# Agency Information Collection Activities: Submission for OMB Review; Comment Request

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2010-22665

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** September 13, 2010
- **Citation:** 75 FR 55584

## Text

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 (OMB), 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, e-mail
paperwork@hrsa.gov
or 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: Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System (OMB No. 0915-0157)—Extension

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 system 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 indicate the disease severity of transplant candidates, 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 to develop transplant, donation and allocation policies, to determine if institutional members are complying with policy, to determine member-specific performance, to ensure patient safety when no alternative sources of data exist and to fulfill the requirements of the OPTN Final Rule. The practical utility of the data collection is further enhanced by requirements that the OPTN data must be made available, consistent with applicable laws, 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.

No revisions of the 29 data collection forms are proposed at this time; however, the OPTN is currently undergoing a review of the forms and expects to submit proposed revisions within the next year.

The annual estimate of burden is as follows:

Form

Number of
respondents

Responses per
respondent

Total
responses

Hours per
response

Total burden hours

Deceased Donor Registration
58
216
12,528
0.7500
9,396.0000

Death referral data
58
12
696
10.0000
6,960.0000

Death Notification Referral—Eligible
58
161
9338
0.2000
1,867.6000

Death Notification Referral—Imminent
58
168
9744
0.5000
4,872.0000

Living Donor Registration
308
39
12,012
0.6500
7,807.8000

Living Donor Follow-up
308
50
15,400
0.5000
7,700.0000

Donor Histocompatibility
156
131
20,436
0.1000
2,043.6000

Recipient Histocompatibility
156
196
30,576
0.2000
6,115.2000

Heart Candidate Registration
127
35
4,445
0.5000
2,222.5000

Lung Candidate Registration
68
42
2,856
0.5000
1,428.0000

Heart/Lung Candidate Registration
51
2
102
0.5000
51.0000

Thoracic Registration
127
36
4,572
0.7500
3,429.0000

Thoracic Follow-up
127
320
40,640
0.6500
26,416.0000

Kidney Candidate Registration
241
183
44,103
0.5000
22,051.5000

Kidney Registration
241
83
20,003
0.7500
15,002.2500

Kidney Follow-up*
241
742
178,822
0.5500
98,352.1000

Liver Candidate Registration
129
109
14,061
0.5000
7,030.5000

Liver Registration
129
58
7,482
0.6500
4,863.3000

Liver Follow-up
129
519
66,951
0.5000
33,475.5000

Kidney/Pancreas Candidate Registration
143
14
2,002
0.5000
1,001.0000

Kidney/Pancreas Registration
143
7
1,001
0.9000
900.9000

Kidney/Pancreas Follow-up
143
85
12,155
0.8500
10,331.7500

Pancreas Candidate Registration
143
7
1,001
0.5000
500.5000

Pancreas Registration
143
3
429
0.7500
321.7500

Pancreas Follow-up
143
20
2,860
0.6500
1,859.0000

Intestine Candidate Registration
44
7
308
0.5000
154.0000

Intestine Registration
44
5
220
0.9000
198.0000

Intestine Follow-up
44
28
1,232
0.8500
1,047.2000

Post Transplant Malignancy
684
10
6,840
0.2000
1,368.0000

Total
463

522,815

278,765.9500

* Includes an estimated 2,500 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 the desk officer for HRSA, either by e-mail to
OIRA_submission@omb.eop.gov
or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.”

Dated: September 3, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.

[FR Doc. 2010-22665 Filed 9-10-10; 8:45 am]
BILLING CODE 4165-15-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2010-22665. Public record. Not legal advice.