The Food and Drug Administration (FDA) has issued notice of the availability of a guidance entitled "Q8 Pharmaceutical Development." The guidance describes the suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format and indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. Written or electronic comments on agency guidance may be submitted at any time. (D/N 2005D-0021, FR Pub 05/22/06 available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-7727.pdf)
Drawback
A duty drawback is a refund by CBP of the duties, taxes, or fees paid on imported goods, which were imposed upon importation as prescribed in 19 U.S.C. 1313(d). More broadly, a drawback also includes the refund or remission of other excise taxes pursuant to other provisions of law.
U.S. Customs and Border Protection (CBP) has posted a notice on its web site, entitled Notice of Examination for October 2006, which announces that the next Customs Broker License Examination will be held on Tuesday, October 3, 2006.
In California Industrial Products, Inc. v. United States, the U.S. Court of Appeals for the Federal Circuit ruled that based upon Customs' prior favorable treatment of substantially identical transactions and its failure to conduct notice and comment proceedings before changing that prior treatment, CIP was entitled to substitution manufacturing drawback (19 USC 1313(b)) on its steel scrap exports.
On May 4, 2006, the House of Representatives amended and passed H.R. 4954, the Security and Accountability for Every (SAFE) Port Act.
ITA Refines its Proposed Changes for Valuing Market Economy Inputs for AD Proceedings Involving NMEs
The International Trade Administration (ITA) has issued a third notice on possible changes to its market economy inputs practice in antidumping (AD) proceedings involving non-market economy countries (NMEs). Written comments on its proposals are due by April 19, 2006.
U.S. Customs and Border Protection (CBP) has scheduled the next Customs Broker License Examination for Monday, April 3, 2006.
The Office of the U.S. Trade Representative (USTR) has issued a press release announcing that the U.S. and Colombia have concluded their work on a free trade agreement (FTA).
On February 7, 2006, U.S. Customs and Border Protection (CBP) issued an ABI administrative message advising ABI filers of drawback claims of a change of address used to mail "hold harmless" agreement documents and cover letters to CBP. According to CBP, these documents are required at the time the ABI filer submits a request to query an importer's entry summary records.
U.S. Customs and Border Protection (CBP) has issued an ABI administrative message advising ABI filers of drawback claims of a change of address used to mail "hold harmless" agreement documents and cover letters to CBP. According to CBP, these documents are required at the time the ABI filer submits a request to query an importer's entry summary records.
At its December 1, 2005 meeting, the Departmental Advisory Committee on Commercial Operations of Customs and Border Protection and Related Functions (COAC) presented its proposal for certain "green lane" benefits for Tier 3 Customs-Trade Partnership Against Terrorism (C-TPAT) members.