Stem Cell Therapeutic Outcomes Database

Forms and Documents

Document Name	Status
Form 100 day Stem Cell Therapeutic Outcomes Database (Post-Trans) Form	New
Form ProdForm Stem Cell Therapeutic Outcomes Database (Prod Form) Form	New
Form pre ted Stem Cell Therapeutic Outcomes Database (Pre-TED) Form	New
cibmtr hipaa letter.pdf Supplementary Document	2007-05-22
stem cell database act.pdf Supplementary Document	2007-05-22
ss stem cell.doc Supporting Statement A	2007-05-22

IC Document Collections

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

ICR Details

OMB Control No: 0915-0310	ICR Reference No: 200705-0915-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Stem Cell Therapeutic Outcomes Database
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/15/2007
	Date Received in OIRA: 05/23/2007
Terms of Clearance: This ICR is approved without change. Should the associated SORN change and alter how the data collected can be used, HRSA should submit an ICR revision.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2010	36 Months From Approved
Responses	30,825	0	0
Time Burden (Hours)	32,040	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: HRSA is requesting approval of the data collection instruments for the Stem Cell Therapeutic Outcomes Database, one component of the C.W. Bill Young Cell Transplantation Program. Operation of this database necessitates certain reporting requirements in order to perform the functions related to hematopoietic stem cell transplantation.

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Authorizing Statute(s): US Code: 42 USC 379A Name of Law: Stem Cell Therapeutic Outcomes Database
  

Citations for New Statutory Requirements: PL: Pub.L. 109 - 129 379A Name of Law: Stem Cell Therapeutic Outcomes Database

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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:
	71 FR 55493	09/22/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 26136	05/08/2007
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 (Pre-TED)	pre ted	pre ted
Stem Cell Therapeutic Outcomes Database (Prod Form)	ProdForm	Product Form
Stem Cell Therapeutic Outcomes Database (Post-Trans)	100 day	post ted 100 day

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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	30,825	0	30,825	0	0	0
Annual Time Burden (Hours)	32,040	0	32,040	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: This activity is a program change with an increase in burden for the agency due to compliance with the Stem Cell Therapeutic and Research Act of 2005 which requires the establishment of a Stem Cell Therapeutic Outcomes Database

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Annual Cost to Federal Government: $3,500,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 05/23/2007

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