Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1988 - Administrative law Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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Page 13
... determination of the ordinary and customary selling price in that retail establishment . At the time of making the introductory offer promotion , the sponsor must intend in good faith to offer the com- modity alone , immediately ...
... determination of the ordinary and customary selling price in that retail establishment . At the time of making the introductory offer promotion , the sponsor must intend in good faith to offer the com- modity alone , immediately ...
Page 22
... determination of the effective- ness of medical devices . 5.50 Notification to petitioners of determi- nations made ... Determinations that medical devices present unreasonable risk of substantial harm . 5.55 Orders to repair or replace ...
... determination of the effective- ness of medical devices . 5.50 Notification to petitioners of determi- nations made ... Determinations that medical devices present unreasonable risk of substantial harm . 5.55 Orders to repair or replace ...
Page 24
... determination of the safety and effectiveness of drugs or to approve new drugs to be used in the treatment of narcotic addicts . ( 9 ) Functions vested in the Secretary pertaining to section 303 ( f ) of the Controlled Substances Act ...
... determination of the safety and effectiveness of drugs or to approve new drugs to be used in the treatment of narcotic addicts . ( 9 ) Functions vested in the Secretary pertaining to section 303 ( f ) of the Controlled Substances Act ...
Page 26
... determinations under section 156 ( d ) ( 2 ) ( B ) , which may not be redele- gated to an Office below the Office of the Commissioner of Food and Drugs . ( 28 ) Functions vested in the Secre- tary under section 1862 ( h ) ( 1 ) , ( 2 ) ...
... determinations under section 156 ( d ) ( 2 ) ( B ) , which may not be redele- gated to an Office below the Office of the Commissioner of Food and Drugs . ( 28 ) Functions vested in the Secre- tary under section 1862 ( h ) ( 1 ) , ( 2 ) ...
Page 29
... determinations to disclose official records and informa- tion under Part 20 of this chapter , except that only the officials listed in paragraph ( a ) ( 1 ) may disclose official records and information under §§ 20.82 and 20.85 of this ...
... determinations to disclose official records and informa- tion under Part 20 of this chapter , except that only the officials listed in paragraph ( a ) ( 1 ) may disclose official records and information under §§ 20.82 and 20.85 of this ...
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Common terms and phrases
74 Stat acid Act Record System advisory committee agency amounts consistent animal drug annatto approval authorized batches thereof Biologics Canthaxanthin cations certifica chapter color additive D&C color additive mixtures coloring foods coloring purposes Compliance conform in identity contain Cosmetic Act D&C Red Data and information Deputy Direc diluents Director and Deputy Dockets Management Branch Drug Administration drug application Drug Products Effective date confirmed employee environmental Exemption from certification FD&C Federal Food FEDERAL REGISTER filed food additive Food and Drug hearing human Identity and specifications institutional review board issue Lead as Pb listed manufacturing practice matter medical devices ment metic million mixtures for coloring mixtures prepared therefrom notice paragraph participation percent person petition presiding officer Privacy Act Record procedures public disclosure public health recall regulations regulatory request restrictions revised standards of identity submitted thereof are exempt tive
Popular passages
Page 165 - A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it.
Page 218 - 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 154 - Government, either directly or indirectly, which is inconsistent with the conscientious performance of his governmental duties. 8. Never use any information coming to him confidentially in the performance of governmental duties as a means for making private profit. 9. Expose corruption wherever discovered. 10. Uphold these principles, ever conscious that public office is a public trust.
Page 327 - 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 64 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 190 - September 27, 1975. (h) Rights of Legal Guardians. For the purposes of this section, the parent of any minor, or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction, may act on behalf of the individual.
Page 254 - The petition shall be submitted in triplicate. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The...
Page 188 - ... (5) To a recipient who has provided the agency with advance adequate written assurance that the record will be used solely as a statistical research or reporting record, and the record is to be transferred in a form that is not individually identifiable; (6) To the National Archives...
Page 221 - ... review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review...
Page 221 - ... and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children,...