Generic Drug User Fee Program

Forms and Documents

Document Name	Status
0727 GDUFA to add CC burden OCT 2023.docx Justification for No Material/Nonsubstantive Change	2023-10-24
0727 GDUFA Program SSA 2022 Ext.docx Supporting Statement A	2022-02-22

IC Document Collections

IC ID	Document Title	Status
262988	Submission of Controlled Correspondence Other-Agency Guidance	New
204809	Generic Drug User Fees Other-E-form Screenshot	Modified

ICR Details

OMB Control No: 0910-0727	ICR Reference No: 202310-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202202-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Generic Drug User Fee Program
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/24/2023

	Requested	Previously Approved
Expiration Date	03/31/2025	03/31/2025
Responses	8,808	3,808
Time Burden (Hours)	26,904	1,904
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports FDA's User Fee program with regard to Generic Drugs. Form FDA 3794, the Generic Drug User Fee Cover Sheet, requests the minimum information necessary from applicants to enable us to determine the total amount of generic drug user fees required, and to account for and track user fees. Generic drug application holders and API and/or FDF facility’s owner will fill out the cover sheet to accompany payment. Although applicants and manufacturers may choose among several methods of payments, all applicants must create and/or submit all GDUFA Cover Sheets by using the FDA’s web-based electronic User Fee System.

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Authorizing Statute(s): PL: Pub.L. 112 - 144 Title III; Generic Drug Fees Name of Law: FDA Safety and Innovation Act of 2012
   US Code: 21 USC 301 et seq. 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 64945	11/19/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 7473	02/09/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Generic Drug User Fees	FDA 3794	GDUFA Cover Sheet (e-form screenshot)
Submission of Controlled Correspondence

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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	8,808	3,808	0	0	5,000	0
Annual Time Burden (Hours)	26,904	1,904	0	0	25,000	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:

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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: 10/24/2023

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