16754 Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices 

on an ad hoc basis to advance these 

goals. ASPR is changing the title of this 

collection from ‘‘Hospital Preparedness 

Program Data Collection’’ to ‘‘Health 

Care Readiness Collections’’ to better 

reflect the scope of data collected under 

this approval. 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(If necessary) 

Respondents 

(If necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

HPP Recipient End-of-Year Performance Report Collection.HPP Recipients ................................ 62 1 21 1,302 

HPP Sub-Recipient End-of-Year Performance Report Collection.HPP Sub-Recipients ........................ 321 1 4 1,284 

Ad hoc Information Collections ......... ASPR Health Care Readiness Portfolio Stakeholders.5,296 1 1 5,296 

Total ........................................... ........................................................... ........................ 3 ........................ 7,882 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–06255 Filed 3–23–22; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Findings of research 

misconduct have been made against 

Daniel Leong, Ph.D. (Respondent), 

formerly a Research Technician, Albert 

Einstein College of Medicine (AECM). 

Respondent engaged in research 

misconduct in research supported by 

U.S. Public Health Service (PHS) funds, 

specifically National Institute of 

Arthritis and Musculoskeletal and Skin 

Diseases (NIAMS), National Institutes of 

Health (NIH), grant R01 AR050968 and 

National Heart, Lung, and Blood 

Institute (NHLBI), NIH, grant P01 

HL110900. The administrative actions, 

including debarment for a period of four 

(4) years followed by supervision for a 

period of four (4) years, were 

implemented beginning on February 28, 

2022, and are detailed below. 

FOR FURTHER INFORMATION CONTACT: 

Wanda K. Jones, Dr.P.H., Acting 

Director, Office of Research Integrity, 

1101 Wootton Parkway, Suite 240, 

Rockville, MD 20852, (240) 453–8200. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that the Office of Research 

Integrity (ORI) has taken final action in 

the following case: 

Daniel Leong, Ph.D., Albert Einstein 

College of Medicine: Based on the report 

of an investigation conducted by AECM 

and analysis conducted by ORI in its 

oversight review, ORI found that Dr. 

Daniel Leong, formerly a Research 

Technician, AECM, engaged in research 

misconduct in research supported by 

PHS funds, specifically NIAMS, NIH, 

grant R01 AR050968 and NHLBI, NIH, 

grant P01 HL110900. 

ORI found that Respondent engaged 

in research misconduct by intentionally, 

knowingly, or recklessly falsifying and/ 

or fabricating data included in sixteen 

(16) grant applications submitted for 

PHS funds: 

• R01 AR065563–01, ‘‘CITED2 and 

Chondroprotection,’’ submitted to 

NIAMS, NIH, on 02/05/2013. 

• R01 AR066009–01, ‘‘Remote 

Loading for Osteoarthritis,’’ submitted 

to NIAMS, NIH, on 06/04/2013. 

• R01 AR065563–01A1, ‘‘CITED2 and 

Chondroprotection,’’ submitted to 

NIAMS, NIH, on 11/05/2014. 

• R41 AR070695–01, ‘‘A novel 

product for tendinopathy treatment,’’ 

submitted to NIAMS, NIH, on 01/05/ 

2015. 

• R01 AG069693–01, ‘‘Chondrocyte 

fate regulation and cartilage protection,’’ 

submitted to National Institute on Aging 

(NIA), NIH, on 06/05/2015. 

• R01 AG039561–06, ‘‘Human tendon 

stem progenitor cell aging and 

regeneration,’’ submitted to NIA, NIH, 

on 03/15/2016 (original grant funding 

from 08/15/2012–04/30/2018). 

• R43 AT009414–01, ‘‘A novel 

nutraceutical drug for tendinopathy 

treatment,’’ submitted to National 

Center for Complementary and 

Alternative Medicine (NCCAM), NIH, 

on 04/05/2016. 

• R01 AR070431–01A1, ‘‘The role of 

Panx1 in the pathogenesis and pain of 

osteoarthritis,’’ submitted to NIAMS, 

NIH, on 07/19/2016. 

• R41 AG056246–01A1, ‘‘A novel 

product for tendinopathy treatment,’’ 

submitted to NIA, NIH, on 09/06/2016, 

funded from 09/15/2017–08/31/2019. 

• R01 AG056623–01, ‘‘Chondrocyte 

fate regulation and osteoarthritis,’’ 

submitted to NIA, NIH, on 10/05/2016. 

• R01 AR072038–01, ‘‘MSC-derived 

exosomes and tendon disorders,’’ 

submitted to NIAMS, NIH, on 10/05/ 

2016. 

• R43 AT009414–01A1, ‘‘A novel 

nutraceutical drug for tendinopathy 

treatment,’’ submitted to NCCAM, NIH, 

on 04/05/2017, funded from 08/01/ 

2018–07/31/2020. 

• R01 AR073194–01, ‘‘Chondrocyte 

fate regulation and cartilage protection,’’ 

submitted to NIAMS, NIH, on 06/05/ 

2017. 

• R01 AR074802–01, ‘‘The role of 

Panx1 in the pathogenesis and pain of 

osteoarthritis,’’ submitted to NIAMS, 

NIH, on 04/02/2018. 

• R01 AR074802–01A1, ‘‘The role of 

Panx1 in the pathogenesis and pain of 

osteoarthritis,’’ submitted to NIAMS, 

NIH, on 08/01/2018. 

• R44 AG065089–01, ‘‘Botanical drug 

for spontaneous osteoarthritis,’’ 

submitted to NIA, NIH, on 01/07/2019. 

ORI found that Respondent 

intentionally, knowingly, or recklessly 

falsified and/or fabricated Western blot 

and histological image data for chronic 

deep tissue conditions including 

osteoarthritis (OA) and tendinopathy in 

murine models by reusing image data, 

with or without manipulating them to 

conceal their similarities, and falsely 

relabeling them as data representing 

different experiments in fifty (50) 

figures included in sixteen (16) PHS 

grant applications. In the absence of 

reliable image data, the figures, 

quantitative data in associated graphs 

purportedly derived from those images, 

statistical analyses, and related text also 

are false. 

Specifically, ORI found that: 

1. Respondent reused and relabeled 

Western blot images from the same 

source to falsely represent different 

proteins and/or experimental results in: 


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Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices 16755 

• Figure 4B in R01 AR065563–01 and 

R01 AR065563–01A1 and Figure 11 in 

R01 AR069693–01, specifically: 

—‘‘b-actin’’ panel for ‘‘Cartilage’’ and 

‘‘b-actin’’ panel for ‘‘Liver’’ are the 

same 

—‘‘b-actin’’ panel for ‘‘Bone’’ and ‘‘bactin’’ panel for ‘‘Spleen’’ are the 

same 

—‘‘Cited2’’ blot band for Cartilage in 

‘‘WT’’ and ‘‘Sham’’ are the same 

—‘‘Cited2’’ blot band for Bone in ‘‘WT’’ 

and ‘‘Sham’’ are the same 

—‘‘Cited2’’ blot band for Liver in ‘‘WT’’ 

and ‘‘Sham’’ are the same 

—‘‘Cited2’’ blot band for Spleen in 

‘‘WT’’ and ‘‘Sham’’ are the same 

• Figure 2A in R01 AG056623–01 and 

R44 AG065089–01 and Figure 1A in R01 

AR073194–01, specifically: 

—‘‘b-actin’’ panel for ‘‘Cartilage’’ and 

‘‘b-actin’’ panel for ‘‘Liver’’ are the 

same 

—Cited2 blot bands in ‘‘WT’’ and 

‘‘Sham’’ within each of the three 

panels represent Cartilage, Bone, and 

Liver 

2. From Figure 11C in R01 

AR065563–01 and Figure 16 in R01 

AR066009–01, Respondent copied blot 

panels representing rAAV-vector and 

rAAV–GFP in human cartilage explants, 

flipped, resized, added a lane to the left, 

and reused and relabeled the bands to 

falsely represent ‘‘Sham’’ and ‘‘KO’’ 

samples in conditional knock out of 

Cited2 gene in cartilage of adult mice in: 

• Figure 4B in R01 AR065563–01 

• Figure 4B in R01 AR065563–01A1 

• Figure 11 in R01 AR069693–01 

• Figure 2A in R01 AG056623–01 

• Figure 1A in R01 AR073194–01 

• Figure 2A in R44 AG065089–01 

3. Respondent reused and relabeled 

the same photomicrographs of 

supraspinatus tendon tissue from 

tendinopathy rats exposed to different 

experimental conditions in: 

• Figure 2A in R01 AR072038–01 to 

falsely represent overuse 

tendinopathy in rats treated with exADSC–2D (control exosomes) 

• Figure 2A in R01 AG039561–06 to 

falsely represent overuse 

tendinopathy nude rats with placebo 

treatment 

• Figure 4A in R41 AR070695–01 to 

falsely represent overuse 

tendinopathy nude rats with placebo 

treatment 

• Figure 3A in R43 AT009414–01 and 

R43 AT009414–01A1 to falsely 

represent collagenase induced 

Achilles tendinopathy in rats with 

placebo treatment 

4. Respondent reused and relabeled 

the same photomicrographs in: 

• Figure 2A in R01 AR072038–01 to 

falsely represent overuse 

tendinopathy in rats injected with exADSC–3D 

• Figure 1A in R01 AG039561–06 to 

falsely represent collagenase-induced 

tendinopathy in rats injected with 

Cited2 reprogrammed tendon stem/ 

progenitor cells (TSPCs) 

5. Respondent reused and relabeled 

photomicrographs from Figure 2C in 

R01 AR072038–01 representing cleaved 

collagen-1 stained supraspinatus tendon 

of overuse tendinopathy rats injected 

with placebo + ex-ADSC–2D to falsely 

represent: 

• Supraspinatus tendon tissue of 

overuse tendinopathy in rats after 

placebo injection in: 

—Figure 2C in R01 AR072038–01 

—Figure 5D in R41 AG056246–01A1 

—Figure 2B in R01 AG039561–06 

• Achilles tendon tissue of collagenaseinduced tendinopathy rats after 

placebo injection in Figure 3D in R43 

AT009414–01 

6. Respondent reused and relabeled 

photomicrographs of human cartilage 

explants presented in R01 AG069693– 

01. Specifically, Respondent reused 

image panels from R01 AG069693–01: 

• Figure 12A representing NITEGE in 

non-arthritic (non-OA) sample in: 

—Figure 11A in R01 AR065563–01, 

Figure 8A in R01 AG069693–01, 

and Figure 1A in R01 AG056623–01 

to falsely represent NITEGE stained 

non-OA sample 

—Figure 3 in R01 AR070431–01A1 to 

falsely represent IL–1b stained OA 

sample 

• Figure 8A representing ADAMTS5 in 

non-OA and OA samples in: 

—Figure 1A in R01 AG056623–01 to 

falsely represent p16 stained 

samples 

• Figure 8A, two images representing 

matrix metalloproteinase 13 (MMP– 

13) and ADAMTS5 of OA samples in: 

—Figure 3 in R01 AR070431–01A1 to 

falsely represent NLRP3 or cleaved 

caspase 1 

—Figure 1A in R01 AG056623–01 to 

falsely represent p21 and p16 

• Figure 8B, two images in sham or 

destabilization of the medial 

meniscus (DMM) operated mouse 

representing: 

—MMP–13 reused and relabeled in 

Figure 1B in R01 AG056623–01 to 

falsely represent p21 

—ADAMTS5 reused and relabeled in 

Figure 1B in R01 AG056623–01 to 

falsely represent p16 

7. Respondent reused and relabeled 

photomicrographs of non-OA or OA 

human cartilage explants presented in 

Figure 3 in R01 AR070431–01A1 

representing: 

• Cleaved caspase 3 to falsely represent 

b-gal staining in Figure 1A in R01 

AG056623–01 

• NLRP3 or cleaved caspase-1 staining 

of non-OA human cartilage to falsely 

represent p21 and p16 in Figure 1A in 

R01 AG056623–01 

8. Respondent reused and relabeled 

photomicrographs from the following 

published papers to falsely represent 

unrelated experimental results in NIH 

grant applications: 

• Green tea polyphenol treatment is 

chondroprotective, anti-inflammatory 

and palliative in a mouse post-traumatic 

osteoarthritis model. Arthritis Res Ther. 

2014 Dec 17;16(6):508; doi: 10.1186/ 

sl3075–014–0508–y (hereafter referred 

to as ‘‘Arthritis Res Ther. 2014’’). 

Erratum in: Arthritis Res Ther. 2019, Jan 

3;21(1):1; doi: 10.1186/s13075–018– 

1791–9. 

• Curcumin slows osteoarthritis 

progression and relieves osteoarthritisassociated pain symptoms in a posttraumatic osteoarthritis mouse model. 

Arthritis Res Ther. 2016 Jun 3; 

18(1):128; doi: 10.1186/s13075–016– 

1025-y (hereafter referred to as 

‘‘Arthritis Res Ther. 2016’’). 

• Procyanidins Mitigate Osteoarthritis 

Pathogenesis by, at Least in Part, 

Suppressing Vascular Endothelial 

Growth Factor Signaling. Int. J. Mol. Sci. 

2016, 17:2065; doi:10.3390/ 

ijms17122065 (hereafter referred to as 

‘‘Int. J. Mol. Sci. 2016’’). 

Specifically, in: 

• R01 AR070431–01A1, Respondent 

reused an image panel from: 

—Arthritis Res Ther. 2016: 

D Figure 6A representing type II 

collagen cleavage epitope (Col2–3/4 

M) vehicle control and relabeled to 

falsely represent aggrecan cleavage in 

DMM WT in Figure 2E in R01 

AR070431–01A1 

D Figure 6D representing ADAMTS5 

staining of a vehicle control and 

relabeled twice in Figure 2F in R01 

AR070431–01A1 to falsely represent 

IL–1b and cleaved caspase staining 

—Arthritis Res Ther. 2014: 

D Figure 2C representing Col2–3/4 M in 

vehicle treated sham operated mice 

and relabeled twice in Figures 2E and 

2F in R01 AR070431–01A1 to falsely 

represent cleaved caspase and IL–1b 

respectively in sham operated WT 

mice 

D Figure 2C representing Col2–3/4 M in 

epigallocatechin3-gallate (EGCG) 

treated DMM mice in Figure 2E in 

R01 AR070431–01A1 and relabeled to 

falsely represent Col2–3/4 M in Panx1 

KO DMM mice 

D Figure 3A representing cleaved 

aggrecan in sham operated EGCG 


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treated mice and relabeled in Figure 

2E in R01 AR070431–01A1 to falsely 

represent cleaved aggrecan in sham 

operated untreated WT mice 

D Figure 3C representing cleaved 

aggrecan in DMM WT mice treated 

with EGCG and relabeled in Figure 2E 

in R01 AR070431–01A1 to falsely 

represent cleaved aggrecan in DMM 

Panx1 KO mice 

D Figure 4A representing MMP–13 in 

sham operated EGCG treated mice and 

relabeled in Figure 4E in R01 

AR070431–01A1 to falsely represent 

antibody-staining control 

D Figure 4C representing MMP–13 in 

sham operated, vehicle-treated mice 

and relabeled in: 

➢ Figure 2E in R01 AR074802–01 

and R01 AR074802–01A1 to falsely 

represent ADAMTS5 staining in 

Pax1 KO DMM mice 

➢ Figure 2F in R01 AR070431–01A1 

to falsely represent NLRP3 staining 

of Pax1 KO DMM mice 

D Figure 4C representing MMP–13 in 

DMM vehicle treated mice and 

relabeled in: 

➢ Figure 2E in R01 AR074802–01 

and R01 AR074802–01A1 to falsely 

represent MMP–13 in DMM WT 

mice 

➢ Figure 2F in R01 AR070431–01A1 

to falsely represent NLRP3 in DMM 

WT mice 

D Figure 5C representing ADAMTS5 in 

sham operated EGCG treated mouse 

and relabeled twice in Figure 2E in 

R01 AR074802–01 and R01 

AR074802–01A1 to falsely represent 

ADAMTS5 in sham operated WT 

mice 

D Figure 5C representing ADAMTS5 in 

vehicle treated DMM operated mouse 

sample and relabeled twice in Figure 

2E in R01 AR074802–01 and R01 

AR074802–01A1 to falsely represent 

ADAMTS5 in DMM WT mouse 

sample 

D R01 AG056623–01, Respondent 

reused an image panel from: 

—Int.J. Mol. Sci. 2016: 

D Figure 1A representing cartilage from 

‘‘sham’’ wildtype C57BL/6 mice 

treated with oral PBS and relabeled in 

Figure 2B in R01 AG056623–01 to 

falsely represent knee cartilage from 

‘‘sham’’ Col2a1CreERTxCited2fl/fl 

mice injected with corn oil without 

tamoxifen 

—Arthritis Res Ther. 2014: 

D Figure 4A representing MMP–13 in 

vehicle-treated mice 4-weeks post 

DMM surgery and relabeled in: 

➢ Figure 8 in R01 AG056623–01 to 

falsely represent p21 in control 

mice following DMM surgery 

➢ Figure 3 in R01 AG056623–01 to 

falsely represent b-gal in Cited2 KO 

mice 

D Figure 4A representing MMP–13 in 

EGCG -treated mice 4-weeks post 

DMM surgery and relabeled in Figure 

8 in R01 AG056623–01 to falsely 

represent p21 following DMM surgery 

in mice overexpressing Cited2 

D Figure 4C representing MMP–13 in 

vehicle-treated mice 8-weeks post 

sham surgery and relabeled in Figure 

2C in R01 AG056623–01 to falsely 

represent p21 staining in Cited2 KO 

mice following DMM surgery 

D Figure 4C representing MMP–13 in 

EGCG-treated mice 8-weeks post 

DMM surgery and relabeled in Figure 

2C in R01 AG056623–01 to falsely 

represent p21 in oil-injected control 

mice with Cited2 conditional deletion 

in cartilage without Tamoxifen 

D Figure 5A representing ADAMTS5 in 

vehicle-treated DMM-induced OA 

mice and relabeled in: 

➢ Figure 8 in R01 AG056623–01 to 

falsely represent p16 in control 

mice following DMM surgery 

➢ Figure 2C in R01 AG056623–01 to 

falsely represent b-gal in Cited2 KO 

mice 

➢ Figure 3 in R01 AG056623–01 to 

falsely represent b-gal in WT 

control mice with conditional 

deletion of Cited2 in cartilage 

D Figure 5C representing ADAMTS5 in 

vehicle-treated DMM-induced OA 

mice and relabeled in: 

➢ Figure 8 in R01 AG056623–01 to 

falsely represent Cited2 in Citedoverexpressing mice, as well as bgal in control mice following DMM 

surgery 

➢ Figure 2C in R01 AG056623–01 to 

falsely represent p16 staining in 

Cited2 KO mice 

➢ Figure 8 in R01 AG056623–01 to 

falsely represent p16 in control 

mice following DMM surgery 

Respondent neither admits nor denies 

ORI’s findings of research misconduct. 

The parties entered into a Voluntary 

Settlement Agreement (Agreement) to 

conclude this matter without further 

expenditure of time, finances, or other 

resources. The settlement is not an 

admission of liability on the part of the 

Respondent. 

Respondent voluntarily agreed to the 

following: 

(1) Respondent will exclude himself 

voluntarily for a period of four (4) years 

beginning on February 28, 2022 (the 

‘‘Exclusion Period’’) from any 

contracting or subcontracting with any 

agency of the United States Government 

and from eligibility for or involvement 

in nonprocurement or procurement 

transactions referred to as ‘‘covered 

transactions’’ in 2 CFR parts 180 and 

376 (collectively the ‘‘Debarment 

Regulations’’). At the conclusion of the 

Exclusion Period, Respondent agreed to 

have his research supervised for a 

period of four (4) years (the 

‘‘Supervision Period’’). During the 

Supervision Period, prior to the 

submission of an application for PHS 

support for a research project on which 

Respondent’s participation is proposed 

and prior to Respondent’s participation 

in any capacity in PHS-supported 

research, Respondent will submit a plan 

for supervision of Respondent’s duties 

to ORI for approval. The supervision 

plan must be designed to ensure the 

integrity of Respondent’s research. 

Respondent will not participate in any 

PHS-supported research until such a 

supervision plan is approved by ORI. 

Respondent will comply with the 

agreed-upon supervision plan. 

(2) During the Supervision Period, the 

requirements for Respondent’s 

supervision plan are as follows: 

i. A committee of 2–3 senior faculty 

members at the institution who are 

familiar with Respondent’s field of 

research, but not including 

Respondent’s supervisor or 

collaborators, will provide oversight and 

guidance. The committee will review 

primary data from Respondent’s 

laboratory on a quarterly basis and 

submit a report to ORI at six (6) month 

intervals setting forth the committee 

meeting dates and Respondent’s 

compliance with appropriate research 

standards and confirming the integrity 

of Respondent’s research. 

ii. The committee will conduct an 

advance review of each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved. The review will include a 

discussion with Respondent of the 

primary data represented in those 

documents and will include a 

certification to ORI that the data 

presented in the proposed application, 

report, manuscript, or abstract is 

supported by the research record. 

(3) During the Supervision Period, 

Respondent will ensure that any 

institution employing him submits, in 

conjunction with each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved, a certification to ORI that the 

data provided by Respondent are based 

on actual experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported in the application, 

report, manuscript, or abstract. 

(4) If no supervision plan is provided 

to ORI, Respondent will provide 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices 16757 

certification to ORI at the conclusion of 

the Supervision Period that his 

participation was not proposed on a 

research project for which an 

application for PHS support was 

submitted and that he has not 

participated in any capacity in PHSsupported research. 

(5) During the Exclusion and 

Supervision Periods, Respondent will 

exclude himself voluntarily from 

serving in any advisory or consultant 

capacity to PHS including, but not 

limited to, service on any PHS advisory 

committee, board, and/or peer review 

committee. 

Dated: March 21, 2022. 

Wanda K. Jones, 

Acting Director, Office of Research Integrity, 

Office of the Assistant Secretary for Health. 

[FR Doc. 2022–06246 Filed 3–23–22; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Peter Tung at 240–669–5483 or 

peter.tung@nih.gov. Licensing 

information and copies of the patent 

applications listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Rockville, MD 20852; tel. 

301–496–2644. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows: 

Novel Compositions of Matter 

Comprising Stabilized Coronavirus 

Antigens and Their Use 

Description of Technology 

Using a computational design 

methodology, SARS-CoV–2 spike 

proteins containing engineered amino 

acid changes to the receptor binding 

domain (RBD) were designed. These 

engineered spike proteins improved the 

immune response upon immunization 

of animals. An engineered RBD was also 

expressed at greater yield, had increased 

temperature stability, and improved the 

immune response upon immunization 

of animals. Specifically, the disclosed 

RBD designs can be produced 

approximately 7 times more efficiently 

than the native sequence, facilitating 

vaccine manufacturing on a global scale. 

The disclosed designs also have up to 

10 °C higher thermal stability than the 

native sequence, suggesting enhanced 

stability during storage and when in the 

body. Finally, immunization of animals 

with the disclosed antigens produces up 

to 10-fold higher levels of blocking 

antibodies than the native sequence and 

30-fold higher levels of pseudoviral 

neutralizing antibodies. An additional 

RBD protein has been engineered to 

eliminate the need for glycosylation, 

facilitating production and singlecomponent nanoparticle display of the 

antigen. The engineered receptor 

binding domain (RBD) and spike protein 

antigens produce significant 

improvements in pre-clinical animal 

models and may be used to develop 

improved coronavirus vaccines. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications 

• Novel SARS-CoV–2 vaccine. 

• Improved SARS-CoV–2 diagnostics 

using stabilized antigens. 

• Method of designing vaccine 

candidates or stabilized antigens by 

computational. optimization of amino 

acid identity, followed by additional 

sequence comparison and selection 

(Stabilizer for Protein Expression and 

Epitope Design (SPEEDesign)). 

Competitive Advantages 

• Novel SARS-CoV–2 spike vaccine 

with improved breadth and duration of 

protection. 

• Novel RBD monomer and 

nanoparticle designs that are more 

immunogenic and stable than the 

naturally occurring RBD sequence. 

• Computational method of designing 

vaccine antigens. 

Development Stage 

• Pre-clinical testing of the novel 

immunogens in non-human primates. 

Inventors: Dr. Niraj Tolia and Dr. 

Thayne Dickey, both of NIAID. 

Publications: ‘‘Design of the SARSCoV–2 RBD vaccine antigen improves 

neutralizing antibody response’’, 

https://doi.org/10.1101/2021.05.09.

443238. 

Intellectual Property: HHS Reference 

No. E–045–2021–0–US–01—U.S. 

Provisional Application No. 63/200,194, 

filed February 18, 2021; PCT/US2022/ 

070744, filed February 1, 2022 

Licensing Contact: To license this 

technology, please contact Peter Tung at 

240–669–5483 or peter.tung@nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize the invention. For 

collaboration opportunities, please 

contact Peter Tung at 240–669–5483; 

peter.tung@nih.gov. 

Dated: March 17, 2022. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2022–06174 Filed 3–23–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Antimicrobial Resistant Infections. 

Date: April 19, 2022. 


khammond on DSKJM1Z7X2PROD with NOTICES