David Elias Mendoza: Final Debarment Order, 68503-68504 [2022-24805]
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Federal Register / Vol. 87, No. 219 / Tuesday, November 15, 2022 / Notices
System No. 09–80–0381; 87 FR 3553
(January 24, 2022).
[FR Doc. 2022–24771 Filed 11–14–22; 8:45 am]
BILLING CODE 4184–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0526]
David Elias Mendoza: 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
David Elias Mendoza 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
Mr. Mendoza engaged in a pattern of
importing or offering for import
misbranded drugs (i.e., in an amount,
frequency, or dosage that is inconsistent
with his personal or household use) that
are not designated in an authorized
electronic data interchange system as
products regulated by FDA. Mr.
Mendoza was given notice of the
proposed debarment and was given an
opportunity to request a hearing to show
why he should not be debarred. As of
March 28, 2022 (30 days after receipt of
the notice), Mr. Mendoza had not
responded. Mr. Mendoza’s failure to
respond and request a hearing within
the timeframe prescribed by regulation
constitutes a waiver of his right to a
hearing and any contentions concerning
this matter.
DATES: This order is applicable
November 15, 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–4144), 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:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
I. Background
Section 306(b)(1)(D) of the FD&C Act
(21 U.S.C. 335a(b)(1)(D)) permits
VerDate Sep<11>2014
19:16 Nov 14, 2022
Jkt 259001
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) that are
not designated in an authorized
electronic data interchange system as
products regulated by FDA.
After an investigation, FDA
discovered that Mr. Mendoza has
engaged in numerous instances of
importing or offering for import
misbranded drugs (i.e., in an amount,
frequency, or dosage that is inconsistent
with his personal or household use) that
were not designated in an authorized
electronic data interchange system as
products that are regulated by FDA; all
the parcels containing the misbranded
drugs serving as the basis for this action,
described in further detail below, were
intercepted by FDA at the John F.
Kennedy (JFK) International Mail
Facility (IMF) and were addressed to
Mr. Mendoza at one of two addresses
connected to him.
On or about June 4, 2019, Mr.
Mendoza offered for import a parcel that
contained 250 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label and lacked adequate
directions for use in its labeling. The
product was refused entry on July 9,
2019.
On or about January 24, 2020, Mr.
Mendoza offered for import a parcel that
contained 250 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label and lacked adequate
directions for use in its labeling. The
product was refused entry on February
20, 2020.
On or about January 29, 2020, Mr.
Mendoza offered for import a parcel that
contained 250 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label and lacked adequate
directions for use in its labeling. The
product was refused entry on February
25, 2020.
On or about January 30, 2020, Mr.
Mendoza offered for import a parcel that
contained 270 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
68503
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label and lacked adequate
directions for use in its labeling. The
product was refused entry on February
25, 2020.
On or about February 14, 2020, Mr.
Mendoza offered for import a parcel that
contained 330 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label and lacked adequate
directions for use in its labeling. The
product was refused entry on March 17,
2020.
On or about February 14, 2020, Mr.
Mendoza offered for import a parcel that
contained 250 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label and lacked adequate
directions for use in its labeling. The
product was refused entry on March 17,
2020.
On or about February 24, 2020, Mr.
Mendoza offered for import a parcel that
contained 250 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label and lacked adequate
directions for use in its labeling. The
product was refused entry on March 19,
2020.
On or about June 10, 2020, Mr.
Mendoza offered for import a parcel that
contained 300 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label. The product was refused
entry on July 10, 2020.
On or about June 10, 2020, Mr.
Mendoza offered for import a parcel that
contained 300 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label. The product was refused
entry on July 7, 2020.
On or about June 16, 2020, Mr.
Mendoza offered for import a parcel that
contained 300 tablets of CENFORCE–
100, which was a misbranded drug
because the product failed to contain
adequate directions for use in its
labeling. The product was refused entry
on July 14, 2020.
On or about June 16, 2020, Mr.
Mendoza offered for import a parcel that
contained 320 tablets of CENFORCE–
100, which was a misbranded drug
E:\FR\FM\15NON1.SGM
15NON1
68504
Federal Register / Vol. 87, No. 219 / Tuesday, November 15, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
because the product failed to contain
adequate directions for use in its
labeling. The product was refused entry
on July 14, 2020.
On or about June 18, 2020, Mr.
Mendoza offered for import a parcel that
contained 300 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label. The product was refused
entry on July 15, 2020.
As a result of Mr. Mendoza’s pattern
of importing or offering for import
misbranded drugs (i.e., in an amount,
frequency, or dosage that is inconsistent
with his 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 Mr. Mendoza,
by certified mail on February 17, 2022,
a notice proposing to debar him for a 5year 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 Mr.
Mendoza’s pattern of conduct and
concluded that his conduct warranted
the imposition of a 5-year period of
debarment.
The proposal informed Mr. Mendoza
of the proposed debarment and offered
him 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 him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Mr.
Mendoza received the proposal and
notice of opportunity for a hearing on
February 26, 2022. Mr. Mendoza failed
to request a hearing within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and waived any
contentions concerning his 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 Mr. David
Elias Mendoza 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 his personal or household use) that
are not designated in an authorized
electronic data interchange system as
VerDate Sep<11>2014
19:16 Nov 14, 2022
Jkt 259001
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,
Mr. Mendoza is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
effective (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
Mr. Mendoza is a prohibited act.
Any application by Mr. Mendoza for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2021–
N–0526 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, 240–402–7500.
Dated: November 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24805 Filed 11–14–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2778]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Threshold of
Regulation for Substances Used in
Food-Contact Articles
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by December
15, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0298. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Threshold of Regulation for Substances
Used in Food-Contact Articles—21 CFR
170.39
OMB Control Number 0910–0298—
Extension
Under section 409(a) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(a)), the use of a food
additive is deemed unsafe unless one of
the following is applicable: (1) it
conforms to an exemption for
investigational use under section 409(j)
of the FD&C Act; (2) it conforms to the
terms of a regulation prescribing its use;
or (3) in the case of a food additive
which meets the definition of a foodcontact substance in section 409(h)(6) of
the FD&C Act, there is either a
regulation authorizing its use in
accordance with section 409(a)(3)(A) of
the FD&C Act or an effective notification
in accordance with section 409(a)(3)(B)
of the FD&C Act.
The regulations in § 170.39 (21 CFR
170.39) established a process that
provides the manufacturer with an
opportunity to demonstrate that the
likelihood or extent of migration to food
of a substance used in a food-contact
article is so trivial that the use need not
be the subject of a food additive listing
regulation or an effective notification.
The Agency has established two
thresholds for the regulation of
substances used in food-contact articles.
The first exempts those substances used
in food-contact articles where the
resulting dietary concentration would
be at or below 0.5 part per billion. The
second exempts regulated direct food
additives for use in food-contact articles
where the resulting dietary exposure is
E:\FR\FM\15NON1.SGM
15NON1
]]>Agencies
[Federal Register Volume 87, Number 219 (Tuesday, November 15, 2022)]
[Notices]
[Pages 68503-68504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24805]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0526]
David Elias Mendoza: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
David Elias Mendoza 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 Mr. Mendoza engaged in a pattern of importing or offering
for import misbranded drugs (i.e., in an amount, frequency, or dosage
that is inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. Mr. Mendoza was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
he should not be debarred. As of March 28, 2022 (30 days after receipt
of the notice), Mr. Mendoza had not responded. Mr. Mendoza's failure to
respond and request a hearing within the timeframe prescribed by
regulation constitutes a waiver of his right to a hearing and any
contentions concerning this matter.
DATES: This order is applicable November 15, 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-4144), 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) that are not designated in
an authorized electronic data interchange system as products regulated
by FDA.
After an investigation, FDA discovered that Mr. Mendoza has engaged
in numerous instances of importing or offering for import misbranded
drugs (i.e., in an amount, frequency, or dosage that is inconsistent
with his personal or household use) that were not designated in an
authorized electronic data interchange system as products that are
regulated by FDA; all the parcels containing the misbranded drugs
serving as the basis for this action, described in further detail
below, were intercepted by FDA at the John F. Kennedy (JFK)
International Mail Facility (IMF) and were addressed to Mr. Mendoza at
one of two addresses connected to him.
On or about June 4, 2019, Mr. Mendoza offered for import a parcel
that contained 250 tablets of CENFORCE-100, which was a misbranded drug
because the product was determined to be a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label and lacked
adequate directions for use in its labeling. The product was refused
entry on July 9, 2019.
On or about January 24, 2020, Mr. Mendoza offered for import a
parcel that contained 250 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on February 20, 2020.
On or about January 29, 2020, Mr. Mendoza offered for import a
parcel that contained 250 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on February 25, 2020.
On or about January 30, 2020, Mr. Mendoza offered for import a
parcel that contained 270 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on February 25, 2020.
On or about February 14, 2020, Mr. Mendoza offered for import a
parcel that contained 330 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on March 17, 2020.
On or about February 14, 2020, Mr. Mendoza offered for import a
parcel that contained 250 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on March 17, 2020.
On or about February 24, 2020, Mr. Mendoza offered for import a
parcel that contained 250 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on March 19, 2020.
On or about June 10, 2020, Mr. Mendoza offered for import a parcel
that contained 300 tablets of CENFORCE-100, which was a misbranded drug
because the product was determined to be a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label. The product
was refused entry on July 10, 2020.
On or about June 10, 2020, Mr. Mendoza offered for import a parcel
that contained 300 tablets of CENFORCE-100, which was a misbranded drug
because the product was determined to be a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label. The product
was refused entry on July 7, 2020.
On or about June 16, 2020, Mr. Mendoza offered for import a parcel
that contained 300 tablets of CENFORCE-100, which was a misbranded drug
because the product failed to contain adequate directions for use in
its labeling. The product was refused entry on July 14, 2020.
On or about June 16, 2020, Mr. Mendoza offered for import a parcel
that contained 320 tablets of CENFORCE-100, which was a misbranded drug
[[Page 68504]]
because the product failed to contain adequate directions for use in
its labeling. The product was refused entry on July 14, 2020.
On or about June 18, 2020, Mr. Mendoza offered for import a parcel
that contained 300 tablets of CENFORCE-100, which was a misbranded drug
because the product was determined to be a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label. The product
was refused entry on July 15, 2020.
As a result of Mr. Mendoza's pattern of importing or offering for
import misbranded drugs (i.e., in an amount, frequency, or dosage that
is inconsistent with his 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 Mr. Mendoza, by certified mail on February 17,
2022, a notice proposing to debar him 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 Mr. Mendoza's pattern of conduct and concluded that his
conduct warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Mendoza of the proposed debarment and
offered him 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 him that failure to request a hearing constituted a waiver of
the opportunity for a hearing and of any contentions concerning this
action. Mr. Mendoza received the proposal and notice of opportunity for
a hearing on February 26, 2022. Mr. Mendoza failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived his opportunity for a hearing and waived any contentions
concerning his 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 Mr. David
Elias Mendoza 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 his 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, Mr. Mendoza is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective (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 Mr. Mendoza is a
prohibited act.
Any application by Mr. Mendoza for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0526 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, 240-402-7500.
Dated: November 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24805 Filed 11-14-22; 8:45 am]
BILLING CODE 4164-01-P
