View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0915-0310
ICR Reference No:
202109-0915-001
Status:
Historical Active
Previous ICR Reference No:
202011-0915-003
Agency/Subagency:
HHS/HSA
Agency Tracking No:
21065
Title:
Stem Cell Therapeutic Outcomes Database
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
09/10/2021
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/23/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/07/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2022
6 Months From Approved
10/31/2022
Responses
95,600
0
95,600
Time Burden (Hours)
63,031
0
62,583
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Emergency Justfication:
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.
Authorizing Statute(s):
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’’
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
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
8
IC Title
Form No.
Form Name
1-Year Post-TED
6
1 Year Post-TED 2450 R5 (current, approved for)
100-Day Post-TED
4
100 Post-TED - 2450 R5 (current, approved for).pdf
2-Year Post-TED
7
2 Year Post-TED 2450 R5 (current, approved for).pdf
3+ Years Post-TED
8
3+ Years Post-TED 2450 R5 (current, approved for).pdf
6-Month Post-TED
5
6 Month Post-TED - 2450 R5 (current, approved for).pdf
Baseline Pre-TED (Transplant Essential Data)
1B, 1A
PandemicImpactTemplate.xlsx PRE-TED
,
FORM 1 - 2400 R8.pdf
Disease Classification
2
2402 R6 (current approved for).pdf
Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts)
3A, 3B, 3C
Infusion - 2006 R5 (current approved for).pdf
,
HLA - 2005 R7 (current approved for).pdf
,
Infectious Disease Markers - 2004 R5 (current approved for).pdf
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
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
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
There were very slight increases in burden per response in Form 1 - Baseline Pre-TED and Form 4 - 100-Post-TED.
Annual Cost to Federal Government:
$4,601,550
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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?
Yes
Agency Contact:
Elyana Bowman 301 443-3983 enadjem@hrsa.gov
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:
09/07/2021
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