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 8
... identity declaration requirements prescribed by § 101.3 of this chapter if the statement of identity on the unit container is not obscured by the multiunit retail package. (ii) A multiunit retail package for soft drinks shall be exempt ...
... identity declaration requirements prescribed by § 101.3 of this chapter if the statement of identity on the unit container is not obscured by the multiunit retail package. (ii) A multiunit retail package for soft drinks shall be exempt ...
Page 8
... identity declaration requirements pre- scribed by § 101.3 of this chapter if the statement of identity on the unit con- tainer is not obscured by the multiunit retail package . ( ii ) A multiunit retail package for soft drinks shall be ...
... identity declaration requirements pre- scribed by § 101.3 of this chapter if the statement of identity on the unit con- tainer is not obscured by the multiunit retail package . ( ii ) A multiunit retail package for soft drinks shall be ...
Page 57
... Identity of the product involved . ( 2 ) Reason for the removal or correc- tion and the date and circumstances under which the product deficiency or possible deficiency was discovered . ( 3 ) Evaluation of the risk associated with the ...
... Identity of the product involved . ( 2 ) Reason for the removal or correc- tion and the date and circumstances under which the product deficiency or possible deficiency was discovered . ( 3 ) Evaluation of the risk associated with the ...
Page 58
... products on hand at the time it was received . ( 3 ) Number of consignees that did not respond ( if needed , the identity of nonresponding consignees may be re- quested by the Food and 58 $ 7.50 21 CFR Ch . I ( 4-1-89 Edition )
... products on hand at the time it was received . ( 3 ) Number of consignees that did not respond ( if needed , the identity of nonresponding consignees may be re- quested by the Food and 58 $ 7.50 21 CFR Ch . I ( 4-1-89 Edition )
Page 107
... identity for a food ; or the issues may have specific applicability to past action and depend upon par- ticular facts concerning only that party , e.g. , the applicability of a grandfather clause to a particular brand of a drug or the ...
... identity for a food ; or the issues may have specific applicability to past action and depend upon par- ticular facts concerning only that party , e.g. , the applicability of a grandfather clause to a particular brand of a drug or the ...
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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...