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

Forms and Documents

Document Name	Status
Form 1b OPTN- Deceased Donor Registration Worksheet Form	Modified
Form 27 OPTN- Post Transplant Malignancy Form	New
Form 26b OPTN- Intestine Follow-up Form	New
Form 25b OPTN- Intestine Registration Form	New
Form 24b OPTN- Intestine Candidate Registration Form	New
Form 23 OPTN- Pancreas Follow-up Form	New
Form 22b OPTN- Pancreas Registration Form	New
Form 21b OPTN- Pancreas Candidate Registration Form	New
Form 20b OPTN- Kidney/Pancreas Follow-up Form	New
Form 19 OPTN- Kidney/Pancreas Registration Form	New
Form 18b OPTN- Kidney/Pancreas Candidate Registration Form	New
Form 17b OPTN- Liver Follow-up Form	New
Form 16 OPTN- Liver Registration Form	New
Form 15b OPTN- Liver Candidate Registration Form	New
Form 14b OPTN- Kidney Follow-up Form	New
Form 13b OPTN- Kidney Registration Form	New
Form 12b OPTN- Kidney Candidate Registration Form	New
Form 11b OPTN- Thoracic Follow-up Form	New
Form 10b OPTN- Thoracic Registration Form	New
Form 9b OPTN- Heart/Lung Candidate Registration Form	New
Form 8 OPTN- Lung Candidate Registration Form	New
Form 7 OPTN- Heart Candidate Registration Form	New
Form 6 OPTN- Recipient Histocompatibility Form	New
Form 5 OPTN- Donor Histocompatibility Form	New
Form 4 OPTN- Living Donor Follow-up Form	New
Form 3 OPTN- Living Donor Registration Form	New
Form 2 OPTN- Death Referral Form	New
0157 comment page2.tif Supplementary Document	2007-07-25
0157 comment.tif Supplementary Document	2007-07-25
FINALss 0157 2007.doc Supporting Statement A	2007-07-25

IC Document Collections

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

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
	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.

	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

IC Title	Form No.	Form Name
OPTN- Kidney/Pancreas Registration	19, 19b	Kidney/Pancreas Registration ,   Kidney/Pancreas Pediatric 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- Pancreas Candidate Registration	21b, 21	Pancreas Candidate Pediatric Registration ,   Pancreas Candidate Registration
OPTN- Pancreas Registration	22, 22b	Pancreas Pediatric Registration ,   Pancreas 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- Intestine Candidate Registration	24b, 24	Intestine Candidate Pediatric Registration ,   Intestine Candidate Registration
OPTN- Intestine Registration	25b, 25	Intestine Pediatric Registration ,   Intestine 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- Post Transplant Malignancy	27, 27b	Post Transplant Malignancy ,   Post Transplant Pediatric Malignancy
OPTN- Deceased Donor Registration Worksheet	1b, 1	Imminent-Eligible Death Doc ,   Deceased Donor Registration
OPTN- Death Referral	2	Death Referral Data
OPTN- Living Donor Registration	3	Living Donor Registration
OPTN- Living Donor Follow-up	4	Living Donor Follow-up
OPTN- Donor Histocompatibility	5	Donor Histocompatibility
OPTN- Recipient Histocompatibility	6	Recipient Histocompatibility
OPTN- Heart Candidate Registration	7, 7b	Heart Candidate Registration ,   Heart Candidate Pediatric Registration
OPTN- Lung Candidate Registration	8, 8b	Lung Candidate Registration ,   Lung Candidate Pediatric Registration
OPTN- Heart/Lung Candidate Registration	9b, 9	Heart/Lung Pediatric Registration ,   Heart./Lung Candidate Registration
OPTN- Thoracic Registration	10b, 10	Thoracic Pediatric Registration ,   Thoracic Registration
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- Kidney Candidate Registration	12b, 12	Kidney Candidate Pediatric Registration ,   Kidney Candidate Registration
OPTN- Kidney Registration	13b, 13	KidneyPediatric Registration ,   Kidney 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- Liver Candidate Registration	15b, 15	Liver Candidate Pediatric Registration ,   Liver Candidate Registration
OPTN- Kidney/Pancreas Candidate Registration	18b, 18	Kidney/Pancreas Pediatric Candidate Registration ,   Kidney /Pancreas Candidate Registration
OPTN- Liver Registration	16, 16b	Liver Registration ,   Liver Pediatric 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

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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	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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