Stem Cell Therapeutic Outcomes Database

OMB Control No: 0915-0310	ICR Reference No: 202507-0915-003
Status: Active	Previous ICR Reference No: 202407-0915-001
Agency/Subagency: HHS/HSA	Agency Tracking No: 21065
Title: Stem Cell Therapeutic Outcomes Database
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/03/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/30/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2028	36 Months From Approved	09/30/2025
Responses	95,808	0	75,101
Time Burden (Hours)	73,070	0	75,101
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): PL: Pub.L. 117 - 15 2 Name of Law: Transplant Act of 2021    PL: Pub.L. 111 - 264 2 Name of Law: The Stem Cell Therapeutic and Research Reauthorization Act of 2010    PL: Pub.L. 114 - 104 2 Name of Law: The Stem Cell Therapeutic and Research Reauthorization Act of 2015    US Code: 42 USC 247k, section 379 Name of Law: TRANSPLANT Act of 2021

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 21049	05/16/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 35913	07/30/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title Form No. Form Name Post-Transplant Periodic Information Collection based on Predetermined Schedule Post-Transplant Periodic Inform Tab Post-Transplant Periodic Information Collection based on Predetermined Schedule Pre-Transplant Information Collection Pre-Transplant Information Coll Tab Pre-Transplant Information Collection Transplant Procedure and Product Information Transplant Procedure_Product Tab Transplant Procedure and Product Information

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	95,808	75,101	0	20,707	0	0
Annual Time Burden (Hours)	73,070	75,101	0	-2,031	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The number of responses increased because the number of transplant centers SCTOD collects from was increased to 182 from 178. Total burden hours for pre-transplant collection increased because average burden increased. Over time, there is an expected increase in the number of recipients for whom data are reported, as the number of transplants performed annually increases and survivorship after transplantation improves. The total burden declined because average burden per response for Transplant Procedure and Product information decreased.

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Annual Cost to Federal Government: $5,900,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Yes

Agency Contact: Laura Cooper 301 443-2126 [email protected]

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
		(a) It is necessary for the proper performance of agency functions;
		(b) It avoids unnecessary duplication;
		(c) It reduces burden on small entities;
		(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
		(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
		(f) It indicates the retention periods for recordkeeping requirements;
		(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
			(i) Why the information is being collected;
			(ii) Use of information;
			(iii) Burden estimate;
			(iv) Nature of response (voluntary, required for a benefit, or mandatory);
			(v) Nature and extent of confidentiality; and
			(vi) Need to display currently valid OMB control number;
		(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
		(i) It uses effective and efficient statistical survey methodology (if applicable); and
		(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date: 07/30/2025

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