[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13378-13380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (HRSA) announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks 
comments from the public regarding the burden estimate, below, or any 
other aspect of the ICR.

DATES: Comments on this Information Collection Request must be received 
within 60 days of this notice.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N39, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: 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 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Organ Procurement and 
Transplantation Network and Scientific Registry of Transplant 
Recipients Data System OMB No. 0915-0157--Revision.
    Abstract: Section 372 of the Public Health Service (PHS) Act, as 
amended, 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 current OPTN data 
collection forms associated with an individual's clinical 
characteristics at the time of registration, transplant, and follow-up 
after the transplant. These specific data elements of the OPTN data 
system are collected from transplant hospitals. The information is used 
to indicate the disease severity of transplant candidates, to monitor 
compliance of member organizations with OPTN rules and requirements, to 
report periodically on the clinical and scientific status of organ 
donation and transplantation and other purposes consistent with the 
law. Data are used to: (1) Facilitate organ placement and match donor 
organs with recipients; (2) monitor compliance of member organizations 
with federal laws and regulations and with OPTN requirements; (3) 
review and report periodically to the public on the status of organ 
donation and transplantation in the United States; (4) provide data to 
researchers and government agencies to study the scientific and 
clinical status of organ transplantation; and (5) perform 
transplantation-related public health surveillance including possible 
transmission of donor disease. 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 members of the public for 
evaluation, research, patient information, and other important 
purposes.
    Likely Respondents: Transplant programs, 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: (1) Review 
instructions; 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; (2) train personnel to respond to a request for 
collection of information; (3) search data sources; (4) complete and 
review the collection of information; and (5) to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this Information Collection Request are summarized in the table below.

[[Page 13379]]



                                     Total Estimated Annualized Burden Hours
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                                                      Average                         Average
                                     Number of       number of     Total number     burden per     Total burden
        Section/activity            respondents    responses per   of responses    response  (in       hours
                                                    respondent                        hours)
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Deceased Donor Registration.....              58           158.2          9175.6             1.1         10093.2
Living Donor Registration.......             307            20.6          6324.2             1.8         11383.6
Living Donor Follow-up..........             307            60.7         18634.9             1.3         24225.4
Donor Histocompatibility........             154            96.7         14891.8             0.2          2978.4
Recipient Histocompatibility....             154           173.5           26719             0.4         10687.6
Heart Candidate Registration....             132            30.5            4026             0.9          3623.4
Heart Recipient Registration....             132            19.9          2626.8             1.2          3152.2
Heart Follow Up (6 Month).......             132              17            2244             0.4           897.6
Heart Follow Up (1-5 Year)......             132            73.9          9754.8             0.9          8779.3
Heart Follow Up (Post 5 Year)...             132           115.2         15206.4             0.5          7603.2
Heart Post-Transplant Malignancy             132              11            1452             0.9          1306.8
 Form...........................
Lung Candidate Registration.....              70            39.6            2772             0.9          2494.8
Lung Recipient Registration.....              70            28.3            1981             1.2          2377.2
Lung Follow Up (6 Month)........              70            26.2            1834             0.5           917.0
Lung Follow Up (1-5 Year).......              70            99.4            6958             1.1          7653.8
Lung Follow Up (Post 5 Year)....              70            65.6            4592             0.6          2755.2
Lung Post-Transplant Malignancy               70             1.5             105             0.4            42.0
 Form...........................
Heart/Lung Candidate                          69             0.7            48.3             1.1            53.1
 Registration...................
Heart/Lung Recipient                          69             0.4            27.6             1.3            35.9
 Registration...................
Heart/Lung Follow Up (6 Month)..              69             0.3            20.7             0.8            16.6
Heart/Lung Follow Up (1-5 Year).              69             1.5           103.5             1.1           113.9
Heart/Lung Follow Up (Post 5                  69             3.1           213.9             0.6           128.3
 Year)..........................
Heart/Lung Post-Transplant                    69             0.2            13.8             0.4             5.5
 Malignancy Form................
Liver Candidate Registration....             141            89.2         12577.2             0.8         10061.8
Liver Recipient Registration....             141            48.8          6880.8             1.2          8257.0
Liver Follow-up (6 Month--5                  141           231.1         32585.1               1         32585.1
 Year)..........................
Liver Follow-up (Post 5 Year)...             141           256.5         36166.5             0.5         18083.3
Liver Recipient Explant                      141            12.3          1734.3             0.6          1040.6
 Pathology Form.................
Liver Post-Transplant Malignancy             141            13.2          1861.2             0.8          1489.0
Intestine Candidate Registration              40             4.4             176             1.3           228.8
Intestine Recipient Registration              40             3.4             136             1.8           244.8
Intestine Follow Up (6 Month--5               40            13.3             532             1.5           798.0
 Year)..........................
Intestine Follow Up (Post 5                   40            13.5             540             0.4           216.0
 Year)..........................
Intestine Post-Transplant                     40             0.6              24               1            24.0
 Malignancy Form................
Kidney Candidate Registration...             238           162.6         38698.8             0.8         30959.0
Kidney Recipient Registration...             238            71.8         17088.4             1.2         20506.1
Kidney Follow-Up (6 Month--5                 238           379.5           90321             0.9         81288.9
 Year)..........................
Kidney Follow-up (Post 5 Year)..             238           346.7         82514.6             0.5         41257.3
Kidney Post-Transplant                       238            18.1          4307.8             0.8          3446.2
 Malignancy Form................
Pancreas Candidate Registration.             141             3.4           479.4             0.6           287.6
Pancreas Recipient Registration.             141             1.8           253.8             1.2           304.6
Pancreas Follow-up (6 Month--5               141             8.2          1156.2             0.5           578.1
 Year)..........................
Pancreas Follow-up (Post 5 Year)             141            13.5          1903.5             0.5           951.8
Pancreas Post-Transplant                     141             0.8           112.8             0.6            67.7
 Malignancy Form................
Kidney/Pancreas Candidate                    141             9.6          1353.6             0.6           812.2
 Registration...................
Kidney/Pancreas Recipient                    141             5.2           733.2             1.2           879.8
 Registration...................
Kidney/Pancreas Follow-up (6                 141            26.9          3792.9             0.5          1896.5
 Month--5 Year).................
Kidney/Pancreas Follow-up (Post              141            48.2          6796.2             0.6          4077.7
 5 Year)........................
Kidney/Pancreas Post-Transplant              141             1.6           225.6             0.4            90.2
 Malignancy Form................
VCA Candidate Registration......              23             1.7            39.1             0.4            15.6
VCA Recipient Registration......              23             1.7            39.1             1.3            50.8
VCA Recipient Follow Up.........              23             1.7            39.1               1            39.1
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    Total.......................           * 457  ..............        471411.4  ..............        359889.5
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* Total number of OPTN transplant hospitals as of October 23, 2015. Number of respondents for transplant
  candidate or recipient forms is based on number of organ specific programs associated with each form.
** Bold entries represent those forms being modified during this submission.


[[Page 13380]]

    HRSA specifically requests comments on (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions; (2) the accuracy of the 
estimated burden; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-05684 Filed 3-11-16; 8:45 am]
 BILLING CODE 4165-15-P