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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
Retrieve Notice of Action (NOA)	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

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.

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

Citations for New Statutory Requirements: None

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

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

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.

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

Agency Contact: JonnaLynn Capezzuto 301 827-4659 jonnalynn.capezzuto@fda.hhs.gov

View ICR - OIRA Conclusion