Registration of Food Facilities

Forms and Documents

Document Name	Status
Form FDA 3537 New domestic facility registration Form and Instruction	Modified
Form FDA 3537a Registration cancellations Form and Instruction	Modified
Form FDA 3537 Registration updates Form and Instruction	Modified
Form FDA 3537 New foreign facility registration Form and Instruction	Modified
Form FDA 3537 Biennial renewal of registration Form and Instruction	Modified
0502 FRIA for 14 July 2016 Final Rule.pdf Supplementary Document	2016-07-14
0502 PRIA 2015 Proposed Rule.pdf Supplementary Document	2016-07-14
0502 SS 2016 Extension and Revision by FSMA.pdf Supporting Statement A	2016-07-14

IC Document Collections

IC ID	Document Title	Status
6215	New domestic facility registration Form and Instruction	Modified
46700	Registration cancellations Form and Instruction	Modified
46699	Registration updates Form and Instruction	Modified
46698	New foreign facility registration Form and Instruction	Modified
222477	Waiver requests	New
222476	ONE-TIME burden for new FSMA element in facility registration	New
222475	U.S. Agency verification	New
222474	Third party registration verification	New
203888	Biennial renewal of registration Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0502	ICR Reference No: 201605-0910-013
Status: Historical Active	Previous ICR Reference No: 201305-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Registration of Food Facilities
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/15/2016
	Date Received in OIRA: 07/14/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved	08/31/2016
Responses	454,322	0	380,830
Time Burden (Hours)	309,752	0	468,117
Cost Burden (Dollars)	0	0	0

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Abstract: Respondents to the information collection are manufacturers, processors, holders, and distributers of foods who must provide registration information to the agency. 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:
0910-AG69	Final or interim final rulemaking	81 FR 45911	07/14/2016

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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: 9

IC Title	Form No.	Form Name
New domestic facility registration	FDA 3537	Food Facility Registration
New foreign facility registration	FDA 3537	Food Facility Registration
Registration updates	FDA 3537	Food Facility Registration
Registration cancellations	FDA 3537a	Cancellation of Food Facility Registration
Biennial renewal of registration	FDA 3537	Food Facility Registration
U.S. Agency verification
Third party registration verification
ONE-TIME burden for new FSMA element in facility registration
Waiver requests

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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	454,322	380,830	0	73,492	0	0
Annual Time Burden (Hours)	309,752	468,117	0	-158,365	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: 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 as a result of agency rulemaking. Changes are discussed in the supporting 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: 07/14/2016

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