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

ICR 201010-0915-001

OMB: 0915-0157

Federal Form Document

Forms and Documents
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Supplementary Document
2010-09-14
Supplementary Document
2010-09-14
Supplementary Document
2010-09-14
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2010-09-14
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2010-09-14
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2010-09-14
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2010-09-14
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2010-09-14
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2010-09-14
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2010-09-14
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2010-09-14
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2010-09-14
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2010-09-14
Supplementary Document
2010-09-14
Supplementary Document
2007-07-17
Supplementary Document
2007-07-17
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2007-07-17
Supplementary Document
2010-09-14
Supplementary Document
2007-07-17
Supplementary Document
2007-07-17
Supplementary Document
2007-07-17
Supplementary Document
2010-09-13
Supporting Statement A
2010-09-16
IC Document Collections
IC ID
Document
Title
Status
6389 Modified
194824 New
194823 New
194822 New
181751 Modified
181750 Modified
181749 Modified
181748 Modified
181747 Modified
181746 Modified
181745 Modified
181744 Modified
181743 Modified
181742 Modified
181741 Modified
181740 Modified
181739 Modified
181738 Modified
181737 Modified
181736 Modified
181735 Modified
181734 Modified
181733 Modified
181732 Modified
181731 Modified
181730 Modified
181729 Modified
181728 Modified
181727 Modified
181726 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


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