The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1991 - 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 3
... hearing before a public board of inquiry ..... Public hearing before a public advisory committee Public hearing before the Commissioner ...... ........................... .. Regulatory hearing before the Food and Drug Ad- ministration ...
... hearing before a public board of inquiry ..... Public hearing before a public advisory committee Public hearing before the Commissioner ...... ........................... .. Regulatory hearing before the Food and Drug Ad- ministration ...
Page 5
... Hearing on refusal of admission . 1.95 Application for authorization to rela- bel and recondition . 1.96 Granting of authorization to relabel and recondition . 1.97 Bonds . 1.99 Costs chargeable in connection with relabeling and ...
... Hearing on refusal of admission . 1.95 Application for authorization to rela- bel and recondition . 1.96 Granting of authorization to relabel and recondition . 1.97 Bonds . 1.99 Costs chargeable in connection with relabeling and ...
Page 14
... Hearing on refusal of admission . ( a ) If it appears that the article may be subject to refusal of admission , the district director shall give the owner or consignee a written notice to that effect , stating the reasons therefor . The ...
... Hearing on refusal of admission . ( a ) If it appears that the article may be subject to refusal of admission , the district director shall give the owner or consignee a written notice to that effect , stating the reasons therefor . The ...
Page 16
... hearing or other formal proceeding is being held . The imminent hazard may be declared at any point in the chain of events which may ultimately result in harm to the public health . The occurrence of the final anticipated injury is not ...
... hearing or other formal proceeding is being held . The imminent hazard may be declared at any point in the chain of events which may ultimately result in harm to the public health . The occurrence of the final anticipated injury is not ...
Page 21
... hearing on the withdrawal of the ap- plication is waived . ( h ) ( 1 ) Each manufacturer of a drug product listed in paragraph ( e ) of this section that is not covered by an ap- proved new drug application shall submit a new drug ...
... hearing on the withdrawal of the ap- plication is waived . ( h ) ( 1 ) Each manufacturer of a drug product listed in paragraph ( e ) of this section that is not covered by an ap- proved new drug application shall submit a new drug ...
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Common terms and phrases
0.2 percent acid action additive shall conform administrative record advisory committee agency amended amounts consistent animal drug approval batches thereof cations CDER Center certifica chapter color additive D&C Color additive mixtures coloring foods coloring purposes Compliance conform in identity contain Cosmetic Act D&C Orange D&C Red D&C Yellow Deputy Direc diluents Director and Deputy Dockets Management Branch Drug Administration drug application 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 listed manufacturing practice matter ment metic million mixtures for coloring mixtures prepared therefrom notice Packaging and Labeling paragraph participant person petition presiding officer procedures public disclosure public health regulations regulatory request requirements of section restrictions revised safely Service sodium salts standards of identity submitted Subpart thereof are exempt tive Total color
Popular passages
Page 227 - Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered In daily life or during the performance of routine physical or psychological examinations or tests.
Page 158 - 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 168 - 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 218 - 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 195 - Congress or subcommittee of any such joint committee; (10) To the Comptroller General, or any of his...
Page 230 - IRB's use of the expedited review procedure. §46.111 Criteria for IRB approval of research. a. In order to approve research covered by this policy, the IRB shall determine that all of the following requirements are satisfied: 1. Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment...
Page 195 - ... (5) to a recipient who has provided the agency with advance adequate written assurance that the record will be used solely as a statistical research or reporting record, and the record is to be transferred in a form that is not individually identifiable ; (6) to the National Archives...
Page 229 - ... review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review...
Page 56 - A guaranty or undertaking referred to in section 5(b)(2) of the act may be: (1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment or delivery; or (2...
Page 222 - 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...