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 vi
... necessary to afford fairness and uniformity in the administrative process . ( c ) The incorporating document is drafted and submitted for publication in accordance with 1 CFR Part 51 . Properly approved incorporations by reference in ...
... necessary to afford fairness and uniformity in the administrative process . ( c ) The incorporating document is drafted and submitted for publication in accordance with 1 CFR Part 51 . Properly approved incorporations by reference in ...
Page 14
... necessary . ( c ) An authorization may be amend- ed upon a showing of reasonable grounds therefor and the filing of an amended application for authorization with the district director . ( d ) If ownership of an article cov- ered by an ...
... necessary . ( c ) An authorization may be amend- ed upon a showing of reasonable grounds therefor and the filing of an amended application for authorization with the district director . ( d ) If ownership of an article cov- ered by an ...
Page 24
... necessary , summarizing the work of the committee during the closed session , and a report , prepared by the executive secretary will be made available promptly to the public . ( c ) When feasible , the public is given a timely ...
... necessary , summarizing the work of the committee during the closed session , and a report , prepared by the executive secretary will be made available promptly to the public . ( c ) When feasible , the public is given a timely ...
Page 25
... necessary or proper on sub- jects related to the functions of the Food and Drug Administration , and to issue information related to health for the use of the public and other perti- nent health information for the use of persons and ...
... necessary or proper on sub- jects related to the functions of the Food and Drug Administration , and to issue information related to health for the use of the public and other perti- nent health information for the use of persons and ...
Page 37
... necessary for a drug for a rare disease or condi- tion to be approved or licensed : ( 1 ) The Director and Scientific Di- rector , National Center for Drugs and Biologics ( NCDB ) . ( 2 ) For drugs under their jurisdic- tion : ( i ) The ...
... necessary for a drug for a rare disease or condi- tion to be approved or licensed : ( 1 ) The Director and Scientific Di- rector , National Center for Drugs and Biologics ( NCDB ) . ( 2 ) For drugs under their jurisdic- tion : ( i ) The ...
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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...