Generic Drug User Fee Cover Sheet - Form FDA 3794

Forms and Documents

Document Name	Status
Form FDA 3794 Generic Drug User Fee Cover Sheet - Form FDA 3794 Form and Instruction	Unchanged
User fee cover sheet change request 2017.pdf Justification for No Material/Nonsubstantive Change	2017-08-08
SUPPORTING STATEMENT 0727 10-19-2015.doc Supporting Statement A	2015-10-19

IC Document Collections

IC ID	Document Title	Status
204809	Generic Drug User Fee Cover Sheet - Form FDA 3794 Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0727	ICR Reference No: 201708-0910-003
Status: Historical Active	Previous ICR Reference No: 201510-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Generic Drug User Fee Cover Sheet - Form FDA 3794
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/11/2017
	Date Received in OIRA: 08/08/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	02/28/2019	02/28/2019
Responses	3,542	0	3,542
Time Burden (Hours)	1,771	0	1,771
Cost Burden (Dollars)	0	0	0

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Abstract: Form FDA 3794, the Generic Drug User Fee Amendments Cover Sheet, requests the minimum necessary information from applicants 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 379f, 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:
	80 FR 31388	06/02/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 60394	10/06/2015
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Generic Drug User Fee Cover Sheet - Form FDA 3794	FDA 3794	Generic Drug User Fee Cover Sheet

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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	3,542	3,542	0	0	0	0
Annual Time Burden (Hours)	1,771	1,771	0	0	0	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 currently approved burden for the form is 1,925 hours. We are adjusting this total to 1,772 hours based on actual receipts during the past 3 years. The one time burden for backlog fees 1,350 hours has also been eliminated for this extension request

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Annual Cost to Federal Government: $88,550

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: 08/08/2017

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