Generic Drug User Fee Program

Forms and Documents

Document Name	Status
0727 Generic Drug User Fee Program SS Ext 2019.pdf Supporting Statement A	2019-02-26
User fee cover sheet change request 2017.pdf Justification for No Material/Nonsubstantive Change	2017-08-08

IC Document Collections

IC ID	Document Title	Status
204809	Generic Drug User Fee Program Other-E-form Screenshot	Modified

ICR Details

OMB Control No: 0910-0727	ICR Reference No: 201902-0910-002
Status: Active	Previous ICR Reference No: 201708-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Generic Drug User Fee Program
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/21/2019
	Date Received in OIRA: 02/27/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	36 Months From Approved	03/31/2019
Responses	3,808	0	3,542
Time Burden (Hours)	1,904	0	1,771
Cost Burden (Dollars)	0	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): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
   PL: Pub.L. 112 - 144 Title III; Generic Drug Fees Name of Law: FDA Safety and Innovation Act of 2012
  

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:
	83 FR 48430	09/25/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 2532	02/07/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Generic Drug User Fee Program

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ICR Summary 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	3,808	3,542	0	0	266	0
Annual Time Burden (Hours)	1,904	1,771	0	0	133	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: The information collection reflects adjustments. Specifically, we have increased our estimate by 266 responses and 133 hours, consistent with an increase in submissions over the past three years.

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Annual Cost to Federal Government: $87,584

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? Uncollected

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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: 02/27/2019

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