81 FR 81149 - Government-Owned Invention; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 222 (November 17, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 222 (November 17, 2016)
| Page Range | 81149-81149 | |
| FR Document | 2016-27676 |
[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)] [Notices] [Page 81149] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27676] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Invention; 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 in the U.S. 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: Licensing information 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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished scientific data. SUPPLEMENTARY INFORMATION: Technology description follows. Polyvalent Influenza Virus-Like Particles (VLPs) and Use as Vaccines Description of Technology: This virus-like particle (VLP) vaccine technology for influenza viruses, based on a mixture of VLPs expressing the hemagglutinin protein or the neuraminidase protein from influenza virus strains belonging to different virus subtypes, has demonstrated broad protection against lethal challenge in mice with various influenza virus strains and virus subtypes. Results from ferret and mouse studies demonstrate broad heterosubtypic protection against various influenza virus subtypes further supporting and strengthening the proposed application of this technology as a universal influenza virus vaccine. 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:Vaccines Competitive Advantages: Broad/universal protection against influenza viruses does not require reformulating vaccine each year as is currently necessary with vaccines available on the market can potentially provide protection against novel influenza viruses that may arise in the future, including potentially pandemic influenza viruses Inventors: Dr. Jeffery Taubenberger of NIAID. Publications: Schwartzman, et al. An Intranasal Virus-Like Particle Vaccine Broadly Protects Mice from Multiple Subtypes of Influenza A Virus. 2015. MBio. 6(4): e01044-15. Intellectual Property: HHS Reference No. E-195-2014, U.S. Provisional Application No. 62/014,814; PCT/US2015/029843. Licensing Contact: Dr. Jenish Patel, (240) 669-2894, [email protected]. 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 this invention, especially for GMP manufacture and clinical evaluation. For collaboration opportunities, please contact Dr. Jenish Patel, (240) 669-2894, [email protected]. Dated: November 14, 2016. Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2016-27676 Filed 11-16-16; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices 81149
or requirements that members of the expeditious commercialization of Application No. 62/014,814; PCT/
public submit reports, keep records, or results of federally-funded research and US2015/029843.
provide information to a third party. development. Foreign patent Licensing Contact: Dr. Jenish Patel,
Section 3506(c)(2)(A) of the PRA applications are filed on selected (240) 669–2894, jenish.patel@nih.gov.
requires federal agencies to publish a inventions to extend market coverage Collaborative Research Opportunity:
60-day notice in the Federal Register for companies and may also be available The National Institute of Allergy and
concerning each proposed collection of for licensing. Infectious Diseases is seeking statements
information, including each proposed FOR FURTHER INFORMATION CONTACT:
of capability or interest from parties
extension or reinstatement of an existing Licensing information may be obtained interested in collaborative research to
collection of information, before by communicating with the indicated further develop, evaluate or
submitting the collection to OMB for licensing contact at the Technology commercialize this invention, especially
approval. To comply with this Transfer and Intellectual Property for GMP manufacture and clinical
requirement, CMS is publishing this Office, National Institute of Allergy and evaluation. For collaboration
notice. Infectious Diseases, 5601 Fishers Lane, opportunities, please contact Dr. Jenish
Rockville, MD 20852; tel. 301–496– Patel, (240) 669–2894, jenish.patel@
Information Collection nih.gov.
2644. A signed Confidential Disclosure
1. Type of Information Collection Agreement will be required to receive Dated: November 14, 2016.
Request: Extension of a currently copies of unpublished scientific data. Suzanne Frisbie,
approved collection; Title of Deputy Director, Technology Transfer and
SUPPLEMENTARY INFORMATION:
Information Collection: Medicare/ Intellectual Property Office, National Institute
Technology description follows.
Medicaid Demonstration/Model of Allergy and Infectious Diseases.
Application; Use: The application is Polyvalent Influenza Virus-Like [FR Doc. 2016–27676 Filed 11–16–16; 8:45 am]
used for solicitation of proposals that Particles (VLPs) and Use as Vaccines BILLING CODE 4140–01–P
are either congressionally mandated or Description of Technology: This virus-
Administration high priority like particle (VLP) vaccine technology
demonstration initiatives which would for influenza viruses, based on a DEPARTMENT OF HEALTH AND
be used to strengthen and modernize the mixture of VLPs expressing the HUMAN SERVICES
Medicare and/or Medicaid programs. hemagglutinin protein or the
The standardized proposal format is not National Institutes of Health
neuraminidase protein from influenza
controversial and will reduce burden on virus strains belonging to different virus
applicants and reviewers. Responses are National Institute of Allergy and
subtypes, has demonstrated broad Infectious Diseases; Notice of Closed
strictly voluntary. The standard format protection against lethal challenge in
will enable CMS to select proposals that Meetings
mice with various influenza virus
meet CMS objectives and show the best strains and virus subtypes. Results from Pursuant to section 10(d) of the
potential for success. Form Number: ferret and mouse studies demonstrate Federal Advisory Committee Act, as
CMS–10069 (OMB control number: broad heterosubtypic protection against amended (5 U.S.C. App.), notice is
0938–0880); Frequency: Once; Affected various influenza virus subtypes further hereby given of the following meetings.
Public: Private sector—Business or other supporting and strengthening the The meetings will be closed to the
for-profits and Not-for-profit proposed application of this technology public in accordance with the
institutions; Number of Respondents: as a universal influenza virus vaccine. provisions set forth in sections
75; Total Annual Responses: 75; Total This technology is available for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Annual Hours: 6,000. (For policy licensing for commercial development as amended. The grant applications and
questions regarding this collection in accordance with 35 U.S.C. 209 and 37 the discussions could disclose
contact John Amoh at 410–786–4910). CFR part 404, as well as for further confidential trade secrets or commercial
Dated: November 10, 2016. development and evaluation under a property such as patentable material,
William N. Parham, III, research collaboration. and personal information concerning
Director, Paperwork Reduction Staff, Office Potential Commercial Applications: individuals associated with the grant
of Strategic Operations and Regulatory • Vaccines applications, the disclosure of which
Affairs. Competitive Advantages: would constitute a clearly unwarranted
[FR Doc. 2016–27550 Filed 11–16–16; 8:45 am] • Broad/universal protection against invasion of personal privacy.
BILLING CODE 4120–01–P influenza viruses Name of Committee: National Institute of
• does not require reformulating Allergy and Infectious Diseases Special
vaccine each year as is currently Emphasis Panel; ‘‘Advancing HIV
DEPARTMENT OF HEALTH AND necessary with vaccines available on the Therapeutic Vaccine Science (U01)’’.
Date: December 12, 2016.
HUMAN SERVICES market
Time: 10:00 a.m. to 4:00 p.m.
• can potentially provide protection Agenda: To review and evaluate grant
National Institutes of Health against novel influenza viruses that may applications.
arise in the future, including potentially Place: National Institutes of Health, 5601
Government-Owned Invention; pandemic influenza viruses Fishers Lane, Rockville, MD 20892
Availability for Licensing Inventors: Dr. Jeffery Taubenberger of (Telephone Conference Call).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: National Institutes of Health, NIAID. Contact Person: Jay R. Radke, Ph.D., AIDS
Publications: Schwartzman, et al. An Review Branch, Scientific Review Program,
HHS. Division of Extramural Activities, Room
ACTION: Notice. Intranasal Virus-Like Particle Vaccine #3G11B, National Institutes of Health, NIAID,
Broadly Protects Mice from Multiple 5601 Fishers Lane MSC–9823, Bethesda, MD
SUMMARY: The invention listed below is Subtypes of Influenza A Virus. 2015. 20892–9823, (240) 669–5046, jay.radke@
owned by an agency of the U.S. MBio. 6(4): e01044–15. nih.gov.
Government and is available for Intellectual Property: HHS Reference Name of Committee: National Institute of
licensing in the U.S. to achieve No. E–195–2014, U.S. Provisional Allergy and Infectious Diseases Special
VerDate Sep<11>2014 21:24 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 E:\FR\FM\17NON1.SGM 17NON1](https://thefederalregister.org/doc/81_FR_81371/page/1.svg)
Document Created: 2016-11-17 03:00:18
Document Modified: 2016-11-17 03:00:18
| 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. | |
| Contact | Licensing information 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 scientific data. | |
| FR Citation | 81 FR 81149 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR