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)- Reporting: 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 2010 11 05.doc Supporting Statement A	2010-11-05

IC Document Collections

IC ID	Document Title	Status
6237	21 CFR 1.280, 1.281- Reporting: 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) - Reporting: 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)- Reporting: 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: 201005-0910-017
Status: Historical Active	Previous ICR Reference No: 200701-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
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 with change	Conclusion Date: 12/01/2010
	Date Received in OIRA: 05/28/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2013	36 Months From Approved	11/30/2010
Responses	10,038,502	0	8,045,878
Time Burden (Hours)	1,859,474	0	1,749,913
Cost Burden (Dollars)	0	0	0

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Abstract: Section 801(m) of the Federal Food Drug and Cosmetic Act(the 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. Sections 1.278 to 1.282 of FDAs regulations ( 21 CFR 1.278 to 1.282) set forth the requirements for submitting prior notice; sections 1.283 (d) and 1.285 (j)set forth the procedure for requesting FDA review after an article of food has been refused admission under section 801 ( m )(1) of the act or placed under hold under section 801 (l) of the act; and section 1.285 (i) ( 21 CFR 1.285 ( i) sets forth the procedure for post- hold submissions. Advance notice of imported food allows FDA, with 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.

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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:
	75 FR 12549	03/16/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 30036	05/28/2010
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 1.285 ( i) - Reporting: Prior Notice Requests For Review & Post - Hold Submissions Under 801 ( l ) of The Federal Food Drug & Cosmetic Act.
21 CFR 1.280, 1.281- Reporting: New Prior Notice Submisions Submitted Through The ABI/ACS System. Regulation Sets Forth Information That the Prior Notice Is Required to Contain
21 CFR 1.280,1.281 - 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 1.282 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)- Reporting: 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) - Reporting: Prior Notice Requests for Review & Post - Hold Submissions Under 801 (m)(1) 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	10,038,502	8,045,878	0	0	1,992,624	0
Annual Time Burden (Hours)	1,859,474	1,749,913	0	0	109,561	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: $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: 05/28/2010

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