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

Forms and Documents

Document Name	Status
0751 SS for PCHF and Food and Animals 2021 REV.docx Supporting Statement A	2021-09-29

IC Document Collections

IC ID	Document Title	Status
249598	Disclosures: Food for Animals	New
249597	Recordkeeping: Food for Animals	New
248149	Quality Facility Attestation; Forms FDA 3942a and 3942b Other-Agency Guidance	Unchanged
218208	Third Party Disclosure: food manufacturing facility address	Unchanged
218207	Reporting: qualified facilities	Unchanged
218206	Recordkeeping: supplier records	Unchanged
218205	Recordkeeping: validation records	Unchanged
205635	Recordkeeping: assurance records	Unchanged
205634	Recordkeeping: Training for preventive controls qualified individual	Unchanged
205633	Recordkeeping: Verification Records	Unchanged
205632	Recordkeeping: Corrective Actions Records	Unchanged
205631	Recordkeeping: Monitoring Records	Unchanged
205630	Recordkeeping: Food Safety Plan	Unchanged

ICR Details

OMB Control No: 0910-0751	ICR Reference No: 202108-0910-008
Status: Received in OIRA	Previous ICR Reference No: 202107-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food and Food for Animals
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/30/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2021
Responses	20,175,345	8,333,247
Time Burden (Hours)	7,456,374	6,265,274
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 103 Name of Law: Food Safety Modernization Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 14436	03/16/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 49543	09/03/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Disclosures: Food for Animals
Quality Facility Attestation; Forms FDA 3942a and 3942b
Recordkeeping: Corrective Actions Records
Recordkeeping: Food Safety Plan
Recordkeeping: Food for Animals
Recordkeeping: Monitoring Records
Recordkeeping: Training for preventive controls qualified individual
Recordkeeping: Verification Records
Recordkeeping: assurance records
Recordkeeping: supplier records
Recordkeeping: validation records
Reporting: qualified facilities
Third Party Disclosure: food manufacturing facility address

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 09/30/2021

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