The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1996 - 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 vi
... approve an incorporation by reference only when the requirements of 1 CFR part 51 are met . Some of the elements on which approval is based are : ( a ) The incorporation will substantially reduce the volume of material pub- lished in ...
... approve an incorporation by reference only when the requirements of 1 CFR part 51 are met . Some of the elements on which approval is based are : ( a ) The incorporation will substantially reduce the volume of material pub- lished in ...
Page 21
... approval of an ap- plication or terminate an IND or INAD notice in accordance with the applica- ble provisions of section 505 of the act and parts 312 and 314 of this chapter , or section 512 of the act and parts 511 and 514 of this ...
... approval of an ap- plication or terminate an IND or INAD notice in accordance with the applica- ble provisions of section 505 of the act and parts 312 and 314 of this chapter , or section 512 of the act and parts 511 and 514 of this ...
Page 22
... approvals from more than one FDA component for such combina- tion products . The second purpose of this regulation is to enhance the effi- ciency of agency management and op- erations by providing procedures for determining which agency ...
... approvals from more than one FDA component for such combina- tion products . The second purpose of this regulation is to enhance the effi- ciency of agency management and op- erations by providing procedures for determining which agency ...
Page 23
... approval of the proposed product the labeling of the approved product would need to be changed , e.g. , to reflect a change in intended use , dosage form , strength , route of admin- istration , or significant change in dose ; or ( 4 ) ...
... approval of the proposed product the labeling of the approved product would need to be changed , e.g. , to reflect a change in intended use , dosage form , strength , route of admin- istration , or significant change in dose ; or ( 4 ) ...
Page 24
... approval or a required investigational notice . Sponsors are encouraged to file a request for designation as soon as ... approval , is mar- keted as not being subject to pre- market approval , or has received an in- vestigational ...
... approval or a required investigational notice . Sponsors are encouraged to file a request for designation as soon as ... approval , is mar- keted as not being subject to pre- market approval , or has received an in- vestigational ...
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Common terms and phrases
acid action administrative record advisory committee agency amended amounts consistent animal drug approval Authority citation biological CDER CDRH Center chapter chlorofluorocarbon color additive D&C Color additive mixtures coloring purposes Commissioner of Food conform in identity Cosmetic Act D&C Orange D&C Red D&C Yellow Deputy Direc Deputy Director diluents Director and Deputy Dockets Management Branch Drug Administration drug applications Drug Evaluation employee environmental Exemption from certification 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 participant percent person petition presiding officer procedures public disclosure regulations regulatory request restrictions revised safely salt sory standards of identity submitted Subpart tification tion tive Total color
Popular passages
Page 248 - 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 284 - ... color additive" means a material which — (A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and...
Page 177 - 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 418 - Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400 — 2499) XXV Corporation for National and Community Service (Parts 2500 — 2599) Title...
Page 224 - Provided, however , that if any individual is denied any right, privilege, or benefit that he would otherwise be entitled "by Federal law, or for which he would otherwise be eligible, as a result of the maintenance of such material, such material shall be provided to such individual...
Page 251 - For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
Page 364 - 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 82 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 364 - 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 196 - ... 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...