Voluntary Qualified Importer Program

Forms and Documents

Document Name	Status
0840 VQIP SSA 2023.docx Supporting Statement A	2023-08-11

IC Document Collections

IC ID	Document Title	Status
223081	QAP maintenance and updates Other-Guidance for Industry	Modified
223080	Quality assurance program (QAP) preparation Other-Guidance for Industry	Modified
223079	Requests for reinstatement Other-Guidance for Industry	Modified
223078	Application renewals - subsequent year Other-Guidance for Industry	Modified
223077	Initial VQIP applications Other-Guidance for Industry	Modified

ICR Details

OMB Control No: 0910-0840	ICR Reference No: 202303-0910-014
Status: Received in OIRA	Previous ICR Reference No: 202006-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Voluntary Qualified Importer Program
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/15/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2023
Responses	24	42
Time Burden (Hours)	1,936	3,780
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports implementation of FDA’s Voluntary Qualified Importer Program (VQIP), a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the United States. Program participants may import products to the United States with greater speed and predictability, avoiding unexpected delays at the point of import entry. Respondents to the information collection are persons that bring food, or cause food to be brought, from a foreign country into the customs territory of the United States (section 806 of the FD&C Act (21 U.S.C. 384b)) as a VQIP importer. Respondents submit applications electronically utilizing the online VQIP application.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 302 Name of Law: Food Safey and 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:
	88 FR 30315	05/11/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 54322	08/10/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Application renewals - subsequent year
Initial VQIP applications
QAP maintenance and updates
Quality assurance program (QAP) preparation
Requests for reinstatement

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ICR Summary of Burden

	Total Request	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	24	42	0	0	-18	0
Annual Time Burden (Hours)	1,936	3,780	0	0	-1,844	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: Our estimated burden for the information collection reflects an overall adjustment decrease of 1,844 hours and a corresponding decrease of 18 responses. Since our last request for OMB approval of the information collection, we have adjusted our estimate of the number of respondents based on actual participation in the program. The adjustment also includes a decrease of 500 hours to the currently approved recordkeeping burden attributed to initial VQIP applications with additional information.

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Annual Cost to Federal Government: $3,435

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.     Yes

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? No

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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: 08/15/2023

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