FDA Seeks Comments on Aspects of Bioterrorism Act

FDA Seeks Comments on Aspects of Bioterrorism Act

WASHINGTONThe Food and Drug Administration (FDA) reopened the commentperiod on several aspects of the Bioterrorism Preparedness and Response Act of2002. FDA is specifically seeking comment on how the regulations are affectingforeign facilities that must hire a U.S. agent for registration, and onalternatives for prior notice submission on shipments.

On the registration front, FDA is seeking information on how foreignproducers selected U.S. agents, the cost associated with that relationship, andwhether companies have ceased exporting to the United States because of thisrequirement. In addition, FDA is asking what impact this requirement has had ondomestic small businesses that may have lost trading partners as a result.

As noted in its interim final rule, FDA plans to explore options regardinghow to submit prior notice of shipments when companies are covered by otheragencies programs, such as the Customs- Trade Partnership Against Terrorismor the Free and Secure Trade program. FDA asked several questions in reopeningthe comment period, primarily concerning the timeframe needed for submittingnotices and factors (i.e., training programs) that may be of interest tocompanies.

Finally, FDA and the Bureau of Customs released a plan on how to increaseintegration of customs and bioterrorism regulations. The agencies are workingtogether on several fronts, including co-locating staff members, enhancingcommunications and reducing time requirements for processing shipmentinformation.

The three notices appeared in the April 14 Federal Register (www.fda.gov/ohrms/dockets/default.htm).Comments on all three issues are due by May 14, and can be filed electronicallyat www.fda.gov/dockets/ecomments.