CSMS Message: 13-000250

FDA is issuing this communication to notify all users of the new “External Lab Analytical Package” document type in FDA's Import Trade Auxiliary Communication Systems (ITACS), and to remind all parties of FDA's willingness and preference to accept private laboratory analytical results in electronic formats.

It is FDA's preference for private laboratory analytical reports to be submitted in an electronic format for greater ease and speed of processing by FDA. The ITACS “External Lab Analytical Package” document type provides users an additional means of submitting private laboratory analytical reports in an electronic format.

FDA has an automated process for the routing and review of private laboratory analytical reports which allows FDA to process private laboratory analytical reports submitted via electronic means more quickly than private laboratory analytical reports submitted in hard copy forms. In order to avoid potential delays, private laboratory analytical reports should be submitted electronically via ITACS.

In general, private laboratory analytical reports should be submitted to FDA Districts as per established District contact points:
* Submission of private laboratory analytical reports via ITACS is the preferred means of submitting those reports.
* Some Districts have set up special email accounts for the purpose of accepting private laboratory analytical reports and other testimony in the Detention and Hearing process.
* Submissions of testimony can be routed to the contact point(s) listed in the specific Notice of FDA Action referencing the detention of the entry/line.

If submitters are unsure as to where to submit information, this should be confirmed with the contact point(s) identified in the Notice of FDA Action.

All analyses conducted by private laboratories and the reports submitted for those analyses are expected to conform to the guidance found in FDA's ORA Laboratory Manual, Volume III, Section 7, “Private Laboratory Guidance”, found at: http://www.fda.gov/downloads/ScienceResearch/FieldScience/LaboratoryManual/UCM092191.pdf

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be directed to FDA's Office of Regulatory Science, at (301) 796-5992.

Instructions on how to use ITACS to submit documentation and information to the FDA can be found at the following link: http://www.fda.gov/ForIndustry/ImportProgram/ucm296314.htm or directed to itacssupport@fda.hhs.gov

Questions involving the status of specific entries and/or the processing of specific entries should be directed to the FDA District covering the Port of Entry for the entry. FDA District contact information can be found at the following link: http://www.fda.gov/ForIndustry/ImportProgram/ucm319216.htm

Questions involving FDA import operations and/or FDA import policy in general should be directed to FDA's Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov