Determination That DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (Diltiazem Hydrochloride), 125 Milligrams/125 Milliliters (1 Milligram/Milliliter) and 250 Milligrams/250 Milliliters (1 Milligram/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 68624-68625 [2024-19233]
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<![CDATA[
68624
Federal Register / Vol. 89, No. 166 / Tuesday, August 27, 2024 / Notices
Docket Web Address: https://
www.regulations.gov/docket/CMS-20240080.
For Policy Related Questions Contact:
Effie George at 410–786–8639.
45. Title: Expressions of Interest in the
Infant Well-Child Visit Affinity Group
Type of Request: Reinstatement of a
previously approved information
collection.
CMS ID Number: CMS–10398 #72.
OMB Control Number: 0938–1148.
eRulemaking Docket ID Number:
CMS–2024–0081.
Docket Web Address: https://
www.regulations.gov/docket/CMS-20240081.
For Policy Related Questions Contact:
Kristin Zycherman at 410–786–6974.
46. Title: Supplemental Payment
Reporting Under the Consolidated
Appropriations Act, 2021
Type of Request: Reinstatement of a
previously approved information
collection.
CMS ID Number: CMS–10398 #73.
OMB Control Number: 0938–1148.
eRulemaking Docket ID Number:
CMS–2024–0082.
Docket Web Address: https://
www.regulations.gov/docket/CMS-20240082.
For Policy Related Questions Contact:
Richard Kimball at 410–786–2278.
47. Title: Coverage of Routine Patient
Cost for Items & Services in Qualifying
Clinical Trials
Type of Request: Reinstatement of a
previously approved information
collection.
CMS ID Number: CMS–10398 #74.
OMB Control Number: 0938–1148.
eRulemaking Docket ID Number:
CMS–2024–0083.
Docket Web Address: https://
www.regulations.gov/docket/CMS-20240083.
For Policy Related Questions Contact:
Myla Adams at 410–786–8107.
ddrumheller on DSK120RN23PROD with NOTICES1
48. Title: ARP 1135 State Plan
Amendment
Type of Request: Reinstatement of a
previously approved information
collection.
CMS ID Number: CMS–10398 #75.
OMB Control Number: 0938–1148.
eRulemaking Docket ID Number:
CMS–2024–0084.
Docket Web Address: https://
www.regulations.gov/docket/CMS-20240084.
For Policy Related Questions Contact:
Kirsten Jensen at 410–786–8146.
VerDate Sep<11>2014
17:14 Aug 26, 2024
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49. Title: Expressions of Interest in the
Improving Maternal Health by Reducing
Low-Risk Cesarean Delivery Affinity
Group
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Type of Request: Reinstatement of a
previously approved information
collection.
CMS ID Number: CMS–10398 #76.
OMB Control Number: 0938–1148.
eRulemaking Docket ID Number:
CMS–2024–0085.
Docket Web Address: https://
www.regulations.gov/docket/CMS-20240085.
For Policy Related Questions Contact:
Richard Kimball at 410–786–2278.
[Docket No. FDA–2024–P–1131]
50. Title: COVID–19 Risk Corridor
Reconciliation Reporting Template
Type of Request: Reinstatement of a
previously approved information
collection.
CMS ID Number: CMS–10398 #79.
OMB Control Number: 0938–1148.
eRulemaking Docket ID Number:
CMS–2024–0086.
Docket Web Address: https://
www.regulations.gov/docket/CMS-20240086.
For Policy Related Questions Contact:
Elizabeth Jones at 410–786–7111.
51. Title: Improving Quality of Care and
Outcomes Data for Pregnant Medicaid
Beneficiaries and Newborn Infants
through Linkage and Evaluation of VR,
BC, DC, and TAF
Type of Request: Reinstatement of a
previously approved information
collection.
CMS ID Number: CMS–10398 #81.
OMB Control Number: 0938–1148.
eRulemaking Docket ID Number:
CMS–2024–0172.
Docket Web Address: https://
www.regulations.gov/docket/CMS-20240172.
For Policy Related Questions Contact:
Ali Fokar at 410–786–0020.
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–19228 Filed 8–26–24; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Food and Drug Administration
Determination That DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
(Diltiazem Hydrochloride), 125
Milligrams/125 Milliliters (1 Milligram/
Milliliter) and 250 Milligrams/250
Milliliters (1 Milligram/Milliliter), 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 or the Agency) has
determined that DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem hydrochloride (HCl)), 125
milligrams (mg)/125 milliliters (mL) (1
mg/mL) and 250 mg/250 mL (1 mg/mL),
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for diltiazem HCl,
125 mg/125 mL (1 mg/mL) and 250 mg/
250 mL (1 mg/mL), if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Neerja Razdan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217,
Silver Spring, MD 20993–0002,
Neerja.Razdan@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
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
SUMMARY:
E:\FR\FM\27AUN1.SGM
27AUN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 166 / Tuesday, August 27, 2024 / Notices
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
(§ 314.162 (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.
DILTIAZEM HYDROCHLORIDE IN
DEXTROSE 5% (diltiazem HCl), 125
mg/125 mL (1 mg/mL) and 250 mg/250
mL (1 mg/mL), is the subject of NDA
215252, held by Exela Pharma Sciences,
LLC, and initially approved on October
28, 2021. DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
is indicated for the following: (1)
temporary control of rapid ventricular
rate in atrial fibrillation or atrial flutter;
and (2) rapid conversion of paroxysmal
supraventricular tachycardias to sinus
rhythm.
DILTIAZEM HYDROCHLORIDE IN
DEXTROSE 5% (diltiazem HCl), 125
mg/125 mL (1 mg/mL) and 250 mg/250
mL (1 mg/mL), is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In previous
instances (see, e.g., 72 FR 9763 (March
5, 2007), 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.
Fresenius Kabi USA, LLC submitted a
citizen petition dated March 5, 2024
(Docket No. FDA–2024–P–1131), under
21 CFR 10.30, requesting that the
Agency determine whether DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/
mL) and 250 mg/250 mL (1 mg/mL), 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 DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/
mL) and 250 mg/250 mL (1 mg/mL), was
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that DILTIAZEM
VerDate Sep<11>2014
17:14 Aug 26, 2024
Jkt 262001
HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/
mL) and 250 mg/250 mL (1 mg/mL), was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
DILTIAZEM HYDROCHLORIDE IN
DEXTROSE 5% (diltiazem HCl), 125
mg/125 mL (1 mg/mL) and 250 mg/250
mL (1 mg/mL), 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 DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/
mL) and 250 mg/250 mL (1 mg/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. 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: August 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19233 Filed 8–26–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3925]
Authorization of Emergency Use of a
Freeze-Dried Plasma Product for
Treatment of Hemorrhage or
Coagulopathy During an Emergency
Involving Agents of Military Combat;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
68625
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) for use of a
freeze-dried plasma product, octaplasLG
Powder, for emergent treatment of
hemorrhage or coagulopathy during an
emergency involving agents of military
combat (e.g., firearms, projectiles, and
explosive devices) when plasma is not
available for use or when the use of
plasma is not practical.
DATES: The Authorization is effective as
of August 8, 2024.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
FOR FURTHER INFORMATION CONTACT:
Andrew C. Harvan, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276), the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5), 21st
Century Cures Act (Pub. L. 114–255),
and Public Law 115–92 (2017), allows
FDA to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents and
other agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces. Among other
actions, section 564 of the FD&C Act
allows FDA to authorize the use of an
unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help ensure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents and other agents that
may cause, or are otherwise associated
with, an imminently life-threatening
E:\FR\FM\27AUN1.SGM
27AUN1
]]>Agencies
[Federal Register Volume 89, Number 166 (Tuesday, August 27, 2024)]
[Notices]
[Pages 68624-68625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19233]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-1131]
Determination That DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
(Diltiazem Hydrochloride), 125 Milligrams/125 Milliliters (1 Milligram/
Milliliter) and 250 Milligrams/250 Milliliters (1 Milligram/
Milliliter), 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 or the Agency) has
determined that DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem
hydrochloride (HCl)), 125 milligrams (mg)/125 milliliters (mL) (1 mg/
mL) and 250 mg/250 mL (1 mg/mL), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for diltiazem HCl,
125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Neerja Razdan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002,
[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 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
[[Page 68625]]
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 (Sec. 314.162 (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.
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem HCl), 125 mg/125
mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), is the subject of NDA 215252,
held by Exela Pharma Sciences, LLC, and initially approved on October
28, 2021. DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% is indicated for the
following: (1) temporary control of rapid ventricular rate in atrial
fibrillation or atrial flutter; and (2) rapid conversion of paroxysmal
supraventricular tachycardias to sinus rhythm.
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem HCl), 125 mg/125
mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book. In
previous instances (see, e.g., 72 FR 9763 (March 5, 2007), 61 FR 25497
(May 21, 1996)), the Agency has determined that, for purposes of
Sec. Sec. 314.161 and 314.162, never marketing an approved drug
product is equivalent to withdrawing the drug from sale.
Fresenius Kabi USA, LLC submitted a citizen petition dated March 5,
2024 (Docket No. FDA-2024-P-1131), under 21 CFR 10.30, requesting that
the Agency determine whether DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL),
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 DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL),
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem HCl), 125 mg/125 mL
(1 mg/mL) and 250 mg/250 mL (1 mg/mL), was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of DILTIAZEM HYDROCHLORIDE IN
DEXTROSE 5% (diltiazem HCl), 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL
(1 mg/mL), 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 DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5% (diltiazem HCl), 125 mg/125 mL (1 mg/mL)
and 250 mg/250 mL (1 mg/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. 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: August 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19233 Filed 8-26-24; 8:45 am]
BILLING CODE 4164-01-P
