0706 Justification Revised 7/20

TO: OMB, OIRA

FROM: FDA

Re: 0910-0706 Justification for Non-material change of currently approved information collection.

In accordance with the OMB Terms of Clearance for ICR 0910-0706: Comparing Nutrition Knowledge, Attitude, and Behavior Among English Dominant Hispanics,

Spanish Dominant Hispanics, and Other Consumers, FDA is submitting this non-material/non-substantive change request (83-C). As reflected in its supporting statements, the study will collect information to help the agency advance its public health mission with regard to nutrition and health among Hispanics, the largest and fastest growing minority group in the nation. The change provides the survey instrument, including the public disclosure burden statement, in both English and Spanish as it is intended to be implemented by FDA. The survey instrument was not provided to OMB upon FDA’s initial referral of the information collection package, however, it does reflect what was approved by OMB for this collection. At the same time, OMB requested that the survey instrument be provided prior to implementation of the study. This change, therefore, is non-material/non-substantive as the instrument being provided in accordance with the terms of clearance presents the questions as FDA will employ them to the study/survey participants.