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	Unchanged
Form FDA 3537 Registration updates Form and Instruction	Unchanged
Form FDA 3537 New foreign facility registration Form and Instruction	Modified
Form FDA 3537 Biennial renewal of registration Form and Instruction	Unchanged
0502 Registration of Food Facilities SSA 2019 Ext.pdf Supporting Statement A	2019-07-23

IC Document Collections

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

ICR Details

OMB Control No: 0910-0502	ICR Reference No: 201907-0910-002
Status: Historical Active	Previous ICR Reference No: 201605-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Registration of Food Facilities
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: 08/22/2019
	Date Received in OIRA: 07/23/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved	08/31/2019
Responses	279,927	0	454,322
Time Burden (Hours)	278,382	0	309,752
Cost Burden (Dollars)	22,248,289	0	0

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Abstract: Respondents to the information collection are manufacturers, processors, holders, and distributors of foods who must register with 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 products are quickly and efficiently removed from the marketplace.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. 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:
	84 FR 16519	04/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 35393	07/23/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
New foreign facility registration	FDA 3537	Food Facility Registration
New domestic 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
Waiver requests
ONE-TIME burden for new FSMA element in 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	279,927	454,322	0	0	-174,395	0
Annual Time Burden (Hours)	278,382	309,752	0	0	-31,370	0
Annual Cost Burden (Dollars)	22,248,289	0	0	0	22,248,289	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 information reflects adjustments. We have decreased the number of respondents completing one-time registrations and waiver requests, thus realizing previous one-time estimates. This results in an overall decrease by 174,395 responses (from 454,322 to 279,927), and by 31,370 hours (from 309,752 to 78,382). We have also uploaded reported cost information to be reflected at omb.report.

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Annual Cost to Federal Government: $1,066,716

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 07/23/2019

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