Commerce interstate

The INDA actually is a request for a Claimed Investigational Exemption to allow the transport of clinical samples of a nonapproved dmg into interstate commerce for the testing in human subjects. 

Handling of Amines. Regulations governing the safe handling and shipping of amines in interstate commerce are given in U.S. Department of Transportation pubHcations (71). Specific information on the safe handling and hazards associated with a particular amine can be found in the Material Safety Data Sheet for that material. For further information on the safety of industrial material see also references 72 and 73. 

Tables 16 and 17 Hst tke analytical test methods for different properties of interest. The Manufacturing Chemists Association, Inc. (MCA) has pubUshed the Chemical Safety Data Sheet SD 63, which describes in detail procedures for safe handling of use of toluene (46). The Interstate Commerce Commission classifies toluene as a flammable Hquid. Accordingly, it must be packaged in authorized containers, and shipping must comply with ICC regulations. Properties related to safe handling are autoignition temperature, 536°C explosive limits, 1.27—7.0 vol % in air and flash point 4.4°C, closed cup.

U.S.C. 13703 (1996) in 1996, the Surface Transportation Board (U.S. Dept, of Transportation) replaced the former Interstate Commerce Commission under provisions of ICC Termination Met of1995, P.L. 104-88. 

Interstate Commerce Commission Reports, Supetintendent of Documents, U.S. Government Printing Office, Washiagton, D.C., cited (Volume) ICC (Page). A series of decisions of the now defunct Interstate Commerce Commission Vol. 1 was pubHshed 1887. 

Interstate Commerce Acts Annotated, Interstate Commerce Commission, Washiagton, D.C. 22 Vols. plus Advance bulletins (last pubHshed Aug. 1981). Compilation of Interstate Commerce Act and related U.S. federal laws, with digests of decisions of federal courts and ICC relating to each section of such Acts. 

Hawkins Index-Digest Analysis of Decisions Under the Interstate Commerce Act, Hawkias Publishing Co., Washiagton, D.C. Loose-leaf service, 10 Vols. collecting and digesting decisions under Interstate Commerce Act primarily to railroads. 

I. L. Sharfman, The Interstate Commerce Commission, 5 Vols., The Commenwealth Fund, New York, 1931—1937. Classic and scholarly study, largely of historical interest. 

In 1938 a new law, the Federal Food, Dmg, and Cosmetic Act of 1938 (18), which instituted several new and important practices, was enacted. Fkst, it clearly stated that, henceforth, the use of any uncertified coal-tar color in any food, dmg, or cosmetic shipped in interstate commerce was stricdy forbidden. This restriction appHed regardless of the inherent toxicity of the colorant. In effect, the colorants that could be used were limited, certification became mandatory, and governmental control was extended to the coloring of dmgs and cosmetics. Next, it created three categories of coal-tar colors ... 

Packaging and labeling for all hazardous materials shipped in interstate commerce. 

The first major federal regulatory event affecting natural gas pipelines was the Natural Gas Act of 1938, which gave the Federal Power Commission jurisdiction to regulate three areas (1) pipeline sales of gas purchased from producers and resold to local distribution companies in interstate commerce (2) transportation m interstate commerce and (3) the facilities used for such sales and such transportation. 

The second major federal regulatoiy event was a Supreme Court decision in 1954 which resulted in the imposition of wellhead price regulation of gas sold in interstate commerce. 

Nevertheless, multiple challenges persist. Reimbursement on a fee-for-service or contractual basis between institutions may not be feasible for the community hospital. Government reimbursement for telemedicine services may remain limited by interstate commerce restrictions and local practice requirements, and may depend on studies demonstrating that the costs of consultation are counterbalanced by avoiding unnecessary transfers. Additionally, privacy concerns must be properly addressed with secure, encrypted transfer of information and rules governing who may access the patient s medical information from a distance. 

Certain limitations of this study are worth reviewing. The FDA standard or action level for PCBs in fish sold in interstate commerce was used even though the river is not commercially fished.. In any event, a study of contamination in fish which will result in comparisons with a regulatory action level for justifying a remedial action must provide results which retain some degree of confidence. 

Because the protection afforded users of economic poisons under the federal law applies only to materials shipped in interstate commerce, state laws must provide adequate protection to users of economic poisons shipped solely within the state, and provide cooperative enforcement of the federal law. 

CPSC Paint is declared banned from household use and interstate commerce if the lead content exceeds 0.06% total weight of solids or paint film CPSC 1973 16CFR 1500.17 EPA 1973c... 

When an IVD is developed as a kit or system to be used with specific equipment and is sold to multiple laboratories, it is considered a device in interstate commerce and is subject to premarket review. When the IVD is a novel test, premarket approval (PMA) will be based on the analytical and clinical validation that will determine whether the test is safe and effective for clinical use. When there is evidence that the IVD is substantially equivalent to a legally marketed device, FDA clears such tests under section 510(k) of the Device Amendments to the Food, Drug and Cosmetic Act. The necessary level of evidence and requirements are described in more detail below. 

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