This PDF is the current document as it appeared on Public Inspection on 04/13/2017 at 08:45 am.
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
In compliance with the Paperwork Reduction Act of 1995, 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 May 15, 2017.
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:
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When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995.
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 a subset of the 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 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 facilitate organ placement and match donor organs with recipients, monitor compliance of member organizations with Federal laws and regulations and with OPTN requirements, review and report periodically to the public on the status of organ donation and transplantation in the United States, provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation, and perform transplantation-related public health surveillance including possible transmission of donor disease. This request revises a subset of the current OPTN data forms associated with donor organ procurement and an individual's clinical characteristics at the time of registration, transplant, and follow up.
In 2015, the OPTN Board of Directors approved policies that necessitate the addition of new data elements to registration forms for heart, lung, heart/lung, liver, intestine, kidney, pancreas, and kidney/pancreas recipients. The OPTN also approved policies that impact the data collection for deceased donor registration, pancreas candidate registration, kidney/pancreas candidate registration, pancreas follow-up, and kidney/pancreas follow-up forms. The policy modifications necessitate changes to 17 of the 52 forms contained in this data collection. For example, the pancreas and kidney/pancreas transplant recipient registration and follow up forms were modified to be consistent with an OPTN policy change pertaining to data collected from pancreas programs for pancreas graft failure. Specifically, the “graft status” section of the pancreas forms was updated to be consistent with a new policy that helps transplant professionals identify when pancreas allograft failure has occurred and how to document the pancreas graft failure event. In addition, “drop down” menus were added to facilitate reporting of toxoplasma serology results and infectious diseases, consistent with revised scope of policy requirements for infectious disease testing and reporting. Finally, a policy modification to improve collection of information on lungs perfused prior to transplant resulted in the creation of easy-to-complete data fields on lung and heart/lung recipient registration forms. The modified forms allow transplant centers to easily provide information on lung perfusion, which contributes to improved accuracy in monitoring of lung allocation, recipient safety, and organ and patient outcomes.
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. The burden will decrease by approximately 3,500 hours.
|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||176.9||10,262||1.1||11,288.2|
|Living Donor Registration||304||19.5||5,936||1.8||10,684.8|
|Living Donor Follow-Up||304||58.2||17,686||1.3||22,991.8|
|Heart Candidate Registration||137||32.4||4,439||0.9||3,995.1|
|Start Printed Page 18002|
|Heart Recipient Registration||137||20.5||2.805||1.2||3,366.0|
|Heart Follow-Up (6 Months)||137||16.5||2,261||0.4||904.4|
|Heart Follow-Up (1-5 Years)||137||77.3||10,595||0.9||9,535.5|
|Heart Follow-Up (Post 5 Years)||137||117.4||16,085||0.5||8,042.5|
|Heart Post-Transplant Malignancy||137||11.8||1,623||0.9||1,460.7|
|Lung Candidate Registration||70||37.0||2,592||0.9||2,332.8|
|Lung Recipient Registration||70||29.4||2,058||1.2||2,469.6|
|Lung Follow-Up (6 Months)||70||25.8||1,809||0.5||904.5|
|Lung Follow-Up (1-5 Years)||70||99.1||6,939||1.1||7,632.9|
|Lung Follow-Up (Post 5 Years)||70||70.0||4,898||0.6||2,938.8|
|Lung Post-Transplant Malignancy||70||15.8||1,106||0.4||442.4|
|Heart/Lung Candidate Registration||68||0.7||46||1.1||50.6|
|Heart/Lung Recipient Registration||68||0.2||14||1.3||18.2|
|Heart/Lung Follow-Up (6 Months)||68||0.2||13||0.8||10.4|
|Heart/Lung Follow-Up (1-5 Years)||68||1.4||94||1.1||103.4|
|Heart/Lung Follow-Up (Post 5 Years)||68||2.9||199||0.6||119.4|
|Heart/Lung Post-Transplant Malignancy||68||0.3||21||0.4||8.4|
|Liver Candidate Registration||140||85.9||12,026||0.8||9,620.8|
|Liver Recipient Registration||140||50.9||7,125||1.2||8,550.0|
|Liver Follow-Up (6 Months-5 Years)||140||235.6||32,985||1||32,985.0|
|Liver Follow-Up (Post 5 Years)||140||279.3||39,108||0.5||19,554.0|
|Liver Recipient Explant Pathology||140||12.9||1,812||0.6||1,087.2|
|Liver Post-Transplant Malignancy||140||14.2||1,985||0.8||1,588.0|
|Intestine Candidate Registration||40||5.0||200||1.3||260.0|
|Intestine Recipient Registration||40||3.5||141||1.8||253.8|
|Intestine Follow-Up (6 Months-5 Years)||40||13.3||530||1.5||795.0|
|Intestine Follow-Up (Post 5 Years)||40||16.4||655||0.4||262.0|
|Intestine Post-Transplant Malignancy||40||0.6||24||1||24.0|
|Kidney Candidate Registration||238||151.6||36,076||0.8||28,860.8|
|Kidney Recipient Registration||238||75.2||17,899||1.2||21,478.8|
|Kidney Follow-Up (6 Months-5 Years)||238||383.3||91,234||0.9||82,110.6|
|Kidney Follow-Up (Post 5 Years)||238||375.9||89,453||0.5||44,726.5|
|Kidney Post-Transplant Malignancy||238||22.4||5,327||0.8||4,261.6|
|Pancreas Candidate Registration||133||2.9||389||0.6||233.4|
|Pancreas Recipient Registration||133||1.8||233||1.2||279.6|
|Pancreas Follow-Up (6 Months-5 Years)||133||9.4||1,252||0.5||626.0|
|Pancreas Follow-Up (Post 5 Years)||133||14.7||1,953||0.5||976.5|
|Pancreas Post-Transplant Malignancy||133||0.9||120||0.6||72.0|
|Kidney/Pancreas Candidate Registration||133||9.5||1,265||0.6||759.0|
|Kidney/Pancreas Recipient Registration||133||5.4||718||1.2||861.6|
|Kidney/Pancreas Follow-Up (6 Months-5 Years)||133||32.0||4,262||0.5||2,131.0|
|Kidney/Pancreas Follow-Up (Post 5 Years)||133||51.7||6,876||0.6||4,125.6|
|Kidney/Pancreas Post-Transplant Malignancy Form||133||2.1||283||0.4||113.2|
|VCA Candidate Registration||28||1.8||49||0.4||19.6|
|VCA Recipient Registration||28||1.8||49||1.3||63.7|
|VCA Recipient Follow-Up||28||1.8||49||1||49.0|
|* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to the nearest tenth.|
|** Total number of OPTN member institutions as of April 6, 2017. Number of respondents for transplant candidate or recipient forms based on the organ-specific programs associated with each form.|
Deputy Director, Division of the Executive Secretariat.
[FR Doc. 2017-07526 Filed 4-13-17; 8:45 am]
BILLING CODE 4165-15-P