Determination That STROMECTOL (Ivermectin) Tablets, 6 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 37158-37159 [2021-14935]
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37158
Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices
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Board of Governors of the Federal Reserve
System, July 9, 2021.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
entitled, ‘‘Agency Information
Collection Activities: Submission for
OMB Review; Comment Request.’’ That
notice invited public comments on three
separate information collection requests
specific to document identifiers: CMS–
10215, CMS–10249, and CMS–10341.
Through the publication of this
document, we are withdrawing the
portion of the notice requesting public
comment on the information collection
request titled ‘‘Section 1115
Demonstration Projects Regulations at
42 CFR 431.408, 431.412, 431.420,
431.424, and 431.428.’’ Form number
CMS–10341 (OMB control number
0938–1162). The withdrawn
information collection request will be
replaced by another 30-day notice in
July or August of this year.
DATES: For CMS–10215 and CMS–
10249, the original comment period for
the notice that published on July 9,
2021, remains in effect and ends August
9, 2021.
SUPPLEMENTARY INFORMATION: In FR
document, 2021–14671, published on
July 9, 2021 (86 FR 36281), we are
withdrawing item 3 ‘‘Section 1115
Demonstration Projects Regulations at
42 CFR 431.408, 431.412, 431.420,
431.424, and 431.428’’ which posted on
page 36282.
Dated: July 9, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–15005 Filed 7–13–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2021–14997 Filed 7–13–21; 8:45 am]
BILLING CODE P
[Docket No. FDA–2021–P–0191]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination That STROMECTOL
(Ivermectin) Tablets, 6 Milligrams,
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
Centers for Medicare & Medicaid
Services
AGENCY:
[Document Identifier: CMS–10341]
ACTION:
lotter on DSK11XQN23PROD with NOTICES1
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice; partial withdrawal.
On Friday, July 9, 2021, the
Centers for Medicare & Medicaid
Services (CMS) published a notice
VerDate Sep<11>2014
17:49 Jul 13, 2021
Jkt 253001
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that STROMECTOL
(ivermectin) tablets, 6 milligrams (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
STROMECTOL (ivermectin) tablets, 6
SUMMARY:
AGENCY:
SUMMARY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Christopher Koepke, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3600,
Christopher.Koepke@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,’’
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.
STROMECTOL (ivermectin) tablets, 6
mg, are the subject of NDA 050742, held
by Merck Sharp and Dohme Corp., and
initially approved on November 22,
1996. STROMECTOL is indicated for
strongyloidiasis of the intestinal tract
and onchocerciasis.
In a letter dated September 14, 2007,
Merck and Co., Inc. notified FDA that
STROMECTOL (ivermectin) tablets, 6
mg, were being discontinued, and FDA
E:\FR\FM\14JYN1.SGM
14JYN1
Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices
lotter on DSK11XQN23PROD with NOTICES1
moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Foley and Lardner, LLP submitted a
citizen petition dated February 16, 2021
(Docket No. FDA–2021–P–0191), under
21 CFR 10.30, requesting that the
Agency determine whether
STROMECTOL (ivermectin) tablets, 6
mg, 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 STROMECTOL
(ivermectin) tablets, 6 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that STROMECTOL
(ivermectin) tablets, 6 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
STROMECTOL (ivermectin) tablets, 6
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 this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list STROMECTOL
(ivermectin) tablets, 6 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 STROMECTOL (ivermectin) tablets, 6
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 this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: July 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14935 Filed 7–13–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:49 Jul 13, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–3361]
Eligibility Criteria for Expanded
Conditional Approval of New Animal
Drugs; Guidance for Industry;
Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of final
guidance for industry (GFI) #261
entitled ‘‘Eligibility Criteria for
Expanded Conditional Approval of New
Animal Drugs.’’ This guidance is
intended for sponsors and potential
sponsors who may be interested in
pursuing conditional approval of new
animal drugs for certain major uses in
major species. Eligibility for conditional
approval has been expanded beyond
minor uses in major species and use in
minor species (MUMS) to include
certain major uses in major species. The
Center for Veterinary Medicine (CVM or
we) refers to the process for
conditionally approving new animal
drugs that are not intended for MUMS
indications as ‘‘expanded conditional
approval.’’ The purpose of expanded
conditional approval is to incentivize
development of new animal drugs for
serious or life-threatening conditions or
unmet animal or human health needs
under circumstances where a
demonstration of effectiveness would
require a complex or particularly
difficult study or studies. This guidance
defines certain terms, clarifies the
eligibility criteria for expanded
conditional approval, and describes the
criteria CVM intends to consider when
determining expanded conditional
approval eligibility.
DATES: The announcement of the
guidance is published in the Federal
Register on July 14, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
PO 00000
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37159
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
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as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
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manner detailed (see ‘‘Written/Paper
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Submit written/paper submissions as
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• Mail/Hand Delivery/Courier (for
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Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–3361 for ‘‘Eligibility Criteria for
Expanded Conditional Approval of New
Animal Drugs.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
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• Confidential Submissions—To
submit a comment with confidential
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‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
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redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Pages 37158-37159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14935]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0191]
Determination That STROMECTOL (Ivermectin) Tablets, 6 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 or Agency) has
determined that STROMECTOL (ivermectin) tablets, 6 milligrams (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 STROMECTOL (ivermectin) tablets, 6 mg, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3600,
[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.
STROMECTOL (ivermectin) tablets, 6 mg, are the subject of NDA
050742, held by Merck Sharp and Dohme Corp., and initially approved on
November 22, 1996. STROMECTOL is indicated for strongyloidiasis of the
intestinal tract and onchocerciasis.
In a letter dated September 14, 2007, Merck and Co., Inc. notified
FDA that STROMECTOL (ivermectin) tablets, 6 mg, were being
discontinued, and FDA
[[Page 37159]]
moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book.
Foley and Lardner, LLP submitted a citizen petition dated February
16, 2021 (Docket No. FDA-2021-P-0191), under 21 CFR 10.30, requesting
that the Agency determine whether STROMECTOL (ivermectin) tablets, 6
mg, 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 Sec. 314.161 that STROMECTOL (ivermectin) tablets, 6 mg, were
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that STROMECTOL
(ivermectin) tablets, 6 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of STROMECTOL (ivermectin) tablets, 6 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 this drug product was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list STROMECTOL
(ivermectin) tablets, 6 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 STROMECTOL (ivermectin) tablets, 6
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 this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: July 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14935 Filed 7-13-21; 8:45 am]
BILLING CODE 4164-01-P
