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 Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Form	New
Form 3540 Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Form	New
Form 3540 Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Form	New
0520 CoverMemotoOMB 1-2007.doc Supplementary Document	2007-01-03
0520-commentC2.pdf Supplementary Document	2007-01-03
0520-commentEC3.pdf Supplementary Document	2007-01-03
0520-commentEC1.pdf Supplementary Document	2007-01-03
0520 Attachment B 21CFR1 278-1 285.doc Supplementary Document	2007-01-03
0520 Attachment A Section 801m of the FFDCA.doc Supplementary Document	2007-01-03
0520 ss 1-2007.doc Supporting Statement A	2007-01-03

IC Document Collections

IC ID	Document Title	Status
6237	Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002	Modified
46714	Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002	New
46713	Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002	New
46712	Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Form	New
46711	Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Form	New
46710	Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Form	New

ICR Details

OMB Control No: 0910-0520	ICR Reference No: 200701-0910-002
Status: Historical Active	Previous ICR Reference No: 200310-0910-001
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 without change	Conclusion Date: 05/24/2007
	Date Received in OIRA: 01/12/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2010	36 Months From Approved	05/31/2007
Responses	8,045,878	0	6,891,625
Time Burden (Hours)	1,749,913	0	2,836,781
Cost Burden (Dollars)	0	0	6,268,000

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Abstract: Section 801(m) of the Federal Food, Drug, and Cosmetic Act requires notification to FDA before the arrival of imported food into the United States. Sections 1.278 to 1.285 of FDA's regulations explain the information that the prior notice is required to contain, the method of submission of the notice, and the period of advance notice required.

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

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:
	71 FR 30940	05/31/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 76344	12/20/2006
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 of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002	3540	Prior Notice Submission
Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002	3540	Prior Notice Submission
Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002	3540	Prior Notice Submission
Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

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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	8,045,878	6,891,625	0	1,154,253	0	0
Annual Time Burden (Hours)	1,749,913	2,836,781	0	-1,086,868	0	0
Annual Cost Burden (Dollars)	0	6,268,000	0	-6,268,000	0	0

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The decrease in burden is due to the decrease in the number of prior notices submitted through CBP's ABI/ACS and an increase in the number of prior notices submitted through FDA's PN System Interface. Also, please see # 15 in the supporting statement.

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Annual Cost to Federal Government: $12

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 01/08/2007

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