Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48743 

oversight, coordination, and logistical 

support for the Medical Expert Panel, as 

well as Clinical Reviewer contracts; (10) 

developing, reviewing, and analyzing 

pending and new legislation relating to 

program changes, new initiatives, the 

ACCV, and changes to the Vaccine and 

Countermeasures Injury Tables; (11) 

providing programmatic outreach efforts 

to maximize public exposure to private 

and public constituencies; and (12) 

providing guidance in using the results 

and decisions of the Medical Claims 

Review Panel to HHS Operating 

Divisions to improve the quality of 

health care in its facilities and by its 

practitioners. 

Division of National Hansen’s Disease 

Program (RRH) 

The National Hansen’s Disease 

Program, in accordance with regulations 

and the Public Health Service (PHS) 

Act, Sec. 320 as amended by Public Law 

105–78, Sec. 211, (1) provides care and 

treatment for persons with Hansen’s 

Disease (leprosy), including managing a 

national short-term and outpatient 

health care delivery program providing 

specialized services to persons with 

Hansen’s Disease; (2) conducts and 

promotes the coordination of research 

(including clinical research), 

investigations, demonstrations, and 

studies relating to the causes, diagnosis, 

treatment, control, and prevention of 

Hansen’s disease and other 

mycobacterial diseases and 

complications related to such diseases; 

(3) conducts training in the diagnosis 

and management of Hansen’s disease 

and related complications; (4) provides 

education and training to staff from the 

outpatient Hansen’s Disease Clinics and 

to private physicians; (5) operates and 

oversees the National Hansen’s Disease 

Museum and Cemetery; (6) consults on 

the coordination of activities within 

HRSA and HHS, and with other federal 

agencies, state and local governments, 

and other public and private 

organizations involved in Hansen’s 

Disease activities; and (7) manages a 

network of contracted outpatient clinics 

providing care to persons with Hansen’s 

Disease; and (8) manages and 

coordinates the National Hansen’s 

Disease Program’s administrative and 

operational activities with HRSA and 

HHS; other federal agencies, state and 

local governments; and other public and 

private organizations involved in 

Hansen’s Disease activities. 

Section R.30 Delegation of Authority 

All prior delegations of authority and 

re-delegations of authority consistent 

with this reorganization are in effect. I 

affirm and ratify any actions taken by 

HHS officials that involved the exercise 

of those authorities prior to the effective 

date of this reorganization. 

(Authority: 44 U.S.C. 3101) 

Dated: August 6, 2021. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2021–18075 Filed 8–27–21; 4:15 pm] 

BILLING CODE 4165–15–P 

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, 


khammond on DSKJM1Z7X2PROD with NOTICES
48744 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 

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 Directorsapproved 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 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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48745 

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 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. aTotal 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. bTotal 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. cTotal 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. dTotal 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Establishment of the Office of Climate 

Change and Health Equity 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

Statement of Organization, Functions, 

and Delegations of Authority 

Part A, Office of the Secretary, 

Statement of Organization, Function, 

and Delegation of Authority for the U.S. 

Department of Health and Human 

Services (HHS) is being amended at 

Chapter AC, Office of the Assistant 

Secretary for Health (OASH), as last 

amended at 75 FR 53304, dated August 

31, 2010, and 72 FR 58095–96, dated 

October 12, 2007. Executive Order 

14008, Tackling the Climate Crisis at 

Home and Abroad, section 222(d), 

directs the Secretary of Health and 

Human Services to establish an Office of 

Climate Change and Health Equity to 

address the impact of climate change on 

the health of the American people. This 

amendment reflects the establishment of 

an office to address the impact of 

climate change on the health of the 

American people and to empower 

individuals through information, data, 

and scientific approaches to pursue 

environmental justice. Specifically, this 

notice establishes the Office of Climate 

Change and Health Equity in the OASH. 

The changes are as follows: 

A. Under Part A, Chapter AC, under 

the Office of the Assistant Secretary for 

Health, add the following: 

1. The Office of Climate Change and 

Health Equity (OCCHE), is headed by a 


khammond on DSKJM1Z7X2PROD with NOTICES