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 Form FDA 3540 Prior Notice Submitted through The PN System Interface Form and Instruction	Modified
0520_Supporting Statement_2023.docx Supporting Statement A	2023-08-04

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: 202301-0910-015
Status: Received in OIRA	Previous ICR Reference No: 202007-0910-006
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	Date Submitted to OIRA: 08/08/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2023
Responses	18,079,001	14,932,412
Time Burden (Hours)	3,677,494	2,907,576
Cost Burden (Dollars)	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)
  

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 12366	02/27/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 51326	08/03/2023
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 Cancelled through PN Systen Interface	Form FDA 3540	Prior Notice of Imported Foods
Prior Notice Cancelled through the ABI/ACS	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
Prior Notice Submitted through ABI/ACS	Form FDA 3540	Prior Notice of Imported Foods
Prior Notice Submitted through The PN System Interface	Form FDA 3540	Prior Notice of Imported Foods

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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	18,079,001	14,932,412	0	0	3,146,589	0
Annual Time Burden (Hours)	3,677,494	2,907,576	0	0	769,918	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: We are adjusting our burden estimate for this information collection by increasing the number of responses and total burden. The number of responses has increased by 3,146,589 responses (from 14,932,412 to 18,079,001). The total burden has increased by 769,918 hours (from 2,907,576 to 3,677,494). We attribute the adjustment to an increase in the number of responses.

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

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: 08/08/2023

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