Prescription Drug User Fee Program

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 4068 Waiver, Refund, and Exemption Request	Form	New	Available
Form FDA 3971 Small Business Waiver and Refund Request	Form and Instruction	Modified	Available
0297 PDUFA SSA 2022 Rev.docx	Supporting Statement A	Uploaded 2022-02-23	Repair queued
0297 PDUFA Non sub to include refund waiver reduction requests AUG 2020.pdf	Justification for No Material/Nonsubstantive Change	Uploaded 2020-08-01	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5861	Prescription Drug User Fee Cover Sheet	Other-E-form Screenshot	Modified
251678	Appeal requests	Other-Authority to Assess and Use Drug Fees	New
251677	Reconsideration requests	Other-Authority to Assess and Use Drug Fees	New
251676	Other waivers, reductions, refunds, exemptions under secs. 735 & 736	Form	New	Waiver, Refund, and Exemption Request
251676	Other waivers, reductions, refunds, exemptions under secs. 735 & 736	Other-Statutory Authority	New
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: 202202-0910-010
Status: Historical Active	Previous ICR Reference No: 202008-0910-002
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 without change	Conclusion Date: 03/28/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/23/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2025	36 Months From Approved	03/31/2022
Responses	411	0	445
Time Burden (Hours)	3,626	0	2,761
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports implementation of the Food and Drug Administration (FDA, us or we) Prescription Drug User Fee program. Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, we have the authority to assess and collect user fees for certain new drug applications (NDAs) and new biologics license applications (BLAs)

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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:
	86 FR 67958	11/30/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 7186	02/08/2022
Did the Agency receive public comments on this ICR? No

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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	FDA 4068	Waiver, Refund, and Exemption Request
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	411	445	0	0	-34	0
Annual Time Burden (Hours)	3,626	2,761	0	0	865	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: Cumulative changes and adjustments result in a decrease of 34 responses and an increase in 865 hours annually. We believe this reflects expected fluctuations in the information collection.

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Annual Cost to Federal Government: $0

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: 02/23/2022

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