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

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]

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