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

Forms and Documents

Document Name	Status
0751 SS for PC for human food final rule.pdf Supporting Statement A	2015-09-17
PCHF Final RIA.docx Supplementary Document	2015-09-16

IC Document Collections

IC ID	Document Title	Status
218208	Third Party Disclosure: food manufacturing facility address	New
218207	Reporting: qualified facilities	New
218206	Recordkeeping: supplier records	New
218205	Recordkeeping: validation records	New
205635	Recordkeeping: assurance records	Modified
205634	Recordkeeping: Training for preventive controls qualified individual	Modified
205633	Recordkeeping: Verification Records	Modified
205632	Recordkeeping: Corrective Actions Records	Modified
205631	Recordkeeping: Monitoring Records	Modified
205630	Recordkeeping: Food Safety Plan	Modified

ICR Details

OMB Control No: 0910-0751	ICR Reference No: 201509-0910-003
Status: Historical Active	Previous ICR Reference No: 201301-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/26/2015
	Date Received in OIRA: 09/17/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2018	36 Months From Approved
Responses	8,314,120	0	0
Time Burden (Hours)	6,255,710	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This rulemaking requires 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, 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:
0910-AG36	Final or interim final rulemaking	80 FR 55907	09/17/2015

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Recordkeeping: validation records
Recordkeeping: supplier records
Reporting: qualified facilities
Third Party Disclosure: food manufacturing facility address
Recordkeeping: Food Safety Plan
Recordkeeping: Monitoring Records
Recordkeeping: Corrective Actions Records
Recordkeeping: Verification Records
Recordkeeping: Training for preventive controls qualified individual
Recordkeeping: assurance records

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ICR Summary of Burden

	Total Approved	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	8,314,120	0	0	8,314,120	0	0
Annual Time Burden (Hours)	6,255,710	0	0	6,255,710	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new information collection request in support of agency rulemaking.

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Annual Cost to Federal Government: $0

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 09/17/2015

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