Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexU.S. General Services Administration, National Archives and Records Service, Office of the Federal Register, 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 3
... a public advisory committee Public hearing before the Commissioner
Regulatory hearing before the Food and Drug Administration . . . . . . Civil money
penalties hearings Standards of conduct and conflicts of interest Public
information .
... a public advisory committee Public hearing before the Commissioner
Regulatory hearing before the Food and Drug Administration . . . . . . Civil money
penalties hearings Standards of conduct and conflicts of interest Public
information .
Page 30
... which allows for the extension of standards of conduct for resolving popatent
terms for human drug products , tential conflicts of interest ; the aumedical
devices , food additives , and thority under section 13 ( a ) ( 1 ) of the Act color
additives ...
... which allows for the extension of standards of conduct for resolving popatent
terms for human drug products , tential conflicts of interest ; the aumedical
devices , food additives , and thority under section 13 ( a ) ( 1 ) of the Act color
additives ...
Page 39
... promotion provelopment agreements and licensing grams , which relate to
their assigned agreements and transmit written ex functions , and to approve
grants for planation of such approval or dis - conducting such programs :
approval to the ...
... promotion provelopment agreements and licensing grams , which relate to
their assigned agreements and transmit written ex functions , and to approve
grants for planation of such approval or dis - conducting such programs :
approval to the ...
Page 42
... memorandum in the proceeding . and to designate other Food and Drug ( d )
These officials may not further Administration employees to serve as redelegate
this authority . the presiding officer , at a regulatory hearing and to conduct such a
...
... memorandum in the proceeding . and to designate other Food and Drug ( d )
These officials may not further Administration employees to serve as redelegate
this authority . the presiding officer , at a regulatory hearing and to conduct such a
...
Page 45
... by the Commissioner of Food and Drugs ( Commissioner ) to conduct
examinations , investigations , or inspections under the act relating to counterfeit
drugs and issued the Food and Drug Administration Official Credential consisting
of Form ...
... by the Commissioner of Food and Drugs ( Commissioner ) to conduct
examinations , investigations , or inspections under the act relating to counterfeit
drugs and issued the Food and Drug Administration Official Credential consisting
of Form ...
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Common terms and phrases
accordance action advisory committee agency amended amounts animal application approval authority batches Biologics Branch CDRH Center certification chapter color additive Commissioner Compliance conduct conform considered contain copy cosmetics decision Deputy Direc Deputy Director designated determination device Director and Deputy disclosure Division Dockets documents Drug Administration effective electronic employee established Evaluation exempt Federal filed final Food and Drug functions further hearing human identity individual initial intended interest involved issue Labeling listed Management manufacturing matter means meeting ment mixtures notice Operations paragraph participant party percent person petition Policy practice prepared present presiding officer procedures proceeding proposed reasonable recall records regulations regulatory relating reports request requirements Research responsible restrictions safely Science Services specifications standards statement submission submitted Subpart tion tors unless views written
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.