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 (44 U.D.C. 3506(c)(2)(A)), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to 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, call the HRSA Reports Clearance Officer on (301) 443-1129.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (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: 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 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.

Revisions in the 26 data collection forms are intended to implement approved reduction in data collection for candidates and recipients, to provide additional information specific to pediatric patients, and to clarify existing questions.

Estimates of Annualized Hour Burden

Form

Number of

respondents

Responses per

respondents

Total

responses

Hours per

response

Total burden

hours

Deceased Donor Registration

58

215

12,470

0.4200

5,237.4000

Death referral data

58

12

696

10.0000

6,960.0000

Living Donor Registration

711

10

7,110

0.4100

2,915.1000

Living Donor Follow-up

711

18

12,798

0.3300

4,223.3400

Donor Histocompatibility

154

95

14,630

0.0600

877.8000

Recipient Histocompatibility

154

172

26,488

0.1100

2,913.6800

Heart Candidate Registration

135

23

3,105

0.2800

869.4000

Lung Candidate Registration

67

27

1,809

0.2800

506.5200

Heart/Lung Candidate Registration

59

1

59

0.2800

16.5200

Thoracic Registration

135

27

3,645

0.4400

1,603.8000

Thoracic Follow-up

135

229

30,915

0.4130

12,767.8950

Kidney Candidate Registration

250

133

33,250

0.2800

9,310.0000

Kidney Registration

250

69

17,250

0.4400

7,590.0000

Kidney Follow-up

250

544

136,000

0.3332

45,315.2000

Liver Candidate Registration

125

89

11,125

0.2800

3,115.0000

Liver Registration

125

54

6,750

0.4000

2,700.0000

Liver Follow-up

125

383

47,875

0.3336

15,971.1000

Kidney/Pancreas Candidate Registration

146

12

1,752

0.2800

490.5600

Kidney/Pancreas Registration

146

7

1,022

0.5300

541.6600

Kidney/Pancreas Follow-up

146

65

9,490

0.5027

4,770.6230

Pancreas Candidate Registration

146

7

1,022

0.2800

286.1600

Pancreas Registration

146

3

438

0.4400

192.7200

Pancreas Follow-up

146

23

3,358

0.4133

1,387.8614

Intestine Candidate Registration

45

8

360

0.2400

86.4000

Intestine Registration

45

4

180

0.5300

95.4000

Intestine Follow-up

45

17

765

0.5059

387.0135

Post Transplant Malignancy

711

6

4,266

0.0800

341.2800

Total

923

388,628

131,472.4329

Send comments to Susan G. Queen, PhD, 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: February 27, 2007.

Alexandra Huttinger,

Acting Director, Division of Policy Review and Coordination.

[FR Doc. E7-3918 Filed 3-6-07; 8:45 am]

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