The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1997 - Administrative law The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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accordance acid action added advisory committee agency amended amounts animal application approval authorized batches Board Branch Center certification chapter color additive Color additive mixtures Commissioner committee Compliance conform considered consistent contain copy cosmetics D&C Red decision Department designated determination device Direc Director and Deputy disclosure ditive Division documents Drug Administration effective employee established Evaluation exempt FD&C Federal filed final Food and Drug functions Health hearing human Identity individual initial intended interest involved issue Labeling listed Management manufacturing matter means meeting ment million necessary notice Office paragraph participation percent person petition practice prepared present presiding officer procedures proceeding proposed protection reasonably records regulations relating request requirements restrictions revised safely safety salt Service specifications standards statement submitted Subpart tion unless written
Popular passages
Page 255 - food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food...
Page 185 - Although relevant, evidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence.
Page 188 - Uphold the Constitution, laws, and legal regulations of the United States and of all governments therein and never be a party to their evasion.
Page 268 - IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. d Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. e...
Page 261 - ... participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any,...
Page 260 - ... rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will Involve no penalty or loss of benefits to which the subject is otherwise entitled...
Page 374 - USP) 2.5. 5, and 10 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen In patients who also have aspirin hypersensitivity.
Page 84 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 374 - HALDOL tablets contain FD&C Yellow No 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals, especially in those who have...
Page 204 - ... would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law...