# 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%3A2022-21119

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** September 29, 2022
- **Citation:** 87 FR 59103

## 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 (HHS).

ACTION:

Notice.

SUMMARY:

In compliance with the requirement for 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 28, 2022.

ADDRESSES:

Submit your comments to
paperwork@hrsa.gov
or by mail to 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 Samantha Miller, the HRSA Information Collection Clearance Officer at (301) 443-9094.

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the information collection request title for reference.

Information Collection Request Title:
Data System for Organ Procurement and Transplantation Network (OPTN), OMB No. 0915-0157—Revision.

Abstract:
Section 372 of the Public Health Service Act requires that the Secretary of HHS, by contract, provide for the establishment and operation of a private, non-profit entity the OPTN, which on behalf of HRSA, oversees the U.S. donation and transplantation system. The OPTN Board of Directors (BOD) determines what data must be collected to appropriately fulfill their responsibilities pursuant to their regulatory authority in 42 CFR 121.11 of the OPTN Final Rule. HRSA, on behalf of the OPTN BOD and in alignment with the Paperwork Reduction Act of 1995, submits OPTN BOD-approved data elements for collection to OMB for official federal approval.

Need and Proposed Use of the Information:
HRSA and the OPTN BOD use data 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. In addition, the regulatory authority in 42 CFR 121.11 of the OPTN Final Rule requires the OPTN data to be made available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, HHS, and members of the public for evaluation, research, patient information, and other important purposes.

This is a request to revise the current OPTN data collection which includes time-sensitive, life-critical data on transplant candidates and donors, the organ matching process, histocompatibility results, organ labeling and packaging, and pre- and post-transplantation data on recipients and donors. This revision also includes OPTN BOD-approved changes to the existing OMB data collection forms. The OPTN collects these specific data elements from transplant hospitals, organ procurement organizations, and histocompatibility laboratories. The OPTN uses this information 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 the possible transmission of donor disease.

HRSA is requesting to make the following OPTN BOD-approved changes to improve the OPTN organ matching and allocation process and improve OPTN member compliance with OPTN requirements:

(1) Adding data collection forms from the OPTN donor management and organ matching system to the existing OMB-approved information collection. The system allows an organ procurement organization to add donors, run the donor/potential transplant recipients matches, and place a donated organ(s) with a computer-matched potential transplant recipient. Transplant centers will access the system to view posted donor information to assist them with accepting decisions, along with other donor/potential transplant recipient functions such as entering offer responses and verifying organ offer refusals. The OPTN donor management and organ matching system is comprised of eight data collection forms:

initial donor registration, organ procurement organization notification limit administration, potential transplant recipient, death notification registration, deceased donor death referral, donor hospital registration, donor organ disposition, and transplant center contact management.

(2) The OPTN BOD-approved additional revisions to existing data collection forms to improve organ matching, allocation, and OPTN policy compliance.

(3) Existing OPTN data collection forms that collect a single race and ethnicity variable will be revised to collect separate race and ethnicity variables, following the minimum standards for collecting and presenting data on race and ethnicity for all federal reporting found within
Revisions of Standards for the Classification of Federal Data on Race and Ethnicity,
OMB Statistical Policy Directive No. 15 in
Federal Register
, 62 FR 58782 (Oct. 30, 1997). Improving data collection around race and ethnicity information of donors and candidates aligns with Executive Order 13985, which calls on agencies to advance equity through identifying and addressing barriers to equal opportunity that underserved communities may face due to government policies and programs.

Likely Respondents:
Transplant programs, organ procurement organizations (OPO), 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.

The estimated total estimated burden hours for this collection increased by 213,662 hours from the currently approved ICR package. This increase is due to the addition of eight collection forms from the OPTN donor management and organ matching system to this data collection package, specifically the burden increase from the Potential Transplant Recipient form. While the data fields collected on the Potential Transplant Recipient form are limited, the volume of organ offer responses is significant due to the large number of potential transplant recipients shown on the organ match run results. The organ match run results produce thousands of potential transplant recipients that require responses from OPOs and transplant hospitals. This volume of candidates significantly impacts the total burden hours for this form.

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
243.560
13,883
1.09
15,132

Living Donor Registration
216
28.106
6,071
2.19
13,295

Living Donor Follow-up
216
90.550
19,559
1.52
29,730

Donor Histocompatibility
141
149.184
21,035
0.20
4,207

Recipient Histocompatibility
141
264.950
37,358
0.40
14,943

Heart Transplant Candidate Registration
145
34.586
5,015
0.90
4,514

Heart Transplant Recipient Registration
145
26.324
3,817
1.40
5,344

Heart Transplant Recipient Follow-Up (6 Months)
145
24.400
3,538
0.40
1,415

Heart Transplant Recipient Follow-Up (1-5 Years)
145
104.140
15,100
0.90
13,590

Heart Transplant Recipient Follow-Up (Post 5 Year)
145
171.100
24,810
0.50
12,405

Heart Post-Transplant Malignancy Form
145
13.170
1,910
0.90
1,719

Lung Transplant Candidate Registration
72
42.970
3,094
0.90
2,785

Lung Transplant Recipient Registration
72
35.010
2,521
1.20
3,025

Lung Transplant Recipient Follow-Up (6 Months)
72
33.630
2,421
0.50
1,211

Lung Transplant Recipient Follow-Up (1-5 Years)
72
139.940
10,076
1.10
11,084

Lung Transplant Recipient Follow-Up (Post 5 Year)
72
136.280
9,812
0.60
5,887

Lung Post-Transplant Malignancy Form
72
22.630
1,629
0.40
652

Heart/Lung Transplant Candidate Registration
70
0.960
67
1.10
74

Heart/Lung Transplant Recipient Registration
70
0.640
45
1.30
59

Heart/Lung Transplant Recipient Follow-Up (6 Months)
70
0.600
42
0.80
34

Heart/Lung Transplant Recipient Follow-Up (1-5 Years)
70
2.100
147
1.10
162

Heart/Lung Transplant Recipient Follow-Up (Post 5 Year)
70
3.360
235
0.60
141

Heart/Lung Post-Transplant Malignancy Form
70
0.290
20
0.40
8

Liver Transplant Candidate Registration
143
96.920
13,860
0.80
11,088

Liver Transplant Recipient Registration
143
64.580
9,235
1.20
11,082

Liver Transplant Recipient Follow-Up (6 Month-5 Year)
143
320.266
45,798
1.00
45,798

Liver Transplant Recipient Follow-Up (Post 5 Year)
143
384.320
54,958
0.50
27,479

Liver Recipient Explant Pathology Form
143
7.300
1,044
0.60
626

Liver Post-Transplant Malignancy
143
19.060
2,726
0.80
2,181

Intestine Transplant Candidate Registration
21
6.860
144
1.30
187

Intestine Transplant Recipient Registration
21
4.570
96
1.80
173

Intestine Transplant Recipient Follow-Up (6 Month-5 Year)
21
20.050
421
1.50
632

Intestine Transplant Recipient Follow-Up (Post 5 Year)
21
40.190
844
0.40
338

Intestine Post-Transplant Malignancy Form
21
0.620
13
1.00
13

Kidney Transplant Candidate Registration
234
177.000
41,418
0.80
33,134

Kidney Transplant Recipient Registration
234
105.397
24,663
1.20
29,596

Kidney Transplant Recipient Follow-Up (6 Month-5 Year)
234
517.124
121,007
0.90
108,906

Kidney Transplant Recipient Follow-Up (Post 5 Year)
234
525.103
122,874
0.50
61,437

Kidney Post-Transplant Malignancy Form
234
24.474
5,727
0.80
4,582

Pancreas Transplant Candidate Registration
120
2.650
318
0.60
191

Pancreas Transplant Recipient Registration
120
1.190
143
1.20
172

Pancreas Transplant Recipient Follow-Up (6 Month-5 Year)
120
6.680
802
0.50
401

Pancreas Transplant Recipient Follow-Up (Post 5 Year)
120
17.820
2138
0.50
1,069

Pancreas Post-Transplant Malignancy Form
120
1.060
127
0.60
76

Kidney/Pancreas Transplant Candidate Registration
120
12.450
1,494
0.60
896

Kidney/Pancreas Transplant Recipient Registration
120
6.840
821
1.20
985

Kidney/Pancreas Transplant Recipient Follow-Up (6 Month-5 Year)
120
39.440
4,733
0.50
2,367

Kidney/Pancreas Transplant Recipient Follow-Up (Post 5 Year)
120
69.410
8,329
0.60
4,997

Kidney/Pancreas Post-Transplant Malignancy Form
120
2.490
299
0.40
120

VCA Transplant Candidate Registration
21
0.330
7
0.40
3

VCA Transplant Recipient Registration
21
0.190
4
1.36
5

VCA Transplant Recipient Follow Up
21
1.000
21
1.31
28

Organ Labeling and Packaging
57
247.720
14,120
0.18
2,542

Organ Tracking and Validating
308
19.487
6,002
0.08
480

Kidney Paired Donation Candidate Registration
159
1.200
191
0.29
55

Kidney Paired Donation Donor Registration
159
1.560
248
1.08
268

Kidney Paired Donation Match Offer Management
159
1.520
242
0.67
162

Disease Transmission Event
308
1.810
557
0.62
345

Living Donor Event
251
0.155
39
0.56
22

Safety Situation
449
0.600
269
0.56
151

Potential Disease Transmission
57
8.720
497
1.27
631

Request to Unlock Form
449
42.399
19,037
0.02
381

Initial Donor Registration
57
335.720
19,136
3.00
57,408

OPO Notification Limit Administration
57
0.490
28
0.17
5

Potential Transplant Recipient
308
4,718.480
1,453,292
0.05
72,665

Death Notification Registration
57
185.770
10,589
0.42
4,447

Deceased Donor Death Referral
57
53.840
3,069
0.50
1,535

Donor Hospital Registration
57
0.040
2
0.08
0

Donor Organ Disposition
57
335.720
19,136
0.17
3,253

Transplant Center Contact Management
251
637.500
160,013
0.06
9,601

Total = 70 forms
9,146

2,352,736

643,929

* The numbers of respondents and the numbers of total responses in the burden table were updated with 2021 OPTN data and reflect increases in the number of organ transplants and changes in the number of respondents (Transplant Hospitals, OPO, and Histocompatibility Labs).

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's and the OPTN'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. 2022-21119 Filed 9-28-22; 8:45 am]
BILLING CODE 4165-15-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2022-21119. Public record. Not legal advice.