AGENCY:
Health Resources and Services Administration, HHS.
ACTION:
Notice.
SUMMARY:
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
DATES:
Comments on this Information Collection Request must be received within 60 days of this notice.
ADDRESSES:
Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N39, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
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 Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION:
When submitting comments or requesting information, please include the information request collection title for reference.
Information Collection Request Title: Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System OMB No. 0915-0157—Revision.
Abstract: Section 372 of the Public Health Service (PHS) Act, as amended, requires that the Secretary, by contract, provide for the establishment and operation of an Organ Procurement and Transplantation Network (OPTN). This is a request for revisions to current OPTN data collection forms associated with an individual's clinical characteristics at the time of registration, transplant, and follow-up after the transplant. These specific data elements of the OPTN data system are collected from transplant hospitals. The information is used to indicate the disease severity of transplant candidates, to monitor compliance of member organizations with OPTN rules and requirements, to report periodically on the clinical and scientific status of organ donation and transplantation and other purposes consistent with the law. Data are used to: (1) Facilitate organ placement and match donor organs with recipients; (2) monitor compliance of member organizations with federal laws and regulations and with OPTN requirements; (3) review and report periodically to the public on the status of organ donation and transplantation in the United States; (4) provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation; and (5) perform transplantation-related public health surveillance including possible transmission of donor disease. 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 members of the public for evaluation, research, patient information, and other important purposes.
Likely Respondents: Transplant programs, medical and scientific organizations, and public organizations.
Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to: (1) Review instructions; develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; (2) train personnel to respond to a request for collection of information; (3) search data sources; (4) complete and review the collection of information; and (5) to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
| Section/activity | Number of respondents | Average number of responses per respondent | Total number of responses | Average burden per response (in hours) | Total burden hours |
|---|---|---|---|---|---|
| Deceased Donor Registration | 58 | 158.2 | 9175.6 | 1.1 | 10093.2 |
| Living Donor Registration | 307 | 20.6 | 6324.2 | 1.8 | 11383.6 |
| Living Donor Follow-up | 307 | 60.7 | 18634.9 | 1.3 | 24225.4 |
| Donor Histocompatibility | 154 | 96.7 | 14891.8 | 0.2 | 2978.4 |
| Recipient Histocompatibility | 154 | 173.5 | 26719 | 0.4 | 10687.6 |
| Heart Candidate Registration | 132 | 30.5 | 4026 | 0.9 | 3623.4 |
| Heart Recipient Registration | 132 | 19.9 | 2626.8 | 1.2 | 3152.2 |
| Heart Follow Up (6 Month) | 132 | 17 | 2244 | 0.4 | 897.6 |
| Heart Follow Up (1-5 Year) | 132 | 73.9 | 9754.8 | 0.9 | 8779.3 |
| Heart Follow Up (Post 5 Year) | 132 | 115.2 | 15206.4 | 0.5 | 7603.2 |
| Heart Post-Transplant Malignancy Form | 132 | 11 | 1452 | 0.9 | 1306.8 |
| Lung Candidate Registration | 70 | 39.6 | 2772 | 0.9 | 2494.8 |
| Lung Recipient Registration | 70 | 28.3 | 1981 | 1.2 | 2377.2 |
| Lung Follow Up (6 Month) | 70 | 26.2 | 1834 | 0.5 | 917.0 |
| Lung Follow Up (1-5 Year) | 70 | 99.4 | 6958 | 1.1 | 7653.8 |
| Lung Follow Up (Post 5 Year) | 70 | 65.6 | 4592 | 0.6 | 2755.2 |
| Lung Post-Transplant Malignancy Form | 70 | 1.5 | 105 | 0.4 | 42.0 |
| Heart/Lung Candidate Registration | 69 | 0.7 | 48.3 | 1.1 | 53.1 |
| Heart/Lung Recipient Registration | 69 | 0.4 | 27.6 | 1.3 | 35.9 |
| Heart/Lung Follow Up (6 Month) | 69 | 0.3 | 20.7 | 0.8 | 16.6 |
| Heart/Lung Follow Up (1-5 Year) | 69 | 1.5 | 103.5 | 1.1 | 113.9 |
| Heart/Lung Follow Up (Post 5 Year) | 69 | 3.1 | 213.9 | 0.6 | 128.3 |
| Heart/Lung Post-Transplant Malignancy Form | 69 | 0.2 | 13.8 | 0.4 | 5.5 |
| Liver Candidate Registration | 141 | 89.2 | 12577.2 | 0.8 | 10061.8 |
| Liver Recipient Registration | 141 | 48.8 | 6880.8 | 1.2 | 8257.0 |
| Liver Follow-up (6 Month—5 Year) | 141 | 231.1 | 32585.1 | 1 | 32585.1 |
| Liver Follow-up (Post 5 Year) | 141 | 256.5 | 36166.5 | 0.5 | 18083.3 |
| Liver Recipient Explant Pathology Form | 141 | 12.3 | 1734.3 | 0.6 | 1040.6 |
| Liver Post-Transplant Malignancy | 141 | 13.2 | 1861.2 | 0.8 | 1489.0 |
| Intestine Candidate Registration | 40 | 4.4 | 176 | 1.3 | 228.8 |
| Intestine Recipient Registration | 40 | 3.4 | 136 | 1.8 | 244.8 |
| Intestine Follow Up (6 Month—5 Year) | 40 | 13.3 | 532 | 1.5 | 798.0 |
| Intestine Follow Up (Post 5 Year) | 40 | 13.5 | 540 | 0.4 | 216.0 |
| Intestine Post-Transplant Malignancy Form | 40 | 0.6 | 24 | 1 | 24.0 |
| Kidney Candidate Registration | 238 | 162.6 | 38698.8 | 0.8 | 30959.0 |
| Kidney Recipient Registration | 238 | 71.8 | 17088.4 | 1.2 | 20506.1 |
| Kidney Follow-Up (6 Month—5 Year) | 238 | 379.5 | 90321 | 0.9 | 81288.9 |
| Kidney Follow-up (Post 5 Year) | 238 | 346.7 | 82514.6 | 0.5 | 41257.3 |
| Kidney Post-Transplant Malignancy Form | 238 | 18.1 | 4307.8 | 0.8 | 3446.2 |
| Pancreas Candidate Registration | 141 | 3.4 | 479.4 | 0.6 | 287.6 |
| Pancreas Recipient Registration | 141 | 1.8 | 253.8 | 1.2 | 304.6 |
| Pancreas Follow-up (6 Month—5 Year) | 141 | 8.2 | 1156.2 | 0.5 | 578.1 |
| Pancreas Follow-up (Post 5 Year) | 141 | 13.5 | 1903.5 | 0.5 | 951.8 |
| Pancreas Post-Transplant Malignancy Form | 141 | 0.8 | 112.8 | 0.6 | 67.7 |
| Kidney/Pancreas Candidate Registration | 141 | 9.6 | 1353.6 | 0.6 | 812.2 |
| Kidney/Pancreas Recipient Registration | 141 | 5.2 | 733.2 | 1.2 | 879.8 |
| Kidney/Pancreas Follow-up (6 Month—5 Year) | 141 | 26.9 | 3792.9 | 0.5 | 1896.5 |
| Kidney/Pancreas Follow-up (Post 5 Year) | 141 | 48.2 | 6796.2 | 0.6 | 4077.7 |
| Kidney/Pancreas Post-Transplant Malignancy Form | 141 | 1.6 | 225.6 | 0.4 | 90.2 |
| VCA Candidate Registration | 23 | 1.7 | 39.1 | 0.4 | 15.6 |
| VCA Recipient Registration | 23 | 1.7 | 39.1 | 1.3 | 50.8 |
| VCA Recipient Follow Up | 23 | 1.7 | 39.1 | 1 | 39.1 |
| Total | * 457 | 471411.4 | 359889.5 | ||
| * Total number of OPTN transplant hospitals as of October 23, 2015. Number of respondents for transplant candidate or recipient forms is based on number of organ specific programs associated with each form. | |||||
| ** Bold entries represent those forms being modified during this submission. |
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-05684 Filed 3-11-16; 8:45 am]
BILLING CODE 4165-15-P