Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Forms and Documents

Document Name	Status
Form Form FDA 3540 Prior Notice Submitted through ABI/ACS Form and Instruction	Modified
Form Form FDA 3540 Prior Notice Requests for Review & Post-Hold Submissions Form and Instruction	Modified
Form Form FDA 3540 Prior Notice Requests for Review & Post-Hold Submissions Form and Instruction	Modified
Form Form FDA 3540 Prior Notice Cancelled through PN Systen Interface Form and Instruction	Modified
Form Form FDA 3540 Prior Notice Cancelled through the ABI/ACS Form and Instruction	Modified
Form FDA Form 3540 Prior Notice Submitted through The PN System Interface Form and Instruction	Modified
0520 ss 6-15-2017.pdf Supporting Statement A	2017-06-15

IC Document Collections

IC ID	Document Title	Status
6237	Prior Notice Submitted through ABI/ACS Form and Instruction	Modified
46714	Prior Notice Requests for Review & Post-Hold Submissions Form and Instruction	Modified
46713	Prior Notice Requests for Review & Post-Hold Submissions Form and Instruction	Modified
46712	Prior Notice Cancelled through PN Systen Interface Form and Instruction	Modified
46711	Prior Notice Cancelled through the ABI/ACS Form and Instruction	Modified
46710	Prior Notice Submitted through The PN System Interface Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0520	ICR Reference No: 201705-0910-003
Status: Historical Active	Previous ICR Reference No: 201312-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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: 07/18/2017
	Date Received in OIRA: 06/16/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	36 Months From Approved	07/31/2017
Responses	14,932,412	0	10,703,882
Time Burden (Hours)	2,907,576	0	2,126,275
Cost Burden (Dollars)	0	0	0

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Abstract: Section 801(m) of the Federal Food Drug and Cosmetic Act (21 U.S.C.381(m) requires that FDA receive prior notice for food, including food for animals, that is imported or offered for import into the United States. This information collection supports the requirements for submitting prior notice under agency regulations. Advance notice of imported food allows FDA, with the support of the Bureau of Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nations' food supply against terrorist acts and other public health emergencies. Respondents to this collection are manufacturers, packers, and distributors of food products.

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Authorizing Statute(s): US Code: 21 USC 381 (m) Name of Law: null
  

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:
	82 FR 1349	01/05/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 24131	05/25/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Prior Notice Submitted through ABI/ACS	Form FDA 3540	Prior Notice of Imported Foods
Prior Notice Submitted through The PN System Interface	FDA Form 3540	Prior Notice of Imported Foods
Prior Notice Cancelled through the ABI/ACS	Form FDA 3540	Prior Notice of Imported Foods
Prior Notice Cancelled through PN Systen Interface	Form FDA 3540	Prior Notice of Imported Foods
Prior Notice Requests for Review & Post-Hold Submissions	Form FDA 3540	Prior Notice of Imported Foods
Prior Notice Requests for Review & Post-Hold Submissions	Form FDA 3540	Prior Notice of Imported Foods

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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	14,932,412	10,703,882	0	0	4,228,530	0
Annual Time Burden (Hours)	2,907,576	2,126,275	0	0	781,301	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: This information collection includes adjustments. Based on our review, the collection reflects a continued increase in submissions. As a result we have increased our annual estimate by 4,228,530 responses and 781,301 burden hours. Burden associated with the individual ICs and our corresponding calculations are discussed more fully under Q12 of this supporting statement.

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Annual Cost to Federal Government: $1,000,000

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: 06/16/2017

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