8804 Federal Register / Vol. 90, No. 21 / Monday, February 3, 2025 / Notices 

intends to consider those comments. 

Please submit any additional comments 

regarding the guidances that you wish 

the Agency to consider, including 

whether it would be appropriate to 

reissue these guidances in draft form or 

consider a later implementation date. 

II. Paperwork Reduction Act of 1995 

While these guidance documents 

contain no collection of information, 

they do refer to previously approved 

FDA collections of information. The 

previously approved collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR 1271 relating to HCT/Ps, 

including establishing and maintaining 

records, investigation and reporting of 

adverse actions and documentation of 

methods used in facilities related to 

HCT/Ps, which, includes but is not 

limited to donor screening, donor 

testing, and labeling have been 

approved under OMB control number 

0910–0543. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidances at https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dorothy A. Fink, 

Acting Secretary, Department of Health and 

Human Services. 

[FR Doc. 2025–02167 Filed 1–31–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4146] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Biosimilars User 

Fee Program 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by March 5, 

2025. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0718. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Biosimilars User Fee Program 

OMB Control Number 0910–0718— 

Revision 

This information collection supports 

FDA’s Biosimilars User Fee Program 

and implementation of the Biologics 

Price Competition and Innovation Act of 

2009 (BPCI Act). The BPCI Act creates 

an abbreviated approval pathway for 

biological products shown to be 

biosimilar to or interchangeable with an 

FDA-licensed reference biological 

product. Section 351(k) of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

262(k)), added by the BPCI Act, allows 

a company to apply for licensure of a 

biosimilar or interchangeable biological 

product (351(k) application). The BPCI 

Act also amended section 735 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 379g) to include 

351(k) applications as a type of 

application under ‘‘human drug 

application’’ for the purposes of the 

prescription drug user fee provisions. 

The FD&C Act as amended by the 

Biosimilar User Fee Amendments of 

2022 (BsUFA III), reauthorizes FDA to 

assess and collect fees for biosimilar 

biological products from October 2022 

through September 2027 to facilitate the 

development of safe and effective 

biosimilar products for the American 

public. 

FDA maintains information on our 

website at https://www.fda.gov/ 

industry/fda-user-fee-programs/ 

biosimilar-user-fee-amendments 

regarding its BsUFA program. Also 

available on our website is the 

Biosimilars Action Plan (BAP), which 

discusses key actions the Agency is 

taking to encourage innovation and 

competition among biologics and the 

development of biosimilars. The BAP 

builds on progress in implementing the 

approval pathway for biosimilar and 

interchangeable products, and provides 

interested persons with updates on 

related deliverables and activities. 

We have revised the information 

collection to reflect the currently 

agreed-upon performance goals 

established and captured in the latest 

reauthorization document entitled, 

‘‘Biosimilar Biological Product 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2023 Through 

2027’’ (BsUFA Commitment Letter). The 

BsUFA Commitment Letter is available 

for download from our website at 

https://www.fda.gov/media/152279/ 

download?attachment. The BsUFA 

Commitment Letter outlines current 

program goals, including information 

technology goals, discusses program 

effectiveness considerations, and 

discusses user fee resource 

management. 

The information collection also 

includes Form FDA 3792, ‘‘Biosimilars 

User Fee Cover Sheet,’’ to be submitted 

by each new biological product 

development (BPD) entrant (identified 

via a new meeting request or 

investigational new drug submission) or 

new biologics license application (BLA) 

applicant. Form FDA 3792 requests the 

minimum information necessary to 

identify the request, to determine the 

amount of the fee to be assessed, and to 

account for and track user fees. Form 

FDA 3792 is completed electronically at 

https://userfees.fda.gov/OA_HTML/ 

bsufaCAcdLogin.jsp, and a notification 

is emailed to the respondent that 

includes information regarding annual 

program fees. We are discontinuing use 

of the associated annual survey at this 

time. 

Relatedly, Form FDA 3971 (Small 

Business Waiver and Refund Request), 

currently approved in OMB control 

number 0910–0297, may also be 

utilized. As instructed on our BsUFA 

web page, respondents should submit 

Form FDA 3971 by email to 

CDERCollections@fda.hhs.gov at least 4 

months prior to the submission of the 

application to see if they qualify for a 

small business waiver. Finally, user fee 

refund and transfer requests, currently 

approved in OMB control number 0910– 


khammond on DSK9W7S144PROD with NOTICES
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). 


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