[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 324-325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28370]



[[Page 324]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Information Collection Request Title: Data 
System for Organ Procurement and Transplantation Network, OMB No. 0915-
0157--Extension

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the requirement for an opportunity for 
public comment on proposed data collection projects of the Paperwork 
Reduction Act of 1995, 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 ICR should be received no later than March 3, 
2020.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 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 Lisa Wright-
Solomon, 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: Data System for Organ 
Procurement and Transplantation Network OMB No. 0915-0157-Extension.
    Abstract: Section 372 of the Public Health Service (PHS) Act (42 
U.S.C. 274) 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 an extension of the current OPTN 
data collection forms associated with an individual's clinical 
characteristics at the time of registration, transplant, and follow-up 
after the transplant. Data are collected from transplant hospitals, 
organ procurement organizations, and histocompatibility 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.
    Need and Proposed Use of the Information: Data are used to develop 
transplant, donation, and allocation policies, to determine whether 
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 members of the public for 
evaluation, research, patient information, and other important 
purposes.
    Burden hours have increased since the last reporting period due to 
an increase in the number of transplant programs for some organs and 
the overall increase in transplant surgeries at existing programs as 
well. An increased number of transplants results in an increasing 
number of forms that require completion while the amount of time it 
takes to complete the forms remains the same.
    Likely Respondents: Transplant programs, organ procurement 
organizations, and histocompatibility laboratories.
    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.
    Total Estimated Annualized Burden Hours:

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                   respondent *                       hours)
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration.....              58           185.0          10,731             1.1        11,804.1
Living Donor Registration.......             300            22.9           6,855             1.8        12,339.0
Living Donor Follow Up..........             300            62.2          18,669             1.3        24,269.7
Donor Histocompatibility........             147           124.0          18,226             0.2         3,645.2
Recipient Histocompatibility....             147           225.1          33,090             0.4        13,236.0
Heart Candidate Registration....             140            33.7           4,717             0.9         4,245.3
Heart Recipient Registration....             140            24.3           3,406             1.2         4,087.2
Heart Follow Up (6 Month).......             140            22.0           3,082             0.4         1,232.8
Heart Follow Up (1-5 Year)......             140            90.6          12,686             0.9        11,417.4
Heart Follow Up (Post 5 Year)...             140           154.0          21,556             0.5        10,778.0
Heart Post-Transplant Malignancy             140            12.8           1,788             0.9         1,609.2
 Form...........................
Lung Candidate Registration.....              71            45.2           3,210             0.9         2,889.0
Lung Recipient Registration.....              71            35.7           2,532             1.2         3,038.4
Lung Follow Up (6 Month)........              71            32.4           2,297             0.5         1,148.5
Lung Follow Up (1-5 Year).......              71           118.8           8,438             1.1         9,281.8
Lung Follow Up (Post 5 Year)....              71           116.5           8,271             0.6         4,962.6
Lung Post-Transplant Malignancy               71            19.7           1,400             0.4           560.0
 Form...........................
Heart/Lung Candidate                          69             1.0              67             1.1            73.7
 Registration...................
Heart/Lung Recipient                          69             0.5              32             1.3            41.6
 Registration...................

[[Page 325]]

 
Heart/Lung Follow Up (6 Month)..              69             0.4              31             0.8            24.8
Heart/Lung Follow Up (1-5 Year).              69             1.1              79             1.1            86.9
Heart/Lung Follow Up (Post 5                  69             3.3             228             0.6           136.8
 Year)..........................
Heart/Lung Post-Transplant                    69             0.3              21             0.4             8.4
 Malignancy Form................
Liver Candidate Registration....             146            90.3          13,183             0.8        10,546.4
Liver Recipient Registration....             146            56.5           8,256             1.2         9,907.2
Liver Follow-up (6 Month-5 Year)             146           266.6          38,919             1.0        38,919.0
Liver Follow-up (Post 5 Year)...             146           316.6          46,225             0.5        23,112.5
Liver Recipient Explant                      146            10.6           1,544             0.6           926.4
 Pathology Form.................
Liver Post-Transplant Malignancy             146            16.3           2,387             0.8         1,909.6
Intestine Candidate Registration              20             7.0             139             1.3           180.7
Intestine Recipient Registration              20             5.2             104             1.8           187.2
Intestine Follow Up (6 Month-5                20            26.2             524             1.5           786.0
 Year)..........................
Intestine Follow Up (Post 5                   20            37.2             744             0.4           297.6
 Year)..........................
Intestine Post-Transplant                     20             2.1              42             1.0            42.0
 Malignancy Form................
Kidney Candidate Registration...             237           168.8          39,998             0.8        31,998.4
Kidney Recipient Registration...             237            89.4          21,195             1.2        25,434.0
Kidney Follow-Up (6 Month-5                  237           431.9         102,350             0.9        92,115.0
 Year)..........................
Kidney Follow-up (Post 5 Year)..             237           449.4         106,507             0.5        53,253.5
Kidney Post-Transplant                       237            22.6           5,365             0.8         4,292.0
 Malignancy Form................
Pancreas Candidate Registration.             133             2.8             368             0.6           220.8
Pancreas Recipient Registration.             133             1.5             194             1.2           232.8
Pancreas Follow-up (6 Month-5                133             7.9           1,047             0.5           523.5
 Year)..........................
Pancreas Follow-up (Post 5 Year)             133            15.9           2,119             0.5         1,059.5
Pancreas Post-Transplant                     133             0.7              97             0.6            58.2
 Malignancy Form................
Kidney/Pancreas Candidate                    133             9.8           1,297             0.6           778.2
 Registration...................
Kidney/Pancreas Recipient                    133             7.7           1,028             1.2         1,233.6
 Registration...................
Kidney/Pancreas Follow-up (6                 133            32.8           4,363             0.5         2,181.5
 Month-5 Year)..................
Kidney/Pancreas Follow-up (Post              133            57.8           7,688             0.6         4,612.8
 5 Year)........................
Kidney/Pancreas Post-Transplant              133             2.2             292             0.4           116.8
 Malignancy Form................
VCA Candidate Registration......              27             0.9              24             0.4             9.6
VCA Recipient Registration......              27             1.6              43             1.3            55.9
VCA Recipient Follow Up.........              27             0.7              18             1.0            18.0
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................           6,204  ..............         567,472  ..............       425,925.1
----------------------------------------------------------------------------------------------------------------
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of
  Respondents and rounding to the nearest tenth.

    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.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-28370 Filed 1-2-20; 8:45 am]
BILLING CODE 4165-15-P