Agency Information Collection Activities: Submission for OMB Review; Comment Request
Federal RegisterMar 10, 2004
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget, in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443-1129.
The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995:
Proposed Project: Data System for Organ Procurement and Transplantation Network and Associated Forms (OMB No. 0915-0157)—Revision
Section 372 of the Public Health Service (PHS) Act requires that the Secretary, by contract, provide for the establishment and operation of an Organ Procurement and Transplantation Network (OPTN). The OPTN, among other responsibilities, operates and maintains a national waiting list of individuals requiring organ transplants, maintains a computerized system for matching donor organs with transplant candidates on the waiting list, and operates a 24-hour telephone service to facilitate matching organs with individuals included in the list.
Data for the OPTN data system are collected from transplant hospitals, organ procurement organizations, and tissue-typing laboratories. The information is used to match donor organs with recipients, to monitor compliance of member organizations with OPTN rules and requirements, and to report periodically on the clinical and scientific status of organ donation and transplantation in this country. Data are used in the development and revision of OPTN rules and requirements, operating procedures, and standards of quality for organ acquisition and preservation, some of which have provided the foundation for development of Federal regulations. The practical utility of the data collection is further enhanced by requirements that the OPTN data must be made available without restriction for use by OPTN members, the Scientific Registry of Transplant Recipients, the Department of Health and Human Services, and others for evaluation, research, patient information, and other important purposes.
Revisions in the 28 data collection forms are intended to clarify existing questions, to provide additional detail and categories to avoid confusion and be more inclusive, to remove obsolete data, and to comply with requests for more complete and precise data.
Estimates of Annualized Hour Burden
Worksheet
Number of respondents
Responses per respondent
Total
responses
Hours per
response
Total burden hours
Deceased Donor Registration
59
173
10,207
0.3
3,062.10
Death referral data
59
12
708
10
7,080.00
Living Donor Registration
692
10
6,920
0.2
1,384.00
Living Donor Follow-up
692
19
13,148
0.1
1,314.80
Donor Histocompatibility
152
87
13,224
0.1
1,322.40
Recipient Histocompatibility
152
163
24,776
0.1
2,477.60
Heart Candidate Registration
139
23
3,197
0.3
959.10
Lung Candidate Registration
70
28
1,960
0.3
588.00
Heart/Lung Candidate Registration
72
1
72
0.3
21.60
Thoracic Registration
139
24
3,336
0.3
1,000.80
Thoracic Follow-up
139
174
24,186
0.2
4,837.20
Kidney Candidate Registration
247
109
26,923
0.2
5,384.60
Kidney Registration
247
65
16,055
0.3
4,816.50
Kidney Follow-up*
247
493
121,771
0.2
24,354.20
Liver Candidate Registration
123
82
10,086
0.2
2,017.20
Liver Registration
123
46
5,658
0.4
2,263.20
Liver Follow-up
123
299
36,777
0.3
11,033.10
Kidney/Pancreas Candidate Registration
139
12
1,668
0.2
333.60
Kidney/Pancreas Registration
139
7
973
0.4
389.20
Kidney/Pancreas Follow-up
139
64
8,896
0.3
2,668.80
Pancreas Candidate Registration
139
7
973
0.2
194.60
Pancreas Registration
139
4
556
0.3
166.80
Pancreas Follow-up
139
20
2,780
0.2
556.00
Intestine Candidate Registration
44
5
220
0.2
44.00
Intestine Registration
44
3
132
0.2
26.40
Intestine Follow-up
44
8
352
0.2
70.40
Immunosuppression Treatment
692
38
26,296
0.025
657.40
Immunosuppression Treatment Follow-up
692
281
194,452
0.025
4,861.30
Post Transplant Malignancy
692
5
3,460
0.05
173.00
Total
903
559,762
84,057.90
* Includes an estimated 6,000 kidney transplant patients transplanted prior to the initiation of the data system.
Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Desk Officer, Health Resources and Services Administration, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC.
Dated: March 3, 2004.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 04-5304 Filed 3-9-04; 8:45 am]
BILLING CODE 4165-15-P
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