The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1995 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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Common terms and phrases
acid action administrative record advisory committee agency amended amounts consistent animal drug approval biological cation CBER CDER CDRH Center chapter chlorofluorocarbon color additive D&C Color additive mixtures coloring purposes Commissioner of Food conform in identity contain Cosmetic Act D&C Orange D&C Red D&C Yellow Deputy Direc Deputy Director diluents Director and Deputy Dockets Management Branch Drug Administration drug applications Drug Evaluation employee environmental Exemption from certification externally applied drugs FD&C Federal Acquisition Regulation Federal Food FEDERAL REGISTER filed food additive Food and Drug hearing Identity and specifications issue Lead as Pb lic health listed manufacturing practice matter ment metic mixtures for coloring mixtures prepared therefrom naphthalenedisulfonic notice paragraph participant percent person petition presiding officer procedures public disclosure regulations regulatory request restrictions safely salt standards of identity submitted Subpart tification tion tive Total color
Popular passages
Page 244 - 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 168 - Any person in Government service should: 1. Put loyalty to the highest moral principles and to country above loyalty to persons, party, or Government department. 2. 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 213 - ... 9 ) to either House of Congress, or, to the extent of matter within its jurisdiction, any committee or subcommittee thereof, any joint committee of Congress or subcommittee of any such joint committee...
Page 239 - When appropriate, one or more of the following elements of information shall also be provided to each subject: (1)A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
Page 183 - ... 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...
Page 354 - 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 239 - For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects...
Page 239 - ... become pregnant) which are currently unforeseeable; (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; (3) Any additional costs to the subject that may result from participation in the research; (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during...
Page 214 - September 27, 1975. (h) Rights of Legal Guardians. For the purposes of this section, the parent of any minor, or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction, may act on behalf of the individual.
Page 238 - A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental...