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

Forms and Documents

Document Name	Status
Form 2 Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation Form	New
20171121 LDC questions from OMB SRTR responses.docx Supplementary Document	2018-01-03
Attachment A_The living donor collective a scientific registry for living donors_2017 AJT Online.pdf Supplementary Document	2017-10-19
20171011 Supporting Statement ICR_SRTR.docx Supporting Statement A	2017-10-19

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	New

ICR Details

OMB Control No: 0906-0034	ICR Reference No: 201710-0906-001
Status: Historical Active	Previous ICR Reference No:
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/03/2018
	Date Received in OIRA: 10/20/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2021	36 Months From Approved
Responses	804	0	0
Time Burden (Hours)	1,358	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Scientific Registry of Transplant Recipients (SRTR) will establish a pilot registry for all potential living donors who provide informed consent to participate that will collect data on registrants’ long-term health outcomes. These data, which are not currently available from any other source, will provide new and useful information to transplant programs in their future donor selection process and will aid potential living donors in informing 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:
	82 FR 22836	05/18/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 46509	10/05/2017
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	1, 2, 3	SRTR Candidate Reasons Did Not Donate_Liver and Kidney Form_10-11-17.docx ,   SRTR Form Potential Living Donor Follow-up Form_1 yr_10-11-17.docx ,   SRTR Initial Registration Worksheet_20171208_updates.docx

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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	804	0	0	804	0	0
Annual Time Burden (Hours)	1,358	0	0	1,358	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: This is a new ICR so the increase is from zero (0) to 1358 burden hours. Privacy Act Statement not necessary as SRTR is recognized as a public health authority under the HIPAA Privacy Rule (42 CFR 164.512(b)).

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Annual Cost to Federal Government: $1,010,004

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? Uncollected

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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: 10/20/2017

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