Generic Drug User Fee Cover Sheet - Form FDA 3794

ICR 201708-0910-003

OMB: 0910-0727

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Unchanged
Justification for No Material/Nonsubstantive Change
2017-08-08
Supporting Statement A
2015-10-19
IC Document Collections
ICR Details
0910-0727 201708-0910-003
Historical Active 201510-0910-003
HHS/FDA CDER
Generic Drug User Fee Cover Sheet - Form FDA 3794
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/11/2017
Retrieve Notice of Action (NOA) 08/08/2017
  Inventory as of this Action Requested Previously Approved
02/28/2019 02/28/2019 02/28/2019
3,542 0 3,542
1,771 0 1,771
0 0 0

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.

US Code: 21 USC 379f, et. seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  80 FR 31388 06/02/2015
80 FR 60394 10/06/2015
No

1
IC Title Form No. Form Name
Generic Drug User Fee Cover Sheet - Form FDA 3794 FDA 3794 Generic Drug User Fee Cover Sheet

  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
No
No
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

$88,550
No
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/08/2017


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