Government-Owned Inventions; Availability for Licensing, 76086 [2020-26168]
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Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices
finalized. FDA made changes to provide
additional clarification, including
adding information regarding in-use
labeling language that we recommend
for multi-dose animal drug products
(mostly food animal drugs) for which
less than the theoretical maximum
number of punctures are used for the inuse stability study; providing examples
of adverse trending that may lead us to
recommend the use of aged product for
in-use stability studies; and clarifying
that if changes are made to the storage
temperature or expiry period that would
impact a current in-use statement on an
approved animal drugs, that we
recommend sponsors reassess the in-use
statement and submit revised labeling
for review.
This final guidance reflects the
Agency’s current thinking on how to
formulate in-use statements, as well as
how to design and carry out in-use
stability studies to support these in-use
statements, for multiple-dose injectable
drug products intended for use in
animals. This current thinking pertains
to both generic drug products and
pioneer drug products regardless of
whether the pioneer RLNAD currently
has an in-use statement on the labeling.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘In-Use Stability
Studies and Associated Labeling
Statements for Multiple-Dose Injectable
Animal Drug Products.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
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II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required.
However, this guidance refers to
previously approved FDA collections of
information. These collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032; the collections of
information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117; and the collections
of information in sections 512(b) and
512(n) of the Federal Food, Drug, and
Cosmetic Act have been approved under
OMB control number 0910–0669.
VerDate Sep<11>2014
19:29 Nov 25, 2020
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III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidance-industry
or https://www.regulations.gov.
Dated: November 20, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26183 Filed 11–25–20; 8:45 am]
BILLING CODE 4164–01–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 inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Licensing information may be obtained
by communicating with Betty B. Tong,
Ph.D., National Institute of Diabetes and
Digestive and Kidney Diseases,
Technology Advancement Office, 12A
South Drive Suite 3011, Bethesda, MD
20892; telephone: 301–451–7836; email:
tongb@mail.nih.gov. A signed
Confidential Disclosure Agreement may
be required to receive any unpublished
information.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Potential Commercial Applications
Development of P2Y14 receptor
antagonist for treatment of disorders,
such as:
• Inflammation
• diabetes
• cystic fibrosis
• asthma
• neurodegeneration
Development Stage:
• Early stage
Inventors: Kenneth A. Jacobson
(NIDDK), Jinha Yu (NIDDK), Antonella
Ciancetta (NIDDK), Zhiwei Wen
(NIDDK), Young-Hwan Jung (NIDDK)
Publications: Yu J, Ciancetta A, Dudas
S, et al., Structure-guided modification
of heterocyclic antagonists of the P2Y14
receptor. J. Med. Chem., 2018, 61: 4860–
4882, Jung YH, Yu J, Wen Z, et al.,
Exploration of alternative scaffolds for
P2Y14 receptor antagonists containing a
biaryl core. J. Med. Chem., 2020,
63:9563–9589.
Intellectual Property: HHS Reference
No. E–028–2018–0/1, US Provisional
Patent Application 62/628,699 filed 09
Feb 2018, International Patent
Application PCT/US2019/17422, filed
11 Feb 2019.
Licensing Contact: Betty B. Tong,
Ph.D.; 301–451–7836; tongb@
mail.nih.gov. This notice is made in
accordance with 35 U.S.C. 209 and 37
CFR part 404.
Dated: November 19, 2020.
Bei Tong,
Senior Licensing and Patenting Manager,
National Institute of Diabetes and Digestive
and Kidney Diseases, Technology
Advancement Office.
[FR Doc. 2020–26168 Filed 11–25–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
P2Y14 Receptor Antagonists Containing
A Biaryl Core
National Institutes of Health
The technology discloses composition
of compounds that fully antagonize the
human P2Y14 receptor, with moderate
affinity with insignificant antagonism of
other P2Y receptors. Therefore, they are
highly selective P2Y14 receptor
antagonists. Even though there is no
P2Y14 receptor modulators in clinical
use currently, selective P2Y14 receptor
antagonists are sought as potential
therapeutic treatments for asthma, cystic
fibrosis, inflammation and possibly
diabetes and neurodegeneration.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Office of the Director; Notice of Charter
Renewal
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the National
Toxicology Program Board of Scientific
Counselors was renewed for an
additional two-year period on
November 14, 2020.
It is determined that the National
Toxicology Program Board of Scientific
Counselors is in the public interest in
connection with the performance of
duties imposed on the National
Institutes of Health by law, and that
these duties can best be performed
E:\FR\FM\27NON1.SGM
27NON1
]]>Agencies
[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Page 76086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26168]
-----------------------------------------------------------------------
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 inventions listed below are owned by an agency of the U.S.
Government and are available for licensing to achieve expeditious
commercialization of results of federally-funded research and
development.
FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained
by communicating with Betty B. Tong, Ph.D., National Institute of
Diabetes and Digestive and Kidney Diseases, Technology Advancement
Office, 12A South Drive Suite 3011, Bethesda, MD 20892; telephone: 301-
451-7836; email: [email protected]. A signed Confidential Disclosure
Agreement may be required to receive any unpublished information.
SUPPLEMENTARY INFORMATION: Technology description follows.
P2Y14 Receptor Antagonists Containing A Biaryl Core
The technology discloses composition of compounds that fully
antagonize the human P2Y14 receptor, with moderate affinity with
insignificant antagonism of other P2Y receptors. Therefore, they are
highly selective P2Y14 receptor antagonists. Even though there is no
P2Y14 receptor modulators in clinical use currently, selective P2Y14
receptor antagonists are sought as potential therapeutic treatments for
asthma, cystic fibrosis, inflammation and possibly diabetes and
neurodegeneration.
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
Development of P2Y14 receptor antagonist for treatment of
disorders, such as:
Inflammation
diabetes
cystic fibrosis
asthma
neurodegeneration
Development Stage:
Early stage
Inventors: Kenneth A. Jacobson (NIDDK), Jinha Yu (NIDDK), Antonella
Ciancetta (NIDDK), Zhiwei Wen (NIDDK), Young-Hwan Jung (NIDDK)
Publications: Yu J, Ciancetta A, Dudas S, et al., Structure-guided
modification of heterocyclic antagonists of the P2Y14 receptor. J. Med.
Chem., 2018, 61: 4860-4882, Jung YH, Yu J, Wen Z, et al., Exploration
of alternative scaffolds for P2Y14 receptor antagonists containing a
biaryl core. J. Med. Chem., 2020, 63:9563-9589.
Intellectual Property: HHS Reference No. E-028-2018-0/1, US
Provisional Patent Application 62/628,699 filed 09 Feb 2018,
International Patent Application PCT/US2019/17422, filed 11 Feb 2019.
Licensing Contact: Betty B. Tong, Ph.D.; 301-451-7836;
[email protected]. This notice is made in accordance with 35 U.S.C.
209 and 37 CFR part 404.
Dated: November 19, 2020.
Bei Tong,
Senior Licensing and Patenting Manager, National Institute of Diabetes
and Digestive and Kidney Diseases, Technology Advancement Office.
[FR Doc. 2020-26168 Filed 11-25-20; 8:45 am]
BILLING CODE 4140-01-P
