FDA’s Voluntary Qualified Importer Program; Guidance for Industry

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
223081	QAP modification	Modified
223080	ONE TIME quality assurance program (QAP) preparation	Modified
223079	Request for VQIP reinstatement	Modified
223078	Subsquent (after initial) VQIP applications	Modified
223077	Initial VQIP applications and applications w/additional information	Modified

ICR Details

OMB Control No: 0910-0840	ICR Reference No: 202006-0910-001
Status: Active	Previous ICR Reference No: 201706-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: FDA’s Voluntary Qualified Importer Program; Guidance for Industry
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 with change	Conclusion Date: 09/16/2020
	Date Received in OIRA: 07/14/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2023	36 Months From Approved	09/30/2020
Responses	42	0	702
Time Burden (Hours)	3,780	0	57,220
Cost Burden (Dollars)	0	0	0

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Abstract: This information solicits applications to the Food and Drug Administration's (FDA) Voluntary Qualified Importer Program (VQIP) established by the Food Safety and Modernization Act. Respondents to the collection are importers of human or animal food.

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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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 6556	02/05/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 35937	06/12/2020
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
QAP modification
Initial VQIP applications and applications w/additional information
Subsquent (after initial) VQIP applications
Request for VQIP reinstatement
ONE TIME quality assurance program (QAP) preparation

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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	42	702	0	0	-660	0
Annual Time Burden (Hours)	3,780	57,220	0	0	-53,440	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:

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Annual Cost to Federal Government: $0

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: 07/14/2020

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