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, 1996 - 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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Results 1-5 of 100
Page 3
... practices and procedures Formal evidentiary public hearing 5 16 22 26 70 80 113 13 14 15 Public hearing before a public ... practice for nonclinical labora- tory studies 265 60 Patent term restoration 278 70 Color additives .... 286 71 ...
... practices and procedures Formal evidentiary public hearing 5 16 22 26 70 80 113 13 14 15 Public hearing before a public ... practice for nonclinical labora- tory studies 265 60 Patent term restoration 278 70 Color additives .... 286 71 ...
Page 16
... practice , posing a significant threat of danger to health , creates a public health situation ( 1 ) that should be corrected immediately to prevent injury and ( 2 ) that should not be per- mitted to continue while a hèaring or other ...
... practice , posing a significant threat of danger to health , creates a public health situation ( 1 ) that should be corrected immediately to prevent injury and ( 2 ) that should not be per- mitted to continue while a hèaring or other ...
Page 46
... practices and false or misleading labeling of new drugs , new animal drugs , and feeds bearing or containing new animal drugs . ( a ) The following officials are author- ized to perform all the functions of the Commissioner of Food and ...
... practices and false or misleading labeling of new drugs , new animal drugs , and feeds bearing or containing new animal drugs . ( a ) The following officials are author- ized to perform all the functions of the Commissioner of Food and ...
Page 70
... practices and procedures of the Food and Drug Administration , enhance pub- lic understanding , improve consumer protection , and assure uniform and consistent application of practices and procedures throughout the agency . [ 43 FR ...
... practices and procedures of the Food and Drug Administration , enhance pub- lic understanding , improve consumer protection , and assure uniform and consistent application of practices and procedures throughout the agency . [ 43 FR ...
Page 80
... PRACTICES AND PROCEDURES Subpart A - General Provisions 10.1 Scope . 10.3 Definitions . 10.10 Summaries of administrative prac- tices and procedures . 10.19 Waiver , suspension , or modification of procedural requirements . Subpart B ...
... PRACTICES AND PROCEDURES Subpart A - General Provisions 10.1 Scope . 10.3 Definitions . 10.10 Summaries of administrative prac- tices and procedures . 10.19 Waiver , suspension , or modification of procedural requirements . Subpart B ...
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Common terms and phrases
acid action administrative record advisory committee agency amended amounts consistent animal drug approval biological cation CBER CDER CDRH Center CFSAN chapter chlorofluorocarbon color additive D&C Color additive mixtures coloring purposes Commissioner of Food conform in identity contain Cosmetic Act D&C Orange D&C Red D&C Yellow Deputy Direc Deputy Director diluents Director and Deputy Dockets Management Branch Drug Administration drug applications Drug Evaluation employee environmental Exemption from certification externally applied drugs FD&C Federal Food FEDERAL REGISTER filed food additive Food and Drug hearing Identity and specifications issue Lead as Pb lic health listed manufacturing practice matter ment metic mixtures for coloring mixtures prepared therefrom naphthalenedisulfonic notice paragraph participant percent person petition presiding officer procedures public disclosure regulations regulatory request restrictions safely salt sory standards of identity submitted Subpart tification tion tive Total color
Popular passages
Page 257 - 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 179 - 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 198 - ... could reasonably be expected to constitute an unwarranted invasion of personal privacy, d. could reasonably be expected to disclose the identity of a confidential source, including a state, local, or foreign agency or authority or any private institution which furnished information on a confidential basis...
Page 254 - An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. (8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Page 198 - ... 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 183 - Make no private promises of any kind binding upon the duties of office, since a Government employee has no private word which can be binding on public duty. 7. Engage in no business with the Government, either directly or indirectly, which is inconsistent with the conscientious performance of his governmental duties.
Page 366 - 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 254 - ... pregnant) which are currently unforeseeable; (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; (3) Any additional costs to the subject that may result from participation in the research; (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during the...
Page 229 - Administration has not reviewed the record to assure that it is accurate, relevant, timely, and complete. §21.74 Providing notice that a record is disputed. Whenever an individual has filed a statement of disagreement with the Food and Drug 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...
Page 183 - Never discriminate unfairly by the dispensing of special favors or privileges to anyone, whether for remuneration or not; and never accept, for himself or his family, favors or benefits under circumstances which...