Applications for FDA Approval to Market a New Drug

ICR 202001-0910-012

OMB: 0910-0001

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2020-01-24
Supporting Statement A
2017-12-27
IC Document Collections
ICR Details
0910-0001 202001-0910-012
Historical Inactive 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
Improperly submitted and continue 01/29/2020
Retrieve Notice of Action (NOA) 01/27/2020
Creation of a new form will need to be submitted as a revision request allowing for the standard public notice and comment periods.
  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

No
No
The estimated burden for the information collection reflects an increase of 1,212,941 annual hours and 7,429 annual responses. Also, we have revised the IC list appearing at omb.report by consolidating the 17 previously itemized regulatory provisions into 4 elements. This is discussed more fully in our SS at Q15.

$146,125,000
No
    No
    No
No
No
No
Uncollected
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.
01/27/2020


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