Determination That CECLOR CD (Cefaclor Extended-Release Tablets) 375 Milligrams and 500 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, Except the Indication of Secondary Bacterial Infections of Acute Bronchitis, Which Was Withdrawn From Sale for Reasons of Safety or Effectiveness, 40587-40588 [2021-16050]
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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
wire transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, account number:
75060099, routing number: 021030004,
SWIFT: FRNYUS33. FDA’s tax
identification number is 53–0196965.
Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16039 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–0649]
Determination That CECLOR CD
(Cefaclor Extended-Release Tablets)
375 Milligrams and 500 Milligrams
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness,
Except the Indication of Secondary
Bacterial Infections of Acute
Bronchitis, Which Was Withdrawn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 CECLOR CD
(cefaclor extended-release tablets) 375
milligrams (mg) and 500 mg were not
withdrawn from sale for reasons of
safety or effectiveness, except with
respect to the indication of secondary
bacterial infections of acute bronchitis
(SBIAB) that was withdrawn for reasons
of safety or effectiveness. This
determination means that FDA will not
begin procedures to suspend approval of
any abbreviated new drug application
(ANDA) that refers to this drug product
and has removed the indication for
SBIAB. This determination also will
allow FDA to continue to approve
ANDAs that refer to these drug products
as long as they meet relevant legal and
regulatory requirements. However, the
Agency will not accept or approve
ANDAs for CECLOR CD (cefaclor
extended-release tablets) 375 mg and
500 mg that include SBIAB as an
indication.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
VerDate Sep<11>2014
17:16 Jul 27, 2021
Jkt 253001
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
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.
Under § 314.161(a)(2), the Agency
must also determine whether a listed
drug was withdrawn from sale for
reasons of safety or effectiveness if
ANDAs that referred to the listed drug
have already been approved prior to its
market withdrawal. If the Agency
determines that a listed drug was
withdrawn from sale for reasons of
safety or effectiveness, and there are
approved ANDAs that reference that
listed drug, FDA will initiate a
proceeding to determine whether the
suspension of the ANDAs is also
required (21 CFR 314.161(d)).
CECLOR CD (cefaclor extendedrelease tablets) 375 mg and 500 mg are
the subject of NDA 050673 held by Eli
Lilly and Co., and initially approved on
June 28, 1996. CECLOR CD (cefaclor
extended-release tablets) is indicated for
the treatment of patients with the
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00144
Fmt 4703
Sfmt 4703
40587
following mild to moderate infections
when caused by susceptible strains of
the designated microorganisms:
• Acute bacterial exacerbations of
chronic bronchitis due to Haemophilus
influenzae (non-b-lactamase-producing
strains only), Moraxella catarrhalis
(including b-lactamase-producing
strains) or Streptococcus pneumoniae.
• Secondary bacterial infections of
acute bronchitis due to H. influenzae
(non-b-lactamase-producing strains
only), M. catarrhalis (including blactamase-producing strains), or S.
pneumoniae.
• Pharyngitis and tonsillitis due to
Streptococcus pyogenes.
• Uncomplicated skin and skin
structure infections due to
Staphylococcus aureus (methicillinsusceptible).
On June 13, 2005, Eli Lilly and Co.
submitted a request to the Agency to
withdraw approval of NDA 050673,
CECLOR CD (cefaclor extended-release
tablets), 375 mg and 500 mg, under 21
CFR 314.150(c). The Agency published
a Federal Register notice on April 22,
2014, withdrawing approval of NDA
050673, effective May 22, 2014.1
After reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CECLOR CD (cefaclor
extended-release tablets), 375 mg and
500 mg, were not withdrawn from sale
for reasons of safety or effectiveness,
except with respect to the indication for
SBIAB.
Based on a review of relevant
information, FDA has concluded that
the SBIAB indication is not appropriate
because most cases of SBIAB are
considered to be viral or noninfectious.
As an antibacterial drug, CECLOR CD
(cefaclor extended-release tablets) is not
considered to be effective to treat
SBIAB. Such use of CECLOR CD
(cefaclor extended-release tablets)
would likely result in inappropriate
antibacterial drug use. Accordingly, for
the treatment of SBIAB, the benefit-risk
profile of CECLOR CD (cefaclor
extended-release tablets) is unfavorable
and does not support approval of these
products (or ANDAs referencing them)
for this indication. For the remaining
indications, the Agency has determined
that CECLOR CD (cefaclor extendedrelease tablets) continues to have a
favorable benefit-risk profile.
Accordingly, the Agency will
continue to list CECLOR CD (cefaclor
extended-release tablets), 375 mg and
500 mg, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The approved ANDA has
1 See
E:\FR\FM\28JYN1.SGM
79 FR 22501 (April 22, 2014).
28JYN1
40588
Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
describes the payment procedures
outsourcing facilities should follow.
These fee rates are effective October 1,
2021, and will remain in effect through
September 30, 2022.
FOR FURTHER INFORMATION CONTACT: For
more information on human drug
compounding and outsourcing facility
fees: Visit FDAs website at: https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/
PharmacyCompounding/default.htm.
For questions relating to this notice:
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:
[FR Doc. 2021–16050 Filed 7–27–21; 8:45 am]
I. Background
removed the SBIAB indication from its
labeling, consistent with this decision.
In addition, FDA will continue to accept
and, where appropriate, approve
ANDAs that refer to CECLOR CD
(cefaclor extended-release tablets) as
long as they meet relevant legal and
regulatory requirements, but FDA will
not accept or approve ANDAs that refer
to this drug product and propose to
include the SBIAB indication. 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.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0698]
Outsourcing Facility Fee Rates for
Fiscal Year 2022
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2022 rates for the
establishment and reinspection fees
related to entities that compound
human drugs and elect to register as
outsourcing facilities under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). The FD&C Act authorizes FDA to
assess and collect an annual
establishment fee from outsourcing
facilities, as well as a reinspection fee
for each reinspection of an outsourcing
facility. This document establishes the
FY 2022 rates for the small business
establishment fee ($5,824), the nonsmall business establishment fee
($18,999), and the reinspection fee
($17,472) for outsourcing facilities;
provides information on how the fees
for FY 2022 were determined; and
SUMMARY:
Under section 503B of the FD&C Act
(21 U.S.C. 353b), a human drug
compounder can become an
‘‘outsourcing facility.’’ Outsourcing
facilities, as defined in section
503B(d)(4), are facilities that meet all
the conditions described in section
503B(a), including registering with FDA
as an outsourcing facility and paying an
annual establishment fee. If the
conditions of section 503B are met, a
drug compounded by or under the
direct supervision of a licensed
pharmacist in an outsourcing facility is
exempt from three sections of the FD&C
Act: (1) Section 502(f)(1) (21 U.S.C.
352(f)(1)) concerning the labeling of
drugs with adequate directions for use;
(2) section 505 (21 U.S.C. 355)
concerning the approval of human drug
products under new drug applications
(NDAs) or abbreviated new drug
applications (ANDAs); and (3) section
582 (21 U.S.C. 360eee–1) concerning
drug supply chain security
requirements. Drugs compounded in
outsourcing facilities are not exempt
from the requirements of section
501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) concerning current good
manufacturing practice requirements for
drugs.
Section 744K of the FD&C Act (21
U.S.C. 379j–62) authorizes FDA to
assess and collect the following fees
associated with outsourcing facilities:
(1) An annual establishment fee from
each outsourcing facility and (2) a
reinspection fee from each outsourcing
facility subject to a reinspection (see
section 744K(a)(1) of the FD&C Act).
Under statutorily defined conditions, a
qualified applicant may pay a reduced
small business establishment fee (see
section 744K(c)(4) of the FD&C Act).
FDA announced in the Federal
Register of November 24, 2014 (79 FR
69856), the availability of a final
guidance for industry entitled ‘‘Fees for
Human Drug Compounding Outsourcing
Facilities Under Sections 503B and
744K of the FD&C Act.’’ The guidance
provides additional information on the
annual fees for outsourcing facilities
and adjustments required by law,
reinspection fees, how to submit
payment, the effect of failure to pay fees,
and how to qualify as a small business
to obtain a reduction of the annual
establishment fee. This guidance can be
accessed on FDA’s website at: https://
www.fda.gov/media/136683/download.
II. Fees for FY 2022
A. Methodology for Calculating FY 2022
Adjustment Factors
1. Inflation Adjustment Factor
Section 744K(c)(2) of the FD&C Act
specifies the annual inflation
adjustment for outsourcing facility fees.
The inflation adjustment has two
components: One based on FDA’s
payroll costs and one based on FDA’s
non-payroll costs for the first 3 of the 4
previous fiscal years. The payroll
component of the annual inflation
adjustment is calculated by taking the
average change in FDA’s per-full time
equivalent (FTE) personnel
compensation and benefits (PC&B) in
the first 3 of the 4 previous fiscal years
(see section 744K(c)(2)(A)(ii) of the
FD&C Act). FDA’s total annual spending
on PC&B is divided by the total number
of FTEs per fiscal year to determine the
average PC&B per FTE.
Table 1 summarizes the actual cost
and FTE data for the specified fiscal
years, and provides the percent change
from the previous fiscal year and the
average percent change over the first 3
of the 4 fiscal years preceding FY 2022.
The 3-year average is 2.7383 percent.
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year
2018
Total PC&B ..........................................................................................
Total FTE .............................................................................................
PC&B per FTE .....................................................................................
Percent change from previous year ....................................................
VerDate Sep<11>2014
19:27 Jul 27, 2021
Jkt 253001
PO 00000
Frm 00145
Fmt 4703
2019
$2,690,678,000
17,023
$158,061
4.2206
Sfmt 4703
2020
$2,620,052,000
17,144
$152,826
¥3.3120
E:\FR\FM\28JYN1.SGM
28JYN1
$2,875,592,000
17,535
$163,992
7.3063
3-Year
average
........................
........................
........................
2.7383
]]>Agencies
[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40587-40588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16050]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0649]
Determination That CECLOR CD (Cefaclor Extended-Release Tablets)
375 Milligrams and 500 Milligrams Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness, Except the Indication of Secondary
Bacterial Infections of Acute Bronchitis, Which Was 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 CECLOR CD (cefaclor extended-release tablets) 375
milligrams (mg) and 500 mg were not withdrawn from sale for reasons of
safety or effectiveness, except with respect to the indication of
secondary bacterial infections of acute bronchitis (SBIAB) that was
withdrawn for reasons of safety or effectiveness. This determination
means that FDA will not begin procedures to suspend approval of any
abbreviated new drug application (ANDA) that refers to this drug
product and has removed the indication for SBIAB. This determination
also will allow FDA to continue to approve ANDAs that refer to these
drug products as long as they meet relevant legal and regulatory
requirements. However, the Agency will not accept or approve ANDAs for
CECLOR CD (cefaclor extended-release tablets) 375 mg and 500 mg that
include SBIAB as an indication.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
[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 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.
Under Sec. 314.161(a)(2), the Agency must also determine whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness if ANDAs that referred to the listed drug have already
been approved prior to its market withdrawal. If the Agency determines
that a listed drug was withdrawn from sale for reasons of safety or
effectiveness, and there are approved ANDAs that reference that listed
drug, FDA will initiate a proceeding to determine whether the
suspension of the ANDAs is also required (21 CFR 314.161(d)).
CECLOR CD (cefaclor extended-release tablets) 375 mg and 500 mg are
the subject of NDA 050673 held by Eli Lilly and Co., and initially
approved on June 28, 1996. CECLOR CD (cefaclor extended-release
tablets) is indicated for the treatment of patients with the following
mild to moderate infections when caused by susceptible strains of the
designated microorganisms:
Acute bacterial exacerbations of chronic bronchitis due to
Haemophilus influenzae (non-[beta]-lactamase-producing strains only),
Moraxella catarrhalis (including [beta]-lactamase-producing strains) or
Streptococcus pneumoniae.
Secondary bacterial infections of acute bronchitis due to
H. influenzae (non-[beta]-lactamase-producing strains only), M.
catarrhalis (including [beta]-lactamase-producing strains), or S.
pneumoniae.
Pharyngitis and tonsillitis due to Streptococcus pyogenes.
Uncomplicated skin and skin structure infections due to
Staphylococcus aureus (methicillin-susceptible).
On June 13, 2005, Eli Lilly and Co. submitted a request to the
Agency to withdraw approval of NDA 050673, CECLOR CD (cefaclor
extended-release tablets), 375 mg and 500 mg, under 21 CFR 314.150(c).
The Agency published a Federal Register notice on April 22, 2014,
withdrawing approval of NDA 050673, effective May 22, 2014.\1\
---------------------------------------------------------------------------
\1\ See 79 FR 22501 (April 22, 2014).
---------------------------------------------------------------------------
After reviewing Agency records and based on the information we have
at this time, FDA has determined under Sec. 314.161 that CECLOR CD
(cefaclor extended-release tablets), 375 mg and 500 mg, were not
withdrawn from sale for reasons of safety or effectiveness, except with
respect to the indication for SBIAB.
Based on a review of relevant information, FDA has concluded that
the SBIAB indication is not appropriate because most cases of SBIAB are
considered to be viral or noninfectious. As an antibacterial drug,
CECLOR CD (cefaclor extended-release tablets) is not considered to be
effective to treat SBIAB. Such use of CECLOR CD (cefaclor extended-
release tablets) would likely result in inappropriate antibacterial
drug use. Accordingly, for the treatment of SBIAB, the benefit-risk
profile of CECLOR CD (cefaclor extended-release tablets) is unfavorable
and does not support approval of these products (or ANDAs referencing
them) for this indication. For the remaining indications, the Agency
has determined that CECLOR CD (cefaclor extended-release tablets)
continues to have a favorable benefit-risk profile.
Accordingly, the Agency will continue to list CECLOR CD (cefaclor
extended-release tablets), 375 mg and 500 mg, in the ``Discontinued
Drug Product List'' section of the Orange Book. The approved ANDA has
[[Page 40588]]
removed the SBIAB indication from its labeling, consistent with this
decision. In addition, FDA will continue to accept and, where
appropriate, approve ANDAs that refer to CECLOR CD (cefaclor extended-
release tablets) as long as they meet relevant legal and regulatory
requirements, but FDA will not accept or approve ANDAs that refer to
this drug product and propose to include the SBIAB indication. 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. 2021-16050 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P
