[Federal Register Volume 75, Number 176 (Monday, September 13, 2010)]
[Notices]
[Pages 55584-55585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22665]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, e-mail 
[email protected] or call the HRSA Reports Clearance Office on (301) 
443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: Organ Procurement and Transplantation Network and 
Scientific Registry of Transplant Recipients Data System (OMB No. 0915-
0157)--Extension

    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). The OPTN, 
among other responsibilities, operates and maintains a national waiting 
list of individuals requiring organ transplants, maintains a 
computerized system for matching donor organs with transplant 
candidates on the waiting list, and operates a 24-hour system to 
facilitate matching organs with individuals included in the list.
    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 if institutional members are 
complying with policy, to determine member-specific performance, to 
ensure patient safety when no alternative sources of data exist 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 others for evaluation, 
research, patient information, and other important purposes.
    No revisions of the 29 data collection forms are proposed at this 
time; however, the OPTN is currently undergoing a review of the forms 
and expects to submit proposed revisions within the next year.
    The annual estimate of burden is as follows:

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                                 Number of      Responses per        Total         Hours per      Total burden
            Form                respondents      respondent        responses       response           hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration.              58               216          12,528          0.7500        9,396.0000
Death referral data.........              58                12             696         10.0000        6,960.0000
Death Notification Referral--             58               161            9338          0.2000        1,867.6000
 Eligible...................
Death Notification Referral--             58               168            9744          0.5000        4,872.0000
 Imminent...................
Living Donor Registration...             308                39          12,012          0.6500        7,807.8000
Living Donor Follow-up......             308                50          15,400          0.5000        7,700.0000
Donor Histocompatibility....             156               131          20,436          0.1000        2,043.6000
Recipient Histocompatibility             156               196          30,576          0.2000        6,115.2000
Heart Candidate Registration             127                35           4,445          0.5000        2,222.5000
Lung Candidate Registration.              68                42           2,856          0.5000        1,428.0000
Heart/Lung Candidate                      51                 2             102          0.5000           51.0000
 Registration...............
Thoracic Registration.......             127                36           4,572          0.7500        3,429.0000
Thoracic Follow-up..........             127               320          40,640          0.6500       26,416.0000
Kidney Candidate                         241               183          44,103          0.5000       22,051.5000
 Registration...............
Kidney Registration.........             241                83          20,003          0.7500       15,002.2500
Kidney Follow-up*...........             241               742         178,822          0.5500       98,352.1000
Liver Candidate Registration             129               109          14,061          0.5000        7,030.5000
Liver Registration..........             129                58           7,482          0.6500        4,863.3000
Liver Follow-up.............             129               519          66,951          0.5000       33,475.5000
Kidney/Pancreas Candidate                143                14           2,002          0.5000        1,001.0000
 Registration...............
Kidney/Pancreas Registration             143                 7           1,001          0.9000          900.9000
Kidney/Pancreas Follow-up...             143                85          12,155          0.8500       10,331.7500
Pancreas Candidate                       143                 7           1,001          0.5000          500.5000
 Registration...............
Pancreas Registration.......             143                 3             429          0.7500          321.7500
Pancreas Follow-up..........             143                20           2,860          0.6500        1,859.0000
Intestine Candidate                       44                 7             308          0.5000          154.0000
 Registration...............
Intestine Registration......              44                 5             220          0.9000          198.0000
Intestine Follow-up.........              44                28           1,232          0.8500        1,047.2000

[[Page 55585]]

 
Post Transplant Malignancy..             684                10           6,840          0.2000        1,368.0000
                             -----------------------------------------------------------------------------------
    Total...................             463  ................         522,815  ..............      278,765.9500
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* Includes an estimated 2,500 kidney transplant patients transplanted prior to the initiation of the data
  system.

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by e-mail to [email protected] or by fax to 202-395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: September 3, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-22665 Filed 9-10-10; 8:45 am]
BILLING CODE 4165-15-P