Information Collection Request

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

ICR 201010-0915-001 · OMB 0915-0157 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form 1b OPTN- Deceased Donor Registration Worksheet Form Modified Available
Form Death Notification Death Notification Referral-Imminent Form and Instruction New Repair queued
Form Death Notification Death Notification Referal - Eligible Form and Instruction New Available
Form Death Referral Dat Death Referral Data Form New Repair queued
Form 27 OPTN- Post Transplant Malignancy Form Modified Repair queued
Form 26b OPTN- Intestine Follow-up Form Modified Available
Form 25b OPTN- Intestine Registration Form Modified Repair queued
Form 24b OPTN- Intestine Candidate Registration Form Modified Available
Form 23 OPTN- Pancreas Follow-up Form Modified Repair queued
Form 22b OPTN- Pancreas Registration Form Modified Available
Form 21b OPTN- Pancreas Candidate Registration Form Modified Available
Form 20b OPTN- Kidney/Pancreas Follow-up Form Modified Repair queued
Form 19 OPTN- Kidney/Pancreas Registration Form Modified Available
Form 18b OPTN- Kidney/Pancreas Candidate Registration Form Modified Available
Form 17b OPTN- Liver Follow-up Form Modified Available
Form 16 OPTN- Liver Registration Form Modified Repair queued
Form 15b OPTN- Liver Candidate Registration Form Modified Available
Form 14b OPTN- Kidney Follow-up Form Modified Repair queued
Form 13 OPTN- Kidney Registration Form Modified Available
Form 12b OPTN- Kidney Candidate Registration Form Modified Repair queued
Form 11b OPTN- Thoracic Follow-up Form Modified Available
Form 10b OPTN- Thoracic Registration Form Modified Repair queued
Form 9b OPTN- Heart/Lung Candidate Registration Form Modified Repair queued
Form 8 OPTN- Lung Candidate Registration Form Modified Available
Form 7 OPTN- Heart Candidate Registration Form Modified Available
Form 6 OPTN- Recipient Histocompatibility Form Modified Available
Form 5 OPTN- Donor Histocompatibility Form Modified Available
Form 4 OPTN- Living Donor Follow-up Form Modified Available
Form 3 OPTN- Living Donor Registration Form Modified Repair queued
Form 2 OPTN- Death Referral Form Removed Repair queued
Death Referral, Imminent, and Eligible Instructions.pdf Supplementary Document Uploaded 2010-09-14 Available
Death Referral, Imminent, and Eligible Instructions.pdf Supplementary Document Uploaded 2010-09-14 Available
Post-Transplant Malignancy.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Recipient Follow-up - Intestine - Post 5-Year.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Follow-up - Intestine.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Recipient Registration - Intestine.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Candidate Registration - Intestine.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Follow-up - Pancreas - Post 5-Year.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Follow-up - Pancreas.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Recipient Registration - Pancreas.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Candidate Registration - Pancreas.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Follow-up - Kidney - Post 5-Year.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Follow-up - Kidney-Pancreas.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Recipient Follow-up - Kidney-Pancreas.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Candidate Registration - Kidney-Pancreas.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Follow-up - Liver.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Recipient Registration - Liver.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Candidate Registration - Liver.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Recipient Follow-up - Kidney - Post 5-Year.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Follow-up - Kidney.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Recipient Registration - Kidney.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Candidate Registration - Kidney.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Follow-up - Thoracic - Post 6-Month.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Follow-up - Thoracic - Post 5-Year.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Recipient Follow-up - Thoracic.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Recipient Registration - Thoracic.doc Supplementary Document Uploaded 2010-09-14 Repair queued
Transplant Candidate Registration - Heart-Lung.doc Supplementary Document Uploaded 2010-09-14 Available
Transplant Candidate Registration - Lung.doc Supplementary Document Uploaded 2010-09-14 Available
TCR Heart Help.pdf Supplementary Document Uploaded 2007-07-17 Available
Recipient Histocompatibility Help.pdf Supplementary Document Uploaded 2007-07-17 Available
Donor Histocompatility Help.pdf Supplementary Document Uploaded 2007-07-17 Available
Living Donor Follow-up.doc Supplementary Document Uploaded 2010-09-14 Available
Living Donor Fol Help.pdf Supplementary Document Uploaded 2007-07-17 Available
Living Donor Reg Help.pdf Supplementary Document Uploaded 2007-07-17 Available
Death Referral Data Help.pdf Supplementary Document Uploaded 2007-07-17 Available
Deceased Donor Registration.doc Supplementary Document Uploaded 2010-09-13 Available
Supporting Statement OPTN UNET Forms_0157_2010.docx Supporting Statement A Uploaded 2010-09-16 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
6389 OPTN- Deceased Donor Registration Worksheet Form Modified
194824 Death Notification Referral-Imminent Form and Instruction New
194823 Death Notification Referal - Eligible Form and Instruction New
194822 Death Referral Data Form New
181751 OPTN- Post Transplant Malignancy Form Modified
181750 OPTN- Intestine Follow-up Form Modified
181749 OPTN- Intestine Registration Form Modified
181748 OPTN- Intestine Candidate Registration Form Modified
181747 OPTN- Pancreas Follow-up Form Modified
181746 OPTN- Pancreas Registration Form Modified
181745 OPTN- Pancreas Candidate Registration Form Modified
181744 OPTN- Kidney/Pancreas Follow-up Form Modified
181743 OPTN- Kidney/Pancreas Registration Form Modified
181742 OPTN- Kidney/Pancreas Candidate Registration Form Modified
181741 OPTN- Liver Follow-up Form Modified
181740 OPTN- Liver Registration Form Modified
181739 OPTN- Liver Candidate Registration Form Modified
181738 OPTN- Kidney Follow-up Form Modified
181737 OPTN- Kidney Registration Form Modified
181736 OPTN- Kidney Candidate Registration Form Modified
181735 OPTN- Thoracic Follow-up Form Modified
181734 OPTN- Thoracic Registration Form Modified
181733 OPTN- Heart/Lung Candidate Registration Form Modified
181732 OPTN- Lung Candidate Registration Form Modified
181731 OPTN- Heart Candidate Registration Form Modified
181730 OPTN- Recipient Histocompatibility Form Modified
181729 OPTN- Donor Histocompatibility Form Modified
181728 OPTN- Living Donor Follow-up Form Modified
181727 OPTN- Living Donor Registration Form Modified
181726 OPTN- Death Referral Form Removed
ICR Details
0915-0157 201010-0915-001
Historical Active 200708-0915-004
HHS/HSA
Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System
Extension without change of a currently approved collection   No
Regular
Approved without change 12/20/2010
Retrieve Notice of Action (NOA) 10/12/2010
Since OPTN is currently undergoing a review of this collection's forms and expects to submit proposed revisions within the next year, this collection is approved for one year only.
  Inventory as of this Action Requested Previously Approved
12/31/2011 36 Months From Approved 12/31/2010
522,815 0 388,628
278,769 0 131,473
0 0 0

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.

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
  
None

Not associated with rulemaking

  75 FR 30032 05/28/2010
75 FR 55584 09/13/2010
No

29
IC Title Form No. Form Name
OPTN- Deceased Donor Registration Worksheet 1, 1b Imminent-Eligible Death Doc ,   Deceased Donor Registration
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 Kidney Registration ,   KidneyPediatric Registration
OPTN- Kidney Follow-up 14b, 14, 14d, 14c 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- Liver Registration 16, 16b Liver Registration ,   Liver Pediatric Registration
OPTN- Liver Follow-up 17b, 17, 17c, 17d Liver Pediatric Follow-up ,   Liver Follow-up ,   Post 5-Year Liver Pediatric Follow-up ,   Post 5-Year Liver Follow-up
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- 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 22b, 22 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- Post Transplant Malignancy 27, 27b Post Transplant Malignancy ,   Post Transplant Pediatric Malignancy
Death Referral Data Death Referral Data Death Referral Data
Death Notification Referal - Eligible Death Notification Referral _Eligible Death Notification Referral _Eligible
Death Notification Referral-Imminent Death Notification Referral-Imminent Death Notification Referral-Imminent
OPTN- Death Referral 2 Death Referral Data
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

  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 522,815 388,628 0 -696 134,883 0
Annual Time Burden (Hours) 278,769 131,473 0 -6,960 154,256 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
The Program is requesting 278,769 hours - an increase of 154,256 hours. This adjustment is the result of an increase in the number of transplant centers and the number of surviving donors and recipients for whom follow-up forms are required. The estimated hours per response for the existing worksheets have been modified. Previously only the time to enter the data was included in the estimated hours per response. The estimated hours per response for this submission include time to gather the information, review instructions if necessary and enter the data.

$103,289
No
No
No
No
No
Uncollected
Gerta Bardhoshi 301 443-1129 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/04/2010