[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Notices]
[Pages 39194-39196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14046]


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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--Extension

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

[[Page 39195]]


ACTION: Notice.

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SUMMARY: In compliance with of 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. OMB may act on HRSA's ICR only after the 30 
day comment period for this notice has closed.

DATES: Comments on this ICR should be received no later than July 30, 
2020.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Lisa Wright-Solomon, 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.
    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 
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. This extension will apply to all forms collecting 
donor (living and deceased) data at the time of transplant as well. 
These specific data elements of the OPTN data system 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.
    A 60-day notice published in the Federal Register on January 3, 
2020, vol. 85, No. 2; pp. 324-325. HRSA received one comment. The 
commenter encouraged HRSA to carefully weigh potential cost 
implications and work burden against added value when considering 
future additions or changes to data collection requirements. The 
commenter suggested that HRSA encourage the use of automated data 
collection techniques to minimize the information collection burden. 
The OPTN contract that went into effect in April 2019 includes new 
tasks to require the OPTN Contractor to: (1) Develop and implement a 
plan to collect official OPTN data through direct electronic data 
submission and (2) supplement official OPTN data collected by the 
Contractor with information from external data sources to reduce the 
burden on OPTN members. HRSA appreciates all feedback, and we will 
continue to review and evaluate all data collection efforts going 
forward in consultation with the OPTN.
    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.
    On May 31, 2019, OMB approved changes to four forms via the change 
memo process. The first change added a field to the Deceased Donor 
Registration form to allow OPOs that perform donor serology testing for 
Strongyloides to report the results. The second change modified a 
section of three forms that collect data on the health of lung 
transplant recipients post-transplant. The change allows for data to be 
collected on Chronic Lung Allograft Dysfunction, which is a broader, 
more contemporary definition of post-transplant lung dysfunction. Other 
fields pertaining to outdated measures of graft function were removed. 
The modifications were made to these three forms: Heart/Lung Transplant 
Recipient Follow-up 6 month form; Heart/Lung Transplant Recipient 
Follow-up 1-5 year form; and Heart/Lung Transplant Recipient Follow-up 
Post 5 year form.
    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
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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           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

[[Page 39196]]

 
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...................
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
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    Total.......................           6,204  ..............         567,472  ..............       425,925.1
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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.
** Numbers based on 2018 forms.


Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-14046 Filed 6-29-20; 8:45 am]
BILLING CODE 4165-15-P