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Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request

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AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Notice.

SUMMARY:

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.

DATES:

Comments on this ICR should be received no later than January 2, 2015.

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:

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.

Total Estimated Annualized Burden—Hours

Form nameNumber of respondentsNumber of responses per respondentTotal responsesAverage burden per response (in hours)Total burden hours
Deceased Donor Registration58158.291741.110091.4
Living Donor Registration29620.259841.810771.2
Living Donor Follow-up29659.5176101.322893.0
Donor Histocompatibility15494.8145980.22919.6
Recipient Histocompatibility154170.1261990.410479.6
Heart Candidate Registration13130.539910.93591.9
Heart Recipient Registration13119.325251.43535.0
Heart Follow Up (6 Month)13117.022290.4891.6
Heart Follow Up (1-5 Year)13173.996830.98714.7
Heart Follow Up (Post 5 Year)131115.2150910.57545.5
Heart Post-Transplant Malignancy Form13111.014470.91302.3
Lung Candidate Registration6539.025340.92280.6
Lung Recipient Registration6529.619231.42692.2
Lung Follow Up (6 Month)6525.816770.5838.5
Lung Follow Up (1-5 Year)6597.963641.17000.4
Lung Follow Up (Post 5 Year)6564.642010.62520.6
Lung Post-Transplant Malignancy Form651.5990.439.6
Heart/Lung Candidate Registration630.7461.150.6
Heart/Lung Recipient Registration630.3211.429.4
Heart/Lung Follow Up (6 Month)630.3200.816.0
Heart/Lung Follow Up (1-5 Year)631.5971.1106.7
Heart/Lung Follow Up (Post 5 Year)633.11940.6116.4
Heart/Lung Post-Transplant Malignancy Form630.2120.44.8
Liver Candidate Registration13688.6120480.89638.4
Liver Recipient Registration13647.564571.38394.1
Liver Follow-up (6 Month-5 Year)136229.4311941.031194.0
Liver Follow-up (Post 5 Year)136254.6346220.517311.0
Liver Recipient Explant Pathology Form13612.216650.6999.0
Liver Post-Transplant Malignancy13613.117860.81428.8
Intestine Candidate Registration414.41821.3236.6
Intestine Recipient Registration412.71091.8196.2
Intestine Follow Up (6 Month-5 Year)4113.35471.5820.5
Intestine Follow Up (Post 5 Year)4113.55530.4221.2
Intestine Post-Transplant Malignancy Form410.6251.025.0
Kidney Candidate Registration235161.2378800.830304.0
Kidney Recipient Registration23571.9169041.321975.2
Kidney Follow-Up (6 Month-5 Year)235376.3884220.979579.8
Kidney Follow-up (Post 5 Year)235343.7807700.540385.0
Kidney Post-Transplant Malignancy Form23517.942130.83370.4
Pancreas Candidate Registration1353.54790.9431.1
Pancreas Recipient Registration1351.92591.1284.9
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Pancreas Follow-up (6 Month-5 Year)13510.413981.01398.0
Pancreas Follow-up (Post 5 Year)13513.418040.5902.0
Pancreas Post-Transplant Malignancy Form1350.81080.664.8
Kidney/Pancreas Candidate Registration1398.512800.91152
Kidney/Pancreas Recipient Registration1355.67601.1836.0
Kidney/Pancreas Follow-up (6 Month-5 Year)13533.445091.04509.0
Kidney/Pancreas Follow-up (Post 5 Year)13547.964650.63879.0
Kidney/Pancreas Post-Transplant Malignancy Form1351.62110.484.4
Vascular Composite Allograft Candidate Registration160.9150.46.0
Vascular Composite Allograft Recipient Registration160.9151.319.5
Vascular Composite Allograft Recipient Follow Up160.9151.015.0
Total* 456460414358092.5
* 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.
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Jackie Painter,

Acting Director, Division of Policy and Information Coordination.

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[FR Doc. 2014-28343 Filed 12-1-14; 8:45 am]

BILLING CODE 4165-15-P