FDA Seeking Comments on Aspects of Bioterrorism Act

WASHINGTON--The Food and Drug Administration (FDA) reopened the comment period on several aspects of the Bioterrorism Preparedness and Response Act of 2002. FDA is specifically seeking comment on how the regulations are affecting foreign facilities that must hire a U.S. agent for registration, and on alternatives for prior notice submission on shipments.

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

As noted in its interim final rule, FDA plans to explore options regarding how to submit prior notice of shipments when companies are covered by other agencies' programs, such as the Customs-Trade Partnership Against Terrorism or the Free and Secure Trade program. FDA asked several questions in reopening the comment period, primarily concerning the timeframe needed for submitting notices and factors (i.e., training programs) that may be of interest to companies.

Finally, FDA and the Bureau of Customs released a plan on how to increase integration of customs and bioterrorism regulations. The agencies are working together on several fronts, including co-locating staff members, enhancing communications and reducing time requirements for processing shipment information.

The three notices are set to appear 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 electronically at www.fda.gov/dockets/ecomments.