Determination That Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection, 5 Milliequivalents, 10 Milliequivalents, 15 Milliequivalents, 20 Milliequivalents, 30 Milliequivalents, and 40 Milliequivalents, in Plastic Containers, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 15194-15195 [2020-05442]
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15194
Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
of the FD&C Act that Mr. Dailey’s felony
convictions for introducing misbranded
drugs into interstate commerce and
importing merchandise contrary to law
were for conduct relating to the
importation into the United States of
any drug or controlled substance
because he illegally imported kratom, a
misbranded drug, for repackaging, sale,
and distribution to U.S. consumers. 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. Dailey’s
offenses, and concluded that each of
these felony offenses independently
warranted a 5-year period of debarment,
and proposed that these debarment
periods be served consecutively under
section 306(c)(2)(A)(iii) of the FD&C
Act.
The proposal informed Mr. Dailey of
the proposed debarment and offered Mr.
Dailey an opportunity to request a
hearing, providing him 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. Dailey received the proposal
and notice of opportunity for a hearing
on October 7, 2019. Mr. Dailey 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).
khammond on DSKJM1Z7X2PROD with NOTICES
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Dailey has
been convicted of two felony counts
under Federal law for conduct relating
to the importation into the United States
of any drug or controlled substance.
FDA finds that each offense should be
accorded a debarment period of 5 years.
Under section 306(c)(2)(A)(iii) of the
FD&C Act, in the case of a person
debarred for multiple offenses, FDA
shall determine whether the periods of
debarment shall run concurrently or
consecutively. FDA has concluded that
the 5-year period of debarment for each
of the 2 offenses of conviction needs to
be served consecutively, resulting in a
total debarment period of 10 years.
As a result of the foregoing finding,
Mr. Dailey is debarred for a period of 10
VerDate Sep<11>2014
17:32 Mar 16, 2020
Jkt 250001
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, 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. Dailey is a
prohibited act.
Any application by Mr. Dailey for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2019–
N–3310 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(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: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05450 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–P–4523]
Determination That Potassium
Chloride in 5% Dextrose and 0.225%
Sodium Chloride Injection, 5
Milliequivalents, 10 Milliequivalents, 15
Milliequivalents, 20 Milliequivalents, 30
Milliequivalents, and 40
Milliequivalents, in Plastic Containers,
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that the potassium chloride
drug products listed in this notice were
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) that refer to these
drug products, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Linda Jong, Center for Drug Evaluation
SUMMARY:
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6288, Silver Spring,
MD 20993–0002, 301–796–3977,
Linda.Jong@fda.hhs.gov.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
The drug products listed in table 1 of
this notice are no longer being
marketed. All the products listed in
table 1 are the subject of NDA 018365,
held by ICU Medical, Inc., and initially
approved on May 29, 1980. The
products are indicated in patients
requiring parenteral administration of
potassium chloride with minimal
carbohydrate calories and sodium
chloride.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\17MRN1.SGM
17MRN1
Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
15195
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 1
Drug
Dosage form/route
Strength
Potassium Chloride (5 milliequivalents (mEq)) in 5%
dextrose and 0.225% sodium chloride, in plastic container.
Potassium Chloride (5 mEq) in 5% dextrose and 0.225%
sodium chloride, in plastic container.
Potassium Chloride (10 mEq) in 5% dextrose and
0.225% sodium chloride, in plastic container.
Potassium Chloride (10 mEq) in 5% dextrose and
0.225% sodium chloride, in plastic container.
Potassium Chloride (15 mEq) in 5% dextrose and
0.225% sodium chloride, in plastic container.
Potassium Chloride (20 mEq) in 5% dextrose and
0.225% sodium chloride, in plastic container.
Potassium Chloride (30 mEq) in 5% dextrose and
0.225% sodium chloride, in plastic container.
Potassium Chloride (40 mEq) in 5% dextrose and
0.225% sodium chloride, in plastic container.
Injectable/Injection ..............
5 grams (g)/100 milliliters (mL); 74.5 milligrams (mg)/
100 mL; 225 mg/100 mL.
Do .......................................
5 g/100 mL; 149 mg/100 mL; 225 mg/100 mL.
Do .......................................
5 g/100 mL; 74.5 mg/100 mL; 225 mg/100 mL.
Do .......................................
5 g/100 mL; 149 mg/100 mL; 225 mg/100 mL.
Do .......................................
5 g/100 mL; 224 mg/100 mL; 225 mg/100 mL.
Do .......................................
5 g/100 mL; 298 mg/100 mL; 225 mg/100 mL.
Do .......................................
5 g/100 mL; 224 mg/100 mL; 225 mg/100 mL.
Do .......................................
5 g/100 mL; 298 mg/100 mL; 225 mg/100 mL.
The products listed in table 1 are
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. Fresenius Kabi USA, LLC,
submitted a citizen petition dated
September 26, 2019 (Docket No. FDA–
2019–P–4523), under 21 CFR 10.30,
requesting that the Agency determine
whether the products listed in table 1
were withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that the potassium chloride
drug products listed in this notice were
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that the potassium chloride
drug products listed in this notice were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of the
potassium chloride drug products listed
in this notice from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that the potassium chloride
drug products listed in this notice were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list the potassium chloride
drug products listed in this notice, in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. If FDA
determines that labeling for this drug
VerDate Sep<11>2014
17:32 Mar 16, 2020
Jkt 250001
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05442 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–2734]
Robert Richard Jodoin: Final
Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Frm 00087
Fmt 4703
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, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, 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:
DATES:
I. Background
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Robert Richard Jodoin for a period of 5
years from importing any drug into the
United States. FDA bases this order on
a finding that Mr. Jodoin was convicted,
as defined in the FD&C Act, of one
felony count under Federal law for
unlawfully importing and attempting to
import a controlled substance into the
United States. The factual basis
supporting the conviction, as described
below, is conduct relating to the
importation into the United States of a
drug or controlled substance. Mr. Jodoin
was given notice of the proposed
debarment and, in accordance with the
FD&C Act, was given an opportunity to
request a hearing to show why he
should not be debarred. As of November
9, 2019 (30 days after receipt of the
SUMMARY:
PO 00000
notice), Mr. Jodoin had not responded.
Mr. Jodoin’s failure to respond and
request a hearing constitutes a waiver of
his right to a hearing concerning this
matter.
Sfmt 4703
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)(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 February 25, 2019, Mr. Jodoin was
convicted as defined in section
306(l)(1)(B) of the FD&C Act, in the
United States District Court for the
Middle District of Florida, Jackson
Division, when the court accepted his
plea of guilty and entered judgment
against him for multiple offenses, one of
which is relevant to this debarment.
Specifically, FDA’s finding that
debarment is appropriate is based on
Mr. Jodoin’s felony conviction for
E:\FR\FM\17MRN1.SGM
17MRN1
]]>Agencies
[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15194-15195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05442]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-4523]
Determination That Potassium Chloride in 5% Dextrose and 0.225%
Sodium Chloride Injection, 5 Milliequivalents, 10 Milliequivalents, 15
Milliequivalents, 20 Milliequivalents, 30 Milliequivalents, and 40
Milliequivalents, in Plastic Containers, Were Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the potassium chloride drug products listed in this
notice were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) that refer to these drug products, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6288, Silver Spring, MD 20993-0002, 301-796-3977,
[email protected].
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
The drug products listed in table 1 of this notice are no longer
being marketed. All the products listed in table 1 are the subject of
NDA 018365, held by ICU Medical, Inc., and initially approved on May
29, 1980. The products are indicated in patients requiring parenteral
administration of potassium chloride with minimal carbohydrate calories
and sodium chloride.
[[Page 15195]]
Table 1
------------------------------------------------------------------------
Drug Dosage form/route Strength
------------------------------------------------------------------------
Potassium Chloride (5 Injectable/ 5 grams (g)/100
milliequivalents (mEq)) in 5% Injection. milliliters (mL);
dextrose and 0.225% sodium 74.5 milligrams (mg)/
chloride, in plastic 100 mL; 225 mg/100
container. mL.
Potassium Chloride (5 mEq) in Do............... 5 g/100 mL; 149 mg/
5% dextrose and 0.225% sodium 100 mL; 225 mg/100
chloride, in plastic mL.
container.
Potassium Chloride (10 mEq) in Do............... 5 g/100 mL; 74.5 mg/
5% dextrose and 0.225% sodium 100 mL; 225 mg/100
chloride, in plastic mL.
container.
Potassium Chloride (10 mEq) in Do............... 5 g/100 mL; 149 mg/
5% dextrose and 0.225% sodium 100 mL; 225 mg/100
chloride, in plastic mL.
container.
Potassium Chloride (15 mEq) in Do............... 5 g/100 mL; 224 mg/
5% dextrose and 0.225% sodium 100 mL; 225 mg/100
chloride, in plastic mL.
container.
Potassium Chloride (20 mEq) in Do............... 5 g/100 mL; 298 mg/
5% dextrose and 0.225% sodium 100 mL; 225 mg/100
chloride, in plastic mL.
container.
Potassium Chloride (30 mEq) in Do............... 5 g/100 mL; 224 mg/
5% dextrose and 0.225% sodium 100 mL; 225 mg/100
chloride, in plastic mL.
container.
Potassium Chloride (40 mEq) in Do............... 5 g/100 mL; 298 mg/
5% dextrose and 0.225% sodium 100 mL; 225 mg/100
chloride, in plastic mL.
container.
------------------------------------------------------------------------
The products listed in table 1 are currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Fresenius Kabi USA, LLC, submitted a citizen petition dated September
26, 2019 (Docket No. FDA-2019-P-4523), under 21 CFR 10.30, requesting
that the Agency determine whether the products listed in table 1 were
withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that the potassium chloride drug products listed in
this notice were not withdrawn for reasons of safety or effectiveness.
The petitioner has identified no data or other information suggesting
that the potassium chloride drug products listed in this notice were
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of the
potassium chloride drug products listed in this notice from sale. We
have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have found no information
that would indicate that the potassium chloride drug products listed in
this notice were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list the potassium
chloride drug products listed in this notice, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. 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: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05442 Filed 3-16-20; 8:45 am]
BILLING CODE 4164-01-P
