Stem Cell Therapeutic Outcomes Database

Forms and Documents

Document Name	Status
Form 8 3+ Years Post-TED Form	Removed
Form 7 2-Year Post-TED Form	Removed
Form 6 1-Year Post-TED Form	Removed
Form 5 6-Month Post-TED Form	Removed
Form 4 100-Day Post-TED Form	Removed
Form 3A Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts) Form	Removed
Form 2 Disease Classification Form	Removed
Form 1A Baseline Pre-TED (Transplant Essential Data) Form	Removed
Supporting Statement _ SCTOD _ CLEAN 7.13.2022.docx Supporting Statement A	2022-07-13
6 - Change Summary_to HRSA 2022-03-29.pdf Supplementary Document	2022-07-13
5e - Information Collection Domain_Pre-Transplant Information Collection _SCTOD.xlsx Supplementary Document	2022-07-13
5d - Header Definitions_to HRSA 2022-03-29.pdf Supplementary Document	2022-07-13
5c - Post-Transplant Info Collection_to HRSA 2022-03-29.pdf Supplementary Document	2022-07-13
5b - Product Procedure Info Collection_to HRSA 2022-03-29.pdf Supplementary Document	2022-07-13
5a - Pre-Transplant Info Collection_to HRSA 2022-03-29.pdf Supplementary Document	2022-07-13

IC Document Collections

IC ID	Document Title	Status
254631	Post-Transplant Periodic Information Collection based on Predetermined Schedule Other-Information to Private Sector	New
254630	Transplant Procedure and Product Information Other-Information for Private Entites	New
254628	Pre-Transplant Information Collection Other-Information to Private Sector	New
237628	3+ Years Post-TED Form	Removed
237627	2-Year Post-TED Form	Removed
237626	1-Year Post-TED Form	Removed
237625	6-Month Post-TED Form	Removed
237624	100-Day Post-TED Form	Removed
237623	Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts) Form	Removed
237622	Disease Classification Form	Removed
180280	Baseline Pre-TED (Transplant Essential Data) Form	Removed

ICR Details

OMB Control No: 0915-0310	ICR Reference No: 202207-0915-001
Status: Received in OIRA	Previous ICR Reference No: 202202-0915-001
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	Date Submitted to OIRA: 07/14/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2025
Responses	75,101	95,600
Time Burden (Hours)	75,101	63,031
Cost Burden (Dollars)	0	0

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Abstract: The Stem Cell Therapeutic Outcomes Database was established under contract by HRSA to establish and maintain information related to patients who have received stem cell therapeutic products using a standardized, electronic format. Data is collected from transplant centers by the Center for International Blood and Marrow Transplant Research and is used for ongoing analysis of transplant outcomes. HRSA uses the information to carry out its statutory responsibilities. Information is needed to monitor the clinical status of transplantation and to provide the Secretary of HHS with an annual report of transplant center-specific survival data.

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Authorizing Statute(s): US Code: 42 USC 24K, section 379 Name of Law: TRANSPLANT Act of 2021
   PL: Pub.L. 111 - 148 0 Name of Law: TRANSPLANT Act of 2021’’
   PL: Pub.L. 109 - 129 0 Name of Law: The Stem Cell Therapeutic and Research Reauthorization Act of 2010
  

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:
	87 FR 15439	03/18/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 34692	06/07/2022
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
1-Year Post-TED	6	1 Year Post-TED 2450 R5 (current, approved for)
100-Day Post-TED	4	100 Post-TED - 2450 R5 (current, approved for).pdf
2-Year Post-TED	7	2 Year Post-TED 2450 R5 (current, approved for).pdf
3+ Years Post-TED	8	3+ Years Post-TED 2450 R5 (current, approved for).pdf
6-Month Post-TED	5	6 Month Post-TED - 2450 R5 (current, approved for).pdf
Baseline Pre-TED (Transplant Essential Data)	1B, 1A	PandemicImpactTemplate.xlsx PRE-TED ,   FORM 1 - 2400 R8.pdf
Disease Classification	2	2402 R6 (current approved for).pdf
Post-Transplant Periodic Information Collection based on Predetermined Schedule
Pre-Transplant Information Collection
Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts)	3A, 3B, 3C	Infusion - 2006 R5 (current approved for).pdf ,   HLA - 2005 R7 (current approved for).pdf ,   Infectious Disease Markers - 2004 R5 (current approved for).pdf
Transplant Procedure and Product Information

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ICR Summary of Burden

	Total Request	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	75,101	95,600	0	7,701	-28,200	0
Annual Time Burden (Hours)	75,101	63,031	0	33,678	-21,608	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: This is a revised collection of information with an estimated reduction to the overall hour burden inventory to 75,106 due to improvements in burden estimation. As noted in Table 1, the total number of responses is less than previous calculations because of improvements in estimation. The number of responses in any given year is a function of three values: the number of transplants in the year of interest, the number of transplants in previous years, and expected patient survival between the time of transplant and any follow-up activity. Previous estimates assumed all years had the same number of transplants. This improved estimate includes accurate transplant counts from prior years, which are often less that the year of interest.

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Annual Cost to Federal Government: $4,730,240

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.     No

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.     No

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

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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: 07/14/2022

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