[Federal Register Volume 76, Number 229 (Tuesday, November 29, 2011)]
[Notices]
[Pages 73650-73651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

    In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and draft instruments, email [email protected] or 
call the HRSA Reports Clearance Officer at (301) 443-1129.
    Comments are invited on: (a) The proposed collection of information 
for the proper performance of the functions of the Agency; (b) the 
accuracy of the Agency's estimate of the burden of the proposed 
collection of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

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

    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 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:

[[Page 73651]]



 
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                                     Number of     Responses per       Total         Hours per     Total burden
              Form                  respondents     respondents      responses       response          hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration.....              58             228          13,224          0.7500         9918.00
Death Referral Data.............              58              12             696         10.0000        6,960.00
Death Notification Referral--                 58             145            8410          0.5000         4205.00
 Eligible.......................
Death Notification Referral--                 58             124            7192          0.5000         3596.00
 Imminent.......................
Living Donor Registration.......             311              23            7153          0.6500         4649.45
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         1353.00
Heart/Lung Candidate                          50               1              50          0.5000           25.00
 Registration...................
Thoracic Registration...........             131              34            4454          0.7500         3340.50
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         4,118.4
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         9180.00
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         2152.80
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         1515.80
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Total...........................             905  ..............         478,270  ..............      258,314.83
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*Includes an estimated 2,430 kidney transplant patients transplanted prior to the initiation of the data system.

    Email comments to [email protected] or mail to the HRSA Reports 
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, 
Rockville, MD 20857. Written comments should be received within 60 days 
of this notice.

    Dated: November 23, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-30779 Filed 11-28-11; 8:45 am]
BILLING CODE 4165-15-P