Applications for FDA Approval to Market a New Drug

ICR 202104-0910-004

OMB: 0910-0001

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Form
Unchanged
Justification for No Material/Nonsubstantive Change
2021-04-05
Supporting Statement A
2021-02-26
ICR Details
0910-0001 202104-0910-004
Received in OIRA 202003-0910-010
HHS/FDA CDER
Applications for FDA Approval to Market a New Drug
No material or nonsubstantive change to a currently approved collection   No
Regular 04/05/2021
  Requested Previously Approved
03/31/2024 03/31/2024
145,969 145,969
4,202,464 4,202,464
0 0

This information collection supports Food and Drug Administration regulations governing applications for FDA approval to market a new drug. Respondents to the collection are individuals or entities submitting such applications to the agency in accordance with applicable statutory and regulatory provisions, and commitments established with industry in accordance with user fee performance goals.

PL: Pub.L. 115 - 52 Titles I-IX Name of Law: FDA Reauthorization Act of 2017
   US Code: 21 USC 355 Name of Law: Federal Food, Drug, and Cosmetic Act; New Drugs
  
None

Not associated with rulemaking

  85 FR 73057 11/16/2020
86 FR 9510 02/16/2021
No

  Total Request 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 145,969 145,969 0 0 0 0
Annual Time Burden (Hours) 4,202,464 4,202,464 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$146,125,000
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [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.
04/05/2021


© 2021 OMB.report | Privacy Policy