The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1990 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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administrative record advisory committee agency amended at 54 ance animal drug antibiotic approval authorized cations CBER Center for Biologics Center for Devices Center for Drug chapter chlorofluorocarbon Color additive mixtures coloring purposes Commissioner of Food conform contain Cosmetic Act D&C Red decision Deputy Direc determination Director and Deputy Division Dockets Management Branch documents Drug Administration drug application Drug Evaluation drug product electronic products employee Evaluation and Research Exemption from certification FD&C Federal Food FEDERAL REGISTER filed following officials food additive Food and Drug Health Service Act human Identity and specifications interested person issue listed manufacturing practice matter medical devices meeting ment notice Office of Compliance oral package Packaging and Labeling paragraph participation percent petition presiding officer procedures proceeding proposed Public Health Service recall regulations request Research CDER sioner submission submitted Subpart tion tive
Popular passages
Page 172 - A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it.
Page 228 - 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 340 - 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 3 - Definitions. (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) "Label" means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity. Subpart B — General Labeling Requirements...
Page 231 - ... (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.
Page 161 - The term official responsibility means the direct administrative or operating authority, whether intermediate or final, and either exercisable alone or with others, and either personally or through subordinates, to approve, disapprove, or otherwise direct government action.
Page 225 - 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 the course of the research which may relate to the subject's...
Page 201 - 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 199 - ... 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 160 - Never discriminate unfairly by the dispensing of special favors or privileges to anyone, whether for remuneration or not; and never accept, for himself or his family, favors or benefits under circumstances which...