# 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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2020-14046

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** June 30, 2020
- **Citation:** 85 FR 39194

## Text

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.

ACTION:

Notice.

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
paperwork@hrsa.gov
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

Form name

Number of
respondents

Number of
responses per
respondent *

Total
responses **

Average
burden per
response
(in hours)

Total
burden
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 Form
140
12.8
1,788
0.9
1,609.2

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 Form
71
19.7
1,400
0.4
560.0

Heart/Lung Candidate Registration
69
1.0
67
1.1
73.7

Heart/Lung Recipient Registration
69
0.5
32
1.3
41.6

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 Year)
69
3.3
228
0.6
136.8

Heart/Lung Post-Transplant Malignancy Form
69
0.3
21
0.4
8.4

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 Pathology Form
146
10.6
1,544
0.6
926.4

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 Year)
20
26.2
524
1.5
786.0

Intestine Follow Up (Post 5 Year)
20
37.2
744
0.4
297.6

Intestine Post-Transplant Malignancy Form
20
2.1
42
1.0
42.0

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 Year)
237
431.9
102,350
0.9
92,115.0

Kidney Follow-up (Post 5 Year)
237
449.4
106,507
0.5
53,253.5

Kidney Post-Transplant Malignancy Form
237
22.6
5,365
0.8
4,292.0

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 Year)
133
7.9
1,047
0.5
523.5

Pancreas Follow-up (Post 5 Year)
133
15.9
2,119
0.5
1,059.5

Pancreas Post-Transplant Malignancy Form
133
0.7
97
0.6
58.2

Kidney/Pancreas Candidate Registration
133
9.8
1,297
0.6
778.2

Kidney/Pancreas Recipient Registration
133
7.7
1,028
1.2
1,233.6

Kidney/Pancreas Follow-up (6 Month-5 Year)
133
32.8
4,363
0.5
2,181.5

Kidney/Pancreas Follow-up (Post 5 Year)
133
57.8
7,688
0.6
4,612.8

Kidney/Pancreas Post-Transplant Malignancy Form
133
2.2
292
0.4
116.8

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

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.
** 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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2020-14046. Public record. Not legal advice.