Miscellaneous International Trade Notices
The Government Accountability Office has issued testimony entitled, "Secure Border Initiative: DHS Needs to Address Significant Risks in Delivering Key Technology Investment," which states, among other things, that it is unclear and uncertain when and how SBInet capabilities will be delivered, and that SBInet has not been effectively managed. (GAO-08-1148T, dated 09/10/08, available at http://www.gao.gov/new.items/d081148t.pdf)
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1. GAO Testifies on SBInet Weaknesses
2. FDA Issues Warning Letters, Import Alert for Drugs from Ranbaxy Plants in India
The Food and Drug Administration has issued two Warning Letters to Ranbaxy Laboratories Ltd. in India, which identify FDA's concerns about certain deviations from U.S. current Good Manufacturing Practice (CGMP) requirements. Because of the extent and nature of the violations, FDA also issued an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India, under which U.S. officials may detain at the U.S. border any active pharmaceutical ingredients (API) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the U.S. (FDA, dated 09/16/08, available at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html)
3. FDA Revises its Import Alert on Unapproved New Drugs
The FDA issued a revised version of its Import Alert (66-41) entitled "Detention without Physical Examination of Unapproved New Drugs Promoted in the U.S." (IA 66-41, revised 09/16/08, available at http://www.fda.gov/ora/fiars/ora_import_ia6641.html)
4. FDA Issues Proposed Rule on Bottled Water Regulations
FDA has issued a proposed rule to amend its bottled water regulations to require that source water, which is currently subject to weekly microbiological testing, be tested specifically for total coliform as is done for finished bottled water products, etc. Comments are due by November 17, 2008. (D/N FDA-2008-N-0446, FR Pub 09/17/08, available at http://edocket.access.gpo.gov/2008/pdf/E8-21619.pdf)
5. State Dept's Committee on Private International Law to Meet
The State Department's Advisory Committee on Private International Law will hold its annual meeting on the "state of the world" concerning private international law on October 6-7, 2008 in Washington, DC. (Public Notice 6292, FR Pub 09/17/08, available at http://edocket.access.gpo.gov/2008/pdf/E8-21755.pdf)
6. BIS Significant Export Enforcement Cases for September 2008
The Bureau of Industry and Security has issued a notice announcing its most significant export enforcement cases for the month of September 2008:
| Entity | Action/Violation/Alleged Violation |
|---|---|
| James Angehr and John Fowler, owners of Engineering Dynamics Inc. | Sentenced to five years probation, and fined $250,000, among other things, for exporting and attempting to export software to Iran without the required BIS and Office of Foreign Assets Control (OFAC) authorization. |
| Nicholas D. Groos | Pled guilty to activities related to a scheme to willfully transship U.S.-origin firefighting equipment to Iran. |
| Mythli Gopal | Fined $5,000, among other things, for illegally exporting controlled electronic components to government entities in India that participate in the development of ballistic missiles, space launch vehicles, and fighter jets. |
| Evan Zhang | Pled guilty to involvement in the export of thermal-imaging cameras to China without the required Commerce Department export license. |
| Robert Quinn and David Tatum | Pled guilty to activities related to the export of forklift truck parts of U.S. origin to Iran by Clark Material Handling Corporation via Sharp Line Trading in Dubai, United Arab Emirates. |
| J. Reece Roth | Convicted for conspiracy to transmit export controlled technical data to foreign nationals from China and Iran. |
(BIS notice, dated September 2008, available at http://www.bis.doc.gov/complianceandenforcement/mcl092008.pdf )
7. CBP Seeks Comments on Information Collections
U.S. Customs and Border Protection is seeking comments on the following information collections for which they have requested or intend to request Office of Management and Budget approval or extension of approval (see notices for specific details):
| Agency | Information Collection | Comments Due |
|---|---|---|
| CBP 1 | Entry and Immediate Delivery Application (CBP Form-3461 and Form-3461 Alternate) | 11/04/08 |
| CBP 2 | Prior Disclosure Regulations | 11/04/08 |
| CBP 3 | Entry and Manifest of Merchandise Free of Duty (CBP Form-7523) | 10/08/08 |
| CBP 4 | Foreign Trade Zone Annual Reconciliation Certification and Record Keeping Requirement | 10/08/08 |
| CBP 5 | Petition for Remission or Mitigation of Forfeitures and Penalties (CBP Form 4609) | 10/08/08 |
| CBP 6 | Crew Effects Declaration (CBP Form-1304) | 10/09/08 |
| CBP 7 | Vessel Entrance or Clearance Statement Form (CBP Form 1300) | 10/09/08 |
CBP 1 Information Collection (FR Pub 09/05/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-20658.pdf
CBP 2 Information Collection (FR Pub 09/05/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-20661.pdf
CBP 3 Information Collection (FR Pub 09/08/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-20769.pdf
CBP 4 Information Collection (FR Pub 09/08/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-20770.pdf
CBP 5 Information Collection (FR Pub 09/08/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-20763.pdf
CBP 6 Information Collection (FR Pub 09/09/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-20798.pdf
CBP 7 Information Collection (FR Pub 09/09/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-20797.pdf