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Agency Information Collection Activities: Proposed Collection: Public Comment Request

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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 paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.

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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 paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443-1984.

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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.

Total Estimated Annualized burden hours:

Section/activityNumber of respondentsAverage number of responses per respondentTotal number of responsesAverage burden per response (in hours)Total burden hours
Deceased Donor Registration58158.291741.110091.4
Living Donor Registration29020.659841.810771.2
Living Donor Follow-up29060.7176101.322893.0
Donor Histocompatibility15196.7145980.22919.6
Recipient Histocompatibility151173.5261990.410479.6
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 Registration6439.625340.92280.6
Lung Recipient Registration6430.019231.42692.2
Lung Follow Up (6 Month)6426.216770.5838.5
Lung Follow Up (1-5 Year)6499.463641.17000.4
Lung Follow Up (Post 5 Year)6465.642010.62520.6
Lung Post-Transplant Malignancy Form641.5990.439.6
Heart/Lung Candidate Registration630.7461.150.6
Heart/Lung Recipient Registration630.3211.429.4
Heart/Lung Follow Up (6 Month)630.3200.816
Heart/Lung Follow Up (1-5 Year)631.5971.1106.7
Heart/Lung Follow Up (Post 5 Year)633.11940.6116.4
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Heart/Lung Post-Transplant Malignancy Form630.2120.44.8
Liver Candidate Registration13589.2120480.89638.4
Liver Recipient Registration13547.864571.38394.1
Liver Follow-up (6 Month-5 Year)135231.131194131194.0
Liver Follow-up (Post 5 Year)135256.5346220.517311.0
Liver Recipient Explant Pathology Form13512.316650.6999.0
Liver Post-Transplant Malignancy13513.217860.81428.8
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 Registration233162.6378800.830304.0
Kidney Recipient Registration23372.5169041.321975.2
Kidney Follow-Up (6 Month-5 Year)233379.5884220.979579.8
Kidney Follow-up (Post 5 Year)233346.7807700.540385.0
Kidney Post-Transplant Malignancy Form23318.142130.83370.4
Pancreas Candidate Registration1343.64790.9431.1
Pancreas Recipient Registration1341.92591.1284.9
Pancreas Follow-up (6 Month-5 Year)13410.413981.01398.0
Pancreas Follow-up (Post 5 Year)13413.518040.5902.0
Pancreas Post-Transplant Malignancy Form1340.81080.664.8
Kidney/Pancreas Candidate Registration1349.612800.91152.0
Kidney/Pancreas Recipient Registration1345.77601.1836.0
Kidney/Pancreas Follow-up (6 Month-5 Year)13433.645091.04509.0
Kidney/Pancreas Follow-up (Post 5 Year)13448.264650.63879.0
Kidney/Pancreas Post-Transplant Malignancy Form1341.62110.484.4
VCA Candidate Registration91.7150.46.0
VCA Recipient Registration91.7151.319.5
VCA Recipient Follow Up91.7151.015.0
Total*453460414358092.5
* 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.

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Dated: August 29, 2014.

Jackie Painter,

Acting Director, Division of Policy and Information Coordination.

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[FR Doc. 2014-21283 Filed 9-5-14; 8:45 am]

BILLING CODE 4165-15-P