Applications for FDA Approval to Market a New Drug

ICR 202002-0910-006

OMB: 0910-0001

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supplementary Document
2020-02-19
Justification for No Material/Nonsubstantive Change
2020-02-19
Supporting Statement A
2017-12-27
IC Document Collections
ICR Details
0910-0001 202002-0910-006
Active 201907-0910-022
HHS/FDA CDER
Applications for FDA Approval to Market a New Drug
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved with change 02/24/2020
Retrieve Notice of Action (NOA) 02/20/2020
  Inventory as of this Action Requested Previously Approved
03/31/2021 03/31/2021 03/31/2021
95,327 0 95,327
4,637,036 0 4,637,036
0 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 the provisions found in the Code of Federal Regulations (CFR), Title 21, Part 314.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  82 FR 24351 05/26/2017
82 FR 58403 12/12/2017
No

  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 95,327 95,327 0 0 0 0
Annual Time Burden (Hours) 4,637,036 4,637,036 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
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.
02/20/2020


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