Stem Cell Therapeutic Outcomes Database

Forms and Documents

Document Name	Status
Form 8 3+ Years Post-TED Form	Modified
Form 7 2-Year Post-TED Form	Modified
Form 6 1-Year Post-TED Form	Modified
Form 5 6-Month Post-TED Form	Modified
Form 4 100-Day Post-TED Form	Modified
Form 3A Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts) Form	Modified
Form 2 Disease Classification Form	Modified
Form 1A Baseline Pre-TED (Transplant Essential Data) Form	Modified
FINAL SUPPORTING STATEMENT A - CLEAN.docx Supporting Statement A	2021-09-03
ATTACH - UNOS DLA HRSA Meeting Agenda.docx Supplementary Document	2021-09-03
HRSA SIGNED Memo for OIRA 8-30-31.pdf Supplementary Document	2021-09-03

IC Document Collections

IC ID	Document Title	Status
237628	3+ Years Post-TED Form	Modified
237627	2-Year Post-TED Form	Modified
237626	1-Year Post-TED Form	Modified
237625	6-Month Post-TED Form	Modified
237624	100-Day Post-TED Form	Modified
237623	Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts) Form	Modified
237622	Disease Classification Form	Modified
180280	Baseline Pre-TED (Transplant Essential Data) Form	Modified

ICR Details

OMB Control No: 0915-0310	ICR Reference No: 202109-0915-001
Status: Received in OIRA	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
Date Submitted to OIRA: 09/07/2021

	Requested	Previously Approved
Expiration Date	6 Months From Approved	10/31/2022
Responses	95,600	95,600
Time Burden (Hours)	63,031	62,583
Cost Burden (Dollars)	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)	3C, 3A, 3B	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 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

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

---

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

---