Distribution date: 18 July 2005

The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter (OTC) cough-cold combination drug products to remove the combination of an oral bronchodilator (products containing ephedrine or its salts) and an expectorant, and to reclassify this combination drug product as Category II (not generally recognized as safe and effective for OTC use). FDA is also proposing to classify the combination of an oral bronchodilator and an oral nasal decongestant as Category II. FDA is issuing this notice of proposed rulemaking after considering data and information on the appropriateness of these combination drug products to treat mild asthma. Elsewhere in this issue of the Federal Register, FDA is proposing to amend the final monograph (FM) for OTC bronchodilator drug products to require additional labeling for all ingredients included in the FM. These proposed rules are part of FDA's ongoing review of OTC drug products.

Products Covered: Human Drug Products  (HS Chapter 30;  ICS 11.120)

Regulation Type: Regular notification

Distribution date: 15 July 2005

Este reglamento técnico se debe aplicar al producto denominado Gas Licuado de Petróleo (GLP) que se comercializa en los países centroamericanos. Especifica las características físico químicas del Gas Licuado de Petróleo (GLP) para dos calidades: propano comercial y butano comercial, generalmente utilizados como combustible de calentamiento en el sector doméstico, comercial e industrial, como combustible automotriz y como materia prima para petroquímica. Se podrá utilizar cualquier mezcla de estos productos siempre que las mezclas cumplan con las especificaciones establecidas en este reglamento.

Products Covered: HS tariff heading 2711;  International Classification for Standards (ICS) code 75.160.20

Regulation Type: Regular notification

Distribution date: 15 July 2005

Este reglamento técnico se debe aplicar al producto denominado Gas Licuado de Petróleo (GLP) que se comercializa en los países centroamericanos. Especifica las características físico químicas del Gas Licuado de Petróleo (GLP) para dos calidades: propano comercial y butano comercial, generalmente utilizados como combustible de calentamiento en el sector doméstico, comercial e industrial, como combustible automotriz y como materia prima para petroquímica. Se podrá utilizar cualquier mezcla de estos productos siempre que las mezclas cumplan con las especificaciones establecidas en este reglamento.

Products Covered: HS tariff heading 2711;  International Classification for Standards (ICS) code 75.160.20

Regulation Type: Regular notification

Distribution date: 15 July 2005

Especificar las características físico químicas que debe cumplir la gasolina regular para uso automotriz. Se aplica al derivado del petróleo conocido como gasolina regular, formado por una mezcla compleja de distintos tipos de hidrocarburos (parafínicos, nafténicos, olefínicos y aromáticos), cuyo rango de destilación (ebullición) varía entre 30 C y 225 C.

Products Covered: HS tariff heading 2710; International Classification for Standards (ICS) code 75.160.20

Regulation Type: Regular notification

Distribution date: 15 July 2005

Especificar las características físico químicas que debe cumplir la gasolina regular para uso automotriz. Se aplica al derivado del petróleo conocido como gasolina regular, formado por una mezcla compleja de distintos tipos de hidrocarburos (parafínicos, nafténicos, olefínicos y aromáticos), cuyo rango de destilación (ebullición) varía entre 30 C y 225 C.

Products Covered: HS tariff heading 2710; International Classification for Standards (ICS) code 75.160.20

Regulation Type: Regular notification

Distribution date: 12 July 2005

This Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, chemical contaminants, analysis of physico-chemical components, microbiological contaminants, methods of analysis, hygiene, packaging, labelling, conformity with other standards, technical references, monitoring and inspection.

Products Covered: Margarine (HS tariff heading 1517)

Regulation Type: Regular notification

Distribution date: 12 July 2005

This Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, chemical contaminants, analysis of physico-chemical components, microbiological contaminants, methods of analysis, hygiene, packaging, labelling, conformity with other standards, technical references, monitoring and inspection.

Products Covered: Margarine (HS tariff heading 1517)

Regulation Type: Regular notification

Distribution date: 08 July 2005

The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 53-2536(1993) which is a mandatory standard and replace it with TIS 53-2548(2005). The standard specifies types, containers, splint, match head, wearing strength of friction surface, striking performance, ignition and absence of afterglow. Includes packaging, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Miscellaneous home equipment (HS Chapter:  3605;  ICS:  97.180)

Regulation Type: Regular notification

Distribution date: 08 July 2005

The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 53-2536(1993) which is a mandatory standard and replace it with TIS 53-2548(2005). The standard specifies types, containers, splint, match head, wearing strength of friction surface, striking performance, ignition and absence of afterglow. Includes packaging, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Miscellaneous home equipment (HS Chapter:  3605;  ICS:  97.180)

Regulation Type: Regular notification

Distribution date: 07 July 2005

Products Covered: In-vitro diagnostic products (HS 3822;  3002;  3821)

Regulation Type: Regular notification