[Federal Register Volume 82, Number 71 (Friday, April 14, 2017)]
[Notices]
[Pages 18001-18002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07526]



[[Page 18001]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; Information Collection 
Request Title: Data System for Organ Procurement and Transplantation 
Network, OMB No. 0915-0157, Revision

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA 
has submitted an Information Collection Request (ICR) to the Office of 
Management and Budget (OMB) for review and approval. Comments submitted 
during the first public review of this ICR will be provided to OMB. OMB 
will accept further comments from the public during the review and 
approval period.

DATES: Comments on this ICR should be received no later than May 15, 
2017.

ADDRESSES: Submit your comments, including the Information Collection 
Request Title, to the desk officer for HRSA, either by email to 
[email protected] or by fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email the HRSA Information 
Collection Clearance Officer at [email protected] or call (301) 443-
1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference, in compliance with Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995.
    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 a subset of the 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 transplant.
    Need and Proposed Use of the Information: Data for the OPTN data 
system are collected from transplant hospitals, organ procurement 
organizations, and tissue-typing laboratories. The information is used 
to facilitate organ placement and match donor organs with recipients, 
monitor compliance of member organizations with Federal laws and 
regulations and with OPTN requirements, review and report periodically 
to the public on the status of organ donation and transplantation in 
the United States, provide data to researchers and government agencies 
to study the scientific and clinical status of organ transplantation, 
and perform transplantation-related public health surveillance 
including possible transmission of donor disease. This request revises 
a subset of the current OPTN data forms associated with donor organ 
procurement and an individual's clinical characteristics at the time of 
registration, transplant, and follow up.
    In 2015, the OPTN Board of Directors approved policies that 
necessitate the addition of new data elements to registration forms for 
heart, lung, heart/lung, liver, intestine, kidney, pancreas, and 
kidney/pancreas recipients. The OPTN also approved policies that impact 
the data collection for deceased donor registration, pancreas candidate 
registration, kidney/pancreas candidate registration, pancreas follow-
up, and kidney/pancreas follow-up forms. The policy modifications 
necessitate changes to 17 of the 52 forms contained in this data 
collection. For example, the pancreas and kidney/pancreas transplant 
recipient registration and follow up forms were modified to be 
consistent with an OPTN policy change pertaining to data collected from 
pancreas programs for pancreas graft failure. Specifically, the ``graft 
status'' section of the pancreas forms was updated to be consistent 
with a new policy that helps transplant professionals identify when 
pancreas allograft failure has occurred and how to document the 
pancreas graft failure event. In addition, ``drop down'' menus were 
added to facilitate reporting of toxoplasma serology results and 
infectious diseases, consistent with revised scope of policy 
requirements for infectious disease testing and reporting. Finally, a 
policy modification to improve collection of information on lungs 
perfused prior to transplant resulted in the creation of easy-to-
complete data fields on lung and heart/lung recipient registration 
forms. The modified forms allow transplant centers to easily provide 
information on lung perfusion, which contributes to improved accuracy 
in monitoring of lung allocation, recipient safety, and organ and 
patient outcomes.
    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; to 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; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this ICR are summarized in the table below. The burden will decrease by 
approximately 3,500 hours.

                                    Total Estimated Annualized Burden--Hours
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                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                   respondent *                       hours)
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Deceased Donor Registration.....              58           176.9          10,262             1.1        11,288.2
Living Donor Registration.......             304            19.5           5,936             1.8        10,684.8
Living Donor Follow-Up..........             304            58.2          17,686             1.3        22,991.8
Donor Histocompatibility........             152           102.7          15,611             0.2         3,122.2
Recipient Histocompatibility....             152           183.0          27,810             0.4        11,124.0
Heart Candidate Registration....             137            32.4           4,439             0.9         3,995.1

[[Page 18002]]

 
Heart Recipient Registration....             137            20.5           2.805             1.2         3,366.0
Heart Follow-Up (6 Months)......             137            16.5           2,261             0.4           904.4
Heart Follow-Up (1-5 Years).....             137            77.3          10,595             0.9         9,535.5
Heart Follow-Up (Post 5 Years)..             137           117.4          16,085             0.5         8,042.5
Heart Post-Transplant Malignancy             137            11.8           1,623             0.9         1,460.7
Lung Candidate Registration.....              70            37.0           2,592             0.9         2,332.8
Lung Recipient Registration.....              70            29.4           2,058             1.2         2,469.6
Lung Follow-Up (6 Months).......              70            25.8           1,809             0.5           904.5
Lung Follow-Up (1-5 Years)......              70            99.1           6,939             1.1         7,632.9
Lung Follow-Up (Post 5 Years)...              70            70.0           4,898             0.6         2,938.8
Lung Post-Transplant Malignancy.              70            15.8           1,106             0.4           442.4
Heart/Lung Candidate                          68             0.7              46             1.1            50.6
 Registration...................
Heart/Lung Recipient                          68             0.2              14             1.3            18.2
 Registration...................
Heart/Lung Follow-Up (6 Months).              68             0.2              13             0.8            10.4
Heart/Lung Follow-Up (1-5 Years)              68             1.4              94             1.1           103.4
Heart/Lung Follow-Up (Post 5                  68             2.9             199             0.6           119.4
 Years).........................
Heart/Lung Post-Transplant                    68             0.3              21             0.4             8.4
 Malignancy.....................
Liver Candidate Registration....             140            85.9          12,026             0.8         9,620.8
Liver Recipient Registration....             140            50.9           7,125             1.2         8,550.0
Liver Follow-Up (6 Months-5                  140           235.6          32,985               1        32,985.0
 Years).........................
Liver Follow-Up (Post 5 Years)..             140           279.3          39,108             0.5        19,554.0
Liver Recipient Explant                      140            12.9           1,812             0.6         1,087.2
 Pathology......................
Liver Post-Transplant Malignancy             140            14.2           1,985             0.8         1,588.0
Intestine Candidate Registration              40             5.0             200             1.3           260.0
Intestine Recipient Registration              40             3.5             141             1.8           253.8
Intestine Follow-Up (6 Months-5               40            13.3             530             1.5           795.0
 Years).........................
Intestine Follow-Up (Post 5                   40            16.4             655             0.4           262.0
 Years).........................
Intestine Post-Transplant                     40             0.6              24               1            24.0
 Malignancy.....................
Kidney Candidate Registration...             238           151.6          36,076             0.8        28,860.8
Kidney Recipient Registration...             238            75.2          17,899             1.2        21,478.8
Kidney Follow-Up (6 Months-5                 238           383.3          91,234             0.9        82,110.6
 Years).........................
Kidney Follow-Up (Post 5 Years).             238           375.9          89,453             0.5        44,726.5
Kidney Post-Transplant                       238            22.4           5,327             0.8         4,261.6
 Malignancy.....................
Pancreas Candidate Registration.             133             2.9             389             0.6           233.4
Pancreas Recipient Registration.             133             1.8             233             1.2           279.6
Pancreas Follow-Up (6 Months-5               133             9.4           1,252             0.5           626.0
 Years).........................
Pancreas Follow-Up (Post 5                   133            14.7           1,953             0.5           976.5
 Years).........................
Pancreas Post-Transplant                     133             0.9             120             0.6            72.0
 Malignancy.....................
Kidney/Pancreas Candidate                    133             9.5           1,265             0.6           759.0
 Registration...................
Kidney/Pancreas Recipient                    133             5.4             718             1.2           861.6
 Registration...................
Kidney/Pancreas Follow-Up (6                 133            32.0           4,262             0.5         2,131.0
 Months-5 Years)................
Kidney/Pancreas Follow-Up (Post              133            51.7           6,876             0.6         4,125.6
 5 Years).......................
Kidney/Pancreas Post-Transplant              133             2.1             283             0.4           113.2
 Malignancy Form................
VCA Candidate Registration......              28             1.8              49             0.4            19.6
VCA Recipient Registration......              28             1.8              49             1.3            63.7
VCA Recipient Follow-Up.........              28             1.8              49               1            49.0
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    Total.......................          ** 463  ..............         488,980  ..............       370,274.9
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* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of
  Respondents and rounding to the nearest tenth.
** Total number of OPTN member institutions as of April 6, 2017. Number of respondents for transplant candidate
  or recipient forms based on the organ-specific programs associated with each form.


Amy McNulty,
Deputy Director, Division of the Executive Secretariat.
[FR Doc. 2017-07526 Filed 4-13-17; 8:45 am]
 BILLING CODE 4165-15-P