Biosimilar User Fee Program

Forms and Documents

Document Name	Status
Form Form FDA 3792 Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual Survey Form and Instruction	Modified
0718BiosimilarUserFeeProgramSSA2025REV.docx Supporting Statement A	2025-01-30

IC Document Collections

IC ID	Document Title	Status
270421	Pediatric Study Plan Other-Agency Guidance	New
250904	Formal Meeting Requests; Meeting Packages Other-Agency Guidance	Modified
250903	Applications and infringement notifications Other-Agency Performance Goals	Modified
250902	Requests for discontinuation from BPD program and /or to move products to discontinued section. Other-Agency Guidance	Modified
202806	Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual Survey Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0718	ICR Reference No: 202408-0910-008
Status: Received in OIRA	Previous ICR Reference No: 202112-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Biosimilar User Fee Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/31/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2025
Responses	419	314
Time Burden (Hours)	26,055	12,986
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports the Food and Drug Administration’s (FDA, us or we) Biosimilars User Fee Program. Respondents to the collection are applicants or sponsors of biosimilar product marketing applications subject to statutory and regulatory requirements administered by FDA.

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Authorizing Statute(s): US Code: 42 USC 262(k) Name of Law: Public Health Service Act; Biologics Price Competition and Innovation Act
   US Code: 21 USC 379g Name of Law: 351(k) Applications
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 77531	09/23/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 8753	01/31/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Applications and infringement notifications
Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual Survey	Form FDA 3792	Biosimilar User Fee Cover Sheet
Formal Meeting Requests; Meeting Packages
Pediatric Study Plan
Requests for discontinuation from BPD program and /or to move products to discontinued section.

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	419	314	0	105	0	0
Annual Time Burden (Hours)	26,055	12,986	0	13,069	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The information collection reflects an increase of 13,069 hours and 105 responses annually. Although part of the increase accounts for burden associated with respondents including the submission of pediatric study plan information, the majority of adjustments correspond with an increase in submissions we are receiving under BsUFA.

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Annual Cost to Federal Government: $1,378,703

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/31/2025

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