Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Forms and Documents

Document Name	Status
Form FDA 3537 21 CFR 1.230-1.233 - Reporting Domestic New Facilities : Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Form and Instruction	Modified
Form FDA 3537a 21 CFR 1.235 Reporting; Requires the Registration For a Previously Registered Facility to Be Cancelled When The Facility Ceases to Operate ... . Form and Instruction	Modified
Form FDA 3537 21 CFR 1.234 Reporting: Requirement for Previously Registered Facilities to Submit Timely Updates Within 60 Days Of A Change to Any Required Item of Registration Information Form and Instruction	Modified
Form FDA 3537 21 CFR 1.230-1.233 - Reporting Foreign New Facilities: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparadness and Response Act of 2002 Form and Instruction	Modified
Form FDA 3537 Biennial Renewal of Registration Additional Data Required by FSMA Form and Instruction	Modified
Form FDA Form 3537 Domestic Registration Additional Data Required by FSMA Form	Removed
0502 SS 2013 Revised.docx Supporting Statement A	2013-05-30

IC Document Collections

IC ID	Document Title	Status
6215	21 CFR 1.230-1.233 - Reporting Domestic New Facilities : Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Form and Instruction	Modified
46700	21 CFR 1.235 Reporting; Requires the Registration For a Previously Registered Facility to Be Cancelled When The Facility Ceases to Operate ... . Form and Instruction	Modified
46699	21 CFR 1.234 Reporting: Requirement for Previously Registered Facilities to Submit Timely Updates Within 60 Days Of A Change to Any Required Item of Registration Information Form and Instruction	Modified
46698	21 CFR 1.230-1.233 - Reporting Foreign New Facilities: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparadness and Response Act of 2002 Form and Instruction	Modified
203889	Occasional Facility Update Additional Data Required by FSMA Other-Agency Guidance	Removed
203888	Biennial Renewal of Registration Additional Data Required by FSMA Form and Instruction	Modified
203887	Foreign New Facility Registration New Data Required by FSMA Other-Agency Guidance	Removed
203886	Domestic Registration Additional Data Required by FSMA Form	Removed

ICR Details

OMB Control No: 0910-0502	ICR Reference No: 201305-0910-006
Status: Historical Active	Previous ICR Reference No: 201210-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 19716
Title: Registration of Food Facilities 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: 08/06/2013
	Date Received in OIRA: 05/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	36 Months From Approved	08/31/2013
Responses	380,830	0	542,240
Time Burden (Hours)	468,117	0	505,696
Cost Burden (Dollars)	0	0	0

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Abstract: This collection requires manufacturers, processors, holders, and distributers of foods to provide registration information to the agency including name,location, contact information, etc. Through this registration program and the information provided under the regulations the agency is able to identify firms in the event of food-related emergencies as well as ensure that contaminated food producsts are quickly and efficiently removed from the marketplace.

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Authorizing Statute(s): US Code: 21 USC 350 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:
	78 FR 4414	01/18/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 18603	03/27/2013
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
21 CFR 1.230-1.233 - Reporting Domestic New Facilities : Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002	FDA 3537	Food Facility Registration
21 CFR 1.230-1.233 - Reporting Foreign New Facilities: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparadness and Response Act of 2002	FDA 3537	Food Facility Registration
21 CFR 1.234 Reporting: Requirement for Previously Registered Facilities to Submit Timely Updates Within 60 Days Of A Change to Any Required Item of Registration Information	FDA 3537	Food Facility Registration
21 CFR 1.235 Reporting; Requires the Registration For a Previously Registered Facility to Be Cancelled When The Facility Ceases to Operate ... .	FDA 3537a	Cancellation of Food Facility Registration
Biennial Renewal of Registration Additional Data Required by FSMA	FDA 3537	Food Facility Registration
Domestic Registration Additional Data Required by FSMA	FDA Form 3537	Food Facility Registration
Foreign New Facility Registration New Data Required by FSMA
Occasional Facility Update Additional Data Required by FSMA

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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	380,830	542,240	0	0	-161,410	0
Annual Time Burden (Hours)	468,117	505,696	0	0	-37,579	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 ICR reflects an adjustment in both burden hours and annual responses. The currently approved annual hour burden of 505,696 has been reduced by 37,579 hours, and the currently approved annual number of responses of 542,240 has been reduced by 161,410. The agency believes that these reductions are appropriately characterized as adjustments and are reflected by the specific actions discussed in the supporting statement at question 15.

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Annual Cost to Federal Government: $8,709,000

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: 05/30/2013

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