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.
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.
There is burden increase due to implementation of the provision of a new statue.
$0
No
No
Yes
Uncollected
No
Uncollected
Denver Presley 3018271462
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:
(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;
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.
SRFE Documents