Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / Notices 1151 

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 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 February 9, 2022. 

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 

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. 

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 memberspecific 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 OMBapproved 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. 


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1152 Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / Notices 

(3) Adding data collection forms in 

the OPTN PSRP to the existing OMBapproved 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 Directorsapproved 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

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 1.80 a 12,339 

Living Donor Follow-up ........................................................ 300 62.23 18,669 1.30 b 24,270 

Donor Histocompatibility ...................................................... 147 123.99 18,226 0.20 3,645 

Recipient Histocompatibility ................................................. 147 225.10 33,090 0.40 13,236 

Heart 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 1,232 

Heart Follow Up (1–5 Year) ................................................. 140 90.61 12,685 0.90 11,417 

Heart 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 Candidate Registration ............................................... 71 45.21 3,210 0.90 2,889 

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

Lung Follow Up (6 Month) ................................................... 71 32.35 2,297 0.50 1,148 

Lung Follow Up (1–5 Year) ................................................. 71 118.85 8,438 1.10 9,282 

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

Heart/Lung Candidate Registration ..................................... 69 0.97 67 1.10 74 

Heart/Lung Recipient Registration ....................................... 69 0.46 32 1.30 42 

Heart/Lung Follow Up (6 Month) ......................................... 69 0.45 31 0.80 25 

Heart/Lung Follow Up (1–5 Year) ........................................ 69 1.14 79 1.10 87 

Heart/Lung 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 Candidate Registration ............................................... 146 90.29 13,182 0.80 10,546 

Liver Recipient Registration ................................................. 146 56.55 8,256 1.20 9,907 

Liver Follow-up (6 Month–5 Year) ....................................... 146 266.57 38,919 1.00 38,919 

Liver 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 Candidate Registration .......................................... 20 6.95 139 1.30 181 

Intestine Recipient Registration ........................................... 20 5.20 104 1.80 187 

Intestine Follow Up (6 Month–5 Year) ................................. 20 26.20 524 1.50 786 

Intestine 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 Candidate Registration ............................................ 237 168.77 39,998 0.80 31,998 

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

Kidney 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 4,292 

Pancreas Candidate Registration ........................................ 133 2.77 368 0.60 221 

Pancreas Recipient Registration ......................................... 133 1.46 194 1.20 233 

Pancreas Follow-up (6 Month–5 Year) ................................ 133 7.87 1,047 0.50 524 

Pancreas Follow-up (Post 5 Year) ...................................... 133 15.93 2,119 0.50 1,060 

Pancreas Post-Transplant Malignancy Form ...................... 133 0.73 97 0.60 58 

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

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

Kidney/Pancreas Follow-up (6 Month–5 Year) .................... 133 32.80 4,362 0.50 2,181 

Kidney/Pancreas Follow-up (Post 5 Year) .......................... 133 57.80 7,687 0.60 4,612 


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Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / Notices 1153 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued 

Form name Number of 

respondents 

Number of 

responses per 

respondent * 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

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

VCA Candidate Registration ................................................ 27 0.89 24 0.40 10 

VCA Recipient Registration ................................................. 27 1.59 43 1.30 c 56 

VCA Recipient Follow Up .................................................... 27 0.67 18 1.00 d 18 

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

Organ Tracking and Validating System ............................... 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 

Living Donor Event .............................................................. 251 0.12 30 0.56 17 

Safety Situation .................................................................... 450 0.48 216 0.56 121 

Potential Disease Transmission Report .............................. 57 6.88 392 1.27 498 

Request to Unlock Form ...................................................... 450 39.22 17,649 0.02 353 

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. abcdTotal 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 1–7–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Extension of the Deadline for 

Nomination of Delegates; Center for 

Indigenous Innovation and Health 

Equity Tribal Advisory Committee; 

Solicitation of Nominations for 

Delegates 

AGENCY: Office of Minority Health, 

Office of the Secretary, Department of 

Health and Human Services. 

ACTION: Deadline extension for notice of 

solicitation of nominations for delegates 

for the Center for Indigenous Innovation 

and Health Equity Tribal Advisory 

Committee. 

SUMMARY: On October 1, 2021, the U.S. 

Department of Health and Human 

Services (HHS) Office of Minority 

Health (OMH) published a notice in the 

Federal Register inviting nominations 

of qualified candidates to serve as 

delegates for the Center for Indigenous 

Innovation and Health Equity Tribal 

Advisory Committee (Center TAC, 

previously referred to as CIIHE TAC), 

including a submission deadline of 

October 29, 2021. An extension for the 

submission deadline of nominations to 

January 7, 2022, was published on 

November 19, 2021. This notice extends 

the deadline date for submission of 

nominations to March 11, 2022, at 11:59 

p.m. EST. 

DATES: Nomination letters for the Center 

TAC must be sent to the address noted 

below no later than 11:59 p.m. EST on 

March 11, 2022. 

ADDRESSES: All nominations should be 

emailed to: Violet Woo, Designated 

Federal Officer for the Center TAC, at 

Violet.Woo@hhs.gov. Please use the 

subject line ‘‘OMH Center Tribal 

Advisory Committee.’’ 

FOR FURTHER INFORMATION CONTACT: For 

information and guidance about the 

nomination process for Center TAC 

delegates, please contact Violet Woo, 

Designated Federal Officer at 

Violet.Woo@hhs.gov. Center TAC 

nomination guidance and sample 

nomination letters also are available on 

the OMH website’s Tribal Leader Letters 

section: https://www.minority

health.hhs.gov/omh/ 

browse.aspx?lvl=3&lvlid=62#triballeader-letters. 

SUPPLEMENTARY INFORMATION: On 

October 1, 2021, the notice of 

solicitation of nominations for delegates 

for the Center TAC was published in the 

Federal Register (86 FR 54462: available 

at https://www.federalregister.gov/ 

documents/2021/10/01/2021-21253/ 

center-for-indigenous-innovation-andhealth-equity-tribal-advisory-committeesolicitation-of). The deadline for 

submission of nomination letters is 

being extended to March 11, 2022. 

Note: All information in the notice of 

solicitation of nominations for delegates 

for the Center for Indigenous Innovation 

and Health Equity Tribal Advisory 

Committee remains the same, except for 

the deadline for the submission of 

nominations and the date the nominees 

will be notified of the status of delegate 

selection. 

Authorized under Section 1707 of the 

Public Health Service Act, 42 U.S.C. 

300u–6, as amended, the mission of 

OMH is to improve the health of racial 

and ethnic minority populations 

through the development of health 

policies and programs that help 

eliminate health disparities. OMH 

awards and other activities are intended 

to support the identification of effective 

policies, programs, and practices for 

improving health outcomes and to 

promote the sustainability and 

dissemination of these approaches. 

Under the authority of Public Law 

116–260 (2021 Consolidated 

Appropriations Act), Congress directed 

OMH to create a Center to support 

research, education, service, and policy 

development advancing Indigenous 

solutions that ultimately address health 

disparities in American Indian/Alaska 

Native (AI/AN) and Native Hawaiian 

and Pacific Islander (NHPI) populations. 

OMH is establishing the Center TAC to 

ensure that Tribal Leaders have 

meaningful and timely input in the 


khammond on DSKJM1Z7X2PROD with NOTICES