Brenda K. Marmas: Final Debarment Order, 7840-7843 [2022-02801]
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Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 / Notices
inform public comment: (1) The draft
clinical practice guideline; (2) the
GRADE tables; (3) the Opioid
Workgroup (OWG) Report, prepared at
the request of the BSC/NCIPC and
which the BSC/NCIPC unanimously
voted to have CDC adopt, and CDC’s
response to observations outlined in the
OWG Report; and (4) an Overview of
Community Engagement and Public
Comment Opportunities, which
describes key themes that emerged
about stakeholders’ values and
preferences regarding pain management,
as well as CDC’s response to input
obtained from these efforts. The GRADE
tables include clinical evidence review
ratings of the evidence for the key
clinical questions. The OWG Report
describes the workgroup’s findings and
observations about the initial draft
clinical practice guideline as presented
to the BSC/NCIPC at a public meeting
on July 16, 2021. The OWG, comprising
three BSC/NCIPC members in
accordance with federal advisory
committee policy, as well as patients
with pain, caregivers, and family
members of patients with pain, and
clinicians and subject matter experts
with a variety of relevant pain
management expertise, was designed to
provide independent, broad, external,
transparent input to the BSC/NCIPC on
the diverse and complex issues
addressed in the clinical practice
guideline. OWG meetings were
coordinated by an NCIPC subject matter
expert who served as the Designated
Federal Official. CDC’s response to the
OWG Report reflects and describes how
CDC incorporated OWG observations
and comments in the revised draft of the
clinical practice guideline. The
Overview of Community Engagement
and Public Comment Opportunities
document provides a summary of efforts
implemented throughout the clinical
practice guideline update process to
better understand the lived experiences
and perspectives of community
members that we serve and to ensure
additional input from patients,
caregivers, clinicians, and the public.
CDC’s response to the themes and
findings that emerged throughout the
community engagement and public
comment opportunities describes how
CDC carefully considered and
incorporated diverse perspectives and
input from multiple sources and
stakeholders into the clinical practice
guideline.
Dated: February 7, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2022–02802 Filed 2–9–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1030]
Brenda K. Marmas: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Brenda K. Marmas for a period of 5
years from importing or offering for
import any drug into the United States.
FDA bases this order on a finding that
Ms. Marmas engaged in a pattern of
importing or offering for import
misbranded drugs (i.e., in an amount,
frequency, or dosage that is inconsistent
with her personal or household use) that
are not designated in an authorized
electronic data interchange system as
products regulated by FDA. Ms. Marmas
was given notice of the proposed
debarment and was given an
opportunity to request a hearing to show
why she should not be debarred. As of
December 12, 2021 (30 days after receipt
of the notice), Ms. Marmas had not
responded. Ms. Marmas’ failure to
respond and request a hearing
constitutes a waiver of her right to a
hearing concerning this matter.
DATES: This order is applicable February
10, 2022.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Enforcement
(ELEM–4029), Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240 402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 306(b)(1)(D) of the FD&C Act
(21 U.S.C. 335a(b)(1)(D)) permits
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debarment of an individual from
importing or offering for import any
drug into the United States if FDA finds,
as required by section 306(b)(3)(D) of
the FD&C Act, that the individual has
engaged in a pattern of importing or
offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage
that is inconsistent with personal or
household use by the importer), and the
shipments are not designated in an
entry in an authorized electronic data
exchange system as products regulated
by FDA.
After an investigation, FDA
discovered that Ms. Marmas has
engaged in numerous instances of
importing or offering for import
misbranded drugs; all the parcels
containing the misbranded drugs
serving as the basis for this action,
described in further detail below, were
intercepted by FDA at either the John F.
Kennedy International Airport (JFK),
San Francisco International Airport
(SFO), or Chicago International Airport
Mail Facilities (MF) and were addressed
to Ms. Marmas at an address connected
to her.
On or about March 3, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
JFK MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
1,000 tablets of levofloxacin IP and was
a misbranded drug for a number of
reasons: (1) The article was determined
to be a prescription drug but did not
include the symbol ‘‘Rx only’’ on its
label; (2) the article had been
determined to lack adequate directions
for use; (3) the drug was not included
in a list required by section 510(j) of the
FD&C Act (21 U.S.C. 360(j)); and (4) the
drug was manufactured, prepared,
propagated, compounded, or processed
in an establishment not duly registered
under section 510 of the FD&C Act. FDA
also determined that another product
contained in this parcel was 900 tablets
of moxifloxacin hydrochloride and was
a misbranded drug for a number of
reasons: (1) The article was determined
to be a prescription drug but did not
include the symbol ‘‘Rx only’’ on its
label; (2) the article had been
determined to lack adequate directions
for use; (3) the drug was not included
in a list required by section 510(j) of the
FD&C Act; and (4) the drug was
manufactured, prepared, propagated,
compounded, or processed in an
establishment not duly registered under
section 510 of the FD&C Act. Both
products were refused entry on March
26, 2020.
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On or about March 3, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
JFK MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
300 tablets of azithromycin IP and was
a misbranded drug because the article
was determined to be a prescription
drug but did not include the symbol ‘‘Rx
only’’ on its label. FDA also determined
that one of the products contained in
this parcel was 600 tablets of
azithromycin IP and was a misbranded
drug because the article was determined
to be a prescription drug but did not
include the symbol ‘‘Rx only’’ on its
label. Both products were refused entry
on March 25, 2020.
On or about July 8, 2020, Ms. Marmas
offered for import a parcel intercepted
and processed by FDA at SFO MF that
was addressed to her. FDA determined
that the product contained in this parcel
was 2,304 capsules of azithromycin 250
milligrams (mg) and was a misbranded
drug because the article was determined
to be a prescription drug but did not
include the symbol ‘‘Rx only’’ on its
label and the drug was not included in
a list required by section 510(j) of the
FD&C Act. The product was refused
entry on August 5, 2020.
On or about July 17, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
SFO MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
300 tablets of amoxicillin 875 mg and
was a misbranded drug for multiple
reasons: (1) The article was determined
to be a prescription drug but did not
include the symbol ‘‘Rx only’’ on its
label; (2) the article had been
determined to lack adequate directions
for use; and (3) the drug was not
included in a list required by section
510(j) of the FD&C Act. FDA also
determined that one of the products
contained in this parcel was 1,400
capsules of clindamycin 300 mg and
was a misbranded drug because the
article had been determined to lack
adequate directions for use and the drug
was not included in a list required by
section 510(j) of the FD&C Act. Both
products were refused entry on
September 23, 2020.
On or about July 17, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
SFO MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was 84
tablets of azithromycin 250 mg and was
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a misbranded drug for multiple reasons:
(1) The article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label; (2)
the article had been determined to lack
adequate directions for use; and (3) the
drug was not included in a list required
by section 510(j) of the FD&C Act. FDA
also determined that one of the products
contained in this parcel was 1,800
capsules of clindamycin 150 mg and
was a misbranded drug because the
article had been determined to lack
adequate directions for use and because
the drug was not included in a list
required by section 510(j) of the FD&C
Act. FDA also determined that one of
the products contained in this parcel
was 500 tablets of roxithromycin 150 mg
and was a misbranded drug because the
article had been determined to lack
adequate directions for use and because
the drug was not included in a list
required by section 510(j) of the FD&C
Act. All three products were refused
entry on September 23, 2020.
On or about July 21, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
SFO MF that was addressed to her. FDA
determined that the product contained
in this parcel was 2,520 capsules of
fluconazole 200 mg and was a
misbranded drug because the drug was
manufactured, prepared, propagated,
compounded, or processed in an
establishment not duly registered under
section 510 of the FD&C Act and
because the drug was not included in a
list required by section 510(j) of the
FD&C Act. The product was refused
entry on August 17, 2020.
On or about July 30, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
SFO MF that was addressed to her. FDA
determined that the product contained
in this parcel was 2,000 capsules of
doxycycline hyclate 100 mg and was a
misbranded drug because the article was
determined to be a prescription drug but
did not include the symbol ‘‘Rx only.’’
The product was refused entry on
October 5, 2020.
On or about July 30, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
SFO MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
500 capsules of amoxicillin trihydrate
500 mg and was a misbranded drug for
multiple reasons: (1) The article was
determined to be a prescription drug but
did not include the symbol ‘‘Rx only’’
on its label; (2) the article had been
determined to lack adequate directions
for use; and (3) the drug was not
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included in a list required by section
510(j) of the FD&C Act. FDA determined
that one of the other products contained
in this parcel was 2,000 capsules of
clindamycin 300 mg and was a
misbranded drug because the article had
been determined to lack adequate
directions for use and because the drug
was not included in a list required by
section 510(j) of the FD&C Act. FDA
determined that one of the other
products contained in this parcel was
300 tablets of amoxicillin/clavulanic
acid 875 mg/125 mg and was a
misbranded drug for multiple reasons:
(1) The article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label; (2)
the article had been determined to lack
adequate directions for use; and (3) the
drug was not included in a list required
by section 510(j) of the FD&C Act. All
three products were refused entry on
October 9, 2020.
On or about July 31, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
SFO MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
576 capsules of azithromycin 250 mg
and was a misbranded drug because the
article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label and
the article had been determined to lack
adequate directions for use. FDA
determined that the other product
contained in this parcel was 1,600
tablets of clarithromycin 500 mg and
was a misbranded drug because the
article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. Both
products were refused entry on
September 4, 2020.
On or about August 13, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
SFO MF that was addressed to her. FDA
determined that the product contained
in this parcel was 2,860 capsules of
doxycycline hyclate 100 mg and was a
misbranded drug because the article was
determined to be a prescription drug but
did not include the symbol ‘‘Rx only.’’
The product was refused entry on
October 6, 2020.
On or about September 30, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
Chicago International Airport MF that
was addressed to her. FDA determined
that the product contained in this parcel
was 1,000 tablets of amoxycillin and
potassium clavulanate IP and was a
misbranded drug because the drug was
manufactured, prepared, propagated,
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compounded, or processed in an
establishment not duly registered under
section 510 of the FD&C Act and
because the drug was not included in a
list required by section 510(j) of the
FD&C Act. The product was refused
entry on October 26, 2020.
On or about October 2, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
JFK MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
230 tablets of LQUIN levofloxacin and
was a misbranded drug because the
article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label and
the article had been determined to lack
adequate directions for use. FDA
determined that the other product
contained in this parcel was 129 tablets
of AZICIP azithromycin and was a
misbranded drug because the article was
determined to be a prescription drug but
did not include the symbol ‘‘Rx only’’
on its label and the article had been
determined to lack adequate directions
for use. Both products were refused
entry on October 28, 2020.
On or about October 16, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
Chicago International Airport MF that
was addressed to her. This parcel
contained multiple products. FDA
determined that one of the products
contained in this parcel was 1,500
capsules of amoxicillin and was a
misbranded drug for multiple reasons:
(1) The required label or labeling was
determined to not be in English in
violation of § 201.15(c)(1) (21 CFR
201.15(c)(1)); (2) the article had been
determined to lack adequate directions
for use; (3) the drug was not included
in a list required by section 510(j) of the
FD&C Act; (4) the drug was
manufactured, prepared, propagated,
compounded, or processed in an
establishment not duly registered under
section 510 of the FD&C Act; and (5) the
article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. FDA
determined that the other product
contained in this parcel was 1,600
tablets of FLOXCIPRO 250 ciprofloxacin
and was a misbranded drug for multiple
reasons: (1) The required label or
labeling was determined to not be in
English in violation of § 201.15(c)(1); (2)
the article had been determined to lack
adequate directions for use; (3) the drug
was not included in a list required by
section 510(j) of the FD&C Act; (4) the
drug was manufactured, prepared,
propagated, compounded, or processed
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in an establishment not duly registered
under section 510 of the FD&C Act; and
(5) the article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. Both
products were refused entry on
December 3, 2020.
On or about November 16, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
JFK MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
300 tablets of AZICIP azithromycin and
was a misbranded drug because the
article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. FDA
determined that the other product
contained in this parcel was 1,000
tablets of CIPRODAC ciprofloxacin and
was a misbranded drug because the
article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. Both
products were refused entry on
December 10, 2020.
On or about December 15, 2020, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
JFK MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
1,000 capsules of cephalexin IP 500 mg
(CEPHADEX 500) and was a misbranded
drug as the article was determined to be
a prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. FDA
determined that one of the products
contained in this parcel was 30 capsules
of vancomycin hydrochloride IP 250 mg
(VANLID 250) and was a misbranded
drug as the article was determined to be
a prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. FDA
determined that one of the other
products contained in this parcel was
250 tablets of trimethoprim and
sulphamethoxazole IP (BACTRIM DS)
and was a misbranded drug as the
article was determined to be a
prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. All
three products were refused entry on
January 19, 2021.
On or about April 23, 2021, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
JFK MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
1,000 capsules of RESTECLIN 500
(tetracycline) and was a misbranded
drug as the article was determined to be
a prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. FDA
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determined that one of the products
contained in this parcel was 400 tablets
of RIFAGUR 400 (rifaximin) and was a
misbranded drug as the article was
determined to be a prescription drug but
did not include the symbol ‘‘Rx only’’
on its label. Both products were refused
entry on May 18, 2021.
On or about May 26, 2021, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
JFK MF that was addressed to her. This
parcel contained multiple products.
FDA determined that one of the
products contained in this parcel was
500 tablets of amoxycillin and
potassium clavulanate IP and was a
misbranded drug because the article was
determined to be a prescription drug but
did not include the symbol ‘‘Rx only’’
on its label. The product was refused
entry on June 25, 2021. FDA determined
that the other product contained in this
parcel was 300 tablets of azithromycin
IP 500 mg and was a misbranded drug
because the article was determined to be
a prescription drug but did not include
the symbol ‘‘Rx only’’ on its label. This
product was refused entry on June 24,
2021.
On or about July 15, 2021, Ms.
Marmas offered for import a parcel
intercepted and processed by FDA at
Chicago International Airport MF that
was addressed to her. FDA determined
that the product contained in this parcel
was 500 tablets of amoxycillin and
potassium clavulanate IP; CIPMOX CV–
625 and was a misbranded drug because
the article had been determined to lack
adequate directions for use and because
the drug was not included in a list
required by section 510(j) of the FD&C
Act. The product was refused entry on
August 13, 2021.
As a result of this pattern of importing
or offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage
that is inconsistent with her personal or
household use) that are not designated
in an authorized electronic data
interchange system as products
regulated by FDA, in accordance with
section 306(b)(3)(D) of the FD&C Act,
FDA sent Ms. Marmas, by certified mail
on November 3, 2021, a notice
proposing to debar her for a 5-year
period from importing or offering for
import any drug into the United States.
In proposing a debarment period,
FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C
Act that it considered applicable to Ms.
Marmas’ pattern of conduct and
concluded that her conduct warranted
the imposition of a 5-year period of
debarment.
The proposal informed Ms. Marmas of
the proposed debarment and offered her
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an opportunity to request a hearing,
providing 30 days from the date of
receipt of the letter in which to file the
request, and advised her that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Ms.
Marmas received the proposal and
notice of opportunity for a hearing on
November 12, 2021. Ms. Marmas failed
to request a hearing within the
timeframe prescribed by regulation and
has, therefore, waived her opportunity
for a hearing and waived any
contentions concerning her debarment.
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(D) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Ms. Brenda K.
Marmas has engaged in a pattern of
importing or offering for import
misbranded drugs (i.e., in an amount,
frequency, or dosage that is inconsistent
with her personal or household use) that
are not designated in an authorized
electronic data interchange system as
products regulated by FDA. FDA finds
that this pattern of conduct should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Ms. Marmas is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
applicable (see DATES). Pursuant to
section 301(cc) of the FD&C Act (21
U.S.C. 331(cc)), the importing or
offering for import into the United
States of any drug or controlled
substance by, with the assistance of, or
at the direction of Ms. Marmas is a
prohibited act.
Any application by Ms. Marmas for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2021–
N–1030 and sent to the Dockets
Management Staff (see ADDRESSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20(j).
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: February 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02801 Filed 2–9–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0556]
Development of Non-Opioid
Analgesics for Acute Pain; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Development of Non-Opioid
Analgesics for Acute Pain.’’ In
connection with the SUPPORT for
Patients and Communities Act
(SUPPORT Act), the purpose of this
guidance is to spur the development of
alternatives to opioids for the
management of acute pain by providing
information about product
development-related issues, ‘‘opioidsparing’’ claims, and expedited
programs as they pertain to this
purpose.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by April 11, 2022 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
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
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
confidential business information, such
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
do not wish to be made available to the
public, submit the comment as a
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written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
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–
2021–N–0556 for ‘‘Development of NonOpioid Analgesics for Acute Pain.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
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Dockets Management Staff between 9
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Friday, 240–402–7500.
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Docket: For access to the docket to
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E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Notices]
[Pages 7840-7843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02801]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1030]
Brenda K. Marmas: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Brenda K. Marmas for a period of 5 years from importing or offering for
import any drug into the United States. FDA bases this order on a
finding that Ms. Marmas engaged in a pattern of importing or offering
for import misbranded drugs (i.e., in an amount, frequency, or dosage
that is inconsistent with her personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. Ms. Marmas was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
she should not be debarred. As of December 12, 2021 (30 days after
receipt of the notice), Ms. Marmas had not responded. Ms. Marmas'
failure to respond and request a hearing constitutes a waiver of her
right to a hearing concerning this matter.
DATES: This order is applicable February 10, 2022.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857, 240 402-8743, or at
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(D) of the FD&C Act, that the individual has engaged
in a pattern of importing or offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage that is inconsistent with
personal or household use by the importer), and the shipments are not
designated in an entry in an authorized electronic data exchange system
as products regulated by FDA.
After an investigation, FDA discovered that Ms. Marmas has engaged
in numerous instances of importing or offering for import misbranded
drugs; all the parcels containing the misbranded drugs serving as the
basis for this action, described in further detail below, were
intercepted by FDA at either the John F. Kennedy International Airport
(JFK), San Francisco International Airport (SFO), or Chicago
International Airport Mail Facilities (MF) and were addressed to Ms.
Marmas at an address connected to her.
On or about March 3, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 1,000 tablets of levofloxacin IP
and was a misbranded drug for a number of reasons: (1) The article was
determined to be a prescription drug but did not include the symbol
``Rx only'' on its label; (2) the article had been determined to lack
adequate directions for use; (3) the drug was not included in a list
required by section 510(j) of the FD&C Act (21 U.S.C. 360(j)); and (4)
the drug was manufactured, prepared, propagated, compounded, or
processed in an establishment not duly registered under section 510 of
the FD&C Act. FDA also determined that another product contained in
this parcel was 900 tablets of moxifloxacin hydrochloride and was a
misbranded drug for a number of reasons: (1) The article was determined
to be a prescription drug but did not include the symbol ``Rx only'' on
its label; (2) the article had been determined to lack adequate
directions for use; (3) the drug was not included in a list required by
section 510(j) of the FD&C Act; and (4) the drug was manufactured,
prepared, propagated, compounded, or processed in an establishment not
duly registered under section 510 of the FD&C Act. Both products were
refused entry on March 26, 2020.
[[Page 7841]]
On or about March 3, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 300 tablets of azithromycin IP
and was a misbranded drug because the article was determined to be a
prescription drug but did not include the symbol ``Rx only'' on its
label. FDA also determined that one of the products contained in this
parcel was 600 tablets of azithromycin IP and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. Both products were
refused entry on March 25, 2020.
On or about July 8, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
FDA determined that the product contained in this parcel was 2,304
capsules of azithromycin 250 milligrams (mg) and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label and the drug was not
included in a list required by section 510(j) of the FD&C Act. The
product was refused entry on August 5, 2020.
On or about July 17, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 300 tablets of amoxicillin 875 mg
and was a misbranded drug for multiple reasons: (1) The article was
determined to be a prescription drug but did not include the symbol
``Rx only'' on its label; (2) the article had been determined to lack
adequate directions for use; and (3) the drug was not included in a
list required by section 510(j) of the FD&C Act. FDA also determined
that one of the products contained in this parcel was 1,400 capsules of
clindamycin 300 mg and was a misbranded drug because the article had
been determined to lack adequate directions for use and the drug was
not included in a list required by section 510(j) of the FD&C Act. Both
products were refused entry on September 23, 2020.
On or about July 17, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 84 tablets of azithromycin 250 mg
and was a misbranded drug for multiple reasons: (1) The article was
determined to be a prescription drug but did not include the symbol
``Rx only'' on its label; (2) the article had been determined to lack
adequate directions for use; and (3) the drug was not included in a
list required by section 510(j) of the FD&C Act. FDA also determined
that one of the products contained in this parcel was 1,800 capsules of
clindamycin 150 mg and was a misbranded drug because the article had
been determined to lack adequate directions for use and because the
drug was not included in a list required by section 510(j) of the FD&C
Act. FDA also determined that one of the products contained in this
parcel was 500 tablets of roxithromycin 150 mg and was a misbranded
drug because the article had been determined to lack adequate
directions for use and because the drug was not included in a list
required by section 510(j) of the FD&C Act. All three products were
refused entry on September 23, 2020.
On or about July 21, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
FDA determined that the product contained in this parcel was 2,520
capsules of fluconazole 200 mg and was a misbranded drug because the
drug was manufactured, prepared, propagated, compounded, or processed
in an establishment not duly registered under section 510 of the FD&C
Act and because the drug was not included in a list required by section
510(j) of the FD&C Act. The product was refused entry on August 17,
2020.
On or about July 30, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
FDA determined that the product contained in this parcel was 2,000
capsules of doxycycline hyclate 100 mg and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only.'' The product was refused entry on
October 5, 2020.
On or about July 30, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 500 capsules of amoxicillin
trihydrate 500 mg and was a misbranded drug for multiple reasons: (1)
The article was determined to be a prescription drug but did not
include the symbol ``Rx only'' on its label; (2) the article had been
determined to lack adequate directions for use; and (3) the drug was
not included in a list required by section 510(j) of the FD&C Act. FDA
determined that one of the other products contained in this parcel was
2,000 capsules of clindamycin 300 mg and was a misbranded drug because
the article had been determined to lack adequate directions for use and
because the drug was not included in a list required by section 510(j)
of the FD&C Act. FDA determined that one of the other products
contained in this parcel was 300 tablets of amoxicillin/clavulanic acid
875 mg/125 mg and was a misbranded drug for multiple reasons: (1) The
article was determined to be a prescription drug but did not include
the symbol ``Rx only'' on its label; (2) the article had been
determined to lack adequate directions for use; and (3) the drug was
not included in a list required by section 510(j) of the FD&C Act. All
three products were refused entry on October 9, 2020.
On or about July 31, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 576 capsules of azithromycin 250
mg and was a misbranded drug because the article was determined to be a
prescription drug but did not include the symbol ``Rx only'' on its
label and the article had been determined to lack adequate directions
for use. FDA determined that the other product contained in this parcel
was 1,600 tablets of clarithromycin 500 mg and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. Both products were
refused entry on September 4, 2020.
On or about August 13, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
FDA determined that the product contained in this parcel was 2,860
capsules of doxycycline hyclate 100 mg and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only.'' The product was refused entry on
October 6, 2020.
On or about September 30, 2020, Ms. Marmas offered for import a
parcel intercepted and processed by FDA at Chicago International
Airport MF that was addressed to her. FDA determined that the product
contained in this parcel was 1,000 tablets of amoxycillin and potassium
clavulanate IP and was a misbranded drug because the drug was
manufactured, prepared, propagated,
[[Page 7842]]
compounded, or processed in an establishment not duly registered under
section 510 of the FD&C Act and because the drug was not included in a
list required by section 510(j) of the FD&C Act. The product was
refused entry on October 26, 2020.
On or about October 2, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 230 tablets of LQUIN levofloxacin
and was a misbranded drug because the article was determined to be a
prescription drug but did not include the symbol ``Rx only'' on its
label and the article had been determined to lack adequate directions
for use. FDA determined that the other product contained in this parcel
was 129 tablets of AZICIP azithromycin and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label and the article had
been determined to lack adequate directions for use. Both products were
refused entry on October 28, 2020.
On or about October 16, 2020, Ms. Marmas offered for import a
parcel intercepted and processed by FDA at Chicago International
Airport MF that was addressed to her. This parcel contained multiple
products. FDA determined that one of the products contained in this
parcel was 1,500 capsules of amoxicillin and was a misbranded drug for
multiple reasons: (1) The required label or labeling was determined to
not be in English in violation of Sec. 201.15(c)(1) (21 CFR
201.15(c)(1)); (2) the article had been determined to lack adequate
directions for use; (3) the drug was not included in a list required by
section 510(j) of the FD&C Act; (4) the drug was manufactured,
prepared, propagated, compounded, or processed in an establishment not
duly registered under section 510 of the FD&C Act; and (5) the article
was determined to be a prescription drug but did not include the symbol
``Rx only'' on its label. FDA determined that the other product
contained in this parcel was 1,600 tablets of FLOXCIPRO 250
ciprofloxacin and was a misbranded drug for multiple reasons: (1) The
required label or labeling was determined to not be in English in
violation of Sec. 201.15(c)(1); (2) the article had been determined to
lack adequate directions for use; (3) the drug was not included in a
list required by section 510(j) of the FD&C Act; (4) the drug was
manufactured, prepared, propagated, compounded, or processed in an
establishment not duly registered under section 510 of the FD&C Act;
and (5) the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. Both products were
refused entry on December 3, 2020.
On or about November 16, 2020, Ms. Marmas offered for import a
parcel intercepted and processed by FDA at JFK MF that was addressed to
her. This parcel contained multiple products. FDA determined that one
of the products contained in this parcel was 300 tablets of AZICIP
azithromycin and was a misbranded drug because the article was
determined to be a prescription drug but did not include the symbol
``Rx only'' on its label. FDA determined that the other product
contained in this parcel was 1,000 tablets of CIPRODAC ciprofloxacin
and was a misbranded drug because the article was determined to be a
prescription drug but did not include the symbol ``Rx only'' on its
label. Both products were refused entry on December 10, 2020.
On or about December 15, 2020, Ms. Marmas offered for import a
parcel intercepted and processed by FDA at JFK MF that was addressed to
her. This parcel contained multiple products. FDA determined that one
of the products contained in this parcel was 1,000 capsules of
cephalexin IP 500 mg (CEPHADEX 500) and was a misbranded drug as the
article was determined to be a prescription drug but did not include
the symbol ``Rx only'' on its label. FDA determined that one of the
products contained in this parcel was 30 capsules of vancomycin
hydrochloride IP 250 mg (VANLID 250) and was a misbranded drug as the
article was determined to be a prescription drug but did not include
the symbol ``Rx only'' on its label. FDA determined that one of the
other products contained in this parcel was 250 tablets of trimethoprim
and sulphamethoxazole IP (BACTRIM DS) and was a misbranded drug as the
article was determined to be a prescription drug but did not include
the symbol ``Rx only'' on its label. All three products were refused
entry on January 19, 2021.
On or about April 23, 2021, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 1,000 capsules of RESTECLIN 500
(tetracycline) and was a misbranded drug as the article was determined
to be a prescription drug but did not include the symbol ``Rx only'' on
its label. FDA determined that one of the products contained in this
parcel was 400 tablets of RIFAGUR 400 (rifaximin) and was a misbranded
drug as the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. Both products were
refused entry on May 18, 2021.
On or about May 26, 2021, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 500 tablets of amoxycillin and
potassium clavulanate IP and was a misbranded drug because the article
was determined to be a prescription drug but did not include the symbol
``Rx only'' on its label. The product was refused entry on June 25,
2021. FDA determined that the other product contained in this parcel
was 300 tablets of azithromycin IP 500 mg and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. This product was
refused entry on June 24, 2021.
On or about July 15, 2021, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at Chicago International Airport MF
that was addressed to her. FDA determined that the product contained in
this parcel was 500 tablets of amoxycillin and potassium clavulanate
IP; CIPMOX CV-625 and was a misbranded drug because the article had
been determined to lack adequate directions for use and because the
drug was not included in a list required by section 510(j) of the FD&C
Act. The product was refused entry on August 13, 2021.
As a result of this pattern of importing or offering for import
misbranded drugs (i.e., in an amount, frequency, or dosage that is
inconsistent with her personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA, in accordance with section 306(b)(3)(D) of
the FD&C Act, FDA sent Ms. Marmas, by certified mail on November 3,
2021, a notice proposing to debar her for a 5-year period from
importing or offering for import any drug into the United States.
In proposing a debarment period, FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C Act that it considered
applicable to Ms. Marmas' pattern of conduct and concluded that her
conduct warranted the imposition of a 5-year period of debarment.
The proposal informed Ms. Marmas of the proposed debarment and
offered her
[[Page 7843]]
an opportunity to request a hearing, providing 30 days from the date of
receipt of the letter in which to file the request, and advised her
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Ms. Marmas received the proposal and notice of opportunity for
a hearing on November 12, 2021. Ms. Marmas failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and waived any contentions
concerning her debarment. (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(D) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms.
Brenda K. Marmas has engaged in a pattern of importing or offering for
import misbranded drugs (i.e., in an amount, frequency, or dosage that
is inconsistent with her personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. FDA finds that this pattern of conduct
should be accorded a debarment period of 5 years as provided by section
306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Ms. Marmas is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, applicable (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug or controlled substance by,
with the assistance of, or at the direction of Ms. Marmas is a
prohibited act.
Any application by Ms. Marmas for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-1030 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02801 Filed 2-9-22; 8:45 am]
BILLING CODE 4164-01-P
