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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 Deceased Donor Registration	Form and Instruction	Modified	Available
Form 52 Vascular Composit Allograft Recipient Follow Up	Form and Instruction	New	Available
Form 51 Vascular Composit Allograft Recipient Registration	Form and Instruction	New	Available
Form 50 Vascular Composit Allograft Candidate Registration	Form and Instruction	New	Available
Form 28 Liver Recipient Explant Pathology Form	Form and Instruction	New	Available
Form 11 Post-Transplant Malignancy Form	Form and Instruction	New	Available
Form 22 Heart, Lung, Heart/Lung Follow Up (Post 5 year)	Form and Instruction	New	Available
Form 21 Heart, Lung, Heart/Lung Follow Up (1-5 year)	Form and Instruction	New	Available
Form 20 Heart, Lung, Heart/Lung Follow Up (6 month)	Form and Instruction	New	Available
Form 19 Heart, Lung, Heart/Lung Recipient Registration	Form and Instruction	New	Available
Form 2 Pancreas Islets Pediatric	Form	Removed	Available
Form 1 Pancreas Islets Adult	Form	Removed	Available
Form 1 Liver Recipient Explant Pathology Worksheet	Form	Removed	Available
Form 1 Death Notification Referral Imminent	Form	Removed	Available
Form 1 Death Notification Referral Eligible	Form	Removed	Available
Form 1 Death Referral Data	Form	Removed	Available
Form 27b Pediatric Post Transplant Malignancy Worksheet	Form	Removed	Available
Form 27 Adult Post Transplant Malignancy Worksheet	Form	Removed	Available
Form 33 Intestine Recipient Follow Up (Post 5 years)	Form and Instruction	Modified	Available
Form 32 Intestine Recipient Follow Up (6 months - 5 years)	Form and Instruction	Modified	Available
Form 31 Intestine Recipient Registration	Form and Instruction	Modified	Available
Form 30 Intestine Candidate Registration	Form and Instruction	Modified	Available
Form 23d Pancreas Pediatric Transplant Recipient Follow Up Worksheet	Form	Removed	Available
Form 23c Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet	Form	Removed	Repair queued
Form 23b Pancreas Adult Transplant Recipient Follow Up Worksheet	Form	Removed	Available
Form 23 Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet	Form	Removed	Available
Form 22b Pancreas Pediatric Transplant Recipient Registration Worksheet	Form	Removed	Available
Form 22 Pancreas Adult Transplant Recipient Registration Worksheet	Form	Removed	Available
Form 43 Pancreas Recipient Follow Up (Post 5 years)	Form and Instruction	Modified	Available
Form 42 Pancreas Recipient Follow Up (6 months - 5 years)	Form and Instruction	Modified	Available
Form 41 Pancreas Recipient Registration	Form and Instruction	Modified	Available
Form 40 Pancreas Candidate Registration	Form and Instruction	Modified	Available
Form 20d Kidney-Pancreas Pediatric Transplant Recipient Follow Up Worksheet	Form	Removed	Available
Form 20c Kidney-Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Workshseet	Form	Removed	Available
Form 20b Kidney-Pancreas Adult Transplant Recipient Follow Up Worksheet	Form	Removed	Available
Form 20 Kidney-Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet	Form	Removed	Available
Form 19b Kidney-Pancreas Pediatric Tranplant Recipient Registration Worksheet	Form	Removed	Available
Form 19 Kidney-Pancreas Adult Transplant Recipient Registration	Form	Removed	Available
Form 48 Kidney/Pancreas Recipient Follow up (Post 5 years)	Form and Instruction	Modified	Available
Form 47 Kidney/Pancreas Recipient Follow up (6 months - 5 years)	Form and Instruction	Modified	Available
Form 46 Kidney/Pancreas Recipient Registration	Form and Instruction	Modified	Available
Form 45 Kidney/Pancreas Candidate Registration	Form and Instruction	Modified	Available
Form 27 Liver Recipient Follow up (Post 5 years)	Form and Instruction	Modified	Available
Form 26 Liver Recipient Follow up (6 months - 5 years)	Form and Instruction	Modified	Available
Form 25 Liver Recipient Registration	Form and Instruction	Modified	Available
Form 24 Liver Candidate Registration	Form and Instruction	Modified	Available
Form 38 Kidney Follow-up (Post 5 years)	Form and Instruction	Modified	Available
Form 37 Kidney Follow-up (6 months - 5 years)	Form and Instruction	Modified	Available
Form 36 Kidney Recipient Registration	Form and Instruction	Modified	Available
Form 35 Kidney Candidate Registration	Form and Instruction	Modified	Available
Form 18 Thoracic Lung Pediatric Transplant Recipient Follow Up	Form	Removed	Available
Form 16 Thoracic Lung Pediatric 6 Month Transplant Recipient Follow Up	Form	Removed	Repair queued
Form 15 Thoracic Lung Adult Transplant Recipient Follow Up	Form	Removed	Available
Form 12 Thoracic Heart Lung Pediatric Transplant Recipient Follow Up	Form	Removed	Available
Form 10 Thoracic Heart Lung Pediatric 6 Month Transplant Recipient Follow Up	Form	Removed	Available
Form 9 Thoracic Heart Lung Adult Transplant Recipient Follow Up	Form	Removed	Available
Form 6 Thoracic Heart Pediatric Transplant Recipient Follow Up	Form	Removed	Available
Form 4 Thoracic Heart Pediatric 6 Month Transplant Recipient Follow Up	Form	Removed	Available
Form 3 Thoracic Heart Adult Transplant Recipient Follow Up	Form	Removed	Available
Form 17 Thoracic Lung Pediatric Post 5	Form	Removed	Available
Form 14 Thoracic Lung Adult Post 5 Follow Up	Form	Removed	Available
Form 13 Thoracic Lung Adult 6 month Follow UP	Form	Removed	Available
Form 11 Thoracic Heart Lung Pediatric Post 5	Form	Removed	Available
Form 8 Thoracic Heart Lung Adult Post 5	Form	Removed	Available
Form 7 Thoracic Heart Lung Adult Six month	Form	Removed	Available
Form 5 Thoracic Heart Pediatric Post 5 Follow Up	Form	Removed	Available
Form 2 Thoracic Heart Adult Post 5 year	Form	Removed	Available
Form 1 Thoracic Heart Adult 6 month Follow-up	Form	Removed	Available
Form 10f Thoracic Lung Pediatric Transplant Recipient Registration Worksheet	Form	Removed	Available
Form 10e Thoracic Lung Adult Transplant Recipient Registration Worksheet	Form	Removed	Available
Form 10d Thoracic Heart-Lung Pediatric Transplant Recipient Registration Worksheet	Form	Removed	Available
Form 10c Thoracic Heart-Lung Adult Transplant Recipient Regisration Worksheet	Form	Removed	Available
Form 10b Thoracic Heart Pediatric Transplant Recipient Registration Worksheet	Form	Removed	Available
Form 10 Thoracic Heart Adult Transplant Recipient Registration Worksheet	Form	Removed	Repair queued
Form 18 Heart/Lung Candidate Registration	Form and Instruction	Modified	Available
Form 12 Lung Candidate Registration	Form and Instruction	Modified	Available
Form 6 Heart Transplant Candidate Registration	Form and Instruction	Modified	Available
Form 5 Recipient Histocompatibility	Form and Instruction	Modified	Available
Form 4 Donor Histocompatibility	Form and Instruction	Modified	Available
Form 3 Living Donor Follow Up	Form and Instruction	Modified	Available
Form 2 Living Donor Registration	Form and Instruction	Modified	Available
Supporting Statement.docx	Supporting Statement A	Uploaded 2015-02-03	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6389	OPTN- Deceased Donor Registration Worksheet	Form and Instruction	Modified	Deceased Donor Registration
214131	Vascular Composite Allograft	Form and Instruction	New	Vascular Composit Allograft Recipient Follow Up
214131	Vascular Composite Allograft	Form and Instruction	New	Vascular Composit Allograft Recipient Registration
214131	Vascular Composite Allograft	Instruction	New
214131	Vascular Composite Allograft	Form and Instruction	New	Vascular Composit Allograft Candidate Registration
214130	Liver Recipient Explant Pathology Form	Form and Instruction	New	Liver Recipient Explant Pathology Form
214129	Post-Transplant Malignancy Form	Form and Instruction	New	Post-Transplant Malignancy Form
214128	Heart, Lung, Heart/Lung Follow Up (Post 5 year)	Form and Instruction	New	Heart, Lung, Heart/Lung Follow Up (Post 5 year)
214127	Heart, Lung, Heart/Lung Follow Up (1-5 year)	Form and Instruction	New	Heart, Lung, Heart/Lung Follow Up (1-5 year)
214126	Heart, Lung, Heart/Lung Follow Up (6 month)	Form and Instruction	New	Heart, Lung, Heart/Lung Follow Up (6 month)
214124	Heart, Lung, Heart/Lung Recipient Registration	Form and Instruction	New	Heart, Lung, Heart/Lung Recipient Registration
201280	Pancreas Islet Candidate Registration	Instruction	Removed
201280	Pancreas Islet Candidate Registration	Form	Removed	Pancreas Islets Pediatric
201280	Pancreas Islet Candidate Registration	Form	Removed	Pancreas Islets Adult
201279	Liver Explant Pathology	Instruction	Removed
201279	Liver Explant Pathology	Form	Removed	Liver Recipient Explant Pathology Worksheet
194824	Death Notification Referral-Imminent	Instruction	Removed
194824	Death Notification Referral-Imminent	Form	Removed	Death Notification Referral Imminent
194823	Death Notification Referal - Eligible	Instruction	Removed
194823	Death Notification Referal - Eligible	Form	Removed	Death Notification Referral Eligible
194822	Death Referral Data	Instruction	Removed
194822	Death Referral Data	Form	Removed	Death Referral Data
181751	OPTN- Post Transplant Malignancy	Form	Removed	Pediatric Post Transplant Malignancy Worksheet
181751	OPTN- Post Transplant Malignancy	Form	Removed	Adult Post Transplant Malignancy Worksheet
181751	OPTN- Post Transplant Malignancy	Instruction	Removed
181750	OPTN- Intestine Follow-up	Form and Instruction	Modified	Intestine Recipient Follow Up (Post 5 years)
181750	OPTN- Intestine Follow-up	Form and Instruction	Modified	Intestine Recipient Follow Up (6 months - 5 years)
181749	OPTN- Intestine Recipient Registration	Form and Instruction	Modified	Intestine Recipient Registration
181748	OPTN- Intestine Candidate Registration	Form and Instruction	Modified	Intestine Candidate Registration
181747	OPTN- Pancreas Follow-up	Form	Removed	Pancreas Pediatric Transplant Recipient Follow Up Worksheet
181747	OPTN- Pancreas Follow-up	Form	Removed	Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet
181747	OPTN- Pancreas Follow-up	Form	Removed	Pancreas Adult Transplant Recipient Follow Up Worksheet
181747	OPTN- Pancreas Follow-up	Form	Removed	Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet
181747	OPTN- Pancreas Follow-up	Instruction	Removed
181746	OPTN- Pancreas Registration	Form	Removed	Pancreas Pediatric Transplant Recipient Registration Worksheet
181746	OPTN- Pancreas Registration	Form	Removed	Pancreas Adult Transplant Recipient Registration Worksheet
181746	OPTN- Pancreas Registration	Instruction	Removed
181745	Pancreas	Form and Instruction	Modified	Pancreas Recipient Follow Up (Post 5 years)
181745	Pancreas	Form and Instruction	Modified	Pancreas Recipient Follow Up (6 months - 5 years)
181745	Pancreas	Form and Instruction	Modified	Pancreas Recipient Registration
181745	Pancreas	Form and Instruction	Modified	Pancreas Candidate Registration
181744	OPTN- Kidney/Pancreas Follow-up	Form	Removed	Kidney-Pancreas Pediatric Transplant Recipient Follow Up Worksheet
181744	OPTN- Kidney/Pancreas Follow-up	Form	Removed	Kidney-Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Workshseet
181744	OPTN- Kidney/Pancreas Follow-up	Form	Removed	Kidney-Pancreas Adult Transplant Recipient Follow Up Worksheet
181744	OPTN- Kidney/Pancreas Follow-up	Form	Removed	Kidney-Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet
181744	OPTN- Kidney/Pancreas Follow-up	Instruction	Removed
181743	OPTN- Kidney/Pancreas Registration	Form	Removed	Kidney-Pancreas Pediatric Tranplant Recipient Registration Worksheet
181743	OPTN- Kidney/Pancreas Registration	Form	Removed	Kidney-Pancreas Adult Transplant Recipient Registration
181743	OPTN- Kidney/Pancreas Registration	Instruction	Removed
181742	Kidney/Pancreas	Form and Instruction	Modified	Kidney/Pancreas Recipient Follow up (Post 5 years)
181742	Kidney/Pancreas	Form and Instruction	Modified	Kidney/Pancreas Recipient Follow up (6 months - 5 years)
181742	Kidney/Pancreas	Form and Instruction	Modified	Kidney/Pancreas Recipient Registration
181742	Kidney/Pancreas	Form and Instruction	Modified	Kidney/Pancreas Candidate Registration
181741	OPTN- Liver Follow-up	Form and Instruction	Modified	Liver Recipient Follow up (Post 5 years)
181741	OPTN- Liver Follow-up	Form and Instruction	Modified	Liver Recipient Follow up (6 months - 5 years)
181740	OPTN- Liver Recipient Registration	Form and Instruction	Modified	Liver Recipient Registration
181739	OPTN- Liver Candidate Registration	Form and Instruction	Modified	Liver Candidate Registration
181738	OPTN- Kidney Follow-up	Form and Instruction	Modified	Kidney Follow-up (Post 5 years)
181738	OPTN- Kidney Follow-up	Form and Instruction	Modified	Kidney Follow-up (6 months - 5 years)
181737	OPTN- Kidney Recipient Registration	Form and Instruction	Modified	Kidney Recipient Registration
181736	OPTN- Kidney Candidate Registration	Form and Instruction	Modified	Kidney Candidate Registration
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Lung Pediatric Transplant Recipient Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Lung Pediatric 6 Month Transplant Recipient Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Lung Adult Transplant Recipient Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Lung Pediatric Transplant Recipient Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Lung Pediatric 6 Month Transplant Recipient Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Lung Adult Transplant Recipient Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Pediatric Transplant Recipient Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Pediatric 6 Month Transplant Recipient Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Adult Transplant Recipient Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Lung Pediatric Post 5
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Lung Adult Post 5 Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Lung Adult 6 month Follow UP
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Lung Pediatric Post 5
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Lung Adult Post 5
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Lung Adult Six month
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Pediatric Post 5 Follow Up
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Adult Post 5 year
181735	OPTN- Thoracic Follow-up	Form	Removed	Thoracic Heart Adult 6 month Follow-up
181735	OPTN- Thoracic Follow-up	Instruction	Removed
181734	OPTN- Thoracic Registration	Form	Removed	Thoracic Lung Pediatric Transplant Recipient Registration Worksheet
181734	OPTN- Thoracic Registration	Form	Removed	Thoracic Lung Adult Transplant Recipient Registration Worksheet
181734	OPTN- Thoracic Registration	Form	Removed	Thoracic Heart-Lung Pediatric Transplant Recipient Registration Worksheet
181734	OPTN- Thoracic Registration	Form	Removed	Thoracic Heart-Lung Adult Transplant Recipient Regisration Worksheet
181734	OPTN- Thoracic Registration	Form	Removed	Thoracic Heart Pediatric Transplant Recipient Registration Worksheet
181734	OPTN- Thoracic Registration	Form	Removed	Thoracic Heart Adult Transplant Recipient Registration Worksheet
181734	OPTN- Thoracic Registration	Instruction	Removed
181733	OPTN- Heart/Lung Candidate Registration	Form and Instruction	Modified	Heart/Lung Candidate Registration
181732	OPTN- Lung Candidate Registration	Form and Instruction	Modified	Lung Candidate Registration
181731	OPTN- Heart Candidate Registration	Form and Instruction	Modified	Heart Transplant Candidate Registration
181730	OPTN- Recipient Histocompatibility	Form and Instruction	Modified	Recipient Histocompatibility
181729	OPTN- Donor Histocompatibility	Form and Instruction	Modified	Donor Histocompatibility
181728	OPTN- Living Donor Follow-up	Form and Instruction	Modified	Living Donor Follow Up
181727	OPTN- Living Donor Registration	Form and Instruction	Modified	Living Donor Registration

ICR Details

OMB Control No: 0915-0157	ICR Reference No: 201411-0915-004
Status: Historical Active	Previous ICR Reference No: 201202-0915-001
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: 02/18/2015
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/16/2014
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	03/31/2015
Responses	472,418	0	477,327
Time Burden (Hours)	373,729	0	258,318
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:
	79 FR 53203	09/08/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 71437	12/02/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 26

table that charts list of burden

IC Title	Form No.	Form Name
Death Notification Referal - Eligible	1	Death Notification Referral Eligible
Death Notification Referral-Imminent	1	Death Notification Referral Imminent
Death Referral Data	1	Death Referral Data
Heart, Lung, Heart/Lung Follow Up (1-5 year)	21	Heart, Lung, Heart/Lung Follow Up (1-5 year)
Heart, Lung, Heart/Lung Follow Up (6 month)	20	Heart, Lung, Heart/Lung Follow Up (6 month)
Heart, Lung, Heart/Lung Follow Up (Post 5 year)	22	Heart, Lung, Heart/Lung Follow Up (Post 5 year)
Heart, Lung, Heart/Lung Recipient Registration	19	Heart, Lung, Heart/Lung Recipient Registration
Kidney/Pancreas	45, 46, 47, 48	Kidney/Pancreas Candidate Registration ,   Kidney/Pancreas Recipient Registration ,   Kidney/Pancreas Recipient Follow up (6 months - 5 years) ,   Kidney/Pancreas Recipient Follow up (Post 5 years)
Liver Explant Pathology	1	Liver Recipient Explant Pathology Worksheet
Liver Recipient Explant Pathology Form	28	Liver Recipient Explant Pathology Form
OPTN- Deceased Donor Registration Worksheet	1	Deceased Donor Registration
OPTN- Donor Histocompatibility	4	Donor Histocompatibility
OPTN- Heart Candidate Registration	6	Heart Transplant Candidate Registration
OPTN- Heart/Lung Candidate Registration	18	Heart/Lung Candidate Registration
OPTN- Intestine Candidate Registration	30	Intestine Candidate Registration
OPTN- Intestine Follow-up	32, 33	Intestine Recipient Follow Up (6 months - 5 years) ,   Intestine Recipient Follow Up (Post 5 years)
OPTN- Intestine Recipient Registration	31	Intestine Recipient Registration
OPTN- Kidney Candidate Registration	35	Kidney Candidate Registration
OPTN- Kidney Follow-up	37, 38	Kidney Follow-up (6 months - 5 years) ,   Kidney Follow-up (Post 5 years)
OPTN- Kidney Recipient Registration	36	Kidney Recipient Registration
OPTN- Kidney/Pancreas Registration	19, 19b	Kidney-Pancreas Adult Transplant Recipient Registration ,   Kidney-Pancreas Pediatric Tranplant Recipient Registration Worksheet
OPTN- Liver Candidate Registration	24	Liver Candidate Registration
OPTN- Liver Follow-up	26, 27	Liver Recipient Follow up (6 months - 5 years) ,   Liver Recipient Follow up (Post 5 years)
OPTN- Liver Recipient Registration	25	Liver Recipient Registration
OPTN- Living Donor Registration	2	Living Donor Registration
OPTN- Lung Candidate Registration	12	Lung Candidate Registration
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- Pancreas Registration	22, 22b	Pancreas Adult Transplant Recipient Registration Worksheet ,   Pancreas Pediatric Transplant Recipient Registration Worksheet
OPTN- Post Transplant Malignancy	27, 27b	Adult Post Transplant Malignancy Worksheet ,   Pediatric Post Transplant Malignancy Worksheet
OPTN- Recipient Histocompatibility	5	Recipient Histocompatibility
OPTN- Thoracic Follow-up	15, 16, 18, 3, 4, 6, 1, 2, 5, 7, 8, 11, 13, 14, 17, 9, 10, 12	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 ,   Thoracic Heart Adult Transplant Recipient Follow Up ,   Thoracic Heart Pediatric 6 Month Transplant Recipient Follow Up ,   Thoracic Heart Pediatric 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 Lung Adult Transplant Recipient Follow Up ,   Thoracic Lung Pediatric 6 Month Transplant Recipient Follow Up ,   Thoracic Lung Pediatric Transplant Recipient Follow Up
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- Kidney/Pancreas Follow-up	20d, 20, 20b, 20c	Kidney-Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet ,   Kidney-Pancreas Adult Transplant Recipient Follow Up Worksheet ,   Kidney-Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Workshseet ,   Kidney-Pancreas Pediatric Transplant Recipient Follow Up Worksheet
OPTN- Living Donor Follow-up	3	Living Donor Follow Up
Pancreas	40, 43, 41, 42	Pancreas Candidate Registration ,   Pancreas Recipient Registration ,   Pancreas Recipient Follow Up (6 months - 5 years) ,   Pancreas Recipient Follow Up (Post 5 years)
Pancreas Islet Candidate Registration	1, 2	Pancreas Islets Adult ,   Pancreas Islets Pediatric
Post-Transplant Malignancy Form	11	Post-Transplant Malignancy Form
Vascular Composite Allograft	50, 51, 52	Vascular Composit Allograft Candidate Registration ,   Vascular Composit Allograft Recipient Registration ,   Vascular Composit Allograft Recipient Follow Up

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ICR Summary of Burden

table that charts list 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	472,418	477,327	0	-4,909	0	0
Annual Time Burden (Hours)	373,729	258,318	0	115,411	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: Miscellaneous Actions

Short Statement: Currently, there are a total of 358,092.5 burden hours in the OMB inventory. The total burden hours has increased since 2011 by 79,326 hours. This increase represents a change in burden estimates based on analysis of the most recent trends in OPTN data form submissions. The current estimates should be a more accurate reflection of total burden since the forms were broken out in a more granular fashion. The pilot study participants provided feedback on each type of form as opposed to grouping them only by organ. For example, a 6 month heart follow up form is much shorter than a 1-5 year heart follow up form and should not require as much effort to complete. There are several factors that must be considered when analyzing the additional burden hours. OPTN policy mandates that transplant programs follow transplant recipients until graft failure, re-transplant or death. So as patient and graft survival increases the number of recipients still alive with a functioning graft increases, and the transplant centers will be responsible for completing more forms. Although it is a slight increase in the burden hours, the burden assessment took into account the three additional VCA forms. The frame work of the VCA forms is based on the current Liver Candidate Registration, Liver Recipient Registration and the Liver Recipient Follow Up. The burden hours for those forms were used for VCA as well since the forms are not currently active. Looking forward, the burden time should trend slightly downward after the modifications from this submission.

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Annual Cost to Federal Government: $263,047

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: 12/16/2014

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