Prescription Drug User Fee Rates for Fiscal Year 2024; Correction, 51330 [2023-16575]
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51330
Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
In July 2017, the Centers for Disease
Control and Prevention notified FDA of
multiple cases of B. cepacia infections
in pediatric patients at Stanford
Children’s Health Lucile Packard
Children’s Hospital in Palo Alto, CA
and Johns Hopkins Children’s Center in
Baltimore, MD. FDA investigated and
collected bottles of Diocto Liquid from
these medical centers. The collected
bottles were from the same lot that
Pharmatech distributed in March
2017—the same lot that Pharmatech
failed to disclose to FDA. Several of the
bottles contained total aerobic microbial
counts and total yeast and mold counts
in excess of acceptable limits and some
of the bottles also tested positive for the
presence of B. cepacia.
In September 2017, FDA initiated an
inspection of Ofcus Pharma. During that
inspection the individual Mr. Figueroa
asked to misrepresent to FDA that they
owned Ofcus Pharma, did in fact make
false statements to an FDA investigator
when they told the investigator they had
full ownership of Ofcus Pharma.
Based on this conviction, FDA sent
Mr. Figueroa by certified mail on March
20, 2023, a notice proposing to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(B) of the FD&C Act, that Mr.
Figueroa was convicted, as set forth in
section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct
relating to the regulation of a drug
product under the FD&C Act. The
proposal also offered Mr. Figueroa an
opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
file a timely request for a hearing would
constitute an election not to use the
opportunity for a hearing and a waiver
of any contentions concerning this
action. Mr. Figueroa received the
proposal on March 30, 2023. He did not
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived his opportunity for a
hearing and any contentions concerning
his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Figueroa
has been convicted of a felony under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act.
VerDate Sep<11>2014
17:35 Aug 02, 2023
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As a result of the foregoing finding,
Mr. Figueroa is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application,
effective (see DATES) (see sections
306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C
Act). Any person with an approved or
pending drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
uses in any capacity the services of Mr.
Figueroa 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 Mr. Figueroa provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment 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 application from Mr. Figueroa
during his period of debarment, other
than in connection with an audit under
section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that,
for purposes of sections 306 and 307 of
the FD&C Act, a ‘‘drug product’’ is
defined as a ‘‘drug subject to regulation
under section 505, 512, or 802 of this
Act [(21 U.S.C. 355, 360b, 382)] or under
section 351 of the Public Health Service
Act [(42 U.S.C. 262)]’’ (section 201(dd)
of the FD&C Act (21 U.S.C. 321(dd))).
and International Affairs, Food and
Drug Administration, 301–796–9115,
Lisa.Granger@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 28, 2023 (88 FR
48881), in FR Doc. 2023–15911, the
following correction is made:
On page 48883, in section II.C., table
4, ‘‘CDER Actual FY 2022 Workload
Volumes and Predicted FY 2024
Workload Volumes,’’ in the third
column (‘‘FY 2024 predictions’’), fourth
row (‘‘NDA/BLA Original’’), ‘‘1,136’’ is
corrected to read ‘‘136.’’
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
SUMMARY:
[FR Doc. 2023–16550 Filed 8–2–23; 8:45 am]
BILLING CODE 4161–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2850]
Prescription Drug User Fee Rates for
Fiscal Year 2024; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Prescription Drug User Fee
Rates for Fiscal Year 2024’’ that
appeared in the Federal Register of July
28, 2023. The document announced the
rates for prescription drug user fees for
fiscal year 2024. The document was
published with an incorrect value in a
table. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy, Legislation,
SUMMARY:
PO 00000
Frm 00072
Fmt 4703
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Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16575 Filed 8–2–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Supplemental Award; Early
Childhood Developmental Health
Systems Cooperative Agreement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of a HRSA-initiated
supplemental award.
AGENCY:
HRSA announces the award
of a supplement for a total of
approximately $1 million in fiscal year
(FY) 2023 for the Early Childhood
Developmental Health Systems (ECDHS)
cooperative agreement. The supplement
will provide approximately $600,000 to
the current recipient during the period
of September 30, 2023, to September 29,
2024, to continue to support the
implementation, spread, and scale of
early childhood development (ECD)
expert integration, and associated early
childhood systems development. This
includes providing intensive,
individualized technical assistance (TA)
to four additional Transforming
Pediatrics in Early Childhood (TPEC)
Program state-level recipients. In
addition, the supplement further
includes approximately $400,000 to
provide TA to HRSA-funded health
centers who are expanding early
childhood developmental services
through ECD funding.
FOR FURTHER INFORMATION CONTACT:
Natalie Surfus, MPH; Public Health
Analyst, Division of Home Visiting and
Early Childhood Systems, Maternal and
Child Health Bureau. Telephone: (240)
381–8202; Email: NSurfus@hrsa.gov.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\03AUN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Page 51330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16575]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2850]
Prescription Drug User Fee Rates for Fiscal Year 2024; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Prescription Drug User Fee Rates for Fiscal Year 2024'' that
appeared in the Federal Register of July 28, 2023. The document
announced the rates for prescription drug user fees for fiscal year
2024. The document was published with an incorrect value in a table.
This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy,
Legislation, and International Affairs, Food and Drug Administration,
301-796-9115, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of July 28, 2023 (88
FR 48881), in FR Doc. 2023-15911, the following correction is made:
On page 48883, in section II.C., table 4, ``CDER Actual FY 2022
Workload Volumes and Predicted FY 2024 Workload Volumes,'' in the third
column (``FY 2024 predictions''), fourth row (``NDA/BLA Original''),
``1,136'' is corrected to read ``136.''
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16575 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P
