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 106
... prepared by a represent- ative of FDA when the agency deter- mines that such documentation will be useful . ( f ) FDA promptly will file in the ap- propriate administrative file memo- randa of meetings prepared by FDA representatives ...
... prepared by a represent- ative of FDA when the agency deter- mines that such documentation will be useful . ( f ) FDA promptly will file in the ap- propriate administrative file memo- randa of meetings prepared by FDA representatives ...
Page 107
... prepared by agency employees and are not in the administrative file have no status or effect . ( e ) FDA employees working on a matter have access to the administra- tive file on that matter , as appropriate for the conduct of their ...
... prepared by agency employees and are not in the administrative file have no status or effect . ( e ) FDA employees working on a matter have access to the administra- tive file on that matter , as appropriate for the conduct of their ...
Page 108
... prepared , the general concepts may be discussed by a representative of FDA with an in- terested person . Details of a draft of a notice or proposed regulation may be discussed with a person outside the ex- ecutive branch only with the ...
... prepared , the general concepts may be discussed by a representative of FDA with an in- terested person . Details of a draft of a notice or proposed regulation may be discussed with a person outside the ex- ecutive branch only with the ...
Page 113
... prepared and made publicly available by FDA each week showing , to the extent feasible , significant events of the previous week , including significant meetings with persons out- side the executive branch , that involve the ...
... prepared and made publicly available by FDA each week showing , to the extent feasible , significant events of the previous week , including significant meetings with persons out- side the executive branch , that involve the ...
Page 114
... prepared for FDA staff , appli- cants / sponsors , and the public that de- scribe the agency's interpretation of or policy on a regulatory issue . ( 2 ) Guidance documents include , but are not limited to , documents that re- late to ...
... prepared for FDA staff , appli- cants / sponsors , and the public that de- scribe the agency's interpretation of or policy on a regulatory issue . ( 2 ) Guidance documents include , but are not limited to , documents that re- late to ...
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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...