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Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157, Revision

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AGENCY:

Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

ACTION:

Notice

SUMMARY:

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.

DATES:

Comments on this ICR should be received no later than May 15, 2017.

ADDRESSES:

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.

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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 paperwork@hrsa.gov or call (301) 443-1984.

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SUPPLEMENTARY INFORMATION:

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.

Total Estimated Annualized Burden—Hours

Form nameNumber of respondentsNumber of responses per respondent *Total responsesAverage burden per response (in hours)Total burden hours
Deceased Donor Registration58176.910,2621.111,288.2
Living Donor Registration30419.55,9361.810,684.8
Living Donor Follow-Up30458.217,6861.322,991.8
Donor Histocompatibility152102.715,6110.23,122.2
Recipient Histocompatibility152183.027,8100.411,124.0
Heart Candidate Registration13732.44,4390.93,995.1
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Heart Recipient Registration13720.52.8051.23,366.0
Heart Follow-Up (6 Months)13716.52,2610.4904.4
Heart Follow-Up (1-5 Years)13777.310,5950.99,535.5
Heart Follow-Up (Post 5 Years)137117.416,0850.58,042.5
Heart Post-Transplant Malignancy13711.81,6230.91,460.7
Lung Candidate Registration7037.02,5920.92,332.8
Lung Recipient Registration7029.42,0581.22,469.6
Lung Follow-Up (6 Months)7025.81,8090.5904.5
Lung Follow-Up (1-5 Years)7099.16,9391.17,632.9
Lung Follow-Up (Post 5 Years)7070.04,8980.62,938.8
Lung Post-Transplant Malignancy7015.81,1060.4442.4
Heart/Lung Candidate Registration680.7461.150.6
Heart/Lung Recipient Registration680.2141.318.2
Heart/Lung Follow-Up (6 Months)680.2130.810.4
Heart/Lung Follow-Up (1-5 Years)681.4941.1103.4
Heart/Lung Follow-Up (Post 5 Years)682.91990.6119.4
Heart/Lung Post-Transplant Malignancy680.3210.48.4
Liver Candidate Registration14085.912,0260.89,620.8
Liver Recipient Registration14050.97,1251.28,550.0
Liver Follow-Up (6 Months-5 Years)140235.632,985132,985.0
Liver Follow-Up (Post 5 Years)140279.339,1080.519,554.0
Liver Recipient Explant Pathology14012.91,8120.61,087.2
Liver Post-Transplant Malignancy14014.21,9850.81,588.0
Intestine Candidate Registration405.02001.3260.0
Intestine Recipient Registration403.51411.8253.8
Intestine Follow-Up (6 Months-5 Years)4013.35301.5795.0
Intestine Follow-Up (Post 5 Years)4016.46550.4262.0
Intestine Post-Transplant Malignancy400.624124.0
Kidney Candidate Registration238151.636,0760.828,860.8
Kidney Recipient Registration23875.217,8991.221,478.8
Kidney Follow-Up (6 Months-5 Years)238383.391,2340.982,110.6
Kidney Follow-Up (Post 5 Years)238375.989,4530.544,726.5
Kidney Post-Transplant Malignancy23822.45,3270.84,261.6
Pancreas Candidate Registration1332.93890.6233.4
Pancreas Recipient Registration1331.82331.2279.6
Pancreas Follow-Up (6 Months-5 Years)1339.41,2520.5626.0
Pancreas Follow-Up (Post 5 Years)13314.71,9530.5976.5
Pancreas Post-Transplant Malignancy1330.91200.672.0
Kidney/Pancreas Candidate Registration1339.51,2650.6759.0
Kidney/Pancreas Recipient Registration1335.47181.2861.6
Kidney/Pancreas Follow-Up (6 Months-5 Years)13332.04,2620.52,131.0
Kidney/Pancreas Follow-Up (Post 5 Years)13351.76,8760.64,125.6
Kidney/Pancreas Post-Transplant Malignancy Form1332.12830.4113.2
VCA Candidate Registration281.8490.419.6
VCA Recipient Registration281.8491.363.7
VCA Recipient Follow-Up281.849149.0
Total** 463488,980370,274.9
* 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.
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Amy McNulty,

Deputy Director, Division of the Executive Secretariat.

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[FR Doc. 2017-07526 Filed 4-13-17; 8:45 am]

BILLING CODE 4165-15-P