75 FR 103 pgs. 30032-30033 - Agency Information Collection Activities: Proposed Collection: Comment Request

Type: NOTICEVolume: 75Number: 103Pages: 30032 - 30033
FR document: [FR Doc. 2010-12964 Filed 5-27-10; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Health Resources and Services Administration
Official PDF Version:  PDF Version

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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