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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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.
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
27
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
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:
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
Agency Contact:
Susan Queen 3014431129
Common Form ICR:
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:
(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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