Notice of Intent To Grant an Exclusive License

AGENCY:

Department of Veterans Affairs.

ACTION:

Notice of intent.

SUMMARY:

Notice is hereby given that the Department of Veterans Affairs (VA), Office of Research and Development, Technology Transfer Program, intends to grant to the Arizona Board of Regents, for and on behalf of Northern Arizona University (NAU), 1395 South Knoles Drive, PO Box 4087, Flagstaff, AZ 86011-4087, an exclusive license to U.S. Patent No. 9,457,009 (“Methods and Compositions for Preventing and Treating Auditory Dysfunctions”) and related patent applications associated with VA Invention Disclosure number 10-148, titled, “Otoprotective Uncaria Tomentosa.” The invention provides methods for treating auditory impairments in a subject in need of treatment comprising administering to said subject an effective amount of a composition comprising, as an active agent, one or more of a carboxy alkyl ester, a quinic acid derivative, a caffeic acid derivative, a ferulic acid derivative, or a quinic acid lactone or derivative thereof or pharmaceutically acceptable salt thereof and an acceptable carrier or excipient, so as to treat auditory impairments in the subject. Ultimately, this invention provides a novel therapeutic option for otoprotection and/or hearing recovery following injury.

DATES:

Comments must be received September 14, 2017.

ADDRESSES:

Written comments may be submitted through www.regulations.gov;; by mail or hand-delivery to the Director, Regulations Management (02REG), Department of Veterans Affairs, 810 Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026 (this is a toll-free number). Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Call (202) 461-4902 for an appointment (this is not a toll-free number). In addition, during the comment period, comments may be viewed online through the Federal Docket Management System at www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Dr. Lee A. Sylvers, Technology Transfer Specialist, Office of Research and Development (10P9TT), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 443-5646 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

It is in the public interest to license this invention. NAU submitted a complete and sufficient application for a license. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 15 days from the date of this published Notice, the Department of Veterans Affairs, Office of Research and Development, Technology Transfer Program receives written evidence and argument which establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Signing Authority

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on August 24, 2017, for publication.