FDA Import Review Continues; Other Services at Reduced Levels, Some Consolidation Between Ports
Food and Drug Administration Import Operations staff are continuing to perform their import review functions during the federal government shutdown, but the agency is working at reduced service levels for inspections and other activities, said United Parcel Service (UPS) Supply Chain Solutions in an update emailed Oct. 7. FDA is consolidating work at some FDA ports of entry during the shutdown. For example, FDA Alexandria Bay, N.Y. clearances will be handled by FDA Ogdensburg, N.Y., the update said.
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
FDA can’t accept fiscal year 2014 user fees during the shutdown. That has put a hold on FY 2014 registration for drug and device facilities (see 13100714). UPS said the agency has also stopped accepting other registrations that require fees, such as the Device Registration Listing Module (DRLM) and the Center for Devices and Radiological Health Export Application and Tracking System (CECATS). The FDA Center for Drug Evaluation and Research is continuing its review of applications submitted before Oct. 1. Also, food facility registrations are unaffected because they don’t require user fees, UPS said.
FDA posted details (here) of how the shutdown will affect its medical product activities under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), Biosimilar User Fee Act, and Medical Device User Fee Act, as well as for other non-PDUFA and non-GDUFA drugs. In general, FDA will continue to accept PDUFA and GDUFA applications that don’t require fees during the shutdown, but will not accept any new applications that require FY 2014 user fees. It expects to continue its review of PDUFA, GDUFA, and MDUFA applications submitted before Oct. 1. The agency said it will halt its activities related to biosimilars during the shutdown, except for emergency work.
Miami FSVP Meeting Canceled
FDA also canceled its meeting on the Foreign Supplier Verification Program and third-party auditor proposed rules that was set for Oct. 10-11 (see 13091720) in Miami, Fla., according to the registration page for the meeting. With the closure of the U.S. federal government, we've been instructed to communicate ... that the meeting has been canceled," said the message on the webpage (here).