Enforcing regulations

Federal authority to establish standards for drinking water systems originated with the enactment by Congress in 1883 of the Interstate Quarantine Act, which authorized the Director of the United States Public Health Services (USPHS) to establish and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases. 

In the final analysis, the purpose of measurement is to provide numerical values as the basis both for making policy decisions and for enforcing regulations. It is critical, therefore, to know whether measurement data are reliable. It is also essential that all the data be intercomparable. 

Regulatory impulses on the demand side (enforcement initiatives) create a market opportunity for innovative products and services. They are more concerned with clearly perceptible impulses (announcement effect or focal campaigns of monitoring authorities) than with enforcing regulations. 

The data requirements for the registration of new drugs were defined in the Pharmaceutical Affairs Law and its Enforcement Regulations. Practical guidelines were issued in PMSB Director General Notification No. 481 dated... 

NDA Application Form (format based on Pharmaceutical Affairs Law Enforcement Regulations)... 

The common carriers utilize the services of the BuExpl in enforcing.regulations as well as in assisting shippers(Refs 1 2)... 

Even after the conversion to an alternative energy economy, it will be necessary to monitor the air quality. To enforce regulations, air quality is monitored near single sources of pollution and also in urban areas. Regardless of the type of instruments used to measure air quality, the collected data will only be representative if the sampling site is correctly selected. Table 3.9... 

CFR 1500.44, Title 16, Commercial Practices, Chapter n, Consumer Product Safety Commission, Part 1500, Hazardous Substances and Articles Administration and Enforcement Regulations Method for determining extremely flammable and flammable solids, U.S. Federal Government, Washington, DC. 

CEPA is also the preferred legislation that Canada will use to enforce regulations to meet its commitments to reduce greenhouse gas emissions as a signatory of the Kyoto Protocol. 

Clinical Trial Protocol Notification. The sponsor is obligated to submit the clinical trial protocol notification of the test drug. The following drugs are required to submit the notification of the clinical trial (The article 66-6 of the Enforcement Regulations of PAL. Notification No. 421 of the PAB in 1997) ... 

The transfer of approvals of manufacturing or import is permitted under some conditions (Article 21-6 and 7 the Enforcement Regulations of PAL. Notification No. 658 of the PAB in 1985). However, the transfer of business licenses of drug manufacturing or import is not permitted. 

The person receiving transfer should submit a transfer notice and necessary documents up to 3 months prior to the planned date of the transfer (5 months for Ministry-licensed products such as biological products, drugs involving recombinant process and etc.) (Article 21-6 and 27 of the Enforcement Regulations of the PAL). 

The PAL and its Enforcement Regulations establishes some basic rules for clinical trials, that is, in summary, it is necessary... 

Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations. 1996. Yakugyo Jiho Tokyo. 

MHLW (Ministry of Health, Labour and Welfare). 2005. Enforcement regulation for the law on special measures against Bovine Spongiform Encephalopathy under jurisdiction of the Ministry of Health, Labour and Welfare. Ministry of Health, Labour and Welfare Ordinance No. 110, Article 2. Tokyo, Japan. 

Despite this fact, some governments are now enforcing regulations that are based on test methods that are not suitable for determining formaldehyde exposure levels and risks. Thus, some countries have regulated the formaldehyde content of particleboard, relying on the perforator method, European Standard Method EN 120) (4) which theoretically measures the total quantity of free formaldehyde in particleboard. The current regulatory situation for some countries is shown in Table II. 

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