Investigational New Drug Applications: Annual Reporting

ICR 202311-0910-007

OMB: 0910-0924

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2023-11-06
Supplementary Document
2023-11-06
ICR Details
202311-0910-007
Received in OIRA
HHS/FDA CDER
Investigational New Drug Applications: Annual Reporting
New collection (Request for a new OMB Control Number)   No
Regular 11/07/2023
  Requested Previously Approved
36 Months From Approved
11,592 0
4,590,432 0
0 0

This information collection supports implementation of FDA rulemaking to revise required elements for annual reporting under 21 CFR 312.33.

US Code: 21 USC 321 et seq. Name of Law: Federal Food Drug & Cosmetic Act
  
None

0910-AI37 Proposed rulemaking 87 FR 75551 12/09/2022

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 11,592 0 0 0 11,592 0
Annual Time Burden (Hours) 4,590,432 0 0 0 4,590,432 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The proposed rulemaking would add 11,592 responses and 4,595,190 hours annually to FDA’s active information collection inventory.

$1,000,000
No
    Yes
    No
No
No
No
No
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.
11/07/2023


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