[Federal Register Volume 79, Number 173 (Monday, September 8, 2014)] [Notices] [Pages 53203-53204] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2014-21283] ----------------------------------------------------------------------- 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 10-29, 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: Data System for Organ Procurement and Transplantation Network OMB No.: 0915-0157--Revision Abstract: 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). This is a request for revisions to current OPTN data collection forms associated with donor organ procurement and an individual's clinical characteristics at the time of registration, transplant, and follow-up after the transplant. 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 whether 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 members of the public for evaluation, research, patient information, and other important purposes. Likely Respondents: Transplant programs, organ procurement organizations, histocompatibility laboratories, 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: 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; train personnel to respond to a request for collection of information; search data sources; complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. ---------------------------------------------------------------------------------------------------------------- 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 9174 1.1 10091.4 Living Donor Registration....... 290 20.6 5984 1.8 10771.2 Living Donor Follow-up.......... 290 60.7 17610 1.3 22893.0 Donor Histocompatibility........ 151 96.7 14598 0.2 2919.6 Recipient Histocompatibility.... 151 173.5 26199 0.4 10479.6 Heart Candidate Registration.... 131 30.5 3991 0.9 3591.9 Heart Recipient Registration.... 131 19.3 2525 1.4 3535.0 Heart Follow Up (6 Month)....... 131 17.0 2229 0.4 891.6 Heart Follow Up (1-5 Year)...... 131 73.9 9683 0.9 8714.7 Heart Follow Up (Post 5 Year)... 131 115.2 15091 0.5 7545.5 Heart Post-Transplant Malignancy 131 11.0 1447 0.9 1302.3 Form........................... Lung Candidate Registration..... 64 39.6 2534 0.9 2280.6 Lung Recipient Registration..... 64 30.0 1923 1.4 2692.2 Lung Follow Up (6 Month)........ 64 26.2 1677 0.5 838.5 Lung Follow Up (1-5 Year)....... 64 99.4 6364 1.1 7000.4 Lung Follow Up (Post 5 Year).... 64 65.6 4201 0.6 2520.6 Lung Post-Transplant Malignancy 64 1.5 99 0.4 39.6 Form........................... Heart/Lung Candidate 63 0.7 46 1.1 50.6 Registration................... Heart/Lung Recipient 63 0.3 21 1.4 29.4 Registration................... Heart/Lung Follow Up (6 Month).. 63 0.3 20 0.8 16 Heart/Lung Follow Up (1-5 Year). 63 1.5 97 1.1 106.7 Heart/Lung Follow Up (Post 5 63 3.1 194 0.6 116.4 Year).......................... [[Page 53204]] Heart/Lung Post-Transplant 63 0.2 12 0.4 4.8 Malignancy Form................ Liver Candidate Registration.... 135 89.2 12048 0.8 9638.4 Liver Recipient Registration.... 135 47.8 6457 1.3 8394.1 Liver Follow-up (6 Month-5 Year) 135 231.1 31194 1 31194.0 Liver Follow-up (Post 5 Year)... 135 256.5 34622 0.5 17311.0 Liver Recipient Explant 135 12.3 1665 0.6 999.0 Pathology Form................. Liver Post-Transplant Malignancy 135 13.2 1786 0.8 1428.8 Intestine Candidate Registration 41 4.4 182 1.3 236.6 Intestine Recipient Registration 41 2.7 109 1.8 196.2 Intestine Follow Up (6 Month-5 41 13.3 547 1.5 820.5 Year).......................... Intestine Follow Up (Post 5 41 13.5 553 0.4 221.2 Year).......................... Intestine Post-Transplant 41 0.6 25 1.0 25.0 Malignancy Form................ Kidney Candidate Registration... 233 162.6 37880 0.8 30304.0 Kidney Recipient Registration... 233 72.5 16904 1.3 21975.2 Kidney Follow-Up (6 Month-5 233 379.5 88422 0.9 79579.8 Year).......................... Kidney Follow-up (Post 5 Year).. 233 346.7 80770 0.5 40385.0 Kidney Post-Transplant 233 18.1 4213 0.8 3370.4 Malignancy Form................ Pancreas Candidate Registration. 134 3.6 479 0.9 431.1 Pancreas Recipient Registration. 134 1.9 259 1.1 284.9 Pancreas Follow-up (6 Month-5 134 10.4 1398 1.0 1398.0 Year).......................... Pancreas Follow-up (Post 5 Year) 134 13.5 1804 0.5 902.0 Pancreas Post-Transplant 134 0.8 108 0.6 64.8 Malignancy Form................ Kidney/Pancreas Candidate 134 9.6 1280 0.9 1152.0 Registration................... Kidney/Pancreas Recipient 134 5.7 760 1.1 836.0 Registration................... Kidney/Pancreas Follow-up (6 134 33.6 4509 1.0 4509.0 Month-5 Year).................. Kidney/Pancreas Follow-up (Post 134 48.2 6465 0.6 3879.0 5 Year)........................ Kidney/Pancreas Post-Transplant 134 1.6 211 0.4 84.4 Malignancy Form................ VCA Candidate Registration...... 9 1.7 15 0.4 6.0 VCA Recipient Registration...... 9 1.7 15 1.3 19.5 VCA Recipient Follow Up......... 9 1.7 15 1.0 15.0 ------------------------------------------------------------------------------- Total....................... *453 .............. 460414 .............. 358092.5 ---------------------------------------------------------------------------------------------------------------- * Total number of OPTN member institutions as of 6/6/2014. Number of respondents for transplant candidate or recipient forms based on number of organ specific programs associated with each form. 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. Dated: August 29, 2014. Jackie Painter, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2014-21283 Filed 9-5-14; 8:45 am] BILLING CODE 4165-15-P