Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials, Inc., 16496-16497 [2022-06159]
Download as PDF
<![CDATA[
jspears on DSK121TN23PROD with NOTICES1
16496
Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices
violation of section 337 by the eight
defaulting respondents and for a
recommendation that the Commission
issue a general exclusion order (‘‘GEO’’)
and cease and desist orders (‘‘CDOs’’).
See Complainants’ Motion for Summary
Determination of Violation and for
Recommended Determination on
Remedy and Bonding. Skull Shaver
accused Yiwu Xingye and Yiwu City of
infringing claims 1–3 of the ’528 patent
and the claim of the ’504 design patent.
Id. at 5. It accused the other respondents
of infringing only claim 1 of the ’528
patent. Id. On June 7, 2021, OUII filed
a response in support of Skull Shaver’s
motion. See Commission Investigative
Staff’s Response to Skull Shaver’s
Motion for Summary Determination of
Violation. No respondent filed a
response to Skull Shaver’s motion.
On September 23, 2021, OUII filed a
notice of supplemental authority
concerning the domestic industry
requirement. On September 28, 2021,
the ALJ issued an order (Order No. 31)
ordering certain supplementation of
Skull Shaver’s domestic industry
analysis. On October 14, 2021, Skull
Shaver submitted its supplement in
response to Order No. 31. No other
responses to Order No. 31 were filed.
On November 18, 2021, the ALJ grantedin-part Skull Shaver’s motion for
summary determination as the subject
ID.
The ID found that Skull Shaver owns
the asserted patents, and that those
patents are valid and enforceable. ID at
3. The ID further found that although all
respondents imported, sold for
importation, or sold within the United
States after importation at least one
accused article, the only respondents
whose articles infringe the asserted
patents are Yiwu Xingye and Yiwu City.
Id. at 3–4. The ID found no infringement
as to the other respondents, whose
products lack a second recess, see ID at
51–52, in view of the ALJ’s construction
of ‘‘recesses’’ as ‘‘indentations that are
substantially concave surfaces,’’ id. at
16 (citation omitted), and Skull Shaver’s
forfeiture of an infringement theory
under the doctrine of equivalents, id. at
50 n.7. The ID found that personal
jurisdiction is not necessary over each
defaulting respondent, but that the
defaulting respondents waived any
opportunity to contest the allegation
that personal jurisdiction exists. Id. The
ID further found that Skull Shaver meets
the technical prong and the economic
prong of the domestic industry
requirement. Id. at 4. As to remedy, the
RD found that there is a widespread
pattern of unauthorized use of the
asserted patents and it is difficult to
identify the source of these products;
VerDate Sep<11>2014
20:07 Mar 22, 2022
Jkt 256001
and that a GEO is necessary to prevent
circumvention. Id. at 4. The RD also
recommended issuance of CDOs against
the two infringing respondents, who are
presumed to maintain domestic
inventories. RD at 80–81. The RD
recommended a bond rate of one
hundred percent (100%) because
complete pricing information is not
available. RD at 82.
No petitions for review of the ID were
filed. The Commission determined to
review the ID’s findings concerning the
economic prong of the domestic
industry requirement, and not to review
the ID’s findings on other issues. Notice,
87 FR 990, 991 (Jan. 7, 2022). The
review notice solicited written
submissions, including on remedy, the
public interest, and bonding from the
parties, interested government agencies,
and the public. Id.
In response to the Commission notice,
Skull Shaver and OUII each filed an
opening submission and a reply. No
other parties filed submissions.
On review, the Commission has
determined to affirm the ID’s finding
that Skull Shaver has satisfied the
economic prong of the domestic
industry requirement, and the
Commission thereby affirms the ID’s
finding of a violation of section 337.
The Commission finds that the RD’s
recommended remedy is appropriate for
the reasons set forth in the attached
opinion. Accordingly, the Commission
finds that the appropriate remedy is: (1)
A general exclusion order prohibiting
the entry of certain electric shavers and
components and accessories thereof;
and (2) cease and desist orders directed
to Yiwu Xingye and Yiwu City. The
Commission has determined that the
public interest factors enumerated in
section 337(d), (f), and/or (g), 19 U.S.C.
1337(d), (f), (g), do not preclude the
issuance of the GEO or the CDOs.
The Commission has determined that
a bond in the amount of one hundred
percent (100%) of the entered value of
the subject articles is required during
the Presidential review period, 19
U.S.C. 1337(j) for the reasons set forth
in the RD and the attached Commission
Opinion. The investigation is hereby
terminated.
While temporary remote operating
procedures are in place in response to
COVID–19, the Office of the Secretary is
not able to serve parties that have not
retained counsel or otherwise provided
a point of contact for electronic service.
Accordingly, pursuant to Commission
Rules 201.16(a) and 210.7(a)(1) (19 CFR
201.16(a), 210.7(a)(1)), the Commission
orders that the Complainant complete
service for any party without a method
of electronic service noted on the
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
attached Certificate of Service and shall
file proof of service on the Electronic
Document Information System (EDIS).
The Commission’s orders and opinion
were delivered to the President and the
United States Trade Representative on
the day of their issuance.
The Commission vote for these
determinations took place on March 17,
2022.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in Part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: March 17, 2022.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2022–06122 Filed 3–22–22; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–985]
Bulk Manufacturer of Controlled
Substances Application: Johnson
Matthey Pharmaceutical Materials, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Johnson Matthey
Pharmaceutical Materials, Inc., has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplementary Information listed below
for further drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before May 23, 2022. Such persons
may also file a written request for a
hearing on the application on or before
May 23, 2022.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
SUMMARY:
E:\FR\FM\23MRN1.SGM
23MRN1
16497
Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 28, 2022,
Johnson Matthey Pharmaceutical
Materials, Inc., 2003 Nolte Drive, West
Deptford, New Jersey 08066–1742,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
drug codes are authorized for this
registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–06159 Filed 3–22–22; 8:45 am]
BILLING CODE P
SUPPLEMENTARY INFORMATION:
Controlled substance
jspears on DSK121TN23PROD with NOTICES1
Gamma Hydroxybutyric
Acid.
Marihuana .......................
Tetrahydrocannabinols ...
Noroxymorphone ............
Difenoxin .........................
Amphetamine .................
Methamphetamine ..........
Lisdexamfetamine ..........
Methylphenidate .............
Nabilone .........................
ANPP (4-Anilino-Nphenethyl-4-piperidine).
Norfentanyl (N-phenyl-N(piperidin-4-yl)
propionamide).
Cocaine ..........................
Codeine ..........................
Dihydrocodeine ...............
Oxycodone .....................
Hydromorphone ..............
Diphenoxylate .................
Ecgonine .........................
Hydrocodone ..................
Levorphanol ....................
Meperidine ......................
Methadone ......................
Methadone intermediate
Morphine .........................
Thebaine .........................
Opium tincture ................
Oxymorphone .................
Noroxymorphone ............
Alfentanil .........................
Remifentanil ....................
Sufentanil ........................
Tapentadol ......................
Fentanyl ..........................
Drug
code
Schedule
2010
I
7360
7370
9145
9168
1100
1105
1205
1724
7379
8333
I
I
I
I
II
II
II
II
II
II
8366
II
9041
9050
9120
9143
9150
9170
9180
9193
9220
9230
9250
9254
9300
9333
9630
9652
9668
9737
9739
9740
9780
9801
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
20:07 Mar 22, 2022
Jkt 256001
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–979]
Importer of Controlled Substances
Application: Sharp Clinical Services,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Sharp Clinical Services, Inc.
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 22, 2022. Such
persons may also file a written request
for a hearing on the application on or
before April 22, 2022.
ADDRESSES: The DEA requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUMMARY:
The company plans to bulk
manufacture the listed controlled
substances for the internal use
intermediates or for sale to its
customers. In reference to drug codes
7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
VerDate Sep<11>2014
DEPARTMENT OF JUSTICE
In
accordance with 21 CFR 1301.34(a), this
is notice that on February 2, 2022, Sharp
Clinical Services, Inc. 2400 Baglyos
Circle, Bethlehem, Pennsylvania 18020–
8024, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Gamma Hydroxybutyric
Acid.
3,4Methylenedioxymethamphetamine.
Drug
code
Schedule
2010
I
7405
I
The company plans to import the
listed control substances for clinical
trials. No other activity for these drug
codes is authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–06161 Filed 3–22–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–984]
Bulk Manufacturer of Controlled
Substances Application: Siemens
Healthcare Diagnostics, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Siemens Healthcare
Diagnostics, Inc. has applied to be
registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to Supplementary
Information listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before May 23, 2022. Such persons
may also file a written request for a
hearing on the application on or before
May 23, 2022.
ADDRESSES: The Drug Enforcement
Administration (DEA) requires that all
comments be submitted electronically
SUMMARY:
E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16496-16497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06159]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-985]
Bulk Manufacturer of Controlled Substances Application: Johnson
Matthey Pharmaceutical Materials, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Johnson Matthey Pharmaceutical Materials, Inc., has applied to
be registered as a bulk manufacturer of basic class(es) of controlled
substance(s). Refer to Supplementary Information listed below for
further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
May 23, 2022. Such persons may also file a written request for a
hearing on the application on or before May 23, 2022.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not
[[Page 16497]]
instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number,
your comment has been successfully submitted and there is no need to
resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on February 28, 2022, Johnson Matthey Pharmaceutical
Materials, Inc., 2003 Nolte Drive, West Deptford, New Jersey 08066-
1742, applied to be registered as a bulk manufacturer of the following
basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Noroxymorphone......................... 9145 I
Difenoxin.............................. 9168 I
Amphetamine............................ 1100 II
Methamphetamine........................ 1105 II
Lisdexamfetamine....................... 1205 II
Methylphenidate........................ 1724 II
Nabilone............................... 7379 II
ANPP (4-Anilino-N-phenethyl-4- 8333 II
piperidine).
Norfentanyl (N-phenyl-N-(piperidin-4- 8366 II
yl) propionamide).
Cocaine................................ 9041 II
Codeine................................ 9050 II
Dihydrocodeine......................... 9120 II
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Diphenoxylate.......................... 9170 II
Ecgonine............................... 9180 II
Hydrocodone............................ 9193 II
Levorphanol............................ 9220 II
Meperidine............................. 9230 II
Methadone.............................. 9250 II
Methadone intermediate................. 9254 II
Morphine............................... 9300 II
Thebaine............................... 9333 II
Opium tincture......................... 9630 II
Oxymorphone............................ 9652 II
Noroxymorphone......................... 9668 II
Alfentanil............................. 9737 II
Remifentanil........................... 9739 II
Sufentanil............................. 9740 II
Tapentadol............................. 9780 II
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the internal use intermediates or for sale to its
customers. In reference to drug codes 7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as synthetic. No other activities for these drug codes are
authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-06159 Filed 3-22-22; 8:45 am]
BILLING CODE P
