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:
201909-0915-001
Status:
Historical Active
Previous ICR Reference No:
201712-0915-001
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:
10/16/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/04/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2022
36 Months From Approved
01/31/2020
Responses
95,600
0
59,800
Time Burden (Hours)
62,583
0
68,660
Cost Burden (Dollars)
0
0
0
Abstract:
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, and the 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 and is used for ongoing analysis of transplant outcomes. HRSA uses the information in order to carry out its statutory responsibilities, including providing the Secretary of HHS with an annual report of transplant center-specific survival data.
Authorizing Statute(s):
PL:
Pub.L. 111 - 264 379
Name of Law: The Stem Cell Therapeutic and Research Act of 2005
PL:
Pub.L. 114 - 104 0
Name of Law: Research Reauthorization Act of 2015
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: Stem Cell Therapeutic Outcomes Database
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:
84 FR 8334
03/07/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 43814
08/22/2019
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
100-Day Post-TED
4
100 DayPost-TED.pdf
2-Year Post-TED
7
2-Year Post-TED
3-Years Post-TED
8
3-Years Post-TED
6-Month Post-TED
5
6-Month Post-TED
Baseline Pre-TED (Transplant Essential Data)
1
Baseline Pre-TED (Transplant Essential Data)
Disease Classification
2
Disease Classification
Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts)
3
ProductForm-Infusion, HLA, Infectious Disease Marker.pdf
Stem Cell Therapeutic Outcomes Database (Post-Trans)
1
Draft 2450 r4. Post-TED form.doc
Stem Cell Therapeutic Outcomes Database (Product Form)
1, 2, 3
Form_2006_R4+. Hematopoietic Cellular Transplant (HCT) Infusion
,
Draft Product Form 2005 HLA r6
,
Form_2004_R4+. Infectious Disease Markers
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
59,800
0
35,800
0
0
Annual Time Burden (Hours)
62,583
68,660
0
-6,077
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:
Changing Forms
Short Statement:
Forms were combined or deleted altogether, therefore increasing and decreasing total burden hours.
Annual Cost to Federal Government:
$4,000,000
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.
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?
Uncollected
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:
09/04/2019
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