Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation (SRTR)

Forms and Documents

Document Name	Status
Form 1 Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation Form and Instruction	Unchanged
04022021 - Change Memo - SRTR Living Organ Donation 0915-0034 - CLEAN.docx Justification for No Material/Nonsubstantive Change	2021-04-07
04022021 - Supporting Statement A - SRTR Change Memo - CLEAN.docx Supporting Statement A	2021-04-07

IC Document Collections

IC ID	Document Title	Status
228713	Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation Form and Instruction	Unchanged

ICR Details

OMB Control No: 0906-0034	ICR Reference No: 202104-0906-004
Status: Received in OIRA	Previous ICR Reference No: 202012-0906-003
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation (SRTR)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/07/2021

	Requested	Previously Approved
Expiration Date	02/29/2024	02/29/2024
Responses	4,242	4,242
Time Burden (Hours)	1,251	1,251
Cost Burden (Dollars)	0	0

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Abstract: The Scientific Registry of Transplant Recipients has established a living donor registry known as the Living Donor Collective, which will collect data on long-term health outcomes of potential living donors registered at participating programs. These data, which are not currently available from any other source, will provide novel and useful information to transplant programs in their future donor selection process and will aid potential living donors in their decision to pursue living donation.

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Authorizing Statute(s): US Code: 42 USC 121 Name of Law: Organ Procurement and Transpantation Network
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 55464	09/08/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 83098	12/21/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation	2, 1, 3	Living Donor Registration Form ,   Potential Living Donor Follow-Up Form ,   Reasons Did Not Donate Form

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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	4,242	4,242	0	0	0	0
Annual Time Burden (Hours)	1,251	1,251	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Burden decrease due to improvements to the efficiency of the processes used by programs for data submission.

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Annual Cost to Federal Government: $2,970

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.     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? No

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Common Form ICR:  No

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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: 04/07/2021

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