Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food and Food for Animals

ICR 202410-0910-013

OMB: 0910-0751

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2024-10-29
ICR Details
0910-0751 202410-0910-013
Received in OIRA 202108-0910-008
HHS/FDA HFP
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food and Food for Animals
Extension without change of a currently approved collection   No
Regular 10/29/2024
  Requested Previously Approved
36 Months From Approved 11/30/2024
20,151,907 20,175,345
7,441,861 7,456,374
0 0

This information collection supports FDA regulations requiring the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility; as well as identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Respondents to the information collection are owners, operators, or agents-in-charge of food facilities required to register under section 415 of the FD&C Act.

PL: Pub.L. 111 - 353 103 Name of Law: Food Safety Modernization Act
  
None

Not associated with rulemaking

  89 FR 48172 06/05/2024
89 FR 84895 10/24/2024
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 20,151,907 20,175,345 0 0 -23,438 0
Annual Time Burden (Hours) 7,441,861 7,456,374 0 0 -14,513 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects adjustment. First, with regard to human foods, we removed the individual element “Reporting: qualified facilities,” as the attendant burden is captured in the line item “Quality Facility Attestation.” For animal foods, we combined two individual IC elements for §§ 507.7(e)(1) and 507.7(e)(2) into one line item for 507.7(e), further decreasing the overall burden by 5,174 hours and 4,334 responses annually. We attribute the latter adjustment to animal food respondents complying with manufacturing address disclosures. We also corrected some inadvertent rounding and calculation errors. Cumulatively the adjustments result in a decrease of 23,438 responses and 14,513 hours annually to our estimate.

$50,000
No
    No
    No
No
No
No
No
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.
10/29/2024


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