Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and Certain Products Containing Same; Notice of Commission Decision To Vacate Its Final Determination on Remand, 60469-60470 [2021-23866]

Download as PDF jspears on DSK121TN23PROD with NOTICES1 Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Notices of the Tariff Act of 1930, as amended, on behalf of Easton Diamond Sports, LLC of Thousand Oaks, California. Supplements to the complaint were filed on October 13 and October 18, 2021. The complaint, as supplemented, alleges violations of 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 composite baseball and softball bats and components thereof by reason of infringement of certain claims of U.S. Patent No. 6,997,826 (‘‘the ’826 Patent’’). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders. ADDRESSES: The complaint, except for any confidential information contained therein, may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal on (202) 205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205– 2000. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. FOR FURTHER INFORMATION CONTACT: Katherine Hiner, Office of Docket Services, U.S. International Trade Commission, telephone (202) 205–1802. SUPPLEMENTARY INFORMATION: Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10 (2020). Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on October 26, 2021, ordered that— (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products VerDate Sep<11>2014 17:42 Nov 01, 2021 Jkt 256001 identified in paragraph (2) by reason of infringement of one or more of claims 1–5, 9–12, 14–15, and 18–19 of the ’826 Patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337; (2) Pursuant to section 210.10(b)(1) of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is ‘‘composite baseball and softball bats having a barrel formed by more than one cylindrical layer of material’’; (3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served: (a) The complainant is: Easton Diamond Sports, LLC, 3500 Willow Lane, Thousand Oaks, CA 91361 (b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served: Juno Athletics LLC, 1000 Williams Boulevard, Unit 2703, Aventura, FL 33160 Monsta Athletics LLC, 1090 5th Street, Suite 115, Calimesa, CA 92320 Proton Sports Inc., 7904 East Chaparral Road, Suite A110, Scottsdale, AZ 85250 (4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge. The Office of Unfair Import Investigations will not participate as a party to this investigation. Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown. Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 60469 right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent. By order of the Commission. Issued: October 27, 2021. Lisa Barton, Secretary to the Commission. [FR Doc. 2021–23824 Filed 11–1–21; 8:45 am] BILLING CODE 7020–02–P INTERNATIONAL TRADE COMMISSION [Investigation No. 337–TA–1145 (Remand)] Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and Certain Products Containing Same; Notice of Commission Decision To Vacate Its Final Determination on Remand U.S. International Trade Commission. ACTION: Notice. AGENCY: Notice is hereby given that the U.S. International Trade Commission has vacated its final determination following dismissal of the appeals to the U.S. Court of Appeals for the Federal Circuit (‘‘Federal Circuit’’) challenging various aspects of that determination. FOR FURTHER INFORMATION CONTACT: Houda Morad, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 708–4716. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. General information concerning the Commission may also be obtained by accessing its internet server at https://www.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: On March 6, 2019, the Commission instituted this investigation under section 337 of the Tariff Act of 1930, as amended, 19 SUMMARY: E:\FR\FM\02NON1.SGM 02NON1 jspears on DSK121TN23PROD with NOTICES1 60470 Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Notices U.S.C. 1337 (‘‘section 337’’), based on a complaint filed by Medytox Inc. of Seoul, South Korea (‘‘Medytox’’); Allergan plc of Dublin, Ireland; and Allergan, Inc. of Irvine, California (collectively, ‘‘Allergan’’) (all collectively, ‘‘Complainants’’). See 84 FR 8112–13 (Mar. 6, 2019). The complaint, as supplemented, alleges a violation of section 337 based upon the importation and the sale in the United States of certain botulinum toxin products, processes for manufacturing or relating to same and certain products containing same by reason of misappropriation of trade secrets, the threat or effect of which is to destroy or substantially injure an industry in the United States. See id. The notice of investigation names as respondents Daewoong Pharmaceuticals Co., Ltd. (‘‘Daewoong’’) of Seoul, South Korea and Evolus, Inc. (‘‘Evolus’’) of Irvine, California (collectively, ‘‘Respondents’’). See id. The Office of Unfair Import Investigations (‘‘OUII’’) was also a party to the investigation. See id. On December 16, 2020, the Commission found a violation of section 337 based on the misappropriation of Complainants’ trade secrets (including the Medytox manufacturing processes but not the Medytox bacterial strain). See 85 FR 83610–11 (Dec. 22, 2020). The Commission issued a limited exclusion order against certain botulinum neurotoxin (‘‘BTX’’) products that are imported and/or sold by Respondents Daewoong and Evolus and a cease and desist order against Evolus (collectively, ‘‘the remedial orders’’). Id. The Commission also set a bond during the period of Presidential review in an amount of $441 per 100U vial of Respondents’ accused products. Id. On February 12, 2021, Complainants filed an appeal from the Commission’s final determination with the Federal Circuit (Appeal No. 21–1653). On the same day, Respondents also filed an appeal from the Commission’s final determination of a violation of section 337 (Appeal No. 21–1654). On February 18, 2021, Complainants and Evolus (collectively, ‘‘the Settling Parties’’) announced that they had reached a settlement to resolve all pending issues between them. On March 3, 2021, the Settling Parties filed a joint petition to rescind the remedial orders based on settlement agreements and other confidential agreements between and among several of the Settling Parties. On April 5, 2021, Daewoong filed a response to the Settling Parties’ petition not opposing recission of the remedial orders and also including a motion for vacatur of the Commission’s final determination. On VerDate Sep<11>2014 17:42 Nov 01, 2021 Jkt 256001 April 8, 2021, OUII filed a response in support of the joint petition to rescind. On April 15, 2021, Medytox filed a response in opposition to Daewoong’s motion to vacate the final determination. On May 3, 2021, the Commission determined to rescind the remedial orders. See 86 FR 24665–66 (May 7, 2021). The Commission also issued an indicative ruling that, if the Federal Circuit dismisses the pending appeals as moot, the Commission will vacate its final determination. See id. The Commission explained that ‘‘if the Federal Circuit finds that the . . . appeals are moot’’ and ‘‘[i]f appellate review for Daewoong is prevented, it would be plainly through happenstance, and vacatur would be warranted to prevent any preclusive effect of the final determination against Daewoong.’’ See Comm’n Op. at 8 (May 3, 2021). On June 21, 2021, Medytox also reached a settlement agreement with AEON Biopharma (‘‘AEON’’). AEON is Daewoong’s exclusive licensee in the United States for therapeutic applications of BTX products, while Evolus is the exclusive licensee for aesthetic applications. Consequently, as Medytox stated before the Federal Circuit, ‘‘the result of the two settlements is that Medytox has now resolved its disputes with and granted licenses to the two companies that hold the exclusive rights to distribute Daewoong’s BTX products in the United States.’’ See ECF 69, Medytox Statement of Non-Opposition at 2 (Fed. Cir. Docket No. 21–1653); ECF 68, Medytox Letter at 1 (Fed. Cir. Docket No. 21–1653). Thus, Medytox did not oppose the Commission’s and Daewoong’s motions to dismiss the appeals as moot and no longer opposes vacatur of the Commission’s final determination upon remand. On July 26, 2021, the Federal Circuit issued an order dismissing the appeals ‘‘to the extent that the appeals are deemed moot’’ and remanding ‘‘the matter . . . for the Commission to address vacatur of its final determination.’’ Medytox v. ITC, No. 21–1653, Order at 2 (Fed. Cir. July 26, 2021). In accordance with the Commission’s May 3, 2021 indicative ruling of vacatur and the Commission’s reasoning related thereto, and in view of the Federal Circuit’s dismissal of the related appeals as moot, the Commission hereby vacates on remand its final determination. Commissioner Karpel does not join the Commission’s decision to vacate. As she has previously stated, the Commission’s decision to exercise its discretion to grant the extraordinary remedy of vacatur requires an analysis, based on a PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 complete record and after having heard from all parties on the issue, that includes a careful balancing of the equities, including with respect to the public interest. See Comm’n Op. at 9– 10 n.15 (May 3, 2021). Commissioner Karpel does not consider that such an analysis was done when the Commission issued its indicative ruling regarding vacatur, see id., or on remand. The Commission’s vote on this determination took place on October 28, 2021. 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: October 28, 2021. Lisa Barton, Secretary to the Commission. [FR Doc. 2021–23866 Filed 11–1–21; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE [OMB Number 1110–0058] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of an Approved Collection; National Incident-Based Reporting System (NIBRS) Federal Bureau of Investigation (FBI), Department of Justice (DOJ). ACTION: 60-Day notice and request for comments. AGENCY: The Criminal Justice Information Services (CJIS) Division, FBI, DOJ, will be submitting the following information collection request to the Office of Management and Budget for review and approval in accordance with the Paperwork Reduction Act (PRA) of 1995. DATES: Comments are encouraged and will be accepted for 60 days until January 3, 2022. FOR FURTHER INFORMATION CONTACT: All comments, suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to the Crime and Law Enforcement Statistics (formerly the Crime Statistics Management) Unit Chief, Amy C. Blasher, FBI, CJIS Division, Module D–1 1000 Custer Hollow Road, Clarksburg, West Virginia, 26306. SUMMARY: E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 86, Number 209 (Tuesday, November 2, 2021)]
[Notices]
[Pages 60469-60470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23866]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1145 (Remand)]


Certain Botulinum Toxin Products, Processes for Manufacturing or 
Relating to Same and Certain Products Containing Same; Notice of 
Commission Decision To Vacate Its Final Determination on Remand

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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

SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has vacated its final determination following dismissal of 
the appeals to the U.S. Court of Appeals for the Federal Circuit 
(``Federal Circuit'') challenging various aspects of that 
determination.

FOR FURTHER INFORMATION CONTACT: Houda Morad, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 708-4716. Copies of non-
confidential documents filed in connection with this investigation may 
be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email 
[email protected]. General information concerning the Commission may 
also be obtained by accessing its internet server at https://www.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: On March 6, 2019, the Commission instituted 
this investigation under section 337 of the Tariff Act of 1930, as 
amended, 19

[[Page 60470]]

U.S.C. 1337 (``section 337''), based on a complaint filed by Medytox 
Inc. of Seoul, South Korea (``Medytox''); Allergan plc of Dublin, 
Ireland; and Allergan, Inc. of Irvine, California (collectively, 
``Allergan'') (all collectively, ``Complainants''). See 84 FR 8112-13 
(Mar. 6, 2019). The complaint, as supplemented, alleges a violation of 
section 337 based upon the importation and the sale in the United 
States of certain botulinum toxin products, processes for manufacturing 
or relating to same and certain products containing same by reason of 
misappropriation of trade secrets, the threat or effect of which is to 
destroy or substantially injure an industry in the United States. See 
id. The notice of investigation names as respondents Daewoong 
Pharmaceuticals Co., Ltd. (``Daewoong'') of Seoul, South Korea and 
Evolus, Inc. (``Evolus'') of Irvine, California (collectively, 
``Respondents''). See id. The Office of Unfair Import Investigations 
(``OUII'') was also a party to the investigation. See id.
    On December 16, 2020, the Commission found a violation of section 
337 based on the misappropriation of Complainants' trade secrets 
(including the Medytox manufacturing processes but not the Medytox 
bacterial strain). See 85 FR 83610-11 (Dec. 22, 2020). The Commission 
issued a limited exclusion order against certain botulinum neurotoxin 
(``BTX'') products that are imported and/or sold by Respondents 
Daewoong and Evolus and a cease and desist order against Evolus 
(collectively, ``the remedial orders''). Id. The Commission also set a 
bond during the period of Presidential review in an amount of $441 per 
100U vial of Respondents' accused products. Id.
    On February 12, 2021, Complainants filed an appeal from the 
Commission's final determination with the Federal Circuit (Appeal No. 
21-1653). On the same day, Respondents also filed an appeal from the 
Commission's final determination of a violation of section 337 (Appeal 
No. 21-1654). On February 18, 2021, Complainants and Evolus 
(collectively, ``the Settling Parties'') announced that they had 
reached a settlement to resolve all pending issues between them.
    On March 3, 2021, the Settling Parties filed a joint petition to 
rescind the remedial orders based on settlement agreements and other 
confidential agreements between and among several of the Settling 
Parties. On April 5, 2021, Daewoong filed a response to the Settling 
Parties' petition not opposing recission of the remedial orders and 
also including a motion for vacatur of the Commission's final 
determination. On April 8, 2021, OUII filed a response in support of 
the joint petition to rescind. On April 15, 2021, Medytox filed a 
response in opposition to Daewoong's motion to vacate the final 
determination.
    On May 3, 2021, the Commission determined to rescind the remedial 
orders. See 86 FR 24665-66 (May 7, 2021). The Commission also issued an 
indicative ruling that, if the Federal Circuit dismisses the pending 
appeals as moot, the Commission will vacate its final determination. 
See id. The Commission explained that ``if the Federal Circuit finds 
that the . . . appeals are moot'' and ``[i]f appellate review for 
Daewoong is prevented, it would be plainly through happenstance, and 
vacatur would be warranted to prevent any preclusive effect of the 
final determination against Daewoong.'' See Comm'n Op. at 8 (May 3, 
2021).
    On June 21, 2021, Medytox also reached a settlement agreement with 
AEON Biopharma (``AEON''). AEON is Daewoong's exclusive licensee in the 
United States for therapeutic applications of BTX products, while 
Evolus is the exclusive licensee for aesthetic applications. 
Consequently, as Medytox stated before the Federal Circuit, ``the 
result of the two settlements is that Medytox has now resolved its 
disputes with and granted licenses to the two companies that hold the 
exclusive rights to distribute Daewoong's BTX products in the United 
States.'' See ECF 69, Medytox Statement of Non-Opposition at 2 (Fed. 
Cir. Docket No. 21-1653); ECF 68, Medytox Letter at 1 (Fed. Cir. Docket 
No. 21-1653). Thus, Medytox did not oppose the Commission's and 
Daewoong's motions to dismiss the appeals as moot and no longer opposes 
vacatur of the Commission's final determination upon remand. On July 
26, 2021, the Federal Circuit issued an order dismissing the appeals 
``to the extent that the appeals are deemed moot'' and remanding ``the 
matter . . . for the Commission to address vacatur of its final 
determination.'' Medytox v. ITC, No. 21-1653, Order at 2 (Fed. Cir. 
July 26, 2021).
    In accordance with the Commission's May 3, 2021 indicative ruling 
of vacatur and the Commission's reasoning related thereto, and in view 
of the Federal Circuit's dismissal of the related appeals as moot, the 
Commission hereby vacates on remand its final determination. 
Commissioner Karpel does not join the Commission's decision to vacate. 
As she has previously stated, the Commission's decision to exercise its 
discretion to grant the extraordinary remedy of vacatur requires an 
analysis, based on a complete record and after having heard from all 
parties on the issue, that includes a careful balancing of the 
equities, including with respect to the public interest. See Comm'n Op. 
at 9-10 n.15 (May 3, 2021). Commissioner Karpel does not consider that 
such an analysis was done when the Commission issued its indicative 
ruling regarding vacatur, see id., or on remand.
    The Commission's vote on this determination took place on October 
28, 2021.
    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: October 28, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021-23866 Filed 11-1-21; 8:45 am]
BILLING CODE 7020-02-P