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 13
... determination of the ordi- nary and customary selling price in that retail establishment . At the time of making the introductory offer pro- motion , the sponsor must intend in good faith to offer the commodity alone , immediately ...
... determination of the ordi- nary and customary selling price in that retail establishment . At the time of making the introductory offer pro- motion , the sponsor must intend in good faith to offer the commodity alone , immediately ...
Page 22
... determination will eliminate , in most cases , the need to receive 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 ...
... determination will eliminate , in most cases , the need to receive 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 ...
Page 24
... determinations de- signed to provide useful guidance to the public . ( 3 ) The sponsor of a premarket appli- cation or ... determination . ( c ) What to file : an original and two copies of the request for designation must be filed . The ...
... determinations de- signed to provide useful guidance to the public . ( 3 ) The sponsor of a premarket appli- cation or ... determination . ( c ) What to file : an original and two copies of the request for designation must be filed . The ...
Page 25
... determination that is subject to change only as provided in paragraph ( b ) of this section . ( b ) The product jurisdiction officer may change the designated agency component with the written consent of the sponsor , or without its ...
... determination that is subject to change only as provided in paragraph ( b ) of this section . ( b ) The product jurisdiction officer may change the designated agency component with the written consent of the sponsor , or without its ...
Page 26
... determination of product primary jurisdiction . 5.33 Premarket approval of a product that is or contains a biologic ... determination of the effective- ness of medical devices . 5.50 Notification to petitioners of deter- minations made ...
... determination of product primary jurisdiction . 5.33 Premarket approval of a product that is or contains a biologic ... determination of the effective- ness of medical devices . 5.50 Notification to petitioners of deter- minations made ...
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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...