FDA Seeks Comments on Information Collection Under Security and Bioterrorism Law

The Food and Drug Administration (FDA) has issued two requests for public comments regarding proposed collections of information under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. One notice involves the registration of domestic and foreign food facilities. FDA is calling on owners, operators or agents “in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States,” to provide comments on (i) whether FDA’s proposed information collection is necessary for the agency’s performance and the information has practical utility, (ii) the accuracy of the agency’s information collection burden estimates, (iii) ways of improving the “quality, utility, and clarity of the information to be collected,” and (iv) ways to minimize collection burdens.

The second notice concerns the collection of information pertaining to prior notice of imported food. Under the Act, FDA must “receive prior notice for food, including food for animals, that is imported or offered for import into the United States.” FDA regulations implementing the law set forth the requirements for submitting prior notice and the procedure for requesting FDA review after a food has been refused admission or placed on hold. According to the notice, the law “allows FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nation’s food supply against terrorist acts and other public health emergencies.”

FDA seeks comments on the same topics outlined in the food-facility registration notice. The deadline for comments on both notices is May 17, 2010. See Federal Register, March 16, 2010.