Stem Cell Therapeutic Outcomes Database

OMB 0915-0310

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
Justification for No Material/Nonsubstantive Change
Justification for No Material/Nonsubstantive Change
Justification for No Material/Nonsubstantive Change
Supplementary Document
Justification for No Material/Nonsubstantive Change
Justification for No Material/Nonsubstantive Change
Justification for No Material/Nonsubstantive Change
Justification for No Material/Nonsubstantive Change
Supplementary Document
Supplementary Document
Justification for No Material/Nonsubstantive Change
Justification for No Material/Nonsubstantive Change
Justification for No Material/Nonsubstantive Change
Supporting Statement A
Supplementary Document
Supplementary Document
Supplementary Document
Supplementary Document
Supplementary Document
Supplementary Document
All Historical Document Collections
Approved without change
No material or nonsubstantive change to a currently approved collection 2024-07-25
Approved without change
No material or nonsubstantive change to a currently approved collection 2024-05-15
Approved without change
No material or nonsubstantive change to a currently approved collection 2024-04-08
Approved without change
No material or nonsubstantive change to a currently approved collection 2024-02-06
Approved without change
No material or nonsubstantive change to a currently approved collection 2023-09-20
Approved without change
No material or nonsubstantive change to a currently approved collection 2023-02-10
Approved without change
Revision of a currently approved collection 2022-07-14
Approved with change
Extension without change of a currently approved collection 2022-02-10
Approved without change
Revision of a currently approved collection 2021-09-07
Withdrawn and continue
No material or nonsubstantive change to a currently approved collection 2021-03-29
Approved without change
No material or nonsubstantive change to a currently approved collection 2020-11-30
Approved without change
No material or nonsubstantive change to a currently approved collection 2020-07-28
Withdrawn and continue
Extension without change of a currently approved collection 2020-07-27
Approved with change
No material or nonsubstantive change to a currently approved collection 2020-04-07
Approved without change
No material or nonsubstantive change to a currently approved collection 2020-03-16
Approved without change
Revision of a currently approved collection 2019-09-04
Approved without change
No material or nonsubstantive change to a currently approved collection 2017-12-21
Approved without change
No material or nonsubstantive change to a currently approved collection 2017-05-04
Approved without change
No material or nonsubstantive change to a currently approved collection 2017-01-09
Approved with change
Revision of a currently approved collection 2016-09-13
Approved without change
Revision of a currently approved collection 2013-12-19
Approved without change
Revision of a currently approved collection 2013-06-13
Approved without change
Extension without change of a currently approved collection 2010-09-30
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 111.10.2020 2400 Form R8 - Change Memo Package SCTOD OMB 0915-0310 CLEAN.docx Fillable FileableForm
Form 1PandemicImpactTemplate.xlsx PRE-TEDFillable FileableForm

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


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