Stem Cell Therapeutic Outcomes Database

Forms and Documents

Document	Type	Status	Availability
Form PostTed Stem Cell Therapeutic Outcomes Database (Post-Trans)	Form	Modified	Repair queued
Form ProdForm Stem Cell Therapeutic Outcomes Database (Prod Form)	Form	Modified	Repair queued
Form pre-ted Stem Cell Therapeutic Outcomes Database (Pre-TED)	Form	Modified	Repair queued
pre-ted-instructions.pdf	Supplementary Document	Uploaded 2010-09-16	Repair queued
CIBMTR - SCTOD PHA Letter 2007Mar23.pdf	Supplementary Document	Uploaded 2007-05-11	Repair queued
Supporting Statement_stem_cell_2010.doc	Supporting Statement A	Uploaded 2010-09-16	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
180282	Stem Cell Therapeutic Outcomes Database (Post-Trans)	Form	Modified
180281	Stem Cell Therapeutic Outcomes Database (Prod Form)	Form	Modified
180280	Stem Cell Therapeutic Outcomes Database (Pre-TED)	Form	Modified

ICR Details

OMB Control No: 0915-0310	ICR Reference No: 201009-0915-006
Status: Historical Active	Previous ICR Reference No: 200705-0915-006
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Stem Cell Therapeutic Outcomes Database
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/20/2010
	Date Received in OIRA: 09/30/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2013	36 Months From Approved	12/31/2010
Responses	38,500	0	30,825
Time Burden (Hours)	38,700	0	32,040
Cost Burden (Dollars)	0	0	0

---

Abstract: HRSA is requesting an extension 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.

---

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

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 20602	04/20/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 48692	08/11/2010
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Stem Cell Therapeutic Outcomes Database (Prod Form)	ProdForm	ProdForm
Stem Cell Therapeutic Outcomes Database (Post-Trans)	PostTed	PostTed
Stem Cell Therapeutic Outcomes Database (Pre-TED)	pre-ted	pre-ted

---

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	38,500	30,825	0	0	7,675	0
Annual Time Burden (Hours)	38,700	32,040	0	0	6,660	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:

---

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]? 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

---

Common Form ICR:  No

---

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: 09/30/2010

---