Archive for April, 2010

CSMS# 10-000105 – OGA-FDA OASIS DOWN ON 04/24/10

CSMS# 10-000105 – OGA-FDA OASIS DOWN ON 04/24/10
Thu, 22 Apr 2010 11:46:40 -0500

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TITLE: OGA-FDA OASIS DOWN ON 04/24/10

TO: ALL FILERS

FROM: FOOD & DRUG ADMINISTRATION

SUBJECT: SCHEDULED OASIS DOWNTIME ON APRIL 24, 2010

FDA’s OASIS IMPORT SYSTEM WILL BE DOWN FOR MAINTENANCE ON SATURDAY APRIL 24, 2010 STARTING AT APPROXIMATELY 01:00 AM (0100), AND IS NOT ANTICIPATED TO BE BACK UP UNTIL 09:00 AM (0900). AS A RESULT, FDA WILL BE OPERATING UNDER THE PRIOR NOTICE SCENARIO 2 CONTINGENCY. DURING THIS DOWNTIME ACS, PNSI AND THE LINK BETWEEN ACS AND OASIS ARE OPERATIONAL. HOWEVER, THE OASIS DOWNTIME WILL PREVENT SUBMITTERS WHO FILED VIA ABI FROM RECEIVING PRIOR NOTICE CONFIRMATION AND WOULD PREVENT CBP FROM AUTO-CHECKING THE PRIOR NOTICE CONFIRMATION FOR ABI FILERS. IF PRIOR NOTICE HAS NOT ALREADY BEEN SUBMITTED, ABI FILERS MAY DECIDE TO WAIT OUT THE OASIS DOWNTIME IF THEY DETERMINE THAT THE TIMELINESS OF PRIOR NOTICE WILL NOT BE ADVERSELY AFFECTED. FILERS WHO CHOOSE THIS OPTION SHOULD UNDERSTAND THAT THEY REMAIN RESPONSIBLE UNDER SECTION 801(M) OF THE ACT AND UNDER THE PRIOR NOTICE FINAL RULE FOR FILING TIMELY PRIOR NOTICE. ABI TRANSMISSIONS RECEIVED BY FDA DURING THE DOWNTIME WILL BE QUEUED AND PROCESSED ONCE THE MAINTENANCE IS COMPLETED. PRIOR NOTICE (PN) CONFIRMATION NUMBERS WILL NOT BE TRANSMITTED BACK TO FILERS DURING THE DOWNTIME.

ALTERNATIVELY, FILERS MAY SUBMIT PRIOR NOTICE VIA PNSI, IN WHICH CASE THE PRIOR NOTICE CONFIRMATION NUMBER MUST ACCOMPANY THE ARTICLE OF FOOD (21 CFR 1.279(G)). IF PRIOR NOTICE IS SUBMITTED THROUGH PNSI, FDA AND CBP RECOMMEND THAT THE PNSI CONFIRMATION PAGE, INCLUDING THE PRIOR NOTICE CONFIRMATION NUMBER AND TIME STAMP, BE PRESENTED TO CBP OFFICERS FOR CARGO RELEASE. IF THE PNSI CONFIRMATION PAGE IS NOT PRESENTED, THIS MAY DELAY CARGO RELEASE WHILE THE CBP OFFICER, WITHOUT BEING ABLE TO ACCESS OASIS, CONTACTS FDA FOR VERIFICATION OF THE PRIOR NOTICE CONFIRMATION NUMBER(S) AND TIME OF SUBMISSION.

IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACS PRIOR TO THE INTERFACE OUTAGE, AND CONFIRMATION HAS ALREADY BEEN RECEIVED, THE SUBMITTER MAY PROCEED WITH PRIOR NOTICE USING THE STANDARD PROCESS. IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACE AND CONFIRMATION HAS NOT BEEN RECEIVED PRIOR TO THE INTERFACE OUTAGE, FDA AND CBP RECOMMEND THAT, RATHER THAN RESUBMITTING VIA PNSI, SUBMITTERS SHOULD PROVIDE TO CBP OFFICERS, AT THE TIME OF CARGO RELEASE, AN ENDORSED (SIGNED) COPY OF THE ABI TRANSMISSION OR SOME OTHER EVIDENCE ADEQUATE TO SHOW THAT PRIOR NOTICE HAS BEEN SUBMITTED VIA ABI/ACS. IF YOU HAVE ANY QUESTIONS DURING THIS DOWNTIME, PLEASE CONTACT THE FDA’S PRIOR NOTICE CENTER AT (866) 521-2297.

Apr 22, 2010

CSMS# 10-000104 – HSU 1002 Changes to the 2010 Harmonized Tariff Schedule

CSMS# 10-000104 – HSU 1002 Changes to the 2010 Harmonized Tariff Schedule
Thu, 22 Apr 2010 11:01:18 -0500

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Harmonized System Update (HSU) 1002 was created on April 15, 2010 and contains 1,839 ABI records and 135 harmonized tariff records.

This update contains harmonized tariff records that have more than eight associated special rates. Due to the recent expansion of the ABI harmonized tariff query and extract reference file, the new records should now display this data.

This update also includes adjustments required by the verification of the 2010 Harmonized Tariff Schedule (HTS).

The modified records are currently available to all ABI participants and can be retrieved electronically via the procedures indicated in the CATAIR. For further information about this process, please contact your client representative. For all other questions regarding this message, please contact Jennifer Keeling via email at Jennifer.Keeling@dhs.gov

Apr 22, 2010

CSMS# 10-000098 – ANTIDUMPING/COUNTERVAILING DUTY QUERY PROBLEM

CSMS# 10-000098 – ANTIDUMPING/COUNTERVAILING DUTY QUERY PROBLEM
Thu, 08 Apr 2010 13:51:10 -0500

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THE ACS ANTIDUMPING/COUNTERVAILING DUTY QUERY (APPLICATION IDENTIFIER CN)IN MANY INSTANCES IS NOT ACCESSING CORRECT ADCVD INFORMATION BASED ON THE QUERY INPUT THAT THE TRADE MAY BE SUBMITTING.

THE COUNTRY CODE (ISO CODE) ASSOCIATED WITH THE TARIFF NUMBERS FOR MANY ADCVD CASE NUMBERS MAY BE MISSING FROM THE ADCVD CASE FILE. AS A RESULT, WHEN THE TRADE ATTEMPTS TO USE THE ISO CODE COUNTRY CODE ALONG WITH A TARIFF NUMBER TO OBTAIN INFORMATION, THE QUERY RESULT MAY INDICATE ‘NO CASE’ WHEN IN FACT THERE MAY BE ADCVD CASES ASSOCIATED WITH THE QUERY INPUT.

IN ADDITION, THE QUERY OUTPUT RECORDS MAY BE INDICATING NO CASH/BOND INDICATOR FOR A CASE WHEN THERE IS ACTUALLY A BOND/CASH INDICATOR FOR THAT CASE (RECORD IDENTIFIER C3 OUTPUT RECORD).

A FUTURE MESSAGE WILL BE POSTED WHEN THE ABOVE ISSUES HAVE BEEN CORRECTED.

QUESTIONS REGARDING THIS MESSAGE, MAY BE DIRECTED TO YOUR LOCAL CLIENT REPRESENTATIVES.

Apr 08, 2010

CSMS# 10-000097 – Update – FDA End-Dating Some Product Codes for Radiation-Emitting Electronic Products

CSMS# 10-000097 – Update – FDA End-Dating Some Product Codes for Radiation-Emitting Electronic Products
Tue, 06 Apr 2010 14:31:32 -0500

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FDA is reissuing the message sent on 4/2/2010, under CSMS #10-000095. Please use the following instructions provided in this version of the message.

FDA has previously advised the trade that the following 25 product codes will be end-dated. See CSMS message 09-000324 dated 10/2/2009.

FDA continues to see these codes used in a substantial number of transactions. The codes will be end-dated on April 15, 2010, and they will no longer be acceptable for transmission over the CBP/FDA Interface.

The codes to be end-dated are:

94C08 Cold-Cathode Gas Discharge Tube for Non-medical Use

94V02 Circuit Breaker, Automatic

94H04 High Voltage Vacuum Tube

94I13 Industrial X-Ray System (Except Cabinet)

94V07 TV Receiver or Product Cont. TV Receiver, Television, Computer Monitor

94I17 Cabinet X-Ray System

94H06 High Voltage Vacuum Switch

94V01 Boards, Printed Circuit

94V05 Cathode Ray Tube

94N14 Analytical X-Ray System or Component for Non-medical Use

94A11 Accelerator for Non-medical Use

95L31 CD Players (compact disc players)

95U20 Ultraviolet Product (Miscellaneous) for Non-medical Use

95L22 Laser Product for Non-Medical Use

95U28 Mercury Vapor Lamp for Non-medical Use

95L29 Laser Light Show

95L32 CD Player Combination Systems

95L30 Laser Printers

95U19 Sunlamp Product (Pre-standard) for Non-medical Use

96H27 Industrial Dielectric Heater

96M01 Microwave Oven for Food Preparation

96H02 Microwave Heating Product (Except Oven for Food

Preparation) for Non-Medical Use

97Y36 Cordless Phones

97Y35 Sound Product (other than Ultrasound) for Non-medical Use

97U09 Ultrasound Product for Non- Medical Use

Replacement codes which break these products out into finer detail have been available for 3 years. For example, 96M01 – Microwave Oven for Food Preparation has been replaced with the following 4 codes:

96RCR Microwave Oven, Consumer (Food Prep)

96RCS Microwave Oven, Commercial (Food Prep)

96RCT Tunnel/Conveyor, Microwave Ovens (Food Prep)

96RCU Vending Machine, Microwave Ovens (Food Prep)

and

94V07 – TV Receiver or Product Cont. TV Receiver, Television, Computer Monitor is replaced with the following codes:

94RAZ Television Receiver, Medical Imaging, Color

94RBA Television Receiver, Medical Imaging Monochrome

94RBB Television Receiver, General Purpose, Color

94RBC Television Receiver, General Purpose, Monochrome

94RBD Video Monitor, Medical Imaging, Color

94RBE Video Monitor, General Purpose, Color

94RBF Video Monitor, Medical Imaging, Monochrome

94RBG Video Monitor, General Purpose, Monochrome

95RHF Digital Display Monitor, General Optical Products, Non-Medical

CDRH’s Radiation-Emitting Electronic Product Codes Database contains names of radiation-emitting electronic products and devices and associated information developed by the Center for Devices and Radiological Health (CDRH). This database contains product names and their associated product codes. Additionally, the radiation type, definition, and applicable performance standards (21 CFR Parts 1020-1050) are provided.

The hyperlink for this product code database is: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/PerformanceStandards/ucm135508.htm

The new product codes are also available in FDA’s Product Code Builder using the following link:http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.cfm

If you still require assistance in determining the correct code(s), after using the tools listed above, please contact FDA at: electronic.products@fda.hhs.gov.

Related CSMS No. 10-000095

Apr 06, 2010

CSMS# 10-000093 – FDA OASIS Down on 04/03/10

CSMS# 10-000093 – FDA OASIS Down on 04/03/10
Thu, 01 Apr 2010 14:56:22 -0500

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TO: ALL FILERS 

FROM: FOOD & DRUG ADMINISTRATION 

SUBJECT: SCHEDULED OASIS DOWNTIME ON 04/03/10 

FDA’s OASIS IMPORT SYSTEM WILL BE DOWN FOR MAINTENANCE ON SATURDAY APRIL 3, 2010 STARTING AT APPROXIMATELY 02:00 AM (0200), AND IS NOT ANTICIPATED TO BE BACK UP UNTIL 06:00 AM (0600). AS A RESULT, FDA WILL BE OPERATING UNDER THE PRIOR NOTICE SCENARIO 2 CONTINGENCY. DURING THIS DOWNTIME ACS, PNSI AND THE LINK BETWEEN ACS AND OASIS ARE OPERATIONAL. HOWEVER, THE OASIS DOWNTIME WILL PREVENT SUBMITTERS WHO FILED VIA ABI FROM RECEIVING PRIOR NOTICE CONFIRMATION AND WOULD PREVENT CBP FROM AUTO-CHECKING THE PRIOR NOTICE CONFIRMATION FOR ABI FILERS. IF PRIOR NOTICE HAS NOT ALREADY BEEN SUBMITTED, ABI FILERS MAY DECIDE TO WAIT OUT THE OASIS DOWNTIME IF THEY DETERMINE THAT THE TIMELINESS OF PRIOR NOTICE WILL NOT BE ADVERSELY AFFECTED. FILERS WHO CHOOSE THIS OPTION SHOULD UNDERSTAND THAT THEY REMAIN RESPONSIBLE UNDER SECTION 801(M) OF THE ACT AND UNDER THE PRIOR NOTICE INTERIM FINAL RULE FOR FILING TIMELY PRIOR NOTICE. ABI TRANSMISSIONS RECEIVED BY FDA DURING THE DOWNTIME WILL BE QUEUED AND PROCESSED ONCE THE MAINTENANCE IS COMPLETED. PRIOR NOTICE (PN) CONFIRMATION NUMBERS WILL NOT BE TRANSMITTED BACK TO FILERS DURING THE DOWNTIME.

ALTERNATIVELY, FILERS MAY SUBMIT PRIOR NOTICE VIA PNSI, IN WHICH CASE THE PRIOR NOTICE CONFIRMATION NUMBER MUST ACCOMPANY THE ARTICLE OF FOOD (21 CFR 1.279(G)). IF PRIOR NOTICE IS SUBMITTED THROUGH PNSI, FDA AND CBP RECOMMEND THAT THE PNSI CONFIRMATION PAGE, INCLUDING THE PRIOR NOTICE CONFIRMATION NUMBER AND TIME STAMP, BE PRESENTED TO CBP OFFICERS 

FOR CARGO RELEASE. IF THE PNSI CONFIRMATION PAGE IS NOT PRESENTED, THIS MAY DELAY CARGO RELEASE WHILE THE CBP OFFICER, WITHOUT BEING ABLE TO ACCESS OASIS, CONTACTS FDA FOR VERIFICATION OF THE PRIOR NOTICE CONFIRMATION NUMBER(S) AND TIME OF SUBMISSION.

IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACS PRIOR TO THE INTERFACE OUTAGE, AND CONFIRMATION HAS ALREADY BEEN RECEIVED, THE SUBMITTER MAY PROCEED WITH PRIOR NOTICE USING THE STANDARD PROCESS. IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACE AND CONFIRMATION HAS NOT BEEN RECEIVED PRIOR TO THE INTERFACE OUTAGE, FDA AND CBP RECOMMEND THAT, RATHER THAN RESUBMITTING VIA PNSI, SUBMITTERS SHOULD PROVIDE TO CBP OFFICERS, AT THE TIME OF CARGO RELEASE, AN ENDORSED (SIGNED) COPY OF THE ABI TRANSMISSION OR SOME OTHER EVIDENCE ADEQUATE TO SHOW THAT PRIOR NOTICE HAS BEEN SUBMITTED VIA ABI/ACS. IF YOU HAVE ANY QUESTIONS DURING THIS DOWNTIME, PLEASE CONTACT THE FDA’S PRIOR NOTICE CENTER AT (866) 521-2297.

Apr 01, 2010