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:
202507-0915-003
Status:
Active
Previous ICR Reference No:
202407-0915-001
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:
09/03/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/30/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2028
36 Months From Approved
09/30/2025
Responses
95,808
0
75,101
Time Burden (Hours)
73,070
0
75,101
Cost Burden (Dollars)
0
0
0
Abstract:
The Stem Cell Therapeutic and Research Act of 2005 (Public Law 109-129, December 20, 2005) as amended and codified in Section 379A of the Public Health Service Act (42 U.S.C. 247l), provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. The Public Health Service Act requires the Secretary of HHS to contract for the establishment and maintenance of information related to patients who have received stem cell therapeutic products and to do so using an electronic format. HRSA has established the Stem Cell Therapeutic Outcomes Database (SCTOD), a component of the C.W. Bill Young Cell Transplantation Program (Program), which necessitates certain electronic record-keeping and reporting requirements to perform functions related to hematopoietic stem cell transplantation (HCT) under contract to HHS. Data are collected from transplant centers by the Center for International Blood and Marrow Transplant Research. They are used for ongoing analysis of transplant outcomes to improve treatment and survival for patients who may benefit from cellular therapies.
Authorizing Statute(s):
PL:
Pub.L. 117 - 15 2
Name of Law: Transplant Act of 2021
PL:
Pub.L. 111 - 264 2
Name of Law: The Stem Cell Therapeutic and Research Reauthorization Act of 2010
PL:
Pub.L. 114 - 104 2
Name of Law: The Stem Cell Therapeutic and Research Reauthorization Act of 2015
US Code:
42 USC 247k, section 379
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
60-day Notice:
Federal Register Citation:
Citation Date:
90 FR 21049
05/16/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 35913
07/30/2025
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
Post-Transplant Periodic Information Collection based on Predetermined Schedule
Post-Transplant Periodic Inform Tab
Post-Transplant Periodic Information Collection based on Predetermined Schedule
Pre-Transplant Information Collection
Pre-Transplant Information Coll Tab
Pre-Transplant Information Collection
Transplant Procedure and Product Information
Transplant Procedure_Product Tab
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
95,808
75,101
0
20,707
0
0
Annual Time Burden (Hours)
73,070
75,101
0
-2,031
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The number of responses increased because the number of transplant centers SCTOD collects from was increased to 182 from 178. Total burden hours for pre-transplant collection increased because average burden increased. Over time, there is an expected increase in the number of recipients for whom data are reported, as the number of transplants performed annually increases and survivorship after transplantation improves. The total burden declined because average burden per response for Transplant Procedure and Product information decreased.
Annual Cost to Federal Government:
$5,900,000
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.
Yes
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.
Yes
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:
Laura Cooper 301 443-2126 lcooper@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:
07/30/2025
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