Government-Owned Inventions; Availability for Licensing, 72673-72674 [2020-25098]

Download as PDF 72673 Federal Register / Vol. 85, No. 220 / Friday, November 13, 2020 / Notices plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Arlyn Garcia-Perez, Director of Policy and Analysis, Office of Intramural Research, Office of the Director, National Institutes of Health, 1 Center Drive MSC 0140, Building 1, Room 160, MSC–0140, Bethesda, Maryland, 20892 or call non-toll-free number (301) 496–1921 or (301) 496– 1381 or Email your request, including your address to: GarciaA@od.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed SUPPLEMENTARY INFORMATION: (OIR), Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: Form Number: NIH–590 is a single form completed by an NIH official for each Guest Researcher or Special Volunteer prior to his/her arrival at NIH. The information on the form is necessary for the approving official to reach a decision on whether to allow a Guest Researcher to use NIH facilities, or whether to accept volunteer services offered by a Special Volunteer. If the original assignment is extended, another form notating the extension is completed to update the file. In addition, each Special Volunteer and Guest Researcher reads and signs an NIH Agreement. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 422. collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Special Volunteer and Guest Researcher Assignment form—EXTENSION OMB # 0925–0177, exp., date February 28, 2021, Office of Intramural Research ESTIMATED ANNUALIZED BURDEN HOURS Average burden per response (in hours) Number of responses per respondent Total annual hour burden hours Type of respondents Special Volunteer and Guest Researcher Assignment. NIH Special Volunteer Agreement .... NIH Guest Researcher Agreement ... Special Volunteers and Guest researchers. Special Volunteers ........................... Guest Researchers .......................... 2,300 1 6/60 230 2,100 200 1 1 5/60 5/60 175 17 Totals ......................................... ........................................................... 2,300 4,600 ........................ 422 Dated: November 4, 2020. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2020–25091 Filed 11–12–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES Number of respondents Form name VerDate Sep<11>2014 17:19 Nov 12, 2020 Jkt 253001 FOR FURTHER INFORMATION CONTACT: Dianca Finch, Ph.D., 240–669–5503; dianca.finch@nih.gov. 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: Identification of a New Human Monoclonal Antibody That More Potently Prevents Malaria Infection Description of Technology: Malaria is a major disease caused by a parasite transmitted through the bite of infected female mosquitoes. Globally, an estimated 214 million cases of malaria and 438,000 deaths from malaria occur annually, with chidren in African and South Asian regions being most vulnerable. Approximately 1,500– PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 2,000 cases of malaria are reported in the United States each year, mostly in returning travelers from malariaendemic countries. Among the international travelers, military personnel, diplomats, pregnant women, children and older individuals with weakened immune systems are more likely to be at risk of malaria infection and mortality. Currently, there is no licensed vaccine against Plasmodium falciparum, the deadliest species of malaria parasites. Antibodies can prevent malaria infection by binding to sporozoites, the infectious form of P. falciparum that is transmitted to humans by the bites of infected mosquitoes. The major target of anti-sporozoite antibodies is the P. falciparum circumsporozoite protein (PfCSP), an abundant surface protein on sporozoites that is essential for infecting liver cells, which is the critical step for initiating a productive infection. PfCSP is comprised of an N-terminal domain, a central region and the C-terminal region. Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) E:\FR\FM\13NON1.SGM 13NON1 72674 Federal Register / Vol. 85, No. 220 / Friday, November 13, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES have isolated a new neutralizing recombinant human monoclonal antibody, L9, from a protected volunteer immunized with whole Plasmodium falciparum sporozoites. L9 is notable for targeting PfCSP, the immunodominant immunogen that coats the surface of the sporozoite, specifically the Plasmodium infectious form injected into the human host by the mosquito. Also, in vivo studies in a mouse model of malaria infection demonstrated that L9 is more potent than CIS43, another antimalarial mAb, at preventing malaria infection. 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: • A passive vaccine candidate to prevent and eradicate malaria. Competitive Advantages: • L9 may represent a more attractive passive vaccine candidate to advance through clinical testing and could yield a product superior to other vaccine candidates due to potency and preferential binding to unique epitopes on PfCSP. • L9 may result in more durable protection than other vaccine candidates. Development Stage: Preclinical Research. Inventors: Robert Alan Seder (NIAID); Lawrence Tsuchun Wang (NIAID); Rachel Marie Vistein (NIAID); Joseph Richard Francica (NIAID). Publications: Wang, L. T., et al. (2020). A Potent Anti-Malarial Human Monoclonal Antibody Targets Circumsporozoite Protein Minor Repeats and Neutralizes Sporozoites in the Liver. Immunity. Intellectual Property: HHS Reference Number E–087–2019 includes PCT Patent Application Number PCT/ US2020/031345 filed on 05/04/2020. Licensing Contact: To license this technology, please contact Dianca Finch, Ph.D., 240–669–5503; dianca.finch@nih.gov. Dated: November 6, 2020. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2020–25098 Filed 11–12–20; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 17:19 Nov 12, 2020 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Environmental Health Training Grant Review Meeting II. Date: November 20, 2020. Time: 10:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Nat. Institute of Environmental Health Sciences, Keystone Building, 530 Davis Drive, Durham, NC 27709 (Virtual Meeting). Contact Person: Varsha Shukla, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Science, 530 Davis Dr., Keystone Bldg., Room 3094, Durham, NC 27713, 984– 287–3288, Varsha.shukla@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Review of EHS Conference Grant Applications. Date: December 3, 2020. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Nat. Institute of Environmental Health Sciences, Keystone Building, 530 Davis Drive, Durham, NC 27709 (Virtual Meeting). Contact Person: Janice B. Allen, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Science, P.O. Box 12233, MD EC–30/ Room 3170 B, Research Triangle Park, NC 27709, 984–287–3232, allen9@niehs.nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Educational Training in Occupational Health and Safety. Date: December 11, 2020. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Time: 11:00 a.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: Nat. Institute of Environmental Health Sciences, Keystone Building, 530 Davis Drive, Durham, NC 27709 (Virtual Meeting). Contact Person: Linda K. Bass, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute Environmental Health Sciences, P.O. Box 12233, MD EC–30, Research Triangle Park, NC 27709, 984–287– 3236, bass@niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: November 6, 2020. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–25097 Filed 11–12–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–3547– EM; Docket ID FEMA–2020–0001] Louisiana; Amendment No. 1 to Notice of an Emergency Declaration Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This notice amends the notice of an emergency declaration for the State of Louisiana (FEMA–3547–EM), dated October 7, 2020, and related determinations. SUMMARY: This amendment was issued October 9, 2020. FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646–2833. SUPPLEMENTARY INFORMATION: The notice of an emergency declaration for the State of Louisiana is hereby amended to include reimbursement for eligible emergency protective measures for the following areas among those areas determined to have been adversely affected by the event declared an DATES: E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Pages 72673-72674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25098]


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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.

-----------------------------------------------------------------------

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: Dianca Finch, Ph.D., 240-669-5503; 
[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:

Identification of a New Human Monoclonal Antibody That More Potently 
Prevents Malaria Infection

    Description of Technology:
    Malaria is a major disease caused by a parasite transmitted through 
the bite of infected female mosquitoes. Globally, an estimated 214 
million cases of malaria and 438,000 deaths from malaria occur 
annually, with chidren in African and South Asian regions being most 
vulnerable. Approximately 1,500-2,000 cases of malaria are reported in 
the United States each year, mostly in returning travelers from 
malaria- endemic countries. Among the international travelers, military 
personnel, diplomats, pregnant women, children and older individuals 
with weakened immune systems are more likely to be at risk of malaria 
infection and mortality.
    Currently, there is no licensed vaccine against Plasmodium 
falciparum, the deadliest species of malaria parasites. Antibodies can 
prevent malaria infection by binding to sporozoites, the infectious 
form of P. falciparum that is transmitted to humans by the bites of 
infected mosquitoes. The major target of anti-sporozoite antibodies is 
the P. falciparum circumsporozoite protein (PfCSP), an abundant surface 
protein on sporozoites that is essential for infecting liver cells, 
which is the critical step for initiating a productive infection. PfCSP 
is comprised of an N-terminal domain, a central region and the C-
terminal region.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID)

[[Page 72674]]

have isolated a new neutralizing recombinant human monoclonal antibody, 
L9, from a protected volunteer immunized with whole Plasmodium 
falciparum sporozoites. L9 is notable for targeting PfCSP, the 
immunodominant immunogen that coats the surface of the sporozoite, 
specifically the Plasmodium infectious form injected into the human 
host by the mosquito. Also, in vivo studies in a mouse model of malaria 
infection demonstrated that L9 is more potent than CIS43, another 
antimalarial mAb, at preventing malaria infection.
    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:
     A passive vaccine candidate to prevent and eradicate 
malaria.
    Competitive Advantages:
     L9 may represent a more attractive passive vaccine 
candidate to advance through clinical testing and could yield a product 
superior to other vaccine candidates due to potency and preferential 
binding to unique epitopes on PfCSP.
     L9 may result in more durable protection than other 
vaccine candidates.
    Development Stage: Preclinical Research.
    Inventors: Robert Alan Seder (NIAID); Lawrence Tsuchun Wang 
(NIAID); Rachel Marie Vistein (NIAID); Joseph Richard Francica (NIAID).
    Publications: Wang, L. T., et al. (2020). A Potent Anti-Malarial 
Human Monoclonal Antibody Targets Circumsporozoite Protein Minor 
Repeats and Neutralizes Sporozoites in the Liver. Immunity.
    Intellectual Property: HHS Reference Number E-087-2019 includes PCT 
Patent Application Number PCT/US2020/031345 filed on 05/04/2020.
    Licensing Contact: To license this technology, please contact 
Dianca Finch, Ph.D., 240-669-5503; [email protected].

    Dated: November 6, 2020.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-25098 Filed 11-12-20; 8:45 am]
BILLING CODE 4140-01-P

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