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 and Instruction	Modified
Form 50 Vascular Composite Allograft Form and Instruction	New
Form 28 Liver Recipient Explant Pathology Form Form and Instruction	New
Form 11 Post-Transplant Malignancy Form Form and Instruction	New
Form 22 Heart, Lung, Heart/Lung Follow Up (Post 5 year) Form and Instruction	New
Form 21 Heart, Lung, Heart/Lung Follow Up (1-5 year) Form and Instruction	New
Form 20 Heart, Lung, Heart/Lung Follow Up (6 month) Form and Instruction	New
Form 19 Heart, Lung, Heart/Lung Recipient Registration Form and Instruction	New
Form 1 Pancreas Islet Candidate Registration Form	Removed
Form 1 Liver Explant Pathology Form	Removed
Form 1 Death Notification Referral-Imminent Form	Removed
Form 1 Death Notification Referal - Eligible Form	Removed
Form 1 Death Referral Data Form	Removed
Form 32 OPTN- Intestine Follow-up Form and Instruction	Modified
Form 31 OPTN- Intestine Recipient Registration Form and Instruction	Modified
Form 30 OPTN- Intestine Candidate Registration Form and Instruction	Modified
Form 40 Pancreas Form and Instruction	Modified
Form 45 Kidney/Pancreas Form and Instruction	Modified
Form 26 OPTN- Liver Follow-up Form and Instruction	Modified
Form 25 OPTN- Liver Recipient Registration Form and Instruction	Modified
Form 24 OPTN- Liver Candidate Registration Form and Instruction	Modified
Form 37 OPTN- Kidney Follow-up Form and Instruction	Modified
Form 36 OPTN- Kidney Recipient Registration Form and Instruction	Modified
Form 35 OPTN- Kidney Candidate Registration Form and Instruction	Modified
Form 18 OPTN- Heart/Lung Candidate Registration Form and Instruction	Modified
Form 12 OPTN- Lung Candidate Registration Form and Instruction	Modified
Form 6 OPTN- Heart Candidate Registration Form and Instruction	Modified
Form 5 OPTN- Recipient Histocompatibility Form and Instruction	Modified
Form 4 OPTN- Donor Histocompatibility Form and Instruction	Modified
Form 3 OPTN- Living Donor Follow-up Form and Instruction	Modified
Form 2 OPTN- Living Donor Registration Form and Instruction	Modified
Supporting Statement.docx Supporting Statement A	2015-02-03

IC Document Collections

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

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
	Date Received in OIRA: 12/16/2014
Terms of Clearance:

	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

IC Title	Form No.	Form Name
OPTN- Liver Recipient Registration	25	Liver Recipient Registration
OPTN- Liver Follow-up	26, 27	Liver Recipient Follow up (6 months - 5 years) ,   Liver Recipient Follow up (Post 5 years)
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)
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)
OPTN- Kidney Candidate Registration	35	Kidney Candidate Registration
OPTN- Kidney Recipient Registration	36	Kidney Recipient Registration
OPTN- Kidney Follow-up	37, 38	Kidney Follow-up (6 months - 5 years) ,   Kidney Follow-up (Post 5 years)
OPTN- Liver Candidate Registration	24	Liver Candidate Registration
OPTN- Recipient Histocompatibility	5	Recipient Histocompatibility
OPTN- Deceased Donor Registration Worksheet	1	Deceased Donor Registration
OPTN- Living Donor Registration	2	Living Donor Registration
OPTN- Living Donor Follow-up	3	Living Donor Follow Up
OPTN- Donor Histocompatibility	4	Donor Histocompatibility
OPTN- Heart Candidate Registration	6	Heart Transplant Candidate Registration
OPTN- Lung Candidate Registration	12	Lung Candidate Registration
OPTN- Heart/Lung Candidate Registration	18	Heart/Lung Candidate Registration
Heart, Lung, Heart/Lung Recipient Registration	19	Heart, Lung, Heart/Lung Recipient Registration
Heart, Lung, Heart/Lung Follow Up (6 month)	20	Heart, Lung, Heart/Lung Follow Up (6 month)
OPTN- Intestine Candidate Registration	30	Intestine Candidate Registration
OPTN- Intestine Recipient Registration	31	Intestine Recipient Registration
OPTN- Intestine Follow-up	32, 33	Intestine Recipient Follow Up (6 months - 5 years) ,   Intestine Recipient Follow Up (Post 5 years)
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
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 (Post 5 year)	22	Heart, Lung, Heart/Lung Follow Up (Post 5 year)
Post-Transplant Malignancy Form	11	Post-Transplant Malignancy Form
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 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 ,   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
Liver Recipient Explant Pathology Form	28	Liver Recipient Explant Pathology Form
Pancreas Islet Candidate Registration	1, 2	Pancreas Islets Adult ,   Pancreas Islets Pediatric
Liver Explant Pathology	1	Liver Recipient Explant Pathology Worksheet
Death Notification Referral-Imminent	1	Death Notification Referral Imminent
Death Notification Referal - Eligible	1	Death Notification Referral Eligible
OPTN- Post Transplant Malignancy	27, 27b	Adult Post Transplant Malignancy Worksheet ,   Pediatric Post Transplant Malignancy Worksheet
Vascular Composite Allograft	50, 51, 52	Vascular Composit Allograft Candidate Registration ,   Vascular Composit Allograft Recipient Registration ,   Vascular Composit Allograft Recipient Follow Up
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- 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- Kidney/Pancreas Registration	19, 19b	Kidney-Pancreas Adult Transplant Recipient Registration ,   Kidney-Pancreas Pediatric Tranplant Recipient Registration Worksheet

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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	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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