CSMS 42635055·Operational·May 8, 2020·View on csms.cbp.gov ↗

FDA Document Submission During COVID-19 Pandemic

Plain-English explanation

CSMS 42635055 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin (operational), published on May 8, 2020. It carries the official CBP guidance brokers and importers must follow for the topic — "FDA Document Submission During COVID-19 Pandemic". CSMS messages are the operational layer between Commerce determinations and at-the-border collections: when Commerce publishes a new rate, scope ruling, or instruction, CBP turns it into a CSMS that ACE/ACS systems and brokers act on.

Message body

Full text as published by U.S. Customs and Border Protection

CSMS #42635055 - FDA Document Submission During COVID-19 Pandemic U.S. Customs and Border Protection sent this bulletin at 05/08/2020 08:18 AM EDT Cargo Systems Messaging Service CSMS #42635055 - FDA Document Submission During COVID-19 Pandemic The Food and Drug Administration (FDA) continues critical work to protect public health during the COVID-19 pandemic. This work includes review of FDA regulated products offered for importation. If a request for documents is received from FDA, filers and/or importers are strongly encouraged to submit product labeling along with regularly submitted entry documents (commercial invoice, packing list, way bill, etc.). Submission of labeling will help expedite the admissibility process during this pandemic. Labeling along with entry documents should be submitted electronically via the FDA Import Trade Auxiliary Communication System (ITACS). ITACS functionality can be accessed at https://itacs.fda.gov . This includes checking statuses, providing requested documentation and location of goods electronically, and checking the estimated laboratory analysis completion dates for lines which have been sampled. Additional information on ITACS, including questions and answers, can be found on FDA’s ITACS for Industry webpage: https://www.fda.gov/industry/import-systems/itacs . For further questions regarding ITACS, please contact itacssupport@fda.hhs.gov . Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page . You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact subscriberhelp.govdelivery.com . This service is provided to you at no charge by U.S. Customs and Border Protection . Privacy Policy | GovDelivery is providing this information on behalf of U.S. Department of Homeland Security, and may not use the information for any other purposes. Powered by Privacy Policy | Cookie Statement | Help

Frequently asked questions

What is CSMS 42635055?

CSMS 42635055 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin titled "FDA Document Submission During COVID-19 Pandemic". CSMS bulletins are the operational instructions CBP issues to brokers, importers, and ACE filers covering rate changes, system updates, scope guidance, and other day-to-day customs-operations changes.

When was CSMS 42635055 published?

CBP published CSMS 42635055 on May 8, 2020. The bulletin's instructions are typically operative as of the publication date unless the body specifies a different effective date.

Is the CBP CSMS the legally binding instruction?

Yes — for at-the-border filing and entry collection. CSMS messages translate Commerce's Federal Register determinations into operational CBP instructions that ACE/ACS systems and brokers execute. The Federal Register notice is the underlying legal authority; the CSMS is the operational implementation. Both should be read together when reconciling a rate or scope change.

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