FDA Progressing on ACE/ITDS Interoperability Legal Hurdles
The Food and Drug Administration is close to finishing its high-level review of a memorandum of understanding (MOU) with CBP that would allow the two agencies to share importer filing information through the International Trade Data System, said an FDA official, speaking at the National Customs Brokers and Forwarders Association of American Government Affairs Conference Sept. 23. The MOU is now with the agency's Office of the General Counsel, which is working to address some “minor issues,” said Ted Poplawski, special assistant to the director in FDA’s Division of Import Operations.
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The completion of the MOU and addition of FDA to the program would mark a major development for ITDS and the Automated Commercial Environment because the FDA plays a major role in importing oversight. Poplawski said the FDA has also provided information for the Participating Government Agency (PGA) message set, which allows for the operational sharing of import data, but the data can't actually be shared until the agencies agree to the MOU. CBP is in the process of completing the MOUs, which are required as a result of privacy laws that require certain protections for the sharing of information, with a number of agencies. FDA has an integration plan and a team that's looking at the various aspects of the rollout of ACE and ITDS, he said. The FDA is also anticipating and developing budgets that are in line with CBP's ACE/ITDS timeframe to make sure the FDA has enough funds to complete the implementation, said Poplawski.
The FDA is also working to add some features to the Import Trade Auxiliary Communication Systems (ITACS), said Poplawski. For instance, the FDA will add some more “robust” messaging. The agency is also looking at how and when to allow the CBP Document Image System to “mesh” with ITACS, he said. The FDA is continuing to look at and make adjustment to its Centralized Review Pilot (see 13061915), though there's no immediate plans to expand the pilot beyond the ports now participating, he said.