Stem Cell Therapeutic Outcomes Database

ICR 202109-0915-001

OMB: 0915-0310

Federal Form Document

IC Document Collections
ICR Details
0915-0310 202109-0915-001
Received in OIRA 202011-0915-003
HHS/HSA 21065
Stem Cell Therapeutic Outcomes Database
Revision of a currently approved collection   No
Emergency 09/10/2021
09/07/2021
  Requested Previously Approved
6 Months From Approved 10/31/2022
95,600 95,600
63,031 62,583
0 0

Given the rapid evolution of COVID-19 and its impact on those with compromised immune systems, it is imperative for the transplant community to quickly collect and update COVID-19 related data. Having access to COVID-19 vaccination status on bone marrow recipients and understanding immune responses will assist with making informed decisions regarding direct clinical care. This information will also help clinicians and researchers make informed policy decisions. For example, CDC advisors are looking for COVID-19 vaccination data on blood stem cell transplant recipients; however, collecting these data on existing OMB forms is not yet approved; therefore, this vital information has not been collected. The CDC could potentially use this information to make informed decisions regarding whether to issue any recommendations for this medically vulnerable population.
The SCTOD data collection changes must be captured and completed as soon as practical. HRSA would like to start requiring data collection no later than September 10, 2021. Given the rapid evolution of the COVID-19 public health emergency and its impact on immunocompromised patients, availability of new vaccines, and continual changes in vaccination recommendations, HRSA wants to leverage the required data collection platform of SCTOD to obtain vaccine information for all US allogeneic hematopoietic stem cell transplant (HCT) recipients.

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: TRANSPLANT Act of 2021
   PL: Pub.L. 111 - 148 0 Name of Law: TRANSPLANT Act of 2021’’
  
None

Not associated with rulemaking

No

  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) 63,031 62,583 0 448 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
There were very slight increases in burden per response in Form 1 - Baseline Pre-TED and Form 4 - 100-Post-TED.

$4,601,550
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.
09/07/2021


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