Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

Forms and Documents

Document Name	Status
Form 3757 Initial Burden (annualized over 3 years); Initial Registration Form and Instruction	Modified
0783 83-C for Form FDA 3757.doc Justification for No Material/Nonsubstantive Change	2016-06-24
SS for Labeling Final Rule for Restaurants and Similar Establishments.pdf Supporting Statement A	2015-02-05

IC Document Collections

IC ID	Document Title	Status
214843	Third Party Burden; Recurring	Unchanged
214842	Third Party Disclosure; Initial Burden	Unchanged
214841	Recurring nutrition analysis records	Unchanged
214840	Initial nutrition analysis records	Unchanged
214839	Annual Burden; Registration Renewal	Unchanged
214838	Initial Burden (annualized over 3 years); Initial Registration Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0783	ICR Reference No: 201606-0910-009
Status: Historical Active	Previous ICR Reference No: 201502-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/28/2016
	Date Received in OIRA: 06/27/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2018	03/31/2018	03/31/2018
Responses	334,219	0	334,219
Time Burden (Hours)	498,508	0	498,508
Cost Burden (Dollars)	0	0	0

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Abstract: This collection request seeks information from chain restaurants and similar retail food establishments (SRFE) with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to disclose certain nutrition information for certain food items offered for sale so that consumers can make more informed choices about the food they purchase.

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Authorizing Statute(s): US Code: 21 USC 343 Name of Law: Nutrition Labeling and Education Act, as amended.
   PL: Pub.L. 111 - 148 4205 Name of Law: Affordable Care Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG57	Final or interim final rulemaking	79 FR 71155	12/01/2014

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 19191	04/06/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 71155	12/01/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Initial Burden (annualized over 3 years); Initial Registration	3757	Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
Annual Burden; Registration Renewal
Initial nutrition analysis records
Third Party Disclosure; Initial Burden
Recurring nutrition analysis records
Third Party Burden; Recurring

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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	334,219	334,219	0	0	0	0
Annual Time Burden (Hours)	498,508	498,508	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: This is a new information collection.

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Annual Cost to Federal Government: $200,000

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]? Yes

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: 06/27/2016

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