| Page Range | 13378-13380 | |
| FR Document | 2016-05684 |
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)] [Notices] [Pages 13378-13380] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05684] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request 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 [email protected] 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 [email protected] 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. [[Page 13379]] Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Average Number of number of Total number burden per Total burden Section/activity respondents responses per of responses response (in hours respondent 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 132 11 1452 0.9 1306.8 Form........................... 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 70 1.5 105 0.4 42.0 Form........................... Heart/Lung Candidate 69 0.7 48.3 1.1 53.1 Registration................... Heart/Lung Recipient 69 0.4 27.6 1.3 35.9 Registration................... 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 69 3.1 213.9 0.6 128.3 Year).......................... Heart/Lung Post-Transplant 69 0.2 13.8 0.4 5.5 Malignancy Form................ 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--5 141 231.1 32585.1 1 32585.1 Year).......................... Liver Follow-up (Post 5 Year)... 141 256.5 36166.5 0.5 18083.3 Liver Recipient Explant 141 12.3 1734.3 0.6 1040.6 Pathology Form................. 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 40 13.3 532 1.5 798.0 Year).......................... Intestine Follow Up (Post 5 40 13.5 540 0.4 216.0 Year).......................... Intestine Post-Transplant 40 0.6 24 1 24.0 Malignancy Form................ 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--5 238 379.5 90321 0.9 81288.9 Year).......................... Kidney Follow-up (Post 5 Year).. 238 346.7 82514.6 0.5 41257.3 Kidney Post-Transplant 238 18.1 4307.8 0.8 3446.2 Malignancy Form................ 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--5 141 8.2 1156.2 0.5 578.1 Year).......................... Pancreas Follow-up (Post 5 Year) 141 13.5 1903.5 0.5 951.8 Pancreas Post-Transplant 141 0.8 112.8 0.6 67.7 Malignancy Form................ Kidney/Pancreas Candidate 141 9.6 1353.6 0.6 812.2 Registration................... Kidney/Pancreas Recipient 141 5.2 733.2 1.2 879.8 Registration................... Kidney/Pancreas Follow-up (6 141 26.9 3792.9 0.5 1896.5 Month--5 Year)................. Kidney/Pancreas Follow-up (Post 141 48.2 6796.2 0.6 4077.7 5 Year)........................ Kidney/Pancreas Post-Transplant 141 1.6 225.6 0.4 90.2 Malignancy Form................ 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. [[Page 13380]] 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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this Information Collection Request must be received within 60 days of this notice. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 81 FR 13378 |