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 Form 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	Modified
Form 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 Form 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	Modified
Form FDA Form 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	Modified
Form FDA Form 3537 Domestic Registration Additional Data Required by FSMA Form	Modified
Justification for Nonmaterial Change 0502.docx Justification for No Material/Nonsubstantive Change	2012-10-18

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	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	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	Modified
203889	Occasional Facility Update Additional Data Required by FSMA Other-Agency Guidance	Modified
203888	Biennial Renewal of Registration Additional Data Required by FSMA Other-Agency Guidance	Modified
203887	Foreign New Facility Registration New Data Required by FSMA Other-Agency Guidance	Modified
203886	Domestic Registration Additional Data Required by FSMA Form	Modified

ICR Details

OMB Control No: 0910-0502	ICR Reference No: 201210-0910-003
Status: Historical Active	Previous ICR Reference No: 201208-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 09/10/2012
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/19/2012
	Date Received in OIRA: 10/19/2012
Terms of Clearance: The change is approved. In the next request for approval, the agency should ensure that the burden statement on their forms and in the system are consistent and reflect the burden accurately. We also ask that FDA submit or report on their progress in developing instructions for both the paper and electronic formats. We also will want to discuss whether the electronic pre-populates the forms for both updates and re-registration.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2013	03/31/2013	03/31/2013
Responses	542,240	0	542,240
Time Burden (Hours)	505,696	0	505,696
Cost Burden (Dollars)	0	0	0

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Abstract: Section 415 of the Federal Food, Drug, and Cosmetic Act requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to be registered with the FDA. Sections 1.230 - 1.235 (21 CFR 1.230-1.235)of FDA's regulations set forth the procedures for registration of food facilities. Information provided to FDA under these regulations will help the agency to notify quickly the facilities that might be affected by a deliberate or accidental contamination of the food supply.

Emergency Justfication: In accordance with the 5 CFR 1320.13, FDA believes that public harm is reasonably likely to occur and the Agency will be at risk of not fulfilling its FSMA mandate, if the normal clearance procedures are followed. In the six months or more it can take to obtain a full PRA clearance, a significant number of consumers could be exposed to the risk of consuming hazardous food products. FDA believes that these circumstances can be mitigated or prevented through prompt communication with facilities that might be affected by a deliberate or accidental contamination of the food supply and through targeted import inspections.

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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

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
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 Form 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 Form 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 ... .	3537a	DHHS/FDA CANCELLATION OF FOOD FACILITY REGISTRATION FORM
Domestic Registration Additional Data Required by FSMA	FDA Form 3537	Food Facility Registration
Foreign New Facility Registration New Data Required by FSMA
Biennial Renewal of Registration Additional Data Required by FSMA
Occasional Facility Update Additional Data Required by FSMA
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 Form 3537	Food Facility Registration

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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	542,240	542,240	0	0	0	0
Annual Time Burden (Hours)	505,696	505,696	0	0	0	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: $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: 10/19/2012

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