Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System

Forms and Documents

Document Name	Status
Form 1 OPTN- Deceased Donor Registration Worksheet Form	Modified
Form 1 Pancreas Islet Candidate Registration Form	New
Form 1 Liver Explant Pathology Form	New
Form 1 Death Notification Referral-Imminent Form	Modified
Form 1 Death Notification Referal - Eligible Form	Modified
Form 1 Death Referral Data Form	Modified
Form 26c OPTN- Intestine Follow-up Form	Modified
Form 20c OPTN- Kidney/Pancreas Follow-up Form	Modified
Form 19b OPTN- Kidney/Pancreas Registration Form	Modified
Form 17 OPTN- Liver Follow-up Form	Modified
Form 16 OPTN- Liver Registration Form	Modified
Form 1 OPTN- Kidney Registration Form	Modified
Form 1 OPTN- Kidney Candidate Registration Form	Modified
Form 8 OPTN- Lung Candidate Registration Form	Modified
Form 1 OPTN- Recipient Histocompatibility Form	Modified
Form 1 OPTN- Donor Histocompatibility Form	Modified
Form 1 OPTN- Living Donor Registration Form	Modified
memo to OMB re FRN comments final.docx Supplementary Document	2012-03-20
Summary Statement OPTN UNET Forms_0157_2012.docx Supporting Statement A	2012-02-03

IC Document Collections

IC ID	Document Title	Status
6389	OPTN- Deceased Donor Registration Worksheet Form	Modified
201280	Pancreas Islet Candidate Registration Form	New
201279	Liver Explant Pathology Form	New
194824	Death Notification Referral-Imminent Form	Modified
194823	Death Notification Referal - Eligible Form	Modified
194822	Death Referral Data Form	Modified
181751	OPTN- Post Transplant Malignancy Instruction	Modified
181750	OPTN- Intestine Follow-up Form	Modified
181749	OPTN- Intestine Registration Instruction	Modified
181748	OPTN- Intestine Candidate Registration Instruction	Modified
181747	OPTN- Pancreas Follow-up Instruction	Modified
181746	OPTN- Pancreas Registration Instruction	Modified
181745	OPTN- Pancreas Candidate Registration Instruction	Modified
181744	OPTN- Kidney/Pancreas Follow-up Form	Modified
181743	OPTN- Kidney/Pancreas Registration Form	Modified
181742	OPTN- Kidney/Pancreas Candidate Registration Instruction	Modified
181741	OPTN- Liver Follow-up Form	Modified
181740	OPTN- Liver Registration Form	Modified
181739	OPTN- Liver Candidate Registration Instruction	Modified
181738	OPTN- Kidney Follow-up Instruction	Modified
181737	OPTN- Kidney Registration Form	Modified
181736	OPTN- Kidney Candidate Registration Form	Modified
181735	OPTN- Thoracic Follow-up Instruction	Modified
181734	OPTN- Thoracic Registration Instruction	Modified
181733	OPTN- Heart/Lung Candidate Registration Instruction	Modified
181732	OPTN- Lung Candidate Registration Form	Modified
181731	OPTN- Heart Candidate Registration Instruction	Modified
181730	OPTN- Recipient Histocompatibility Form	Modified
181729	OPTN- Donor Histocompatibility Form	Modified
181728	OPTN- Living Donor Follow-up Instruction	Modified
181727	OPTN- Living Donor Registration Form	Modified

ICR Details

OMB Control No: 0915-0157	ICR Reference No: 201202-0915-001
Status: Historical Active	Previous ICR Reference No: 201010-0915-001
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/23/2012
	Date Received in OIRA: 02/17/2012
Terms of Clearance: OMB notes that the revisions to this approved collection do not affect its burden. The burden change is appropriately characterized as an adjustment.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	36 Months From Approved	03/31/2012
Responses	477,327	0	522,815
Time Burden (Hours)	258,318	0	278,769
Cost Burden (Dollars)	0	0	0

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Abstract: The Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry for Transplant Recipients (SRTR) collect information on transplant recipients and transplant procedures in accordance with Section 372 of the Public Health Service Act. This information is required for to monitor and evaluate the scientific and clinical status of organ transplantation, and to ensure the distribution of organs equitably among transplant patients nationwide and adopt and use standards of quality for the acquisition and transportation of donated organs. The OPTN must maintain a national waiting list of individuals requiring organ transplants and maintain a computerized system for matching donor organs its transplant candidates list.

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Authorizing Statute(s): US Code: 42 USC 274 Name of Law: Organ Procurement and Transplantation Network
   US Code: 42 USC 273 Name of Law: Organ Procurement Organizations
   US Code: 42 USC 274a Name of Law: Scientific Registry
  

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:
	76 FR 73650	11/29/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 2732	01/19/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 31

IC Title	Form No.	Form Name
OPTN- Recipient Histocompatibility	1	Recipient Histocompatibility
OPTN- Deceased Donor Registration Worksheet	1	Deceased Donor Registration
OPTN- Living Donor Registration	1	Living Donor Registration
OPTN- Living Donor Follow-up	1	Living Donor Follow-up
OPTN- Donor Histocompatibility	1	Donor Histocompatibility
OPTN- Heart Candidate Registration	7, 7b	Heart Adult Candidate Transplant Registration ,   Heart Pediatric Transplant Candidate Registration
OPTN- Lung Candidate Registration	8, 8b	Lung Adult Transplant candidate Registration Worksheet ,   Lung Pediatric Transplant candidate Registration Worksheet
OPTN- Heart/Lung Candidate Registration	9, 9b	Heart-Lung Adult Transplant Candidate Registration Worksheet ,   Heart-Lung Pediatric Transplant Candidate Registration Worksheet
OPTN- Thoracic Registration	10f, 10, 10b, 10c, 10d, 10e	Thoracic Heart Adult Transplant Recipient Registration Worksheet ,   Thoracic Heart Pediatric Transplant Recipient Registration Worksheet ,   Thoracic Heart-Lung Adult Transplant Recipient Regisration Worksheet ,   Thoracic Heart-Lung Pediatric Transplant Recipient Registration Worksheet ,   Thoracic Lung Adult Transplant Recipient Registration Worksheet ,   Thoracic Lung Pediatric Transplant Recipient Registration Worksheet
OPTN- Thoracic Follow-up	9, 10, 12, 15, 16, 18, 3, 4, 6, 1, 2, 5, 7, 8, 11, 13, 14, 17	Thoracic Lung Adult Transplant Recipient Follow Up ,   Thoracic Heart Adult Transplant Recipient Follow Up ,   Thoracic Lung Pediatric 6 Month Transplant Recipient Follow Up ,   Thoracic Heart Lung Adult Transplant Recipient Follow Up ,   Thoracic Heart Lung Pediatric 6 Month Transplant Recipient Follow Up ,   Thoracic Heart Lung Pediatric Transplant Recipient Follow Up ,   Thoracic Heart Pediatric Transplant Recipient Follow Up ,   Thoracic Lung Pediatric Transplant Recipient Follow Up ,   Thoracic Heart Pediatric 6 Month Transplant Recipient Follow Up ,   Thoracic Heart Adult 6 month Follow-up ,   Thoracic Heart Adult Post 5 year ,   Thoracic Heart Pediatric Post 5 Follow Up ,   Thoracic Heart Lung Adult Six month ,   Thoracic Heart Lung Adult Post 5 ,   Thoracic Heart Lung Pediatric Post 5 ,   Thoracic Lung Adult 6 month Follow UP ,   Thoracic Lung Adult Post 5 Follow Up ,   Thoracic Lung Pediatric Post 5
OPTN- Kidney Candidate Registration	1, 2	Kidney Adult Candidate Registration ,   Kidney Pediatric Transplant
Liver Explant Pathology	1	Liver Recipient Explant Pathology Worksheet
Pancreas Islet Candidate Registration	1, 2	Pancreas Islets Adult ,   Pancreas Islets Pediatric
OPTN- Kidney Registration	1, 2	Kidney Adult Transplant Recipient Registration ,   Kidney Pediatric Transplant Recipient Registration
OPTN- Kidney Follow-up	14c, 14d, 14, 14b	Kidney Adult Post 5 year Transplant Recipient Follow Up worksheet ,   Kidney Adult Transplant Recipient Follow Up Worksheet ,   Kidney Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet ,   Kidney Pediatric Transplant Recipient Follow Up Worksheet
OPTN- Liver Candidate Registration	15, 15b	Liver Adullt Transplant candidate Registration Worksheet ,   Liver Pediatric Transplant candidate Registration Worksheet
OPTN- Liver Registration	16, 16b	Liver Adult Transplant Recipient Registration Worksheet ,   Liver Pediatric Transplant Recipient Registration Worksheet
OPTN- Liver Follow-up	17b, 17d, 17, 17c	Liver Adult Post 5 year Transplant Recipient Follow Up Worksheet ,   Liver Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet ,   Liver Adult Transplant Recipient Follow Up Worksheet ,   Liver Pediatric Transplant Recipient Follow Up Worksheet
OPTN- Kidney/Pancreas Candidate Registration	18, 18b	Kidney-Pancreas Adult Transplant Candidate Registration Worksheet ,   Kidney-Pancreas Pediatric Transplant Candidate Registration Worksheet
OPTN- Kidney/Pancreas Registration	19, 19b	Kidney-Pancreas Pediatric Tranplant Recipient Registration Worksheet ,   Kidney-Pancreas Adult Transplant Recipient Registration
OPTN- Kidney/Pancreas Follow-up	20, 20d, 20b, 20c	Kidney-Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Workshseet ,   Kidney-Pancreas Pediatric Transplant Recipient Follow Up Worksheet ,   Kidney-Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet ,   Kidney-Pancreas Adult Transplant Recipient Follow Up Worksheet
OPTN- Pancreas Candidate Registration	21, 21b	Pancreas and Pancreas Islets Adult Transplant Candidate Registration Worksheet ,   Pancreas and Pancreas Islets Pediatric Tranpslant Candidate Registration Worksheet
OPTN- Pancreas Registration	22, 22b	Pancreas Adult Transplant Recipient Registration Worksheet ,   Pancreas Pediatric Transplant Recipient Registration Worksheet
OPTN- Pancreas Follow-up	23, 23b, 23c, 23d	Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet ,   Pancreas Adult Transplant Recipient Follow Up Worksheet ,   Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet ,   Pancreas Pediatric Transplant Recipient Follow Up Worksheet
OPTN- Intestine Candidate Registration	24, 24b	Intestine Adult Transplant Candidate Registration Worksheet ,   Intestine Pediatric Transplant Candidate Registration Worksheet
OPTN- Intestine Registration	25, 25b	Intestine Adult Transplant Recipient Registration Worksheet ,   Intestine Pediatric Transplant Recipient Registration Worksheet
OPTN- Intestine Follow-up	26, 26b, 26c, 26d	Intestine Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet ,   Intestine Pediatric Transplant Recipient Follow Up Worksheet ,   Intestine Adult Post 5 Year Transplant Recipient Follow Up Worksheet ,   Intestine Adult Transplant Recipient Follow Up Worksheet
OPTN- Post Transplant Malignancy	27, 27b	Adult Post Transplant Malignancy Worksheet ,   Pediatric Post Transplant Malignancy Worksheet
Death Referral Data	1	Death Referral Data
Death Notification Referal - Eligible	1	Death Notification Referral Eligible
Death Notification Referral-Imminent	1	Death Notification Referral Imminent

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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	477,327	522,815	0	0	-45,488	0
Annual Time Burden (Hours)	258,318	278,769	0	0	-20,451	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:

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Annual Cost to Federal Government: $103,289

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 02/17/2012

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