Ordinance concerning the transplantation of human organs, tissues and cells and Ordinance concerning the transplantation of animal organs, tissues and cells (Available in German/French; 32/16 pages)

Distribution date: 12 January 2006
According to article 49 of the Transplantation Law some regulations of the Law on Therapeutic Products are applicable in a general manner in addition to the rules of the Transplantation Law. Transplant products as well as therapeutic products are approved by the Swiss Agency for therapeutic products and this organization is also responsible for inspections in the area of transplant products. The Transplantation Ordinance prescribes within the area of applicability which rules are applicable to the contact with organs, tissues and cells which shall be used for the production of transplant products. Animal transplant products are also approved by the Swiss Agency for therapeutic products. The guarantee of the protection against infection however falls into the sphere of responsibility of the Swiss Federal Office of Public Health.
Products Covered: Transplant products
Regulation Type: Regular notification
Ordinance concerning the transplantation of human organs, tissues and cells and Ordinance concerning the transplantation of animal organs, tissues and cells (Available in German/French; 32/16 pages)

Distribution date: 12 January 2006
According to article 49 of the Transplantation Law some regulations of the Law on Therapeutic Products are applicable in a general manner in addition to the rules of the Transplantation Law. Transplant products as well as therapeutic products are approved by the Swiss Agency for therapeutic products and this organization is also responsible for inspections in the area of transplant products. The Transplantation Ordinance prescribes within the area of applicability which rules are applicable to the contact with organs, tissues and cells which shall be used for the production of transplant products. Animal transplant products are also approved by the Swiss Agency for therapeutic products. The guarantee of the protection against infection however falls into the sphere of responsibility of the Swiss Federal Office of Public Health.
Products Covered: Transplant products
Regulation Type: Regular notification
Central American Technical Regulation No. 01.01.11:05. Quantity of Product in Prepackages (21 pages, in Spanish).

Distribution date: 11 January 2006
Establece los requisitos de metrología legal para productos preempacados (conocidos también como bienes de consumo preempacados o preembalados) etiquetados en cantidades nominales predeterminadas de masa, volumen, longitud, área o conteo, y los procedimientos y planes de muestreo para uso de los oficiales de metrología legal en la verificación de la cantidad de producto en preempacados.
Products Covered: HS Chapters 02-38
Regulation Type: Regular notification
Central American Technical Regulation No. 01.01.11:05. Quantity of Product in Prepackages (21 pages, in Spanish).

Distribution date: 11 January 2006
Establece los requisitos de metrología legal para productos preempacados (conocidos también como bienes de consumo preempacados o preembalados) etiquetados en cantidades nominales predeterminadas de masa, volumen, longitud, área o conteo, y los procedimientos y planes de muestreo para uso de los oficiales de metrología legal en la verificación de la cantidad de producto en preempacados.
Products Covered: HS Chapters 02-38
Regulation Type: Regular notification
Draft of Scope, Application and Specification Standards for Food Additive: Calcium Citrate (Available in English, 2 pages)

Distribution date: 10 January 2006
To establish the application and specification standards for a new food additive, calcium citrate, as nutritional additive.
Products Covered: Calcium citrate
Regulation Type: Regular notification
Draft of Scope, Application and Specification Standards for Food Additive: Calcium Citrate (Available in English, 2 pages)

Distribution date: 10 January 2006
To establish the application and specification standards for a new food additive, calcium citrate, as nutritional additive.
Products Covered: Calcium citrate
Regulation Type: Regular notification
Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monograph (10 pages, in English)

Distribution date: 06 January 2006
The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products.
Products Covered: Human Drug Products (HS Chapter: 3003; ICS: 11.120)
Regulation Type: Regular notification
Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monograph (10 pages, in English)

Distribution date: 06 January 2006
The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products.
Products Covered: Human Drug Products (HS Chapter: 3003; ICS: 11.120)
Regulation Type: Regular notification
Benzaldehyde, Captafol, Hexaconazole, Paraformaldehyde, Sodium dimethyldithiocarbamate, and Tetradifon; Proposed Tolerance Actions (5 pages, in English)

Distribution date: 06 January 2006
EPA is proposing to revoke specific tolerances and tolerance exemptions for residues of the insecticides paraformaldehyde and tetradifon; fungicides captafol, hexaconazole, and sodium dimethyldithiocarbamate; and bee repellant benzaldehyde. EPA canceled food use registrations or deleted food uses from registrations following requests for voluntary cancellation or use deletion by the registrants, or non-payment of registration maintenance fees. Also, stakeholders have withdrawn their support for import tolerances for captafol and hexaconazole. EPA expects to determine whether any individuals or groups want to support these tolerances. The regulatory actions proposed in this document contribute toward the Agency's tolerance reassessment requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances that were in existence on 2 August 1996. The regulatory actions proposed in this document pertain to the proposed revocation of 39 tolerances and tolerance exemptions of which 38 would be counted as tolerance reassessments toward the August 2006 review deadline.
Products Covered: Pesticides (HS Chapter: 3808; ICS: 13)
Regulation Type: Regular notification
Benzaldehyde, Captafol, Hexaconazole, Paraformaldehyde, Sodium dimethyldithiocarbamate, and Tetradifon; Proposed Tolerance Actions (5 pages, in English)

Distribution date: 06 January 2006
EPA is proposing to revoke specific tolerances and tolerance exemptions for residues of the insecticides paraformaldehyde and tetradifon; fungicides captafol, hexaconazole, and sodium dimethyldithiocarbamate; and bee repellant benzaldehyde. EPA canceled food use registrations or deleted food uses from registrations following requests for voluntary cancellation or use deletion by the registrants, or non-payment of registration maintenance fees. Also, stakeholders have withdrawn their support for import tolerances for captafol and hexaconazole. EPA expects to determine whether any individuals or groups want to support these tolerances. The regulatory actions proposed in this document contribute toward the Agency's tolerance reassessment requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances that were in existence on 2 August 1996. The regulatory actions proposed in this document pertain to the proposed revocation of 39 tolerances and tolerance exemptions of which 38 would be counted as tolerance reassessments toward the August 2006 review deadline.
Products Covered: Pesticides (HS Chapter: 3808; ICS: 13)
Regulation Type: Regular notification
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