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

Forms and Documents

Document Name	Status
0750 Accreditation of 3rd Part Cert Supporting Statement for FR.pdf Supporting Statement A	2016-05-13

IC Document Collections

IC ID	Document Title	Status
208299	CB submission of regulatory audit report to FDA	Removed
208298	Unaccredited CBs--additional reporting burden	Removed
208297	CB reporting conditions that could contribute to seroius risk to public health to ABs	Removed
208296	CB reporting conditions that could contribute to serious risk to public health to its eligible entities clients	Removed
208295	CB reporting conditions to FDA that could contribute to serious risk to public health	Removed
208294	Directly accredited CB submission of self assessment to FDA	Removed
208293	CB submission of self assessment to its AB	Removed
208292	Directly accredited CB submission of regulatory audit report to FDA	Removed
208291	CB submission of regulatory audit report to FDA	Removed
208290	CB completion of additional information on certificates	Removed
208289	AB submission of self-assessments	Removed
208288	AB submission of assessment of its CBs	Removed
208287	CB application for renewal of direct accreditation	Removed
208286	AB application for renewal of recognition	Removed
208285	Unaccredited CBs (ADDITIONAL ONE TIME BURDEN)	Removed
208284	CB application for direct accreditation (ONE TIME BURDEN)	Removed
208283	CB modification of certification design (ONE TIME BURDEN)	Removed
208282	AB application for recognition	Removed
208281	Unaccredited CBs--accreditation burden	Removed
208280	CB modification of food safety audit report	Removed
208279	Report SAHCODHA conditions	Removed
208278	CB public dissemination of information via website	Removed
208277	AB public dissemination of information via website	Removed
208276	AB maintenance of regulatory audit records	Removed
208275	Unaccredited CBs--accreditation burden (ONE TIME BURDEN)	Removed
208274	ANNUAL reporting ABs and CBs	Unchanged
208273	ONE TIME reporting ABs and CBs	Modified
208272	ANNUAL recordkeeping certfication bodies (CBs)	Unchanged
208271	ANNUAL recordkeeping accreditation bodies (ABs)	Unchanged
208270	ONE TIME recordkeeping for certification bodies (CBs)	Modified
208269	ONE TIME recordkeeping for accreditation bodies (ABs)	Modified

ICR Details

OMB Control No: 0910-0750	ICR Reference No: 201605-0910-010
Status: Historical Active	Previous ICR Reference No: 201605-0910-001
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: 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: 06/08/2016
	Date Received in OIRA: 05/16/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved
Responses	72,977	0	0
Time Burden (Hours)	74,822	0	0
Cost Burden (Dollars)	11,585,345	0	0

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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
CB public dissemination of information via website
CB reporting conditions that could contribute to seroius risk to public health to ABs
Unaccredited CBs--accreditation burden
Directly accredited CB submission of regulatory audit report to FDA
AB submission of self-assessments
AB application for renewal of recognition
CB application for direct accreditation (ONE TIME BURDEN)
Report SAHCODHA conditions
CB submission of regulatory audit report to FDA
CB modification of certification design (ONE TIME BURDEN)
ANNUAL recordkeeping certfication bodies (CBs)
ANNUAL reporting ABs and CBs
ONE TIME recordkeeping for accreditation bodies (ABs)
ONE TIME recordkeeping for certification bodies (CBs)
AB application for recognition
AB public dissemination of information via website
CB modification of food safety audit report
Directly accredited CB submission of self assessment to FDA
CB submission of self assessment to its AB
CB completion of additional information on certificates
ONE TIME reporting ABs and CBs
Unaccredited CBs (ADDITIONAL ONE TIME BURDEN)
CB application for renewal of direct accreditation
ANNUAL recordkeeping accreditation bodies (ABs)
Unaccredited CBs--accreditation burden (ONE TIME BURDEN)
Unaccredited CBs--additional reporting burden
CB reporting conditions that could contribute to serious risk to public health to its eligible entities clients
CB reporting conditions to FDA that could contribute to serious risk to public health
CB submission of regulatory audit report to FDA
AB submission of assessment of its CBs
AB maintenance of regulatory audit 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	72,977	0	11,008	61,969	0	0
Annual Time Burden (Hours)	74,822	0	60,650	14,172	0	0
Annual Cost Burden (Dollars)	11,585,345	0	0	11,585,345	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 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: 05/16/2016

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