FDA seeks second round of comments on bioterror rules
The U.S. Food and Drug Administration will reopen for an additional 30 days the comment periods for the food facility registration and prior notice requirements once notice is published in the Federal Register Wednesday.
The FDA published an interim final rule last October requiring foreign and domestic manufacturers, processors and distributors of food products to register with the FDA by Dec. 12, as mandated by the Bioterrorism Act. Importers were also required to electronically provide the government advance notice of imports.
Agency officials originally promised last year that they would reopen the comment period in March to prepare improved final rules after industry had a chance to deal with FDA's reporting timeframes, electronic filing process and required data elements.
The agency is interested in determining the degree to which the advance reporting system can be integrated with the Customs and Border Protection advance manifest filing system and expedited clearance programs, such as the Customs-Trade Partnership Against Terrorism and the Free and Secure Trade program for truck traffic. The agency also seeks information on the impact of the rules so far on industry, including the cost to foreign suppliers of hiring a U.S. agent for registration purposes, and whether there should be flexible alternatives to prior notice.
Comments should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or submitted online at http://www.fda.gov/dockets/ecomments.