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 3540 21 CFR 1.282, 1.283(a)(5)- Prior Notice Cancellation Through The PN Systen Interface. Regulation Sets Forth Cancellation Requirements & Information That the Prior Notice ... . Form	Modified
Form 3540 21 CFR 1.282 Reporting; Prior Notice Cancellation Through the ABI/ACS System. Regulation Sets Forth Cancellation Requirements & Information That Prior Notice Is Required to Contain. Form	Modified
Form 3540 21 CFR 1.280,1.281 - Reporting: New Prior Notice Submission Submitted Through The PN System Interface. Regulation Sets Forth Information That The Prior Notice Is Required to Contain Form	Modified
0520 Supporting Statement rev 2014.doc Supporting Statement A	2014-06-10

IC Document Collections

IC ID	Document Title	Status
6237	21 CFR 1.280, 1.281- New Prior Notice Submisions Submitted Through The ABI/ACS System. Regulation Sets Forth Information That the Prior Notice Is Required to Contain	Modified
46714	21 CFR 1.285 ( i) - Reporting: Prior Notice Requests For Review & Post - Hold Submissions Under 801 ( l ) of The Federal Food Drug & Cosmetic Act.	Modified
46713	21 CFR 1.283 (d);1.285(i);1.285(j) - Prior Notice Requests for Review & Post - Hold Submissions Under 801 (m)(1) of The Federal Food, Drug & Cosmetic Act.	Modified
46712	21 CFR 1.282, 1.283(a)(5)- Prior Notice Cancellation Through The PN Systen Interface. Regulation Sets Forth Cancellation Requirements & Information That the Prior Notice ... . Form	Modified
46711	21 CFR 1.282 Reporting; Prior Notice Cancellation Through the ABI/ACS System. Regulation Sets Forth Cancellation Requirements & Information That Prior Notice Is Required to Contain. Form	Modified
46710	21 CFR 1.280,1.281 - Reporting: New Prior Notice Submission Submitted Through The PN System Interface. Regulation Sets Forth Information That The Prior Notice Is Required to Contain Form	Modified

ICR Details

OMB Control No: 0910-0520	ICR Reference No: 201312-0910-013
Status: Historical Active	Previous ICR Reference No: 201005-0910-017
Agency/Subagency: HHS/FDA	Agency Tracking No: 21201
Title: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/13/2014
	Date Received in OIRA: 12/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2017	36 Months From Approved	06/30/2014
Responses	10,703,882	0	10,038,502
Time Burden (Hours)	2,126,275	0	1,859,474
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:
	78 FR 65670	11/01/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 78971	12/27/2013
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
21 CFR 1.280,1.281 - Reporting: New Prior Notice Submission Submitted Through The PN System Interface. Regulation Sets Forth Information That The Prior Notice Is Required to Contain	3540	Prior Notice Submission
21 CFR 1.280, 1.281- New Prior Notice Submisions Submitted Through The ABI/ACS System. Regulation Sets Forth Information That the Prior Notice Is Required to Contain
21 CFR 1.282 Reporting; Prior Notice Cancellation Through the ABI/ACS System. Regulation Sets Forth Cancellation Requirements & Information That Prior Notice Is Required to Contain.	3540	Prior Notice Submission
21 CFR 1.282, 1.283(a)(5)- Prior Notice Cancellation Through The PN Systen Interface. Regulation Sets Forth Cancellation Requirements & Information That the Prior Notice ... .	3540	Prior Notice Submission
21 CFR 1.283 (d);1.285(i);1.285(j) - Prior Notice Requests for Review & Post - Hold Submissions Under 801 (m)(1) of The Federal Food, Drug & Cosmetic Act.
21 CFR 1.285 ( i) - Reporting: Prior Notice Requests For Review & Post - Hold Submissions Under 801 ( l ) of The Federal Food Drug & Cosmetic Act.

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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	10,703,882	10,038,502	0	0	665,380	0
Annual Time Burden (Hours)	2,126,275	1,859,474	0	0	266,801	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 is a revision of a currently approved collection. We are seeking to incorporate the the annual burden from ICR 0910-0683 into this collection, and have made adjustments to the number of annual responses and hourly burden. An explaination of the changes can be found at Q.15 of the supporting statement part A.

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Annual Cost to Federal Government: $12,500,000

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: 12/30/2013

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