Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and Index
U.S. General Services Administration, National Archives and Records Service, Office of the Federal Register, 1997
Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
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accordance acid action added advisory committee agency amended amounts animal application approval authorized batches Board Branch Center certification chapter color additive Color additive mixtures Commissioner committee Compliance conform considered consistent contain copy cosmetics D&C Red decision Department designated determination device Direc Director and Deputy disclosure ditive Division documents Drug Administration effective employee established Evaluation exempt FD&C Federal filed final Food and Drug functions Health hearing human Identity individual initial intended interest involved issue Labeling listed Management manufacturing matter means meeting ment million necessary notice Office paragraph participation percent person petition practice prepared present presiding officer procedures proceeding proposed protection reasonably records regulations relating request requirements restrictions revised safely safety salt Service specifications standards statement submitted Subpart tion unless written
Página 267 - 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...
Página 190 - Any person in Government service should: 1. 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.
Página 187 - Although! relevant, evidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the Issues, or misleading the Jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence.
Página 206 - ... could reasonably be expected to constitute an unwarranted invasion of personal privacy, d. could reasonably be expected to disclose the identity of a confidential source, including a state, local, or foreign agency or authority or any private institution which furnished information on a confidential basis...
Página 263 - 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, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Página 206 - ... would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law...
Página 263 - ... pregnant) which are currently unforeseeable; (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; (3) Any additional costs to the subject that may result from participation in the research; (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during the...
Página 263 - ... (1) 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; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative...
Página 272 - 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...
Página 184 - ... the discovery not be had; (2) that the discovery may be had only on specified terms and conditions, including a designation of the time or place; (3) that the discovery may be had only by a method of discovery other than that selected by the party seeking discovery...