National Institute of Mental Health; Amended Notice of Meeting, 3749 [2023-01018]
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
that the offense warranted the
imposition of a 5-year period of
debarment.
The proposal informed Ms. Godding
of the proposed debarment and offered
her an opportunity to request a hearing,
providing her 30 days from the date of
receipt of the letter in which to file the
request, and advised her that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Ms.
Godding received the proposal and
notice of opportunity for a hearing on
August 30, 2022. Ms. Godding failed to
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived her opportunity for a
hearing and waived any contentions
concerning her debarment (21 CFR part
12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Ms. Linda
Godding has been convicted of a felony
under Federal law for conduct relating
to the importation into the United States
of any drug or controlled substance.
FDA finds that the offense should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Ms. Godding is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
effective (see DATES). Pursuant to section
301(cc) of the FD&C Act (21 U.S.C.
331(cc)), the importing or offering for
import into the United States of any
drug by, with the assistance of, or at the
direction of Ms. Godding is a prohibited
act.
Any application by Ms. Godding for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2022–
N–1398 and sent to the Dockets
Management Staff (see ADDRESSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20(j).
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Dated: January 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00997 Filed 1–19–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Mental Health Special Emphasis Panel,
January 24, 2023, 12:00 p.m. to January
24, 2023, 4:00 p.m., National Institutes
of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD,
20852, which was published in the
Federal Register on December 30, 2022,
FR Doc 2022–28446, 87 FR 80554.
This notice is being amended to
change the meeting date from January
24, 2023, to February 2, 2023. Meeting
location and time remain the same. The
meeting is closed to the public.
Dated: January 13, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–01018 Filed 1–19–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Small Cell Lung
Cancer Subtyping Using Plasma CellFree Nucleosomes
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute
(NCI), an institute of the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive,
sublicensable patent license to Yissum
Research and Development (‘‘Yissum’’),
the technology transfer company of the
Hebrew University of Jerusalem, a nonprofit research institution located in
Jerusalem, Israel for NCI’s rights to the
patent applications listed in the
SUPPLEMENTARY INFORMATION section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before February 6, 2023 will be
considered.
SUMMARY:
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive patent license should be
ADDRESSES:
PO 00000
Frm 00045
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3749
directed to: Michaela McCrary, Ph.D.,
Licensing and Patenting Manager, NCI
Technology Transfer Center, at: Email:
michaela.mccrary@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
The following and all continuing U.S.
and foreign patents/patent applications
thereof are the intellectual properties to
be licensed under the prospective
agreement to Yissum: United States
Provisional Patent Application No. 63/
342,763, filed May 17, 2022 and entitled
‘‘SMALL CELL LUNG CANCER
SUBTYPING USING PLASMA CELL–
FREE NUCELOSOMES’’ [HHS Reference
No. E–172–2022–0–US–01].
The patent rights in these inventions
have been assigned to the Government
of the United States of America and
Yissum. The prospective license will be
for the purpose of consolidating the
patent rights to Yissum, the co-owners
of said rights, for commercial
development and marketing.
Consolidation of these co-owned rights
is intended to expedite development of
the invention, consistent with the goals
of the Bayh-Dole Act codified as 35
U.S.C. 200–212.
The prospective patent license
territory will be worldwide, exclusive,
and may be limited to those fields of use
commensurate in scope with the patent
rights. It will be sublicensable, and any
sublicenses granted by Yissum will be
subject to the provisions of 37 CFR part
401 and 404.
This technology discloses a noninvasive method to molecularly subtype
SCLC from plasma samples using
chromatin immunoprecipitation of cellfree nucleosomes carrying active
chromatin modification followed by
sequencing (cfChIP–seq).
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
include terms for the sharing of royalty
income with NCI from commercial
sublicenses of the patent rights. The
prospective exclusive license may be
granted unless within fifteen (15) days
from the date of this published notice,
the National Cancer Institute receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.
Complete applications for a license
that are timely filed in response to this
notice will be treated as objections to
the grant of the contemplated exclusive
patent license. In response to this
Notice, the public may file comments or
objections. Comments and objections,
other than those in the form of a license
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[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Page 3749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01018]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the National
Institute of Mental Health Special Emphasis Panel, January 24, 2023,
12:00 p.m. to January 24, 2023, 4:00 p.m., National Institutes of
Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD,
20852, which was published in the Federal Register on December 30,
2022, FR Doc 2022-28446, 87 FR 80554.
This notice is being amended to change the meeting date from
January 24, 2023, to February 2, 2023. Meeting location and time remain
the same. The meeting is closed to the public.
Dated: January 13, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-01018 Filed 1-19-23; 8:45 am]
BILLING CODE 4140-01-P
