Federal Register / Vol. 90, No. 21 / Monday, February 3, 2025 / Notices 8805 

0805, may be submitted to FDA using 

Forms FDA 3913 and FDA 3914, 

respectively. 

Patent infringement notifications are 

also included in the scope of collection 

activity. Section 351(l) of the PHS Act 

provides for the exchange of patent 

information and resolution of patent 

disputes between a 351(k) biosimilar 

applicant and the holder of the 351(a) 

BLA reference product. If a biosimilar 

applicant is served with a complaint in 

an action for a patent infringement 

described in section 351(l)(6) of the PHS 

Act, the biosimilar applicant is required 

to provide the Secretary of HHS with 

notice and a copy of the complaint 

within 30 days of service. FDA is 

required to publish notice of a 

complaint received under section 

351(l)(6)(C) of the PHS Act in the 

Federal Register. 

Relevant information regarding 

applicable statutory requirements is 

discussed in topical guidance 

documents, issued consistent with our 

BsUFA Commitment Letter and Agency 

Good Guidance Practice regulations in 

21 CFR 10.115, which provide for 

public comment at any time. The 

following draft and final guidance 

documents include instructional and 

procedural information on 

communicating with FDA regarding the 

BsUFA program: 

• ‘‘Assessing User Fees Under the 

Biosimilar User Fee Amendments of 

2022’’ (July 2023), available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

assessing-user-fees-under-biosimilaruser-fee-amendments-2022. The 

guidance document instructs 

respondents on requesting 

discontinuation from the BPD program, 

as well as requesting to move products 

to the discontinued section of the 

biosimilar list. The guidance document 

also provides information on the 

consequences of failing to pay BsUFA III 

fees as well as processes for submitting 

reconsideration and appeal requests. 

• ‘‘Formal Meetings Between the FDA 

and Sponsors or Applicants of BsUFA 

Products’’ (August 2023), available at: 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/formal-meetings-betweenfda-and-sponsors-or-applicants-bsufaproducts-guidance-industry. The 

guidance document explains 

standardized procedures for requesting, 

preparing, scheduling, conducting, and 

documenting formal meetings with 

FDA, and discusses good meeting 

management practices. 

• As listed on our Center for Drug 

Evaluation and Research 2023 and 2024 

Annual Guidance agenda (available at: 

https://www.fda.gov/media/134778/ 

download), we are planning to issue a 

draft guidance for industry entitled 

‘‘Pediatric Study Plans for Biosimilar 

Products,’’ to help implement 

provisions of the Pediatric Research 

Equity Act, codified in section 505B of 

the FD&C Act (21 U.S.C. 355c). For more 

information regarding FDA guidance 

documents, including ways to 

participate, please visit https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. 

Description of Respondents: Sponsors 

and applicants who have or intend to 

submit an application for a biosimilar 

product for licensure under section 

351(k) of the PHS Act or who intend to 

submit an initial pediatric study plan 

(iPSP) as described in section 505B(e) of 

the FD&C Act for those products 

intended to be licensed under section 

351(k) of the PHS Act and being 

developed as a proposed biosimilar to a 

reference product. 

In the Federal Register of September 

23, 2024 (89 FR 77531), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

FDA form; survey Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Biosimilar User Fee Cover Sheet (Form FDA 3792) ...................... 30 2 60 0.5 (30 minutes).30 

Request for discontinuation from BPD program or to move products to discontinued section of Biosimilar List.6 1 6 1 ..................... 6 

Biosimilar product & interchangeable product applications 

(351(k)); patent infringement notifications (351(l)).

16 1.94 31 610.90 ............ 18,938 

Formal meeting requests as recommended in FDA guidance ....... 135 2.30 311 21.42 .............. 6,661 

Submission of Pediatric Assessment; iPSP template information, 

including deferrals of pediatric assessments for proposed biosimilar products; iPSP amendments as recommended in FDA 

guidance.

11 1 11 38.18 .............. 420 

Total .......................................................................................... .................... ........................ 419 ........................ 26,055 

Our estimated burden for the 

information collection reflects an 

overall increase of 13,069 hours and 105 

responses annually. Although part of 

the increase may be attributed to the 

inclusion of burden associated with the 

submission of pediatric study plans, the 

majority of adjustments correspond with 

an increase in submissions we are 

receiving. 

Dated: January 28, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–02153 Filed 1–30–25; 11:15 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[CIS No. 2803–25] 

Vacatur of 2025 Temporary Protected 

Status Decision for Venezuela 

AGENCY: U.S. Citizenship and 

Immigration Services (USCIS), 

Department of Homeland Security 

(DHS). 


khammond on DSK9W7S144PROD with NOTICES
8806 Federal Register / Vol. 90, No. 21 / Monday, February 3, 2025 / Notices 

1Although section 244(b)(1) of the INA continues 

to refer to the Attorney General, this authority now 

resides with the Secretary of Homeland Security by 

operation of the Homeland Security Act of 2002, 

Public Law 107–296, 116 Stat. 2135, as amended. 

See, e.g., 6 U.S.C. 557; 8 U.S.C. 1103(a)(1). The 

Secretary may designate a country (or part of a 

country) for TPS on the basis of (1) an ongoing 

armed conflict such that returning would pose a 

serious threat to the personal safety of the country’s 

nationals, (2) an environmental disaster (including 

an epidemic), or (3) extraordinary and temporary 

conditions in the country that prevent the safe 

return of the country’s nationals. For environmental 

disaster-based designations, certain other statutory 

requirements must be met, including that the 

foreign government must officially request a TPS 

designation. A designation based on extraordinary 

and temporary conditions cannot be made if the 

Secretary finds that allowing the country’s nationals 

to remain temporarily in the United States is 

contrary to the U.S. national interest. INA sec. 

244(b)(1), 8 U.S.C. 1254a(b)(1). 

2See INA 103(a), 244(b)(3), (b)(5)(A); 8 U.S.C. 

1103(a), 1254a(b)(3), (b)(5)(A); Reconsideration and 

Rescission of Termination of the Designation of El 

Salvador for Temporary Protected Status; Extension 

of the Temporary Protected Status Designation for 

El Salvador, 88 FR 40282, 40285 (June 21, 2023) 

(‘‘An agency has inherent (that is, statutorily 

implicit) authority to revisit its prior decisions 

unless Congress has expressly limited that 

authority. The TPS statute does not limit the 

Secretary’s inherent authority to reconsider any 

ACTION: Notice of Temporary Protected 

Status (TPS) vacatur. 

SUMMARY: Through this notice, the 

Department of Homeland Security 

(DHS) announces that the Secretary of 

Homeland Security (Secretary) has 

decided to vacate the January 10, 2025, 

decision of former Secretary of 

Homeland Security Alejandro Mayorkas 

regarding TPS for Venezuela. Former 

Secretary Mayorkas extended the 2023 

designation of Venezuela for TPS for 18 

months, allowed a consolidation of 

filing processes such that all eligible 

Venezuela TPS beneficiaries (whether 

under the 2021 or 2023 designations) 

may obtain TPS through the same 

extension date of October 2, 2026, and 

extended certain Employment 

Authorization Documents (EADs). All of 

this also had the effect of extending the 

2021 designation. This notice vacates 

Mayorkas’ notice immediately. 

DATES: The vacatur is effective 

immediately. 

FOR FURTHER INFORMATION CONTACT: 

Samantha Deshommes, Chief, 

Regulatory Coordination Division, 

Office of Policy and Strategy, U.S. 

Citizenship and Immigration Services, 

Department of Homeland Security, 800– 

375–5283. 

SUPPLEMENTARY INFORMATION: 

I. Temporary Protected Status (TPS) 

Generally 

The Immigration and Nationality Act 

(INA) authorizes the Secretary, after 

consultation with appropriate U.S. 

Government agencies, to designate a 

foreign state (or part thereof) for TPS if 

the Secretary determines that certain 

country conditions exist. INA 244(b)(1), 

8 U.S.C. 1254a(b)(1).1 The 

determination whether to designate any 

foreign state (or part thereof) for TPS is 

discretionary, and there is no judicial 

review of ‘‘any determination of the 

[Secretary] with respect to the 

designation, or termination or extension 

of a designation, of a foreign state’’ for 

TPS. INA 244(b)(5)(A), 8 U.S.C. 

1254a(b)(5)(A). The Secretary, in the 

Secretary’s discretion, may then grant 

TPS to eligible nationals of that foreign 

state (or individual aliens having no 

nationality who last habitually resided 

in the designated foreign state). See INA 

244(a)(1)(A), 8 U.S.C. 1254a(a)(1)(A). 

At least 60 days before the expiration 

of a foreign state’s TPS designation or 

extension, the Secretary, after 

consultation with appropriate U.S. 

Government agencies, must review the 

conditions in the foreign state 

designated for TPS to determine 

whether they continue to meet the 

conditions for the TPS designation. See 

INA 244(b)(3)(A), 8 U.S.C. 

1254a(b)(3)(A). If the Secretary 

determines that the conditions in the 

foreign state continue to meet the 

conditions for TPS designation, the 

designation will be extended for an 

additional period of 6 months or, in the 

Secretary’s discretion, 12 or 18 months. 

See INA 244(b)(3)(A), (C), 8 U.S.C. 

1254a(b)(3)(A), (C). If the Secretary 

determines that the foreign state no 

longer meets the conditions for TPS 

designation, the Secretary must 

terminate the designation. See INA 

244(b)(3)(B), 8 U.S.C. 1254a(b)(3)(B). 

II. Background 

On March 9, 2021, Secretary 

Mayorkas designated Venezuela for TPS 

on the basis of extraordinary and 

temporary conditions in Venezuela that 

prevented nationals of Venezuela from 

returning in safety (2021 designation). 

See Designation of Venezuela for 

Temporary Protected Status and 

Implementation of Employment 

Authorization for Venezuelans Covered 

by Deferred Enforced Departure, 86 FR 

13574 (Mar. 9, 2021). 

On September 8, 2022, DHS extended 

the Venezuela 2021 TPS designation for 

18 months. See Extension of the 

Designation of Venezuela for Temporary 

Protected Status, 87 FR 55024 (Sept. 8, 

2022). On October 3, 2023, DHS 

extended the Venezuela 2021 TPS 

designation for another 18 months with 

an expiration date of September 10, 

2025, and separately newly designated 

Venezuela, which then Secretary 

Mayorkas called a ‘‘redesignation,’’ for 

18 months (the Venezuela 2023 

designation) with an expiration of April 

2, 2025, resulting in two separate and 

concurrent Venezuela TPS designations. 

See Extension and Redesignation of 

Venezuela for Temporary Protected 

Status, 88 FR 68130 (Oct. 3, 2023). 

The Venezuela 2023 TPS designation 

expires on April 2, 2025, and the 

Secretary must make a decision by 

February 1, 2025. The Venezuela 2021 

TPS designation expires on September 

10, 2025, and the Secretary must make 

a decision by July 12, 2025. 

Notwithstanding the fact that these are 

both decisions that would lie with new 

Secretary of Homeland Security Kristi 

Noem, Secretary Mayorkas took action 

with respect to both designations. 

On January 17, 2025, Secretary 

Mayorkas issued a notice extending the 

2023 designation of Venezuela for TPS 

for 18 months (Mayorkas Notice). The 

notice was based on Secretary 

Mayorkas’ January 10, 2025, 

determination that the conditions for 

the designation continued to be met. See 

INA 244(b)(3)(A), 8 U.S.C. 

1254a(b)(3)(A). In the Mayorkas Notice, 

Secretary Mayorkas did not expressly 

extend or terminate the 2021 

designation. Instead, the notice allowed 

for a consolidation of filing processes 

such that all eligible Venezuela TPS 

beneficiaries (whether under the 2021 or 

2023 designations) could obtain TPS 

through the same extension date of 

October 2, 2026. See Extension of the 

2023 Designation of Venezuela for 

Temporary Protected Status, 90 FR 5961 

(Jan. 17, 2025). The notice also extended 

certain EADs. The effect of Secretary 

Mayorkas’ actions, however, resulted in 

an extension of the 2021 Venezuela TPS 

designation. 

III. Vacatur of the 2025 Decision 

The Secretary of Homeland Security 

is vacating the January 10, 2025 

decision of Secretary Mayorkas which 

(1) extended the 2023 Venezuela TPS 

designation and (2) allowed the 

consolidation of filing processes for 

both designations, which had the effect 

of extending the 2021 Venezuela TPS 

designation, and (3) extended certain 

EADs. An agency has inherent (that is, 

statutorily implicit) authority to revisit 

its prior decisions unless Congress has 

expressly limited that authority. The 

TPS statute does not limit the 

Secretary’s inherent authority under the 

INA to reconsider any TPS-related 

determination, and upon 

reconsideration, to vacate or amend the 

determination.2


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Federal Register / Vol. 90, No. 21 / Monday, February 3, 2025 / Notices 8807 

TPS-related determination, and upon 

reconsideration, to change the determination.’’); see 

also, e.g., Ivy Sports Medicine, LLC v. Burwell, 767 

F.3d 81, 86 (D.C. Cir. 2014) (Kavanaugh, J.) 

(‘‘[A]dministrative agencies are assumed to possess 

at least some inherent authority to revisit their prior 

decisions, at least if done in a timely fashion. . . . 

‘‘[I]nherent authority for timely administrative 

reconsideration is premised on the notion that the 

power to reconsider is inherent in the power to 

decide.’’ (quotation marks and citations omitted)); 

Macktal v. Chao, 286 F.3d 822, 825–26 (5th Cir. 

2002) (‘‘It is generally accepted that in the absence 

of a specific statutory limitation, an administrative 

agency has the inherent authority to reconsider its 

decisions.’’) (collecting cases); Mazaleski v. 

Treusdell, 562 F.2d 701, 720 (D.C. Cir. 1977) (‘‘We 

have many times held that an agency has the 

inherent power to reconsider and change a decision 

if it does so within a reasonable period of time.’’); 

cf. Last Best Beef, LLC v. Dudas, 506 F.3d 333, 340 

(4th Cir. 2007) (agencies possess especially ‘‘broad 

authority to correct their prior errors’’). 

3See Exec. Order, Protecting the American People 

Against Invasion, sec. 16(b) (Jan. 20, 2025), 

available at https://www.whitehouse.gov/ 

presidential-actions/2025/01/protecting-theamerican-people-against-invasion/. 

4 If there is an existing TPS designation for a 

foreign state, the Secretary must review country 

conditions in consultation with appropriate U.S. 

Government agencies and make a determination— 

at least 60 days before the designation is set to 

expire—whether to extend or terminate that 

country’s TPS designation (i.e., whether the 

conditions for the designation continue to be met). 

INA 244(b)(3), 8 U.S.C. 1254a(b)(3). 

5As noted above, any Venezuela 2021 registrants 

who elected, pursuant to the Mayorkas Notice, to 

register under the Venezuela 2023 designation will 

have their Venezuela 2021 registration restored. 

A. Reason for the Vacatur 

The Mayorkas Notice adopted a novel 

approach of implicitly negating the 2021 

Venezuela TPS designation by 

effectively subsuming it within the 2023 

Venezuela TPS designation. As 

described above, Secretary Mayorkas 

explicitly made a determination to 

extend the 2023 designation. While he 

did not make an explicit determination 

to extend the 2021 designation, he did 

allow consolidated filing processes for 

both the 2021 and 2023 designations, 

which in effect extended the 2021 

designation by up to 13 months. 

Furthermore, he allowed extensions for 

certain EADs. 

The Mayorkas Notice states that 

Existing TPS beneficiaries, including 

those registered under the October 3, 

2023 TPS designation or the prior 

March 9, 2021 TPS designation, who 

wish to extend their status through 

October 2, 2026, must re-register during 

the re-registration period described in 

the January 2025 decision. This, and 

other language in the Mayorkas Notice, 

indicate that the practical effect of 

Secretary Mayorkas’ decision was to 

combine both designations and to 

provide an extension until October 2, 

2026, for the population of both 

designations. 

The Mayorkas Notice did not 

acknowledge the novelty of its approach 

or explain how it is consistent with the 

TPS statute. See INA 244(b)(2)(B), 8 

U.S.C. 1254a(b)(2)(B) (providing that a 

TPS country designation ‘‘shall remain 

in effect until the effective date of the 

termination of the designation under 

[INA 244(b)(3)(B), 8 U.S.C. 

1254a(b)(3)(B)]’’). This novel approach 

has included multiple notices, 

overlapping populations, overlapping 

dates, and sometimes multiple actions 

happening in a single document. While 

the Mayorkas Notice may have made 

attempts to address these overlapping 

populations, the explanations in the 

Mayorkas Notice, particularly the 

explanation for operational impacts, are 

thin and inadequately developed. Given 

these deficiencies and lack of clarity, 

vacatur is warranted to untangle the 

confusion, and provide an opportunity 

for informed determinations regarding 

the TPS designations and clear 

guidance.3

Given the exceedingly brief period in 

which the January 17, 2025 extension 

notice has been in effect and the fact 

that the effect of this vacatur will restore 

the status quo preceding that notice, any 

putative reliance interests on the 

extension notice are negligible. 

Venezuela 2023 registrants will retain 

their temporary protected status under 

the pre-existing designation at least 

until April 2, 2025. With respect to any 

Venezuela 2021 registrants who elected, 

pursuant to the Mayorkas Notice, to 

register under the Venezuela 2023 

designation, USCIS will restore their 

Venezuela 2021 registration. And, in 

any event, any putative reliance 

interests arguably engendered by the 

Mayorkas Notice are outweighed by the 

overriding interests and concerns 

articulated in this notice. 

B. Effect of the Vacatur 

As a result of the vacatur, the 2021 

Venezuela TPS designation and the 

2023 Venezuela designation remain in 

effect and their associated statutory 

deadlines remain in effect. The statutory 

deadline 4 for each of those designations 

is as follows: The Secretary (1) must 

determine, by February 1, 2025, whether 

to extend or terminate the 2023 

Venezuela TPS designation and (2) must 

determine, by July 12, 2025, whether to 

extend or terminate the 2021 Venezuela 

TPS designation. 

If the Secretary does not make a 

timely determination (for example, if 

the Secretary were not to make 

determination by February 1, 2025 

whether to extend or terminate the 2023 

Venezuela TPS designation), then the 

statute provides for an automatic 

extension of the designation for an 

additional period of 6 months. INA 

244(b)(3)(C), 8 U.S.C. 1254a(b)(3)(C). 

Pursuant to this vacatur, USCIS will 

no longer accept Venezuela TPS reregistration applications (Form I–821) 

and associated Applications for 

Employment Authorization (Form I– 

765) filed under the Mayorkas Notice. 

For TPS beneficiaries who have already 

filed applications to re-register for TPS 

pursuant to the Mayorkas Notice and 

paid any fees associated with their 

applications, USCIS will cease 

processing their applications, and issue 

refunds of any fees paid by those 

aliens.5 Additionally, USCIS will 

invalidate EADs; Forms I–797, Notice of 

Action (Approval Notice); and Forms I– 

94, Arrival/Departure Record 

(collectively known as TPS-related 

documentation) that have been issued 

with October 2, 2026 expiration dates 

under the Mayorkas Notice. USCIS will 

provide refunds to any fees paid by 

these aliens as well. 

Additionally, pursuant to this vacatur 

the automatic EAD extensions provided 

in the Mayorkas Notice are hereby 

rescinded. USCIS will provide 

additional guidance regarding the two 

Venezuela TPS designations on a future 

date in accordance with applicable 

laws. 

IV. Notice of Vacatur of Secretary 

Mayorkas’ 2025 Decision 

By the authority vested in me as 

Secretary under section 244 of the 

Immigration and Nationality Act, 8 

U.S.C. 1254a, I am vacating the 

decisions announced in the January 17, 

2025 notice titled Extension of the 2023 

Designation of Venezuela for TPS. In 

doing so, I am vacating the (1) extension 

of the Venezuela 2023 TPS designation, 

(2) the consolidation of filing processes 

for both designations, which, in effect, 

resulted in the extension of the 2021 

TPS designation, and (3) the EADs that 

were extended. As a result, the 

Venezuela 2023 TPS designation and 

the Venezuela 2021 TPS designation 

remain in effect and their associated 

statutory deadlines remain in effect. 

Kristi Noem, 

Secretary, U.S. Department of Homeland 

Security. 

[FR Doc. 2025–02183 Filed 1–30–25; 11:15 am] 

BILLING CODE 9111–97–P 


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