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 60
... Participant " means any person par- ticipating in any proceeding , including each party and any other interested person . " Party " means the bureau of the Food and Drug Administration respon- sible for a matter involved and every ...
... Participant " means any person par- ticipating in any proceeding , including each party and any other interested person . " Party " means the bureau of the Food and Drug Administration respon- sible for a matter involved and every ...
Page 61
... participant , waive , sus- pend , or modify any provision in Parts 12 through 16 applicable to the con- duct of a public hearing by announce- ment at the hearing or by notice in ad- vance of the hearing if no participant will be ...
... participant , waive , sus- pend , or modify any provision in Parts 12 through 16 applicable to the con- duct of a public hearing by announce- ment at the hearing or by notice in ad- vance of the hearing if no participant will be ...
Page 63
... participants , or only to counsel for parties or participants ) , and persons not specifically permitted access to the data will be excluded from the in camera part of the proceeding . The administrative law judge or other pre- siding ...
... participants , or only to counsel for parties or participants ) , and persons not specifically permitted access to the data will be excluded from the in camera part of the proceeding . The administrative law judge or other pre- siding ...
Page 76
... participants and filed with the Dockets Management Branch . A person , including a representative of a participant in the hearing , who is in- volved in an oral communication con- trary to this section , must , if possible , be made ...
... participants and filed with the Dockets Management Branch . A person , including a representative of a participant in the hearing , who is in- volved in an oral communication con- trary to this section , must , if possible , be made ...
Page 87
... participant in a proceeding will have an opportunity to consider a proposed settlement . Unaccepted pro- posals of settlement and related mat- ters , e.g. , proposed stipulations not agreed to , will not be admissible in evi- dence in ...
... participant in a proceeding will have an opportunity to consider a proposed settlement . Unaccepted pro- posals of settlement and related mat- ters , e.g. , proposed stipulations not agreed to , will not be admissible in evi- dence in ...
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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...