Prescription Drug User Fee Program

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form Form FDA 3397 Prescription Drug User Fee Cover Sheet	Form	Modified	Repair queued
Form FDA 3971 Small Business Waiver and Refund Request	Form and Instruction	Modified	Repair queued
0297PDUFA SSA2025 1-29-25.docx	Supporting Statement A	Uploaded 2025-02-10	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5861	Prescription Drug User Fee Cover Sheet	Form	Modified	Prescription Drug User Fee Cover Sheet
5861	Prescription Drug User Fee Cover Sheet	Other-E-form Screenshot	Modified
251678	Appeal requests	Other-Authority to Assess and Use Drug Fees	Modified
251677	Reconsideration requests	Other-Authority to Assess and Use Drug Fees	Modified
251676	Other waivers, reductions, refunds, exemptions under secs. 735 & 736	Other-Statutory Authority	Modified
242948	Small business waiver requests	Form and Instruction	Modified	Small Business Waiver and Refund Request
242948	Small business waiver requests	Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0297	ICR Reference No: 202407-0910-006
Status: Active	Previous ICR Reference No: 202202-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug User Fee Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/14/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/18/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2029	36 Months From Approved	01/31/2026
Responses	408	0	411
Time Burden (Hours)	3,829	0	3,626
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from certain drug and biologic manufacturers who are subject to Prescription Drug User fees. These fees are related to the submission of certain new drug and biologics license applications as well as for certain approved annual program fees. In addition, the ICR collects information relating to the submission of requests for waivers, exemptions, reductions, or for refunds of these user fees. Manufacturers submit information in accordance with established statutory authorities. Form FDA 3397, Prescription Drug User Fee Cover Sheet, and Form FDA 3971, Small Business Waivers and Refund Requests, were developed to assist respondents with submission of required information.

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Authorizing Statute(s): US Code: 21 USC 379 Name of Law: Federal Food Drug and Cosmetic Act
  

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 90705	11/18/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 18673	05/01/2025
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Appeal requests
Other waivers, reductions, refunds, exemptions under secs. 735 & 736
Prescription Drug User Fee Cover Sheet	Form FDA 3397	Prescription Drug User Fee Cover Sheet
Reconsideration requests
Small business waiver requests	FDA 3971	Small Business Waiver and Refund Request

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	408	411	0	0	-3	0
Annual Time Burden (Hours)	3,829	3,626	0	0	203	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: There is decrease of 3 responses and an increase of 203 burden hours annually. Because we are including the recently reauthorized PDUFA commitment goals letter, we have characterized our submission as a revision.

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Annual Cost to Federal Government: $4,707,766

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: 06/18/2025

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