Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

Forms and Documents

Document Name	Status
FSVP-PRA-SuppState FINAL 7-30-13.doc Supporting Statement A	2013-07-31

IC Document Collections

IC ID	Document Title	Status
208153	Written assurances from very small importer/very small supplier	New
208152	Document very small importer/very small supplier status	New
208151	Determine and document verification activities for importers of DS	New
208150	Written assurances for food produced under DS CGMPs	New
208149	Investigate and determine FSVP adequacy	New
208148	Investigate adulteration or misbranding	New
208147	Review records	New
208146	Conduct periodic sampling/testing	New
208145	Conduct/review audits	New
208144	Determine and document type of verification activities	New
208143	Written assurances from suppliers	New
208142	Written procedures for verification	New
208141	Written list of suppliers	New
208140	Review hazard analysis	New
208139	Determine and document hazards	New
208138	Review compliance status for food and supplier	New
208137	Controls for LACF	New
208136	DUNS Number for filing with CBP	New
208135	Exemption for Food for research	New

ICR Details

OMB Control No: 0910-0752	ICR Reference No: 201308-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 15588
Title: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
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: 08/09/2013
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: The proposed FSVP regulations would require importers of most imported foods to take steps to verify that the foods they import into the United States are produced so they are safe and properly labeled with respect to allergens. These regulations are intended to work in tandem with other provisions of FSMA and the FD&C Act to create a more seamless system of food safety to protect U.S. consumers.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 301 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-AG64	Proposed rulemaking	78 FR 45729	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: 19

IC Title	Form No.	Form Name
Exemption for Food for research
DUNS Number for filing with CBP
Controls for LACF
Review compliance status for food and supplier
Determine and document hazards
Review hazard analysis
Written list of suppliers
Written procedures for verification
Written assurances from suppliers
Conduct/review audits
Conduct periodic sampling/testing
Review records
Investigate adulteration or misbranding
Investigate and determine FSVP adequacy
Written assurances for food produced under DS CGMPs
Determine and document verification activities for importers of DS
Document very small importer/very small supplier status
Written assurances from very small importer/very small supplier
Determine and document type of verification activities

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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 requirement.

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Annual Cost to Federal Government: $134,625

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: 08/09/2013

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