Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

OMB Control No. 0910-0783

JUSTIFICATION MEMORANDUM FOR 83-C CHANGE REQUEST

The Food and Drug Administration (we) is submitting this nonmaterial/non-substantive change request (83-C) in order to make minor edits to Form FDA 3757 (attached with edits highlighted). This form is also approved for use under OMB Control No. 0910-0782, Food Labeling; Calorie Labeling of Articles of Food in Vending Machines (Vending). The edits for Vending only apply to the business phone number and mailing address. The edits clarify and conform to the information collection provisions in both supporting statements, which were previously approved by OIRA. The edits will help FDA to better identify respondents providing nutrition information for menu and vending machine labeling pursuant to the Patient Protection and Affordable Care Act of 2010. We do not expect a change in the hour or cost burden estimates.

We propose to add a line to the form so a business may provide any trade names it may have. This line is applicable only if the respondent uses a trade name that is different from the business name listed on the form.

We propose to add lines for business phone and email. The current form only has a line for the email of the on-site official. Further, we propose to add a line for the on-site official’s phone number. With the addition of the lines for business phone and email, the line for the on-site official’s phone number and email is applicable only if this information is different from the business.

We propose to add a line for mailing address, which is applicable only if the address is different from the business address. This will allow FDA to send correspondence to the respondent’s preferred address.

These minor edits are consistent with what was delineated in the supporting statements for 0910-0783 and to a lesser extent, 0910-0782 (please see section 2 of both supporting statements) with approval by OIRA on 3/10/2015.