Stem Cell Therapeutic Outcomes Database

Forms and Documents

Document Name	Status
Form 1 Stem Cell Therapeutic Outcomes Database (Post-Trans) Form	Unchanged
Form 1 Stem Cell Therapeutic Outcomes Database (Product Form) Form	Unchanged
Form 1 Stem Cell Therapeutic Outcomes Database (Pre-TED Form 2400) Form	Unchanged
Draft 2402 r1 - Pre-TED Disease (split-track changes).docx Supplementary Document	2017-01-05
Draft 2400 r5 - Pre-TED (split-track changes).docx Supplementary Document	2017-01-05
2016 OMB Request for Non-Substantive Change_SCTOD Pre-TED OMB0915-0310 DRAFT v3 2016-12-07.docx Justification for No Material/Nonsubstantive Change	2017-01-05
HIPAA- Privacy Rule Letter.pdf Supplementary Document	2016-09-12
Supporting Statement_Revised PASSBACK 2016-11-08 CLEAN.docx Supporting Statement A	2017-01-03

IC Document Collections

IC ID	Document Title	Status
180282	Stem Cell Therapeutic Outcomes Database (Post-Trans) Form	Unchanged
180281	Stem Cell Therapeutic Outcomes Database (Product Form) Form	Unchanged
180280	Stem Cell Therapeutic Outcomes Database (Pre-TED Form 2400) Form	Unchanged

ICR Details

OMB Control No: 0915-0310	ICR Reference No: 201701-0915-001
Status: Historical Active	Previous ICR Reference No: 201609-0915-002
Agency/Subagency: HHS/HSA	Agency Tracking No: 21065
Title: Stem Cell Therapeutic Outcomes Database
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/09/2017
	Date Received in OIRA: 01/09/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	01/31/2020	01/31/2020
Responses	59,800	0	59,800
Time Burden (Hours)	68,660	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. 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 by the Center for International Blood and Marrow Transplant Research and is used for ongoing analysis of transplant outcomes. HRSA uses the information in order 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. The increase in burden is due to an increase in the annual number of transplants and increasing survivorship after transplantation.

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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. 109 - 129 0 Name of Law: The Stem Cell Therapeutic and Research Reauthorization Act of 2010
   PL: Pub.L. 114 - 104 0 Name of Law: Research Reauthorization Act of 2015
   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:
	81 FR 31244	05/18/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 59641	08/30/2016
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
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
Stem Cell Therapeutic Outcomes Database (Pre-TED Form 2400)	1	Form_2400_R4+. Pre-Transplant Essential Data (Pre-Ted Form 2400)
Stem Cell Therapeutic Outcomes Database (Post-Trans)	1	Draft 2450 r4. Post-TED form.doc

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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	59,800	59,800	0	0	0	0
Annual Time Burden (Hours)	68,660	68,660	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: There will be a gradual increase in the cumulative reporting burden over time commensurate with the number of survivors for which transplant centers must submit an Annual Post-TED.

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

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 01/09/2017

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