Prescription Drug User Fee Cover Sheet; Form FDA 3397

ICR 201510-0910-011

OMB: 0910-0297

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2015-10-23
IC Document Collections
ICR Details
0910-0297 201510-0910-011
Historical Active 201211-0910-001
HHS/FDA CBER
Prescription Drug User Fee Cover Sheet; Form FDA 3397
Extension without change of a currently approved collection   No
Regular
Approved without change 03/03/2016
Retrieve Notice of Action (NOA) 10/27/2015
  Inventory as of this Action Requested Previously Approved
03/31/2019 36 Months From Approved 03/31/2016
3,709 0 4,131
1,855 0 2,066
0 0 0

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 for FDA 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 form provides a cross-reference of the fee submitted for an application or supplement utilizing a unique number tracking system. It also identifies pertinent statutory provisions under which the application may qualify for a fee exemption. 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 NDAs, BLAs 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

  80 FR 20232 04/15/2015
80 FR 63227 10/19/2015
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 3,709 4,131 0 0 -422 0
Annual Time Burden (Hours) 1,855 2,066 0 0 -211 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The previous burden estimate was 2,066 hours. The current decrease in burden to 1,855 hours (-211 hours) is mostly attributed to the decrease in the number of certain supplements (mostly manufacturing supplements submitted to CDER) submitted to FDA under total annual responses. The overall decrease is due to the normal variation in the submission of applications and supplements to FDA.

$200,340
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
10/27/2015


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