Prescription Drug User Fee Program

ICR 201902-0910-014

OMB: 0910-0297

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-02-28
IC Document Collections
ICR Details
0910-0297 201902-0910-014
Historical Active 201708-0910-004
HHS/FDA CBER
Prescription 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) 02/28/2019
  Inventory as of this Action Requested Previously Approved
03/31/2022 36 Months From Approved 03/31/2019
262 0 3,709
131 0 1,855
0 0 0

This information collection supports implementation of the Food and Drug Administration (FDA, us or we) Prescription Drug User Fee program. 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, we have the authority to assess and collect user fees for certain new drug applications (NDAs) and new biologics license applications (BLAs)

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

Not associated with rulemaking

  83 FR 42900 08/24/2018
84 FR 2235 02/06/2019
No

1
IC Title Form No. Form Name
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 262 3,709 0 0 -3,447 0
Annual Time Burden (Hours) 131 1,855 0 0 -1,724 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects adjustments. We have decreased the burden estimate by 1,724 hours and 3,447 responses to reflect a decrease in submissions. This is discussed more fully in our supporting statement at Question 15.

$14,934
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.
02/28/2019


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