# 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-Revision

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2021-18688

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** August 31, 2021
- **Citation:** 86 FR 48743

## Text

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—Revision

AGENCY:

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

ACTION:

Notice.

SUMMARY:

In compliance with the requirement for the 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 November 1, 2021.

ADDRESSES:

Submit your comments to
paperwork@hrsa.gov
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
paperwork@hrsa.gov
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—Revision.

Abstract:
Section 372 of the Public Health Service Act requires that the Secretary, by contract, provide for the establishment and operation of a private, non-profit entity: The Organ Procurement and Transplantation Network (OPTN). The data collected pursuant to the OPTN's regulatory authority in 42 CFR 121.11 of the OPTN Final Rule is collected through OMB approved data collection forms. Therefore, data approved for collection by the OPTN Board of Directors are submitted by HRSA for OMB approval under the Paperwork Reduction Act of 1995.

This is a request for revising the current OPTN data collection associated with an individual's clinical characteristics at the time of registration, transplant, and follow-up after the transplant to include data collection forms in the OPTN Organ Labeling, Packaging, and Tracking System, the OPTN Kidney Paired Donation Pilot Program (KPDPP), and the OPTN Patient Safety Reporting Portal (PSRP). This revision also includes OPTN Board of Directors approved changes to the existing OMB data collection forms. 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 (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; (5) perform transplantation-related public health surveillance including the possible transmission of donor disease.

HRSA is submitting the following changes to improve the OPTN organ matching and allocation process and improve OPTN member compliance with OPTN requirements. All of these proposed changes have been approved by the OPTN Board of Directors.

(1) Adding two data collection forms for the OPTN Organ Labeling, Packaging, and Tracking System to the existing OMB approved Data System for Organ Procurement and Transplantation Network. The system has two forms that are used through mobile and web-based applications to ensure the correct organ is transplanted into the correct patient, minimize labeling and transport errors, accelerate organ information transfer,

and capture data regarding organ procurement. OPTN Organ Labeling, Packaging, and Tracking System is comprised of two data collection forms: Organ labeling and packaging, and organ tracking and validating.

(2) Adding data collection forms for the OPTN KPDPP to the existing OMB approved Data System for Organ Procurement and Transplantation Network. Kidney paired donation is a transplant option for those patients waiting for a kidney transplant who have a willing living donor who is medically able but cannot donate a kidney to their intended candidate because they are incompatible. OPTN KPDPP matches living donors, and their intended candidates with other living donors or intended candidate pairs when the living donors cannot donate to the person(s) they initially hoped would receive their kidney. OPTN KPDPP is comprised of three data collection forms: Candidate registration, donor registration, and match offer management.

(3) Adding data collection forms in the OPTN PSRP to the existing OMB approved Data System for Organ Procurement and Transplantation Network. OPTN PSRP allows the OPTN to collect reports on any event or process variance that could cause concerns from transplantation, donation, safety, or quality perspective. OPTN PSRP is comprised of four data collection forms: Disease transmission event, living donor event, safety situation, and potential disease transmission.

(4) Additional revisions to existing data collection forms were made based on the OPTN Board of Directors-approved changes to improve organ matching, allocation, and OPTN policy compliance.

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.

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 to collect, validate, and verify information, process and maintain information, and disclose and provide information; to train personnel and 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
57
188.26
10,731
1.10
11,804

Living Donor Registration
300
22.85
6,855
2.19

a
15,012

Living Donor Follow-up
300
62.23
18,669
1.53

b
28,564

Donor Histocompatibility
147
123.99
18,227
0.20
3,645

Recipient Histocompatibility
147
225.10
33,090
0.40
13,236

Heart Transplant Candidate Registration
140
33.69
4,717
0.90
4,245

Heart Recipient Registration
140
24.33
3,406
1.20
4,087

Heart Follow Up (6 Month)
140
22.01
3,081
0.40
1,233

Heart Transplant Recipient Follow Up 1-5 Year
140
90.61
12,685
0.90
11,417

Heart Transplant Recipient Follow Up Post 5 Year
140
153.97
21,556
0.50
10,778

Heart Post-Transplant Malignancy Form
140
12.77
1,788
0.90
1,609

Lung Transplant Candidate Registration
71
45.21
3,210
0.90
2,889

Lung Transplant Recipient Registration
71
35.66
2,532
1.20
3,038

Lung Transplant Recipient Follow Up 6 Month
71
32.35
2,297
0.50
1,148

Lung Transplant Recipient Follow Up 1-5 Year
71
118.85
8,438
1.10
9,282

Lung Transplant Recipient Follow Up Post 5 Year
71
116.49
8,271
0.60
4,962

Lung- Post-Transplant Malignancy Form
71
19.72
1,400
0.40
560

Heart/Lung Transplant Candidate Registration
69
0.97
67
1.10
74

Heart/Lung Recipient Registration
69
0.46
32
1.30
41

Heart/Lung Transplant Recipient Follow Up 6 Month
69
0.45
31
0.80
25

Heart/Lung Transplant Recipient Follow Up 1-5 Year
69
1.14
79
1.10
87

Heart/Lung Transplant Recipient Follow Up Post 5 Year
69
3.30
228
0.60
137

Heart/Lung Post-Transplant Malignancy Form
69
0.30
21
0.40
8

Liver Transplant Candidate Registration
146
90.29
13,182
0.80
10,546

Liver Transplant Recipient Registration
146
56.55
8,256
1.20
9,908

Liver Transplant Recipient Follow-Up 6 Month—5 Year
146
266.57
38,919
1.00
38,919

Liver Transplant Recipient Follow-up Post 5 Year
146
316.61
46,225
0.50
23,113

Liver Recipient Explant Pathology Form
146
10.58
1,545
0.60
927

Liver Post-Transplant Malignancy
146
16.35
2,387
0.80
1,910

Intestine Transplant Candidate Registration
20
6.95
139
1.30
181

Intestine Transplant Recipient Registration
20
5.20
104
1.80
187

Intestine Transplant Recipient Follow Up 6 Month—5 Year
20
26.20
524
1.50
786

Intestine Transplant Recipient Follow Up Post 5 Year
20
37.20
744
0.40
298

Intestine Post-Transplant Malignancy Form
20
2.10
42
1.00
42

Kidney Transplant Candidate Registration
237
168.77
39,998
0.80
31,999

Kidney Transplant Recipient Registration
237
89.43
21,195
1.20
25,434

Kidney Transplant Recipient Follow-Up 6 Month—5 Year
237
431.86
102,351
0.90
92,116

Kidney Transplant Recipient Follow-Up Post 5 Year
237
449.40
106,508
0.50
53,254

Kidney Post-Transplant Malignancy Form
237
22.64
5,366
0.80
4,293

Pancreas Transplant Candidate Registration
133
2.77
368
0.60
221

Pancreas Transplant Recipient Registration
133
1.46
194
1.20
233

Pancreas Transplant Recipient Follow-Up 6 Month—5 Year
133
7.87
1,047
0.50
523

Pancreas Transplant Recipient Follow-Up Post 5 Year
133
15.93
2,119
0.50
1,059

Pancreas Post-Transplant Malignancy Form
133
0.73
97
0.60
58

Kidney/Pancreas Transplant Candidate Registration
133
9.75
1,297
0.60
778

Kidney/Pancreas Transplant Recipient Registration
133
7.73
1,028
1.20
1,234

Kidney/Pancreas Transplant Recipient Follow-Up 6 Month—5 Year
133
32.80
4,362
0.50
2,181

Kidney/Pancreas Transplant Recipient Follow-Up Post 5 Year
133
57.80
7,687
0.60
4,612

Kidney/Pancreas Post-Transplant Malignancy Form
133
2.20
293
0.40
117

VCA Transplant Candidate Registration
27
0.89
24
0.40
11

VCA Transplant Recipient Registration
27
1.59
43
1.36

c
58

VCA Transplant Recipient Follow Up
27
0.67
18
1.31

d
24

Organ Labeling and Packaging
57
208.25
11,870
0.18
2,137

Organ Tracking and Validating
34
169.06
5,748
0.08
460

Kidney Paired Donation Candidate Registration
160
1.38
221
0.29
64

Kidney Paired Donation Donor Registration
160
1.46
234
1.07
250

Kidney Paired Donation Match Offer Management
160
1.51
242
0.67
162

Disease Transmission Event
308
1.44
444
0.62
275

Living Donor Event
251
0.12
30
0.56
17

Safety Situation
450
0.48
216
0.56
121

Potential Disease Transmission
57
6.88
392
1.27
498

Request to Unlock
450
39.22
17,649
0.02
353

Total
8,290

604,519

437,240

* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to the nearest tenth.

a
Total burden increased due to the approval of the “Modify Data Collection on VCA Living Donors” proposal approved by the OPTN Board of Directors (BOD) in December of 2020. The proposal required adding 54 new data fields onto this form and removing 1 data field from this form.

b
Total burden increased due to the approval of the “Modify Data Collection on VCA Living Donors” proposal approved by the OPTN BOD in December of 2020. The proposal required adding 17 new data fields onto this form.

c
Total burden increased due to the approval of the “Programming VCA Allocation in UNet” proposal approved by the OPTN BOD in December of 2020. The proposal required adding 16 new data fields onto this form and removing 10 data fields from this form.

d
Total burden increased due to the approval of the “Programming VCA Allocation in UNet” proposal approved by the OPTN BOD in December of 2020. The proposal required adding 54 new data fields onto this form and removing 5 data fields from this form.

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. 2021-18688 Filed 8-30-21; 8:45 am]
BILLING CODE 4165-15-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2021-18688. Public record. Not legal advice.