OMB control number

Stem Cell Therapeutic Outcomes Database

OMB 0915-0310 · 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 can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form Post-Transplant Pe Post-Transplant Periodic Information Collection based on Predetermined Schedule Form
Form Post-Transplant Pe Post-Transplant Periodic Information Collection based on Predetermined Schedule Form
Form Transplant Procedu Transplant Procedure and Product Information Form
Form Transplant Procedu Transplant Procedure and Product Information Form
Form Pre-Transplant Inf Pre-Transplant Information Collection Form
Form Pre-Transplant Inf Pre-Transplant Information Collection Form
CIBMTR-HIPAA Ltr PHA Letter 2008Mar26.pdf Supplementary Document
CIBMTR-HIPAA Ltr PHA Letter 2008Mar26.pdf Supplementary Document
Appendices Final_ 10July2025.pdf Supplementary Document
Appendices Final_ 10July2025.pdf Supplementary Document
07102025 - Supporting Statement A - 051620255001 - CLEAN.docx Supporting Statement A
07102025 - Supporting Statement A - 051620255001 - CLEAN.docx Supporting Statement A
Post-Transplant Periodic Information Collection based on Predetermined Schedule Form
Post-Transplant Periodic Information Collection based on Predetermined Schedule Form
Post-Transplant Periodic Information Collection based on Predetermined Schedule Instruction
Transplant Procedure and Product Information Form
Transplant Procedure and Product Information Form
Transplant Procedure and Product Information Instruction
Pre-Transplant Information Collection Form
Pre-Transplant Information Collection Form
Pre-Transplant Information Collection Instruction

All Historical Document Collections

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

OMB Details

Pre-Transplant Information Collection

Federal Enterprise Architecture: Health - Health Care Services

Form Pre-Transplant Information Coll Tab

Pre-Transplant Information Collection

Fillable Fileable

Form

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