Animal Drug Amendments of 1967, Hearing Before the Subcommittee on Public Health and Welfare ... 90-1, on H.R. 3639, a Bill to Protect the Public Health by Amending the Federal Food, Drug and Cosmetic Act to Consolidate Certain Provisions Assuring the Safety and Effectiveness of New Animal Drugs, and for Other Purposes and Identical Bills, October 3, 1967 |
Common terms and phrases
30 days 89th Congress adulterated ANCHER NELSEN Animal Drug Amendments animal drug application animal feed bearing Animal Health Institute antibiotics application was approved application with respect ARMSTRONG bacitracin basic Act batch bearing or containing bill broiler Bureau of Veterinary certification Chairman chlortetracycline clause coccidiosis coccidiostats Committee on Interstate consolidate containing new animal containing such drugs Cosmetic Act D.C. DEAR deemed Drug Administration drug is intended drug manufacturer drugs for animal effective date enactment exemption existing law export Federal Food feed additives food additives Food and Drug food production Food-Producing Animal Foreign Commerce GODDARD hearing human drugs Interstate and Foreign JOHN JARMAN KINGMA legislation manufacturing practices meat medicated feed ments NELSEN new-drug application paragraph poultry industry premarketing clearance provisions public health pursuant to subsection record regulations requirements Roehm ROGERS safety and effectiveness section 505 SKUBITZ statement statutory streptomycin submitted Thank thereof tion unsafe Veterinary Medicine Washington
Popular passages
Page 43 - Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals...
Page 10 - ... for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions...
Page 7 - ... a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug...
Page 6 - Secretary's order. (i) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
Page 5 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be, concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
Page 4 - That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Page 12 - ... no residue of such drug will be found (by methods of examination prescribed or approved by the Secretary...
Page 5 - ... (B) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet; and (C) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.
Page 16 - I wish to express my appreciation for the opportunity you have given me to appear before you in support of HR 7655.
Page 9 - new drug" means — (1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...