Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Honeoye Manufacturing, 35331-35332 [2020-12383]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 111 / Tuesday, June 9, 2020 / Notices Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal, telephone 202–205–1810. SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on April 9, 2019, based on a complaint filed on behalf of Hanwha Q CELLS USA, Inc. of Dalton, Georgia and HQC– AMC 1 of Seoul, Republic of Korea (collectively, ‘‘Hanwha’’). 84 FR 14134– 35 (April 9, 2019). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (‘‘section 337’’), based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain photovoltaic cells and products containing same by reason of infringement of certain claims of U.S. Patent No. 9,893,215. The complaint further alleges the existence of a domestic industry. The Commission’s notice of investigation named the following respondents: JinkoSolar Holding Co., Ltd., c/o Conyers Trust Company (Cayman) Limited of Grand Cayman KY1–111, Cayman Islands; JinkoSolar (U.S.) Inc. of San Francisco, California; Jinko Solar (U.S.) Industries Inc. of San Francisco, California; Jinko Solar Co., Ltd. of Jiangxi, China; Zhejiang Jinko Solar Co., Ltd. of Haining City, China; Jinko Solar Technology Sdn. Bhd. of Persekutuan, Malaysia (collectively, ‘‘Jinko’’); LONGi Solar Technology Co., Ltd. of Shaanxi, China; LONGi Green Energy Technology Co., Ltd. of Shaanxi, China; LONGi (H.K.) Trading Ltd. of Wanchai, Hong Kong; LONGi (Kuching) Sdn. Bhd. of Sarawak, Malaysia; Taizhou LONGi Solar Technology Ltd. of Jiangsu, China; Zhejiang LONGi Solar Technology Ltd. of Zhejiang, China; Hefei LONGi Solar Technology Ltd. of Anhui, China; LONGi Solar Technology (U.S.) Inc. of San Ramon, California (collectively, ‘‘LONGi’’); and REC Solar Holdings AS of Oslo, Norway; REC Solar Pte. Ltd. of Tuas, Singapore; and REC Americas, LLC of San Mateo, California (collectively, ‘‘REC’’) (collectively, ‘‘Respondents’’). The Office of Unfair Import Investigations (‘‘OUII’’) is participating in the investigation. On August 19, September 13, and September 18, 2019, LONGi, Jinko, and REC, respectively, filed a motion for summary determination on infringement. On September 26, 2019, 1 Complainant HQC–AMC was subsequently replaced by Hanwha Solutions Corporation. Order No. 38 (Jan. 30, 2020), unreviewed by Comm’n Notice (Mar. 2, 2020); see also 85 FR 13182–83 (Mar. 6, 2020). VerDate Sep<11>2014 23:08 Jun 08, 2020 Jkt 250001 the ALJ issued a Markman Order (Order No. 24), construing certain claim terms in dispute. On October 10, 2019, the ALJ issued Order No. 26, which struck Hanwha’s late-filed contentions concerning infringement under the doctrine of equivalents (DOE). On April 10, 2020, the ALJ issued the subject ID (Order No. 40), granting Respondents’ motions for summary determination of non-infringement. The subject ID finds no literal infringement by any of the accused products. Although the ALJ struck Hanwha’s latefiled DOE contentions in Order No. 26, the ID also addresses the merits of the DOE contentions and finds no infringement by equivalents due to prosecution history estoppel. On April 22, 2020, Hanwha filed a petition for review seeking review of the finding of no literal infringement. Hanwha does not seek review of the ALJ’s decision to strike its DOE contentions. On May 5, 2020, Respondents and OUII each filed a response in opposition to Hanwha’s petition. Having reviewed the record including Order No. 24, the subject ID, the parties’ briefing before the ALJ, and Hanwha’s petition and responses thereto, the Commission has determined to review in part the subject ID (and underlying Markman Order). On review, the Commission has determined to affirm with modification the ID’s grant of summary determination. Specifically, the Commission clarifies that the findings made on pages 24–26 of the ID relate to statements made by the patentee during prosecution. The ID notes that those findings support the determination that prosecution history estoppel precludes the application of the DOE with respect to the claim terms at issue. The Commission clarifies that these findings also support Order No. 24’s claim construction of these terms, including a determination that prosecution disclaimer applies in construing these terms. As one example, the finding on page 25 of the ID that ‘‘the patentee ‘made numerous and unambiguous’ representations that the ’215 patent claims solar cells hav[ing] a two-layer passivation stack, and no more’’ lends support to a finding of prosecution disclaimer and Order No. 24’s construction of the claim terms at issue. See, e.g., Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323–24 (Fed. Cir. 2003); Trading Technologies Intern., Inc. v. Open E Cry, LLC, 728 F.3d 1309, 1322 (Fed. Cir. 2013) (‘‘a single action during prosecution can engender both a prosecution disclaimer and prosecution history estoppel.’’) (emphasis in original). PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 35331 The investigation is terminated with a finding of no violation of section 337. The Commission vote for this determination took place on June 3, 2020. 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: June 3, 2020. Lisa Barton, Secretary to the Commission. [FR Doc. 2020–12411 Filed 6–8–20; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–656] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Honeoye Manufacturing ACTION: Notice of application. The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to proposed regulations that, if finalized, would govern the program of growing marihuana for scientific and medical research under DEA registration. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections to the issuance of the proposed registration on or before August 10, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW 8701 Morrissette Drive, Springfield, Virginia 22152. To ensure proper handling of comments, please reference Docket No. DEA–656 in all correspondence, including attachments. SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing SUMMARY: E:\FR\FM\09JNN1.SGM 09JNN1 35332 Federal Register / Vol. 85, No. 111 / Tuesday, June 9, 2020 / Notices notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted. The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place. As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA proposes to conduct this evaluation in the manner described in the rule proposed at 85 FR 16292, published on March 23, 2020, if finalized. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on May 7, 2020, Honeoye Manufacturing, 4825 County Road 36, Honeoye, New York 14471, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Controlled substance Marihuana ........................ Drug code Schedule 7360 I The applicant noticed above applied to become registered with DEA to grow marihuana as a bulk manufacturer subsequent to a 2020 DEA notice of proposed rulemaking that provided information on how DEA intends to expand the number of registrations, and described the way it would oversee those additional growers. If finalized, the proposed rule would govern persons seeking to become registered with DEA to grow marihuana as a bulk manufacturer, consistent with applicable law. The notice of proposed rulemaking is available at 85 FR 16292. William T. McDermott, Assistant Administrator. [FR Doc. 2020–12383 Filed 6–8–20; 8:45 am] BILLING CODE 4410–09–P Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before July 9, 2020. Such persons may also file a written request for a hearing on the application on or before July 9, 2020. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also 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. ADDRESSES: In accordance with 21 CFR 1301.34(a), this is notice that on May 15, 2020, Research Triangle Institute, 3040 East Cornwallis Road, Hermann Building, Room 106, Research Triangle Park, North Carolina 27709–2194, applied to be registered as an importer of the following basic class(es) of controlled substances: SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–661] Importer of Controlled Substances Application: Research Triangle Institute ACTION: Notice of application. jbell on DSKJLSW7X2PROD with NOTICES Controlled substance Drug code 3-Fluoro-N-methylcathinone (3–FMC) ............................................................................................................................. Cathinone ........................................................................................................................................................................ Methcathinone ................................................................................................................................................................. 4-Fluoro-N-methylcathinone (4–FMC) ............................................................................................................................. Pentedrone (a-methylaminovalerophenone) ................................................................................................................... Mephedrone (4-Methyl-N-methylcathinone) .................................................................................................................... 4-Methyl-N-ethylcathinone (4–MEC) ............................................................................................................................... Naphyrone ....................................................................................................................................................................... N-Ethylamphetamine ....................................................................................................................................................... N,N-Dimethylamphetamine .............................................................................................................................................. Fenethylline ..................................................................................................................................................................... Aminorex .......................................................................................................................................................................... 4-Methylaminorex (cis isomer) ........................................................................................................................................ Gamma Hydroxybutyric Acid ........................................................................................................................................... Methaqualone .................................................................................................................................................................. Mecloqualone .................................................................................................................................................................. JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) .................................................................................................. SR–18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) ................................................ ADB–FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .............. 5-Fluoro-UR–144 and XLR11 [1-(5-Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ................ AB–FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ..................... FUB–144 (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone) ............................................... JWH–019 (1-Hexyl-3-(1-naphthoyl)indole) ...................................................................................................................... MDMB–FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-1H indazole-3-carboxamido)-3,3-dimethylbutanoate) ...................... FUB–AMB, MMBFUBINACA, AMB–FUBINACA (2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3methylbutanoate). AB–PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole3-carboxamide) .......................................... VerDate Sep<11>2014 23:08 Jun 08, 2020 Jkt 250001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\09JNN1.SGM 09JNN1 Schedule 1233 1235 1237 1238 1246 1248 1249 1258 1475 1480 1503 1585 1590 2010 2565 2572 6250 7008 7010 7011 7012 7014 7019 7020 7021 I I I I I I I I I I I I I I I I I I I I I I I I I 7023 I

Agencies

[Federal Register Volume 85, Number 111 (Tuesday, June 9, 2020)]
[Notices]
[Pages 35331-35332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12383]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-656]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturer of Marihuana: Honeoye Manufacturing

ACTION: Notice of application.

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

SUMMARY: The Drug Enforcement Administration (DEA) is providing notice 
of an application it has received from an entity applying to be 
registered to manufacture in bulk basic class(es) of controlled 
substances listed in schedule I. DEA intends to evaluate this and other 
pending applications according to proposed regulations that, if 
finalized, would govern the program of growing marihuana for scientific 
and medical research under DEA registration.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefor, may file written comments on or objections to 
the issuance of the proposed registration on or before August 10, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW 8701 
Morrissette Drive, Springfield, Virginia 22152. To ensure proper 
handling of comments, please reference Docket No. DEA-656 in all 
correspondence, including attachments.

SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) 
prohibits the cultivation and distribution of marihuana except by 
persons who are registered under the CSA to do so for lawful purposes. 
In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is 
providing

[[Page 35332]]

notice that the entity identified below has applied for registration as 
a bulk manufacturer of schedule I controlled substances. In response, 
registered bulk manufacturers of the affected basic class(es), and 
applicants therefor, may file written comments on or objections of the 
requested registration, as provided in this notice. This notice does 
not constitute any evaluation or determination of the merits of the 
application submitted.
    The applicant plans to manufacture bulk active pharmaceutical 
ingredients (APIs) for product development and distribution to DEA 
registered researchers. If the application for registration is granted, 
the registrant would not be authorized to conduct other activity under 
this registration aside from those coincident activities specifically 
authorized by DEA regulations. DEA will evaluate the application for 
registration as a bulk manufacturer for compliance with all applicable 
laws, treaties, and regulations and to ensure adequate safeguards 
against diversion are in place.
    As this applicant has applied to become registered as a bulk 
manufacturer of marihuana, the application will be evaluated under the 
criteria of 21 U.S.C. 823(a). DEA proposes to conduct this evaluation 
in the manner described in the rule proposed at 85 FR 16292, published 
on March 23, 2020, if finalized.
    In accordance with 21 CFR 1301.33(a), DEA is providing notice that 
on May 7, 2020, Honeoye Manufacturing, 4825 County Road 36, Honeoye, 
New York 14471, applied to be registered as a bulk manufacturer of the 
following basic class(es) of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana...............................    7360  I
------------------------------------------------------------------------

    The applicant noticed above applied to become registered with DEA 
to grow marihuana as a bulk manufacturer subsequent to a 2020 DEA 
notice of proposed rulemaking that provided information on how DEA 
intends to expand the number of registrations, and described the way it 
would oversee those additional growers. If finalized, the proposed rule 
would govern persons seeking to become registered with DEA to grow 
marihuana as a bulk manufacturer, consistent with applicable law. The 
notice of proposed rulemaking is available at 85 FR 16292.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-12383 Filed 6-8-20; 8:45 am]
 BILLING CODE 4410-09-P
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