Pan American Laboratories, LLC, et al.; Withdrawal of Approval of Three New Drug Applications, 15192-15193 [2020-05498]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
15192
Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
306(l)(1)(A) of the FD&C Act, in the
United States District Court for the
Northern District of Texas Dallas
Division, when the court entered
judgment against him for the offense of
Mail Fraud in violation of 18 U.S.C.
1343.
FDA’s finding that the debarment is
appropriate is based on the felony
conviction referenced herein. The
factual basis for this conviction is as
follows: As contained in the Factual
Resume in his case, filed on March 12,
2018, Mr. Dong, along with other
employees of his employer Genabolix
USA, Inc. and Shanghai Yongyi
Biotechnology Co., Ltd. (Genabolix), did
in or around February 2017, agree to sell
synthetic stimulant ingredients,
including 1,4 Dimethylamylamine (1,4DMAA), to a purported dietary
supplement manufacturer. That
manufacturer told Mr. Dong that the
ingredients supplied by Mr. Dong would
not be accurately listed on the labels of
the finished dietary supplements
produced with those ingredients. As Mr.
Dong knew, the synthetic stimulant
ingredients would be omitted from the
ingredient label of the dietary
supplements so that American retailers
would sell the product. Mr. Dong then
sent unlabeled shipments of these
ingredients to a third party in the
United States. Subsequently, on June 8,
2017, Mr. Dong (along with others)
caused 50kg of 1,3 Dimethylamylamine
(1,3-DMAA) to be shipped via
commercial carrier in interstate
commerce in the United States.
As a result of this conviction, FDA
sent Mr. Dong, by certified mail on
October 18, 2019, a notice proposing to
debar him for a period of 5 years from
importing articles of food or offering
such articles for import into the United
States. The proposal was based on a
finding under section 306(b)(1)(C) of the
FD&C Act that Mr. Dong’s felony
conviction for Mail Fraud in violation of
18 U.S.C. 1343, constitutes conduct
relating to the importation into the
United States of an article of food
because Mr. Dong unlawfully imported
synthetic stimulant ingredients which
Mr. Dong then caused to be shipped in
interstate commerce and ultimately
used in dietary supplements that did
not list the synthetic stimulants as an
ingredient.
The proposal was also based on a
determination, after consideration of the
relevant factors set forth in section
306(c)(3) of the FD&C Act, that Mr. Dong
should be subject to a 5-year period of
debarment. The proposal also offered
Mr. Dong an opportunity to request a
hearing, providing him 30 days from the
VerDate Sep<11>2014
17:32 Mar 16, 2020
Jkt 250001
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. Dong failed to respond
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).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Findings and Order
HHS.
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Dong has
been convicted of a felony count under
Federal law for conduct relating to the
importation into the United States of an
article of food and that he is subject to
a 5-year period of debarment.
As a result of the foregoing finding,
Mr. Dong is debarred for a period of 5
years from importing articles of food or
offering such articles for import 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 an article of food by, with the
assistance of, or at the direction of Mr.
Dong is a prohibited act.
Any application by Mr. Dong for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2019–
N–3474 and sent to the Dockets
Management Staff (see ADDRESSES). All
such submissions are to be filed in four
copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20.
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: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05443 Filed 3–16–20; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
Food and Drug Administration
[Docket No. FDA–2020–N–0419]
Pan American Laboratories, LLC, et al.;
Withdrawal of Approval of Three New
Drug Applications
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of three new drug applications
(NDAs) from multiple holders of those
NDAs. The basis for the withdrawal is
that these NDA holders have repeatedly
failed to file required annual reports for
those NDAs.
SUMMARY:
Approval is withdrawn as of
March 17, 2020.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly S. Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
The
holder of an approved application to
market a new drug for human use is
required to submit annual reports to
FDA concerning its approved
application in accordance with § 314.81
(21 CFR 314.81).
In the Federal Register of November
18, 2019 (84 FR 63661), FDA published
a notice offering an opportunity for a
hearing (NOOH) on a proposal to
withdraw approval of these NDAs
because the holders of those NDAs had
repeatedly failed to submit the required
annual reports for those NDAs. The
holders of the NDAs identified in table
1 did not respond to the NOOH. Failure
to file a written notice of participation
and request for hearing as required by
§ 314.200 (21 CFR 314.200) constitutes
an election by those holders of the
NDAs not to make use of the
opportunity for a hearing concerning the
proposal to withdraw approval of their
NDAs and a waiver of any contentions
concerning the legal status of the drug
products. Therefore, FDA is
withdrawing approval of the three
applications listed in table 1 of this
document. FDA notes that the NOOH
also proposed to withdraw approval of
NDA 018663, but FDA has decided not
to pursue withdrawal of approval of this
NDA at this time.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\17MRN1.SGM
17MRN1
Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
15193
TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Application No.
Drug
NDA holder
NDA 014217 ...
Maolate (chlorphenesin carbamate) Tablet, 400 milligrams
(mg).
Iontocaine (epinephrine and lidocaine hydrochloride (HCl))
Topical Solution, 0.01 mg/milliliter; 2%.
LidoSite Topical System: LidoSite Patch (lidocaine HCl and
epinephrine topical iontophoretic patch) 10%/0.1% and
LidoSite Controller.
Pan American Laboratories, LLC, 4099 Highway 190, Covington, LA 70433.
Iomed, Inc., 2441 South 3850 West, Suite A, Salt Lake City,
UT 84120–9941.
Vyteris, Inc., 13–01 Pollitt Dr., Fair Lawn, NJ 07410.
NDA 020530 ...
NDA 021504 ...
FDA finds that the holders of the
NDAs listed in table 1 have repeatedly
failed to submit reports required by
§ 314.81. In addition, under § 314.200,
FDA finds that the holders of the NDAs
have waived any contentions
concerning the legal status of the drug
products. Therefore, under these
findings, approval of the NDAs listed in
table 1 and all amendments and
supplements thereto are hereby
withdrawn as of March 17, 2020.1
Dated: March 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05498 Filed 3–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3310]
Matthew Dailey: 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
Matthew Dailey for a period of 10 years
from importing or offering for import
any drug into the United States. FDA
bases this order on a finding that Mr.
Dailey was convicted, as defined in the
FD&C Act, of one felony count under
Federal law for introducing misbranded
drugs into interstate commerce and one
felony count of importing merchandise
contrary to law. The factual basis
supporting both felony convictions, as
described below, is conduct relating to
the importation into the United States of
a drug or controlled substance. Mr.
Dailey was given notice of the proposed
debarment and was given an
opportunity to request a hearing within
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
1 Although it was not a factor in FDA’s
determination, we note that all three drugs covered
by these NDAs are in discontinued marketing
status.
VerDate Sep<11>2014
17:32 Mar 16, 2020
Jkt 250001
the timeframe prescribed by regulation
to show why he should not be debarred.
As of November 8, 2019 (30 days after
receipt of the notice), Mr. Dailey had not
responded. Mr. Dailey’s failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable March
17, 2020.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa (ELEM–4029), Division
of Enforcement, 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:
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 the FDA
finds, as required by section 306(b)(3)(C)
of the FD&C Act, that the individual has
been convicted of a felony for conduct
relating to the importation into the
United States of any drug or controlled
substance.
On May 8, 2019, Mr. Dailey was
convicted as defined in section 306(l)(1)
of the FD&C Act, in the U.S. District
Court for the Eastern District of
Michigan, when the court accepted his
plea of guilty and entered judgment
against him for the offenses of
introducing misbranded drugs into
interstate commerce in violation of
section 301(a) of the FD&C Act (21
U.S.C. 331(a)) and importing
merchandise contrary to law in
violation of 18 U.S.C. 545.
The FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for these convictions is as
follows: As contained in the Stipulation
of Facts incorporated into the Plea
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
Agreement, filed on January 8, 2019,
from on or about March 2011 through
November 2016, Mr. Dailey imported
hundreds of shipments of kratom into
the United States. To evade the lawful
regulatory authority of FDA, he
instructed his foreign suppliers to label
shipments of bulk kratom with
materially false statements that
described the kratom as ‘‘incense,’’
‘‘paint pigment,’’ and other substances
not regulated by the FDA. Mr. Dailey
also provided the FDA (sometimes
through import brokers) materially false
written descriptions of his bulk kratom
imports. After receiving the kratom, Mr.
Dailey then apportioned bulk shipments
of kratom into smaller portions and
repackaged the kratom into smaller
plastic bags at a location not registered
as a facility that manufactures, prepares,
propagates, compounds, and processes
drugs. Mr. Dailey then sold kratom
products to hundreds of consumers
through the United States through a
website he managed. The labeling of his
kratom products did not include any
directions for use, such as indications,
dosage instructions, methods of
administration, or contraindications. In
selling his kratom product, Mr. Dailey
intended that consumers use his kratom
products as a ‘‘drug’’ within the
meaning of section 201(g)(1) of the
FD&C Act (21 U.S.C. 321(g)(1)).
Specifically, Mr. Dailey intended that
consumers use the kratom he imported
to treat and mitigate diseases, including
but not limited to chronic pain,
fibromyalgia, opiate withdrawal, and
Lyme disease, and to affect the structure
and function of the human body by
taking the kratom products as
substitutes for drugs of abuse and
prescription pills. As stated in the
Stipulation of Facts, Mr. Dailey’s actions
were in violation of section 301(a) of the
FD&C Act and 18 U.S.C. 545.
As a result of this conviction, FDA
sent Mr. Dailey by certified mail on
October 2, 2019, a notice proposing to
debar him for 2 consecutive 5-year
periods (10 years) from importing or
offering for import any drug into the
United States. The proposal was based
on a finding under section 306(b)(3)(C)
E:\FR\FM\17MRN1.SGM
17MRN1
]]>Agencies
[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15192-15193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05498]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0419]
Pan American Laboratories, LLC, et al.; Withdrawal of Approval of
Three New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of three new drug applications (NDAs) from multiple holders of those
NDAs. The basis for the withdrawal is that these NDA holders have
repeatedly failed to file required annual reports for those NDAs.
DATES: Approval is withdrawn as of March 17, 2020.
FOR FURTHER INFORMATION CONTACT: Kimberly S. Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.
SUPPLEMENTARY INFORMATION: The holder of an approved application to
market a new drug for human use is required to submit annual reports to
FDA concerning its approved application in accordance with Sec. 314.81
(21 CFR 314.81).
In the Federal Register of November 18, 2019 (84 FR 63661), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of these NDAs because the holders of
those NDAs had repeatedly failed to submit the required annual reports
for those NDAs. The holders of the NDAs identified in table 1 did not
respond to the NOOH. Failure to file a written notice of participation
and request for hearing as required by Sec. 314.200 (21 CFR 314.200)
constitutes an election by those holders of the NDAs not to make use of
the opportunity for a hearing concerning the proposal to withdraw
approval of their NDAs and a waiver of any contentions concerning the
legal status of the drug products. Therefore, FDA is withdrawing
approval of the three applications listed in table 1 of this document.
FDA notes that the NOOH also proposed to withdraw approval of NDA
018663, but FDA has decided not to pursue withdrawal of approval of
this NDA at this time.
[[Page 15193]]
Table 1--Approved NDAs for Which Required Reports Have Not Been
Submitted
------------------------------------------------------------------------
Application No. Drug NDA holder
------------------------------------------------------------------------
NDA 014217............ Maolate (chlorphenesin Pan American
carbamate) Tablet, 400 Laboratories, LLC,
milligrams (mg). 4099 Highway 190,
Covington, LA 70433.
NDA 020530............ Iontocaine (epinephrine Iomed, Inc., 2441 South
and lidocaine 3850 West, Suite A,
hydrochloride (HCl)) Salt Lake City, UT
Topical Solution, 0.01 84120-9941.
mg/milliliter; 2%.
NDA 021504............ LidoSite Topical Vyteris, Inc., 13-01
System: LidoSite Patch Pollitt Dr., Fair
(lidocaine HCl and Lawn, NJ 07410.
epinephrine topical
iontophoretic patch)
10%/0.1% and LidoSite
Controller.
------------------------------------------------------------------------
FDA finds that the holders of the NDAs listed in table 1 have
repeatedly failed to submit reports required by Sec. 314.81. In
addition, under Sec. 314.200, FDA finds that the holders of the NDAs
have waived any contentions concerning the legal status of the drug
products. Therefore, under these findings, approval of the NDAs listed
in table 1 and all amendments and supplements thereto are hereby
withdrawn as of March 17, 2020.\1\
---------------------------------------------------------------------------
\1\ Although it was not a factor in FDA's determination, we note
that all three drugs covered by these NDAs are in discontinued
marketing status.
Dated: March 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05498 Filed 3-16-20; 8:45 am]
BILLING CODE 4164-01-P
