Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 2001 |
From inside the book
Results 1-5 of 91
Page 19
... conforming to §314.94 of this chap- ter is acceptable in lieu of a full new drug application for any product in- cluded in the classes of products in paragraph ( e ) of this section if the product is one that is described under §314.92 ...
... conforming to §314.94 of this chap- ter is acceptable in lieu of a full new drug application for any product in- cluded in the classes of products in paragraph ( e ) of this section if the product is one that is described under §314.92 ...
Page 182
... conform with the evidence as justice may require . 817.11 Default upon failure to file an answer . ( a ) If the respondent does not file an answer within the time prescribed in § 17.9 and if service has been effected as provided in ...
... conform with the evidence as justice may require . 817.11 Default upon failure to file an answer . ( a ) If the respondent does not file an answer within the time prescribed in § 17.9 and if service has been effected as provided in ...
Page 249
... conform to the requirements for EIS's as speci- fied in 40 CFR part 1502 and 1506.6 ( f ) . ( b ) Comments on the EIS may be sub- mitted after the approval of the drug , animal drug , biologic product , or de- vice . Those comments can ...
... conform to the requirements for EIS's as speci- fied in 40 CFR part 1502 and 1506.6 ( f ) . ( b ) Comments on the EIS may be sub- mitted after the approval of the drug , animal drug , biologic product , or de- vice . Those comments can ...
Page 287
... conforms with applicable law . ( 2 ) The duly constituted institutional review board , described in paragraph ( d ) ( 1 ) ( v ) of this section , must include at least 3 nonaffiliated members who shall not be employees or officers of ...
... conforms with applicable law . ( 2 ) The duly constituted institutional review board , described in paragraph ( d ) ( 1 ) ( v ) of this section , must include at least 3 nonaffiliated members who shall not be employees or officers of ...
Page 329
... conform to good pharmacological practice . § 70.42 Criteria for evaluating the safe- ty of color additives . ( a ) In deciding whether a petition is complete and suitable for filing and in reaching a decision on any petition filed , the ...
... conform to good pharmacological practice . § 70.42 Criteria for evaluating the safe- ty of color additives . ( a ) In deciding whether a petition is complete and suitable for filing and in reaching a decision on any petition filed , the ...
Other editions - View all
Common terms and phrases
acid action advisory committee agency amended amounts consistent approval Authority citation revised biological Canthaxanthin cation CDER CDRH CFSAN chapter color additive D&C Color additive mixtures coloring purposes Commis Commissioner of Food Compliance conform in identity Cosmetic Act D&C Orange D&C Red D&C Yellow Deputy Direc Deputy Director diluents Director and Deputy Dockets Management Branch Drug Administration drug application employee Evaluation Exemption from certification FD&C Federal Acquisition Regulation Federal Food FEDERAL REGISTER filed food additive Food and Drug hearing Identity and specifications issue Lead as Pb lic health listed manufacturing practice matter medical devices ment metics mixtures for coloring mixtures prepared therefrom naphthalenedisulfonic notice paragraph participation party percent person petition presiding officer procedures public disclosure quirements regulations regulatory request restrictions safely salt sioner sory submitted Subpart tification tion tive tors Total color
Popular passages
Page 324 - ... color additive" means a material which— (A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and...
Page 191 - 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.
Page 471 - VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799) Title...
Page 238 - 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 472 - Office of Personnel Management (Parts 800—899) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000—1099) XI National Foundation on the Arts and the Humanities (Parts 1100—1199) XII Corporation for National and Community Service (Parts 1200 — 1299) XIII Office of Human Development Services, Department of Health and Human Services (Parts 1300—1399) XVI Legal Services Corporation (Parts 1600—1699) XVII National Commission...
Page vii - MF, 8 am to 4 pmest or fax your order to 202-512-2250, 24 hours a day. For payment by check, write to the Superintendent of Documents, Attn: New Orders, PO Box 371954, Pittsburgh, PA 15250-7954. For GPO Customer Service call 202-512-1803. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, the LSA (List of CFR Sections Affected), The United States Government Manual, the Federal Register, Public Laws, Public Papers, Weekly Compilation of Presidential Documents and the Privacy Act...
Page 287 - 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 291 - ... rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled...
Page 83 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 241 - The Congress authorizes and directs that, to the fullest extent possible: (1) the policies, regulations, and public laws of the United States shall be interpreted and administered in accordance with the policies set forth in this Act...