The International Trade Administration initiated administrative reviews for companies subject to the antidumping orders on frozen warmwater shrimp from India and Thailand. The ITA intends to issue the final results of these reviews by Feb. 28, 2014. The ITA published its notice initiating other antidumping and countervailing duty reviews in the March 29 Federal Register (see 13032816).
On March 29-31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is extending until July 3 the period for submitting comments on the results of its product tracing pilot. The Institute of Food Technologists submitted its report in early March on the pilot, which included companies involved in supply chains for frozen and dry Kung Pao chicken and fresh tomatoes (see 13030418). According to the report, the pilot participants appeared to have in place many of the tools necessary to capture and submit data required for product tracing, although inconsistencies in the data often delayed interpretation by IFT.
The Food and Drug Administration posted a new guidance on user fees and refunds for Premarket Approval Applications (PMAs) and device Biologics License Applications (BLAs). The guidance identifies the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that don’t have a user fee, FDA said. It also identifies circumstances where the fee may be refunded. The guidance is (here).
The Food and Drug Administration amended its regulations on biologics license applications, and BLA amendments and supplements, to show a change of address for the Center for Devices and Radiological Health effective April 2. The new address is 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
The Food and Drug Administration is revising statements required in labeling for over-the-counter nicotine replacement therapy products, it said in a notice set for publication in the April 2 Federal Register. The agency said recent evidence shows that statements on concurrent use of nicotine replacement products with other products that contain nicotine, including cigarettes, as well as a statement on use of nicotine replacement therapy products beyond the intended period, are no longer necessary to ensure safe and effective use. FDA said it is encouraging submission of supplemental new drug applications to modify these statements. See FDA’s notice for new recommended language.
On March 29 the Foreign Agricultural Service issued the following GAIN reports:
The Agricultural Marketing Service said two draft guidance documents are now available on classification and use of materials in organic products. The two National Organic Program draft guidances are intended to remedy confusion on classification of materials as natural or synthetic, and whether a material is on the National List. The guidances also clarify which materials are allowed for use in organic products, AMS said. Comments on the guidances are due by June 3.
A listing of recent antidumping and countervailing duty messages from the International Trade Administration posted to CBP's website March 29, along with the case number(s) and CBP message number, is provided below. The messages are available by searching for the listed CBP message number at addcvd.cbp.gov. (CBP occasionally adds backdated messages without otherwise indicating which message was added. ITT will include a message date in parentheses in such cases.)
The Food Safety and Inspection Service’s pilot on electronic filing of import inspection applications through the Automated Commercial Environment (ACE) will begin in summer 2013, and will include all products under FSIS jurisdiction, including meat, poultry, and processed egg products, the agency said. While FSIS doesn’t currently plan to restrict the number of participants, it may do so based on the number of volunteers responding to the request for participation in the pilot, it said. And although the Federal Register notice announcing the pilot said requests to participate are due by May 28 (see 13032829), FSIS will evaluate any request to volunteer for the pilot, including late requests, and “consider such requests appropriately,” the agency told us.