Stem Cell Therapeutic Outcomes Database

ICR 202103-0915-003

OMB: 0915-0310

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Form
Modified
Form
Modified
Form
Modified
Form
Modified
Form
Unchanged
Form
Unchanged
Form
Modified
Justification for No Material/Nonsubstantive Change
2021-03-29
Justification for No Material/Nonsubstantive Change
2021-03-29
Justification for No Material/Nonsubstantive Change
2020-11-30
Justification for No Material/Nonsubstantive Change
2020-07-28
Justification for No Material/Nonsubstantive Change
2020-07-28
Justification for No Material/Nonsubstantive Change
2020-04-08
Justification for No Material/Nonsubstantive Change
2020-03-16
Supplementary Document
2019-09-03
Supplementary Document
2019-09-03
Supplementary Document
2019-09-03
Supporting Statement A
2019-09-03
IC Document Collections
ICR Details
0915-0310 202103-0915-003
Received in OIRA 202011-0915-003
HHS/HSA 21065
Stem Cell Therapeutic Outcomes Database
No material or nonsubstantive change to a currently approved collection   No
Regular 03/29/2021
  Requested Previously Approved
10/31/2022 10/31/2022
95,600 95,600
62,583 62,583
0 0

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.

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
   US Code: 42 USC 24K, section 379 Name of Law: Stem Cell Therapeutic Outcomes Database
   PL: Pub.L. 114 - 104 0 Name of Law: Research Reauthorization Act of 2015
  
None

Not associated with rulemaking

  84 FR 8334 03/07/2019
84 FR 43814 08/22/2019
No

8
IC Title Form No. Form Name
1-Year Post-TED 6, 6 R, 9, 9 R Form 2450 R5 - CURRENT.pdf 1 YEAR POST-TED 3/29/21 ,   Form 2450 R6 - REDLINE.docx 1 YEAR POST-TED 3/29/21 ,   Form 2900 R4 - CURRENT.pdf ,   Form 2900 R5 - REDLINE.docx
100-Day Post-TED 4, 4 R, 9, 9 R Form 2450 R5 - CURRENT.pdf 100 day Post-TED 3/29/21 ,   Form 2450 R6 - REDLINE.docx 100 day Post-TED 3/29/21 ,   Form 2900 R4 - CURRENT.pdf ,   Form 2900 R5 - REDLINE.docx
2-Year Post-TED 7, 7 R, 9 , 9 R Form 2450 R5 - CURRENT.pdf 2 YEAR POST-TED 3/29/21 ,   Form 2450 R6 - REDLINE.docx 2 YEAR POST-TED 3/29/21 ,   Form 2900 R4 - CURRENT.pdf ,   Form 2900 R5 - REDLINE.docx
3-Years Post-TED 8 R, 8, 9 R, 9 Form 2450 R5 - CURRENT.pdf 3 YEAR POST-TED 3/29/21 ,   Form 2450 R6 - REDLINE.docx 3 YEAR POST-TED 3/29/21 ,   Form 2900 R4 - CURRENT.pdf ,   Form 2900 R5 - REDLINE.docx
6-Month Post-TED 5, 5 R, 9, 9 R Form 2450 R5 - CURRENT.pdf 6 MONTH POST-TED 3/29/21 ,   Form 2450 R6 - REDLINE.docx 6 MONTH POST-TED 3/29/21 ,   Form 2900 R4 - CURRENT.pdf ,   Form 2900 R5 - REDLINE.docx
Baseline Pre-TED (Transplant Essential Data) 1, 2R, 2 PandemicImpactTemplate.xlsx PRE-TED ,   Form 2400 R8 - CURRENT.pdf ,   Form 2400 R9 - REDLINE.docx
Disease Classification 2, 2-2 Form 2402 R5.pdf Disease Classification ,   Draft 2402 R6.docx Disease Classification 2
Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts) 3 FormProductForm-Infusion, HLA, Infectious Disease Marker.pdf

  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 95,600 95,600 0 0 0 0
Annual Time Burden (Hours) 62,583 62,583 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$4,000,000
No
    No
    No
No
No
No
Yes
Elyana Bowman 301 443-3983 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/29/2021


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