Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77531 

to reflect a resulting increase of 114 

hours and 94 responses annually. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21676 Filed 9–20–24; 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; Proposed Collection; 

Comment Request; Biosimilars User 

Fee Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with the Agency’s 

Biosimilars User Fee Program. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

November 22, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 22, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–4146 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Biosimilars User Fee Program.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

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: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed revision of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 


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77532 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

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 FDA’s 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 (IND) 

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– 

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 

(42 U.S.C. 242(l)) 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 CDER 2023 and 

2024 Annual Guidance agenda, 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) 


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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77533 

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. 

FDA estimate the burden of this 

collection of information 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, we 

regard the majority of adjustments as 

nominal fluctuations consistent with the 

number of applications and submissions 

we are receiving. 

Dated: September 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21671 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Adult Lifespan Psychopathology 

Study Section. 

Date: October 17–18, 2024. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Benjamin G. Shapero, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3182, 

MSC 7848, Bethesda, MD 20892, (301) 402– 

4786, shaperobg@mail.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group; Gene 

Regulation in Cancer Study Section. 

Date: October 21–22, 2024. 

Time: 9:30 a.m. to 7:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Manzoor A. Zarger, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6208, 

MSC 7804, Bethesda, MD 20892, (301) 435– 

2477, zargerma@csr.nih.gov. 

Name of Committee: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Biobehavioral Regulation, Learning 

and Ethology Study Section. 

Date: October 21–22, 2024. 

Time: 9:30 a.m. to 7:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Sara Louise Hargrave, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 3170, 

Bethesda, MD 20892, (301) 443–7193, 

hargravesl@mail.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group; Basic 

Cancer Immunobiology Study Section. 

Date: October 22–23, 2024. 

Time: 8:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Meeting Format: In Person. 

Contact Person: Sarita Kandula Sastry, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20782, 301–402–4788, sarita.sastry@nih.gov. 

Name of Committee: Applied Therapeutics 

for Cancer Integrated Review Group; 

Mechanisms of Cancer Therapeutics C Study 

Section. 

Date: October 22–23, 2024. 

Time: 8:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Darcy Hotel, 1515 Rhode Island 

Ave, NW, Washington, DC 20005. 

Meeting Format: In Person. 

Contact Person: Gloria Huei-Ting Su, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, 301–496–0465, gloria.su@nih.gov. 

Name of Committee: Musculoskeletal, Oral 

and Skin Sciences Integrated Review Group; 

Skeletal Muscle and Exercise Physiology 

Study Section. 

Date: October 22–23, 2024. 

Time: 8:00 a.m. to 10:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Meeting Format: In Person. 

Contact Person: Carmen Bertoni, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 805B, 


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