This PDF is the current document as it appeared on Public Inspection on 12/01/2014 at 08:45 am.
Health Resources and Services Administration, HHS.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Comments on this ICR should be received no later than January 2, 2015.
Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806.Start Further Info
FOR FURTHER INFORMATION CONTACT:
To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at firstname.lastname@example.org or call (301) 443-1984.End Further Info End Preamble Start Supplemental Information Start Printed Page 71438
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.
Need and Proposed Use of the Information: 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; to 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; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.
|Form name||Number of respondents||Number of responses per respondent||Total responses||Average burden per response (in hours)||Total burden hours|
|Deceased Donor Registration||58||158.2||9174||1.1||10091.4|
|Living Donor Registration||296||20.2||5984||1.8||10771.2|
|Living Donor Follow-up||296||59.5||17610||1.3||22893.0|
|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 Form||131||11.0||1447||0.9||1302.3|
|Lung Candidate Registration||65||39.0||2534||0.9||2280.6|
|Lung Recipient Registration||65||29.6||1923||1.4||2692.2|
|Lung Follow Up (6 Month)||65||25.8||1677||0.5||838.5|
|Lung Follow Up (1-5 Year)||65||97.9||6364||1.1||7000.4|
|Lung Follow Up (Post 5 Year)||65||64.6||4201||0.6||2520.6|
|Lung Post-Transplant Malignancy Form||65||1.5||99||0.4||39.6|
|Heart/Lung Candidate Registration||63||0.7||46||1.1||50.6|
|Heart/Lung Recipient Registration||63||0.3||21||1.4||29.4|
|Heart/Lung Follow Up (6 Month)||63||0.3||20||0.8||16.0|
|Heart/Lung Follow Up (1-5 Year)||63||1.5||97||1.1||106.7|
|Heart/Lung Follow Up (Post 5 Year)||63||3.1||194||0.6||116.4|
|Heart/Lung Post-Transplant Malignancy Form||63||0.2||12||0.4||4.8|
|Liver Candidate Registration||136||88.6||12048||0.8||9638.4|
|Liver Recipient Registration||136||47.5||6457||1.3||8394.1|
|Liver Follow-up (6 Month-5 Year)||136||229.4||31194||1.0||31194.0|
|Liver Follow-up (Post 5 Year)||136||254.6||34622||0.5||17311.0|
|Liver Recipient Explant Pathology Form||136||12.2||1665||0.6||999.0|
|Liver Post-Transplant Malignancy||136||13.1||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 Year)||41||13.3||547||1.5||820.5|
|Intestine Follow Up (Post 5 Year)||41||13.5||553||0.4||221.2|
|Intestine Post-Transplant Malignancy Form||41||0.6||25||1.0||25.0|
|Kidney Candidate Registration||235||161.2||37880||0.8||30304.0|
|Kidney Recipient Registration||235||71.9||16904||1.3||21975.2|
|Kidney Follow-Up (6 Month-5 Year)||235||376.3||88422||0.9||79579.8|
|Kidney Follow-up (Post 5 Year)||235||343.7||80770||0.5||40385.0|
|Kidney Post-Transplant Malignancy Form||235||17.9||4213||0.8||3370.4|
|Pancreas Candidate Registration||135||3.5||479||0.9||431.1|
|Pancreas Recipient Registration||135||1.9||259||1.1||284.9|
|Start Printed Page 71439|
|Pancreas Follow-up (6 Month-5 Year)||135||10.4||1398||1.0||1398.0|
|Pancreas Follow-up (Post 5 Year)||135||13.4||1804||0.5||902.0|
|Pancreas Post-Transplant Malignancy Form||135||0.8||108||0.6||64.8|
|Kidney/Pancreas Candidate Registration||13||98.5||1280||0.9||1152|
|Kidney/Pancreas Recipient Registration||135||5.6||760||1.1||836.0|
|Kidney/Pancreas Follow-up (6 Month-5 Year)||135||33.4||4509||1.0||4509.0|
|Kidney/Pancreas Follow-up (Post 5 Year)||135||47.9||6465||0.6||3879.0|
|Kidney/Pancreas Post-Transplant Malignancy Form||135||1.6||211||0.4||84.4|
|Vascular Composite Allograft Candidate Registration||16||0.9||15||0.4||6.0|
|Vascular Composite Allograft Recipient Registration||16||0.9||15||1.3||19.5|
|Vascular Composite Allograft Recipient Follow Up||16||0.9||15||1.0||15.0|
|* Total number of OPTN member institutions as of 09/9/2014. Number of respondents for transplant candidate or recipient forms based on number of organ specific programs associated with each form.|
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-28343 Filed 12-1-14; 8:45 am]
BILLING CODE 4165-15-P