Prescription Drug User Fee Cover Sheet; Form FDA 3397

ICR 201211-0910-001

OMB: 0910-0297

Federal Form Document

Forms and Documents
IC Document Collections
ICR Details
0910-0297 201211-0910-001
Historical Active 200911-0910-003
HHS/FDA
Prescription Drug User Fee Cover Sheet; Form FDA 3397
Extension without change of a currently approved collection   No
Regular
Approved without change 12/27/2012
Retrieve Notice of Action (NOA) 11/06/2012
  Inventory as of this Action Requested Previously Approved
12/31/2015 36 Months From Approved 01/31/2013
4,131 0 3,917
2,066 0 1,959
0 0 0

Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and collect user fees for certain drug and biologics license applications and supplements. The Prescription Drug User Fee Cover Sheet, Form FDA 3397, is required to be included with each applicable new drug application (NDA), biologics license application (BLA), and supplemental application to an NDA or BLA submitted to FDA for review. The Prescription Drug User Fee Cover Sheet is designed to provide the minimum necessary information to determine whether a fee is required for the review of an application, to determine the amount of the fee required, and to account for and track user fees. The information collected is used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of new drug applications, biologics license applications and/or supplemental applications to those applications.

US Code: 21 USC 379 Name of Law: Federal Food Drug and Cosmetic Act
  
None

Not associated with rulemaking

  77 FR 29663 05/18/2012
77 FR 64523 10/22/2012
No

1
IC Title Form No. Form Name
Prescription Drug User Fee Cover Sheet; Form FDA 3397 3397 Prescription 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 4,131 3,917 0 0 214 0
Annual Time Burden (Hours) 2,066 1,959 0 0 107 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$198,288
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.
11/06/2012


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