82_FR_41479 82 FR 41312 - Notice of Intent To Grant an Exclusive License

82 FR 41312 - Notice of Intent To Grant an Exclusive License

DEPARTMENT OF VETERANS AFFAIRS

Federal Register Volume 82, Issue 167 (August 30, 2017)

Page Range41312-41313
FR Document2017-18370

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.

Federal Register, Volume 82 Issue 167 (Wednesday, August 30, 2017)
[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41312-41313]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18370]


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DEPARTMENT OF VETERANS AFFAIRS


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.

[[Page 41313]]

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.

    Dated: August 24, 2017.
Jeffrey Martin,
Office Program Manager, Office of Regulation Policy & Management, 
Office of the Secretary, Department of Veterans Affairs.
[FR Doc. 2017-18370 Filed 8-29-17; 8:45 am]
 BILLING CODE 8320-01-P



                                                  41312                      Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices

                                                     OMB Control Number: 1545–2044.                       chapter 3. A Form W–14 must be                        treatment comprising administering to
                                                     Type of Review: Extension without                    provided to the acquiring agency (U.S.                said subject an effective amount of a
                                                  change of a currently approved                          government department, agency,                        composition comprising, as an active
                                                  collection.                                             independent establishment, or                         agent, one or more of a carboxy alkyl
                                                     Abstract: This revenue procedure                     corporation) to: Establish that they are a            ester, a quinic acid derivative, a caffeic
                                                  2015–40 provides guidance on the                        foreign contracting party; and If                     acid derivative, a ferulic acid derivative,
                                                  process of requesting and obtaining                     applicable, claim an exemption from                   or a quinic acid lactone or derivative
                                                  assistance under U.S. tax treaties from                 withholding based on an international                 thereof or pharmaceutically acceptable
                                                  the U.S. competent authority, acting                    agreement (such as a tax treaty); or                  salt thereof and an acceptable carrier or
                                                  through the Advance Pricing and                         Claim an exemption from withholding,                  excipient, so as to treat auditory
                                                  Mutual Agreement Program and the                        in whole or in part, based on an                      impairments in the subject. Ultimately,
                                                  Treaty Assistance and Interpretation                    international procurement agreement or                this invention provides a novel
                                                  Team of the Deputy Commissioner                         because goods are produced, or services               therapeutic option for otoprotection
                                                  (International), Large Business &                       are performed in the United States. A                 and/or hearing recovery following
                                                  International Division of the Internal                  Form W–14 must be provided to the                     injury.
                                                  Revenue Service. This revenue                           acquiring agency if a foreign contracting
                                                  procedure updates and supersedes Rev.                   party has been paid a specified Federal               DATES:Comments must be received
                                                  Proc. 2006–54, 2006–2 C.B. 1035, and is                 procurement payment and the foreign                   September 14, 2017.
                                                  being issued concurrently with Rev.                     contracting party is seeking to claim an              ADDRESSES:   Written comments may be
                                                  Proc. 2015–41, 2015–35 I.R.B., which                    exemption (in whole or in part) from the              submitted through www.regulations.gov;
                                                  provides guidance with respect to                       tax imposed by section 5000C. Form W–                 by mail or hand-delivery to the Director,
                                                  advance pricing agreements.                             14 must be submitted when requested                   Regulations Management (02REG),
                                                     This revenue procedure also reflects                 by the acquiring agency, whether or not               Department of Veterans Affairs, 810
                                                  modifications based on continuing                       an exemption (in whole or in part) is                 Vermont Avenue NW., Room 1068,
                                                  internal monitoring of the                              claimed from withholding under section                Washington, DC 20420; or by fax to
                                                  administrative procedures of the U.S.                   5000C.                                                (202) 273–9026 (this is a toll-free
                                                  competent authority to ensure that the                    Form: W–14.                                         number). Copies of comments received
                                                  administration of U.S. tax treaties is                    Affected Public: Federal Government.                will be available for public inspection in
                                                  consistently principled, effective, and                   Estimated Total Annual Burden                       the Office of Regulation Policy and
                                                  efficient.                                              Hours: 11,840.
                                                     Form: None.                                                                                                Management, Room 1063B, between the
                                                     Affected Public: Individuals or                        Authority: 44 U.S.C. 3501 et seq.                   hours of 8:00 a.m. and 4:30 p.m.,
                                                  Households.                                               Dated: August 24, 2017.                             Monday through Friday (except
                                                     Estimated Total Annual Burden                                                                              holidays). Call (202) 461–4902 for an
                                                                                                          Jennifer P. Leonard,
                                                  Hours: 9,000.                                                                                                 appointment (this is not a toll-free
                                                                                                          Treasury PRA Clearance Officer.
                                                     Title: Form W–14—Certificate of                                                                            number). In addition, during the
                                                                                                          [FR Doc. 2017–18364 Filed 8–29–17; 8:45 am]           comment period, comments may be
                                                  Foreign Contracting Party Receiving
                                                  Federal Procurement Payments.
                                                                                                          BILLING CODE 4830–01–P                                viewed online through the Federal
                                                     OMB Control Number: 1545–2263.                                                                             Docket Management System at
                                                     Type of Review: Extension without                                                                          www.regulations.gov.
                                                  change of a currently approved                          DEPARTMENT OF VETERANS
                                                                                                          AFFAIRS                                               FOR FURTHER INFORMATION CONTACT:       Dr.
                                                  collection.                                                                                                   Lee A. Sylvers, Technology Transfer
                                                     Abstract: Tax on Certain Foreign
                                                                                                          Notice of Intent To Grant an Exclusive                Specialist, Office of Research and
                                                  Procurement, Notice of Purposed
                                                                                                          License                                               Development (10P9TT), Department of
                                                  Rulemaking, contains proposed
                                                                                                                                                                Veterans Affairs, 810 Vermont Avenue
                                                  regulations under section 5000C of the                  AGENCY:   Department of Veterans Affairs.             NW., Washington, DC 20420, (202) 443–
                                                  Internal Revenue Code. The proposed                     ACTION:   Notice of intent.                           5646 (this is not a toll-free number).
                                                  regulations affect U.S. government
                                                  acquiring agencies and foreign persons                  SUMMARY:   Notice is hereby given that                SUPPLEMENTARY INFORMATION:      It is in the
                                                  providing certain goods or services to                  the Department of Veterans Affairs (VA),              public interest to license this invention.
                                                  the U.S. government pursuant to a                       Office of Research and Development,                   NAU submitted a complete and
                                                  contract. This document also contains                   Technology Transfer Program, intends                  sufficient application for a license. The
                                                  proposed regulations under section                      to grant to the Arizona Board of Regents,             prospective exclusive license will be
                                                  6114, with respect to foreign persons                   for and on behalf of Northern Arizona                 royalty-bearing and will comply with
                                                  claiming an exemption from the tax                      University (NAU), 1395 South Knoles                   the terms and conditions of 35 U.S.C.
                                                  under an income tax treaty. Section                     Drive, PO Box 4087, Flagstaff, AZ                     209 and 37 CFR 404.7. The prospective
                                                  5000C imposes a 2% tax on foreign                       86011–4087, an exclusive license to                   exclusive license may be granted unless,
                                                  persons (as defined in section                          U.S. Patent No. 9,457,009 (‘‘Methods                  within 15 days from the date of this
                                                  7701(a)(30)), that are parties to specified             and Compositions for Preventing and                   published Notice, the Department of
                                                  Federal procurement contracts with the                  Treating Auditory Dysfunctions’’) and                 Veterans Affairs, Office of Research and
                                                  U.S. government entered into on and                     related patent applications associated                Development, Technology Transfer
                                                  after January 2, 2011. This tax is                      with VA Invention Disclosure number                   Program receives written evidence and
mstockstill on DSK30JT082PROD with NOTICES




                                                  imposed on the gross amount of                          10–148, titled, ‘‘Otoprotective Uncaria               argument which establishes that the
                                                  specified Federal procurement                           Tomentosa.’’ The invention provides                   grant of the license would not be
                                                  payments and is generally collected by                  methods for treating auditory                         consistent with the requirements of 35
                                                  increasing the amount withheld under                    impairments in a subject in need of                   U.S.C. 209 and 37 CFR 404.7.




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                                                                             Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices                                                 41313

                                                  Signing Authority                                       electronically as an official document of               Dated: August 24, 2017.
                                                                                                          the Department of Veterans Affairs. Gina              Jeffrey Martin,
                                                    The Secretary of Veterans Affairs, or                 S. Farrisee, Deputy Chief of Staff,                   Office Program Manager, Office of Regulation
                                                  designee, approved this document and                    Department of Veterans Affairs,                       Policy & Management, Office of the Secretary,
                                                  authorized the undersigned to sign and                                                                        Department of Veterans Affairs.
                                                                                                          approved this document on August 24,
                                                  submit the document to the Office of the                                                                      [FR Doc. 2017–18370 Filed 8–29–17; 8:45 am]
                                                                                                          2017, for publication.
                                                  Federal Register for publication                                                                              BILLING CODE 8320–01–P
mstockstill on DSK30JT082PROD with NOTICES




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Document Created: 2017-08-30 04:08:30
Document Modified: 2017-08-30 04:08:30
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 of intent.
DatesComments must be received September 14, 2017.
ContactDr. 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).
FR Citation82 FR 41312 

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