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, email

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)—[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 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.

The OPTN is recommending addition of a new Liver Explant Pathology form to the OPTN data system. This new form was developed by the OPTN Liver and Intestinal Organ Transplantation Committee and will be used to collect pathology data on liver transplant recipients who received waitlist exception points as a result of a diagnosis of hepatocellular carcinoma. Existing OPTN policy requires submission of post-transplant pathology reports by fax transmission, and the proposed form will provide standardized collection of this already-required information.

There are also minor revisions to the existing data collection forms; the added fields were inadvertently left off of the forms at the time of the initial submission. Several of these fields are “read only” and are included on the forms for information purposes only. One field is proposed to be removed as it represented duplicative information.

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

228

13,224

0.7500

9918.00

Death Referral Data

58

12

696

10.0000

6,960.00

Death Notification Referral—Eligible

58

145

8410

0.5000

4205.00

Death Notification Referral—Imminent

58

124

7192

0.5000

3596.00

Living Donor Registration

311

23

7153

0.6500

4649.45

Living Donor Follow-up

311

78

24,258

0.5000

12,129.00

Donor Histocompatibility

158

94

14,852

0.1000

1,485.20

Recipient Histocompatibility

158

171

27,018

0.2000

5,403.60

Heart Candidate Registration

131

27

3,537

0.5000

1,768.50

Lung Candidate Registration

66

41

2706

0.5000

1353.00

Heart/Lung Candidate Registration

50

1

50

0.5000

25.00

Thoracic Registration

131

34

4454

0.7500

3340.50

Thoracic Follow-up

131

277

36,287

0.6500

23,586.55

Kidney Candidate Registration

239

154

36,806

0.5000

18,403.00

Kidney Registration

239

72

17,208

0.7500

12,906.00

Kidney Follow-up *

239

693

165,627

0.5500

91,094.85

Liver Candidate Registration

132

98

12,936

0.5000

6,468.00

Liver Registration

132

48

6,336

0.6500

4,118.4

Liver Explant Pathology

132

11

1,452

0.3400

493.68

Liver Follow-up

132

459

60,588

0.5000

30,294.00

Kidney/Pancreas Candidate Registration

144

11

1,584

0.5000

792.00

Kidney/Pancreas Registration

144

6

864

0.9000

777.60

Kidney/Pancreas Follow-up

144

75

10,800

0.8500

9180.00

Pancreas Candidate Registration

144

4

576

0.5000

288.00

Pancreas Islet Candidate Registration

23

5

115

0.5000

57.50

Pancreas Registration

144

2

288

0.7500

216.00

Pancreas Follow-up

144

23

3312

0.6500

2152.80

Intestine Candidate Registration

43

5

215

0.5000

107.50

Intestine Registration

43

3

129

0.9000

116.10

Intestine Follow-up

43

25

1075

0.8500

913.75

Post Transplant Malignancy

689

11

7579

0.2000

1515.80

Total

905

478,270

258,314.83

*Includes an estimated 2,430 kidney transplant patients transplanted prior to the initiation of the data system.

Email comments to

paperwork@hrsa.gov

or mail to 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: November 23, 2011.

Reva Harris,

Acting Director, Division of Policy and Information Coordination.

[FR Doc. 2011-30779 Filed 11-28-11; 8:45 am]

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