National Institute of Environmental Health Sciences; Notice of Closed Meeting, 68910 [2024-19319]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
68910
Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
FENTANYL CITRATE Injections, EQ
2.5 mg base/50 mL (EQ 0.05 mg base/
mL) and EQ 5 mg base/100 mL (EQ 0.05
mg base/mL), are the subject of NDA
215870, held by Exela Pharma Sciences,
LLC, and initially approved on February
8, 2023. FENTANYL CITRATE is
indicated in adult and pediatric patients
ages 2 years and older for use as an
opioid analgesic supplement in general
anesthesia, for administration with a
neuroleptic for the induction of
anesthesia and as an adjunct in the
maintenance of general anesthesia, and
for use as an anesthetic agent with
oxygen in selected high-risk patients,
such as those undergoing open heart
surgery or certain complicated
neurological or orthopedic procedures.
Exela Pharma Sciences, LLC, has
never marketed FENTANYL Injections,
EQ 2.5 mg base/50 mL (EQ 0.05 mg
base/mL) and EQ 5 mg base/100mL (EQ
0.05 mg base/mL). In a letter dated May
5, 2023, Exela Pharma Sciences, LLC,
notified FDA that FENTANYL CITRATE
Injections, EQ 2.5 mg base/50 mL (EQ
0.05 mg base/mL) and EQ 5 mg base/100
mL (EQ 0.05 mg base/mL), were being
discontinued, and FDA moved these
drug products to the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. In previous instances (see, e.g., 72
FR 9763 (March 5, 2007) and 61 FR
25497 (May 21, 1996)), the Agency has
determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale.
VerDate Sep<11>2014
18:13 Aug 27, 2024
Jkt 262001
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated
February 13, 2024 (Docket No. FDA–
2024–P–0805), under 21 CFR 10.30,
requesting that the Agency determine
whether FENTANYL CITRATE
Injections, EQ 2.5 mg base/50 mL (EQ
0.05 mg base/mL) and EQ 5 mg base/100
mL (EQ 0.05 mg base/mL), were
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that FENTANYL CITRATE
Injections, EQ 2.5 mg base/50 mL (EQ
0.05 mg base/mL) and EQ 5 mg base/100
mL (EQ 0.05 mg base/mL), were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that these drug products
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
FENTANYL CITRATE Injections, EQ 2.5
mg base/50 mL (EQ 0.05 mg base/mL)
and EQ 5 mg base/100 mL (EQ 0.05 mg
base/mL), from sale. We have reviewed
the available evidence and determined
that these drug products were not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list FENTANYL CITRATE
Injections, EQ 2.5 mg base/50 mL (EQ
0.05 mg base/mL) and EQ 5 mg base/100
mL (EQ 0.05 mg base/mL), in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to FENTANYL CITRATE Injections, EQ
2.5 mg base/50 mL (EQ 0.05 mg base/
mL) and EQ 5 mg base/100 mL (EQ 0.05
mg base/mL), may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for these drug
products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Dated: August 23, 2024.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–19333 Filed 8–27–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00062
Fmt 4703
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National
Institute of Environmental Health
Sciences Special Emphasis Panel:
NIEHS Support for Conferences and
Scientific Meeting R13.
Date: September 27, 2024.
Time: 11:30 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of
Environmental Health Sciences,
Keystone Building, 530 Davis Drive,
Durham, NC 27709 (Virtual Meeting).
Contact Person: Murali Ganesan,
Ph.D., Scientific Review Officer,
Scientific Review Branch, Division of
Extramural Research and Training
(DERT), National Institute of
Environmental Health Sciences,
National Institutes of Health, Keystone
Building, Room 3097, Research Triangle
Park, NC 27713, Phone: 984–287–4674,
Email: murali.ganesan@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation Health Risks from Environmental
Exposures; 93.142, NIEHS Hazardous Waste
Worker Health and Safety Training; 93.143,
NIEHS Superfund Hazardous Substances—
Basic Research and Education; 93.894,
Resources and Manpower Development in
the Environmental Health Sciences; 93.113,
Biological Response to Environmental Health
Hazards; 93.114, Applied Toxicological
Research and Testing, National Institutes of
Health, HHS)
[FR Doc. 2024–19319 Filed 8–27–24; 8:45 am]
BILLING CODE 4140–01–P
Sfmt 4703
E:\FR\FM\28AUN1.SGM
28AUN1
]]>Agencies
[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Page 68910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19319]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences; Notice of
Closed Meeting
Pursuant to section 1009 of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Environmental Health
Sciences Special Emphasis Panel: NIEHS Support for Conferences and
Scientific Meeting R13.
Date: September 27, 2024.
Time: 11:30 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Environmental Health Sciences,
Keystone Building, 530 Davis Drive, Durham, NC 27709 (Virtual Meeting).
Contact Person: Murali Ganesan, Ph.D., Scientific Review Officer,
Scientific Review Branch, Division of Extramural Research and Training
(DERT), National Institute of Environmental Health Sciences, National
Institutes of Health, Keystone Building, Room 3097, Research Triangle
Park, NC 27713, Phone: 984-287-4674, Email: [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.115,
Biometry and Risk Estimation Health Risks from Environmental
Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund Hazardous Substances--Basic
Research and Education; 93.894, Resources and Manpower Development
in the Environmental Health Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114, Applied Toxicological Research
and Testing, National Institutes of Health, HHS)
Dated: August 23, 2024.
Bruce A. George,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-19319 Filed 8-27-24; 8:45 am]
BILLING CODE 4140-01-P
