Section 4205 of the Patient Protection and Affordable Care Act ( P.L. 111-148: Restaurant Menu Labeling : Registration For Small Chains

Forms and Documents

Document Name	Status
Form 3757 Reporting - Re- registrations ( recurring) Form and Instruction	Modified
Form 3757 Reporting - New Registrations ( recurring) Form and Instruction	Modified
Form 3757 Reporting: Registration for Other SRFE ( initial) Form and Instruction	Modified
Form 3757 Reporting : Registration for C-store ( initial) Form and Instruction	Modified
Form 3757 Reporting: Registration for Grocery ( initial) Form and Instruction	Modified
Form 3757 Reporting- Registration for Restaurants ( initial) Form and Instruction	Modified
FRN-0910-0664.pdf Supplementary Document	2011-01-31
SS-0910-0664.- Rev. 04-01-11.doc Supporting Statement A	2011-04-01

IC Document Collections

IC ID	Document Title	Status
193810	Reporting - Re- registrations ( recurring) Form and Instruction	Modified
193809	Reporting - New Registrations ( recurring) Form and Instruction	Modified
193808	Reporting: Registration for Other SRFE ( initial) Form and Instruction	Modified
193807	Reporting : Registration for C-store ( initial) Form and Instruction	Modified
193806	Reporting: Registration for Grocery ( initial) Form and Instruction	Modified
193805	Reporting- Registration for Restaurants ( initial) Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0664	ICR Reference No: 201101-0910-007
Status: Historical Active	Previous ICR Reference No: 201007-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Section 4205 of the Patient Protection and Affordable Care Act ( P.L. 111-148: Restaurant Menu Labeling : Registration For Small Chains
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: 04/25/2011
	Date Received in OIRA: 01/31/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2014	36 Months From Approved	04/30/2011
Responses	724	0	2,432
Time Burden (Hours)	820	0	1,755
Cost Burden (Dollars)	0	0	0

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Abstract: In addition to restaurant menu and vending machine labeling, section 4205 of the "Affordable Care Act" provides that persons or firms not subject to the disclosure of nutrition information required by this legislation, such as chain restaurants with fewer than 20 locations or vending machine operators with fewer than 20 vencing machines may elect to be subject to the requirements provided under section 4205 by registering biannually with FDA. Under section 4205, FDA must publish notice in the FEDERAL REGISTER within 120 days of the date of enactment ot the legislation ( i.e. July 21, 2010), providing information on the terms and conditions for persons who voluntarily elect to be subject to nutition disclosue requirements specified in the legislation.

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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 67978	11/04/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 5384	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: 6

IC Title	Form No.	Form Name
Reporting- Registration for Restaurants ( initial)	3757	DHHS/FDA MENU AND VENDING MACHINE VOLUNTARY REGISTRATION
Reporting: Registration for Grocery ( initial)	3757	DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION
Reporting : Registration for C-store ( initial)	3757	DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION
Reporting: Registration for Other SRFE ( initial)	3757	DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION
Reporting - New Registrations ( recurring)	3757	DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION
Reporting - Re- registrations ( recurring)	3757	DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY 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	724	2,432	0	-1,708	0	0
Annual Time Burden (Hours)	820	1,755	0	-935	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: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There has been a program change reduction of 935 annual estimated burden hours due to agency descretion as a result of an overestimate at the emergency approval stage. Please refer to item 15 of the supporting statement for additional details.

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Annual Cost to Federal Government: $260,000

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: 01/31/2011

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