Adequate provision requirement

Sponsors of broadcast advertisements are also required to present a brief summary or, alternatively, may make adequate provision. .. for dissemination of the approved or permitted package labeling in connection with the broadcast presentation (21 CFR 202.1(e)(1)). This is referred to as the adequate provision requirement. The regulations thus specify that the major statement, together with adequate provision for dissemination of the product s approved labeling, can provide the information disclosure required for broadcast advertisements. 

This is probably one of the most powerful requirements in the standard, much underused in ISO 9000 quality systems. If you examine the words closely you will find that it can be applied to any situation where measures can be taken to prevent problems. A common weakness in many organizations is the absence of planning. Planning is a preventive action. We plan to achieve an objective which we would fail to meet if we didn t make adequate provision for the resources and activities needed to meet our objective. Therefore, although the standard does not require plans for every activity, if preparation is necessary before an activity can take place and such preparation has not been accom-... 

A typical laboratory will require a variety of common utilities, such as water, gas, and electric power. There must also be sewer connections and adequate provision for ventilation, as well as means for heating and cooling the area. In addition, there are often special laboratory needs, such as compressed air and vacuum. 

Additional requirements are that adequate provisions exist for monitoring the data collected, adequate provisions exist to protect the privacy of subjects and maintain the confidentiality of the data, and that appropriate safeguards be included to protect the rights and welfare of subjects who are ...vulnerable to coercion or undue influence... or persons who are economically or educationally disadvantage..(45 CFR 46.1). 

The purpose of this guidance is to describe an approach that FDA believes can fulfill the requirement for adequate provision in connection with consumer-directed broadcast advertisements for prescription drug and biological products. The approach presumes that such advertisements ... 

When a broadcast advertisement is broadly disseminated, FDA believes that ensuring that passive and privacy-sensitive information seekers have adequate access to detailed product information is critical to complying with the adequate provision regulatory requirement. Thus, print advertisements associated with broadly disseminated broadcast advertisements should be comparably broadly disseminated in terms of the targeted audiences. 

Air-cooled exchangers require large plan areas, and adequate provision must be made for cool air to flow into the underside of these units. Installations covering 104-105 m2 of land are becoming more common. 

Draft Guidance for Industry on DTCA Allowed broadcast advertisements to contain limited risk and benefit information Required adequate provision for alternative sources of complete labeling information... 

There are more examples for the application of these requirements If a study involves analytical procedures, the facility has to have an adequate power supply with adequate provisions for the case of power failures or breakdowns. The same provisions have to be taken for the air-conditioning system of the animal rooms. It is self-evident that the IT system of a test facility will have to be protected against this kind of event, too. Furthermore, an adequate ventilation system will be needed in order to protect test systems, equipment and technicians from noxious or corrosive gases and volatile solvents. In the area of in vitro test systems, a surveillance system for the facilities (i.e. the containers) used to store cell lines in a deep-frozen stage will have to assure that the level of liquid nitrogen does not fall below the critical minimal level. Many more examples could be cited and the appropriateness of the facility and its construction can be followed down to the small table on which the balance to be used in the study is placed Does this table have sturdy legs and a special. 

The Administrator shall...approve...[a SIP]...if he determines that it was adopted after reasonable notice and hearing and that...(E) it contains adequate provisions (i) prohibiting any stationary source within the State from emitting any air pollutant in amounts which will (I) prevent attainment or maintenance by any other State of any such national primary or secondary ambient air quality standard, or (II) interfere with measures required to be included in the applicable implementation plan for any other State under Part C to prevent significant deterioration of air quality or to protect visibility, and (ii) insuring compliance with the requirements of Section 126, relating to interstate pollution abatement ... 

An important design consideration of aerobic fermentations is the adequate provision of the oxygen requirements of the culture. This field is almost as old as the... 

Upgrade. Are adequate provisions made in the maintenance operation to accomplish upgrades as required by manufacturers, major commands, or regulations ... 

Inspection plan Were inspection requirements considered during design and adequate provisions made for safely inspecting critical components ... 

Such a classification system requires that we make adequate provision for cross-referencing. Thus a compound with only one organic residue can often be described in terms of more than one chemical class or a compound might contain two or more organic residues each of which can be classified. Within each class entries are arranged in order of increasing molecular formulae. Entries are of two types —... 

The use of cash and near cash programs requires functioning markets and adequate provision of basic services to ensure that supply is sufficient to respond to increased demand (Barrientos and Dejong 2004). Indeed, these programs are only effective where food is readily available on the private market, where the problem for the poor is adequate... 

Conditions may include requirements to provide adequate provision for long-term maintenance and transfer of responsibility for maintenance if the ownership of a site were to change in the future... 

NS28 To ensure adequate provision of funds for equipment, weaponry, mobility and communication of security forces, especially in the naxal/militant/terrorist-affected States. Funds for infrastructural/ operational requirements of pohce forces D6... 

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