Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Notices 41855 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Improved Live-Attenuated 

Vaccine for Respiratory Syncytial Virus 

AGENCY: National Institutes of Health. 

ACTION: Notice. 

SUMMARY: The National Institute of 

Allergy and Infectious Diseases, an 

institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Commercialization 

Patent License to practice the inventions 

embodied in the Patents and Patent 

Applications listed in the Summary 

Information section of this notice to 

Codagenix, Inc. (Codagenix), having a 

place of business in Farmingdale, New 

York, U.S.A. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Institute of 

Allergy and Infectious Diseases’ 

Technology Transfer and Intellectual 

Property Office on or before August 18, 

2021 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

Exclusive Commercialization Patent 

License should be directed to: Peter 

Soukas, Technology Transfer and Patent 

Specialist, Technology Transfer and 

Intellectual Property Office, National 

Institute of Allergy and Infectious 

Diseases, National Institutes of Health; 

Email: ps193c@nih.gov; Telephone: 

(301) 496–2644; Facsimile: (240) 627– 

3117. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

U.S. Provisional Patent Application 

Number 63/023,949, filed May 13, 2020 

and PCT Patent Application Number 

PCT/US2021/32305, filed May 13, 2021, 

entitled ‘‘Improved Live-Attenuated 

Vaccine for Respiratory Syncytial Virus 

(RSV) Bearing Codon-Pair Deoptimized 

NS1, NS2, N, P, M and SH Genes and 

Additional Point Mutations in the P 

Gene,’’ [HHS Reference No. E–104– 

2020–0]; and U.S. and foreign patent 

applications claiming priority to the 

aforementioned applications. 

The patent rights in this invention 

have been assigned to the Government 

of the United States of America. 

The prospective exclusive licensed 

territory may be worldwide, and the 

field of use may be limited to: ‘‘Liveattenuated codon-deoptimized human 

respiratory syncytial virus vaccine.’’ 

RSV is the most important viral agent 

of severe respiratory disease in infants 

and young children worldwide and also 

causes substantial morbidity and 

mortality in older adults. RSV is 

estimated to cause more than 33 million 

lower respiratory tract illnesses, three 

million hospitalizations, and nearly 

200,000 childhood deaths worldwide 

annually, with many deaths occurring 

in developing countries. However, 

despite the prevalence of RSV and the 

dangers associated with infection, no 

RSV vaccine has been successfully 

developed to date. Accordingly, there is 

a public health need for RSV vaccines. 

This vaccine candidate comprises live 

RSV that was attenuated by subjecting 

the protein-coding sequences of the 

viral NS1, NS2, N, P, M, and SH genes 

to codon-pair deoptimization, which 

resulted in many nucleotide 

substitutions that were silent at the 

amino acid level but conferred 

attenuation. In addition, specific amino 

acid substitutions were identified and 

introduced into the P protein that 

improved attenuation and genetic 

stability. Genetic stability was 

confirmed in vitro, and attenuation was 

confirmed in experimental animals. 

This live-attenuated RSV vaccine is 

designed to be administered intranasally 

by drops or spray to infants and young 

children. Based on experience with 

other live-attenuated RSV vaccine 

candidates, the present candidates are 

anticipated to be well tolerated in 

humans and are available for clinical 

evaluation. The National Institute of 

Allergy and Infectious Diseases has 

extensive experience and capability in 

evaluating live-attenuated RSV vaccine 

candidates in pediatric clinical studies. 

This notice is made in accordance 

with 35 U.S.C. 209 and 37 CFR part 404. 

The prospective exclusive license will 

be royalty bearing, and the prospective 

exclusive license may be granted unless 

within fifteen (15) days from the date of 

this published notice, the National 

Institute of Allergy and Infectious 

Diseases receives written evidence and 

argument that establishes that the grant 

of the license would not be consistent 

with the requirements of 35 U.S.C. 209 

and 37 CFR part 404. 

Complete applications for a license in 

the prospective field of use that are 

timely filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive patent 

commercialization license. In response 

to this Notice, the public may file 

comments or objections. Comments and 

objections, other than those in the form 

of a license application, will not be 

treated confidentially, and may be made 

publicly available. License applications 

submitted in response to this Notice 

will be presumed to contain business 

confidential information, and any 

release of information in these license 

applications will be made only as 

required and upon a request under the 

Freedom of Information Act, 5 U.S.C. 

552. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2021–16462 Filed 8–2–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA–2021–0016; OMB No. 

1660–0086] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; National Flood 

Insurance Program—Mortgage 

Portfolio Protection Program (MPPP); 

Ask the Advocate Web Form 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security. 

ACTION: 30-Day notice of revision and 

request for comments. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA), as part of 

its continuing effort to reduce 

paperwork and respondent burden, 

invites the general public to take this 

opportunity to comment on a revision of 

a previously approved information 

collection for which approval has 

expired. FEMA will submit the 

information collection abstracted below 

to the Office of Management and Budget 

for review and clearance in accordance 

with the Paperwork Reduction Act of 

1995, this notice seeks comments 

concerning an amendment to a 

currently-approved collection of 

information related to the National 

Flood Insurance Program (NFIP), 

Mortgage Portfolio Protection Program 

(MPPP), which is an option that 

companies participating in the National 

Flood Insurance Program can use to 

bring their mortgage loan portfolios into 

compliance with the flood insurance 

purchase requirements. This amended 

notice seeks comments concerning the 

collection of information related to the 

Office of the Flood Insurance Advocate 

(OFIA). 

DATES: Comments must be submitted on 

or before September 2, 2021. 


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