Export Notification and Recordkeeping Requirements

ICR 202507-0910-003

OMB: 0910-0482

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2025-07-30
ICR Details
0910-0482 202507-0910-003
Received in OIRA 202201-0910-009
HHS/FDA CROSS CENTER
Export Notification and Recordkeeping Requirements
Reinstatement with change of a previously approved collection   No
Regular 07/30/2025
  Requested Previously Approved
36 Months From Approved
2,690 0
55,498 0
0 0

The information collection supports FDA regulations at 21 CFR 1.101 and pertains to the notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports under sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or section 351 of the Public Health Service Act (42 U.S.C. 262).

US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 21 USC 301, et. seq. Name of Law: FFDCA
  
None

Not associated with rulemaking

  90 FR 18691 07/29/2025
90 FR 35697 07/29/2025
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 2,690 0 0 0 2,690 0
Annual Time Burden (Hours) 55,498 0 0 0 55,498 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Based on a review of Agency data, our estimated burden for the information collection reflects an overall increase of 10,419 hours and a corresponding increase of 2,690 responses. In the previous extension request FDA included burden for the Center for Food Safety and Applied Nutrition (now known as Human Foods Program (HFP)). However, upon reevaluation of these burden estimates, we have determined that the burden associated with HFP is already accounted for under OMB Control Number 0910-0793.

$310,856
No
    No
    No
No
No
No
No
Amber Sanford 301 796-8867 [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.
07/30/2025


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