COAC Urges FDA to Allow Advance Data Submissions, Improve Messaging to Reduce Delays

The effort is intended to “help improve the quality of data submitted to FDA and reduce the number of rejects that don’t pass the automated screening process in PREDICT,” FDA’s automated screening tool, said Susie Hoeger, director of trade compliance at Abbott Laboratories. “According to FDA, only 30 percent of lines get an automated ‘may proceed’ at the time of entry, with the remainder, 70 percent, requiring some level of manual review by FDA personnel,” said Hoeger as she introduced the working group’s report. “Less than 0.01% of those lines are ultimately refused entry, so there’s a lot of manual process, and not a lot of violative product being caught in the process,” she said.

As FDA moves toward implementation of the International Trade Data System (ITDS) and the Participating Government Agency (PGA) Message Set in ACE, the agency “would like to see a higher level of automated may proceeds, allowing them to redeploy their limited resources to higher risk shipments,” said Hoeger. The list of 32 recommendations focused on practical actions FDA can take that are “achievable within a reasonable amount of time” and don’t “require a huge amount of funds to move forward,” according to working group participant Mike Mullen of the Express Association of America.

Of the 32 recommendations listed by the FDA working group, which operates under COAC’s One U.S. Government at the Border Subcommittee, 11 were adopted by the full COAC. The other 21 were not put up for formal adoption. The 11 recommendations in the report adopted by COAC include:

Advance data submissions. CBP and FDA should accept and review advance data submissions as early as possible to allow for preclearance prior to arrival. Earlier submissions would allow the agencies to better assess and resolve risks, as well as provide for earlier admissibility decisions, well before the physical arrival of the goods at the port.

Ability to amend FDA data elements. Working with FDA, CBP should develop a mechanism in ACE for importers and filers to amend specific FDA data elements, including port codes, without having to cancel and replace the entire entry.

Align foreign site identification numbers. Foreign site identification numbers (e.g. MID, DUNS, IOR, FEI, FFR, etc.) used by CBP, FDA and other agencies in ACE should be reduced to a single ID number, creating a uniform standard in ACE/ITDS. The creation and maintenance of FEIs requires FDA resources that could be better deployed to other higher risk targeting activities.

Specific and timely messaging. FDA transactional messaging in ACE should be specific and timely, notifying the filer what's missing, incorrect, or has been changed by FDA, and a full audit trail should be maintained for any changes that have been made to an entry.

Intended use codes. CBP should work with FDA to define optional Intended Use Codes in the PGA Message Set in order to allow importers and filers to give reasons for disclaiming FDA on certain imported goods, like U.S. goods returned, where the HTS code may trigger FDA review but the goods aren't subject to FDA regulation.

Increased outreach. CBP should hold an FDA Workshop as a regular breakout session at the annual Trade Symposium. The relevant CEEs should also partner with FDA to host periodic outreach and training events for importers and filers, with targeted training at ports with higher rates of non-automatic may proceeds.

Section 321 entries. CBP and FDA should provide guidance to the trade community regarding the use of Section 321 entries for FDA-regulated goods.

Standard filer evaluation process. CBP should collaborate with FDA to implement a standardized filer evaluation process, based on guidance to the brokerage industry on how the evaluations will be conducted.

Integration into CEEs. CBP and FDA should consider consolidating and integrating FDA field and port operations into corresponding CBP Centers of Excellence and Expertise to provide better uniformity and resource utilization.

Consult with the trade. CBP, via the Border Interagency Executive Council, should encourage FDA and other PGAs to continue to consult with the trade community via COAC. In addition, FDA should use periodic trade surveys to identify current areas of opportunity, allowing the agency to better focus on areas that need further analysis or attention.

Agency buy-in. To ensure full agency buy-in, any actions taken to fulfill these recommendations should be pushed down from the Commissioner level to the operational level at both CBP and FDA.

The other 21 recommendations in the working group’s report were not put up for adoption by the full COAC, but are nonetheless being provided to FDA, with highlights as follows:

• An FDA trusted trader program, and accounting for an importer’s “known” or “trusted” status to decrease targeting in PREDICT.
• More targeted import alerts that include the foreign establishment’s registration number.
• Prevaluation of importer/filer data sets (master data) outside of the entry process.
• Improvement of the product code builder and the addition of a new feature allowing importers and filers to request more descriptive product codes.
• A new help desk to provide guidance to importers and filers on FDA Product Codes and Affirmation of Compliance (AoC) codes, with a response time of less than 24 hours.
• Compliance guides for industry defining what information is required for each product category and the consequences of not providing that data.
• Additional FDA outreach to foreign shippers on U.S. import requirements.
• Better guidance on FDA Units of Measure when different from CBP.
• Increase the use of ITACS to eliminate duplicate communication and interface with the ACE Document Imaging System.
• Allow the importer to designate where Notices of Action are sent, or disseminate Notices of Action to all interested parties.
• Develop a process whereby frequent importers of U.S. Goods Returned can provide additional information on the nature of their business.

FDA Official Welcomes Suggestions

A top FDA import official present at the COAC meeting praised the working group’s recommendations, and pledged to continue the dialogue while the report is reviewed throughout the agency. “For us to do our jobs, we have to have good communication,” said Douglas Stearn, director of FDA’s Office of Enforcement and Import Operations. “I have seen areas where we did have success, where we were able to facilitate that kind of feedback back and forth between the trade where we were able to remove some of those barriers,” said Stearn. “I think that’s especially important in areas that are more regulated, because they’re areas where that kind of disconnect can happen.”