Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT

Forms and Documents

Document Name	Status
Sampling Plan B ALERT 6-18-09.doc Supporting Statement B	2009-08-21
ALERT ss Part A 3-18-09.doc Supporting Statement A	2009-03-18

IC Document Collections

IC ID	Document Title	Status
188670	Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT Other-Survey	New
188669	Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT Other-Survey	New
188668	Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT Other-Survey	New
188667	Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT Other-Survey	New
188666	Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT Other-Survey	New

ICR Details

OMB Control No: 0910-0644	ICR Reference No: 200904-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/24/2009
	Date Received in OIRA: 04/02/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2012	36 Months From Approved
Responses	7,549	0	0
Time Burden (Hours)	1,139	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In July 2006, FDA announced its Food Defense Awareness Initiative, called ALERT (the letters stand for the five key components of the initiative: assure, look, employees, report, and threat). The purpose of the ALERT initiative is to raise the awareness of state and local government agencies and the food industry regarding food defense issues. ALERT identifies five key points that industry and businesses can use to decrease the risk of intentional food contamination at their facility.

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Authorizing Statute(s): US Code: 21 USC 393 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:
	73 FR 29759	05/22/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 14135	03/30/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT
Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT
Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT
Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT
Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT

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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	7,549	0	0	7,549	0	0
Annual Time Burden (Hours)	1,139	0	0	1,139	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: No

Burden Reduction Due to:

Short Statement: This is a new data collection. The new burden hours are due to a one-time survey and its related cognitive interviews, pre-test and screener. In July 2006, FDA announced its Food Defense Awareness Initiative, called ALERT (the letters stand for the five key components of the initiative: assure, look, employees, report, and threat). The purpose of the ALERT initiative is to raise the awareness of state and local government agencies and the food industry regarding food defense issues. ALERT identifies five key points that industry and businesses can use to decrease the risk of intentional food contamination at their facility.

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Annual Cost to Federal Government: $135,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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)? 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: 04/02/2009

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