Determination That FORADIL (Formoterol Fumarate) Inhalation Powder, 0.012 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 76218-76219 [2023-24506]
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Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices
catalogs or other public documents
during the normal course of business.
The nominal amount of burden imposed
on the public is simply to relay the
requested information.
Respondents: 14,000.
Responses per Respondent: 1.
Total Annual Responses: 14,000.
Hours per Response: 0.03 (2 minutes).
Total Burden Hours: 420.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate and
based on valid assumptions and
methodology; and ways to enhance the
quality, utility, and clarity of the
information to be collected.
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information collection documents from
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GSARegSec@gsa.gov.
Please cite OMB Control No. 3090–
0250, FSS Contract Administration
Information, in all correspondence.
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
BILLING CODE 6820–14–P
GENERAL SERVICES
ADMINISTRATION
[Notice-MRB–2023–06; Docket No. 2023–
0002; Sequence No. 37]
GSA Acquisition Policy Federal
Advisory Committee; Notification of
Upcoming Web-Based Public Meeting
Office of Government-wide
Policy (OGP), General Services
Administration (GSA).
ACTION: Meeting notice.
AGENCY:
GSA is providing notice of a
meeting of the GSA Acquisition Policy
Federal Advisory Committee
(hereinafter ‘‘the Committee’’ or ‘‘the
GAP FAC’’) in accordance with the
requirements of the Federal Advisory
Committee Act (FACA). This meeting
will be open to the public, accessible via
webcast. Information on attending and
providing written public comment is
under the SUPPLEMENTARY INFORMATION
section.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
The GAP FAC will hold an open
public meeting on Tuesday, December
5, 2023, from 1 p.m. to 4:30 p.m. eastern
standard time (EST).
VerDate Sep<11>2014
17:53 Nov 03, 2023
Jkt 262001
SUPPLEMENTARY INFORMATION:
Purpose of the Meeting
The purpose of this meeting is for
each of the three subcommittees (Policy
and Practice, Industry Partnerships, and
Acquisition Workforce) to present
recommendations to the full Committee.
The Committee will, in turn, deliberate
and vote on GAP FAC recommendations
to be delivered to the GSA
Administrator.
Meeting Agenda
[FR Doc. 2023–24433 Filed 11–3–23; 8:45 am]
DATES:
The meeting will be
accessible via webcast. Registrants will
receive the webcast information before
the meeting.
FOR FURTHER INFORMATION CONTACT:
Boris Arratia, Designated Federal
Officer, OGP, 703–795–0816, or email:
boris.arratia@gsa.gov; or Stephanie
Hardison, OGP, 202–258–6823, or
email: stephanie.hardison@gsa.gov.
Additional information about the
Committee, including meeting materials
and agendas, are available on-line at
https://gsa.gov/policy-regulations/
policy/acquisition-policy/gsaacquisition-policy-federal-advisorycommittee.
ADDRESSES:
• Opening Remarks
• Guest Speaker
• Acquisition Workforce Subcommittee
Recommendations and Discussion
• Vote on recommendations
• Industry Partnerships Subcommittee
Recommendations and Discussion
• Vote on recommendations
• Policy and Practices Subcommittee
Recommendations and Discussion
• Vote on recommendations
• Closing Remarks and Adjourn
Meeting Registration
This meeting is open to the public
and will be accessible by webcast.
Registration information is located on
the GAP FAC website: https://
www.gsa.gov/policy-regulations/policy/
acquisition-policy/gsa-acquisitionpolicy-federal-advisory-committee.
Public attendees who want to attend
virtually will need to register no later
than 5 p.m. EST, on Monday, December
4, 2023 to obtain the meeting webcast
information. All registrants will be
asked to provide their name, affiliation,
and email address. After registration,
individuals will receive webcast access
information details via email.
Public Comments:
Written public comments are being
accepted via email at gapfac@gsa.gov.
To submit a written public comment,
please email at gapfac.gsa.gov and
PO 00000
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include your name, organization name
(if applicable).
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
[FR Doc. 2023–24432 Filed 11–3–23; 8:45 am]
BILLING CODE 6820–RV–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–P–2536]
Determination That FORADIL
(Formoterol Fumarate) Inhalation
Powder, 0.012 Milligrams, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) has determined that FORADIL
(formoterol fumarate) inhalation
powder, 0.012 milligrams (mg)/
inhalation (inh), was not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
formoterol fumarate inhalation powder,
0.012 mg/inh, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Joe
Thomas, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6217, Silver Spring,
MD 20993–0002, 202–815–5571,
joseph.thomas1@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved; and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
SUMMARY:
E:\FR\FM\06NON1.SGM
06NON1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices
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.
FORADIL (formoterol fumarate)
inhalation powder, 0.012 mg/inh, is the
subject of NDA 020831, held by
Novartis Pharmaceuticals Corp., and
initially approved on February 16, 2001.
FORADIL is indicated for treatment of
asthma in patients 5 years of age and
older as an add-on to a long-term
asthma control medication such as an
inhaled corticosteroid; prevention of
exercise-induced bronchospasm (EIB) in
patients 5 years of age and older; and
maintenance treatment of
bronchoconstriction in patients with
chronic obstructive pulmonary disease.
In a letter dated September 30, 2015,
Novartis Pharmaceuticals Corp. notified
FDA that FORADIL (formoterol
fumarate) inhalation powder, 0.012 mg/
inh, was being discontinued, and FDA
moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In the
Federal Register of June 21, 2018 (83 FR
28856), FDA announced that it was
withdrawing approval of NDA 020831,
effective July 23, 2018.
K&L Gates LLP submitted a citizen
petition dated June 21, 2023 (Docket No.
FDA–2023–P–2536), under 21 CFR
10.30, requesting that the Agency
determine whether FORADIL
(formoterol fumarate) inhalation
powder, 0.012 mg/inh, was 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 FORADIL (formoterol
fumarate) inhalation powder, 0.012 mg/
inh, was not withdrawn for reasons of
safety or effectiveness. The petitioner
VerDate Sep<11>2014
17:53 Nov 03, 2023
Jkt 262001
has identified no data or other
information suggesting that FORADIL
(formoterol fumarate) inhalation
powder, 0.012 mg/inh, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
FORADIL (formoterol fumarate)
inhalation powder, 0.012 mg/inh, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list FORADIL (formoterol
fumarate) inhalation powder, 0.012 mg/
inh, 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. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also 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 this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: November 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–24506 Filed 11–3–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Revision of HHS National
Environmental Policy Act Compliance
Procedures To Incorporate Federal
Flood Risk Management Standard
Procedures
Assistant Secretary for
Administration, U.S. Department of
Health and Human Services (HHS).
ACTION: Notice; request for comments.
AGENCY:
HHS is proposing a revision
to its floodplain management
procedures to include climate science if
an action takes place in a floodplain.
DATES: Interested parties should submit
written comments to FOR FURTHER
INFORMATION CONTACT section shown
below on or before December 6, 2023 to
be considered in the formation of the
final procedures.
SUMMARY:
PO 00000
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76219
CDR
Leo Angelo Gumapas, Environmental
Engineering Program Chief, at 202–669–
6942 or by email at leoangelo.gumapas@
psc.hhs.gov, for clarification of content.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Background
E.O. 13690 of January 30, 2015—
Establishing a Federal Flood Risk
Management Standard and a Process for
Further Soliciting and Considering
Stakeholder Input—was issued to
improve the nation’s resilience to
flooding and to better prepare for the
impacts of climate change. In amending
and building upon E.O. 11988—
Floodplain Management—which was
issued in 1977, E.O. 13690 and the
associated FFRMS reinforce the
important tenets and concepts
articulated in E.O. 11988, such as
avoiding actions in or impacting a
floodplain and minimizing potential
harm if an action must be located in a
floodplain. When avoiding a floodplain
is not possible, E.O. 13690 calls for
agencies to improve the resilience of
communities and federal actions.
On August 15, 2017, E.O. 13807 was
issued, which revoked E.O. 13690.
Accordingly, the ‘‘Revised Guidelines
for Implementing Executive Order
11988, Floodplain Management’’ and its
supplementary policy were withdrawn.
On May 20, 2021, E.O. 14030, reinstated
E.O. 13690 and all supplementary
policies.
HHS’s current floodplain management
procedures are published in the General
Administration Manual Part 30:
Environmental Protection (GAM–30)
section 30–40–40 Floodplain
Management, and they are based on E.O.
11988. The GAM–30 was last updated
on February 25, 2000, and it is based on
outdated laws and regulations. Program
Support Center (PSC) √ Real Estate,
Logistics, Operations (RLO) √ Real
Property Management Service (RPMS) √
Real Property Policy and Strategy
(RPPS) drafted HHS FFRMS procedures
based on E.O. 13690 to update GAM–30
Section 30–40–40 Floodplain
Management.
The Council on Environmental
Quality (CEQ) reviewed HHS’s FFRMS
procedures and provided favorable
comments on December 2022.
Procedure Revisions
Revised General Administration
Manual, HHS Part 30, Environmental
Protection
Part 30—Environmental Protection
30–40 Natural Asset Review
30–40–40 Floodplain Management
E:\FR\FM\06NON1.SGM
06NON1
]]>Agencies
[Federal Register Volume 88, Number 213 (Monday, November 6, 2023)]
[Notices]
[Pages 76218-76219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24506]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-2536]
Determination That FORADIL (Formoterol Fumarate) Inhalation
Powder, 0.012 Milligrams, Was Not Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) has
determined that FORADIL (formoterol fumarate) inhalation powder, 0.012
milligrams (mg)/inhalation (inh), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for formoterol
fumarate inhalation powder, 0.012 mg/inh, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Joe Thomas, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 202-815-5571,
[email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved; and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all
[[Page 76219]]
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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, is
the subject of NDA 020831, held by Novartis Pharmaceuticals Corp., and
initially approved on February 16, 2001. FORADIL is indicated for
treatment of asthma in patients 5 years of age and older as an add-on
to a long-term asthma control medication such as an inhaled
corticosteroid; prevention of exercise-induced bronchospasm (EIB) in
patients 5 years of age and older; and maintenance treatment of
bronchoconstriction in patients with chronic obstructive pulmonary
disease.
In a letter dated September 30, 2015, Novartis Pharmaceuticals
Corp. notified FDA that FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, was being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book. In the Federal Register of June 21, 2018 (83 FR 28856), FDA
announced that it was withdrawing approval of NDA 020831, effective
July 23, 2018.
K&L Gates LLP submitted a citizen petition dated June 21, 2023
(Docket No. FDA-2023-P-2536), under 21 CFR 10.30, requesting that the
Agency determine whether FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, was 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 Sec. 314.161 that FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events.
We have reviewed the available evidence and determined that this drug
product was not withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list FORADIL (formoterol
fumarate) inhalation powder, 0.012 mg/inh, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also 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 this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
Dated: November 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24506 Filed 11-3-23; 8:45 am]
BILLING CODE 4164-01-P
