FDA’s Voluntary Qualified Importer Program; Guidance for Industry

Forms and Documents

Document	Type	Status	Availability
VQIP Supporting Statement 2016.pdf	Supporting Statement A	Uploaded 2016-08-17	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
223081	QAP modification	Other-Guidance for Industry	New
223080	ONE TIME quality assurance program (QAP) preparation	Other-Guidance for Industry	New
223079	Request for VQIP reinstatement	Other-Guidance for Industry	New
223078	Subsquent (after initial) VQIP applications	Other-Guidance for Industry	New
223077	Initial VQIP applications and applications w/additional information	Other-Guidance for Industry	New

ICR Details

OMB Control No: 0910-0840	ICR Reference No: 201608-0910-011
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: FDA’s Voluntary Qualified Importer Program; Guidance for Industry
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 10/19/2016
	Date Received in OIRA: 08/18/2016
Terms of Clearance: Withdrawn per Agency request.

	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: This information solicits applications to FDA's Voluntary Qualified Importer Program 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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 32136	06/05/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 54809	08/17/2016
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Initial VQIP applications and applications w/additional information
QAP modification
Subsquent (after initial) VQIP applications
Request for VQIP reinstatement
ONE TIME quality assurance program (QAP) preparation

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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 request.

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Annual Cost to Federal Government: $0

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: 08/18/2016

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