Generic Drug User Fee Program

ICR 201902-0910-002

OMB: 0910-0727

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-02-26
Justification for No Material/Nonsubstantive Change
2017-08-08
IC Document Collections
IC ID
Document
Title
Status
204809 Modified
ICR Details
0910-0727 201902-0910-002
Active 201708-0910-003
HHS/FDA CDER
Generic Drug User Fee Program
Extension without change of a currently approved collection   No
Regular
Approved without change 03/21/2019
Retrieve Notice of Action (NOA) 02/27/2019
  Inventory as of this Action Requested Previously Approved
03/31/2022 36 Months From Approved 03/31/2019
3,808 0 3,542
1,904 0 1,771
0 0 0

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.

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
  
None

Not associated with rulemaking

  83 FR 48430 09/25/2018
84 FR 2532 02/07/2019
Yes

1
IC Title Form No. Form Name
Generic Drug User Fee Program

  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
No
No
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.

$87,584
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
02/27/2019


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