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 26
... Commissioner of Food and Drugs 5.20 General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration . 5.21 Emergency functions . 5.22 Certification of true copies and use of Department seal ...
... Commissioner of Food and Drugs 5.20 General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration . 5.21 Emergency functions . 5.22 Certification of true copies and use of Department seal ...
Page 33
... Commissioner of Food and Drugs , with authority to redele- gate , the authority to certify true cop- ies of any books , records , or other doc- uments on file within the Food and Drug Administration or extracts from such ; to certify ...
... Commissioner of Food and Drugs , with authority to redele- gate , the authority to certify true cop- ies of any books , records , or other doc- uments on file within the Food and Drug Administration or extracts from such ; to certify ...
Page 34
... Commissioner of Food and Drugs § 5.20 General redelegations of author- ity from the Commissioner to other officers of the Food and Drug Ad- ministration . ( a ) Final authority of the Commis- sioner of Food and Drugs is redelegated as ...
... Commissioner of Food and Drugs § 5.20 General redelegations of author- ity from the Commissioner to other officers of the Food and Drug Ad- ministration . ( a ) Final authority of the Commis- sioner of Food and Drugs is redelegated as ...
Page 35
... Commissioners . ( 3 ) ( i ) The Director , Office of Execu- tive Operations . ( ii ) The Director , Executive Secretar- iat . ( iii ) The Director , Program Manage- ment Staff . ( 4 ) The Executive Assistant to the Commissioner , Office ...
... Commissioners . ( 3 ) ( i ) The Director , Office of Execu- tive Operations . ( ii ) The Director , Executive Secretar- iat . ( iii ) The Director , Program Manage- ment Staff . ( 4 ) The Executive Assistant to the Commissioner , Office ...
Page 37
... Commissioner for Regulatory Affairs , Deputy Associ- ate Commissioner for Regulatory Af- fairs , and Director , Office of Enforce- ment , FDA . ( ii ) The Director , Deputy Director , and Associate Director for Policy Co- ordination and ...
... Commissioner for Regulatory Affairs , Deputy Associ- ate Commissioner for Regulatory Af- fairs , and Director , Office of Enforce- ment , FDA . ( ii ) The Director , Deputy Director , and Associate Director for Policy Co- ordination and ...
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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...