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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Page 72
... , and assure uniform and consistent application of practices and procedures throughout the agency . [ 43 FR 26218 , June 16 , 1978 ] $ 7.3 Definitions . ( a ) Agency means the 72 §7.1 21 CFR Ch . I ( 4-1-97 Edition ) Enforcement policy 10.
... , and assure uniform and consistent application of practices and procedures throughout the agency . [ 43 FR 26218 , June 16 , 1978 ] $ 7.3 Definitions . ( a ) Agency means the 72 §7.1 21 CFR Ch . I ( 4-1-97 Edition ) Enforcement policy 10.
Page 102
... consistent with the prompt completion of other assign- ments , an agency employee who has worked on a matter may record indi- vidual views on that matter in a writ- ten memorandum , which is to be placed in the file . ( c ) A written ...
... consistent with the prompt completion of other assign- ments , an agency employee who has worked on a matter may record indi- vidual views on that matter in a writ- ten memorandum , which is to be placed in the file . ( c ) A written ...
Page 111
... consistent application of practices and procedures throughout the agency . § 10.203 Definitions . ( a ) Public administrative proceeding as used in this guideline means any FDA proceeding which the public has a right to attend . This ...
... consistent application of practices and procedures throughout the agency . § 10.203 Definitions . ( a ) Public administrative proceeding as used in this guideline means any FDA proceeding which the public has a right to attend . This ...
Page 116
... consistent in- tended performance , and the ability to discern invalid or altered records . ( b ) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection ...
... consistent in- tended performance , and the ability to discern invalid or altered records . ( b ) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection ...
Page 129
... consistent with the right of all interested persons to participate and the public interest in promptly settling controversial mat- ters affecting the public health and welfare . ( b ) Accordingly , the evidence at a hearing is to be ...
... consistent with the right of all interested persons to participate and the public interest in promptly settling controversial mat- ters affecting the public health and welfare . ( b ) Accordingly , the evidence at a hearing is to be ...
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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 CFSAN chapter 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 Center Deputy Direc Deputy Director diluents Director and Deputy Dockets Management Branch Drug Administration drug applications 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 participation percent person petition presiding officer procedures public disclosure quirements regulations regulatory request restrictions safely salt sory submitted Subpart tification tion tive Total color
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...