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, 1984 - 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 18
... tive controls and recovery and repro- ducibility studies . ( Sec . 707 , 57 Stat . 500 ; 21 U.S.C. 377 ) [ 42 FR 15559 , Mar. 22 , 1977 , as amended at 47 FR 946 , Jan. 8 , 1982 ] Subpart B - Human and Animal Foods § 2.25 Grain seed ...
... tive controls and recovery and repro- ducibility studies . ( Sec . 707 , 57 Stat . 500 ; 21 U.S.C. 377 ) [ 42 FR 15559 , Mar. 22 , 1977 , as amended at 47 FR 946 , Jan. 8 , 1982 ] Subpart B - Human and Animal Foods § 2.25 Grain seed ...
Page 27
... tive Director of Regional Operations . ( 7 ) The Director , Scientific Director , Associate Director for Program Devel- opment and Operations , and Directors and Deputy Directors of Offices of the National Center for Drugs and Biolo ...
... tive Director of Regional Operations . ( 7 ) The Director , Scientific Director , Associate Director for Program Devel- opment and Operations , and Directors and Deputy Directors of Offices of the National Center for Drugs and Biolo ...
Page 37
... tives that relate to the assigned func- tions of the respective Bureau . ( b ) ( 1 ) The Director and Deputy Di- rector of the Bureau of Foods are au- thorized to perform all the functions of the Commissioner of Food and Drugs under ...
... tives that relate to the assigned func- tions of the respective Bureau . ( b ) ( 1 ) The Director and Deputy Di- rector of the Bureau of Foods are au- thorized to perform all the functions of the Commissioner of Food and Drugs under ...
Page 39
... tive drug ) , and products under the ju- risdiction of the Bureau of Biologics in § 312.1 ( j ) of this chapter for which au- thority has been delegated in para- graph ( b ) of this section . ( 1 ) The Associate Director for New Drug ...
... tive drug ) , and products under the ju- risdiction of the Bureau of Biologics in § 312.1 ( j ) of this chapter for which au- thority has been delegated in para- graph ( b ) of this section . ( 1 ) The Associate Director for New Drug ...
Page 47
... tive , or in writing . ( d ) " Responsible individual " includes those in positions of power or authori- ty to detect , prevent , or correct vicla- tions of the Federal Food , Drug , and Cosmetic Act . ( e ) [ Reserved ] ( f ) " Product ...
... tive , or in writing . ( d ) " Responsible individual " includes those in positions of power or authori- ty to detect , prevent , or correct vicla- tions of the Federal Food , Drug , and Cosmetic Act . ( e ) [ Reserved ] ( f ) " Product ...
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Common terms and phrases
52 Stat 74 Stat acid Act Record System action administrative record advisory committee agency amounts consistent animal drug annatto approval available for public batches thereof Bureau cations chapter color additive D&C Color additive mixtures coloring purposes conform in identity D&C Orange D&C Red D&C Yellow Data and information diluents Director and Deputy disclosed Dockets Management Branch Drug Adminis Drug Administration drug applications Effective date confirmed employee Exemption from certification FD&C Federal Food FEDERAL REGISTER filed food additive Food and Drug hearing Identity and specifications impact statement individual institutional review board issue Labeling Lead as Pb listed manufacturing practice matter ment metics mixtures for coloring mixtures prepared therefrom NCDB notice paragraph participant percent person petition Privacy Act Record procedures public disclosure public health pursuant regulations request requirements revised safely standards of identity submitted Subpart thereof are exempt tion tive
Popular passages
Page 162 - A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it.
Page 200 - 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 151 - For the purposes of sections 205 and 207 of this title, the term "official responsibility" means the direct administrative or operating authority, whether intermediate or final, and either exercisable alone or with others, and either personally or through subordinates, to approve, disapprove, or otherwise direct Government action.
Page 188 - 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 191 - September 27, 1975. (h) Rights of Legal Guardians. For the purposes of this section, the parent of any minor, or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction, may act on behalf of the individual.
Page 203 - A statement that the study Involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental...
Page 204 - ... medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects...
Page 196 - Code, and shall accompany the proposal through the existing agency review processes; (D) study, develop, and describe appropriate alternatives to recommended courses of action in any proposal which involves unresolved conflicts concerning alternative uses of available resources...
Page 246 - 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 60 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...