40564 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

Parties: Hoegh Autoliners AS and 

Nippon Yusen Kaisha. 

Filing Party: Kristen Chung; NYK Line 

(North America) Inc. 

Synopsis: The amendment removes 

all authority to jointly negotiate or 

procure terminal services in the United 

States. 

Proposed Effective Date: 7/19/2021. 

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

FMC.Agreements.Web/Public/ 

AgreementHistory/1931. 

Agreement No.: 201326–001. 

Agreement Name: Sallaum Lines/ 

NYK Space Charter Agreement. 

Parties: Sallaum Lines Switzerland 

SA and Nippon Yusen Kaisha. 

Filing Party: Kristen Chung; NYK Line 

(North America) Inc. 

Synopsis: This amendment removes 

all authority to jointly negotiate or 

procure terminal services in the United 

States and updates the names of the 

parties. 

Proposed Effective Date: 7/19/2021. 

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

FMC.Agreements.Web/Public/ 

AgreementHistory/26450. 

Agreement No.: 012422–001. 

Agreement Name: Liberty Global 

Logistics/NYK Space Charter 

Agreement. 

Parties: Liberty Global Logistics LLC 

and Nippon Yusen Kaisha. 

Filing Party: Kristen Chung; NYK Line 

(North America) Inc. 

Synopsis: The amendment removes 

all authority to jointly negotiate or 

procure terminal services in the United 

States. 

Proposed Effective Date: 7/19/2021. 

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

FMC.Agreements.Web/Public/ 

AgreementHistory/1893. 

Agreement No.: 012423–001. 

Agreement Name: Glovis/NYK Space 

Charter Agreement. 

Parties: Hyundai Glovis Co., Ltd. and 

Nippon Yusen Kaisha. 

Filing Party: Kristen Chung; NYK Line 

(North America) Inc. 

Synopsis: The amendment removes 

all authority to jointly negotiate or 

procure terminal services in the United 

States. 

Proposed Effective Date: 7/20/2021. 

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

FMC.Agreements.Web/Public/ 

AgreementHistory/1894. 

Agreement No.: 012313–001. 

Agreement Name: NYK/EUKOR North 

America/Caribbean and Central America 

Space Charter Agreement. 

Parties: Nippon Yusen Kaisha and 

EUKOR Car Carriers, Inc. 

Filing Party: Kristen Chung; NYK Line 

(North America) Inc. 

Synopsis: The amendment removes 

all authority to jointly negotiate or 

procure terminal services in the United 

States. 

Proposed Effective Date: 7/21/2021. 

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

FMC.Agreements.Web/Public/ 

AgreementHistory/186. 

Agreement No.: 201298–001. 

Agreement Name: CMA CGM/COSCO 

SHIPPING China-U.S. West Coast 

Service Slot Charter Agreement. 

Parties: CMA CGM S.A. and COSCO 

SHIPPING Lines Co., Ltd. 

Filing Party: Robert Magovern; Cozen 

O’Connor. 

Synopsis: The amendment revises 

Articles 1, 5, and 8 of the Agreement to 

update the respective services on which 

the parties will exchange space under 

the Agreement. 

Proposed Effective Date: 7/21/2021. 

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

FMC.Agreements.Web/Public/ 

AgreementHistory/21398. 

Agreement No.: 012227–001. 

Agreement Name: NYK/EUKOR North 

America/Far East Space Charter 

Agreement. 

Parties: Nippon Yusen Kaisha and 

EUKOR Car Carriers, Inc. 

Filing Party: Kristen Chung; NYK Line 

(North America) Inc. 

Synopsis: The amendment removes 

all authority to jointly negotiate or 

procure terminal services in the United 

States. 

Proposed Effective Date: 7/21/2021. 

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

FMC.Agreements.Web/Public/ 

AgreementHistory/276. 

Dated: July 23, 2021. 

Rachel E. Dickon, 

Secretary. 

[FR Doc. 2021–16090 Filed 7–27–21; 8:45 am] 

BILLING CODE P 

FEDERAL RETIREMENT THRIFT 

INVESTMENT BOARD 

Privacy Act of 1974; System of 

Records 

AGENCY: Federal Retirement Thrift 

Investment Board (FRTIB). 

ACTION: Notice of a new system of 

records. 

SUMMARY: Pursuant to the Privacy Act of 

1974, the Federal Retirement Thrift 

Investment Board (FRTIB) proposes to 

establish a new system of records. 

Records contained in this system will be 

used to implement FRTIB’s Insider 

Threat Program. 

DATES: This system will become 

effective upon its publication in today’s 

Federal Register, with the exception of 

the routine uses which will be effective 

on August 27, 2021. FRTIB invites 

written comments on the routine uses 

and other aspects of this system of 

records. Submit any comments by 

August 27, 2021. 

ADDRESSES: You may submit written 

comments to FRTIB by any one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

website instructions for submitting 

comments. 

• Fax: 202–942–1676. 

• Mail or Hand Delivery: Office of 

General Counsel, Federal Retirement 

Thrift Investment Board, 77 K Street NE, 

Suite 1000, Washington, DC 20002. 

FOR FURTHER INFORMATION CONTACT: 

Dharmesh Vashee, General Counsel and 

Senior Agency Official for Privacy, 

Federal Retirement Thrift Investment 

Board, Office of General Counsel, 77 K 

Street NE, Suite 1000, Washington, DC 

20002, (202) 942–1600. For access to 

any of the FRTIB’s systems of records, 

contact Amanda Haas, FOIA Officer, 

Office of General Counsel, at the above 

address and phone number. 

SUPPLEMENTARY INFORMATION: FRTIB 

proposes to establish a new system of 

records entitled, ‘‘FRTIB–23, Insider 

Threat Program Records.’’ FRTIB is 

committed to protecting FRTIB 

facilities, information, and information 

systems. In order to better protect these 

resources, FRTIB has established an 

Insider Threat Program to prevent, 

detect, and mitigate the effects of insider 

threats. An insider threat is an 

individual who has or had authorized 

access to an organization’s assets, and 

uses their access, either maliciously or 

unintentionally, to act in a way that 

could cause harm to FRTIB facilities, 

information systems, or data. 

FRTIB is not legally required to have 

an insider threat program under 

Executive Order 13587, as the agency 

does not maintain classified 

information. However, FRTIB has 

implemented this program as a best 

practice in order to protect the 

information that it maintains, including 

controlled unclassified information. 

FRTIB’s Insider Threat Program is based 

on standards developed by the National 

Institute of Standards and Technology 

and the National Insider Threat Task 

Force. The records compiled to 

administer the insider threat program 

may be from any program, record, or 

source, and may contain records 

pertaining to information security, 

personnel security, or physical security. 

FRTIB will publish regulations to 

exempt such material in the new system 

of records from certain requirements 

under the Privacy Act of 1974 (5 U.S.C. 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40565 

552a), based on subsection (k)(2) of the 

Act. 

The collection and maintenance of 

these records is new. The 

implementation of this new system of 

records will be effective on July 28, 

2021. FRTIB proposes to apply eleven 

routine uses to FRTIB–23. 

Dharmesh Vashee, 

General Counsel and Senior Agency Official 

for Privacy. 

SYSTEM NAME AND NUMBER: 

FRTIB–23, Insider Threat Program 

Records. 

SECURITY CLASSIFICATION: 

Unclassified. 

SYSTEM LOCATION: 

Records are located at the Federal 

Retirement Thrift Investment Board, 77 

K Street NE, Suite 1000, Washington, 

DC 20002. Records may also be 

maintained at the business offices of 

third-party service providers. Records 

may also be maintained at additional 

locations for Business Continuity 

purposes. 

SYSTEM MANAGER: 

Insider Threat Program Manager, 

Federal Retirement Thrift Investment 

Board, 77 K Street NE, Suite 1000, 

Washington, DC 20002, (202) 942–1600. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

5 U.S.C. 8474; 44 U.S.C. Chapter 35; 

44 U.S.C. 3101. 

PURPOSE(S) OF THE SYSTEM: 

FRTIB’s Insider Threat Program is 

being implemented to prevent, detect, 

and mitigate the effects of insider 

threats, defined as, ‘‘the potential for an 

individual who has or had authorized 

access to an organization’s assets to use 

their access, either maliciously or 

unintentionally, to act in a way that 

could negatively affect the 

organization.’’ 

The Insider Threat Program system of 

records is being established to manage 

insider threat matters; facilitate insider 

threat activities, inquiries, and 

investigations; identify insider threats to 

FRTIB facilities, information, and 

information systems; track referrals of 

potential insider threats from FRTIB’s 

hotline; and to track referrals of 

potential insider threats to internal and 

external partners. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

This system collects information on 

current or former FRTIB employees, 

contractors, subcontractors, or any other 

individuals who have or have 

previously had authorized access to 

FRTIB facilities, information, or 

information systems. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

The categories of records compiled for 

each insider threat report, inquiry, or 

investigation may vary significantly 

based on the nature of each actual or 

potential insider threat incident. 

Categories of records in the Insider 

Threat Program system of records may 

include name; social security number; 

date of birth; place of birth; personal 

and business email address; personal 

and business phone number; work 

history; background investigation 

information (including any information 

derived from SF–85, SF–85P, and SF–86 

forms and background investigation 

processes); user ID; user activity 

performed on FRTIB devices; 

correspondence sent or received on an 

FRTIB device or network; personnel 

records (including disciplinary records 

and performance records); records of 

access to FRTIB facilities; records of 

security violations; reports from FRTIB’s 

hotline for fraud, waste, abuse, and 

other misconduct; and law enforcement 

referrals. 

RECORD SOURCE CATEGORIES: 

To monitor, identify, and respond to 

potential insider threats, information in 

the system will be received on an asneeded basis depending on the nature of 

the inquiry or investigation from: FRTIB 

employees, contractors, vendors, or 

other individuals with access to FRTIB 

facilities, information, or information 

systems; FRTIB’s hotline for reporting 

fraud, waste, abuse, and other 

misconduct; information collected 

through user activity monitoring; 

officials from other foreign, federal, 

tribal, state, and local government 

agencies and organizations; nongovernment, commercial, public, and 

private agencies and organizations; and 

from relevant records, including 

information security databases and files; 

personnel security databases and files; 

FRTIB human resources databases and 

files; access records for FRTIB facilities; 

FRTIB contractor files; FRTIB’s Office of 

Technology Services; FRTIB telephone 

usage records; federal, state, tribal, 

territorial, and local law enforcement 

and investigatory records; other Federal 

agencies; and publicly available 

information. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

PURPOSES OF SUCH USES: 

Information about covered 

individuals may be disclosed without 

consent as permitted by the Privacy Act 

of 1974, as amended, 5 U.S.C. 552a(b); 

and: 

1. Routine Use—Audit: A record from 

this system of records may be disclosed 

to an agency, organization, or individual 

for the purpose of performing an audit 

or oversight operations as authorized by 

law, but only such information as is 

necessary and relevant to such audit or 

oversight function when necessary to 

accomplish an agency function related 

to this system of records. Individuals 

provided information under this routine 

use are subject to the same Privacy Act 

requirements and limitations on 

disclosure as are applicable to FRTIB 

officers and employees. 

2. Routine Use—Breach Mitigation 

and Notification: Response to Breach of 

FRTIB Records: A record from this 

system of records may be disclosed to 

appropriate agencies, entities, and 

persons when (1) FRTIB suspects or has 

confirmed that there has been a breach 

of the system of records; (2) FRTIB has 

determined that as a result of the 

suspected or confirmed breach there is 

a risk of harm to individuals, FRTIB 

(including its information systems, 

programs, and operations), the Federal 

Government, or national security; and 

(3) the disclosure made to such 

agencies, entities, and persons is 

reasonably necessary to assist in 

connection with FRTIB’s efforts to 

respond to the suspected or confirmed 

breach or to prevent, minimize, or 

remedy such harm. 

3. Routine Use—Response to Breach 

of Other Records: A record from this 

system of records may be disclosed to 

another Federal agency or Federal 

entity, when FRTIB determines that 

information from this system of records 

is reasonably necessary to assist the 

recipient agency or entity in (1) 

responding to a suspected or confirmed 

breach or (2) preventing, minimizing, or 

remedying the risk of harm to 

individuals, the recipient agency or 

entity (including its information 

systems, programs, and operations), the 

Federal Government, or national 

security, resulting from a suspected or 

confirmed breach. 

4. Routine Use—Congressional 

Inquiries: A record from this system of 

records may be disclosed to a 

Congressional office from the record of 

an individual in response to an inquiry 

from that Congressional office made at 

the request of the individual to whom 

the record pertains. 

5. Routine Use—Contractors, et al.: A 

record from this system of records may 

be disclosed to contractors, grantees, 

experts, consultants, the agents thereof, 

and others performing or working on a 

contract, service, grant, cooperative 

agreement, interagency agreement, or 

other assignment for FRTIB, when 


khammond on DSKJM1Z7X2PROD with NOTICES
40566 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

necessary to accomplish an agency 

function related to this system of 

records. Individuals provided 

information under this routine use are 

subject to the same Privacy Act 

requirements and limitations on 

disclosure as are applicable to FRTIB 

officers and employees. 

6. Routine Use—Third-Party Service 

Providers: A record from this system of 

records may be disclosed to third-party 

service providers, including other 

government agencies, such as the 

Department of Justice, that provide 

support for FRTIB’s Insider Threat 

Program under a contract or interagency 

agreement. 

7. Routine Use—Disclosure to Law 

Enforcement: Where a record, either 

alone or in conjunction with other 

information, indicates a violation or 

potential violation of law—criminal, 

civil, or regulatory in nature—the 

relevant records may be referred to the 

appropriate federal, state, local, 

territorial, tribal, or foreign law 

enforcement authority or other 

appropriate entity charged with the 

responsibility for investigating or 

prosecuting such violation or charged 

with enforcing or implementing such 

law. 

8. Routine Use—Litigation, DOJ or 

Outside Counsel: A record from this 

system of records may be disclosed to 

the Department of Justice, FRTIB’s 

outside counsel, other Federal agency 

conducting litigation or in proceedings 

before any court, adjudicative or 

administrative body, when: (1) FRTIB, 

or (2) any employee of FRTIB in his or 

her official capacity, or (3) any 

employee of FRTIB in his or her 

individual capacity where DOJ or FRTIB 

has agreed to represent the employee, or 

(4) the United States or any agency 

thereof, is a party to the litigation or has 

an interest in such litigation, and FRTIB 

determines that the records are both 

relevant and necessary to the litigation 

and the use of such records is 

compatible with the purpose for which 

FRTIB collected the records. 

9. Routine Use—Litigation, Opposing 

Counsel: A record from this system of 

records may be disclosed to a court, 

magistrate, or administrative tribunal in 

the course of presenting evidence, 

including disclosures to opposing 

counsel or witnesses in the course of 

civil discovery, litigation, or settlement 

negotiations or in connection with 

criminal law proceedings or in response 

to a subpoena. 

10. Routine Use—NARA/Records 

Management: A record from this system 

of records may be disclosed to the 

National Archives and Records 

Administration (NARA) or other Federal 

Government agencies pursuant to the 

Federal Records Act. 

11. Routine Use—Insider Threat 

Community of Practice: A record from 

this system of records may be disclosed 

to any Federal agency or group of 

agencies with responsibilities for 

activities related to counterintelligence 

or the detection of insider threats. 

POLICIES AND PRACTICES FOR STORAGE OF

RECORDS: 

Records are maintained in paper and 

electronic form, including on computer 

databases and cloud-based services, all 

of which are securely stored. 

POLICIES AND PRACTICES FOR RETRIEVAL OF

RECORDS: 

Records are retrieved by name, phone 

number, case number, or internal FRTIB 

identification (including FRTIB email, 

username, etc.). 

POLICIES AND PRACTICES FOR RETENTION AND

DISPOSAL OF RECORDS: 

These records are maintained in 

accordance with General Records 

Schedule 5.6 (Security Records), Items 

210 through 240, issued by the National 

Archives and Records Administration 

(NARA). 

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL

SAFEGUARDS: 

FRTIB has adopted appropriate 

administrative, technical, and physical 

controls in accordance with FRTIB’s 

security program to protect the security, 

confidentiality, availability, and 

integrity of the information and to 

ensure that records are not disclosed to 

or accessed by unauthorized 

individuals. Access to the records in 

this system is limited to individuals 

who have the appropriate permissions 

and who have a need to know the 

information in order to perform their 

official duties. 

RECORD ACCESS PROCEDURES: 

Individuals seeking to access records 

within this system must submit a 

request pursuant to 5 CFR part 1630. 

Attorneys or other persons acting on 

behalf of an individual must provide 

written authorization from that 

individual, such as a Power of Attorney, 

in order for the representative to act on 

their behalf. 

CONTESTING RECORD PROCEDURES: 

See Record Access Procedures above. 

NOTIFICATION PROCEDURES: 

See Record Access Procedures above. 

EXEMPTIONS PROMULGATED FOR THE SYSTEM: 

Records in this system will be 

exempt, based on 5 U.S.C. 552a(k)(2), 

from the requirements in subsections 

(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and 

(f) of the Privacy Act. The Agency has 

promulgated regulations implementing 

the Privacy Act at 5 CFR 1632.15 that 

establish this exemption. 

HISTORY: 

None. 

[FR Doc. 2021–16016 Filed 7–27–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0299] 

Determination That EFUDEX 

(Fluorouracil) Topical Solution, 5 

Percent, Was 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 EFUDEX (fluorouracil) 

topical solution, 5 percent, was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of the abbreviated new drug application 

(ANDA) that refers to this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Kaetochi Okemgbo, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, Rm. 6272, 

Silver Spring, MD 20993–0002, 240– 

825–9944, Kaetochi.Okemgbo@

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). 


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