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
0502 supporting statement for proposed rule 9 APR 2015.pdf Supporting Statement A	2015-04-09

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
216023	US Agent Verification procedure	New
216022	Third party registration verification procedure	New
216021	One-time reporting burden for all facilities to comply w/new requirements	New
203888	Biennial Renewal of Registration Additional Data Required by FSMA Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0502	ICR Reference No: 201504-0910-003
Status: Historical Inactive	Previous ICR Reference No: 201305-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 05/13/2015
	Date Received in OIRA: 04/09/2015
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	36 Months From Approved	08/31/2016
Responses	380,830	0	380,830
Time Burden (Hours)	468,117	0	468,117
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. Information provided under the regulations enables FDA to respond to potential threats to the US food supply, to identify affected firms and products in the event of food-related emergencies, and to ensure that contaminated food producsts are quickly and efficiently removed from the marketplace.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 102 et al. Name of Law: Food Safety Modernization Act
   PL: Pub.L. 107 - 188 305(d) Name of Law: Public Health Security and Bioterrorism Preparedness and Response Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG69	Proposed rulemaking	80 FR 19159	04/09/2015

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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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 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
One-time reporting burden for all facilities to comply w/new requirements
Third party registration verification procedure
US Agent Verification procedure

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: This information collection is being revised to support proposed rulemaking.

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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: 04/09/2015

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