75 FR 176 pgs. 55584-55585 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
Type: NOTICEVolume: 75Number: 176Pages: 55584 - 55585
FR document: [FR Doc. 2010-22665 Filed 9-10-10; 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: 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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