FDA and CBP to Examine Whether FDA's PN Timeframes Can be the Same as CBPs Advance Cargo Information

The Food and Drug Administration (FDA) has issued a notice with U.S. Customs and Border Protection (CBP) announcing a plan entitled "Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice (PN) Timeframes." Written or electronic comments on the joint plan should be submitted by May 14, 2004.

According to the joint plan, FDA and CBP intend to examine whether the timeframe requirements in FDA's PN interim final rule could be the same as the advance notice timeframes for cargo arriving by land via road or rail, or arriving via air as those currently in CBP's final rule on the advance electronic presentation of cargo information.

(According to FDA sources, FDA is not considering amending its PN timeframes for ocean cargo to mirror those in CBP's final rule.)

FDA and CBP's joint plan, which they intend to implement in August 2004, includes the following with respect to PN timeframes:

August 12, 2004 - October 12, 2004. From August 12, 2004 to October 12, 2004, FDA and CBP plan to assess existing procedures and staffing needed to receive, review, and respond to the prior notices submitted in accordance with the PN interim final rule. The timeframes currently in place are 2 hours before arrival by land by road, 4 hours before arrival by air or land by rail; and 8 hours before arrival by water.

October 13, 2004 - November 12, 2004. FDA states that from October 13, 2004 to November 12, 2004, FDA and CBP intend to identify what changes to work practices and staffing would be necessary to determine if FDA could continue to receive, review, and respond to all PN submissions with reduced timeframes (e.g., 1 hour (or 30 minutes for Free and Secure Trade (FAST)/Customs-Trade Partnership Against Terrorism (C-TPAT) participants before arrival by land by road); 2 hours before arrival by land by rail; and by "wheels up" for flights originating in North and Central America, South America (north of the Equator only), the Caribbean, and Bermuda; otherwise 4 hours before arrival by air.)

November 13, 2004 - February 12, 2005. From November 13, 2004 to February 12, 2005, FDA and CBP plan to implement necessary changes and make appropriate adjustments to ensure that they could receive, review, and respond to all PN submissions with reduced timeframes.

March 2005. In March 2005, FDA and CBP intend to issue a PN final rule that responds to the comments received on the PN interim final rule, including this plan, during the two open comment periods.

Evaluation of Whether to Reduce Timeframes for PN Will Depend on Compliance

FDA explains that any timeframe must be sufficient to receive, review, and respond to PN submissions, as set out in certain provisions of the Federal Food, Drug, and Cosmetic Act. FDA and CBP emphasize that the evaluation of whether to reduce the timeframes for PN review will depend on the level of compliance industry achieves during the assessment.

FDA stresses that if it and CBP are unable to make such an assessment, the intended timeframe for issuing a PN final rule may be delayed.

FDA and CBP Also Working to Increase Integration

In addition to the above-described assessment of PN timeframes, FDA and CBP are currently working to increase integration in the following ways:

Co-location of all FDA PN staff with CBP's National Targeting Center (NTC 1);

Further refinement to FDA's targeting rule sets in CBP's Automated Targeting System (ATS), coupled with additional training in targeting techniques;

Continued targeting support from CBP and other Federal law enforcement analysts at the NTC; and

Enhancement of communications and cooperation with CBP to facilitate information exchange and ensure expeditious access to foods subject to PN holds.

• written or electronic comments due by May 14, 2004.

(See ITT's Online Archives or today's ITT, 04041410, for BP summary of FDA's reopening of the PN comment period.

See ITT's Online Archives or 11/10/03 news, 03111010, for BP summary of the FDA's interim final rule on PN. See ITT's Online Archives or 01/20/04 news, 04012035, for BP summary of CBP final rule on advance electronic presentation of cargo information.)

FDA Plan (dated 04/14/04) available at http://www.cfsan.fda.gov/pn/pnplan.html

FDA Notice (D/N 2002N-0278, FR Pub 04/14/04) available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-8515.pdf.