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

Forms and Documents

Document Name	Status
0752 FSVP SSA 2019 Ext.pdf Supporting Statement A	2019-02-28

IC Document Collections

IC ID	Document Title	Status
208153	RECORDS under 1.512(b); assurances from very small importer/certain small foreign supplier	Unchanged
208152	RECORDS under 1.512(b)(1); document very small importer/certain foreign supplier status	Unchanged
208151	RECORDS under 1.511(b); assurances for food produced under dietary supplement GMP	Unchanged
208138	RECORDS supporting FSVP including hazard determination; written procedures; reevaluation; audits; and corrective actions	Modified
208137	RECORDS under 1.502(b); controls for LACF	Unchanged
208136	REPORT under 1.509(a), 1.511(c), 1.512(b)(2); importer identification information for filing with CBP.	Unchanged
208135	REPORT under 1.501(c); exemption for food for research	Unchanged

ICR Details

OMB Control No: 0910-0752	ICR Reference No: 201902-0910-005
Status: Active	Previous ICR Reference No: 201512-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/02/2019
	Date Received in OIRA: 02/28/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2022	36 Months From Approved	04/30/2019
Responses	15,591,006	0	15,591,006
Time Burden (Hours)	2,669,646	0	2,669,646
Cost Burden (Dollars)	0	0	167,986,680

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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: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 53271	10/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 6152	02/26/2019
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
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

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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	15,591,006	0	0	0	0
Annual Time Burden (Hours)	2,669,646	2,669,646	0	0	0	0
Annual Cost Burden (Dollars)	0	167,986,680	0	0	-167,986,680	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $134,625

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 02/28/2019

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