Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65697 

ps193c@nih.gov; Telephone: (301) 496– 

2644; Facsimile: (240) 627–3117. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

U.S. Provisional Patent Application 

Number 62/307,170, filed March 11, 

2016 and entitled ‘‘Live Attenuated Zika 

Virus Vaccines,’’ [HHS Reference No. E– 

118–2016–0–US–01]; PCT Patent 

Application Number PCT/US2017/ 

0021989, filed March 11, 2017 and 

entitled ‘‘Live Attenuated Zika Virus 

Vaccines,’’ [HHS Reference No. E–118– 

2016–0–PCT–02]; Indian Patent 

Application Number 201817036778 

filed September 28, 2018 and entitled 

‘‘Live Attenuated Zika Virus Vaccines,’’ 

[HHS Reference No. E–118–2016–0–IN– 

09]; 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 co-exclusive licensed 

territory may be limited to India, and 

the field of use may be limited to: 

‘‘Monovalent live attenuated Zika 

vaccines and multivalent live attenuated 

flavivirus vaccines.’’ 

Zika virus (ZIKV) is an emerging 

infectious disease that was first 

identified in 1947, and that has more 

recently become a major public health 

threat around the world. ZIKV has 

recently been shown to cause 

devastating neurological damage in 

infants and serious complications in 

adults in some cases, and may have 

other effects that have not yet been 

identified or definitively linked to the 

virus. There are no treatments or 

vaccines for this insidious virus. 

Recommendations that women who live 

in or travel to endemic areas avoid 

pregnancy for long periods of time are 

unrealistic, particularly in contexts 

where access to reproductive services is 

limited, and threaten to leave those 

most likely to suffer the devastating 

consequences of Zika without effective 

protection. There is therefore urgent 

need to develop biomedical 

interventions in parallel with ongoing 

public health efforts against ZIKV. 

No vaccine exists today to prevent 

ZIKV infections. The methods and 

compositions of this invention provide 

a means for prevention of ZIKV 

infection by immunization with live 

attenuated, immunogenic viral vaccines 

against ZIKV and/or Dengue virus. 

Many entities, governmental, 

academic, and commercial, are actively 

pursuing development of ZIKV vaccines 

each using a different approach to 

address this public health need. The 

U.S. Government is coordinating its 

vaccine development response to ZIKV 

and has published this plan at https:// 

www.phe.gov/Preparedness/planning/ 

Pages/zika-white-paper.aspx. 

Vaccine development approaches for 

ZIKV include but are not limited to 

inactivated virus (dead virus), live 

attenuated virus (weakened virus), 

recombinant viral vectors (weakened 

virus with target genes added), and 

subunit (portion of a virus) as well as 

mRNA- and DNA-based (gene-targeted). 

These various strategies provide 

multiple redundancies, expanded 

choice, and ensure short and long term 

maximal benefits to the public. 

This notice is made in accordance 

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

The prospective co-exclusive license 

will be royalty bearing, and the 

prospective co-exclusive license may be 

granted unless within thirty (30) 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 licenses 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 co-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. 

Dated: December 11, 2018, 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–27672 Filed 12–20–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Production of Monovalent 

Live Attenuated Zika Vaccines and 

Multivalent Live Attenuated Zika and 

Dengue Vaccines 

AGENCY: National Institutes of Health, 

HHS. 

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 

Fundacao Butantan (Butantan), having a 

place of business in Sao Paulo, Brazil. 

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 January 22, 

2019 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, 

5601 Fishers Lane, Suite 6D, Rockville, 

MD 20852–9804; Email: ps193c@

nih.gov; Telephone: (301) 496–2644; 

Facsimile: (240) 627–3117. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

U.S. Provisional Patent Application 

Number 62/307,170, filed March 11, 

2016 and entitled ‘‘Live Attenuated Zika 

Virus Vaccines,’’ [HHS Reference No. E– 

118–2016–0–US–01]; PCT Patent 

Application Number PCT/US2017/ 

0021989, filed March 11, 2017 and 

entitled ‘‘Live Attenuated Zika Virus 

Vaccines,’’ [HHS Reference No. E–118– 

2016–0–PCT–02]; U.S. Patent 

Application Number 16/083,652 filed 

September 10, 2018 and entitled ‘‘Live 

Attenuated Zika Virus Vaccines,’’ [HHS 

Reference No. E–118–2016–0–US–14]; 

Canadian Patent Application Number 

3016697 filed March 11, 2017 and 

entitled ‘‘Live Attenuated Zika Virus 

Vaccines,’’ [HHS Reference No. E–118– 


amozie on DSK3GDR082PROD with NOTICES1
65698 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

2016–0–CA–05]; Mexican Patent 

Application Number MX/A/2018/ 

010958 filed March 11, 2017 and 

entitled ‘‘Live Attenuated Zika Virus 

Vaccines,’’ [HHS Reference No. E–118– 

2016–0–MX–12]; Brazilian Patent 

Application Number 1120180683426 

filed September 11, 2018 and entitled 

‘‘Live Attenuated Zika Virus Vaccines,’’ 

[HHS Reference No. E–118–2016–0–BR– 

04]; Colombian Patent Application 

Number NC2018/0010874 filed March 

11, 2017 and entitled ‘‘Live Attenuated 

Zika Virus Vaccines,’’ [HHS Reference 

No. E–118–2016–0–CO–07]; 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 limited to the United 

States of America, Canada, Mexico, 

Brazil and Colombia, and the field of 

use may be limited to: ‘‘Monovalent live 

attenuated Zika vaccines and 

multivalent live attenuated flavivirus 

vaccines.’’ 

Zika virus (ZIKV) is an emerging 

infectious disease that was first 

identified in 1947, and that has more 

recently become a major public health 

threat around the world. ZIKV has 

recently been shown to cause 

devastating neurological damage in 

infants and serious complications in 

adults in some cases, and may have 

other effects that have not yet been 

identified or definitively linked to the 

virus. There are no treatments or 

vaccines for this insidious virus. 

Recommendations that women who live 

in or travel to endemic areas avoid 

pregnancy for long periods of time are 

unrealistic, particularly in contexts 

where access to reproductive services is 

limited, and threaten to leave those 

most likely to suffer the devastating 

consequences of Zika without effective 

protection. There is therefore urgent 

need to develop biomedical 

interventions in parallel with ongoing 

public health efforts against ZIKV. 

No vaccine exists today to prevent 

ZIKV infections. The methods and 

compositions of this invention provide 

a means for prevention of ZIKV 

infection by immunization with live 

attenuated, immunogenic viral vaccines 

against ZIKV and/or Dengue virus. 

Many entities, governmental, 

academic, and commercial, are actively 

pursuing development of ZIKV vaccines 

each using a different approach to 

address this public health need. The 

U.S. Government is coordinating its 

vaccine development response to ZIKV 

and has published this plan at https:// 

www.phe.gov/Preparedness/planning/ 

Pages/zika-white-paper.aspx. 

Vaccine development approaches for 

ZIKV include but are not limited to 

inactivated virus (dead virus), live 

attenuated virus (weakened virus), 

recombinant viral vectors (weakened 

virus with target genes added), and 

subunit (portion of a virus) as well as 

mRNA- and DNA-based (gene-targeted). 

These various strategies provide 

multiple redundancies, expanded 

choice, and ensure short and long term 

maximal benefits to the public. 

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 thirty (30) 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 licenses 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. 

Dated: December 11, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–27673 Filed 12–20–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Technology Transfer Centers 

(TTC) Network Program Monitoring— 

NEW 

The Substance Abuse and Mental 

Health Administration’s (SAMHSA) will 

monitor program performance of its 

Technology Transfer Centers (TTCs). 

The TTCs disseminate current 

behavioral health and HIV services 

research from the National Institute on 

Drug Abuse, National Institute on 

Alcohol Abuse and Alcoholism, 

National Institute of Mental Health, 

Agency for Healthcare Research and 

Quality National Institute of Justice, and 

other sources, as well as other SAMHSA 

programs. To accomplish this, the TTCs 

develop and update state-of-the-art, 

research-based curricula and 

professional development training. 

The TTCs hold a variety of events: 

technical assistance events, meetings, 

trainings, and learning collaboratives. A 

TTC technical assistance event is 

defined as a jointly planned 

consultation generally involving a series 

of contacts between the TTC and an 

outside organization/institution during 

which the TTC provides expertise and 

gives direction toward resolving a 

problem or improving conditions. 

Technical assistance events can be 

categorized into universal, targeted and 

intensive. Other TTC events such as 

meetings, training, strategic planning 

and learning collaboratives are utilized 

to support technical assistance. These 

events are TTC-sponsored or cosponsored events in which a group of 

people representing one or more 

agencies other than the TTC work 

cooperatively on a project, problem, 

and/or policy. 

SAMHSA intends to use five (5) 

instruments for program monitoring of 

TTC events as well as ongoing quality 

improvement, which are described 

below. 

1. Event Description Form (EDF): The 

EDF collects event information. This 

instrument asks approximately 10 

questions of TTC faculty/staff relating to 

the event focus and format. It allows the 

TTCs and SAMHSA to track the number 

of events held (See Attachment 1). 

2. TTC Post Event Form—Domestic: 

The Post Event Form—Domestic will be 

administered immediately following the 

event. It asks approximately 11 

questions of each individual that 

participated in the event (Attachment 

2). The instrument asks the participants 


amozie on DSK3GDR082PROD with NOTICES1