The Food and Drug Administration (FDA) has proposed two new information collections related to voluntary registration, recordkeeping and mandatory third-party disclosure under section 4205 of the Patient Protection and Affordable Care Act of 2010. Section 4205 requires chain restaurants with 20 or more locations, as well as operators of 20 or more vending machines, to disclose “certain nutritional information on certain food items offered for sale so that consumers can make more informed choices about the food they purchase.” In addition, it provides for restaurants or operators with fewer than 20 locations to biannually opt in to the federal requirements.

The first proposed information collection pertains to FDA’s program for voluntary registration under section 4205. FDA anticipates that chains with 10 to 19 outlets “may choose to register, either because they are growing quickly, or because they are concerned about possible regulation.” According to FDA, “[t]he primary source of potential registrants will be restaurant and specialty food chains,” but also convenience and grocery stores with take-away services and food establishments in retail, hotel, corporate, education, military or entertainment settings.

The proposed information collection would apply to these businesses, which must register using Form FDA 3757 and provide details that include (i) contact information for the authorized official or vending machine operator, as well as for each restaurant location and each vending machine being registered, and (ii) “[c]ertification that the information submitted is true and accurate, that the person or firm submitting it is authorized to do so, and that each registered” restaurant or vending machine will be subject to the menu labeling provisions of the Act. After the initial registration, these businesses must register “every other year with FDA, and the registration will expire if not renewed.”

The secondproposed information collection involves section 4205’s recordkeeping and mandatory third-party disclosure requirements. According to FDA, section 4205 requires, in part, that chain retail food establishments disclose calorie counts for each standard menu item on menus and menu boards, and that vending machine operators make this information available on “a sign in close proximity to each article of food (or the selection button).” In addition to this mandatory third-party disclosure on menus and vending machines, these businesses must demonstrate recordkeeping compliance for the calorie analysis.  

The agency has estimated that the reporting burden for the voluntary registration program will be 724 hours in the first year and 96 hours each year thereafter. FDA has also provided detailed reporting estimates “associated with discovering and recording the calorie count for each menu/vending item; and the third party disclosure burden associated with communicating that information to the consumer”; that is, the time needed “to change out redesigned menu boards.” Among other things, FDA requests feedback on whether each proposed information collection is necessary and whether the estimated reporting burdens are accurate. FDA will accept comments on the first proposed collection until January 3, 2011, and on the second until January 4, 2011. See Federal Register, November 4, 2010.