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

ICR 202108-0910-008

OMB: 0910-0751

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0751 202108-0910-008
Received in OIRA 202107-0910-001
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food and Food for Animals
Revision of a currently approved collection   No
Regular 09/30/2021
  Requested Previously Approved
36 Months From Approved 10/31/2021
20,175,345 8,333,247
7,456,374 6,265,274
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

Not associated with rulemaking

  86 FR 14436 03/16/2021
86 FR 49543 09/03/2021

  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 20,175,345 8,333,247 0 0 11,842,098 0
Annual Time Burden (Hours) 7,456,374 6,265,274 0 0 1,191,100 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
The information collection reflects changes and adjustments. We have revised the information collection to include related activities associated with food for animals, currently approved under 0910-0789. This results in an increase to the collection by 11,842,098 responses and 1,191,100 burden hours annually.

Domini Bean 301 796-5733 [email protected]


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.

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