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:
202207-0915-001
Status:
Historical Active
Previous ICR Reference No:
202202-0915-001
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:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/19/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/14/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2025
36 Months From Approved
03/31/2025
Responses
75,101
0
95,600
Time Burden (Hours)
75,101
0
63,031
Cost Burden (Dollars)
0
0
0
Abstract:
The Stem Cell Therapeutic Outcomes Database was established under contract by HRSA to establish and maintain information related to patients who have received stem cell therapeutic products 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 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.
Authorizing Statute(s):
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’’
PL:
Pub.L. 109 - 129 0
Name of Law: The Stem Cell Therapeutic and Research Reauthorization Act of 2010
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:
87 FR 15439
03/18/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 34692
06/07/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
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
Post-Transplant Periodic Information Collection based on Predetermined Schedule
Pre-Transplant Information Collection
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
Transplant Procedure and Product Information
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
75,101
95,600
0
7,701
-28,200
0
Annual Time Burden (Hours)
75,101
63,031
0
33,678
-21,608
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
This is a revised collection of information with an estimated reduction to the overall hour burden inventory to 75,106 due to improvements in burden estimation. As noted in Table 1, the total number of responses is less than previous calculations because of improvements in estimation. The number of responses in any given year is a function of three values: the number of transplants in the year of interest, the number of transplants in previous years, and expected patient survival between the time of transplant and any follow-up activity. Previous estimates assumed all years had the same number of transplants. This improved estimate includes accurate transplant counts from prior years, which are often less that the year of interest.
Annual Cost to Federal Government:
$4,730,240
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:
Joella Roland 301 945-0232 jroland@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:
07/14/2022
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