Notification procedures

The contract can specify the amount of time the client needs to remove its materials from the toller s facility and lays out notification procedures for dissolving the contract. Chapter 6, Closure and Audit, Example 6-1 is a sample contract termination checklist. It is an illustration of one company s inventoiy list for closing out a tolling project. It addresses material, financial, legal and environmental considerations. 

Pre-incident planning, coordination, and notification procedures with outside parties as required by 29 CFR 1910.120. (Start with your local fire department—it may have more expertise than you are aware of)... 

If a manufacturer has developed a new device for which no suitable predicate device exists, he/she may be able to use a de novo 510(k) notification procedure. 

In the five and one-half years of ensuing Congressional activity, many additional aspects were considered and some were included in the Act as finally enacted. Possibly the most controversial had to do with the treatment of new substances. Were these to be treated by registration, as is the case in the Federal Insecticide Fungicide and Rodenticide Act (FIFRA), or were they to be subject to a less onerous notification procedure This would begin the attempt to assess their risks more in balance with the growth in commercial volume of the substance, and hence with its capacity to pay the costs for the frequently costly testing required. Without such a balance, the... 

Additional temporary protections, e.g., a firewatch with fire extinguisher and emergency notification procedure that includes covering sewer openings, construction of fire boxes of flame resistant material to contain sparks, etc. 

The notification procedure of existing active substances, which had started in 2000, was finalized on 31 January 2003. After having succeeded the notification procedure, the names of existing active substances have been published in the Official Journal of the European Communities (OJ). At the next step, the full dossier including aU test reports should be submitted to the Rapporteur Member State in agreed Data Formats including the risk assessment of the active substance. At the last step, the Rapporteur Member State in cooperation with all other Member States will decide whether the active substance wUl be entered onto the positive lists or not. 

In the past, petitioners filed petitions with FDA to review the GRAS status of a substance and affirm the substance as GRAS. In 1997, FDA proposed to replace this GRAS affirmation petition process with a proposed voluntary notification procedure where any interested party may notify FDA of the determination that a substance is... 

Many of the items reviewed by a client will be similar to those reviewed by the FDA. There may be specific requirements, however, as dictated by the clients SOPs or policies or quality agreements with the manufacturer. There will also be some focus on procedures of notifying the client if there is a problem found during stability or with processing. The client will typically be interested in the notification procedures for changes to the master production record. There should be procedures in place to verify that a client s request was at the very least reviewed or implemented. 

Existing substances are defined as those substances in use within the EU before September 1981 and listed in EINECS (European Inventory of Existing Commercial Chemical Substances). Accordingly, substances not listed in EINECS are regarded as new substances and subject to a notification procedure (Section 2.2.2). 

If a deviation from harmonised legislation is in place, it must be actively demonstrated to the European Commission through notification procedures (see [250]). 

Socio-economic considerations for measures aimed at achieving occupational or environmental protection set under legislative frameworks based on Articles 138 or 175 of the EC Treaty would be outside the scope of REACH. For standards under Directive 98/34 proportionality must already be demonstrated by the Member State through the notification procedure. 

A Notification Procedure for Special Emergency Group in Response to Lightning Priority Signal and Duty Regulations of ERU Leaders and Functional Tasks of ERU Teams have been developed and put into action at PA Mayak . 

Witnesses or discovers a release of a hazardous material is trained to notify the proper authorities. Training includes the recognition and identification of hazardous materials, proper notification procedures, and the employee s role in the Emergency Response Plan. 

It is also prudent to be aware of the materials, reagents, and solvent used in the manufacture of the excipient and consider potential interactions between such residues and the active ingredient. It may also be advisable to agree to a Change Control notification procedure with the vendor, to avoid the introduction of new materials in the manufacture of the excipient without prior consideration of the possible impact on the medicinal product. 

The notification procedure for the clinical trials phase IV and its definition... 

The DDX scheme is a notification procedure for a doctor or dentist plcinning to conduct a clinical trial independently of a commercially interested party and entirely on his or her own responsibility, using an unlicensed medicine or a licensed medicine supplied other them in response to a prescription. The scheme allows a... 

The data provided in the new substances notification procedure are used to assign one of the following risk assessments41 to the new substance ... 

Review for HAZMAT teams as well as a introduction for awareness level personnel. Examples of chemical spills, types of releases, spill containment, cleanup procedures, notification procedures, spill response levels, decontamination, and affected surfaces. Part of four-volume series, "A Refresher Course in Chemical Safety. ... 

Summary for management covering notification procedures, job assessment, and information needed before awarding asbestos removal contract. 

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