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 31
... participate in ef- forts to commercialize inventions they made while in the service of the United States ; the authority under section 11 ( c ) ( 3 ) ( A ) of the Act ( 15 U.S.C. 3710a ( c ) ( 3 ) ( A ) ) to review employee standards of ...
... participate in ef- forts to commercialize inventions they made while in the service of the United States ; the authority under section 11 ( c ) ( 3 ) ( A ) of the Act ( 15 U.S.C. 3710a ( c ) ( 3 ) ( A ) ) to review employee standards of ...
Page 80
... participation of other persons only if they appear with the respondent or the respondent's designated rep- resentative , and at the request of , and on behalf of , the respondent . ( c ) A respondent may present any in- formation of any ...
... participation of other persons only if they appear with the respondent or the respondent's designated rep- resentative , and at the request of , and on behalf of , the respondent . ( c ) A respondent may present any in- formation of any ...
Page 82
... Participation in outside standard set- ting activities . 10.100 Public calendars . 10.105 Representation by an organization . 10.110 Settlement proposals . Subpart C - Electronic Media Coverage of Public Administrative Proceedings ...
... Participation in outside standard set- ting activities . 10.100 Public calendars . 10.105 Representation by an organization . 10.110 Settlement proposals . Subpart C - Electronic Media Coverage of Public Administrative Proceedings ...
Page 84
... participation in all agency activities , the Commis- sioner will prepare for public distribu- tion summaries of FDA administrative practices and procedures in readily un- derstandable terms . § 10.19 Waiver , suspension , or modi ...
... participation in all agency activities , the Commis- sioner will prepare for public distribu- tion summaries of FDA administrative practices and procedures in readily un- derstandable terms . § 10.19 Waiver , suspension , or modi ...
Page 86
... participants ) , and persons not specifi- cally permitted access to the data will be excluded from the in camera part of the proceeding . The administrative law judge or other presiding officer may impose other conditions or safeguards ...
... participants ) , and persons not specifi- cally permitted access to the data will be excluded from the in camera part of the proceeding . The administrative law judge or other presiding officer may impose other conditions or safeguards ...
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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...