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

Forms and Documents

Document Name	Status
Third Party Supporting Statement 8-12-13.doc Supporting Statement A	2013-08-12

IC Document Collections

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

ICR Details

OMB Control No: 0910-0750	ICR Reference No: 201308-0910-005
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 20263
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: Comment filed on proposed rule	Conclusion Date: 10/23/2013
	Date Received in OIRA: 08/20/2013
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, OMB is not approving the collection at this time. Prior to publication of the final rule, the agency should provide a summary of all comments related to the information collection requirements contained in the rule and any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	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 our Third Party proposed 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 U.S. We will use certifications issued by accredited third party auditors/certification bodies in deciding whether to admit certain imported food into the U.S. that FDA has determined poses a food safety risk and in deciding whether an importer is eligible to participate in a program of expedited review and entry of food imports.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG64	Proposed rulemaking	78 FR 45781	07/29/2013

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 31

IC Title	Form No.	Form Name
CB public dissemination of information via website
Report SAHCODHA conditions
CB modification of food safety audit report
Unaccredited CBs--accreditation burden
AB application for recognition
CB modification of certification design (ONE TIME BURDEN)
CB application for direct accreditation (ONE TIME BURDEN)
Unaccredited CBs (ADDITIONAL ONE TIME BURDEN)
AB application for renewal of recognition
CB application for renewal of direct accreditation
AB submission of assessment of its CBs
AB submission of self-assessments
CB completion of additional information on certificates
CB submission of regulatory audit report to FDA
Directly accredited CB submission of regulatory audit report to FDA
CB submission of self assessment to its AB
Directly accredited CB submission of self assessment to FDA
CB reporting conditions to FDA that could contribute to serious risk to public health
CB reporting conditions that could contribute to serious risk to public health to its eligible entities clients
CB reporting conditions that could contribute to seroius risk to public health to ABs
Unaccredited CBs--additional reporting burden
CB submission of regulatory audit report to FDA
AB maintenance of regulatory audit records
AB public dissemination of information via website
AB modify recordkeeping protocol (ONE TIME BURDEN)
CB modify recordkeeping protocol (ONE TIME BURDEN)
AB public dissemination of information via website (ONE TIME BURDEN)
CB public dissemination of information via website (ONE TIME BURDEN)
AB contract modification (ONE TIME BURDEN)
CB contract modification (ONE TIME BURDEN)
Unaccredited CBs--accreditation burden (ONE TIME BURDEN)

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new information collection.

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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: 08/20/2013

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