Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications

Forms and Documents

Document	Type	Status	Availability
0750 3rd Party IT System Screen Shots.doc	Supplementary Document	Uploaded 2017-03-01	Available
0750 Non Sub Request for IT 2017.pdf	Justification for No Material/Nonsubstantive Change	Uploaded 2017-03-01	Available
0750 Accreditation of 3rd Part Cert Supporting Statement for FR.pdf	Supporting Statement A	Uploaded 2016-05-13	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
208274	ANNUAL reporting ABs and CBs		Unchanged
208273	ONE TIME reporting ABs and CBs		Unchanged
208272	ANNUAL recordkeeping certfication bodies (CBs)		Unchanged
208271	ANNUAL recordkeeping accreditation bodies (ABs)		Unchanged
208270	ONE TIME recordkeeping for certification bodies (CBs)		Unchanged
208269	ONE TIME recordkeeping for accreditation bodies (ABs)		Unchanged

ICR Details

OMB Control No: 0910-0750	ICR Reference No: 201703-0910-001
Status: Historical Active	Previous ICR Reference No: 201605-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/02/2017
	Date Received in OIRA: 03/01/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	06/30/2019	06/30/2019
Responses	72,977	0	72,977
Time Burden (Hours)	74,822	0	74,822
Cost Burden (Dollars)	11,585,345	0	11,585,345

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Abstract: This ICR collects information from recognized accreditation bodies and accredited auditors/certification bodies regarding food and feed products of eligible entities that offer their food or feed for import to the United States. Eligible entities will participate in FDA Third Party program to obtain food safety audits and certifications from third party auditors/certification bodies on an annual basis for the purpose of verifying that the food is produced in compliance with applicable regulations.

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Authorizing Statute(s): US Code: 21 USC 384d Name of Law: FFDCA
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 353 307 Name of Law: Food Safety Modernization Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG66	Final or interim final rulemaking	80 FR 74570	11/27/2015

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 45781	07/29/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 74570	11/27/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
ANNUAL reporting ABs and CBs
ONE TIME recordkeeping for accreditation bodies (ABs)
ONE TIME recordkeeping for certification bodies (CBs)
ANNUAL recordkeeping certfication bodies (CBs)
ONE TIME reporting ABs and CBs
ANNUAL recordkeeping accreditation bodies (ABs)

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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	72,977	72,977	0	0	0	0
Annual Time Burden (Hours)	74,822	74,822	0	0	0	0
Annual Cost Burden (Dollars)	11,585,345	11,585,345	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: This is a new information collection associated with rulemaking.

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Annual Cost to Federal Government: $17,000,000

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: 03/01/2017

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