The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1992 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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Common terms and phrases
acid action additive shall conform administrative record advisory committee agency amended amounts consistent animal drug approval Authority citation batches thereof cations CDER CDRH 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 Department 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 institutional review board issue Lead as Pb listed manufacturing practice matter ment metic million mixtures for coloring mixtures prepared therefrom notice paragraph participant person petition presiding officer procedures proposed public disclosure regulations regulatory request requirements of section restrictions revised safely sodium salts standards of identity submitted Subpart thereof are exempt tive Total color
Popular passages
Page 231 - 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 174 - 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 160 - 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.
Page 5 - Definitions. (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) "Label" means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity. Subpart B — General Labeling Requirements...
Page 228 - 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 course of the research which may relate to the subject's...
Page 236 - 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 235 - IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. d. Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
Page 235 - Except when an expedited review procedure is used (see §56.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
Page 202 - ... 3 ) Any person who knowingly and willfully requests or obtains any record concerning an individual from an agency under false pretenses shall be guilty of a misdemeanor and fined not more than $5,000.
Page 201 - Congress or subcommittee of any such joint committee; (10) to the Comptroller General, or any of his authorized representatives, in the course of the performance of the duties of the General Accounting Office; or (11) pursuant to the order of a court of competent jurisdiction.