Stem Cell Therapeutic Outcomes Database

Forms and Documents

Document Name	Status
Form 8 3-Years Post-TED Form	New
Form 7 2-Year Post-TED Form	New
Form 6 1-Year Post-TED Form	New
Form 5 6-Month Post-TED Form	New
Form 4 100-Day Post-TED Form	New
Form 3 Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts) Form	New
Form 2 Disease Classification Form	New
Form 1 Stem Cell Therapeutic Outcomes Database (Post-Trans) Form	Removed
Form 1 Stem Cell Therapeutic Outcomes Database (Product Form) Form	Removed
Form 1 Baseline Pre-TED (Transplant Essential Data) Form	Modified
Form Change Summary TED Forms - Round 2 CLEAN.docx Supplementary Document	2019-09-03
CIBMTR HIPAA Letter 03.26.08.pdf Supplementary Document	2019-09-03
06.13.19 - Published 60-Day SCTOD FRN 03.07.19.pdf .pdf Supplementary Document	2019-09-03
Supporting Statement A .docx Supporting Statement A	2019-09-03

IC Document Collections

IC ID	Document Title	Status
237628	3-Years Post-TED Form	New
237627	2-Year Post-TED Form	New
237626	1-Year Post-TED Form	New
237625	6-Month Post-TED Form	New
237624	100-Day Post-TED Form	New
237623	Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts) Form	New
237622	Disease Classification Form	New
180282	Stem Cell Therapeutic Outcomes Database (Post-Trans) Form	Removed
180281	Stem Cell Therapeutic Outcomes Database (Product Form) Form	Removed
180280	Baseline Pre-TED (Transplant Essential Data) Form	Modified

ICR Details

OMB Control No: 0915-0310	ICR Reference No: 201909-0915-001
Status: Historical Active	Previous ICR Reference No: 201712-0915-001
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: 10/16/2019
	Date Received in OIRA: 09/04/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	01/31/2020
Responses	95,600	0	59,800
Time Burden (Hours)	62,583	0	68,660
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): PL: Pub.L. 111 - 264 379 Name of Law: The Stem Cell Therapeutic and Research Act of 2005
   PL: Pub.L. 114 - 104 0 Name of Law: Research Reauthorization Act of 2015
   PL: Pub.L. 109 - 129 0 Name of Law: The Stem Cell Therapeutic and Research Reauthorization Act of 2010
   US Code: 42 USC 24K, section 379 Name of Law: Stem Cell Therapeutic Outcomes Database
  

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:
	84 FR 8334	03/07/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 43814	08/22/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Stem Cell Therapeutic Outcomes Database (Post-Trans)	1	Draft 2450 r4. Post-TED form.doc
Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts)	3	ProductForm-Infusion, HLA, Infectious Disease Marker.pdf
1-Year Post-TED	6	1-Year Post-TED
2-Year Post-TED	7	2-Year Post-TED
100-Day Post-TED	4	100 DayPost-TED.pdf
6-Month Post-TED	5	6-Month Post-TED
3-Years Post-TED	8	3-Years Post-TED
Disease Classification	2	Disease Classification
Baseline Pre-TED (Transplant Essential Data)	1	Baseline Pre-TED (Transplant Essential Data)
Stem Cell Therapeutic Outcomes Database (Product Form)	1, 2, 3	Form_2006_R4+. Hematopoietic Cellular Transplant (HCT) Infusion ,   Draft Product Form 2005 HLA r6 ,   Form_2004_R4+. Infectious Disease Markers

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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	95,600	59,800	0	35,800	0	0
Annual Time Burden (Hours)	62,583	68,660	0	-6,077	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: Changing Forms

Short Statement: Forms were combined or deleted altogether, therefore increasing and decreasing total burden hours.

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Annual Cost to Federal Government: $4,000,000

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.     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? Uncollected

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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: 09/04/2019

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