Stem Cell Therapeutic Outcomes Database

OMB 0915-0310

The Stem Cell Therapeutic and Research Act of 2005, Public Law (Pub. L.) 109–129, as amended by the Stem Cell Therapeutic and Research Reauthorization Act of 2015, Public Law 114-104 (the Act), provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. HRSA’s Healthcare Systems Bureau has established the Stem Cell Therapeutic Outcomes Database, and the operation of this database necessitates certain record keeping and reporting requirements in order to perform the functions related to hematopoietic stem cell transplantation under contract to the U.S. Department of Health and Human Services (HHS). The Act requires the Secretary to contract for the establishment and maintenance of information related to patients who have received stem cell therapeutic products and to do so using a standardized, electronic format. Data is collected from transplant centers and is used for ongoing analysis of transplant outcomes. HRSA uses the information in order to carry out its statutory responsibilities, including providing the Secretary of HHS with an annual report of transplant center-specific survival data.

The latest form for Stem Cell Therapeutic Outcomes Database expires 2022-10-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
MASTER_Current SCTOD Information Collections-Spring 2024_to HRSA 2024-04-08.xlsx Justification for No Material/Nonsubstantive Change
MASTER_Current SCTOD Information Collections-Spring 2024_to HRSA 2024-04-08.xlsx Justification for No Material/Nonsubstantive Change
SCTOD_OMB NonSubstantive Change Request Spring 2024_to HRSA 2024-04-08.docx Justification for No Material/Nonsubstantive Change
SCTOD_OMB NonSubstantive Change Request Spring 2024_to HRSA 2024-04-08.docx Justification for No Material/Nonsubstantive Change
02062024 - Current SCTOD Information Collections to HRSA - 020620245001.xlsx Justification for No Material/Nonsubstantive Change
02062024 - Current SCTOD Information Collections to HRSA - 020620245001.xlsx Justification for No Material/Nonsubstantive Change
02062024 - Memo to OMB - SCTOD OMB Non-Substantive Change Request - CLEAN.docx Justification for No Material/Nonsubstantive Change
02062024 - Memo to OMB - SCTOD OMB Non-Substantive Change Request - CLEAN.docx Justification for No Material/Nonsubstantive Change
08142023 - Tab B - Current SCTOD Information Collections to HRSA - 081420235006.xlsx Supplementary Document
08142023 - Tab B - Current SCTOD Information Collections to HRSA - 081420235006.xlsx Supplementary Document
08142023 - Tab A - Published FRN 2022-12225 Highlighted - 081420235006.PDF Supplementary Document
08142023 - Tab A - Published FRN 2022-12225 Highlighted - 081420235006.PDF Supplementary Document
08182023 - SCTOD Non-Substantive Change Memo - OMB 0915-0310 - 081420235006.docx Justification for No Material/Nonsubstantive Change
08182023 - SCTOD Non-Substantive Change Memo - OMB 0915-0310 - 081420235006.docx Justification for No Material/Nonsubstantive Change
01262023 - Attachment 1 - Current SCTOD Information Collections - Incremental Changes.xlsx Justification for No Material/Nonsubstantive Change
01262023 - Attachment 1 - Current SCTOD Information Collections - Incremental Changes.xlsx Justification for No Material/Nonsubstantive Change
01262023 - Change Memo - SCTOD Collection - OMB 0915-0310.docx Justification for No Material/Nonsubstantive Change
01262023 - Change Memo - SCTOD Collection - OMB 0915-0310.docx Justification for No Material/Nonsubstantive Change
Supporting Statement _ SCTOD _ CLEAN 7.13.2022.docx Supporting Statement A
Supporting Statement _ SCTOD _ CLEAN 7.13.2022.docx Supporting Statement A
6 - Change Summary_to HRSA 2022-03-29.pdf Supplementary Document
6 - Change Summary_to HRSA 2022-03-29.pdf Supplementary Document
5e - Information Collection Domain_Pre-Transplant Information Collection _SCTOD.xlsx Supplementary Document
5e - Information Collection Domain_Pre-Transplant Information Collection _SCTOD.xlsx Supplementary Document
5d - Header Definitions_to HRSA 2022-03-29.pdf Supplementary Document
5d - Header Definitions_to HRSA 2022-03-29.pdf Supplementary Document
5c - Post-Transplant Info Collection_to HRSA 2022-03-29.pdf Supplementary Document
5c - Post-Transplant Info Collection_to HRSA 2022-03-29.pdf Supplementary Document
5b - Product Procedure Info Collection_to HRSA 2022-03-29.pdf Supplementary Document
5b - Product Procedure Info Collection_to HRSA 2022-03-29.pdf Supplementary Document
5a - Pre-Transplant Info Collection_to HRSA 2022-03-29.pdf Supplementary Document
5a - Pre-Transplant Info Collection_to HRSA 2022-03-29.pdf Supplementary Document
Post-Transplant Periodic Information Collection based on Predetermined Schedule Other-Information to Private Sector
Transplant Procedure and Product Information Other-Information for Private Entites
Pre-Transplant Information Collection Other-Information to Private Sector

All Historical Document Collections

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

Baseline Pre-TED (Transplant Essential Data)

Federal Enterprise Architecture: Health - Health Care Services

Form 1	11.10.2020 2400 Form R8 - Change Memo Package SCTOD OMB 0915-0310 CLEAN.docx	Fillable Fileable	Form
Form 1	PandemicImpactTemplate.xlsx PRE-TED	Fillable Fileable	Form

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