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 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 23
... determinations de- signed to provide useful guidance to the public . ( 3 ) The sponsor of a premarket appli- cation or required investigational fil- ing for a combination or other product covered by these guidance documents may contact ...
... determinations de- signed to provide useful guidance to the public . ( 3 ) The sponsor of a premarket appli- cation or required investigational fil- ing for a combination or other product covered by these guidance documents may contact ...
Page 24
... determination . ( c ) What to file : an original and two copies of the request for designation must be filed . The request for designa- tion must not exceed 15 pages , includ- ing attachments , and must set forth : ( 1 ) The identity of ...
... determination . ( c ) What to file : an original and two copies of the request for designation must be filed . The request for designa- tion must not exceed 15 pages , includ- ing attachments , and must set forth : ( 1 ) The identity of ...
Page 25
... determination that is subject to change only as provided in paragraph ( b ) of this section . ( b ) The product ... determinations and infor- mal hearings . Petitions under part 10 . 5.28 Hearings . 5.29 5.30 Authority to select ...
... determination that is subject to change only as provided in paragraph ( b ) of this section . ( b ) The product ... determinations and infor- mal hearings . Petitions under part 10 . 5.28 Hearings . 5.29 5.30 Authority to select ...
Page 26
... determination of the effective- ness of medical devices . 5.404 Notification of petitioners of deter- minations made on petitions for reclassi- fication of medical devices . 5.405 Determination of classification of de- vices . 5.406 ...
... determination of the effective- ness of medical devices . 5.404 Notification of petitioners of deter- minations made on petitions for reclassi- fication of medical devices . 5.405 Determination of classification of de- vices . 5.406 ...
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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.