Agency Information Collection Activities: Proposed Collection: Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection: Comment Request

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, e-mail

paperwork@hrsa.gov

or call the HRSA Reports Clearance Officer at (301) 443-1129.

Comments are invited on:

(a) The proposed collection of information for the proper performance of the functions of the agency; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

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 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 26 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

respondents

Total

responses

Hours per

response

Total burden

hours

Deceased Donor Registration

58

216

12,528

0.7500

9,396.00

Death referral data

58

12

696

10.0000

6,960.00

Death Notification Referral—Eligible

58

161

9338

0.2000

1,867.60

Death Notification Referral—Imminent

58

168

9744

0.5000

4,872.00

Living Donor Registration

308

39

12,012

0.6500

7,807.80

Living Donor Follow-up

308

50

15,400

0.5000

7,700.00

Donor Histocompatibility

156

131

20,436

0.1000

2,043.60

Recipient Histocompatibility

156

196

30,576

0.2000

6,115.20

Heart Candidate Registration

127

35

4,445

0.5000

2,222.50

Lung Candidate Registration

68

42

2,856

0.5000

1,428.00

Heart/Lung Candidate Registration

51

2

102

0.5000

51.00

Thoracic Registration

127

36

4,572

0.7500

3,429.00

Thoracic Follow-up

127

320

40,640

0.6500

26,416.00

Kidney Candidate Registration

241

183

44,103

0.5000

22,051.50

Kidney Registration

241

83

20,003

0.7500

15,002.25

Kidney Follow-up *

241

742

178,822

0.5500

98,352.10

Liver Candidate Registration

129

109

14,061

0.5000

7,030.50

Liver Registration

129

58

7,482

0.6500

4,863.30

Liver Follow-up

129

519

66,951

0.5000

33,475.50

Kidney/Pancreas Candidate Registration

143

14

2,002

0.5000

1,001.00

Kidney/Pancreas Registration

143

7

1,001

0.9000

900.90

Kidney/Pancreas Follow-up

143

85

12,155

0.8500

10,331.75

Pancreas Candidate Registration

143

7

1,001

0.5000

500.50

Pancreas Registration

143

3

429

0.7500

321.75

Pancreas Follow-up

143

20

2,860

0.6500

1,859.00

Intestine Candidate Registration

44

7

308

0.5000

154.00

Intestine Registration

44

5

220

0.9000

198.00

Intestine Follow-up

44

28

1,232

0.8500

1,047.20

Post Transplant Malignancy

684

10

6,840

0.2000

1,368.00

Total

463

522,815

278,765.95

* Includes an estimated 2,500 kidney transplant patients transplanted prior to the initiation of the data system.

E-mail comments to

paperwork@hrsa.gov

or mail the HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice.

Dated: May 25, 2010.

Sahira Rafiullah,

Director, Division of Policy and Information Coordination.

[FR Doc. 2010-12964 Filed 5-27-10; 8:45 am]

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