Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 37157 

joint procurement and joint negotiation 

authority. 

Proposed Effective Date: 6/30/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/317. 

Agreement No.: 012390–001. 

Agreement Name: Siem Car Carriers 

AS/Liberty Global Logistics LLC Space 

Charter Agreement. 

Parties: Siem Car Carriers AS and 

Liberty Global Logistics LLC. 

Filing Party: Ashley Craig; Venable 

LLP. 

Synopsis: The amendment updates 

Article 5.3 of the Agreement to remove 

joint procurement and joint negotiation 

authority. 

Proposed Effective Date: 6/30/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/1006. 

Agreement No.: 201363. 

Agreement Name: Ho ̈egh Autoliners/ 

National Shipping Company of Saudi 

Arabia (Bahri) Space Charter 

Agreement. 

Parties: Hoegh Autoliners AS and The 

National Shipping Company of Saudi 

Arabia d.b.a. Bahri AS. 

Filing Party: Wayne Rohde; Cozen 

O’Connor. 

Synopsis: The Agreement authorizes 

the parties to charter space to/from one 

another in all U.S. trades worldwide. 

Proposed Effective Date: 8/15/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/47520. 

Agreement No.: 201348–001. 

Agreement Name: APL/Swire Guam, 

Saipan—S. Korea, Japan Slot Charter 

Agreement. 

Parties: American President Lines, 

LLC and The China Navigation Co. Pte. 

Ltd. d/b/a Swire Shipping. 

Filing Party: Patricia O’Neill; 

American President Lines, LLC. 

Synopsis: The Amendment revises 

Article 5.1 to add Hakata, Japan as a 

port call under the Agreement. 

Proposed Effective Date: 7/2/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/34502. 

Agreement No.: 012426–006. 

Agreement Name: The OCEAN 

Alliance Agreement. 

Parties: COSCO SHIPPING Lines Co., 

Ltd.; CMA CGM S.A. and APL Co. Pte. 

Ltd. (acting as a single party); Evergreen 

Marine Corporation (Taiwan) Ltd.; and 

Orient Overseas Container Line Limited. 

Filing Party: Robert Magovern; Cozen 

O’Connor. 

Synopsis: The Amendment revises 

Article 2 to add Evergreen Marine (Asia) 

Pte. Ltd. as a sub-party to the 

Agreement. 

Proposed Effective Date: 8/20/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/1214. 

Agreement No.: 201351–001. 

Agreement Name: Foundation Carrier 

Agreement. 

Parties: Maersk A/S; CMA CGM S.A. 

MSC Mediterranean Shipping Company 

S.A.; Hapag-Lloyd AG; and Ocean 

Network Express Pte Ltd. 

Filing Party: Wayne Rohde; Cozen 

O’Connor. 

Synopsis: The amendment adds 

Hapag-Lloyd Aktiengesellschaft and 

Ocean Network Express Pte Ltd. as 

parties to the Agreement, and makes 

corresponding adjustments in Articles 

5.1(b), 5.3(c), and 6.4 of the Agreement. 

Proposed Effective Date: 8/21/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/36502. 

Agreement No.: 201364. 

Agreement Name: Agreement 

Between the City of Los Angeles, the 

City of Long Beach, Portcheck, LLC, and 

Marine Terminal Operators. 

Parties: Portcheck, LLC; The City of 

Long Beach Harbor Department; The 

City of Long Beach Harbor Department; 

APM Terminals Pacific LLC; Fenix 

Marine Services, Ltd.; Everport 

Terminal Services, Inc.; International 

Transportation Service, LLC; LBCT LLC; 

Total Terminals International, LLC; 

West Basin Container Terminal LLC; 

Pacific Maritime Services, LLC; SSAT 

(Pier A), LLC; Yusen Terminals LLC; 

Trapac LLC, and SSA Terminals, LLC. 

Filing Party: Wayne Rohde; Cozen 

O’Connor. 

Synopsis: The Agreement sets forth 

the terms and conditions under which 

PortCheck LLC and the marine terminal 

operators will provide certain services 

to the ports as provided for in tariffs 

published by the ports. These services 

relate to the collection of a clean truck 

fee in accordance with provisions to be 

published in the ports’ respective tariffs. 

Proposed Effective Date: 8/20/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/47525. 

Agreement No.: 012214–001. 

Agreement Name: Glovis/’’K’’ Line 

Space Charter Agreement. 

Parties: Kawasaki Kisen Kaisha, Ltd. 

and Hyundai Glovis Co., Ltd. 

Filing Party: John Meade, ‘‘K’’ Line 

America, Inc. 

Synopsis: The amendment eliminates 

the parties’ authority to jointly negotiate 

for covered services under the 

Agreement and updates the address for 

Hyundai Glovis. 

Proposed Effective Date: 7/1/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/265. 

Agreement No.: 201365–002. 

Agreement Name: Volkswagen 

Konzernlogistik GmbH & Co. OHG/NYK 

Line Space Charter Agreement. 

Parties: Volkswagen Konzernlogistik 

GmbH & Co. OHG and Nippon Yusen 

Kaisha. 

Filing Party: Kristen Chung; NYK 

Group Americas Inc. 

Synopsis: The amendment removes 

all authority to jointly negotiate or 

procure terminal services in the United 

States. 

Proposed Effective Date: 7/2/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/60. 

Agreement No.: 012386–001. 

Agreement Name: K Line/NYK Space 

Charter Agreement. 

Parties: Kawasaki Kisen Kaisha, Ltd. 

and Nippon Yusen Kaisha. 

Filing Party: Kristen Chung; NYK 

Group Americas Inc. 

Synopsis: This amendment removes 

all authority to jointly negotiate or 

procure terminal services in the United 

States. 

Proposed Effective Date: 7/2/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/1002. 

Dated: July 8, 2021. 

Rachel E. Dickon, 

Secretary. 

[FR Doc. 2021–14926 Filed 7–13–21; 8:45 am] 

BILLING CODE 6730–02–P 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 


lotter on DSK11XQN23PROD with NOTICES1
37158 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

standards enumerated in the BHC Act 

(12 U.S.C. 1842(c)). 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington, DC 20551–0001, not later 

than August 13, 2021. 

A. Federal Reserve Bank of Boston 

(Prabal Chakrabarti, Senior Vice 

President) 600 Atlantic Avenue, Boston, 

Massachusetts 02210–2204. Comments 

can also be sent electronically to 

BOS.SRC.Applications.Comments@

bos.frb.org: 

1. Independent Bank Corp., 

(‘‘Independent’’) through its subsidiary, 

Bradford Merger Sub Inc., both of 

Rockland, Massachusetts; to merge with 

Meridian Bancorp, Inc., Peabody, 

Massachusetts (‘‘Meridian’’), with 

Meridian as the survivor, and thereby 

indirectly acquire East Boston Savings 

Bank, Boston, Massachusetts. 

Immediately after, Meridian to merge 

with Independent, with Independent as 

the survivor, and East Boston Savings 

Bank to merge with and into Rockland 

Trust, Rockland, Massachusetts, a 

wholly owned subsidiary bank of 

Independent, with Rockland Trust as 

the surviving bank. 

Board of Governors of the Federal Reserve 

System, July 9, 2021. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2021–14997 Filed 7–13–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10341] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice; partial withdrawal. 

SUMMARY: On Friday, July 9, 2021, the 

Centers for Medicare & Medicaid 

Services (CMS) published a notice 

entitled, ‘‘Agency Information 

Collection Activities: Submission for 

OMB Review; Comment Request.’’ That 

notice invited public comments on three 

separate information collection requests 

specific to document identifiers: CMS– 

10215, CMS–10249, and CMS–10341. 

Through the publication of this 

document, we are withdrawing the 

portion of the notice requesting public 

comment on the information collection 

request titled ‘‘Section 1115 

Demonstration Projects Regulations at 

42 CFR 431.408, 431.412, 431.420, 

431.424, and 431.428.’’ Form number 

CMS–10341 (OMB control number 

0938–1162). The withdrawn 

information collection request will be 

replaced by another 30-day notice in 

July or August of this year. 

DATES: For CMS–10215 and CMS– 

10249, the original comment period for 

the notice that published on July 9, 

2021, remains in effect and ends August 

9, 2021. 

SUPPLEMENTARY INFORMATION: In FR 

document, 2021–14671, published on 

July 9, 2021 (86 FR 36281), we are 

withdrawing item 3 ‘‘Section 1115 

Demonstration Projects Regulations at 

42 CFR 431.408, 431.412, 431.420, 

431.424, and 431.428’’ which posted on 

page 36282. 

Dated: July 9, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–15005 Filed 7–13–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0191] 

Determination That STROMECTOL 

(Ivermectin) Tablets, 6 Milligrams, 

Were Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that STROMECTOL 

(ivermectin) tablets, 6 milligrams (mg), 

were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for 

STROMECTOL (ivermectin) tablets, 6 

mg, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Koepke, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3600, 

Christopher.Koepke@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

STROMECTOL (ivermectin) tablets, 6 

mg, are the subject of NDA 050742, held 

by Merck Sharp and Dohme Corp., and 

initially approved on November 22, 

1996. STROMECTOL is indicated for 

strongyloidiasis of the intestinal tract 

and onchocerciasis. 

In a letter dated September 14, 2007, 

Merck and Co., Inc. notified FDA that 

STROMECTOL (ivermectin) tablets, 6 

mg, were being discontinued, and FDA 


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