Stem Cell Therapeutic Outcomes Database

ICR 201701-0915-001

OMB: 0915-0310

Federal Form Document

ICR Details
0915-0310 201701-0915-001
Historical Active 201609-0915-002
HHS/HSA 21065
Stem Cell Therapeutic Outcomes Database
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 01/09/2017
Retrieve Notice of Action (NOA) 01/09/2017
  Inventory as of this Action Requested Previously Approved
01/31/2020 01/31/2020 01/31/2020
59,800 0 59,800
68,660 0 68,660
0 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. 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.

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
  
None

Not associated with rulemaking

  81 FR 31244 05/18/2016
81 FR 59641 08/30/2016
No

  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
No
No
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.

$4,000,000
No
No
No
No
No
Uncollected
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.
01/09/2017


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