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 15
... Research - Divi- sion of Case Management ( HFM - 610 ) , Office of Compliance and Biologics Quality , Center for Biologics Evalua- tion and Research , Food and Drug Ad- ministration , 1401 Rockville Pike , rm . 200N , Rockville , MD ...
... Research - Divi- sion of Case Management ( HFM - 610 ) , Office of Compliance and Biologics Quality , Center for Biologics Evalua- tion and Research , Food and Drug Ad- ministration , 1401 Rockville Pike , rm . 200N , Rockville , MD ...
Page 23
... Research ; " " Intercenter Agreement Between the Center for Drug Evalua- tion and Research and the Center for Biologics Evaluation and Research . " The availability of any amendments to these intercenter agreements will be announced by ...
... Research ; " " Intercenter Agreement Between the Center for Drug Evalua- tion and Research and the Center for Biologics Evaluation and Research . " The availability of any amendments to these intercenter agreements will be announced by ...
Page 25
... Research , investigation , and testing programs and health information and promotion programs . 5.26 5.27 5.28 Service fellowships . Patent term extensions for human drug products , medical devices , and food and color additives ; and ...
... Research , investigation , and testing programs and health information and promotion programs . 5.26 5.27 5.28 Service fellowships . Patent term extensions for human drug products , medical devices , and food and color additives ; and ...
Page 26
... Research Direc- tor's program authorities . 5.202 Issuance of notices of opportunity for a hearing on proposals for denial of ap- proval of applications for licenses , sus- pension of licenses , or revocation of li- censes and certain ...
... Research Direc- tor's program authorities . 5.202 Issuance of notices of opportunity for a hearing on proposals for denial of ap- proval of applications for licenses , sus- pension of licenses , or revocation of li- censes and certain ...
Page 28
... research on the use and effect of drugs to protect the identity of their research subjects with respect to drugs scheduled under Public Law 91-513 for which an investigational new drug ap- plication is filed with the Food and Drug ...
... research on the use and effect of drugs to protect the identity of their research subjects with respect to drugs scheduled under Public Law 91-513 for which an investigational new drug ap- plication is filed with the Food and Drug ...
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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...