Prescription Drug Products Containing Acetaminophen; Actions To Reduce Liver Injury From Unintentional Overdose

Distribution date: 08 February 2011 | Final date for Comment: 09 April 2011
Description of Content: The Food and Drug Administration (FDA) is taking steps to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. This change will provide an increased margin of safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem. This notice explains the reasons for the reduction in dosage unit strength and describes how FDA is implementing it for approved prescription drug products that exceed the new maximum tablet or capsule strength. FDA is also requiring safety labeling changes, including a new boxed warning, for acetaminophen-containing prescription drug products to address new safety information about the risk of liver damage. ; NOTE: Sponsors of approved prescription drug products containing more than 325 milligrams (mg) of acetaminophen have until 14 January 2014 to request that FDA withdraw approval of the product's application, after which they may be subject to action by FDA. ;
Products Covered: ICS numbers may be provided in addition, where applicable): Prescription Drug Products Containing Acetaminophen (HS 3004; ICS 11.120.10)
Regulation Type: Regular notification
Draft Decree of Minister of Industry on Mandatory Implementation of Indonesia National Standard for Rubber Seals for LPG steel cylinder valve (SNI 7655:2010)

Distribution date: 11 February 2011 | Final date for Comment: 12 April 2011
This draft of decree states that all of Rubber seals for LPG steel cylinder valve products produced within the country or imported, distributed and marketed in the country shall fulfil the SNI requirements. The producers which produced these products therefore shall comply with the requirements of SNI proven by having Product Certificate for Using SNI Mark and put SNI mark on every Rubber seals for LPG steel cylinder valve product. ; The product certificate on SNI marking shall be issued by a Product Certification Body which has been designated by the Minister of Industry through: ; a. Testing of the conformity of the products quality against SNI requirements; and ; b. Audit on the implementation of the Quality Management System (QMS) SNI ISO 9001:2008 or its revision; or other recognized Quality Management System. ; ; Directorate General Manufactured Based Industry, Ministry of Industry is the institution that is responsible for the implementation of this decree and shall provide a technical guidance of the decree, which cover procedure of Product Certification and SNI Marking. ; Products which are distributed in domestic market that originated domestically and imported shall meet the requirements consisted in SNI 7655:2010, Rubber seals for LPG steel cylinder valve , which specify term and definition, quality requirements, sampling, testing method, testing acceptance, marking requirement and packaging (this standard is available in Indonesian language). ;
Products Covered: Rubber seals for LPG steel cylinder valve (SNI 7655:2010), HS 4016.93.90.00 ; ;
Regulation Type: Regular notification
Draft Decree of Minister of Industry on Mandatory Implementation of Indonesia National Standard for Rubber Seals for LPG steel cylinder valve (SNI 7655:2010)

Distribution date: 11 February 2011 | Final date for Comment: 12 April 2011
This draft of decree states that all of Rubber seals for LPG steel cylinder valve products produced within the country or imported, distributed and marketed in the country shall fulfil the SNI requirements. The producers which produced these products therefore shall comply with the requirements of SNI proven by having Product Certificate for Using SNI Mark and put SNI mark on every Rubber seals for LPG steel cylinder valve product. ; The product certificate on SNI marking shall be issued by a Product Certification Body which has been designated by the Minister of Industry through: ; a. Testing of the conformity of the products quality against SNI requirements; and ; b. Audit on the implementation of the Quality Management System (QMS) SNI ISO 9001:2008 or its revision; or other recognized Quality Management System. ; ; Directorate General Manufactured Based Industry, Ministry of Industry is the institution that is responsible for the implementation of this decree and shall provide a technical guidance of the decree, which cover procedure of Product Certification and SNI Marking. ; Products which are distributed in domestic market that originated domestically and imported shall meet the requirements consisted in SNI 7655:2010, Rubber seals for LPG steel cylinder valve , which specify term and definition, quality requirements, sampling, testing method, testing acceptance, marking requirement and packaging (this standard is available in Indonesian language). ;
Products Covered: Rubber seals for LPG steel cylinder valve (SNI 7655:2010), HS 4016.93.90.00 ; ;
Regulation Type: Regular notification
Health measure concerning the registration of efficacy trial technical departments and producers and importers of agricultural bio-inputs

Distribution date: 22 February 2011 | Final date for Comment: 10 May 2025
The Republic of Colombia hereby notifies that the draft Resolution of the Colombian Agricultural Institute (ICA) "Laying down requirements for the registration of efficacy trial technical departments and producers and importers of agricultural bio-inputs and adopting other provisions", notified on 29 March 2010 by the World Trade Organization in document G/SPS/N/COL/188, was issued on 4 February 2011, pursuant to Colombian Agricultural Institute Resolution No. 000698.Text available online at: http://members.wto.org/crnattachments/2011/sps/COL/11_0557_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Health measure concerning the registration of efficacy trial technical departments and producers and importers of agricultural bio-inputs

Distribution date: 22 February 2011 | Final date for Comment: 10 May 2025
The Republic of Colombia hereby notifies that the draft Resolution of the Colombian Agricultural Institute (ICA) "Laying down requirements for the registration of efficacy trial technical departments and producers and importers of agricultural bio-inputs and adopting other provisions", notified on 29 March 2010 by the World Trade Organization in document G/SPS/N/COL/188, was issued on 4 February 2011, pursuant to Colombian Agricultural Institute Resolution No. 000698.Text available online at: http://members.wto.org/crnattachments/2011/sps/COL/11_0557_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
This addendum aims to inform that the Conformity Assessment Procedure, issued by Inmetro National Institute of Metrology, Standardization and Industrial Quality and notified under G/TBT/N/BRA/400 (conformity assessment procedure for hydraulic brake fluids for automotive vehicles), was adopted as a final text and published in the Brazilian Official Journal as Ministerial Act nº 78, 03 February 2011. (Portaria N.º 78, de 3 de Fevereiro de 2011 D.O.U 07/02/2011).

Distribution date: 24 February 2011 | Final date for Comment: 10 May 2025
Products Covered: Hydraulic brake fluids for automotive vehicles (HS 381900)
Regulation Type: Addendum to Regular Notification
This addendum aims to inform that the Conformity Assessment Procedure, issued by Inmetro National Institute of Metrology, Standardization and Industrial Quality and notified under G/TBT/N/BRA/400 (conformity assessment procedure for hydraulic brake fluids for automotive vehicles), was adopted as a final text and published in the Brazilian Official Journal as Ministerial Act nº 78, 03 February 2011. (Portaria N.º 78, de 3 de Fevereiro de 2011 D.O.U 07/02/2011).

Distribution date: 24 February 2011 | Final date for Comment: 10 May 2025
Products Covered: Hydraulic brake fluids for automotive vehicles (HS 381900)
Regulation Type: Addendum to Regular Notification
KS 2290: 2011 Organic fertilizer-Specification (11 pages, in English). ;

Distribution date: 01 March 2011 | Final date for Comment: 30 April 2011
Specifies requirements and prescribes methods of test for organic fertilizers ;
Products Covered: Organic fertilizers (HS: 3101). ;
Regulation Type: Regular notification
KS 2290: 2011 Organic fertilizer-Specification (11 pages, in English). ;

Distribution date: 01 March 2011 | Final date for Comment: 30 April 2011
Specifies requirements and prescribes methods of test for organic fertilizers ;
Products Covered: Organic fertilizers (HS: 3101). ;
Regulation Type: Regular notification
KS 2287: High Purity Acetylene gas Specification (17 pages, in English). ;

Distribution date: 01 March 2011 | Final date for Comment: 30 April 2011
IS 308: 1988 Specification for dissolved acetylene (gas). CGA-510 Compressed Gas Association Specification for AAS Grade Acetylene ;
Products Covered: Organic fertilizers (HS: 3101). ;
Regulation Type: Regular notification
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