[Federal Register Volume 77, Number 12 (Thursday, January 19, 2012)]
[Notices]
[Pages 2732-2734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-954]


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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, email 
[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: Data System for Organ Procurement and Transplantation 
Network and Associated Forms (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

[[Page 2733]]

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.
    The OPTN is recommending addition of a new Liver Explant Pathology 
form to the OPTN data system. This new form was developed by the OPTN 
Liver and Intestinal Organ Transplantation Committee and will be used 
to collect pathology data on liver transplant recipients who received 
waitlist exception points as a result of a diagnosis of hepatocellular 
carcinoma. Existing OPTN policy requires submission of post-transplant 
pathology reports by fax transmission, and the proposed form will 
provide standardized collection of this already-required information.
    There are also minor revisions to the existing data collection 
forms; the added fields were inadvertently left off of the forms at the 
time of the initial submission. Several of these fields are ``read 
only'' and are included on the forms for information purposes only. One 
field is proposed to be removed as it represented duplicative 
information.
    The annual estimate of burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
              Form                  respondents     respondents      responses       response          hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration.....              58             228          13,224          0.7500        9,918.00
Death referral data.............              58              12             696         10.0000        6,960.00
Death Notification Referral--                 58             145            8410          0.5000        4,205.00
 Eligible.......................
Death Notification Referral--                 58             124            7192          0.5000        3,596.00
 Imminent.......................
Living Donor Registration.......             311              23            7153          0.6500        4,649.45
Living Donor Follow-up..........             311              78          24,258          0.5000       12,129.00
Donor Histocompatibility........             158              94          14,852          0.1000        1,485.20
Recipient Histocompatibility....             158             171          27,018          0.2000        5,403.60
Heart Candidate Registration....             131              27           3,537          0.5000        1,768.50
Lung Candidate Registration.....              66              41            2706          0.5000        1,353.00
Heart/Lung Candidate                          50               1              50          0.5000           25.00
 Registration...................
Thoracic Registration...........             131              34            4454          0.7500        3,340.50
Thoracic Follow-up..............             131             277          36,287          0.6500       23,586.55
Kidney Candidate Registration...             239             154          36,806          0.5000       18,403.00
Kidney Registration.............             239              72          17,208          0.7500       12,906.00
Kidney Follow-up *..............             239             693         165,627          0.5500       91,094.85
Liver Candidate Registration....             132              98          12,936          0.5000        6,468.00
Liver Registration..............             132              48           6,336          0.6500        4,118.40
Liver Explant Pathology.........             132              11           1,452          0.3400          493.68
Liver Follow-up.................             132             459          60,588          0.5000       30,294.00
Kidney/Pancreas Candidate                    144              11           1,584          0.5000          792.00
 Registration...................
Kidney/Pancreas Registration....             144               6             864          0.9000          777.60
Kidney/Pancreas Follow-up.......             144              75          10,800          0.8500        9,180.00
Pancreas Candidate Registration.             144               4             576          0.5000          288.00
Pancreas Islet Candidate                      23               5             115          0.5000           57.50
 Registration...................
Pancreas Registration...........             144               2             288          0.7500          216.00
Pancreas Follow-up..............             144              23            3312          0.6500        2,152.80
Intestine Candidate Registration              43               5             215          0.5000          107.50
Intestine Registration..........              43               3             129          0.9000          116.10
Intestine Follow-up.............              43              25            1075          0.8500          913.75
Post Transplant Malignancy......             689              11            7579          0.2000        1,515.80
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    Total.......................  ..............  ..............         478,270  ..............      258,314.78
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* Includes an estimated 2,430 kidney transplant patients transplanted prior to the initiation of the data
  system.


[[Page 2734]]

    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 email to [email protected] or by fax to (202) 395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: January 12, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-954 Filed 1-18-12; 8:45 am]
BILLING CODE 4165-15-P