The Food and Drug Administration said it intends to take enforcement action against unapproved injectable drug products containing sodium nitrite or sodium thiosulfate labeled for the treatment of cyanide poisoning, as well as against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. The antidotes carry serious risks, and unapproved drug products may lack warnings required in the labeling of approved cyanide antidotes, FDA said.
On Nov. 26 the Foreign Agricultural Service issued the following GAIN reports:
The Animal and Plant Health Inspection Service announced changes Nov. 26 to Plant Protection and Quarantine (PPQ) electronic manuals. While some changes are minor, other changes may affect the admissibility of the plant products, including fruits, vegetables, and flowers.
A listing of recent antidumping and countervailing duty messages from the International Trade Administration posted to CBP's website Nov. 26, 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 http://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 Nov. 27 proposed rule to amend import inspection regulations for meat, poultry, and egg products would allow for electronic submission of import inspection applications, foreign inspection certificates, and foreign establishment certificates through the Public Health Information System (PHIS) Import Component. But FSIS is proposing other changes that will affect importers. The agency is more strictly defining the time frame for prior notification of imported products, ceasing to accept foreign inspection certificate replacement guarantees for entry into the U.S. when the certificate has been lost or contains errors, and said it will work with CBP to monitor “failures to present” for import reinspection. Comments on the proposed rule are due Jan. 28.
The Bureau of Industry and Security proposed its long-promised “clean-up” of the Commerce Control List (CCL), in a rule scheduled for publication in the Nov. 29 Federal Register. The proposed rule follows a December 2010 request for comments on how to make descriptions of items controlled on the CCL clearer. ECCNs in all categories of the CCL, as well as its basic structure, would be affected by the proposal. Comments on the proposed rule are due by Jan. 28.
Mexico's Diario Oficial of Nov. 26, lists notices from the Secretary of the Economy as follows:
The International Trade Commission is publishing notices in the Nov. 26 Federal Register on the following AD/CV injury, Section 337 patent, and other trade proceedings (any notices that warrant a more detailed summary will appear in another ITT article):
The International Trade Administration published notices in the Nov. 26 Federal Register on the following AD/CV proceedings (any notices that announce changes to AD/CV duty rates, scope, affected firms, or effective dates will be detailed in another ITT article):
The Food and Drug Administration submitted its proposed rule on “Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes” for approval by the Office of Management and Budget Nov. 24. The rule would set out regulations on FDA’s use of accreditation bodies to approve third-party auditors. The third-party auditors would conduct certifications foreign establishments for use in FDA’s coming Voluntary Qualified Importer Program (VQIP), pursuant to the Food Safety Modernization Act.