Government-Owned Inventions; Availability for Licensing, 53887-53888 [2018-23312]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Dated: October 18, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Chronic Disease and Epidemiology. Date: November 1, 2018. Time: 11:00 a.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 20892, 301–435– 0684, olufokunbisamd@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; AIDS and Related Research. Date: November 9, 2018. Time: 9:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Barna Dey, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, Bethesda, MD 20892, 301–451–2796, bdey@ mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Review of Aging Applications. Date: November 20, 2018. Time: 1:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Seetha Bhagavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD 20892, (301) 237– 9838, bhagavas@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–18– 727: Molecular Profiles and Biomarkers of Food and Nutrient Intake. Date: November 20, 2018. Time: 1:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Gregory S. Shelness, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6156, Bethesda, MD 20892–7892, (301) 435–0492, shelnessgs@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) [FR Doc. 2018–23265 Filed 10–24–18; 8:45 am] VerDate Sep<11>2014 18:10 Oct 24, 2018 Jkt 247001 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Office of AIDS Research Advisory Council. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Office of AIDS Research Advisory Council. Date: November 15, 2018. Time: 8:30 a.m. to 4:30 p.m. Agenda: The forty-ninth OARAC meeting will include review of the DHHS HIV/AIDS Treatment and Prevention Guidelines; the OAR Director’s Report; updates on the OAR cost sharing activities with the National Institute on Aging, the FY2019/2020 TransNIH Plan for HIV-Related Research; other HIV/AIDS research activities across selected NIH Institutes; and public comment. Place: National Institutes of Health, Conference Room 1D13, 5601 Fishers Lane, Rockville, MD 20892. Contact Person: Jay R. Radke, Ph.D., Scientific Review Officer, Office of AIDS Research, National Institutes of Health, Ofc of the Director, 5601 Fishers Lane, Room 2E61 MSC–9834, Bethesda, MD 20892–9834, (240) 669–5046, jay.radke@nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: www.oar.nih.gov, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 53887 Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: October 19, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–23263 Filed 10–24–18; 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. FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. 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. SUMMARY: Use of Rostafuroxin To Inhibit Viral Infection Description of Technology: Acute respiratory infections during early childhood constitute a major human health burden. Human respiratory syncytial virus (RSV) is the most common and important viral cause of severe acute pediatric respiratory infections worldwide. Mortality due to RSV in the post-neonatal (28 days to 1 year old) population is second only to malaria. It is estimated that RSV causes 34 million lower respiratory tract infections, 4 million hospitalizations, and 66,000–199,000 deaths every year in children less than 5 years of age. E:\FR\FM\25OCN1.SGM 25OCN1 daltland on DSKBBV9HB2PROD with NOTICES 53888 Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices Most mortality occurs in the developing world where clinical care is less accessible. Mortality is low in the developed countries, but the morbidity is substantial: In the United States alone, RSV is associated with an estimated 132,000–172,000 hospitalizations annually in children less than 5 years old. There is not yet available a vaccine or an effective antiviral drug suitable for routine use. This invention relates to a broadly antiviral small chemical molecule, Rostafuroxin, expected to be well tolerated in humans and available for clinical evaluation. In particular, this patent application relates to the novel and unexpected finding that Rostafuroxin substantially inhibits RSV infection. ATP1A1 is a host protein involved with cellular entry of RSV. RSV entry was found to require activation of a signaling cascade mediated by ATP1A1 which resembles the signaling pathway (also mediated by ATP1A1) triggered by cardiotonic steroids. Though not evaluated for RSV, ATPA1A was previously implicated as a pro-viral factor in the infection cycles of a number of viruses, but the nature of its involvement and mechanism of action were unknown. Rostafuroxin, a synthetic digitoxigenin derivative, is a smallmolecule that is known to specifically bind ATP1A1. It has not been previously known to have any antiviral activity. The inventors have evidence that Rostafuroxin inhibits RSV infection in respiratory epithelial cells. Rostafuroxin inhibits RSV induced ATP1A1mediated signaling pathway required for RSV entry. This was demonstrated in A549 cells, a widely used human respiratory epithelial cell line, and in primary human airway epithelial cells derived from a healthy human. Rostafuroxin has been previously tested in clinical studies as an antihypertensive agent. It has no adverse effects in healthy humans and, importantly, does not lower the normal systolic blood pressure of healthy individuals. Rostafuroxin is a promising anti-viral drug candidate for RSV and possibly other viruses that use the same pathway for host cell entry. 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: • Viral therapeutics VerDate Sep<11>2014 18:10 Oct 24, 2018 Jkt 247001 • Viral diagnostics • Vaccine research Competitive Advantages: • Ease of manufacture • Broad antiviral activity • Favorable safety profile in clinical trials Development Stage: • In vivo data assessment (animal) Inventors: Shirin Munir (NIAID), Matthias Lingemann (NIAID), Peter Collins (NIAID). Intellectual Property: HHS Reference No. E–202–2018–0—U.S. Provisional Application No. 62/737,899, filed September 27, 2018 (pending). Licensing Contact: Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. 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 for development of a vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. Dated: October 15, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018–23312 Filed 10–24–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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: Center for Scientific Review Special Emphasis Panel; Member Conflict: Chronic Disease and Epidemiology. Date: October 24, 2018. Frm 00042 Fmt 4703 Sfmt 4703 Dated: October 18, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–23266 Filed 10–24–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2018–0002; Internal Agency Docket No. FEMA–B–1855] Changes in Flood Hazard Determinations Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents SUMMARY: Center for Scientific Review; Notice of Closed Meeting PO 00000 Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 20892, 301–435– 0684, olufokunbisamd@csr.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. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53887-53888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23312]


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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: Peter Soukas, J.D., 301-594-8730; 
[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.

Use of Rostafuroxin To Inhibit Viral Infection

    Description of Technology: Acute respiratory infections during 
early childhood constitute a major human health burden. Human 
respiratory syncytial virus (RSV) is the most common and important 
viral cause of severe acute pediatric respiratory infections worldwide. 
Mortality due to RSV in the post-neonatal (28 days to 1 year old) 
population is second only to malaria. It is estimated that RSV causes 
34 million lower respiratory tract infections, 4 million 
hospitalizations, and 66,000-199,000 deaths every year in children less 
than 5 years of age.

[[Page 53888]]

Most mortality occurs in the developing world where clinical care is 
less accessible. Mortality is low in the developed countries, but the 
morbidity is substantial: In the United States alone, RSV is associated 
with an estimated 132,000-172,000 hospitalizations annually in children 
less than 5 years old. There is not yet available a vaccine or an 
effective antiviral drug suitable for routine use.
    This invention relates to a broadly antiviral small chemical 
molecule, Rostafuroxin, expected to be well tolerated in humans and 
available for clinical evaluation. In particular, this patent 
application relates to the novel and unexpected finding that 
Rostafuroxin substantially inhibits RSV infection.
    ATP1A1 is a host protein involved with cellular entry of RSV. RSV 
entry was found to require activation of a signaling cascade mediated 
by ATP1A1 which resembles the signaling pathway (also mediated by 
ATP1A1) triggered by cardiotonic steroids.
    Though not evaluated for RSV, ATPA1A was previously implicated as a 
pro-viral factor in the infection cycles of a number of viruses, but 
the nature of its involvement and mechanism of action were unknown.
    Rostafuroxin, a synthetic digitoxigenin derivative, is a small-
molecule that is known to specifically bind ATP1A1. It has not been 
previously known to have any antiviral activity.
    The inventors have evidence that Rostafuroxin inhibits RSV 
infection in respiratory epithelial cells. Rostafuroxin inhibits RSV 
induced ATP1A1-mediated signaling pathway required for RSV entry. This 
was demonstrated in A549 cells, a widely used human respiratory 
epithelial cell line, and in primary human airway epithelial cells 
derived from a healthy human.
    Rostafuroxin has been previously tested in clinical studies as an 
anti-hypertensive agent. It has no adverse effects in healthy humans 
and, importantly, does not lower the normal systolic blood pressure of 
healthy individuals.
    Rostafuroxin is a promising anti-viral drug candidate for RSV and 
possibly other viruses that use the same pathway for host cell entry.
    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:

 Viral therapeutics
 Viral diagnostics
 Vaccine research

    Competitive Advantages:

 Ease of manufacture
 Broad antiviral activity
 Favorable safety profile in clinical trials

    Development Stage:

 In vivo data assessment (animal)

    Inventors: Shirin Munir (NIAID), Matthias Lingemann (NIAID), Peter 
Collins (NIAID).
    Intellectual Property: HHS Reference No. E-202-2018-0--U.S. 
Provisional Application No. 62/737,899, filed September 27, 2018 
(pending).
    Licensing Contact: Peter Soukas, J.D., 301-594-8730; 
[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 for development of a vaccine for 
respiratory or other infections. For collaboration opportunities, 
please contact Peter Soukas, J.D., 301-594-8730; [email protected].

    Dated: October 15, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-23312 Filed 10-24-18; 8:45 am]
 BILLING CODE 4140-01-P