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). 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40567 

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. 

EFUDEX (fluorouracil) topical 

solution, 5 percent, is the subject of 

NDA 016831, held by Bausch Health 

Americas, Inc., and initially approved 

on July 29, 1970. EFUDEX is indicated 

for the topical treatment of multiple 

actinic or solar keratoses, and treatment 

of superficial basal cell carcinomas 

when conventional methods are 

impractical, such as with multiple 

lesions or difficult treatment sites. 

EFUDEX (fluorouracil) topical solution, 

5 percent, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Encube Ethicals Private Ltd. 

submitted a citizen petition dated 

March 16, 2021 (Docket No. FDA–2021– 

P–0299), under 21 CFR 10.30, 

requesting that the Agency determine 

whether EFUDEX (fluorouracil) topical 

solution, 5 percent, was withdrawn 

from sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that EFUDEX (fluorouracil) 

topical solution, 5 percent, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that EFUDEX (fluorouracil) 

topical solution, 5 percent, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of EFUDEX 

(fluorouracil) topical solution, 5 

percent, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list EFUDEX (fluorouracil) 

topical solution, 5 percent, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of the approved ANDA that refers to this 

drug product. Additional ANDAs that 

refer to EFUDEX (fluorouracil) topical 

solution, 5 percent, may also be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16037 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0708] 

Biosimilar User Fee Rates for Fiscal 

Year 2022 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the rates for biosimilar user 

fees for fiscal year (FY) 2022. The 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), as amended by the 

Biosimilar User Fee Amendments of 

2017 (BsUFA II), authorizes FDA to 

assess and collect user fees for certain 

activities in connection with biosimilar 

biological product development; review 

of certain applications for approval of 

biosimilar biological products; and each 

biosimilar biological product approved 

in a biosimilar biological product 

application. BsUFA II directs FDA to 

establish, before the beginning of each 

fiscal year, the amount of initial and 

annual biosimilar biological product 

development (BPD) fees, the 

reactivation fee, and the biosimilar 

biological product application and 

program fees for such year. These fees 

apply to the period from October 1, 

2021, through September 30, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Hurley, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 61075, Beltsville, MD 20705–4304, 

240–402–4585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 744G, 744H, and 744I of the 

FD&C Act (21 U.S.C. 379j-51, 379j-52, 

and 379j-53), as amended by BsUFA II 

(title IV of the FDA Reauthorization Act 

of 2017, Pub. L. 115–52), authorize the 

collection of fees for biosimilar 

biological products. Under section 

744H(a)(1)(A) of the FD&C Act, the 

initial BPD fee for a product is due 

when the sponsor submits an 

investigational new drug (IND) 

application that FDA determines is 

intended to support a biosimilar 

biological product application or within 

5 calendar days after FDA grants the 

first BPD meeting, whichever occurs 

first. A sponsor who has paid the initial 

BPD fee is considered to be participating 

in FDA’s BPD program for that product. 

Under section 744H(a)(1)(B) of the 

FD&C Act, once a sponsor has paid the 

initial BPD fee for a product, the annual 

BPD fee is assessed beginning with the 

next fiscal year. The annual BPD fee is 

assessed for the product each fiscal year 

until the sponsor submits a marketing 

application for the product that is 

accepted for filing or the sponsor 

discontinues participation in FDA’s 

BPD program for the product. 

Under section 744H(a)(1)(D) of the 

FD&C Act, if a sponsor has discontinued 

participation in FDA’s BPD program and 

wants to reengage with FDA on 

development of the product, the sponsor 

must pay a reactivation fee to resume 

participation in the program. The 

sponsor must pay the reactivation fee by 

the earlier of the following dates: No 

later than 5 calendar days after FDA 

grants the sponsor’s request for a BPD 

meeting for that product or upon the 

date of submission by the sponsor of an 

IND describing an investigation that 

FDA determines is intended to support 

a biosimilar biological product 

application for that product. The 

sponsor will be assessed an annual BPD 

fee beginning with the first fiscal year 

after payment of the reactivation fee. 

BsUFA II also authorizes fees for 

certain biosimilar biological product 


khammond on DSKJM1Z7X2PROD with NOTICES