[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
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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]
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