83 FR 24318 - Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 102 (May 25, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 102 (May 25, 2018)
| Page Range | 24318-24319 | |
| FR Document | 2018-11257 |
[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)] [Notices] [Pages 24318-24319] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11257] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines AGENCY: National Institute of Allergy and Infectious Diseases, National Institutes of Health, Public Health Service, DHHS. 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 to Fundacao Butantan, having a place of business in Sao Paulo, Brazil. DATES: Only written comments and/or application for a license which are received by the NIAID Technology Transfer and Intellectual Property Office on or before June 25, 2018 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials 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,'' Whitehead et al., and PCT Patent Application Number PCT/US2017/0021989, filed March 11, 2017 and entitled ``Live Attenuated Zika Virus Vaccines,'' Whitehead et al. [HHS Reference E-118-2016/0]; and U.S. and foreign patent applications claiming priority to the aforementioned applications. The patent rights in these inventions have been assigned to the government of the United States of America. [[Page 24319]] The field of use may be limited to monovalent live attenuated Zika vaccines and multivalent live attenuated flavivirus vaccines. The Licensed Territory may be limited to the United States of America, Canada, Mexico, Brazil and Argentina. 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. While important, current measures for mosquito control are insufficient in most settings to prevent the spread of the 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 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 filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Commercialization Patent License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: May 14, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018-11257 Filed 5-24-18; 8:45 am] BILLING CODE 4140-01-P
![24318 Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
the need for childhood vaccination DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
products that result in fewer or no HUMAN SERVICES HUMAN SERVICES
significant adverse reactions; surveying
federal, state, and local programs and National Institutes of Health National Institutes of Health
activities related to gathering
Clinical Center; Notice of Closed Prospective Grant of Exclusive
information on injuries associated with
Meeting License: Production of Monovalent
the administration of childhood
Live Attenuated Zika Vaccines and
vaccines, including the adverse reaction Multivalent Live Attenuated Flavivirus
Pursuant to section 10(d) of the
reporting requirements of section 2125 Vaccines
Federal Advisory Committee Act, as
(b) of the PHS Act; advising the
amended, notice is hereby given of a AGENCY: National Institute of Allergy
Secretary on the methods of obtaining,
meeting of the Board of Scientific and Infectious Diseases, National
compiling, publishing, and using
Counselors of the NIH Clinical Center. Institutes of Health, Public Health
credible data related to the frequency
and severity of adverse reactions The meeting will be closed to the Service, DHHS.
associated with childhood vaccines; public as indicated below in accordance ACTION: Notice.
consulting on the development or with the provisions set forth in section
revision of Vaccine Information 552b(c)(6), Title 5 U.S.C., as amended SUMMARY: The National Institute of
Statements; and recommending to the for the review, discussion, and Allergy and Infectious Diseases, an
Director of the National Vaccine evaluation of individual intramural institute of the National Institutes of
Program research related to vaccine programs and projects conducted by the Health, Department of Health and
CLINICAL CENTER, including Human Services, is contemplating the
injuries which should be conducted to
consideration of personnel grant of an Exclusive Commercialization
carry out the VICP.
qualifications and performance, and the Patent License to practice the inventions
Agenda: During the June 15, 2018, embodied in the Patents and Patent
competence of individual investigators,
meeting, agenda items may include Applications listed in the Summary
the disclosure of which would
updates from DICP, Department of Information section of this notice to to
constitute a clearly unwarranted
Justice (DOJ), National Vaccine Program Fundacao Butantan, having a place of
invasion of personal privacy.
Office (NVPO), Immunization Safety business in Sao Paulo, Brazil.
Office (Centers for Disease Control and Name of Committee: Board of Scientific DATES: Only written comments and/or
Prevention), National Institute of Counselors of the NIH Clinical Center Board application for a license which are
Allergy and Infectious Diseases meeting. received by the NIAID Technology
(National Institutes of Health) and Date: June 15, 2018. Transfer and Intellectual Property Office
Center for Biologics, Evaluation and Time: 8:00 a.m. to 4:00 p.m.
on or before June 25, 2018 will be
Agenda: To review and evaluate reports
Research (Food and Drug considered.
and responses to the following Clinic
Administration). Information about the ADDRESSES: Requests for a copy of the
Center’s Departments: Rehabilitation
ACCV, a roster of members, the meeting Medicine, Bioethics, Critical Care Medicine, patent application, inquiries, comments
agenda, as well as past meeting Imaging Sciences, Transfusion Medicine, and other materials relating to the
summaries, is located on the ACCV Laboratory Medicine, Nursing, and contemplated Exclusive
website: http://www.hrsa.gov/ Pediatrics. Commercialization Patent License
advisorycommittees/childhoodvaccines/ Place: National Institutes of Health, should be directed to: Peter Soukas,
index.html. Agenda items are subject to Building 10, 10 Center Drive, Bethesda, MD Technology Transfer and Patent
change as priorities dictate. 20892. Specialist, Technology Transfer and
Public Participation: Members of the Contact Person: John I. Gallin, M.D., Intellectual Property Office, National
public will have the opportunity to Associate Director for Clinical Research, Institute of Allergy and Infectious
provide comments. Oral comments will Office of Director, NIH Clinical Center, 1 Diseases, National Institutes of Health,
Center Drive, Room 201, Bethesda, MD 5601 Fishers Lane, Suite 6D, Rockville,
be honored in the order they are
20892, 301–827–5428. MD 20852–9804; Email: ps193c@
requested and may be limited as time
allows. Requests to make oral comments Any interested person may file written nih.gov; Telephone: (301) 496–2644;
or provide written comments to the comments with the committee by forwarding Facsimile: (240) 627–3117.
the statement to the Contact Person listed on SUPPLEMENTARY INFORMATION:
ACCV should be sent to Annie Herzog
this notice. The statement should include the
by June 5, 2018. Individuals who plan name, address, telephone number and when Intellectual Property
to participate and need special applicable, the business or professional
assistance, such as sign language U.S. Provisional Patent Application
affiliation of the interested person. Number 62/307,170, filed March 11,
interpretation or other reasonable
Dated: May 18, 2018. 2016 and entitled ‘‘Live Attenuated Zika
accommodations, should notify Annie
Michelle D. Trout, Virus Vaccines,’’ Whitehead et al., and
Herzog, using the address and phone PCT Patent Application Number PCT/
number above at least 10 days prior to Program Analyst, Office of Federal Advisory
Committee Policy.
US2017/0021989, filed March 11, 2017
the meeting. and entitled ‘‘Live Attenuated Zika
[FR Doc. 2018–11212 Filed 5–24–18; 8:45 am]
Amy P. McNulty, Virus Vaccines,’’ Whitehead et al. [HHS
amozie on DSK3GDR082PROD with NOTICES1
BILLING CODE 4140–01–P Reference E–118–2016/0]; and U.S. and
Acting Director, Division of the Executive
Secretariat. foreign patent applications claiming
[FR Doc. 2018–11298 Filed 5–24–18; 8:45 am]
priority to the aforementioned
applications.
BILLING CODE 4165–15–P
The patent rights in these inventions
have been assigned to the government of
the United States of America.
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![Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices 24319
The field of use may be limited to exclusive license may be granted unless Institute on Drug Abuse, National Institutes
monovalent live attenuated Zika within thirty (30) days from the date of of Health, DHHS, 6001 Executive Boulevard,
vaccines and multivalent live attenuated this published notice, the National Room 4238, MSC 9550, Bethesda, MD 20892,
301–827–5820, hiromi.ono@nih.gov.
flavivirus vaccines. The Licensed Institute of Allergy and Infectious
Territory may be limited to the United Diseases receives written evidence and Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; NIH
States of America, Canada, Mexico, argument that establishes that the grant Pathway to Independence Award (K99/R00).
Brazil and Argentina. of the license would not be consistent Date: June 25, 2018.
Zika virus (ZIKV) is an emerging with the requirements of 35 U.S.C. 209 Time: 12:00 p.m. to 5:00 p.m.
infectious disease that was first and 37 CFR part 404. Agenda: To review and evaluate grant
identified in 1947, and that has more Complete applications for a license in applications.
recently become a major public health the prospective field of use that are filed Place: National Institutes of Health,
threat around the world. ZIKV has in response to this notice will be treated Neuroscience Center, 6001 Executive
recently been shown to cause as objections to the grant of the Boulevard, Rockville, MD 20852 (Telephone
devastating neurological damage in contemplated Exclusive Conference Call).
infants and serious complications in Contact Person: Susan O. McGuire, Ph.D.,
Commercialization Patent License Scientific Review Officer, Office of
adults in some cases, and may have Agreement. Comments and objections Extramural Policy and Review, National
other effects that have not yet been submitted to this notice will not be Institute on Drug Abuse, National Institutes
identified or definitively linked to the made available for public inspection of Health, DHHS, 6001 Executive Blvd.,
virus. There are no treatments or and, to the extent permitted by law, will Room 4245, Rockville, MD 20852, (301) 827–
vaccines for this insidious virus. While not be released under the Freedom of 5817, mcguireso@mail.nih.gov.
important, current measures for Information Act, 5 U.S.C. 552. (Catalogue of Federal Domestic Assistance
mosquito control are insufficient in Program Nos.: 93.279, Drug Abuse and
Dated: May 14, 2018.
most settings to prevent the spread of Addiction Research Programs, National
the virus. Recommendations that Suzanne M. Frisbie, Institutes of Health, HHS)
women who live in or travel to endemic Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute Dated: May 21, 2018.
areas avoid pregnancy for long periods Natasha M. Copeland,
of Allergy and Infectious Diseases.
of time are unrealistic, particularly in
[FR Doc. 2018–11257 Filed 5–24–18; 8:45 am] Program Analyst, Office of Federal Advisory
contexts where access to reproductive Committee Policy.
services is limited, and threaten to leave BILLING CODE 4140–01–P
[FR Doc. 2018–11220 Filed 5–24–18; 8:45 am]
those most likely to suffer the
BILLING CODE 4140–01–P
devastating consequences of Zika
without effective protection. There is DEPARTMENT OF HEALTH AND
therefore urgent need to develop HUMAN SERVICES
DEPARTMENT OF HEALTH AND
biomedical interventions in parallel National Institutes of Health HUMAN SERVICES
with ongoing public health efforts
against ZIKV. National Institute on Drug Abuse; National Institutes of Health
No vaccine exists today to prevent Notice of Closed Meetings
ZIKV infections. The methods and National Institute on Drug Abuse;
compositions of this invention provide Pursuant to section 10(d) of the Notice of Closed Meetings
a means for prevention of ZIKV Federal Advisory Committee Act, as
infection by immunization with live amended, notice is hereby given of the Pursuant to section 10(d) of the
attenuated, immunogenic viral vaccines following meetings. Federal Advisory Committee Act, as
against ZIKV and/or Dengue virus. The meetings will be closed to the amended, notice is hereby given of the
Many entities, governmental, public in accordance with the following meetings.
academic, and commercial, are actively provisions set forth in sections The meetings will be closed to the
pursuing development of ZIKV vaccines 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., public in accordance with the
each using a different approach to as amended. The grant applications and provisions set forth in sections
address this public health need. The the discussions could disclose 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
U.S. Government is coordinating its confidential trade secrets or commercial as amended. The contract proposals and
vaccine development response to ZIKV property such as patentable material, the discussions could disclose
and has published this plan at https:// and personal information concerning confidential trade secrets or commercial
www.phe.gov/Preparedness/planning/ individuals associated with the grant property such as patentable material,
Pages/zika-white-paper.aspx. applications, the disclosure of which and personal information concerning
Vaccine development approaches for would constitute a clearly unwarranted individuals associated with the contract
ZIKV include but are not limited to invasion of personal privacy. proposals, the disclosure of which
inactivated virus (dead virus), live would constitute a clearly unwarranted
Name of Committee: National Institute on
attenuated virus (weakened virus), Drug Abuse Special Emphasis Panel;
invasion of personal privacy.
recombinant viral vectors (weakened Summer Research Education Experience Name of Committee: National Institute on
virus with target genes added), and Programs (R25). Drug Abuse Special Emphasis Panel; SBIR
subunit (portion of a virus) as well as Date: June 21, 2018. Phase II ‘‘Analytical Tools for Scholarly
mRNA- and DNA-based (gene-targeted). Time: 12:00 p.m. to 1:30 p.m. Research Assessment and Decision in the
These various strategies provide Agenda: To review and evaluate grant Biomedical Enterprise’’ (1214, 1217).
amozie on DSK3GDR082PROD with NOTICES1
multiple redundancies, expanded applications. Date: May 31, 2018.
Place: National Institutes of Health, Time: 11:00 a.m. to 1:00 p.m.
choice, and ensure short and long term Neuroscience Center, 6001 Executive Agenda: To review and evaluate contract
maximal benefits to the public. Boulevard, Rockville, MD 20852 (Telephone proposals.
This notice is made in accordance Conference Call). Place: National Institutes of Health,
with 35 U.S.C. 209 and 37 CFR part 404. Contact Person: Hiromi Ono, Ph.D., Neuroscience Center, 6001 Executive
The prospective exclusive license will Scientific Review Officer, Office of Boulevard, Rockville, MD 20852 (Telephone
be royalty bearing, and the prospective Extramural Policy and Review, National Conference Call).
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Document Created: 2018-05-25 02:13:17
Document Modified: 2018-05-25 02:13:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Only written comments and/or application for a license which are received by the NIAID Technology Transfer and Intellectual Property Office on or before June 25, 2018 will be considered. | |
| FR Citation | 83 FR 24318 |
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