Determination That ISOPTIN (Verapamil Hydrochloride) Tablets 40 Milligrams, 80 Milligrams, and 120 Milligrams, and CALAN (Verapamil Hydrochloride) Tablets, 40 Milligrams, 80 Milligrams, 120 Milligrams, and 160 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 27092-27093 [2021-10552]
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27092
Federal Register / Vol. 86, No. 95 / Wednesday, May 19, 2021 / Notices
Food and Drug Administration
[Docket Nos. FDA–2019–N–5666, FDA–
2011–N–0231, FDA–2010–N–0161, FDA–
2011–N–0275, and FDA–2013–D–0575]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Empirical Study of Promotional Implications of Proprietary Prescription Drug Names ..........................................
Adverse Experience Reporting for Licensed Biological Products; and General Records ......................................
Export Certificates for FDA Regulated Products .....................................................................................................
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions ...........................
Expedited Program for Serious Conditions-Drugs and Biologics ...........................................................................
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10535 Filed 5–18–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–P–2244 and FDA–
2020–P–2245]
Determination That ISOPTIN
(Verapamil Hydrochloride) Tablets 40
Milligrams, 80 Milligrams, and 120
Milligrams, and CALAN (Verapamil
Hydrochloride) Tablets, 40 Milligrams,
80 Milligrams, 120 Milligrams, and 160
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that ISOPTIN
(verapamil hydrochloride) tablets, 40
milligrams (mg), 80 mg, and 120 mg,
and CALAN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, 120 mg, and 160
mg, were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for ISOPTIN
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:43 May 18, 2021
Jkt 253001
(verapamil hydrochloride) tablets, 40
mg, 80 mg, and 120 mg, and CALAN
(verapamil hydrochloride) tablets, 40
mg, 80 mg, 120 mg, and 160 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–3601, Nicole.Mueller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which 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,’’
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
0910–0896
0910–0308
0910–0498
0910–0616
0910–0765
Date approval
expires
4/30/2023
4/30/2024
4/30/2024
4/30/2024
4/30/2024
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.
ISOPTIN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, and 120 mg, are
the subject of NDA 018593, held by Mt.
Adams Technologies, LLC, and initially
approved on March 8, 1982. CALAN
(verapamil hydrochloride) tablets, 40
mg, 80 mg, 120 mg, and 160 mg, are the
subject of NDA 018817, held by Pfizer
Inc., and initially approved on
September 10, 1984. ISOPTIN and
CALAN are indicated for the treatment
of angina, arrythmias, and essential
hypertension.
Center Laboratories, Inc., submitted
two citizen petitions dated November
30, 2020 (Docket Nos. FDA–2020–P–
2244 and FDA–2020–P–2245), under 21
CFR 10.30, requesting that the Agency
determine whether ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
E:\FR\FM\19MYN1.SGM
19MYN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 95 / Wednesday, May 19, 2021 / Notices
and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
120 mg, and 160 mg, were withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petitions
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
120 mg, and 160 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
120 mg, and 160 mg, were withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
ISOPTIN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, and 120 mg, and
CALAN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, 120 mg, and 160
mg, 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 these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
120 mg, and 160 mg, 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 ISOPTIN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, and 120 mg, and
CALAN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, 120 mg, and 160
mg, 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.
Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10552 Filed 5–18–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:43 May 18, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Evaluation of Office of
Acquisitions System (OASYS) and
FFRDC Contract Administration
System (FCAS) Vendor Portals
National Cancer Institute (NCI)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of propose
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Marla Jacobson, 9609 Medical
Center Drive, MSC 9742, Rockville, MD
20850 or call non-toll-free number 240–
276–5267 or Email your request,
including your address to:
marla.jacobson@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
27093
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: Evaluation
of Office of Acquisitions System
(OASYS) and FFRDC Contract
Administration System (FCAS) Vendor
Portals National Cancer Institute (NCI),
0925–NEW, Expiration Date XX/XX/
XXXX, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute (NCI) Office of Acquisitions
(OA), located within the Office of the
Director (OD) in the Office of
Management (OM) at the National
Cancer Institute (NCI), awards and
administers contracts and simplified
acquisitions in support of the Institute’s
mission to prevent, diagnose and treat
cancer. During the acquisition process,
the OA ensures that customer service is
paramount, and communications are
open and continuous. Currently
requests and correspondence are sent to
and received from vendors through
email with the exception of the FFRDC
Contractor who submits through the
FCAS Vendor Portal which is in
production. To streamline processes,
increase transparency and gain
efficiencies, the OA developed OASYS
and FCAS vendor portals to replace
processes that are handled through
email (future OASYS Vendor Portal
Users) and were (current FCAS Vendor
Portal Users) to individual OA
recipients. The FCAS Vendor Portal and
in the future, the OASYS Vendor Portal
will serve as a one-stop shop for
transmission of requests, reports,
deliverables and other correspondence
due on numerous research and
development, in support of R&D
contracts as well as those contract
vehicles awarded using various Federal
Acquisition Procedures including but
not limited to FAR Part 8, Required
Sources of Supplies and Services, FAR
Part 13, Simplified Acquisition
Procedures, and FAR Part 12,
Acquisition of Commercial Items. These
reports and deliverables cover a wide
variety of topics in the areas of cancer
research including prevention,
detection, diagnosis, and control.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
12,120.
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[Federal Register Volume 86, Number 95 (Wednesday, May 19, 2021)]
[Notices]
[Pages 27092-27093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10552]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-P-2244 and FDA-2020-P-2245]
Determination That ISOPTIN (Verapamil Hydrochloride) Tablets 40
Milligrams, 80 Milligrams, and 120 Milligrams, and CALAN (Verapamil
Hydrochloride) Tablets, 40 Milligrams, 80 Milligrams, 120 Milligrams,
and 160 Milligrams, Were 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, Agency, or we) has
determined that ISOPTIN (verapamil hydrochloride) tablets, 40
milligrams (mg), 80 mg, and 120 mg, and CALAN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, 120 mg, and 160 mg, were not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for ISOPTIN
(verapamil hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN
(verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601, [email protected].
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
ISOPTIN (verapamil hydrochloride) tablets, 40 mg, 80 mg, and 120
mg, are the subject of NDA 018593, held by Mt. Adams Technologies, LLC,
and initially approved on March 8, 1982. CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, are the
subject of NDA 018817, held by Pfizer Inc., and initially approved on
September 10, 1984. ISOPTIN and CALAN are indicated for the treatment
of angina, arrythmias, and essential hypertension.
Center Laboratories, Inc., submitted two citizen petitions dated
November 30, 2020 (Docket Nos. FDA-2020-P-2244 and FDA-2020-P-2245),
under 21 CFR 10.30, requesting that the Agency determine whether
ISOPTIN (verapamil hydrochloride) tablets, 40 mg, 80 mg,
[[Page 27093]]
and 120 mg, and CALAN (verapamil hydrochloride) tablets, 40 mg, 80 mg,
120 mg, and 160 mg, were withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec. 314.161 that ISOPTIN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, 120 mg, and 160 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, were
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of ISOPTIN
(verapamil hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN
(verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg,
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 these drug products were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, 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 ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, 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.
Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10552 Filed 5-18-21; 8:45 am]
BILLING CODE 4164-01-P
