 Approved with change
202003-0915-002 No material or nonsubstantive change to a currently approved collection 2020-03-16 Approved without change
201909-0915-001 Revision of a currently approved collection 2019-09-04 Approved without change
201712-0915-001 No material or nonsubstantive change to a currently approved collection 2017-12-21 Approved without change
201705-0915-001 No material or nonsubstantive change to a currently approved collection 2017-05-04 Approved without change
201701-0915-001 No material or nonsubstantive change to a currently approved collection 2017-01-09 Approved without change
201609-0915-002 Revision of a currently approved collection 2016-09-13 Approved with change
201312-0915-004 Revision of a currently approved collection 2013-12-19 Approved without change
201306-0915-002 Revision of a currently approved collection 2013-06-13 Approved without change
201009-0915-006 Extension without change of a currently approved collection 2010-09-30 Approved without change
200705-0915-006 New collection (Request for a new OMB Control Number) 2007-05-23 Approved without change

OMB Details

Pre-Transplant Information Collection

Federal Enterprise Architecture: Health - Health Care Services

Information collection instruments
FormNameElectronic accessType
Form Pre-Transplant Information Coll TabPre-Transplant Information CollectionFillable FileableForm

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.