83610 Federal Register / Vol. 85, No. 246 / Tuesday, December 22, 2020 / Notices 

1Because the Ozark hellbender is a long-lived 

species, population trends take a longer amount of 

time to be realized. Thus, a longer period of time 

is needed to monitor population trends. 

some individuals possibly still present 

in the main stem of the White River, 

Spring River, and Jacks Fork (Briggler 

2013, pers. comm.; Irwin 2013, pers. 

comm.). 

The primary reason for Ozark 

hellbender population declines remains 

unclear. However, several potential 

factors have been identified and include 

degraded water quality, habitat loss 

resulting from impoundments and 

sedimentation, disease, illegal and/or 

scientific collection, and potential 

increased predation from some native 

and non-native species of stocked fish 

(Service 2011). Population declines 

have necessitated the use of captive 

propagation efforts to ensure the longterm survival of the species until threats 

are better understood and abated. 

Under the Act, the Service added the 

Ozark hellbender to the Federal List of 

Endangered and Threatened Wildlife as 

an endangered species on October 6, 

2011 (76 FR 61956). This final rule took 

effect on November 7, 2011. 

Recovery Criteria 

The draft recovery criteria are 

summarized below. For the recovery 

strategy, management actions, and 

estimated time and costs associated 

with recovery, refer to the Draft 

Recovery Plan for the Ozark hellbender 

(see ADDRESSES for document 

availability). 

The ultimate recovery goal is to 

remove the Ozark hellbender from the 

Federal List of Endangered and 

Threatened Wildlife (‘‘delist’’) by 

ensuring the long-term viability of the 

species in the wild. In the recovery 

plan, we define the following criteria for 

reclassification (‘‘downlisting’’ from 

endangered to threatened) and delisting 

based on the best available information 

on the species. 

Downlisting Criteria 

Because each of the three extant 

Ozark hellbender populations is 

genetically unique, all three populations 

are necessary to maintain the 

evolutionary potential of the species. 

Given the small range of each 

population, the persistence of all three 

populations is also necessary to guard 

against extinction from catastrophic 

events such as extreme flooding, 

drought, and chemical spills. Therefore, 

to downlist the Ozark hellbender, the 

following criteria should be achieved for 

each of three Ozark hellbender 

populations (the North Fork White 

River, Eleven Point River, and Current 

River): 

1. There is a positive population trend 

for a 15 year period.1

2. There is evidence of successful 

recruitment to maintain a sustaining 

population, with recruitment defined as 

attainment of sexual maturity by young. 

3. Habitat quantity and quality are 

sufficient to support all life stages. 

4. Within each watershed the number 

and distribution of occupied habitat 

patches and abundance of individuals 

within these patches is such that (1) the 

population is resilient to stochastic and 

catastrophic events and (2) connectivity 

and gene flow is sufficient to maintain 

genetic diversity and provide for natural 

re-establishment if a patch is extirpated. 

5. Causes of population declines have 

been identified, and it is clear what 

actions are needed to address these 

threats. 

Delisting Criteria 

To delist the Ozark hellbender, the 

following criteria should be achieved for 

each of three Ozark hellbender 

populations (the North Fork White 

River, Eleven Point River, and Current 

River): 

1. Downlisting criteria have been met. 

2. Threats and causes of decline have 

been reduced or eliminated such that 

delisting criterion 1 will continue to be 

met into the foreseeable future. 

Availability of Public Comments 

Before including your address, phone 

number, email address, or other 

personal identifying information in your 

comment, you should be aware that 

your entire comment—including your 

personal identifying information—may 

be made publicly available at any time. 

While you can ask us in your comment 

to withhold your personal identifying 

information from public review, we 

cannot guarantee that we will be able to 

do so. 

Authority 

The authority for this action is section 

4(f) of the Endangered Species Act, 16 

U.S.C. 1533(f). 

Lori Nordstrom, 

Assistant Regional Director, Ecological 

Services, Midwest Region. 

[FR Doc. 2020–28172 Filed 12–21–20; 8:45 am] 

BILLING CODE 4333–15–P 

INTERNATIONAL TRADE 

COMMISSION 

[Investigation No. 337–TA–1145] 

Certain Botulinum Toxin Products, 

Processes for Manufacturing or 

Relating to Same and Certain Products 

Containing Same Commission Final 

Determination Finding a Violation of 

Section 337; Issuance of a Limited 

Exclusion Order and a Cease and 

Desist Order; 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 found a violation of 

section 337 in the above-captioned 

investigation. The Commission has 

determined to issue a limited exclusion 

order (‘‘LEO’’) prohibiting the 

importation by respondents Daewoong 

Pharmaceuticals Co., Ltd. (‘‘Daewoong’’) 

of Seoul, South Korea and Evolus, Inc. 

(‘‘Evolus’’) of Irvine, California 

(collectively, ‘‘Respondents’’) of certain 

botulinum toxin products, processes for 

manufacturing or relating to same and 

certain products containing same. The 

Commission has also issued a cease and 

desist order (‘‘CDO’’) directed to 

respondent Evolus. The investigation is 

terminated. 

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. 

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: On March 

6, 2019, the Commission instituted this 

investigation under section 337 of the 

Tariff Act of 1930, as amended, 19 

U.S.C. 1337 (‘‘section 337’’), based on a 

complaint filed by Medytox Inc. of 

Seoul, South Korea; Allergan Limited of 

Dublin, Ireland; and Allergan, Inc. of 


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Federal Register / Vol. 85, No. 246 / Tuesday, December 22, 2020 / Notices 83611 

Irvine, California (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 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 a 

domestic industry in the United States. 

See id. The notice of investigation 

names Daewoong and Evolus as 

respondents in this investigation. See 

id. The Office of Unfair Import 

Investigations is also a party to the 

investigation. See id. 

On July 6, 2020, the Administrative 

Law Judge (‘‘ALJ’’) issued a final initial 

determination (‘‘FID’’) finding a 

violation of section 337 based on the 

importation and sale in the United 

States of Respondents’ botulinum 

neurotoxin products by reason of the 

misappropriation of trade secrets, the 

threat or effect of which is to destroy or 

substantially injure an industry in the 

United States. See FID at 273. The ALJ 

issued a recommended determination 

(‘‘RD’’) recommending that, if a 

violation is found, the Commission 

issue: (1) An LEO barring entry of 

certain botulinum toxin products that 

are imported and/or sold by 

respondents Daewoong and Evolus; and 

(2) a CDO against Evolus. The RD also 

recommends that the Commission 

impose a bond based on price 

differential during the period of 

Presidential review. 

On July 28, 2020, the Commission 

issued a notice requesting statements on 

the public interest. See 85 FR 46711 

(Aug. 3, 2020) (‘‘the PI Notice’’). On 

August 17–18, 2020, several non-parties 

filed submissions in response to the PI 

Notice. 

On September 21, 2020, the 

Commission issued a notice 

determining to review the FID in part. 

See 85 FR 60489–90 (Sept. 25, 2020) 

(‘‘the WTR/Remedy Notice’’). 

Specifically, the Commission 

determined to review the FID’s findings 

with respect to subject matter 

jurisdiction, standing, trade secret 

existence and misappropriation, and 

domestic industry, including the 

existence of such domestic industry as 

well as any actual or threatened injury 

thereto. See id. The Commission 

determined not to review the remainder 

of the FID. See id. The Commission’s 

notice also requested written 

submissions on remedy, the public 

interest, and bonding. See id. 

On October 9, 2020, the parties, 

including the IA, filed written 

submissions in response to the WTR/ 

Remedy Notice, and on October 16, 

2020, the parties filed responses to each 

other’s submissions. In addition, on 

October 5–9, 2020, several non-parties 

filed submissions on the proposed 

remedy and/or the public interest in 

response to the WTR/Remedy Notice. 

Having examined the record of this 

investigation, including the FID, the RD, 

and the parties’ and non-parties’ 

submissions, the Commission has 

determined to affirm the FID in part and 

reverse in part. Specifically, as 

explained in the Commission Opinion 

filed concurrently herewith, the 

Commission has determined to affirm 

with modification the FID’s findings 

with respect to subject matter 

jurisdiction, standing, domestic 

industry as to BOTOX®, and trade secret 

existence and misappropriation as it 

relates to Medytox’s manufacturing 

processes. The Commission has also 

determined to reverse the FID’s finding 

that a trade secret exists with respect to 

Medytox’s bacterial strain. All findings 

in the FID that are not inconsistent with 

the Commission’s determination are 

affirmed. 

Accordingly, the Commission finds 

that there is a violation of section 337. 

The Commission has determined that 

the appropriate remedy is an LEO 

against Respondents’ botulinum toxin 

products, and a CDO against Evolus, 

barring Respondents’ unfair acts for a 

duration of 21 months. The Commission 

has also determined that the public 

interest factors enumerated in 

subsections 337(d)(1) and (f)(1) (19 

U.S.C. 1337(d)(1), (f)(1)) do not preclude 

the issuance of the LEO and CDO. The 

Commission has further determined to 

set a bond during the period of 

Presidential review in an amount of 

$441 per 100U vial of Respondents’ 

accused products. 

The Commission’s orders and opinion 

were delivered to the President and to 

the United States Trade Representative 

on the day of their issuance. 

The investigation is terminated. 

The Commission’s vote on this 

determination took place on December 

16, 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: December 16, 2020. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2020–28158 Filed 12–21–20; 8:45 am] 

BILLING CODE 7020–02–P 

INTERNATIONAL TRADE 

COMMISSION 

[Investigation Nos. 701–TA–649 and 731– 

TA–1523 (Final)] 

Twist Ties From China; Scheduling of 

the Final Phase of Countervailing Duty 

and Antidumping Duty Investigations 

AGENCY: United States International 

Trade Commission. 

ACTION: Notice. 

SUMMARY: The Commission hereby gives 

notice of the scheduling of the final 

phase of antidumping and 

countervailing duty investigation Nos. 

701–TA–649 and 731–TA–1523 (Final) 

pursuant to the Tariff Act of 1930 (‘‘the 

Act’’) to determine whether an industry 

in the United States is materially 

injured or threatened with material 

injury, or the establishment of an 

industry in the United States is 

materially retarded, by reason of 

imports of twist ties from China, 

provided for in subheadings 

8309.90.0000 and 5609.00.3000 of the 

Harmonized Tariff Schedule of the 

United States, preliminarily determined 

by the Department of Commerce 

(‘‘Commerce’’) to be subsidized and sold 

at less-than-fair-value. 

DATES: December 3, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Christopher W. Robinson ((202) 205– 

2542), Office of Investigations, U.S. 

International Trade Commission, 500 E 

Street SW, Washington, DC 20436. 

Hearing-impaired persons can obtain 

information on this matter 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 (https://

www.usitc.gov). The public record for 

these investigations may be viewed on 

the Commission’s electronic docket 

(EDIS) at https://edis.usitc.gov. 

SUPPLEMENTARY INFORMATION: 

Scope.—For purposes of these 

investigations, Commerce has defined 

the subject merchandise as twist ties, 

which are thin, bendable ties for closing 

containers, such as bags, bundle items, 

or identifying objects. A twist tie in 


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