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

ICR 202107-0910-001

OMB: 0910-0751

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2021-07-01
Supporting Statement A
2018-08-31
ICR Details
0910-0751 202107-0910-001
Received in OIRA 201808-0910-015
HHS/FDA CFSAN
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food
No material or nonsubstantive change to a currently approved collection   No
Regular 07/01/2021
  Requested Previously Approved
10/31/2021 10/31/2021
8,333,247 8,314,120
6,265,274 6,255,710
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

  83 FR 25466 06/01/2018
83 FR 46500 09/13/2018
Yes

  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 8,333,247 8,314,120 0 0 19,127 0
Annual Time Burden (Hours) 6,265,274 6,255,710 0 0 9,564 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    No
    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.
07/01/2021


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