83 FR 53887 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 207 (October 25, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 207 (October 25, 2018)
| Page Range | 53887-53888 | |
| FR Document | 2018-23312 |
[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)] [Notices] [Pages 53887-53888] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23312] ----------------------------------------------------------------------- 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; 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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.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. 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; 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
![Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices 53887
individuals associated with the grant Dated: October 18, 2018. Scholarship Program for Individuals from
applications, the disclosure of which Melanie J. Pantoja, Disadvantaged Backgrounds, National
would constitute a clearly unwarranted Program Analyst, Office of Federal Advisory Institutes of Health, HHS)
invasion of personal privacy. Committee Policy. Dated: October 19, 2018.
Name of Committee: Center for Scientific [FR Doc. 2018–23265 Filed 10–24–18; 8:45 am] Natasha M. Copeland,
Review Special Emphasis Panel; Member BILLING CODE 4140–01–P Program Analyst, Office of Federal Advisory
Conflict: Chronic Disease and Epidemiology. Committee Policy.
Date: November 1, 2018. [FR Doc. 2018–23263 Filed 10–24–18; 8:45 am]
Time: 11:00 a.m. to 1:30 p.m. DEPARTMENT OF HEALTH AND BILLING CODE 4140–01–P
Agenda: To review and evaluate grant HUMAN SERVICES
applications.
Place: National Institutes of Health, 6701 National Institutes of Health
Rockledge Drive, Bethesda, MD 20892 DEPARTMENT OF HEALTH AND
(Telephone Conference Call). Office of the Director, National HUMAN SERVICES
Contact Person: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for Institutes of Health; Notice of Meeting National Institutes of Health
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
Pursuant to section 10(a) of the Government-Owned Inventions;
MSC 7770, Bethesda, MD 20892, 301–435– Federal Advisory Committee Act, as Availability for Licensing
0684, olufokunbisamd@csr.nih.gov. amended (5 U.S.C. App.), notice is
Name of Committee: Center for Scientific hereby given of a meeting of the Office AGENCY: National Institutes of Health,
Review Special Emphasis Panel; AIDS and of AIDS Research Advisory Council. HHS.
Related Research. The meeting will be open to the ACTION: Notice.
Date: November 9, 2018. public, with attendance limited to space
Time: 9:00 a.m. to 3:00 p.m. available. Individuals who plan to SUMMARY: The invention listed below is
Agenda: To review and evaluate grant attend and need special assistance, such owned by an agency of the U.S.
applications. as sign language interpretation or other Government and is available for
Place: National Institutes of Health, 6701 licensing to achieve expeditious
Rockledge Drive, Bethesda, MD 20892
reasonable accommodations, should
notify the Contact Person listed below commercialization of results of
(Virtual Meeting).
Contact Person: Barna Dey, Ph.D., in advance of the meeting. federally-funded research and
Scientific Review Officer, Center for Name of Committee: Office of AIDS
development. Foreign patent
Scientific Review, National Institutes of Research Advisory Council. applications are filed on selected
Health, 6701 Rockledge Drive, Room 3184, Date: November 15, 2018. inventions to extend market coverage
Bethesda, MD 20892, 301–451–2796, bdey@ Time: 8:30 a.m. to 4:30 p.m. for companies and may also be available
mail.nih.gov. Agenda: The forty-ninth OARAC meeting for licensing.
Name of Committee: Center for Scientific will include review of the DHHS HIV/AIDS FOR FURTHER INFORMATION CONTACT:
Review Special Emphasis Panel; PAR Panel: Treatment and Prevention Guidelines; the Peter Soukas, J.D., 301–594–8730;
Review of Aging Applications. OAR Director’s Report; updates on the OAR
Date: November 20, 2018. cost sharing activities with the National peter.soukas@nih.gov. Licensing
Time: 1:00 p.m. to 4:30 p.m. Institute on Aging, the FY2019/2020 Trans- information and copies of the patent
Agenda: To review and evaluate grant NIH Plan for HIV-Related Research; other applications listed below may be
applications. HIV/AIDS research activities across selected obtained by communicating with the
Place: National Institutes of Health, 6701 NIH Institutes; and public comment. indicated licensing contact at the
Rockledge Drive, Bethesda, MD 20892 Place: National Institutes of Health, Technology Transfer and Intellectual
(Virtual Meeting). Conference Room 1D13, 5601 Fishers Lane, Property Office, National Institute of
Contact Person: Seetha Bhagavan, Ph.D., Rockville, MD 20892. Allergy and Infectious Diseases, 5601
Scientific Review Officer, Center for Contact Person: Jay R. Radke, Ph.D.,
Scientific Review, National Institutes of Scientific Review Officer, Office of AIDS
Fishers Lane, Rockville, MD 20852; tel.
Health, 6701 Rockledge Drive, Room 5194, Research, National Institutes of Health, Ofc of 301–496–2644. A signed Confidential
MSC 7846, Bethesda, MD 20892, (301) 237– the Director, 5601 Fishers Lane, Room 2E61 Disclosure Agreement will be required
9838, bhagavas@csr.nih.gov. MSC–9834, Bethesda, MD 20892–9834, (240) to receive copies of unpublished patent
Name of Committee: Center for Scientific 669–5046, jay.radke@nih.gov. applications.
Review Special Emphasis Panel; PAR–18– Any interested person may file written SUPPLEMENTARY INFORMATION:
727: Molecular Profiles and Biomarkers of comments with the committee by forwarding Technology description follows.
Food and Nutrient Intake. the statement to the Contact Person listed on
Date: November 20, 2018. this notice. The statement should include the Use of Rostafuroxin To Inhibit Viral
Time: 1:00 p.m. to 4:30 p.m. name, address, telephone number and when Infection
Agenda: To review and evaluate grant applicable, the business or professional
applications. affiliation of the interested person.
Description of Technology: Acute
Place: National Institutes of Health, 6701 Information is also available on the respiratory infections during early
Rockledge Drive, Bethesda, MD 20892 Institute’s/Center’s home page: childhood constitute a major human
(Telephone Conference Call). www.oar.nih.gov, where an agenda and any health burden. Human respiratory
Contact Person: Gregory S. Shelness, Ph.D., additional information for the meeting will syncytial virus (RSV) is the most
Scientific Review Officer, Center for be posted when available. common and important viral cause of
Scientific Review, National Institutes of (Catalogue of Federal Domestic Assistance severe acute pediatric respiratory
Health, 6701 Rockledge Drive, Room 6156, Program Nos. 93.14, Intramural Research infections worldwide. Mortality due to
daltland on DSKBBV9HB2PROD with NOTICES
Bethesda, MD 20892–7892, (301) 435–0492, Training Award; 93.22, Clinical Research
shelnessgs@csr.nih.gov.
RSV in the post-neonatal (28 days to 1
Loan Repayment Program for Individuals year old) population is second only to
(Catalogue of Federal Domestic Assistance from Disadvantaged Backgrounds; 93.232,
Program Nos. 93.306, Comparative Medicine; Loan Repayment Program for Research malaria. It is estimated that RSV causes
93.333, Clinical Research; 93.306, 93.333, Generally; 93.39, Academic Research 34 million lower respiratory tract
93.337, 93.393–93.396, 93.837–93.844, Enhancement Award; 93.936, NIH Acquired infections, 4 million hospitalizations,
93.846–93.878, 93.892, 93.893, National Immunodeficiency Syndrome Research Loan and 66,000–199,000 deaths every year
Institutes of Health, HHS) Repayment Program; 93.187, Undergraduate in children less than 5 years of age.
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![53888 Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
Most mortality occurs in the developing • Viral diagnostics Time: 1:00 p.m. to 3:00 p.m.
world where clinical care is less • Vaccine research Agenda: To review and evaluate grant
accessible. Mortality is low in the applications.
Competitive Advantages:
developed countries, but the morbidity Place: National Institutes of Health, 6701
• Ease of manufacture Rockledge Drive, Bethesda, MD 20892
is substantial: In the United States • Broad antiviral activity (Telephone Conference Call).
alone, RSV is associated with an • Favorable safety profile in clinical Contact Person: Delia Olufokunbi Sam,
estimated 132,000–172,000 trials Ph.D., Scientific Review Officer, Center for
hospitalizations annually in children Scientific Review, National Institutes of
Development Stage:
less than 5 years old. There is not yet Health, 6701 Rockledge Drive, Room 3158,
available a vaccine or an effective • In vivo data assessment (animal) MSC 7770, Bethesda, MD 20892, 301–435–
antiviral drug suitable for routine use. Inventors: Shirin Munir (NIAID), 0684, olufokunbisamd@csr.nih.gov.
This invention relates to a broadly Matthias Lingemann (NIAID), Peter This notice is being published less than 15
antiviral small chemical molecule, Collins (NIAID). days prior to the meeting due to the timing
Rostafuroxin, expected to be well Intellectual Property: HHS Reference limitations imposed by the review and
tolerated in humans and available for No. E–202–2018–0—U.S. Provisional funding cycle.
clinical evaluation. In particular, this Application No. 62/737,899, filed (Catalogue of Federal Domestic Assistance
patent application relates to the novel September 27, 2018 (pending). Program Nos. 93.306, Comparative Medicine;
Licensing Contact: Peter Soukas, J.D., 93.333, Clinical Research; 93.306, 93.333,
and unexpected finding that 93.337, 93.393–93.396, 93.837–93.844,
Rostafuroxin substantially inhibits RSV 301–594–8730; peter.soukas@nih.gov.
93.846–93.878, 93.892, 93.893, National
infection. Collaborative Research Opportunity:
Institutes of Health, HHS)
ATP1A1 is a host protein involved The National Institute of Allergy and
Infectious Diseases is seeking statements Dated: October 18, 2018.
with cellular entry of RSV. RSV entry
was found to require activation of a of capability or interest from parties Melanie J. Pantoja,
signaling cascade mediated by ATP1A1 interested in collaborative research to Program Analyst, Office of Federal Advisory
which resembles the signaling pathway further develop, evaluate or Committee Policy.
(also mediated by ATP1A1) triggered by commercialize for development of a [FR Doc. 2018–23266 Filed 10–24–18; 8:45 am]
cardiotonic steroids. vaccine for respiratory or other BILLING CODE 4140–01–P
Though not evaluated for RSV, infections. For collaboration
ATPA1A was previously implicated as opportunities, please contact Peter
a pro-viral factor in the infection cycles Soukas, J.D., 301–594–8730; DEPARTMENT OF HOMELAND
of a number of viruses, but the nature peter.soukas@nih.gov. SECURITY
of its involvement and mechanism of Dated: October 15, 2018.
action were unknown. Federal Emergency Management
Suzanne M. Frisbie,
Rostafuroxin, a synthetic Agency
Deputy Director, Technology Transfer and
digitoxigenin derivative, is a small- Intellectual Property Office, National Institute [Docket ID FEMA–2018–0002; Internal
molecule that is known to specifically of Allergy and Infectious Diseases. Agency Docket No. FEMA–B–1855]
bind ATP1A1. It has not been [FR Doc. 2018–23312 Filed 10–24–18; 8:45 am]
previously known to have any antiviral BILLING CODE 4140–01–P
Changes in Flood Hazard
activity. Determinations
The inventors have evidence that AGENCY: Federal Emergency
Rostafuroxin inhibits RSV infection in DEPARTMENT OF HEALTH AND Management Agency, DHS.
respiratory epithelial cells. Rostafuroxin HUMAN SERVICES ACTION: Notice.
inhibits RSV induced ATP1A1-
mediated signaling pathway required for National Institutes of Health SUMMARY: This notice lists communities
RSV entry. This was demonstrated in where the addition or modification of
A549 cells, a widely used human Center for Scientific Review; Notice of
Base Flood Elevations (BFEs), base flood
respiratory epithelial cell line, and in Closed Meeting
depths, Special Flood Hazard Area
primary human airway epithelial cells Pursuant to section 10(d) of the (SFHA) boundaries or zone
derived from a healthy human. Federal Advisory Committee Act, as designations, or the regulatory floodway
Rostafuroxin has been previously amended, notice is hereby given of the (hereinafter referred to as flood hazard
tested in clinical studies as an anti- following meeting. determinations), as shown on the Flood
hypertensive agent. It has no adverse The meeting will be closed to the Insurance Rate Maps (FIRMs), and
effects in healthy humans and, public in accordance with the where applicable, in the supporting
importantly, does not lower the normal provisions set forth in sections Flood Insurance Study (FIS) reports,
systolic blood pressure of healthy 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., prepared by the Federal Emergency
individuals. as amended. The grant applications and Management Agency (FEMA) for each
Rostafuroxin is a promising anti-viral the discussions could disclose community, is appropriate because of
drug candidate for RSV and possibly confidential trade secrets or commercial new scientific or technical data. The
other viruses that use the same pathway property such as patentable material, FIRM, and where applicable, portions of
for host cell entry. and personal information concerning the FIS report, have been revised to
This technology is available for individuals associated with the grant reflect these flood hazard
daltland on DSKBBV9HB2PROD with NOTICES
licensing for commercial development applications, the disclosure of which determinations through issuance of a
in accordance with 35 U.S.C. 209 and 37 would constitute a clearly unwarranted Letter of Map Revision (LOMR), in
CFR part 404, as well as for further invasion of personal privacy. accordance with Federal Regulations.
development and evaluation under a The LOMR will be used by insurance
Name of Committee: Center for Scientific
research collaboration. Review Special Emphasis Panel; Member agents and others to calculate
Potential Commercial Applications: Conflict: Chronic Disease and Epidemiology. appropriate flood insurance premium
• Viral therapeutics Date: October 24, 2018. rates for new buildings and the contents
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Document Created: 2018-10-25 01:43:30
Document Modified: 2018-10-25 01:43:30
| 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 | 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. | |
| FR Citation | 83 FR 53887 |
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