82_FR_6656 82 FR 6644 - Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof; Commission Determination to Review In-Part a Final Initial Determination on Remand, and on Remand To Affirm With Modification; Vacatur of Suspended Remedial Orders; and Termination of the Investigation

82 FR 6644 - Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof; Commission Determination to Review In-Part a Final Initial Determination on Remand, and on Remand To Affirm With Modification; Vacatur of Suspended Remedial Orders; and Termination of the Investigation

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range6644-6645
FR Document2017-01143

Notice is hereby given that the U.S. International Trade Commission has determined to review in-part the presiding Administrative Law Judge's (``ALJ'') final initial determination on remand (``RID'') for the limited purpose of modifying pages 20-21 and 24 of the RID. The Commission has also determined to vacate the issued remedial orders, which are currently suspended.

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6644-6645]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-01143]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-890 (Remand)]


Certain Sleep-Disordered Breathing Treatment Systems and 
Components Thereof; Commission Determination to Review In-Part a Final 
Initial Determination on Remand, and on Remand To Affirm With 
Modification; Vacatur of Suspended Remedial Orders; and Termination of 
the Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has determined to review in-part the presiding 
Administrative Law Judge's (``ALJ'') final initial determination on 
remand (``RID'') for the limited purpose of modifying pages 20-21 and 
24 of the RID. The Commission has also determined to vacate the issued 
remedial orders, which are currently suspended.

FOR FURTHER INFORMATION CONTACT: Panyin A. Hughes, Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street SW., 
Washington, DC 20436, telephone (202) 205-3042. Copies of non-
confidential documents filed in connection with this investigation are 
or will be available for inspection during official business hours 
(8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. 
International Trade Commission, 500 E Street SW., Washington, DC 20436, 
telephone (202) 205-2000. General information concerning the Commission 
may also be obtained by accessing its Internet server (https://www.usitc.gov). The public record for this investigation may be viewed 
on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. 
Hearing-impaired persons are advised that information on this matter 
can be obtained by contacting the Commission's TDD terminal on (202) 
205-1810.

SUPPLEMENTARY INFORMATION: The Commission instituted this investigation 
on August 23, 2013, based on a complaint filed by ResMed Corporation of 
San Diego, California; ResMed Incorporated of San Diego, California; 
and ResMed Limited of New South Wales, Australia (collectively, 
``ResMed''). 78 FR 52564 (Aug. 23, 2013). The complaint alleged 
violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in 
the importation into the United States, the sale for importation, and 
the sale within the United States after importation of certain sleep-
disordered breathing treatment systems and components thereof that 
infringe one or more of claims 32-37, 53, 79, 80, and 88 of U.S. Patent 
No. 7,997,267 (``the '267 patent''); claims 1-7 of U.S. Patent No. 
7,614,398 (``the '398 patent''); claim 1 of U.S. Patent No. 7,938,116 
(``the '116 patent''); claims 30, 37, and 38 of U.S. Patent No. 
7,341,060 (the '060 patent); claims 1, 3, 5, 11, 28, 30, 31, and 56 of 
U.S. Patent No. 8,312,883 (``the '883 patent''); claims 1, 3, 6, 7, 9, 
29, 32, 35, 40, 42, 45, 50, 51, 56, 59, 89, 92, 94, and 96 of U.S. 
Patent No. 7,178,527 (the '527 patent); claims 19-24, 26, 29-36, and 
39-41 of U.S. Patent No. 7,950,392 (the '392 patent); and claims 13, 
15, 16, 26-28, 51, 52, and 55 of U.S. Patent No 7,926,487 (``the '487 
patent''). The following patents are collectively referred to as the 
mask patents: the '527 patent; the '392 patent; the '267 patent; the 
'060 patent; and the'883 patent. The notice of investigation named the 
following respondents: BMC Medical Co., Ltd. of Beijing, China; 3B 
Medical, Inc. of Lake Wales, Florida; and 3B Products, L.L.C., of Lake 
Wales, Florida (collectively ``BMC''). The Office of Unfair Import 
Investigations (``OUII'') participated in the investigation.
    On January 9, 2014, the ALJ issued an initial determination 
(``ID'') granting a motion by ResMed to amend the complaint and notice 
of investigation to substitute U.S. Patent No. RE 44,453 (``the '453 
patent'') for the '398 patent and to terminate the investigation as to 
the '398 patent. See Order No. 7 (Jan. 9, 2014). The Commission 
determined not to review the ID. See Commission Notice of Non-Review 
(Feb. 10, 2014); 79 FR 9000-01 (Feb. 14, 2014).
    On February 24, 2014, the ALJ issued an ID granting a motion by 
ResMed to withdraw its allegations with respect to the '116 patent. See 
Order No. 11 (Feb. 24, 2014). The Commission determined not to review 
the ID. See Commission Notice of Non-Review (March 11, 2014). On March 
18, 2014, the ALJ granted a motion by ResMed to terminate the 
investigation as to claims 26-28 of the '487 Patent. See Order No. 20 
(Mar 18, 2012). The Commission determined not to review the ID. See 
Commission Notice of Non-Review (Apr. 29, 2014).
    On August 21, 2014, the ALJ issued a final ID, finding a violation 
of section 337 by BMC with respect to certain asserted claims of the 
'392, '267, '060, '883, '527, and '453 patents. The ALJ found no 
violation of section 337 with respect to the asserted claims of the 
'487 patent.
    On September 3, 2014, the parties filed petitions for review of the 
ID. On September 11, 2014, the parties filed responses to the petitions 
for review.
    On October 16, 2014, the Commission determined to review the final 
ID in part. 79 FR 63163-65 (Oct. 22, 2014). On review, the Commission 
determined to affirm the ALJ's finding of violation of section 337. The 
Commission, however, found the '453 patent invalid for anticipation. 
Having found a violation of section 337, the Commission determined that 
the appropriate form of relief was (1) a limited exclusion order 
prohibiting the unlicensed entry of sleep-disordered breathing 
treatment systems and components thereof that infringe one or more of 
claims 1, 9, 32, 89, and 92 of the '527 patent; claims 19, 21, 29, 32, 
and 36 of the '392 patent; claims 32, 33, 34, and 53 of the '267 
patent; claims 30, 37, and 38 of the '060 patent; and claims 1, 3, 5, 
11, 28, 30, 31, and 56 of the '883 patent that are manufactured by, or 
on behalf of, or are imported by or on behalf of BMC Medical Co., Ltd., 
3B Medical, Inc., or 3B Products L.L.C. or any of their affiliated 
companies, parents, subsidiaries, agents, or other related business 
entities, or their successors or assigns, except for service

[[Page 6645]]

and replacement parts for customers that purchased their covered 
products prior to the date the exclusion order becomes final; and (2) 
cease and desist orders prohibiting domestic respondents BMC Medical 
Co., Ltd., 3B Medical, Inc. from conducting any of the following 
activities in the United States: Importing, selling, marketing, 
advertising, distributing, transferring (except for exportation), and 
soliciting U.S. agents or distributors for, sleep-disordered breathing 
treatment systems and components thereof covered by claims 1, 9, 32, 
89, and 92 of the '527 patent; claims 19, 21, 29, 32, and 36 of the 
'392 patent; claims 32, 33, 34, and 53 of the '267 patent; claims 30, 
37, and 38 of the '060 patent; and claims 1, 3, 5, 11, 28, 30, 31, and 
56 of the '883 patent.
    On February 18, 2015, ResMed filed a notice of appeal in the U.S. 
Court of Appeals for the Federal Circuit, seeking review of the 
Commission's determination as to the '453 patent (Appeal No. 2015-
1360). On April 14, 2015, BMC filed a notice of appeal in the Federal 
Circuit, seeking review of the Commission's domestic industry 
determination as well as the Commission's finding that prior art does 
not render the asserted claims of the '267 patent invalid for 
obviousness (Appeal No. 2015-1576). The Court consolidated the two 
appeals on April 23, 2015.
    On March 16, 2016, the parties jointly moved to dismiss ResMed's 
appeal as to the '453 patent. On March 17, 2016, the Commission moved 
to remand BMC's appeal in light of intervening domestic industry 
precedent in Lelo Inc. v. International Trade Commisson, 789 F.3d 879 
(Fed. Cir. 2015). On March 29, 2016, the Court granted the motion to 
dismiss ResMed's appeal. On April 22, 2016, the Court granted the 
Commission's remand motion.
    On May 12, 2016, the Commission issued a notice suspending the 
remedial orders in place during the pendency of the remand proceedings. 
81 FR 31254-55 (May 18, 2016). The Commission also issued an order 
asking the parties to comment on further proceedings. On June 8, 2016, 
the parties submitted initial comments. The parties filed responses on 
July 15, 2016. On August 16, 2016, the Commission issued an order 
remanding the investigation to the ALJ to: (1) Apply the Federal 
Circuit's intervening domestic industry precedent in Lelo to the 
existing record (as to the mask patents, the only patents remaining); 
and (2) issue an RID on remand as to violation.
    On November 10, 2016, the ALJ issued the RID finding that ResMed 
failed to establish the existence of a domestic industry that practices 
the mask patents. RID at 1. No petitions for review were received.
    Having examined the record of this investigation, the Commission 
has determined to review in-part the RID for the limited purpose of 
modifying pages 20-21 and 24 of the RID. The Commission does not adopt 
the RID's statements that ``the amount a complainant spends to purchase 
components manufactured in the United States is immaterial to the 
economic prong analysis'' (RID at 20-21) or that evidence of payments 
to domestic suppliers is ``per se insufficient to include in the 
quantitative analysis.'' RID at 24. The Commission has determined to 
otherwise not review the RID. The Commission has determined to vacate 
the suspended remedial orders. The investigation is terminated.
    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: January 12, 2017.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2017-01143 Filed 1-18-17; 8:45 am]
 BILLING CODE 7020-02-P



                                                  6644                         Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices

                                                  Decision (ROD). The ROD is available at                 Counsel, U.S. International Trade                      Unfair Import Investigations (‘‘OUII’’)
                                                  boemoceaninfo.com.                                      Commission, 500 E Street SW.,                          participated in the investigation.
                                                  FOR FURTHER INFORMATION CONTACT: Jill                   Washington, DC 20436, telephone (202)                     On January 9, 2014, the ALJ issued an
                                                  Lewandowski, Ph.D., Bureau of Ocean                     205–3042. Copies of non-confidential                   initial determination (‘‘ID’’) granting a
                                                  Energy Management, 45600 Woodland                       documents filed in connection with this                motion by ResMed to amend the
                                                  Road VAM–OEP, Sterling, VA 20166.                       investigation are or will be available for             complaint and notice of investigation to
                                                  Dr. Lewandowski may also be reached                     inspection during official business                    substitute U.S. Patent No. RE 44,453
                                                  by telephone at (703) 787–1703.                         hours (8:45 a.m. to 5:15 p.m.) in the                  (‘‘the ’453 patent’’) for the ’398 patent
                                                                                                          Office of the Secretary, U.S.                          and to terminate the investigation as to
                                                  SUPPLEMENTARY INFORMATION: In
                                                                                                          International Trade Commission, 500 E                  the ’398 patent. See Order No. 7 (Jan. 9,
                                                  accordance with 40 CFR 1505.2, the                                                                             2014). The Commission determined not
                                                  Bureau of Ocean Energy Management                       Street SW., Washington, DC 20436,
                                                                                                          telephone (202) 205–2000. General                      to review the ID. See Commission
                                                  (BOEM) announces the availability of                                                                           Notice of Non-Review (Feb. 10, 2014);
                                                  the 2017–2022 Outer Continental Shelf                   information concerning the Commission
                                                                                                          may also be obtained by accessing its                  79 FR 9000–01 (Feb. 14, 2014).
                                                  (OCS) Oil and Gas Leasing Program                                                                                 On February 24, 2014, the ALJ issued
                                                  Final Programmatic EIS (Final                           Internet server (https://www.usitc.gov).
                                                                                                          The public record for this investigation               an ID granting a motion by ResMed to
                                                  Programmatic EIS) Record of Decision                                                                           withdraw its allegations with respect to
                                                  (ROD). The ROD is available at                          may be viewed on the Commission’s
                                                                                                          electronic docket (EDIS) at https://                   the ’116 patent. See Order No. 11 (Feb.
                                                  boemoceaninfo.com.                                                                                             24, 2014). The Commission determined
                                                    The Final Programmatic EIS was                        edis.usitc.gov. Hearing-impaired
                                                                                                          persons are advised that information on                not to review the ID. See Commission
                                                  published on November 25, 2016 (81 FR                                                                          Notice of Non-Review (March 11, 2014).
                                                  85221). BOEM considered comments                        this matter can be obtained by
                                                                                                          contacting the Commission’s TDD                        On March 18, 2014, the ALJ granted a
                                                  submitted on the Final Programmatic                                                                            motion by ResMed to terminate the
                                                  EIS before a final decision was made.                   terminal on (202) 205–1810.
                                                                                                                                                                 investigation as to claims 26–28 of the
                                                                                                          SUPPLEMENTARY INFORMATION: The
                                                     Authority: This Notice of Availability of                                                                   ’487 Patent. See Order No. 20 (Mar 18,
                                                  a ROD is issued in accordance with the
                                                                                                          Commission instituted this investigation               2012). The Commission determined not
                                                  National Environmental Policy Act of 1969,              on August 23, 2013, based on a                         to review the ID. See Commission
                                                  as amended (Pub. L. 91–190, 42 U.S.C. 4231              complaint filed by ResMed Corporation                  Notice of Non-Review (Apr. 29, 2014).
                                                  et seq.), and implementing regulations (See             of San Diego, California; ResMed                          On August 21, 2014, the ALJ issued a
                                                  40 CFR 1505.2).                                         Incorporated of San Diego, California;                 final ID, finding a violation of section
                                                                                                          and ResMed Limited of New South                        337 by BMC with respect to certain
                                                  Walter D. Cruickshank,
                                                                                                          Wales, Australia (collectively,                        asserted claims of the ’392, ’267, ’060,
                                                  Acting Director, Bureau of Ocean Energy                 ‘‘ResMed’’). 78 FR 52564 (Aug. 23,
                                                  Management.                                                                                                    ’883, ’527, and ’453 patents. The ALJ
                                                                                                          2013). The complaint alleged violations                found no violation of section 337 with
                                                  [FR Doc. 2017–00886 Filed 1–18–17; 8:45 am]
                                                                                                          of section 337 of the Tariff Act of 1930               respect to the asserted claims of the ’487
                                                  BILLING CODE 4310–MR–P                                  (19 U.S.C. 1337) in the importation into               patent.
                                                                                                          the United States, the sale for                           On September 3, 2014, the parties
                                                                                                          importation, and the sale within the                   filed petitions for review of the ID. On
                                                  INTERNATIONAL TRADE                                     United States after importation of                     September 11, 2014, the parties filed
                                                  COMMISSION                                              certain sleep-disordered breathing                     responses to the petitions for review.
                                                                                                          treatment systems and components                          On October 16, 2014, the Commission
                                                  [Investigation No. 337–TA–890 (Remand)]
                                                                                                          thereof that infringe one or more of                   determined to review the final ID in
                                                  Certain Sleep-Disordered Breathing                      claims 32–37, 53, 79, 80, and 88 of U.S.               part. 79 FR 63163–65 (Oct. 22, 2014).
                                                  Treatment Systems and Components                        Patent No. 7,997,267 (‘‘the ’267 patent’’);            On review, the Commission determined
                                                  Thereof; Commission Determination to                    claims 1–7 of U.S. Patent No. 7,614,398                to affirm the ALJ’s finding of violation
                                                  Review In-Part a Final Initial                          (‘‘the ’398 patent’’); claim 1 of U.S.                 of section 337. The Commission,
                                                  Determination on Remand, and on                         Patent No. 7,938,116 (‘‘the ’116 patent’’);            however, found the ’453 patent invalid
                                                  Remand To Affirm With Modification;                     claims 30, 37, and 38 of U.S. Patent No.               for anticipation. Having found a
                                                  Vacatur of Suspended Remedial                           7,341,060 (the ’060 patent); claims 1, 3,              violation of section 337, the
                                                  Orders; and Termination of the                          5, 11, 28, 30, 31, and 56 of U.S. Patent               Commission determined that the
                                                  Investigation                                           No. 8,312,883 (‘‘the ’883 patent’’);                   appropriate form of relief was (1) a
                                                                                                          claims 1, 3, 6, 7, 9, 29, 32, 35, 40, 42,              limited exclusion order prohibiting the
                                                  AGENCY: U.S. International Trade                        45, 50, 51, 56, 59, 89, 92, 94, and 96 of              unlicensed entry of sleep-disordered
                                                  Commission.                                             U.S. Patent No. 7,178,527 (the ’527                    breathing treatment systems and
                                                  ACTION: Notice.                                         patent); claims 19–24, 26, 29–36, and                  components thereof that infringe one or
                                                                                                          39–41 of U.S. Patent No. 7,950,392 (the                more of claims 1, 9, 32, 89, and 92 of
                                                  SUMMARY:   Notice is hereby given that                  ’392 patent); and claims 13, 15, 16, 26–               the ’527 patent; claims 19, 21, 29, 32,
                                                  the U.S. International Trade                            28, 51, 52, and 55 of U.S. Patent No                   and 36 of the ’392 patent; claims 32, 33,
                                                  Commission has determined to review                     7,926,487 (‘‘the ’487 patent’’). The                   34, and 53 of the ’267 patent; claims 30,
                                                  in-part the presiding Administrative                    following patents are collectively                     37, and 38 of the ’060 patent; and claims
                                                  Law Judge’s (‘‘ALJ’’) final initial                     referred to as the mask patents: the ’527              1, 3, 5, 11, 28, 30, 31, and 56 of the ’883
                                                  determination on remand (‘‘RID’’) for                   patent; the ’392 patent; the ’267 patent;              patent that are manufactured by, or on
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                                                  the limited purpose of modifying pages                  the ’060 patent; and the’883 patent. The               behalf of, or are imported by or on
                                                  20–21 and 24 of the RID. The                            notice of investigation named the                      behalf of BMC Medical Co., Ltd., 3B
                                                  Commission has also determined to                       following respondents: BMC Medical                     Medical, Inc., or 3B Products L.L.C. or
                                                  vacate the issued remedial orders,                      Co., Ltd. of Beijing, China; 3B Medical,               any of their affiliated companies,
                                                  which are currently suspended.                          Inc. of Lake Wales, Florida; and 3B                    parents, subsidiaries, agents, or other
                                                  FOR FURTHER INFORMATION CONTACT:                        Products, L.L.C., of Lake Wales, Florida               related business entities, or their
                                                  Panyin A. Hughes, Office of the General                 (collectively ‘‘BMC’’). The Office of                  successors or assigns, except for service


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                                                                               Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices                                                      6645

                                                  and replacement parts for customers                     failed to establish the existence of a                 exercise all necessary functions with
                                                  that purchased their covered products                   domestic industry that practices the                   respect to the promulgation and
                                                  prior to the date the exclusion order                   mask patents. RID at 1. No petitions for               implementation of 21 CFR part 1301,
                                                  becomes final; and (2) cease and desist                 review were received.                                  incident to the registration of
                                                  orders prohibiting domestic respondents                    Having examined the record of this                  manufacturers, distributors, dispensers,
                                                  BMC Medical Co., Ltd., 3B Medical, Inc.                 investigation, the Commission has                      importers, and exporters of controlled
                                                  from conducting any of the following                    determined to review in-part the RID for               substances (other than final orders in
                                                  activities in the United States:                        the limited purpose of modifying pages                 connection with suspension, denial, or
                                                  Importing, selling, marketing,                          20–21 and 24 of the RID. The                           revocation of registration) has been
                                                  advertising, distributing, transferring                 Commission does not adopt the RID’s                    redelegated to the Assistant
                                                  (except for exportation), and soliciting                statements that ‘‘the amount a                         Administrator of the DEA Diversion
                                                  U.S. agents or distributors for, sleep-                 complainant spends to purchase
                                                  disordered breathing treatment systems                                                                         Control Division (‘‘Assistant
                                                                                                          components manufactured in the United
                                                  and components thereof covered by                                                                              Administrator’’) pursuant to section 7 of
                                                                                                          States is immaterial to the economic
                                                  claims 1, 9, 32, 89, and 92 of the ’527                                                                        28 CFR part 0, appendix to subpart R.
                                                                                                          prong analysis’’ (RID at 20–21) or that
                                                  patent; claims 19, 21, 29, 32, and 36 of                evidence of payments to domestic                         In accordance with 21 CFR
                                                  the ’392 patent; claims 32, 33, 34, and                 suppliers is ‘‘per se insufficient to                  1301.33(a), this is notice that on July 12,
                                                  53 of the ’267 patent; claims 30, 37, and               include in the quantitative analysis.’’                2016, Noramco, Inc., 500 Swedes
                                                  38 of the ’060 patent; and claims 1, 3,                 RID at 24. The Commission has                          Landing Road, Wilmington, Delaware
                                                  5, 11, 28, 30, 31, and 56 of the ’883                   determined to otherwise not review the                 19801–4417 applied to be registered as
                                                  patent.                                                 RID. The Commission has determined to                  a bulk manufacturer of the following
                                                     On February 18, 2015, ResMed filed a                 vacate the suspended remedial orders.                  basic classes of controlled substances:
                                                  notice of appeal in the U.S. Court of                   The investigation is terminated.
                                                  Appeals for the Federal Circuit, seeking                   The authority for the Commission’s                                                 Drug
                                                  review of the Commission’s                                                                                     Controlled substance                    Schedule
                                                                                                          determination is contained in section                                                 code
                                                  determination as to the ’453 patent                     337 of the Tariff Act of 1930, as
                                                  (Appeal No. 2015–1360). On April 14,                    amended (19 U.S.C. 1337), and in Part                  Marihuana .................      7360   I
                                                  2015, BMC filed a notice of appeal in                   210 of the Commission’s Rules of                       Codeine-N-oxide .......          9053   I
                                                  the Federal Circuit, seeking review of                  Practice and Procedure (19 CFR part                    Dihydromorphine ......           9145   I
                                                  the Commission’s domestic industry                      210).                                                  Hydromorphinol ........          9301   I
                                                  determination as well as the                                                                                   Morphine-N-oxide .....           9307   I
                                                  Commission’s finding that prior art does                  By order of the Commission.                          Amphetamine ...........          1100   II
                                                  not render the asserted claims of the                     Issued: January 12, 2017.                            Methylphenidate .......          1724   II
                                                  ’267 patent invalid for obviousness                     Lisa R. Barton,                                        Phenylacetone ..........         8501   II
                                                  (Appeal No. 2015–1576). The Court                       Secretary to the Commission.                           Codeine ....................     9050   II
                                                  consolidated the two appeals on April                   [FR Doc. 2017–01143 Filed 1–18–17; 8:45 am]            Dihydrocodeine .........         9120   II
                                                  23, 2015.                                               BILLING CODE 7020–02–P
                                                                                                                                                                 Oxycodone ...............        9143   II
                                                     On March 16, 2016, the parties jointly                                                                      Hydromorphone ........           9150   II
                                                  moved to dismiss ResMed’s appeal as to                                                                         Hydrocodone ............         9193   II
                                                  the ’453 patent. On March 17, 2016, the                 DEPARTMENT OF JUSTICE
                                                                                                                                                                 Morphine ...................     9300   II
                                                  Commission moved to remand BMC’s                                                                               Oripavine ..................     9330   II
                                                  appeal in light of intervening domestic                 Drug Enforcement Administration                        Thebaine ...................     9333   II
                                                  industry precedent in Lelo Inc. v.                                                                             Opium extracts .........         9610   II
                                                  International Trade Commisson, 789                      [Docket No. DEA–392]                                   Opium fluid extract ...          9620   II
                                                  F.3d 879 (Fed. Cir. 2015). On March 29,                                                                        Opium tincture ..........        9630   II
                                                                                                          Bulk Manufacturer of Controlled                        Opium, powdered .....            9639   II
                                                  2016, the Court granted the motion to
                                                                                                          Substances Application: Noramco, Inc.                  Opium, granulated ....           9640   II
                                                  dismiss ResMed’s appeal. On April 22,
                                                  2016, the Court granted the                                                                                    Oxymorphone ...........          9652   II
                                                                                                          ACTION:   Notice of application.
                                                  Commission’s remand motion.                                                                                    Noroxymorphone ......            9668   II
                                                     On May 12, 2016, the Commission                                                                             Tapentadol ................      9780   II
                                                                                                          DATES:  Registered bulk manufacturers of
                                                  issued a notice suspending the remedial                 the affected basic classes, and
                                                  orders in place during the pendency of                  applicants therefore, may file written                   The company plans to manufacture
                                                  the remand proceedings. 81 FR 31254–                    comments on or objections to the                       the above-listed controlled substances
                                                  55 (May 18, 2016). The Commission also                  issuance of the proposed registration in               in bulk for distribution to its customers.
                                                  issued an order asking the parties to                   accordance with 21 CFR 1301.33(a) on                   In reference to drug code 7360, the
                                                  comment on further proceedings. On                      or before March 20, 2017.                              company plans to manufacture a
                                                  June 8, 2016, the parties submitted                                                                            synthetic version of cannabidiol in bulk
                                                                                                          ADDRESSES: Written comments should
                                                  initial comments. The parties filed                                                                            for sale to its customers, who are final
                                                                                                          be sent to: Drug Enforcement
                                                  responses on July 15, 2016. On August
                                                                                                          Administration, Attention: DEA Federal                 dosage form manufacturers. No other
                                                  16, 2016, the Commission issued an
                                                                                                          Register Representative/DRW, 8701                      activity for this drug code is authorized
                                                  order remanding the investigation to the
                                                                                                          Morrissette Drive, Springfield, Virginia               for this registration.
                                                  ALJ to: (1) Apply the Federal Circuit’s
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                                                                                                          22152.
                                                  intervening domestic industry                                                                                    Dated: January 11, 2017.
                                                  precedent in Lelo to the existing record                SUPPLEMENTARY INFORMATION:   The                       Louis J. Milione,
                                                  (as to the mask patents, the only patents               Attorney General has delegated her                     Assistant Administrator.
                                                  remaining); and (2) issue an RID on                     authority under the Controlled
                                                                                                                                                                 [FR Doc. 2017–01103 Filed 1–18–17; 8:45 am]
                                                  remand as to violation.                                 Substances Act to the Administrator of
                                                                                                                                                                 BILLING CODE 4410–09–P
                                                     On November 10, 2016, the ALJ                        the Drug Enforcement Administration
                                                  issued the RID finding that ResMed                      (DEA), 28 CFR 0.100(b). Authority to


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Document Created: 2018-02-01 15:15:47
Document Modified: 2018-02-01 15:15:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactPanyin A. Hughes, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-3042. Copies of non- confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (https:// www.usitc.gov). The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.
FR Citation82 FR 6644 

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