The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1989 - 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 12
... manufacture , package , or import such commodities and who do not prescribe or specify by any means the manner in which such commodities are packaged or labeled by a manufacturer , packag- er , or importer : ( a ) A " cents - off , " or ...
... manufacture , package , or import such commodities and who do not prescribe or specify by any means the manner in which such commodities are packaged or labeled by a manufacturer , packag- er , or importer : ( a ) A " cents - off , " or ...
Page 22
... manufacture and preparation of biological products . Sec . 5.69 Notification of release for distribution of biological 22 Part 5 21 CFR Ch . I ( 4-1-89 Edition ) Delegations of authority and organization...........................
... manufacture and preparation of biological products . Sec . 5.69 Notification of release for distribution of biological 22 Part 5 21 CFR Ch . I ( 4-1-89 Edition ) Delegations of authority and organization...........................
Page 23
... Manufacturers requirement to provide data to ultimate purchasers of electronic products . 5.91 Dealer and distributor direction to provide data to manufacturers of elec- tronic products . 5.92 Acceptance of assistance from State and ...
... Manufacturers requirement to provide data to ultimate purchasers of electronic products . 5.91 Dealer and distributor direction to provide data to manufacturers of elec- tronic products . 5.92 Acceptance of assistance from State and ...
Page 34
... manufacture and preparation of bio- logical products ; ( ii ) Section 5.69 Notification of re- lease for distribution of biological products ; ( iii ) Section 5.71 Termination of ex- emptions for new drugs for investiga- tional use in ...
... manufacture and preparation of bio- logical products ; ( ii ) Section 5.69 Notification of re- lease for distribution of biological products ; ( iii ) Section 5.71 Termination of ex- emptions for new drugs for investiga- tional use in ...
Page 36
... Manufacturers of sunlamp prod- ucts and ultraviolet lamps intended for use in any sunlamp product as de- fined in § 1040.20 ( b ) of this chapter . [ 48 FR 8441 , Mar. 1 , 1983 , as amended at 48 FR 56946 , Dec. 27 , 1983 ; 49 FR 14933 ...
... Manufacturers of sunlamp prod- ucts and ultraviolet lamps intended for use in any sunlamp product as de- fined in § 1040.20 ( b ) of this chapter . [ 48 FR 8441 , Mar. 1 , 1983 , as amended at 48 FR 56946 , Dec. 27 , 1983 ; 49 FR 14933 ...
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Common terms and phrases
52 Stat Act Record System administrative record advisory committee agency amended 21 U.S.C. amended at 54 animal drug approval authorized available for public cation CBER CDER CDRH chapter chlorofluorocarbon Color additive mixtures coloring purposes Commissioner of Food conform contain copy Cosmetic Act D&C Red decision Deputy Direc determination diluents Director and Deputy Division Dockets Management Branch documents Drug Administration drug application Drug Evaluation employee environmental established Evaluation and Research Exemption from certification FD&C Federal Food FEDERAL REGISTER filed following officials food additive Food and Drug functions interested person issue label listed manufacturing practice matter medical devices meeting ment ministration notice Office of Compliance oral package Packaging and Labeling paragraph participant percent petition presiding officer Privacy Act Record procedures proceeding proposed public disclosure pursuant recall regulations regulatory request requirements sioner submission submitted Subpart tion tive
Popular passages
Page 167 - 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 217 - 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 6 - label" means a display of written, printed, or graphic matter upon the immediate container of any article ; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. (1) The...
Page 193 - 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 220 - 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 220 - 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 64 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 227 - Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members...
Page 54 - The application of a guaranty or undertaking referred to in section 303 (c) (2) of the Act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes...
Page 196 - 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.