Miscellaneous International Trade Notices
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)
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1. FDA Announces Q8 Pharmaceutical Development Guidance
2. OFAC Final Rule on Amendments to Reflect IEEPA
The Treasury Department's Office of Foreign Assets Control (OFAC) has issued a final rule, effective May 22, 2006, revising its regulations in 31 CFR Parts 535, 536, 537, 538, 539, 540, 541, 542, 560, 588, 594, and 595 to reflect amendments to the International Emergency Economic Powers Act (IEEPA) made by the Combating Terrorism Financing Act of 2005 (CTFA). The OFAC has amended the current IEEPA-based sanctions programs regulations to reflect the revised penalties prescribed by the CTFA by raising the maximum civil penalty from $11,000 to $50,000 and the maximum term of imprisonment from 10 years to 20 years. (FR Pub 05/22/06 available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-4705.pdf)
3. FTC Confirms Rule on Deceptive Advertising
The Federal Trade Commission (FTC) has completed its regulatory review of the Rule concerning Deceptive Advertising as to Sizes of Viewable Pictures Shown by Television Receiving Sets (the Picture Tube Rule). It has determined to retain the Rule in its current form, effective June 14, 2006. (FR Pub 06/14/06 available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-9233.pdf)
4. NOAA Lists Elkhorn and Staghorn Corals as Threatened Species under Endangered Species Act
The National Oceanic and Atmospheric Administration (NOAA) has issued a final rule, effective June 8, 2006, which implements its determination to list elkhorn and staghorn corals as threatened species under the Endangered Species Act of 1973, as amended. NOAA has also issued a correction notice that contains certain revised data for the final rule notice published on May 9, 2006. (Final rule, D/N 050304058-6116-03; I.D. No. 060204C, FR Pub 05/09/06, available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-4321.pdf, and Correction notice, FR Pub 06/02/06, available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-4988.pdf)
5. OFAC Reaches Settlement Agreement with Exel for Trade Violation
The Office of Foreign Assets Control (OFAC) has issued a press release announcing Penalty Notices through May 5, 2006 for violations of OFAC regulations. Among other settlements, Exel Global Logistics, Inc., Hayward, CA 94545 (Exel), has remitted $6,226.50 to settle allegations for making illegal shipments to Iran between February and September 2001. (OFAC Press release, dated 06/07/06, available at http://www.treas.gov/offices/enforcement/ofac/civpen/penalties/05052006.pdf)
7. Various Agencies Seek Comments on Information Collections
Various U.S. government agencies are seeking comments on the following information collections for which they have requested Office of Management and Budget (OMB) approval or extension of approval (see notices for specific details):
| Agency | Information Collection | Comments Due |
|---|---|---|
| TTB 1 | Drawback on Wines Exported | 08/07/06 |
| APHIS | Irradiation Phytosanitary Treatment of Imported Fruits and Vegetables. | 08/0706 |
| TTB 2 | Importer's Records and Reports | 08/07/06 |
| TTB 3 | Tobacco Export Warehouse - Record Of Operations | 08/07/06 |
| TTB 4 | Methods or Procedures and Emergency Variations from Requirements for Exports of Liquors | 08/07/06 |
| TTB 5 | Supporting Data for Nonbeverage Drawback Claims | 08/07/06 |
| TTB 6 | Recordkeeping Requirements for Importers of Tobacco Products | 08/07/06 |
(TTB 1 Information Collection, FR Pub 06/08/06, available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-8855.pdf)
(APHIS Information Collection, FR Pub 06/08/06, available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-8934.pdf)
(TTB 2 - 6 Information Collection, FR Pub 06/08/06, available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-8856.pdf)