83_FR_827 83 FR 822 - Government-Owned Inventions; Availability for Licensing

83 FR 822 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 5 (January 8, 2018)

Page Range822-823
FR Document2018-00121

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 5 (Monday, January 8, 2018)
[Federal Register Volume 83, Number 5 (Monday, January 8, 2018)]
[Notices]
[Pages 822-823]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00121]


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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: Peter Tung, 240-669-5483; 
[email protected]. Licensing information and copies of the patent 
applications 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unpublished patent applications.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.

Compositions and Methods for Blocking Transmission of Plasmodium

    Description of Technology: According to the World Health 
Organization, about 3.2 billion people--nearly half of the world's 
population--are at risk of infection by Plasmodium parasites, resulting 
in malaria. An estimated 214 million cases and 438,000 deaths were due 
to malaria in 2015.
    P47 protein expressed by Plasmodium species allow malaria parasites 
to evade the mosquito immune system, thereby facilitating the 
transmission of malaria parasites. NIAID inventors have discovered the 
region of P47 protein responsible for the immune evasion function of 
this protein. Specific sequences of protein fragments of P47

[[Page 823]]

have proven to be both highly antigenic and shown to be responsible in 
allowing malaria parasites to evade the mosquito immune system. Proof 
of concept in a mouse model has demonstrated that vaccination using 
specific P47 protein fragments blocks Plasmodium transmission by 
mosquitoes.
    Immunization with the P47 protein variants of this technology 
provides a candidate for a potential, effective, transmission blocking 
malaria vaccine against Plasmodium species.
    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:

 Transmission blocking malaria vaccine

    Competitive Advantages:

 Transmission blocking of Plasmodium
 Transmission blocking activity based on recruiting the 
mosquito immune system to kill Plasmodium parasites by blocking 
Plasmodium immune evasion

    Development Stage:

 Early-stage
 In vitro data available
 In vivo data available (animal)

    Inventors: Carolina Veronica Barillas-Mury, Alvaro Molina-Cruz, 
Gaspar Exequiel Canepa, all of NIAID.
    Publications:
    Intellectual Property: HHS Reference No. E-294-2016/0--U.S. 
Provisional Application No. 62/463,011, filed February 24, 2017.
    Licensing Contact: Peter Tung, 240-669-5483; [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 P47 protein fragments as a 
transmission blocking vaccine. For collaboration opportunities, please 
contact Peter Tung at 240-669-5483; [email protected].

    Dated: December 13, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-00121 Filed 1-5-18; 8:45 am]
 BILLING CODE 4140-01-P



                                                822                            Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices

                                                DEPARTMENT OF HEALTH AND                                under section 254b of the PHS Act. Of                  candidates from all groups and
                                                HUMAN SERVICES                                          these 12, at least nine must be patient                locations.
                                                                                                        members of health center governing
                                                                                                                                                               Amy McNulty,
                                                Health Resources and Services                           boards who are familiar with the
                                                Administration                                                                                                 Acting Director, Division of the Executive
                                                                                                        delivery of health care to migratory and
                                                                                                                                                               Secretariat.
                                                                                                        seasonal agricultural workers. The
                                                National Advisory Council on Migrant                                                                           [FR Doc. 2018–00096 Filed 1–5–18; 8:45 am]
                                                                                                        remaining three Council members must
                                                Health                                                  be individuals qualified by training and               BILLING CODE 4165–15–P

                                                AGENCY: Health Resources and Services                   experience in the medical sciences or in
                                                Administration (HRSA), Department of                    the administration of health programs.
                                                                                                                                                               DEPARTMENT OF HEALTH AND
                                                Health and Human Services (HHS).                        New members filling a vacancy that
                                                                                                                                                               HUMAN SERVICES
                                                                                                        occurred prior to expiration of a term
                                                ACTION: Notice of request for
                                                                                                        may serve only for the remainder of                    National Institutes of Health
                                                nominations for voting members.                         such term.
                                                SUMMARY:  HRSA is requesting                               Compensation: Members who are not                   Government-Owned Inventions;
                                                nominations to fill vacancies on the                    full-time federal employees shall be                   Availability for Licensing
                                                National Advisory Council on Migrant                    paid at the rate of $200 per day,
                                                                                                        including travel time plus per diem and                AGENCY:   National Institutes of Health,
                                                Health (NACMH). The NACMH is                                                                                   HHS.
                                                                                                        travel expenses in accordance with
                                                authorized and governed under the                                                                              ACTION:   Notice.
                                                                                                        Standard Government Travel
                                                Public Health Service (PHS) Act, as
                                                                                                        Regulations.
                                                amended.                                                   Specifically, HRSA is requesting                    SUMMARY:   The invention listed below is
                                                DATES:  The agency will receive                         nominations for:                                       owned by an agency of the U.S.
                                                nominations on a continuous basis.                                                                             Government and is available for
                                                                                                        Governing Board Members (8                             licensing to achieve expeditious
                                                ADDRESSES: All nominations must be                      Vacancies)                                             commercialization of results of
                                                submitted in hardcopy to the Designated                                                                        federally-funded research and
                                                Federal Official (DFO), NACMH,                             Nominees must be members of a
                                                                                                        governing board of a migrant health                    development. Foreign patent
                                                Strategic Initiatives and Planning                                                                             applications are filed on selected
                                                Division, Office of Policy and Program                  center or other entity assisted under
                                                                                                        section 330 of the PHS Act. Of the eight               inventions to extend market coverage
                                                Development, Bureau of Primary Health                                                                          for companies and may also be available
                                                Care, HRSA, 16N38B, 5600 Fishers                        board member vacancies, five nominees
                                                                                                        must also be patients of the entities they             for licensing.
                                                Lane, Rockville, Maryland 20857.
                                                                                                        represent. (The Council has four current               FOR FURTHER INFORMATION CONTACT:
                                                FOR FURTHER INFORMATION CONTACT: All                    board members who are patients.)                       Peter Tung, 240–669–5483; peter.tung@
                                                requests for information regarding the                  Additionally, board member nominees                    nih.gov. Licensing information and
                                                NACMH nominations should be sent to                     must be familiar with the delivery of                  copies of the patent applications listed
                                                Esther Paul, DFO, NACMH, HRSA, in                       primary health care to migratory and                   below may be obtained by
                                                one of three ways: (1) Send a request to                seasonal agricultural workers and their                communicating with the indicated
                                                the following address: Esther Paul,                     families.                                              licensing contact at the Technology
                                                Office of Policy and Program                               A complete nomination package                       Transfer and Intellectual Property
                                                Development, Bureau of Primary Health                   should include the following                           Office, National Institute of Allergy and
                                                Care, HRSA, 5600 Fishers Lane,                          information for each nominee: (1) A                    Infectious Diseases, 5601 Fishers Lane,
                                                16N38B, Rockville, Maryland 20857; (2)                  NACMH nomination form; (2) three                       Rockville, MD, 20852; tel. 301–496–
                                                call (301) 594–4300; or (3) send an email               letters of reference; (3) a statement of               2644. A signed Confidential Disclosure
                                                to epaul@hrsa.gov.                                      prior service on the NACMH; and (4) a                  Agreement will be required to receive
                                                SUPPLEMENTARY INFORMATION: As                           biographical sketch of the nominee or a                copies of unpublished patent
                                                authorized under section 217 of the PHS                 copy of his/her curriculum vitae. The                  applications.
                                                Act, as amended (42 U.S.C. 218), the                    nomination package must also state that                SUPPLEMENTARY INFORMATION:
                                                Secretary established the NACMH. The                    the nominee is willing to serve as a                   Technology description follows.
                                                NACMH is governed by the Federal                        member of the NACMH and appears to
                                                Advisory Committee Act (5 U.S.C.                        have no conflict of interest that would                Compositions and Methods for Blocking
                                                Appendix 2), which sets forth standards                 preclude membership. An ethics review                  Transmission of Plasmodium
                                                for the formation and use of advisory                   is conducted for each selected nominee.                  Description of Technology: According
                                                committees.                                             Please contact Esther Paul at epaul@                   to the World Health Organization, about
                                                  The NACMH consults with and makes                     hrsa.gov and/or Carole Chamberlain at                  3.2 billion people—nearly half of the
                                                recommendations to the HHS Secretary                    cchamberlain@hrsa.gov to obtain a                      world’s population—are at risk of
                                                and the HRSA Administrator                              nomination form.                                       infection by Plasmodium parasites,
                                                concerning the organization, operation,                    HHS strives to ensure that the                      resulting in malaria. An estimated 214
                                                selection, and funding of migrant health                membership of HHS federal advisory                     million cases and 438,000 deaths were
                                                centers and other entities under grants                 committees is balanced in terms of                     due to malaria in 2015.
                                                and contracts under section 330 of the                  points of view represented, consistent                   P47 protein expressed by Plasmodium
                                                PHS Act (42 U.S.C. 254b).                               with the committee’s authorizing statute               species allow malaria parasites to evade
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                                                  The authorizing statute and the                       and charter. Appointment to the                        the mosquito immune system, thereby
                                                NACMH Charter require that the                          NACMH shall be made without                            facilitating the transmission of malaria
                                                Council consist of 15 members, each                     discrimination on the basis of age, race,              parasites. NIAID inventors have
                                                serving a 4-year term. Twelve Council                   ethnicity, gender, sexual orientation,                 discovered the region of P47 protein
                                                members are required by statute to be                   disability, and cultural, religious, or                responsible for the immune evasion
                                                governing board members of migrant                      socioeconomic status. The Department                   function of this protein. Specific
                                                health centers or other entities assisted               encourages nominations of qualified                    sequences of protein fragments of P47


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                                                                               Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices                                                 823

                                                have proven to be both highly antigenic                 DEPARTMENT OF HEALTH AND                               approaches in a regulatory context. Case
                                                and shown to be responsible in allowing                 HUMAN SERVICES                                         studies will be presented to highlight
                                                malaria parasites to evade the mosquito                                                                        where such techniques have been
                                                immune system. Proof of concept in a                    National Institutes of Health                          successfully applied both nationally and
                                                mouse model has demonstrated that                                                                              internationally. The preliminary agenda
                                                vaccination using specific P47 protein                  Interagency Coordinating Committee                     and additional information about
                                                fragments blocks Plasmodium                             on the Validation of Alternative                       presentations will be posted at http://
                                                transmission by mosquitoes.                             Methods Communities of Practice                        ntp.niehs.nih.gov/go/commprac-2018 as
                                                                                                        Webinar on Machine Learning in                         available.
                                                   Immunization with the P47 protein                    Toxicology: Fundamentals of
                                                variants of this technology provides a                                                                            Webinar and Registration: This
                                                                                                        Application and Interpretation; Notice                 webinar is open to the public with time
                                                candidate for a potential, effective,                   of Public Webinar; Registration
                                                transmission blocking malaria vaccine                                                                          scheduled for questions by participants
                                                                                                        Information                                            following each presentation.
                                                against Plasmodium species.
                                                                                                        AGENCY:    National Institutes of Health,              Registration for the webinar is required
                                                   This technology is available for
                                                                                                        HHS.                                                   and is open through 2:30 p.m. on
                                                licensing for commercial development
                                                                                                        ACTION:   Notice.                                      January 23, 2018. Registration is
                                                in accordance with 35 U.S.C. 209 and 37
                                                                                                                                                               available at http://ntp.niehs.nih.gov/go/
                                                CFR part 404, as well as for further
                                                                                                        SUMMARY:   The Interagency Coordinating                commprac-2018. Interested individuals
                                                development and evaluation under a
                                                                                                        Committee on the Validation of                         are encouraged to visit this web page to
                                                research collaboration.
                                                                                                        Alternative Methods (ICCVAM)                           stay abreast of the most current webinar
                                                   Potential Commercial Applications:                   announces a public webinar ‘‘Machine                   information. Registrants will receive
                                                • Transmission blocking malaria                         Learning in Toxicology: Fundamentals                   instructions on how to access and
                                                  vaccine                                               of Application and Interpretation.’’ The               participate in the webinar in an email
                                                                                                        webinar is organized on behalf of                      sent shortly before the webinar.
                                                   Competitive Advantages:                              ICCVAM by the National Toxicology                         Individuals with disabilities who
                                                • Transmission blocking of                              Program Interagency Center for the                     need accommodation to participate in
                                                  Plasmodium                                            Evaluation of Alternative Toxicological                this event should contact Elizabeth
                                                                                                        Methods (NICEATM). Interested persons                  Maull at phone: (984) 287–3157 or
                                                • Transmission blocking activity based
                                                                                                        may participate via WebEx. Time will                   email: maull@niehs.nih.gov. TTY users
                                                  on recruiting the mosquito immune
                                                                                                        be allotted for questions from the                     should contact the Federal TTY Relay
                                                  system to kill Plasmodium parasites
                                                                                                        audience.                                              Service at (800) 877–8339. Requests
                                                  by blocking Plasmodium immune
                                                                                                                                                               should be made at least five business
                                                  evasion                                               DATES:  Webinar: January 23, 2018, 1:00
                                                                                                                                                               days in advance of the event.
                                                                                                        p.m. to approximately 2:30 p.m. Eastern
                                                   Development Stage:                                                                                             Background Information on ICCVAM
                                                                                                        Standard Time (EST). Registration for
                                                                                                                                                               and NICEATM: ICCVAM is an
                                                • Early-stage                                           the Webinar: December 18, 2017, until
                                                                                                                                                               interagency committee composed of
                                                • In vitro data available                               2:30 p.m. on January 23, 2018.
                                                                                                                                                               representatives from 16 federal
                                                                                                        ADDRESSES: Webinar web page: http://
                                                • In vivo data available (animal)                                                                              regulatory and research agencies that
                                                                                                        ntp.niehs.nih.gov/go/commprac-2018.                    require, use, generate, or disseminate
                                                   Inventors: Carolina Veronica Barillas-               FOR FURTHER INFORMATION CONTACT: Dr.                   toxicological and safety testing
                                                Mury, Alvaro Molina-Cruz, Gaspar                        Warren Casey, Director, NICEATM;                       information. ICCVAM conducts
                                                Exequiel Canepa, all of NIAID.                          telephone: (984) 287–3118; email:                      technical evaluations of new, revised,
                                                   Publications:                                        warren.casey@nih.gov.                                  and alternative safety testing methods
                                                   Intellectual Property: HHS Reference                 SUPPLEMENTARY INFORMATION:                             and integrated testing strategies with
                                                No. E–294–2016/0—U.S. Provisional                       Background: ICCVAM promotes the                        regulatory applicability and promotes
                                                Application No. 62/463,011, filed                       development and validation of toxicity                 the scientific validation and regulatory
                                                February 24, 2017.                                      testing methods that protect human                     acceptance of testing methods that more
                                                   Licensing Contact: Peter Tung, 240–                  health and the environment while                       accurately assess the safety and hazards
                                                669–5483; peter.tung@nih.gov.                           replacing, reducing, or refining animal                of chemicals and products and replace,
                                                                                                        use. ICCVAM also provides guidance to                  reduce, or refine (enhance animal well-
                                                   Collaborative Research Opportunity:                                                                         being and lessen or avoid pain and
                                                                                                        test method developers and facilitates
                                                The National Institute of Allergy and                                                                          distress) animal use.
                                                                                                        collaborations that promote the
                                                Infectious Diseases is seeking statements
                                                                                                        development of new test methods. To                       The ICCVAM Authorization Act of
                                                of capability or interest from parties
                                                                                                        address these goals, ICCVAM will hold                  2000 (42 U.S.C. 285l–3) establishes
                                                interested in collaborative research to
                                                                                                        a Communities of Practice webinar on                   ICCVAM as a permanent interagency
                                                further develop, evaluate or
                                                                                                        ‘‘Machine Learning in Toxicology:                      committee of the National Institute of
                                                commercialize P47 protein fragments as
                                                                                                        Fundamentals of Application and                        Environmental Health Sciences and
                                                a transmission blocking vaccine. For
                                                                                                        Interpretation.’’                                      provides the authority for ICCVAM
                                                collaboration opportunities, please
                                                                                                          The ICCVAM webinar will explore                      involvement in activities relevant to the
                                                contact Peter Tung at 240–669–5483;
                                                                                                        the fundamentals of machine learning                   development of alternative test
                                                peter.tung@nih.gov.
                                                                                                        approaches, including how they work,                   methods. ICCVAM acts to ensure that
sradovich on DSK3GMQ082PROD with NOTICES




                                                   Dated: December 13, 2017.                            how they are interpreted, and                          new and revised test methods are
                                                Suzanne Frisbie,                                        precautions that should be taken when                  validated to meet the needs of federal
                                                Deputy Director, Technology Transfer and                evaluating their output. It will feature               agencies, increase the efficiency and
                                                Intellectual Property Office, National Institute        presentations by two experts in use of                 effectiveness of federal agency test
                                                of Allergy and Infectious Diseases.                     machine learning in toxicity texting                   method review, and optimize utilization
                                                [FR Doc. 2018–00121 Filed 1–5–18; 8:45 am]              applications that will address issues                  of scientific expertise outside the federal
                                                BILLING CODE 4140–01–P                                  specific to use of machine learning                    government. Additional information


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Document Created: 2018-01-06 02:32:02
Document Modified: 2018-01-06 02:32:02
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactPeter Tung, 240-669-5483; [email protected] Licensing information and copies of the patent applications 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 Citation83 FR 822 

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