Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and Index
Division of the Federal Register, the National Archives, 1989 - Administrative law
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accordance action advisory committee agency amended amounts animal application approval authorized batches Board Branch Center certification chapter color additive Commissioner Compliance conduct conform considered contain copy cosmetics D&C Red decision Department Deputy Direc designated determination device Director and Deputy disclosure Division Dockets documents Drug Administration effective employee environmental established Evaluation exempt Federal filed final Food and Drug functions hearing human identity individual initial intended interest involved issue label listed Management manufacturing matter means meeting ment million mixtures notice Office paragraph participant percent period person petition practice prepared present presiding procedures proceeding proposed reasonable recall records REGISTER regulations relating representative request requirements responsible restrictions revised safely safety Service specifications standards Stat statement submitted Subpart tion unless written
Page 159 - 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 188 - Government departments and agencies. Where appropriate, the letter disclosing the information shall indicate that the Food and Drug 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...
Page 147 - Put loyalty to the highest moral principles and to country above loyalty to persons, party, or Government department. 2. uphold the Constitution, laws, and legal regulations of the United States and of all governments therein and never be a party to their evasion. 3. Give a full day's labor for a full day's pay; giving to the performance of his duties his earnest effort and best thought.
Page 219 - Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
Page 212 - An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject...
Page 60 - Environmental impact (A claim for categorical exclusion under § 25.24 of this chapter or an environmental assessment under § 25.31 of this chapter.) D. Economic impact (The following information is to be submitted only when requested by the Commissioner following review of the petition: A statement of the effect of requested action on: (1) Cost (and price) increases to industry, government, and consumers; (2) productivity of wage earners, businesses, or government; (3) competition; (4) supplies...
Page 234 - The determination that a study may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration.
Page 213 - IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.