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, 2002 - 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 7
... proposed findings if section 5 ( b ) of the Fair Packaging and Labeling Act applies , pursuant to parts 10 , 12 , 13 , 14 , 15 , 16 , and 19 of this chapter . §1.24 Exemptions from required label statements . The following exemptions ...
... proposed findings if section 5 ( b ) of the Fair Packaging and Labeling Act applies , pursuant to parts 10 , 12 , 13 , 14 , 15 , 16 , and 19 of this chapter . §1.24 Exemptions from required label statements . The following exemptions ...
Page 12
... proposals for bringing the article into compliance with the act or rendering it other than a food , drug , device , or cosmetic . ( b ) Specify the time and place where such operations will be carried out and the approximate time for ...
... proposals for bringing the article into compliance with the act or rendering it other than a food , drug , device , or cosmetic . ( b ) Specify the time and place where such operations will be carried out and the approximate time for ...
Page 21
... proposed or final monograph issued under the provisions of 21 CFR part 330 . ( iv ) Nonoxynol 9 in an aerosol foam suitable for vaginal administration as a contraceptive foam . The aerosol foam must contain 8 to 12.5 percent of ...
... proposed or final monograph issued under the provisions of 21 CFR part 330 . ( iv ) Nonoxynol 9 in an aerosol foam suitable for vaginal administration as a contraceptive foam . The aerosol foam must contain 8 to 12.5 percent of ...
Page 22
... proposed labeling is intended for use only with an approved individually specified drug , device , or biological product where both are required to achieve the intended use , indication , or effect and where upon approval of the proposed ...
... proposed labeling is intended for use only with an approved individually specified drug , device , or biological product where both are required to achieve the intended use , indication , or effect and where upon approval of the proposed ...
Page 24
... Proposed use or indications ; ( ix ) Description of all known modes of action , the sponsor's identification of the primary mode of action , and the basis for that determination ; ( x ) Schedule and duration of use ; ( xi ) Dose and ...
... Proposed use or indications ; ( ix ) Description of all known modes of action , the sponsor's identification of the primary mode of action , and the basis for that determination ; ( x ) Schedule and duration of use ; ( xi ) Dose and ...
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Common terms and phrases
acid Act Record System action Adminis administrative record advisory committee agency amended amounts consistent animal drug approval available for public batches CBER CDER CDRH CFSAN chapter chlorofluorocarbon cluding Color additive mixtures coloring purposes Commis conform Cosmetic Act D&C Red decision Deputy Direc Deputy Director determination diluents Director and Deputy ditive Division Dockets Management Branch Drug Administration drug applications electronic employee Exemption from certification FD&C Federal Food FEDERAL REGISTER filed following officials food additive Food and Drug functions further redelegate guidance document hearing Identity and specifications investigation issue ized Labeling listed manufacturing practice matter medical devices ment metic mittee notice Office of Compliance officials are author OHIP paragraph participation party percent person petition premarket presiding officer procedures proceeding public disclosure Regulations and Policy regulatory request requirements sioner sory submission submitted Subpart tion tive tors for Science
Popular passages
Page 300 - 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 329 - 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 191 - 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 467 - Department of Agriculture (Parts 2900—2999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 3000—3099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299) Chap.
Page 210 - ... 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...
Page 412 - 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 240 - ... 9 ) to either House of Congress, or, to the extent of matter within its jurisdiction, any committee or subcommittee thereof, any joint committee of Congress or subcommittee of any such joint committee...
Page 195 - 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 304 - Except when an expedited review procedure is used (see §56.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
Page 5 - Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) "Label" means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.