Reporting and Recordkeeping Requirements for Reportable Food

ICR 202303-0910-024

OMB: 0910-0643

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2023-10-25
ICR Details
0910-0643 202303-0910-024
Received in OIRA 202009-0910-004
HHS/FDA CFSAN
Reporting and Recordkeeping Requirements for Reportable Food
Extension without change of a currently approved collection   No
Regular 10/25/2023
  Requested Previously Approved
36 Months From Approved 10/31/2023
2,404 2,404
3,181 3,181
0 0

This information collection supports implementation of section 417 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350f) to establish a reportable food registry regarding the safe manufacturing, processing, packing, or holding of food for consumption in the United States.

US Code: 21 USC 350f Name of Law: FFDCA; Reportable Food Registry
  
None

Not associated with rulemaking

  88 FR 32775 05/22/2023
88 FR 72486 10/20/2023
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 2,404 2,404 0 0 0 0
Annual Time Burden (Hours) 3,181 3,181 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$313,271
No
    No
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@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.
10/25/2023


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