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, 1989 - Administrative law Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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Page i
... Revised as of April 1 , 1989 CONTAINING A CODIFICATION OF DOCUMENTS OF GENERAL APPLICABILITY AND FUTURE EFFECT AS OF APRIL 1 , 1989 With Ancillaries Published by the Office of the Federal Register National Archives and Records ...
... Revised as of April 1 , 1989 CONTAINING A CODIFICATION OF DOCUMENTS OF GENERAL APPLICABILITY AND FUTURE EFFECT AS OF APRIL 1 , 1989 With Ancillaries Published by the Office of the Federal Register National Archives and Records ...
Page v
... revised at least once each calendar year and issued on a quarterly basis approximately as follows : Title 1 through ... revision date is printed on the cover of each volume . LEGAL STATUS The contents of the Federal Register are required ...
... revised at least once each calendar year and issued on a quarterly basis approximately as follows : Title 1 through ... revision date is printed on the cover of each volume . LEGAL STATUS The contents of the Federal Register are required ...
Page vi
... revision date stated on the cover of each volume are not carried . Code users may find the text of provisions in ... revised annually as of January 1 , entitled CFR INDEX AND FINDING AIDS . This volume contains the Parallel Table of ...
... revision date stated on the cover of each volume are not carried . Code users may find the text of provisions in ... revised annually as of January 1 , entitled CFR INDEX AND FINDING AIDS . This volume contains the Parallel Table of ...
Page vii
... revision dates of the 50 CFR titles . REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appeari Code of Federal Regulations . INQUIRIES AND SALES For a summary , legal interpretation , or other ...
... revision dates of the 50 CFR titles . REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appeari Code of Federal Regulations . INQUIRIES AND SALES For a summary , legal interpretation , or other ...
Page viii
... A subject index to the Code of Fede volume , revised annually as of January This volume contains the Parallel Tak Rules ( Table I ) , and Acts Requiring Pu THIS TITLE Title 21 - Food and Drugs is composed V date certain for expiration ,
... A subject index to the Code of Fede volume , revised annually as of January This volume contains the Parallel Tak Rules ( Table I ) , and Acts Requiring Pu THIS TITLE Title 21 - Food and Drugs is composed V date certain for expiration ,
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Common terms and phrases
52 Stat acid Act Record System action administrative record advisory committee agency amended at 54 animal drug annatto approval authorized available for public cation CDER CDRH Center chapter chlorofluorocarbon color additive mixtures coloring purposes Commissioner of Food Compliance conform contain copy Cosmetic Act D&C Red Data and information Deputy Direc determination diluents Director and Deputy Division Dockets Management Branch documents Drug Adminis Drug Administration drug application employee environmental established Exemption from certification FD&C Federal Food FEDERAL REGISTER filed food additive Food and Drug functions human Identity and specifications institutional review board issue label listed manufacturing practice matter medical devices meeting ment notice paragraph participant percent petition presiding officer Privacy Act Record procedures proceeding proposed public disclosure public health pursuant recall regulations regulatory request standards of identity submission submitted Subpart tion tive
Popular passages
Page 157 - 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 185 - ... 9 ) to either House of Congress, or, to the extent of matter within its jurisdiction, any committee or subcommittee thereof, any joint committee of Congress or subcommittee of any such joint committee...
Page 186 - 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 145 - 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 217 - 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 210 - 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 232 - 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 211 - 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.
Page 184 - ... (5) to a recipient who has provided the agency with advance adequate written assurance that the record will be used solely as a statistical research or reporting record, and...