83 FR 42919 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 165 (August 24, 2018)

Page Range		42919-42920
FR Document		2018-18397

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.

Federal Register, Volume 83 Issue 165 (Friday, August 24, 2018)

[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42919-42920]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18397]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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: Vince Contreras, Ph.D., 240-669-2823; 
[email protected]. Licensing information and copies of the U.S. 
patent application 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to receive copies of unpublished patent applications.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.

Prefusion HPIV F Immunogens and Their Use

    Description of Technology: Human parainfluenza virus (hPIV) is an 
RNA-based paramyxovirus that causes respiratory infections in children 
and adults. There are four serotypes that can result in a myriad of 
diseases of the respiratory tract including croup, bronchitis, and 
pneumonia (Mao et al., 2012). hPIV is a leading cause of respiratory 
tract infection and hospitalization among children under 5, only 
surpassed by the respiratory syncytial virus (RSV). Currently, there 
are limited treatment options and no approved vaccines. Recently, 
studies showed that a large proportion of neutralizing antibodies 
preferentially recognize exposed epitopes in the prefusion conformation 
of the RSV F protein, which together with other evidence suggests that 
creation of stabilized prefusion F protein immunogens might be a 
universal strategy to develop vaccine candidates for inducing 
protective immune responses in RSV and other related viruses, such as 
hPIV.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases created immunogenic PIV 
fusion (F) glycoproteins for types 1,2,3 and 4 (hPIV1, hPIV2, hPIV3 and 
hPIV4) that have been modified to stabilize the prefusion conformation.
    These stabilized prefusion F immunogens, especially hPIV3, induced 
high titer neutralizing responses in mice and rhesus macaques, and 
should thus serve as promising candidates for the prevention of PIV 
infection in humans.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    Potential Commercial Applications:
     hPIV vaccines for people of all ages;
     Specific focus on the elderly and young children.
    Competitive Advantages:
     Use as a multivalent hPIV vaccine;
     Use in combination with influenza or RSV vaccine 
compositions;
     hPIV3 neutralizing titers induced in both mice and rhesus 
macaques were substantially higher than the highest PIV3 neutralizing 
titers observed in a cohort of over 100 humans.
    Development Stage:
     In vivo testing (primates and mice).
    Inventors: Peter Kwong (NIAID), Gwo-Yu Chuang (NIAID), Kai Xu 
(NIAID),Tongqing Zhou (NIAID), Yaroslav Tsybovsky (Leidos Biomedical 
Research, Inc), Aliaksandr Druz (NIAID), Antonio Lanzavecchia 
(Institute for Research in Biomedicine), Davide Corti (Institute for 
Research in Biomedicine), Guillaume BE Stewart-Jones (NIAID), Baoshan 
Zhang (NIAID), Yongping Yang (NIAID), Paul Thomas (NIAID), John Mascola 
(NIAID), Li Ou (NIAID), Wing-pui Kong (NIAID).
    Intellectual Property: HHS Reference Number E-215-2016 includes 
U.S. Provisional Patent Application Number 62/412,699 filed 10/25/2016 
and PCT Application Number PCT/US2017/058322 filed 10/25/2017 
(pending).
    Related Intellectual Property: HHS Reference Number: E-064-2016.
    Licensing Contact: Vince Contreras, Ph.D., 240-669-2823; 
[email protected].


[[Page 42920]]


    Dated: August 10, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-18397 Filed 8-23-18; 8:45 am]
 BILLING CODE 4140-01-P

42920 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices

Dated: August 10, 2018. into account the effects of undertakings and the Office of Policy Development,
Suzanne M. Frisbie, they carry out, license, permit, or fund Strategic Planning, and Performance
Deputy Director, Technology Transfer and to historic properties and provide the within the Office of the Secretary,
Intellectual Property Office, National Institute Advisory Council on Historic USDOT (‘‘OST–P’’); representatives
of Allergy and Infectious Diseases. Preservation (‘‘ACHP’’) a reasonable from the railroad and rail transit
[FR Doc. 2018–18397 Filed 8–23–18; 8:45 am] opportunity to comment with regard to industries; and historic preservation
BILLING CODE 4140–01–P such undertakings. The ACHP has stakeholders to develop the final
issued the regulations that set forth the Section 106 program alternative for rail
process through which federal agencies ROW. The ACHP communicated
ADVISORY COUNCIL ON HISTORIC comply with these responsibilities. extensively with the staff of the Senate
PRESERVATION Those regulations are codified under 36 Committee on Commerce, Science, and
CFR part 800 (‘‘Section 106 Transportation (‘‘Senate Committee’’) as
Notice of Issuance of Program regulations’’). well in developing this program
Comment To Exempt Consideration of Under Section 800.14(e) of those alternative. The ACHP recommended
Effects to Rail Properties Within Rail regulations, federal agencies can request incorporating the originally proposed
Rights-of-Way the ACHP to issue a ‘‘Program exemption within a Program Comment
Comment’’ on a particular category of to better achieve the intent and purpose
AGENCY: Advisory Council on Historic undertakings in lieu of conducting of the FAST Act and meet the needs of
Preservation. reviews for each individual undertaking the various stakeholders.
ACTION: Program Comment issued to in the category. An agency can meet its The Program Comment is the product
exempt consideration of effects to rail Section 106 responsibilities with regard of consultation and careful review. The
properties within rail rights-of-way. to the effects of those undertakings by USDOT and FRA conducted outreach
implementing an applicable Program on the preliminary exemption concept
SUMMARY: The Advisory Council on Comment that has been issued by the and early drafts prior to submitting a
Historic Preservation (‘‘ACHP’’) issued a ACHP. formal request to the ACHP in July
Program Comment to exempt 2017. The ACHP in turn published the
consideration of effects to rail properties I. Background
draft Program Comment in the Federal
within rail rights-of-way at the request At the request of the U.S. Department Register (82 FR 54390, November 17,
of the U.S. Department of of Transportation (‘‘USDOT’’), the 2017), and hosted additional meetings
Transportation to accelerate the review ACHP has issued a Program Comment with industry and preservation
of these undertakings under Section 106 that provides new efficiencies in the representatives in 2018. Recognizing the
of the National Historic Preservation Act Section 106 review for undertakings complexity of the issues to be addressed
and to meet the requirement of Section with the potential to affect historic rail and wanting to ensure the final product
11504 of the Fixing America’s Surface properties within railroad and rail met the statutory requirement of the
Transportation Act. The Program transit rights-of-way (‘‘rail ROW’’). FAST Act to be consistent with the
Comment can be used by any federal Section 11504 of the Fixing America’s interstate highway exemption, the staff
agency with responsibility to consider Surface Transportation Act (‘‘FAST for the Senate Committee extended the
the effects of undertakings within rail Act’’) (49 U.S.C. 24202), enacted on deadline for the final issuance of the
rights-of-way. Federal agencies using December 4, 2015, mandated the Program Comment. The final Program
the Program Comment may fulfill their development of a Section 106 Comment takes into account the many
Section 106 responsibilities for the exemption for ‘‘railroad rights-of-way.’’ significant comments and questions
relevant undertakings by implementing The FAST Act required that ‘‘the raised by various stakeholders over the
the terms of this comment, which Secretary [of the USDOT] shall submit course of its development and
include identifying those activities that a proposed exemption of railroad rights- represents the collective work of the
meet the conditions in Appendix A and of-way from the review under section ACHP, USDOT (inclusive of FRA, FTA,
opting into the process to identify 306108 of title 54 to the [ACHP] for FHWA, and OST–P), and the Senate
excluded historic rail properties and consideration, consistent with the Committee staff to ensure that it meets
seek further streamlining of the review exemption for interstate highways the FAST Act requirement.
process under the property-based approved on March 10, 2005 (70 FR The Program Comment is comprised
approach. 11928).’’ The FAST Act continued that, of two major parts: (1) An activity-based
DATES: The Program Comment was ‘‘Not later than 180 days after the date approach, and (2) a property-based
issued by the ACHP on August 17, 2018. on which the Secretary submits the approach. The activity-based approach
proposed exemption . . . to the provides a list of activities in Appendix
ADDRESSES: Address all questions
Council, the Council shall issue a final A for which, when the specific
concerning the Program Comment to exemption of railroad rights-of-way conditions are met, no further Section
Kelly Y. Fanizzo, Office of General from review under chapter 3061 of title 106 review is required. Based on the
Counsel, Advisory Council on Historic 54 consistent with the exemption for past experience of USDOT Operating
Preservation, 401 F Street NW, Suite interstate highways approved on March Administrations (‘‘USDOT OAs’’),
308, Washington, DC 20001–2637. You 10, 2005 (70 FR 11928).’’ While the undertakings limited to the activities
may submit questions through Section 106 regulations provide the specified in Appendix A have typically
electronic mail to: kfanizzo@achp.gov. process and criteria for development of resulted in effects to historic properties
FOR FURTHER INFORMATION CONTACT: program alternatives, the FAST Act that are either minimal or not adverse.
daltland on DSKBBV9HB2PROD with NOTICES

Kelly Y. Fanizzo, (202) 517–0193, modified the timeframe and directed The property-based approach
kfanizzo@achp.gov. agency actions. establishes a process whereby project
SUPPLEMENTARY INFORMATION: Section The ACHP worked closely with the sponsors can opt to work with the
106 of the National Historic Federal Railroad Administration relevant USDOT OA and stakeholders to
Preservation Act (‘‘NHPA’’), as (‘‘FRA’’), the Federal Transit develop a list of excluded historic rail
amended, 54 U.S.C. 306108 (‘‘Section Administration (‘‘FTA’’), the Federal properties that would remain subject to
106’’), requires federal agencies to take Highway Administration (‘‘FHWA’’), Section 106 review, and exempt from

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Document Created: 2018-08-24 04:14:18
Document Modified: 2018-08-24 04:14:18

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		Vince Contreras, Ph.D., 240-669-2823; [email protected] Licensing information and copies of the U.S. patent application 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.
FR Citation		83 FR 42919

83 FR 42919 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 165 (August 24, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health