Determination That EFUDEX (Fluorouracil) Topical Solution, 5 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 40566-40567 [2021-16037]
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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
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establish this exemption.
HISTORY:
None.
[FR Doc. 2021–16016 Filed 7–27–21; 8:45 am]
BILLING CODE P
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RECORDS:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0299]
Records are retrieved by name, phone
number, case number, or internal FRTIB
identification (including FRTIB email,
username, etc.).
Determination That EFUDEX
(Fluorouracil) Topical Solution, 5
Percent, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:
AGENCY:
These records are maintained in
accordance with General Records
Schedule 5.6 (Security Records), Items
210 through 240, issued by the National
Archives and Records Administration
(NARA).
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security program to protect the security,
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ensure that records are not disclosed to
or accessed by unauthorized
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this system is limited to individuals
who have the appropriate permissions
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information in order to perform their
official duties.
RECORD ACCESS PROCEDURES:
Individuals seeking to access records
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written authorization from that
individual, such as a Power of Attorney,
in order for the representative to act on
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Records in this system will be
exempt, based on 5 U.S.C. 552a(k)(2),
from the requirements in subsections
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Sfmt 4703
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that EFUDEX (fluorouracil)
topical solution, 5 percent, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of the abbreviated new drug application
(ANDA) that refers to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6272,
Silver Spring, MD 20993–0002, 240–
825–9944, Kaetochi.Okemgbo@
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).
SUMMARY:
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
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.
EFUDEX (fluorouracil) topical
solution, 5 percent, is the subject of
NDA 016831, held by Bausch Health
Americas, Inc., and initially approved
on July 29, 1970. EFUDEX is indicated
for the topical treatment of multiple
actinic or solar keratoses, and treatment
of superficial basal cell carcinomas
when conventional methods are
impractical, such as with multiple
lesions or difficult treatment sites.
EFUDEX (fluorouracil) topical solution,
5 percent, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Encube Ethicals Private Ltd.
submitted a citizen petition dated
March 16, 2021 (Docket No. FDA–2021–
P–0299), under 21 CFR 10.30,
requesting that the Agency determine
whether EFUDEX (fluorouracil) topical
solution, 5 percent, 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 EFUDEX (fluorouracil)
topical solution, 5 percent, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that EFUDEX (fluorouracil)
topical solution, 5 percent, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of EFUDEX
(fluorouracil) topical solution, 5
VerDate Sep<11>2014
17:16 Jul 27, 2021
Jkt 253001
percent, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list EFUDEX (fluorouracil)
topical solution, 5 percent, 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 the approved ANDA that refers to this
drug product. Additional ANDAs that
refer to EFUDEX (fluorouracil) topical
solution, 5 percent, 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: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16037 Filed 7–27–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0708]
Biosimilar User Fee Rates for Fiscal
Year 2022
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA or we) is
announcing the rates for biosimilar user
fees for fiscal year (FY) 2022. The
Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the
Biosimilar User Fee Amendments of
2017 (BsUFA II), authorizes FDA to
assess and collect user fees for certain
activities in connection with biosimilar
biological product development; review
of certain applications for approval of
biosimilar biological products; and each
biosimilar biological product approved
in a biosimilar biological product
application. BsUFA II directs FDA to
establish, before the beginning of each
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
40567
fiscal year, the amount of initial and
annual biosimilar biological product
development (BPD) fees, the
reactivation fee, and the biosimilar
biological product application and
program fees for such year. These fees
apply to the period from October 1,
2021, through September 30, 2022.
FOR FURTHER INFORMATION CONTACT:
Melissa Hurley, Office of Financial
Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
Rm. 61075, Beltsville, MD 20705–4304,
240–402–4585.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 744G, 744H, and 744I of the
FD&C Act (21 U.S.C. 379j-51, 379j-52,
and 379j-53), as amended by BsUFA II
(title IV of the FDA Reauthorization Act
of 2017, Pub. L. 115–52), authorize the
collection of fees for biosimilar
biological products. Under section
744H(a)(1)(A) of the FD&C Act, the
initial BPD fee for a product is due
when the sponsor submits an
investigational new drug (IND)
application that FDA determines is
intended to support a biosimilar
biological product application or within
5 calendar days after FDA grants the
first BPD meeting, whichever occurs
first. A sponsor who has paid the initial
BPD fee is considered to be participating
in FDA’s BPD program for that product.
Under section 744H(a)(1)(B) of the
FD&C Act, once a sponsor has paid the
initial BPD fee for a product, the annual
BPD fee is assessed beginning with the
next fiscal year. The annual BPD fee is
assessed for the product each fiscal year
until the sponsor submits a marketing
application for the product that is
accepted for filing or the sponsor
discontinues participation in FDA’s
BPD program for the product.
Under section 744H(a)(1)(D) of the
FD&C Act, if a sponsor has discontinued
participation in FDA’s BPD program and
wants to reengage with FDA on
development of the product, the sponsor
must pay a reactivation fee to resume
participation in the program. The
sponsor must pay the reactivation fee by
the earlier of the following dates: No
later than 5 calendar days after FDA
grants the sponsor’s request for a BPD
meeting for that product or upon the
date of submission by the sponsor of an
IND describing an investigation that
FDA determines is intended to support
a biosimilar biological product
application for that product. The
sponsor will be assessed an annual BPD
fee beginning with the first fiscal year
after payment of the reactivation fee.
BsUFA II also authorizes fees for
certain biosimilar biological product
E:\FR\FM\28JYN1.SGM
28JYN1
]]>Agencies
[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40566-40567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16037]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0299]
Determination That EFUDEX (Fluorouracil) Topical Solution, 5
Percent, 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 Agency) has
determined that EFUDEX (fluorouracil) topical solution, 5 percent, was
not withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of the abbreviated new drug application (ANDA) that refers to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6272, Silver Spring, MD 20993-0002, 240-
825-9944, [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).
[[Page 40567]]
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.
EFUDEX (fluorouracil) topical solution, 5 percent, is the subject
of NDA 016831, held by Bausch Health Americas, Inc., and initially
approved on July 29, 1970. EFUDEX is indicated for the topical
treatment of multiple actinic or solar keratoses, and treatment of
superficial basal cell carcinomas when conventional methods are
impractical, such as with multiple lesions or difficult treatment
sites. EFUDEX (fluorouracil) topical solution, 5 percent, is currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
Encube Ethicals Private Ltd. submitted a citizen petition dated
March 16, 2021 (Docket No. FDA-2021-P-0299), under 21 CFR 10.30,
requesting that the Agency determine whether EFUDEX (fluorouracil)
topical solution, 5 percent, 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 EFUDEX (fluorouracil) topical solution, 5
percent, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
EFUDEX (fluorouracil) topical solution, 5 percent, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of EFUDEX (fluorouracil)
topical solution, 5 percent, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this drug product was withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list EFUDEX (fluorouracil)
topical solution, 5 percent, 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
the approved ANDA that refers to this drug product. Additional ANDAs
that refer to EFUDEX (fluorouracil) topical solution, 5 percent, 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: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16037 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P
