Section 4205 of the Patient Protection and Affordable Care Act Restaurant Menu Labeling; Recordkeeping and Mandatory Third Party Disclosure

Forms and Documents

Document Name	Status
0910-0665 Correction to Q15 of the supporting statement (4).doc Supplementary Document	2011-06-09
SS- 0910-0665 Rev 05-16-11 att2.doc Supporting Statement A	2011-05-16

IC Document Collections

IC ID	Document Title	Status
193803	SRFE Documents Other-Guidance	Removed
193802	Third Party Disclosure: Vending ( growth) Calorie Content Other-Guidance	Modified
193801	Third Party Disclosure: Vending ( ongoing)- Calorie Content Other-Guidance	Modified
193800	Third Party Disclosure: New SRFE Outlets- Calorie Content Other-Guidance	Modified
193799	Third Party Disclosure: New Menu Items Calorie Content Other-Guidance	Removed
193798	Third Party Disclosure: Other Chains - Calorie Content Other-Guidance	Modified
193797	Third Party Disclosure: C-Store Chains- Calorie Content Other-Guidance	Removed
193796	Third Party Disclosue: Grocery and Convenience Store Chains - Calorie Content Other-Guidance	Modified
193795	Third Party Disclosure: Restaurant Chains - Calorie Content Other-Guidance	Modified
193794	Recordkeeping : New Vendors- Calorie Analysis and Recording (recurring) Other-Guidance	Modified
193793	Recordkeeping: New Chains - Calorie Analysis and Recording ( recurring) Other-Guidance	Modified
193792	Recordkeeping: New Reformulated Items- Calorie Analysis and Recording ( recurring) Other-Guidance	Modified
193791	Recordkeeping: Vending Operators- Calorie Analysis and Recording ( initial) Other-Guidance	Modified
193790	Recordkeeping: Other Chains - Calorie Analysis and Recording ( initial) Other-Guidance	Modified
193789	Recordkeeping- C-Store Chains: Calorie Analysis and Recording ( initial) Other-Guidance	Removed
193788	Recordkeeping- Grocery and Convenience Store Chains: Calorie Analysis and Recording Other-Guidance	Modified
193787	Recordkeeping-Restaurant Chains - Calorie Analysis and Recording Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0665	ICR Reference No: 201101-0910-008
Status: Historical Active	Previous ICR Reference No: 201007-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Section 4205 of the Patient Protection and Affordable Care Act Restaurant Menu Labeling; Recordkeeping and Mandatory Third Party Disclosure
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/09/2011
	Date Received in OIRA: 01/31/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	36 Months From Approved	06/30/2011
Responses	280,907,133	0	318,821,987
Time Burden (Hours)	14,531,562	0	14,536,183
Cost Burden (Dollars)	121,355,912	0	69,937,166

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Abstract: On March 23,2010, the President signed into law the Patient Protection and Affordable Care Act( P.L. 11-148)( the legislation or PPACA). Section 4205 of the legislation, which principally amends Sections 403 and 403A of the Federal Food Drug and Cosmetic Act ( the act), requires restaurants or 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 ("chain restaurants or similar retail food establishments") as well as owners or operators of 20 or more vending machines ("chain vending machines") to disclose cetain nutition information on certain food items offered for sale so that consumers can make more informed choices about the nutritional content of the food they purchase. Non-Federal nutrition labeling laws for chain restaurants or similar retail food establishments and vending machines are preempted.

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Authorizing Statute(s): US Code: 21 USC 4205 Name of Law: null
  

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:
	75 FR 68361	11/05/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 5380	01/31/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Recordkeeping-Restaurant Chains - Calorie Analysis and Recording
Third Party Disclosure: Restaurant Chains - Calorie Content
Third Party Disclosue: Grocery and Convenience Store Chains - Calorie Content
Third Party Disclosure: Other Chains - Calorie Content
Third Party Disclosure: New SRFE Outlets- Calorie Content
Third Party Disclosure: Vending ( ongoing)- Calorie Content
Third Party Disclosure: Vending ( growth) Calorie Content
Third Party Disclosure: C-Store Chains- Calorie Content
Third Party Disclosure: New Menu Items Calorie Content
SRFE Documents
Recordkeeping- Grocery and Convenience Store Chains: Calorie Analysis and Recording
Recordkeeping- C-Store Chains: Calorie Analysis and Recording ( initial)
Recordkeeping: Other Chains - Calorie Analysis and Recording ( initial)
Recordkeeping: Vending Operators- Calorie Analysis and Recording ( initial)
Recordkeeping: New Reformulated Items- Calorie Analysis and Recording ( recurring)
Recordkeeping: New Chains - Calorie Analysis and Recording ( recurring)
Recordkeeping : New Vendors- Calorie Analysis and Recording (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	280,907,133	318,821,987	0	0	-37,914,854	0
Annual Time Burden (Hours)	14,531,562	14,536,183	0	0	-4,621	0
Annual Cost Burden (Dollars)	121,355,912	69,937,166	0	0	51,418,746	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There are no program changes associated with this collection. Any reported increase within an IC were due to a revision in the way the ICs were organized. There has been a reduction in burden as a result of recalculation of reapondents and burden.

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Annual Cost to Federal Government: $0

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: 01/31/2011

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