Billing Code: 4165-15

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; 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 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 [INSERT DATE 30 DAYS
AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER].

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 Samantha Miller, the acting HRSA Information Collection
Clearance Officer at paperwork@hrsa.gov or call (301) 443-9094.
SUPPLEMENTARY INFORMATION:
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 will be collected through OMBapproved 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.
A 60-day notice was published in the Federal Register, 86 FR 48743 (Aug. 31, 2021).
One comment was received. The commenter supported the necessity and utility of the proposed
information collection and the use of automated collection techniques. The commenter
recommended that HRSA account for anticipated increased staff hours and recommended
emphasizing collecting data pertaining to race, ethnicity, social determinants of health, and any
other characteristics that will help achieve equity in organ donation and transplantation. HRSA
appreciates all feedback, and we will continue to review and evaluate all data collection efforts
going forward in consultation with the OPTN.

The 60-day notice proposed data collection changes to existing data collection forms
related to Vascularized Composite Allograft (VCA) transplantation, to implement policies
approved by the OPTN Board of Directors. The OPTN expects to make additional changes to
these VCA data collection forms in the near future so implementation of data collection changes
has been postponed. These data collection changes are not included in this 30-day notice and
will be included for review in a future submission.
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.
This is a request to revise 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 Directorsapproved 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 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) Adding a request to unlock form
5) 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.
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.
The total burden hours in the OMB inventory increased by 4,337 hours from the
previously OMB-approved data collection package from August 25, 2020. This increase is due
to including new data collection forms and additional data to existing data collection forms.
However, the total burden hours of this request is less than the total burden hours presented in
the 60-day notice, because of the removal of the proposed data collection changes associated
with implementing the “Modify Data Collection on VCA Living Donors” and “Programming
VCA Allocation in UNet” policies.

Total Estimated Annualized Burden - Hours

Number
of
Respondents

Number of
Responses
per
Respondent*

Total
Responses

188.26

10,731

Average
Burden
per
Response
(in hours)
1.10

Living Donor Registration

22.85

6,855

1.80

12,339a

Living Donor Follow-up

62.23

18,669

1.30

24,270b

Donor Histocompatibility

123.99

18,226

0.20

3,645

Recipient Histocompatibility

225.10

33,090

0.40

13,236

Heart Candidate Registration

33.69

4,717

0.90

4,245

Heart Recipient Registration

24.33

3,406

1.20

4,087

22.01

3,081

0.40

1,232

90.61

12,685

0.90

11,417

153.97

21,556

0.50

10,778

12.77

1,788

0.90

1,609

Lung Candidate Registration

45.21

3,210

0.90

2,889

Lung Recipient Registration

35.66

2,532

1.20

3,038

32.35

2,297

0.50

1,148

118.85

8,438

1.10

9,282

Form Name

Deceased Donor Registration

Heart Follow Up
(6 Month)
Heart Follow Up
(1-5 Year)
Heart Follow Up
(Post 5 Year)
Heart Post-Transplant
Malignancy Form

Lung Follow Up
(6 Month)
Lung Follow Up
(1-5 Year)

Total
Burden
Hours
11,804

Number
of
Respondents

Number of
Responses
per
Respondent*

Total
Responses

Average
Burden
per
Response
(in hours)

19.72

1,400

0.40

69

0.97

1.10

69

0.46

1.30

69

0.45

0.80

69

1.14

1.10

69

3.30

0.60

69

0.30

0.40

Liver Candidate Registration

90.29

13,182

0.80

10,546

Liver Recipient Registration

56.55

8,256

1.20

9,907

266.57

38,919

1.00

38,919

316.61

46,225

0.50

23,113

10.58

1,545

0.60

146

16.35

2,387

0.80

1,910

6.95

1.30

20

5.20

1.80

20

26.20

1.50

20

37.20

0.40

20

2.10

1.00

Kidney Candidate Registration

168.77

39,998

0.80

31,998

Kidney Recipient Registration

89.43

21,195

1.20

25,434

Form Name
Lung Post-Transplant
Malignancy Form
Heart/Lung Candidate
Registration
Heart/Lung Recipient
Registration
Heart/Lung Follow Up
(6 Month)
Heart/Lung Follow Up
(1-5 Year)
Heart/Lung Follow Up
(Post 5 Year)
Heart/Lung Post-Transplant
Malignancy Form

Liver Follow-up
(6 Month - 5 Year)
Liver Follow-up
(Post 5 Year)
Liver Recipient Explant
Pathology Form
Liver Post-Transplant
Malignancy
Intestine Candidate
Registration
Intestine Recipient
Registration
Intestine Follow Up
(6 Month - 5 Year)
Intestine Follow Up
(Post 5 Year)
Intestine Post-Transplant
Malignancy Form

Total
Burden
Hours

Number
of
Respondents

Number of
Responses
per
Respondent*

Total
Responses

Average
Burden
per
Response
(in hours)

449.40

106,508

0.50

53,254

22.64

5,366

0.80

4,292

2.77

0.60

133

1.46

1.20

133

7.87

1,047

0.50

133

15.93

2,119

0.50

1,060

0.73

0.60

133

9.75

1,297

0.60

133

7.73

1,028

1.20

1,234

32.80

4,362

0.50

2,181

57.80

7,687

0.60

4,612

2.20

0.40

VCA Candidate Registration

0.89

0.40

VCA Recipient Registration

1.59

1.30

56c

VCA Recipient Follow Up

0.67

1.00

18d

208.25

11,870

0.18

2,137

169.06

5,748

0.08

160

1.38

0.29

160

1.46

1.07

160

1.51

0.67

Number
of
Respondents

Number of
Responses
per
Respondent*

Total
Responses

Average
Burden
per
Response
(in hours)

Form Name
Kidney Follow-up
(Post 5 Year)
Kidney Post-Transplant
Malignancy Form
Pancreas Candidate
Registration
Pancreas Recipient
Registration
Pancreas Follow-up
(6 Month - 5 Year)
Pancreas Follow-up
(Post 5 Year)
Pancreas Post-Transplant
Malignancy Form
Kidney/Pancreas Candidate
Registration
Kidney/Pancreas Recipient
Registration
Kidney/Pancreas Follow-up
(6 Month - 5 Year)
Kidney/Pancreas Follow-up
(Post 5 Year)
Kidney/Pancreas PostTransplant Malignancy Form

Organ Labeling and Packaging
System
Organ Tracking and Validating
System
Kidney Paired Donation
Candidate Registration
Kidney Paired Donation Donor
Registration
Kidney Paired Donation Match
Offer Management

Form Name

Total
Burden
Hours

Total
Burden
Hours

Living Donor Event

0.12

0.56

Safety Situation

0.48

0.56

57

6.88

1.27

450

39.22

17,649

0.02

Potential Disease Transmission
Report
Request to Unlock Form
Total

8,290

604,519

430,267

*The Number of Reponses per Respondent was calculated by dividing the Total Responses by
the Number of Respondents and rounding to the nearest tenth.
a), b), c), d) Total burden hours in these forms decreased from estimates provided in the 60-day
Notice due to the removal of the proposed data collection changes associated with implementing
the “Modify Data Collection on VCA Living Donors” and “Programming VCA Allocation in
UNet” policies.
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. 2022-00239 Filed: 1/7/2022 8:45 am; Publication Date: 1/10/2022]