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

Forms and Documents

Document Name	Status
0752 FSVP Supporting Statement for FR 27 Nov 2015.pdf Supporting Statement A	2015-12-17

IC Document Collections

IC ID	Document Title	Status
208153	RECORDS under 1.512(b); assurances from very small importer/certain small foreign supplier	Modified
208152	RECORDS under 1.512(b)(1); document very small importer/certain foreign supplier status	Modified
208151	RECORDS under 1.511(b); assurances for food produced under dietary supplement GMP	Modified
208150	Written assurances for food produced under DS CGMPs	Removed
208149	Investigate and determine FSVP adequacy	Removed
208148	Investigate adulteration or misbranding	Removed
208147	Review records	Removed
208146	Conduct periodic sampling/testing	Removed
208145	Conduct/review audits	Removed
208144	Determine and document type of verification activities	Removed
208143	Written assurances from suppliers	Removed
208142	Written procedures for verification	Removed
208141	Written list of suppliers	Removed
208140	Review hazard analysis	Removed
208139	Determine and document hazards	Removed
208138	RECORDS supporting FSVP including hazard determination; written procedures; reevaluation; audits; and corrective actions	Modified
208137	RECORDS under 1.502(b); controls for LACF	Modified
208136	REPORT under 1.509(a), 1.511(c), 1.512(b)(2); importer identification information for filing with CBP.	Modified
208135	REPORT under 1.501(c); exemption for food for research	Modified

ICR Details

OMB Control No: 0910-0752	ICR Reference No: 201512-0910-006
Status: Historical Active	Previous ICR Reference No: 201308-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
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: Approved without change	Conclusion Date: 02/05/2016
	Date Received in OIRA: 12/18/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	36 Months From Approved
Responses	15,591,006	0	0
Time Burden (Hours)	2,669,646	0	0
Cost Burden (Dollars)	167,986,680	0	0

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Abstract: The FSVP regulations 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. Respondents to the collection are persons who import food into the United States subject to agency regulations.

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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: PL: Pub.L. 111 - 353 805 Name of Law: FSMA; Importation of Food

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG64	Final or interim final rulemaking	80 FR 74225	11/27/2015

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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: 7

IC Title	Form No.	Form Name
RECORDS under 1.511(b); assurances for food produced under dietary supplement GMP
RECORDS under 1.512(b)(1); document very small importer/certain foreign supplier status
RECORDS under 1.512(b); assurances from very small importer/certain small foreign supplier
Determine and document hazards
Review hazard analysis
Conduct periodic sampling/testing
Investigate and determine FSVP adequacy
Written list of suppliers
Determine and document type of verification activities
Written assurances from suppliers
Review records
REPORT under 1.501(c); exemption for food for research
REPORT under 1.509(a), 1.511(c), 1.512(b)(2); importer identification information for filing with CBP.
RECORDS under 1.502(b); controls for LACF
RECORDS supporting FSVP including hazard determination; written procedures; reevaluation; audits; and corrective actions
Written procedures for verification
Conduct/review audits
Investigate adulteration or misbranding
Written assurances for food produced under DS CGMPs

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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	15,591,006	0	0	15,591,006	0	0
Annual Time Burden (Hours)	2,669,646	0	0	2,669,646	0	0
Annual Cost Burden (Dollars)	167,986,680	0	0	167,986,680	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 request in support of agency rulemaking.

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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: 12/18/2015

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