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 7
... relating to possible product haz- ards ) required in labeling for food , drugs , devices , or cosmetics under the act . ( 2 ) Permit a statement of differences of opinion with respect to the effective- ness of a drug unless each of the ...
... relating to possible product haz- ards ) required in labeling for food , drugs , devices , or cosmetics under the act . ( 2 ) Permit a statement of differences of opinion with respect to the effective- ness of a drug unless each of the ...
Page 26
... relating to technology trans- fer . 5.25 Research , investigation , and testing programs and health information and health promotion programs . 5.26 Service fellowships . 5.27 Patent term extensions for human drug products , medical ...
... relating to technology trans- fer . 5.25 Research , investigation , and testing programs and health information and health promotion programs . 5.26 Service fellowships . 5.27 Patent term extensions for human drug products , medical ...
Page 27
... relating to propos- als to refuse approval or to withdraw ap- proval of new drug applications and their supplements . 5.83 Approval of new animal drug applica- tions and their supplements . 5.84 Issuance of notices , proposals , and or ...
... relating to propos- als to refuse approval or to withdraw ap- proval of new drug applications and their supplements . 5.83 Approval of new animal drug applica- tions and their supplements . 5.84 Issuance of notices , proposals , and or ...
Page 30
... relating to the prohibition of the application of lead - based paint to cooking , drinking , or eating utensils . ( 24 ) Functions vested in the Sec- retary for the health information and health promotion program under title XVII of the ...
... relating to the prohibition of the application of lead - based paint to cooking , drinking , or eating utensils . ( 24 ) Functions vested in the Sec- retary for the health information and health promotion program under title XVII of the ...
Page 32
... Relating to Blood Banks ) and section 2672 ( a ) ( 2 ) ( Informa- tion and Training Programs ) of the Public Health Service Act ( 42 U.S.C. 300ff et seq . ) , as amended , insofar as these authorities pertain to the func- tions assigned ...
... Relating to Blood Banks ) and section 2672 ( a ) ( 2 ) ( Informa- tion and Training Programs ) of the Public Health Service Act ( 42 U.S.C. 300ff et seq . ) , as amended , insofar as these authorities pertain to the func- tions assigned ...
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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...