Justification for Nonsubstantive Change for ROCIS updates

UNITED STATES FOOD & DRUG ADMINISTRATION

OMB Control No. 0910-0546: Reporting Associated with Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of Color Additives on Animal Food Labels

Request for Non-Substantive/Non-Material Change:

FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue regulations concerning animal food. Specifically, section 403(i) of the FD&C Act (21 U.S.C. 343(i)) requires that certified color additives used in or on a food must be declared by their common or usual names and not be designated by the collective term “colorings.” Our regulations in part 501 (21 CFR part 501) set forth the requirements for animal food labeling. Under 21 CFR 501.22(k), animal food manufacturers must declare on the animal food label the presence of certified and noncertified color additives in their animal food products. The information collection associated with 21 CFR 501.22(k) is approved under both OMB control numbers 0910-0721 and 0910-0546.

We intend to discontinue OMB control number 0910-0721, for government efficiency, consistent with language in the supporting statement for OMB control number 0910-0546. Before we submit the discontinue request, we seek approval to update the ROCIS database entry for OMB control number 0910-0546. Specifically, regarding the information collection associated with declaration of color additives on animal food labels, we added the statutory authority reference and information in the abstract. We also updated the percentage of respondents reporting electronically and the number of respondents to reflect the estimates already accounted for in the supporting statement. Therefore, we have made no adjustment to the currently approved burden estimate in control no. 0910-0546.

Submitted: September 2023