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	New
SUPPORTING STATEMENT FOR GDUFA 11-8-12.doc Supporting Statement A	2012-11-08

IC Document Collections

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

ICR Details

OMB Control No: 0910-0727	ICR Reference No: 201211-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Generic Drug User Fee Cover Sheet - Form FDA 3794
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/27/2012
	Date Received in OIRA: 11/09/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2015	36 Months From Approved
Responses	3,850	0	0
Time Burden (Hours)	1,925	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Proposed 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. The information collected would be used by the FDA's Center for Drug Evaluation and Research to initiate the administrative screening of generic drug submissions and drug master files, support the inspection of generic drug facilities, and otherwise support the generic drug program.

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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:
	77 FR 43844	07/26/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 66620	11/06/2012
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	3,850	0	0	0	3,850	0
Annual Time Burden (Hours)	1,925	0	0	0	1,925	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: $88,550

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 11/09/2012

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