Meeting Notice Correction, 4832 [2023-01448]
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4832
Federal Register / Vol. 88, No. 16 / Wednesday, January 25, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
length of debarment. With respect to the
third and fourth factors, he supports the
findings that he mitigated the impact of
his offenses on the public by fully
cooperating with investigators and that
he had no convictions involving matters
within the jurisdiction of FDA.
Considering all the applicable factors
listed in section 306(c)(3) of the FD&C
Act, the Chief Scientist finds that Dr.
Palaparty’s conviction and underlying
conduct warrant the 3-year debarment
proposed by ORA. It is undisputed that
Dr. Palaparty pled guilty to a serious
misdemeanor offense by causing the
introduction into interstate commerce of
drugs that were misbranded by virtue of
their unapproved status. It is
undisputed that Dr. Palaparty had a
managerial role, further cementing the
serious nature of Dr. Palaparty’s
conduct. While Dr. Palaparty ultimately
took voluntary steps to mitigate the
effect on the public health from the
unlawful conduct and does not have
any previous criminal convictions
related to matters within FDA’s
jurisdiction, those considerations do not
outweigh the nature and seriousness of
the conduct to a degree that would
warrant a debarment period of less than
3 years. Therefore, a 3-year debarment is
appropriate.
Separately, Dr. Palaparty requests
that, in lieu of debarment by FDA, he
enter into a settlement agreement with
FDA whereby he would voluntarily
agree to the terms of the proposed
debarment for the proposed period of
debarment and to not provide services
in any capacity to a person that has an
approved or pending drug product
application. Dr. Palaparty appears to be
proposing an informal resolution of this
debarment matter. However, his request
is now moot, given the foregoing
findings, which establish that Dr.
Palaparty has failed to justify a hearing
with respect to ORA’s proposal to debar
him for 3 years, and support his
debarment for the proposed time.
III. Findings and Order
Therefore, the Chief Scientist, under
section 306(b)(2)(B)(i)(I) of the FD&C
Act and authority delegated to her by
the Commissioner of Food and Drugs,
finds that Dr. Palaparty has been
convicted of a misdemeanor under
Federal law for causing the introduction
into interstate commerce of prescription
drugs that were misbranded under the
FD&C Act and that the conduct
underlying the conviction undermines
the process for the regulation of drugs.
FDA considered the relevant factors
listed in section 306(c)(3) of the FD&C
Act and determined that a 3-year
debarment is appropriate.
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As a result of the foregoing findings,
Dr. Palaparty is debarred for 3 years
from providing services in any capacity
to a person with an approved or
pending drug product application under
sections 505, 512, or 802 of the FD&C
Act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective
January 25, 2023, (see 21 U.S.C.
335a(c)(1)(B) and (c)(2)(A)(iii) and 21
U.S.C. 321(dd)). Any person with an
approved or pending drug application
who knowingly uses the services of Dr.
Palaparty, in any capacity during his
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
FD&C Act (21 U.S.C. 335b(a)(6))). If Dr.
Palaparty, during his period of
debarment, provides services in any
capacity to a person with an approved
or pending drug product application, he
will be subject to civil money penalties
(section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review
any abbreviated new drug applications
submitted by or with the assistance of
Dr. Palaparty during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Dated: January 19, 2023.
Namandje N. Bumpus,
Chief Scientist.
[FR Doc. 2023–01419 Filed 1–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting Notice Correction
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice; correction.
AGENCY:
HRSA published a document
in the Federal Register of December 20,
2022, concerning a meeting of the
National Advisory Council on the
National Health Service Corps
(NACNHSC). The document referenced
the incorrect year. The meeting date
erroneously stated a meeting will occur
in November 2022 when it should state
November 2023.
FOR FURTHER INFORMATION CONTACT:
Diane Fabiyi-King, Designated Federal
Official, Division of National Health
Service Corps, HRSA, 5600 Fishers
Lane, Room 14N23, Rockville, Maryland
20857; phone (301) 443–3609; or
NHSCAdvisoryCouncil@hrsa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Correction
In the Federal Register of December
20, 2022, FR Doc. 2022–27532, page
77850, column 1, section two, bullet
three, correct the ‘‘November 14, 2022,
9:00 a.m.–5:00 p.m. ET and November
15, 2022, 9 a.m.–2 p.m. ET’’ caption to
read: November 14, 2023, 9 a.m.–5 p.m.
ET and November 15, 2023, 9 a.m.–2
p.m. ET.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–01448 Filed 1–24–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board;
Public Meeting
Administration for Strategic
Preparedness and Response (ASPR),
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The National Biodefense
Science Board (NBSB or the Board),
authorized under Section 319M of the
Public Health Service (PHS) Act, as
added by Section 402 of the Pandemic
and All-Hazards Preparedness Act of
2006 and amended by Section 404 of the
Pandemic and All-Hazards
Preparedness Reauthorization Act, will
hold a virtual, public meeting on March
9, 2023. The NBSB provides expert
advice and guidance to the Department
of Health and Human Services (HHS)
regarding current and future chemical,
biological, radiological, and nuclear
threats, as well as other matters related
to disaster preparedness and response.
The Administration for Strategic
Preparedness and Response (ASPR)
manages and convenes the NBSB on
behalf the Secretary of HHS. The NBSB
public meeting will beginning at 11:00
a.m. Eastern time. A detailed agenda
and Zoom registration instructions will
be available on the ASPR website.
Procedures for Public Participation:
The link to pre-register for the public
meeting will be posted on the meeting
website. The online meeting, which use
a webinar format, will include
American Sign Language interpretation
and live captioning.
Members of the public may provide
written comments or submit questions
at any time via email to NBSB@hhs.gov.
Additionally, the NBSB invites
stakeholders to request up to seven
minutes to address the Board in-person
during the meeting. The Board wishes to
hear from experts from relevant
SUMMARY:
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]]>Agencies
[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Page 4832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01448]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting Notice Correction
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: HRSA published a document in the Federal Register of December
20, 2022, concerning a meeting of the National Advisory Council on the
National Health Service Corps (NACNHSC). The document referenced the
incorrect year. The meeting date erroneously stated a meeting will
occur in November 2022 when it should state November 2023.
FOR FURTHER INFORMATION CONTACT: Diane Fabiyi-King, Designated Federal
Official, Division of National Health Service Corps, HRSA, 5600 Fishers
Lane, Room 14N23, Rockville, Maryland 20857; phone (301) 443-3609; or
[email protected].
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of December 20, 2022, FR Doc. 2022-27532,
page 77850, column 1, section two, bullet three, correct the ``November
14, 2022, 9:00 a.m.-5:00 p.m. ET and November 15, 2022, 9 a.m.-2 p.m.
ET'' caption to read: November 14, 2023, 9 a.m.-5 p.m. ET and November
15, 2023, 9 a.m.-2 p.m. ET.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-01448 Filed 1-24-23; 8:45 am]
BILLING CODE 4165-15-P
