The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 2002 - 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 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 . Hearings . 5.29 Petitions under part 10 . 5.30 5.31 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 . Hearings . 5.29 Petitions under part 10 . 5.30 5.31 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 action administrative record advisory committee agency amended amounts consistent animal drug approval Authority citation revised biological Canthaxanthin cation CBER CDER CDRH Center CFSAN chapter color additive D&C Color additive mixtures coloring purposes Commis conform in identity Cosmetic Act D&C Orange D&C Red D&C Yellow Deputy Direc Deputy Director determination diluents Director and Deputy Dockets Management Branch Drug Administration drug application employee Evaluation Exemption from certification FD&C Federal Acquisition Regulation Federal Food FEDERAL REGISTER filed following officials food additive Food and Drug hearing Identity and specifications issue Lead as Pb lic health listed manufacturing practice matter medical devices ment metics mixtures for coloring mixtures prepared therefrom notice paragraph participation party percent person petition premarket presiding officer procedures public disclosure quirements regulatory request Research restrictions safely salt Service sioner sory submitted Subpart tification tion tive
Popular passages
Page 325 - ... 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 187 - 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 234 - 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 289 - ... participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any,...
Page 480 - Central Intelligence Agency Chief Financial Officer, Office of Child Support Enforcement, Office of Children and Families, Administration for Civil Rights, Commission on Civil Rights, Office for Coast Guard Coast Guard (Great Lakes Pilotage) Commerce Department Census Bureau Economic Affairs, Under...
Page vii - MF, 8 am to 4 pmest or fax your order to 202-512-2250, 24 hours a day. For payment by check, write to the Superintendent of Documents, Attn: New Orders, PO Box 371954, Pittsburgh, PA 15250-7954. For GPO Customer Service call 202-512-1803. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, the LSA (List of CFR Sections Affected), The United States Government Manual, the Federal Register, Public Laws, Public Papers, Weekly Compilation of Presidential Documents and the Privacy Act...
Page 237 - Administration concerning a refusal to amend a record under § 21.51(a)(2) or with another agency that provides the record to the Food and Drug Administration, the Food and Drug Administration shall in any subsequent disclosure under this subpart provide a copy of the statement of disagreement and a concise statement by the agency, if one has been prepared, of the reasons for not making the amendment(s) requested. § 21.75 Rights of legal guardians. For the purposes of this part, the parent of any...
Page 288 - ... rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled...
Page 408 - 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 85 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...