Biological Effects of Ionizing Radiation: Pertinent Federal Laws and Regulations, Volume 1

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U.S. Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health, 1979 - 18 páginas
 

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Página 246 - ... or because of conditions revealed by such application or statement of fact or any report, record or inspection or other means which would warrant the Commission to refuse to grant a license on an original application...
Página 267 - For a drug product, device, or additive subject to the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act...
Página 240 - ... authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
Página 180 - Applications shall be submitted in quintuplicate to the Hearing Clerk, Food and Drug Administration, Rm. 4-65, 5600 Fishers Lane, Rockville, MD 20857.
Página 245 - Tests. Each licensee shall perform, or permit the Commission to perform, such tests as the Commission deems appropriate or necessary for the administration of the regulations in this part...
Página 239 - research and development' means (1) theoretical analysis, exploration, or experimentation ; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. "y. The term 'Restricted Data...
Página 267 - Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA) , a biologic product license issued by FDA, or a "Notice of Claimed Investigational Exemption for a New Drug...
Página 128 - Apr. 29, 1996] § 176.805 On deck stowage. When break bulk Class 8 (corrosive materials) materials being transported on a vessel are stowed on deck: (a) Provisions must be made for leakage from any package to drain away from other cargo into an overboard scupper or freeing port. The drainage may not enter an enclosed drainage system other than a direct overboard scupper. If this stowage...
Página 107 - Ten millirem per hour at any point 2 meters (six feet) from the vertical planes projected by the outer lateral surface of the car or vehicle; or if the load is transported in an open transport vehicle, at any point 2 meters (six feet) from the vertical planes projected from the outer edges of the vehicle.
Página 240 - ... all communications and reports concerning the regulations in this part and applications filed under them should be addressed to the Director of Nuclear Material Safety and Safeguards (the Director), US Nuclear Regulatory Commission, Washington, DC 20555.

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