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 8
... intended for sale at retail , shall be exempt from the required declaration of net quantity of contents specified in this part . ( 4 ) Individually wrapped pieces of penny candy and other confectionery of less than one - half ounce net ...
... intended for sale at retail , shall be exempt from the required declaration of net quantity of contents specified in this part . ( 4 ) Individually wrapped pieces of penny candy and other confectionery of less than one - half ounce net ...
Page 11
... intended to be separated from the retail package under conditions of retail sale ; and ( iii ) Each unit container is labeled with the statement " This Unit Not La- beled For Retail Sale " in type size not less than one - sixteenth of ...
... intended to be separated from the retail package under conditions of retail sale ; and ( iii ) Each unit container is labeled with the statement " This Unit Not La- beled For Retail Sale " in type size not less than one - sixteenth of ...
Page 23
... intended for use only with an approved individually specified drug , device , or biological product where both are required to achieve the intended use , indication , or effect and where upon approval of the proposed product the ...
... intended for use only with an approved individually specified drug , device , or biological product where both are required to achieve the intended use , indication , or effect and where upon approval of the proposed product the ...
Page 29
... intended to result in recommendations for regu- latory decisions under the Federal Food , Drug , and Cosmetic Act and which are concerned with matters list- ed in 5 U.S.C. 552 ( b ) ( 4 ) , ( 5 ) , and ( 7 ) ; ( iii ) Meetings held for ...
... intended to result in recommendations for regu- latory decisions under the Federal Food , Drug , and Cosmetic Act and which are concerned with matters list- ed in 5 U.S.C. 552 ( b ) ( 4 ) , ( 5 ) , and ( 7 ) ; ( iii ) Meetings held for ...
Page 33
... intended only to improve the internal management of the Department of Health and Human Services , and is not intended to create any right or benefit , substantive or procedural , enforceable at law by a party against the United States ...
... intended only to improve the internal management of the Department of Health and Human Services , and is not intended to create any right or benefit , substantive or procedural , enforceable at law by a party against the United States ...
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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...