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