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	Modified	Available
Form 1b Imminent-Eligible Death Doc	Form	Modified	Available
Form 27b Post Transplant Pediatric Malignancy	Form	New	Available
Form 27 Post Transplant Malignancy	Form	New	Available
Form 26d Post 5-Year Intestine Pediatric Follow-up	Form	New	Available
Form 26c Post 5-Year Intestine Follow-up	Form	New	Available
Form 26 Intestine Follow-up	Form	New	Available
Form 26b Intestine Pediatric Follow-up	Form	New	Available
Form 25 Intestine Registration	Form	New	Available
Form 25b Intestine Pediatric Registration	Form	New	Available
Form 24 Intestine Candidate Registration	Form	New	Available
Form 24b Intestine Candidate Pediatric Registration	Form	New	Available
Form 23d Post 5-Year Pancreas Pediatric Follow-up	Form	New	Available
Form 23c Post 5-Year Pancreas Follow-up	Form	New	Available
Form 23b Pancreas Pediatric Follow-up	Form	New	Available
Form 23 Pancreas Follow-up	Form	New	Repair queued
Form 22 Pancreas Registration	Form	New	Available
Form 22b Pancreas Pediatric Registration	Form	New	Available
Form 21 Pancreas Candidate Registration	Form	New	Available
Form 21b Pancreas Candidate Pediatric Registration	Form	New	Available
Form 20d Post 5-Year Kidney/Pancreas Pediatric Follow-up	Form	New	Available
Form 20c Post 5-Year Kidney/Pancreas Follow-up	Form	New	Repair queued
Form 20 Kidney/Pancreas Follow-up	Form	New	Available
Form 20b Kidney/Pancreas Pediatric Follow-up	Form	New	Available
Form 19b Kidney/Pancreas Pediatric Registration	Form	New	Repair queued
Form 19 Kidney/Pancreas Registration	Form	New	Available
Form 18 Kidney /Pancreas Candidate Registration	Form	New	Available
Form 18b Kidney/Pancreas Pediatric Candidate Registration	Form	New	Available
Form 17c Post 5-Year Liver Follow-up	Form	New	Available
Form 17d Post 5-Year Liver Pediatric Follow-up	Form	New	Available
Form 17 Liver Follow-up	Form	New	Available
Form 17b Liver Pediatric Follow-up	Form	New	Available
Form 16b Liver Pediatric Registration	Form	New	Available
Form 16 Liver Registration	Form	New	Available
Form 15 Liver Candidate Registration	Form	New	Available
Form 15b Liver Candidate Pediatric Registration	Form	New	Available
Form 14d Post 5-Year Kidney Pediatric Follow-up	Form	New	Available
Form 14c Post 5-Year Kidney Follow-up	Form	New	Available
Form 14 Kidney Follow-up	Form	New	Available
Form 14b Kidney Follow-up Pediatric	Form	New	Available
Form 13 Kidney Registration	Form	New	Available
Form 13b KidneyPediatric Registration	Form	New	Available
Form 12 Kidney Candidate Registration	Form	New	Available
Form 12b Kidney Candidate Pediatric Registration	Form	New	Available
Form 11f Post 5-Year Kidney Pediatric Follow-up	Form	New	Available
Form 11e Post 5-Year Thoracic Follow-up	Form	New	Available
Form 11d Thoracic Follow-up Annual Pediatric	Form	New	Available
Form 11c Thoracic Follow-up Annual	Form	New	Available
Form 11 Thoracic Follow-up	Form	New	Available
Form 11b Thoracic Pediatric Follow-up	Form	New	Available
Form 10 Thoracic Registration	Form	New	Available
Form 10b Thoracic Pediatric Registration	Form	New	Available
Form 9 Heart./Lung Candidate Registration	Form	New	Available
Form 9b Heart/Lung Pediatric Registration	Form	New	Available
Form 8b Lung Candidate Pediatric Registration	Form	New	Available
Form 8 Lung Candidate Registration	Form	New	Available
Form 7b Heart Candidate Pediatric Registration	Form	New	Available
Form 7 Heart Candidate Registration	Form	New	Available
Form 6 Recipient Histocompatibility	Form	New	Available
Form 5 Donor Histocompatibility	Form	New	Available
Form 4 Living Donor Follow-up	Form	New	Available
Form 3 Living Donor Registration	Form	New	Available
Form 2 Death Referral Data	Form	New	Available
0157 comment page2.tif	Supplementary Document	Uploaded 2007-07-25	Available
0157 comment.tif	Supplementary Document	Uploaded 2007-07-25	Available
FINALss 0157 2007.doc	Supporting Statement A	Uploaded 2007-07-25	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6389	OPTN- Deceased Donor Registration Worksheet	Form	Modified	Deceased Donor Registration
6389	OPTN- Deceased Donor Registration Worksheet	Form	Modified	Imminent-Eligible Death Doc
181751	OPTN- Post Transplant Malignancy	Form	New	Post Transplant Pediatric Malignancy
181751	OPTN- Post Transplant Malignancy	Form	New	Post Transplant Malignancy
181750	OPTN- Intestine Follow-up	Form	New	Post 5-Year Intestine Pediatric Follow-up
181750	OPTN- Intestine Follow-up	Form	New	Post 5-Year Intestine Follow-up
181750	OPTN- Intestine Follow-up	Form	New	Intestine Follow-up
181750	OPTN- Intestine Follow-up	Form	New	Intestine Pediatric Follow-up
181749	OPTN- Intestine Registration	Form	New	Intestine Registration
181749	OPTN- Intestine Registration	Form	New	Intestine Pediatric Registration
181748	OPTN- Intestine Candidate Registration	Form	New	Intestine Candidate Registration
181748	OPTN- Intestine Candidate Registration	Form	New	Intestine Candidate Pediatric Registration
181747	OPTN- Pancreas Follow-up	Form	New	Post 5-Year Pancreas Pediatric Follow-up
181747	OPTN- Pancreas Follow-up	Form	New	Post 5-Year Pancreas Follow-up
181747	OPTN- Pancreas Follow-up	Form	New	Pancreas Pediatric Follow-up
181747	OPTN- Pancreas Follow-up	Form	New	Pancreas Follow-up
181746	OPTN- Pancreas Registration	Form	New	Pancreas Registration
181746	OPTN- Pancreas Registration	Form	New	Pancreas Pediatric Registration
181745	OPTN- Pancreas Candidate Registration	Form	New	Pancreas Candidate Registration
181745	OPTN- Pancreas Candidate Registration	Form	New	Pancreas Candidate Pediatric Registration
181744	OPTN- Kidney/Pancreas Follow-up	Form	New	Post 5-Year Kidney/Pancreas Pediatric Follow-up
181744	OPTN- Kidney/Pancreas Follow-up	Form	New	Post 5-Year Kidney/Pancreas Follow-up
181744	OPTN- Kidney/Pancreas Follow-up	Form	New	Kidney/Pancreas Follow-up
181744	OPTN- Kidney/Pancreas Follow-up	Form	New	Kidney/Pancreas Pediatric Follow-up
181743	OPTN- Kidney/Pancreas Registration	Form	New	Kidney/Pancreas Pediatric Registration
181743	OPTN- Kidney/Pancreas Registration	Form	New	Kidney/Pancreas Registration
181742	OPTN- Kidney/Pancreas Candidate Registration	Form	New	Kidney /Pancreas Candidate Registration
181742	OPTN- Kidney/Pancreas Candidate Registration	Form	New	Kidney/Pancreas Pediatric Candidate Registration
181741	OPTN- Liver Follow-up	Form	New	Post 5-Year Liver Follow-up
181741	OPTN- Liver Follow-up	Form	New	Post 5-Year Liver Pediatric Follow-up
181741	OPTN- Liver Follow-up	Form	New	Liver Follow-up
181741	OPTN- Liver Follow-up	Form	New	Liver Pediatric Follow-up
181740	OPTN- Liver Registration	Form	New	Liver Pediatric Registration
181740	OPTN- Liver Registration	Form	New	Liver Registration
181739	OPTN- Liver Candidate Registration	Form	New	Liver Candidate Registration
181739	OPTN- Liver Candidate Registration	Form	New	Liver Candidate Pediatric Registration
181738	OPTN- Kidney Follow-up	Form	New	Post 5-Year Kidney Pediatric Follow-up
181738	OPTN- Kidney Follow-up	Form	New	Post 5-Year Kidney Follow-up
181738	OPTN- Kidney Follow-up	Form	New	Kidney Follow-up
181738	OPTN- Kidney Follow-up	Form	New	Kidney Follow-up Pediatric
181737	OPTN- Kidney Registration	Form	New	Kidney Registration
181737	OPTN- Kidney Registration	Form	New	KidneyPediatric Registration
181736	OPTN- Kidney Candidate Registration	Form	New	Kidney Candidate Registration
181736	OPTN- Kidney Candidate Registration	Form	New	Kidney Candidate Pediatric Registration
181735	OPTN- Thoracic Follow-up	Form	New	Post 5-Year Kidney Pediatric Follow-up
181735	OPTN- Thoracic Follow-up	Form	New	Post 5-Year Thoracic Follow-up
181735	OPTN- Thoracic Follow-up	Form	New	Thoracic Follow-up Annual Pediatric
181735	OPTN- Thoracic Follow-up	Form	New	Thoracic Follow-up Annual
181735	OPTN- Thoracic Follow-up	Form	New	Thoracic Follow-up
181735	OPTN- Thoracic Follow-up	Form	New	Thoracic Pediatric Follow-up
181734	OPTN- Thoracic Registration	Form	New	Thoracic Registration
181734	OPTN- Thoracic Registration	Form	New	Thoracic Pediatric Registration
181733	OPTN- Heart/Lung Candidate Registration	Form	New	Heart./Lung Candidate Registration
181733	OPTN- Heart/Lung Candidate Registration	Form	New	Heart/Lung Pediatric Registration
181732	OPTN- Lung Candidate Registration	Form	New	Lung Candidate Pediatric Registration
181732	OPTN- Lung Candidate Registration	Form	New	Lung Candidate Registration
181731	OPTN- Heart Candidate Registration	Form	New	Heart Candidate Pediatric Registration
181731	OPTN- Heart Candidate Registration	Form	New	Heart Candidate Registration
181730	OPTN- Recipient Histocompatibility	Form	New	Recipient Histocompatibility
181729	OPTN- Donor Histocompatibility	Form	New	Donor Histocompatibility
181728	OPTN- Living Donor Follow-up	Form	New	Living Donor Follow-up
181727	OPTN- Living Donor Registration	Form	New	Living Donor Registration
181726	OPTN- Death Referral	Form	New	Death Referral Data

ICR Details

OMB Control No: 0915-0157	ICR Reference No: 200708-0915-004
Status: Historical Active	Previous ICR Reference No: 200403-0915-001
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/25/2007
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/21/2007
Terms of Clearance: This ICR is approved on the understanding that it is an extension of a previously approved collection, not a revision. As such, approval is also contingent on the understanding that HRSA has fulfilled all previous terms of clearance.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2010	36 Months From Approved	10/31/2007
Responses	388,628	0	559,762
Time Burden (Hours)	131,473	0	84,057
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:
	72 FR 10226	03/07/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 37249	07/09/2007
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 27

table that charts list of burden

IC Title	Form No.	Form Name
OPTN- Death Referral	2	Death Referral Data
OPTN- Deceased Donor Registration Worksheet	1b, 1	Imminent-Eligible Death Doc ,   Deceased Donor Registration
OPTN- Donor Histocompatibility	5	Donor Histocompatibility
OPTN- Heart Candidate Registration	7, 7b	Heart Candidate Registration ,   Heart Candidate Pediatric Registration
OPTN- Heart/Lung Candidate Registration	9b, 9	Heart/Lung Pediatric Registration ,   Heart./Lung Candidate Registration
OPTN- Intestine Candidate Registration	24b, 24	Intestine Candidate Pediatric Registration ,   Intestine Candidate Registration
OPTN- Intestine Follow-up	26b, 26, 26c, 26d	Intestine Pediatric Follow-up ,   Intestine Follow-up ,   Post 5-Year Intestine Follow-up ,   Post 5-Year Intestine Pediatric Follow-up
OPTN- Intestine Registration	25b, 25	Intestine Pediatric Registration ,   Intestine Registration
OPTN- Kidney Candidate Registration	12b, 12	Kidney Candidate Pediatric Registration ,   Kidney Candidate Registration
OPTN- Kidney Follow-up	14b, 14, 14c, 14d	Kidney Follow-up Pediatric ,   Kidney Follow-up ,   Post 5-Year Kidney Follow-up ,   Post 5-Year Kidney Pediatric Follow-up
OPTN- Kidney Registration	13b, 13	KidneyPediatric Registration ,   Kidney Registration
OPTN- Kidney/Pancreas Candidate Registration	18b, 18	Kidney/Pancreas Pediatric Candidate Registration ,   Kidney /Pancreas Candidate Registration
OPTN- Kidney/Pancreas Registration	19, 19b	Kidney/Pancreas Registration ,   Kidney/Pancreas Pediatric Registration
OPTN- Liver Candidate Registration	15b, 15	Liver Candidate Pediatric Registration ,   Liver Candidate Registration
OPTN- Liver Follow-up	17b, 17, 17d, 17c	Liver Pediatric Follow-up ,   Liver Follow-up ,   Post 5-Year Liver Pediatric Follow-up ,   Post 5-Year Liver Follow-up
OPTN- Liver Registration	16, 16b	Liver Registration ,   Liver Pediatric Registration
OPTN- Living Donor Registration	3	Living Donor Registration
OPTN- Lung Candidate Registration	8, 8b	Lung Candidate Registration ,   Lung Candidate Pediatric Registration
OPTN- Pancreas Candidate Registration	21b, 21	Pancreas Candidate Pediatric Registration ,   Pancreas Candidate Registration
OPTN- Pancreas Follow-up	23, 23b, 23c, 23d	Pancreas Follow-up ,   Pancreas Pediatric Follow-up ,   Post 5-Year Pancreas Follow-up ,   Post 5-Year Pancreas Pediatric Follow-up
OPTN- Pancreas Registration	22, 22b	Pancreas Pediatric Registration ,   Pancreas Registration
OPTN- Post Transplant Malignancy	27, 27b	Post Transplant Malignancy ,   Post Transplant Pediatric Malignancy
OPTN- Recipient Histocompatibility	6	Recipient Histocompatibility
OPTN- Thoracic Follow-up	11b, 11, 11c, 11d, 11e, 11f	Thoracic Pediatric Follow-up ,   Thoracic Follow-up ,   Thoracic Follow-up Annual ,   Thoracic Follow-up Annual Pediatric ,   Post 5-Year Thoracic Follow-up ,   Post 5-Year Kidney Pediatric Follow-up
OPTN- Thoracic Registration	10b, 10	Thoracic Pediatric Registration ,   Thoracic Registration
OPTN- Kidney/Pancreas Follow-up	20b, 20, 20c, 20d	Kidney/Pancreas Pediatric Follow-up ,   Kidney/Pancreas Follow-up ,   Post 5-Year Kidney/Pancreas Follow-up ,   Post 5-Year Kidney/Pancreas Pediatric Follow-up
OPTN- Living Donor Follow-up	4	Living Donor 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	388,628	559,762	0	0	-171,134	0
Annual Time Burden (Hours)	131,473	84,057	0	0	47,416	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: $137,134

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 08/21/2007

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