This is a direct post from federalregister.gov because we want everyone to be aware.
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments—Small Entity Compliance Guide”. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.”
In the Federal Register of December 1, 2014 (79 FR 71156), we issued a final rule requiring nutrition labeling of standard menu items in restaurants and similar retail food establishments (the final rule). The final rule, which is codified at 21 CFR 101.11, is effective December 1, 2015.
We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rule will have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-28), we are making available the SECG to explain the actions that a small entity must take to comply with the rule.
We are issuing the SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents our current thinking on nutrition labeling of standard menu items in restaurants and similar retail food establishments. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Paperwork Reduction Act of 1995:
This SECG refers to collections of information described in FDA's final rule that published in the Federal Register of December 1, 2014 (79 FR 71156), and that will be effective on December 1, 2015. As stated in the final rule, these collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). In compliance with the PRA (44 U.S.C. 3507(d)), the Agency has submitted the information collection provisions of the final rule to OMB for review. FDA will publish a document in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.