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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0665
ICR Reference No:
201007-0910-001
Status:
Historical Active
Previous ICR Reference No:
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:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
07/16/2010
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/16/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/15/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2011
6 Months From Approved
Responses
318,821,987
0
0
Time Burden (Hours)
14,536,183
0
0
Cost Burden (Dollars)
69,937,166
0
0
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.
Emergency Justfication:
FDA is requesting emergency OMB approval of the collection of information requirements imposed by PPACA that became effective March 23, 2010 to alleviate as quickly as possible the resulting violation of the PRA. In addition, FDA seeks OMB approval of these information collection provisions of PPACA by July 16,2010, so the agency can publish final guidance. FDAs guidance will (1) Inform State and local governments and the industy about the immediate effects of the law;(2) describe FDAs current plans with respect to enforcement discretion pending the issuance of additional guidance; and (3)clarify Section 4205`s effect on State and local menu and vending machine labeling laws.
Authorizing Statute(s):
US Code:
21 USC 4205
Citations for New Statutory Requirements:
US Code: 21 USC 4205
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
17
IC Title
Form No.
Form Name
Recordkeeping : New Vendors- Calorie Analysis and Recording (recurring)
Recordkeeping- C-Store Chains: Calorie Analysis and Recording ( initial)
Recordkeeping- Grocery Chains: Calorie Analysis and Recording ( initial)
Recordkeeping-Restaurant Chains - Calorie Analysis and Recording (initial)
Recordkeeping: New Chains - Calorie Analysis and Recording ( recurring)
Recordkeeping: New Items- Calorie Analysis and Recording ( recurring)
Recordkeeping: Other Chains - Calorie Analysis and Recording ( initial)
Recordkeeping: Vending Operators- Calorie Analysis and Recording ( initial)
SRFE Documents
Third Party Disclosue: Grocery Chains - Calorie Content
Third Party Disclosure: C-Store Chains- Calorie Content
Third Party Disclosure: New Menu Items Calorie Content
Third Party Disclosure: New SRFE Outlets- Calorie Content
Third Party Disclosure: Other Chains - Calorie Content
Third Party Disclosure: Restaurant Chains - Calorie Content
Third Party Disclosure: Vending ( growth) Calorie Content
Third Party Disclosure: Vending ( ongoing)- Calorie Content
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
318,821,987
0
318,821,987
0
0
0
Annual Time Burden (Hours)
14,536,183
0
14,536,183
0
0
0
Annual Cost Burden (Dollars)
69,937,166
0
69,937,166
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:
There is burden increase due to implementation of the provision of a new statue.
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]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Denver Presley 3018271462
Common Form ICR:
No
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:
07/15/2010
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