PRN 2001-X Draft: Spray and Dust Drift Label Statements for Pesticide Products
This Notice sets forth the U.S. Environmental Protection Agency's (EPA or Agency) draft guidance for labeling statements for controlling spray drift and dust drift from application sites and for implementing these statements for risk mitigation.
21 CFR 201.15 - Drugs; prominence of required label statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; prominence of required label statements. 201.15 Section 201.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.15 Drugs; prominence of required label statements. (a) A word, statement,...
PRN Notice 96-6: Pet Pesticide Product Label Statements
This notice specifies statements that should be added to the labels of pesticide products registered for use on dogs and/or cats. These label statements will help to ensure that products bear labeling to reduce the potential for misuse of pet products.
21 CFR 801.15 - Medical devices; prominence of required label statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required label statements. (a...
21 CFR 501.17 - Animal food labeling warning statements.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Animal food labeling warning statements. 501.17... food labeling warning statements. (a) Self-pressurized containers. (1) The label of a food packaged in... the following warning: Warning Avoid spraying in eyes. Contents under pressure. Do not puncture or...
40 CFR 82.110 - Form of label bearing warning statement.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Form of label bearing warning... Substances § 82.110 Form of label bearing warning statement. (a) Conspicuousness and contrast. The warning... matter on the label. The warning statement shall appear in sharp contrast to any background upon which it...
40 CFR 82.110 - Form of label bearing warning statement.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Form of label bearing warning... Substances § 82.110 Form of label bearing warning statement. (a) Conspicuousness and contrast. The warning... matter on the label. The warning statement shall appear in sharp contrast to any background upon which it...
PRN 93-3: Labeling Statement Prohibiting Application to Water
This notice explaining the policy on label statement prohibiting pesticide application to water pertains only to the labeling statement on pesticide products. It does not address the term wetlands as defined with respect to the Clean Water Act.
PRN 2000-5: Guidance for Mandatory and Advisory Labeling Statements
This notice provides guidance for improving the clarity of labeling statements in order to avoid confusing directions and precautions and to prevent the misuse of pesticides. It includes definitions and examples for mandatory and advisory label statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...
Code of Federal Regulations, 2013 CFR
2013-04-01
... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...
Code of Federal Regulations, 2014 CFR
2014-04-01
... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...
Code of Federal Regulations, 2012 CFR
2012-04-01
... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...
Code of Federal Regulations, 2011 CFR
2011-04-01
... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-02
... Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug... information entitled ``Food Labeling; Notification Procedures for Statements on Dietary Supplements'' to OMB... collection of information entitled ``Food Labeling; Notification Procedures for Statements on Dietary...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
...] Effectiveness Indications Statements in Veterinary Biologics Labeling; Notice of Public Meeting and Request for... this notice to inform producers and users of veterinary biological products, as well as other...) concerning effectiveness indications statements in veterinary biologics labeling. We are also making the...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-27
... Request; Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages... and title ``Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food... review and clearance. Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food...
21 CFR 801.61 - Statement of identity.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...
21 CFR 801.61 - Statement of identity.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...
21 CFR 801.61 - Statement of identity.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...
21 CFR 801.61 - Statement of identity.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...
21 CFR 801.61 - Statement of identity.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...
40 CFR 82.112 - Removal of label bearing warning statement.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Removal of label bearing warning... Substances § 82.112 Removal of label bearing warning statement. (a) Prohibition on removal. Except as described in paragraph (b) or (c) of this section, any warning statement that accompanies a product or...
40 CFR 82.112 - Removal of label bearing warning statement.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Removal of label bearing warning... Substances § 82.112 Removal of label bearing warning statement. (a) Prohibition on removal. Except as described in paragraph (b) or (c) of this section, any warning statement that accompanies a product or...
21 CFR 201.61 - Statement of identity.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...
21 CFR 201.61 - Statement of identity.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...
21 CFR 201.61 - Statement of identity.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...
21 CFR 201.61 - Statement of identity.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...
21 CFR 201.61 - Statement of identity.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...
Price, Rebecca M.; Andrews, Tessa C.; McElhinny, Teresa L.; Mead, Louise S.; Abraham, Joel K.; Thanukos, Anna; Perez, Kathryn E.
2014-01-01
Understanding genetic drift is crucial for a comprehensive understanding of biology, yet it is difficult to learn because it combines the conceptual challenges of both evolution and randomness. To help assess strategies for teaching genetic drift, we have developed and evaluated the Genetic Drift Inventory (GeDI), a concept inventory that measures upper-division students’ understanding of this concept. We used an iterative approach that included extensive interviews and field tests involving 1723 students across five different undergraduate campuses. The GeDI consists of 22 agree–disagree statements that assess four key concepts and six misconceptions. Student scores ranged from 4/22 to 22/22. Statements ranged in mean difficulty from 0.29 to 0.80 and in discrimination from 0.09 to 0.46. The internal consistency, as measured with Cronbach's alpha, ranged from 0.58 to 0.88 across five iterations. Test–retest analysis resulted in a coefficient of stability of 0.82. The true–false format means that the GeDI can test how well students grasp key concepts central to understanding genetic drift, while simultaneously testing for the presence of misconceptions that indicate an incomplete understanding of genetic drift. The insights gained from this testing will, over time, allow us to improve instruction about this key component of evolution. PMID:24591505
27 CFR 19.517 - Statements required on labels under an exemption from label approval.
Code of Federal Regulations, 2011 CFR
2011-04-01
... chapter; (d) State of distillation. In the case of whisky, the state of distillation statement on the... conform to the requirements of § 19.518; (g) Age of whisky containing no neutral spirits. In the case of whisky containing no neutral spirits, statements of age and percentage by volume on the label must...
21 CFR 201.50 - Statement of identity.
Code of Federal Regulations, 2013 CFR
2013-04-01
...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...
21 CFR 201.50 - Statement of identity.
Code of Federal Regulations, 2014 CFR
2014-04-01
...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...
21 CFR 201.50 - Statement of identity.
Code of Federal Regulations, 2012 CFR
2012-04-01
...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...
21 CFR 201.50 - Statement of identity.
Code of Federal Regulations, 2010 CFR
2010-04-01
...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...
21 CFR 201.50 - Statement of identity.
Code of Federal Regulations, 2011 CFR
2011-04-01
...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...
9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2011 CFR
2011-01-01
... INSPECTION REGULATIONS Nutrition Labeling § 381.480 Label statements relating to usefulness in reducing or... special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition labeling in...) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic...
9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2012 CFR
2012-01-01
... INSPECTION REGULATIONS Nutrition Labeling § 381.480 Label statements relating to usefulness in reducing or... special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition labeling in...) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic...
9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2013 CFR
2013-01-01
... INSPECTION REGULATIONS Nutrition Labeling § 381.480 Label statements relating to usefulness in reducing or... special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition labeling in...) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic...
9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2010 CFR
2010-01-01
... INSPECTION REGULATIONS Nutrition Labeling § 381.480 Label statements relating to usefulness in reducing or... special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition labeling in...) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic...
PRN 96-4: Label Statements Involving Product Efficacy and Potential for Harm to Property
This notice explains EPA procedures in approving pesticide labels that include claims relating to the efficacy of agricultural pesticides and provides a warning to growers regarding reliance on label statements regarding pesticide efficacy.
PRN 93-8: Labeling Statement Prohibiting Application to Water; Amendment to PR Notice 93-3
This notice adds one paragraph to P.R. Notice 93-3, which requested registrants to amend product labeling to include a new labeling statement prohibiting application of a pesticide to water for certain products.
PRN 83-3: Label Improvement Program - Storage and Disposal Label Statements
This Notice is to inform all registrants that the label of all pesticide products must include updated storage and disposal statements. No application for amended registration is required if you use the exact wording contained in this Notice.
21 CFR 201.6 - Drugs; misleading statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.6 Drugs; misleading statements. (a) Among...
21 CFR 201.6 - Drugs; misleading statements.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.6 Drugs; misleading statements. (a) Among...
21 CFR 201.6 - Drugs; misleading statements.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.6 Drugs; misleading statements. (a) Among...
21 CFR 201.6 - Drugs; misleading statements.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.6 Drugs; misleading statements. (a) Among...
2003-03-03
TTB is amending the regulations to prohibit the appearance on labels or in advertisements of any health-related statement, including a specific health claim, that is untrue in any particular or tends to create a misleading impression. A specific health claim on a label or in an advertisement is considered misleading unless the claim is truthful and adequately substantiated by scientific evidence; properly detailed and qualified with respect to the categories of individuals to whom the claim applies; adequately discloses the health risks associated with both moderate and heavier levels of alcohol consumption; and outlines the categories of individuals for whom any levels of alcohol consumption may cause health risks. In addition, TTB will consult with the Food and Drug Administration (FDA), as needed, on the use of specific health claims on labels. If FDA determines that a specific health claim is a drug claim that is not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not approve the use of such statement on a label. Health-related statements that are not specific health claims or health-related directional statements will be evaluated on a case-by-case basis to determine if they tend to mislead consumers. The final rule provides that health-related directional statements (statements that direct or refer consumers to a third party or other source for information regarding the effects on health of alcohol consumption) will be presumed misleading unless those statements include a brief disclaimer advising consumers that the statement should not encourage consumption of alcohol for health reasons, or some other appropriate disclaimer to avoid misleading consumers. TTB believes that the final regulations will ensure that labels and advertisements do not contain statements or claims that would tend to mislead the consumer about the significant health consequences of alcohol consumption.
21 CFR 201.55 - Statement of dosage.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...
21 CFR 201.55 - Statement of dosage.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...
21 CFR 201.55 - Statement of dosage.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...
40 CFR 156.10 - Labeling requirements.
Code of Federal Regulations, 2011 CFR
2011-07-01
...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...
40 CFR 156.10 - Labeling requirements.
Code of Federal Regulations, 2012 CFR
2012-07-01
...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...
40 CFR 156.10 - Labeling requirements.
Code of Federal Regulations, 2010 CFR
2010-07-01
...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...
40 CFR 156.10 - Labeling requirements.
Code of Federal Regulations, 2013 CFR
2013-07-01
...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...
40 CFR 156.10 - Labeling requirements.
Code of Federal Regulations, 2014 CFR
2014-07-01
...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...
21 CFR 201.10 - Drugs; statement of ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...
21 CFR 201.10 - Drugs; statement of ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...
21 CFR 201.10 - Drugs; statement of ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...
21 CFR 201.10 - Drugs; statement of ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...
21 CFR 201.55 - Statement of dosage.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...
21 CFR 201.55 - Statement of dosage.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...
40 CFR 82.110 - Form of label bearing warning statement.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Form of label bearing warning statement. 82.110 Section 82.110 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE The Labeling of Products Using Ozone-Depleting...
40 CFR 82.112 - Removal of label bearing warning statement.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Removal of label bearing warning statement. 82.112 Section 82.112 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE The Labeling of Products Using Ozone-Depleting...
76 FR 52947 - SFIREG POM Working Committee; Notice of Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-24
... Pesticide Control Officials regarding drift labeling? 2. Buffers for aerial application in forests--Pitch... Requirements on Fumigation Labels Issue Paper. 6. Real World Web Distributed Labels--Which Model does SFIREG...
Young Children's Competency to Take the Oath: Effects of Task, Maltreatment, and Age.
Lyon, Thomas D; Carrick, Nathalie; Quas, Jodi A
2010-04-01
This study examined maltreated and non-maltreated children's (N = 183) emerging understanding of "truth" and "lie," terms about which they are quizzed to qualify as competent to testify. Four- to six-year-old children were asked to accept or reject true and false (T/F) statements, label T/F statements as the "truth" or "a lie," label T/F statements as "good" or "bad," and label "truth" and "lie" as "good" or "bad." The youngest children were at ceiling in accepting/rejecting T/F statements. The labeling tasks revealed improvement with age and children performed similarly across the tasks. Most children were better able to evaluate "truth" than "lie." Maltreated children exhibited somewhat different response patterns, suggesting greater sensitivity to the immorality of lying.
PRN 93-10: Effluent Discharge Labeling Statements
This notice describes revised effluent discharge labeling statements required on all manufacturing use products and end use products that may be discharged to waters of the United States ormunicipal sewer systems.
21 CFR 501.17 - Animal food labeling warning statements.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Animal food labeling warning statements. 501.17 Section 501.17 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal...
PRN 84-5: Label Improvement Program for Fumigants
This notice required registrants of fumigant products to revise the labeling of products registered under FIFRA section 3 or 24(c) to include additional precautionary statements and other statements described in the notice.
9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2013 CFR
2013-01-01
... DEVICES, AND CONTAINERS Nutrition Labeling § 317.380 Label statements relating to usefulness in reducing... represented for special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition... as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if...
9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2012 CFR
2012-01-01
... DEVICES, AND CONTAINERS Nutrition Labeling § 317.380 Label statements relating to usefulness in reducing... represented for special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition... as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if...
9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2011 CFR
2011-01-01
... DEVICES, AND CONTAINERS Nutrition Labeling § 317.380 Label statements relating to usefulness in reducing... represented for special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition... as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-26
... Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and... supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a... manufacturer, packer, or distributor of the dietary supplement product; (2) the text of the statement that is...
21 CFR 501.17 - Animal food labeling warning statements.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...
21 CFR 501.17 - Animal food labeling warning statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...
21 CFR 501.17 - Animal food labeling warning statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
Young Children’s Competency to Take the Oath: Effects of Task, Maltreatment, and Age
Carrick, Nathalie; Quas, Jodi A.
2012-01-01
This study examined maltreated and non-maltreated children’s (N = 183) emerging understanding of “truth” and “lie,” terms about which they are quizzed to qualify as competent to testify. Four- to six-year-old children were asked to accept or reject true and false (T/F) statements, label T/F statements as the “truth” or “a lie,” label T/F statements as “good” or “bad,” and label “truth” and “lie” as “good” or “bad.” The youngest children were at ceiling in accepting/rejecting T/F statements. The labeling tasks revealed improvement with age and children performed similarly across the tasks. Most children were better able to evaluate “truth” than “lie.” Maltreated children exhibited somewhat different response patterns, suggesting greater sensitivity to the immorality of lying. PMID:19263199
PRN 95-1: Effluent Discharge Labeling Statements
This notice exempts certain pesticide products from bearing effluent discharge labeling statements specified by P.R. Notice 93-10 for manufacturing use products and end use products that may be discharged to waters of the U.S. or municipal sewer systems.
Label Review Training: Module 1: Label Basics, Page 26
This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about mandatory and advisory label statements.
Allergens labeling on French processed foods - an Oqali study.
Battisti, Charlène; Chambefort, Amélie; Digaud, Olivier; Duplessis, Barbara; Perrin, Cécile; Volatier, Jean-Luc; Gauvreau-Béziat, Julie; Menard, Céline
2017-07-01
The French Observatory of Food Quality (Oqali) aims at collecting all nutritional data provided on labels of processed foods (nutritional information and composition), at branded products level, in order to follow nutritional labeling changes over time. This study carries out an overview of allergens labeling frequencies by distinguishing allergens used in recipes from those listed on precautionary statements, for the fourteen allergen categories for which labeling is mandatory according to European legislation. 17,309 products were collected, between 2008 and 2012, from 26 food categories. Products were classified per family and type of brand (national brands, retailer brands, entry-level retailer brands, hard discount, and specialized retailer brands). Allergenic ingredients were identified from ingredients lists and precautionary statements. 73% of the 17,309 products studied contained at least one allergen in their ingredients list and 39% had a precautionary statement for one or more allergens. Milk (53%), gluten (41%), and egg (22%) were the most commonly used allergens in ingredients lists. For precautionary statement, nuts (20%), egg (14%), peanut (13%), soybean (12%), and milk (11%) were the most common allergens listed. Precautionary statement was most frequently found among first-price products (hard discount and entry-level retailer brands). National brands seemed to use it less frequently. For all these results, differences depended both on food categories and allergen categories. This study will enable to follow allergens labeling and their use as ingredients over time, particularly by assessing an hypothetical increase in allergens presence in processed food.
Label Review Training: Module 1: Label Basics, Page 27
This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. See examples of mandatory and advisory label statements.
Improving Labels to Reduce Pesticide Drift
We encourage pesticide manufacturers to state on their product labels that applicators should use DRT-rated technologies in applying pesticide products. The page includes information on how to obtain approval to add these instructions.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-26
... Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and... and clearance. Food Labeling; Notification Procedures for Statements on Dietary Supplements--21 CFR...)) requires that the agency be notified by manufacturers, packers, and distributors of dietary supplements...
21 CFR 801.6 - Medical devices; misleading statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading...
21 CFR 801.6 - Medical devices; misleading statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading...
21 CFR 740.2 - Conspicuousness of warning statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
21 CFR 740.2 - Conspicuousness of warning statements.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
21 CFR 740.2 - Conspicuousness of warning statements.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
21 CFR 740.2 - Conspicuousness of warning statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
21 CFR 740.2 - Conspicuousness of warning statements.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
2012-09-01
as potential tools for large area detection coverage while being moderately inexpensive (Wettergren, Performance of Search via Track - Before - Detect for...via Track - Before - Detect for Distribute 34 Sensor Networks, 2008). These statements highlight three specific needs to further sensor network research...Bay hydrography. Journal of Marine Systems, 12, 221–236. Wettergren, T. A. (2008). Performance of search via track - before - detect for distributed
21 CFR 740.1 - Establishment of warning statements.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
21 CFR 740.1 - Establishment of warning statements.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
21 CFR 740.1 - Establishment of warning statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
21 CFR 740.1 - Establishment of warning statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
21 CFR 740.1 - Establishment of warning statements.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
This Notice requires registrants of certain pesticide products claimed to control commensal rodents and registered under FIFRA to revise the labeling of such products to bear certain statements concerning tamper-resistant bait stations.
40 CFR 156.68 - First aid statement.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 23 2010-07-01 2010-07-01 false First aid statement. 156.68 Section... aid statement. (a) Product as sold and distributed. Each product must bear a first aid statement if... with water prior to use, the label may also include a statement describing how the first aid measures...
High-speed carrier-envelope phase drift detection of amplified laser pulses.
Fordell, T; Miranda, M; Arnold, C L; L'Huillier, A
2011-11-21
An instrument for measuring carrier-envelope phase (CEP) drift of amplified femtosecond laser pulses at repetition rates up to the 100-kHz regime is presented. The device can be used for real-time pulse labeling and it could also enable single-loop CEP control of future high-repetition rate laser amplifiers. The scheme is demonstrated by measuring the CEP drift of a 1-kHz source. © 2011 Optical Society of America
Label Review Training: Module 3: Special Issues, Page 12
This module further describes and provides strategies for reviewing some of the label parts introduced in Module 2 of the pesticide label training, such as precautionary statements, directions for use, worker protection labeling, and more.
Label Review Training: Module 3: Special Issues, Page 23
This module further describes and provides strategies for reviewing some of the label parts introduced in Module 2 of the pesticide label training, such as precautionary statements, directions for use, worker protection labeling, and more.
Label Review Training: Module 3: Special Issues, Page 3
This module further describes and provides strategies for reviewing some of the label parts introduced in Module 2 of the pesticide label training, such as precautionary statements, directions for use, worker protection labeling, and more.
Label Review Training: Module 3: Special Issues, Page 9
This module further describes and provides strategies for reviewing some of the label parts introduced in Module 2 of the pesticide label training, such as precautionary statements, directions for use, worker protection labeling, and more.
Bedford, Binaifer; Yu, Ye; Wang, Xue; Garber, Eric A E; Jackson, Lauren S
2017-04-01
Undeclared allergens in chocolate products have been responsible for numerous allergen-related recalls in the United States. A survey was conducted to determine the prevalence of undeclared milk and peanut in 88 and 78 dark chocolate bars, respectively. Concentrations of milk (as nonfat dry milk) or peanut in three samples of each chocolate product were determined with two milk- or peanut-specific enzyme-linked immunosorbent assay kits. In 75% of the chocolate bar products with a milk advisory statement, milk concentrations were above the limit of quantitation (2.5 μg/g [ppm]), with the majority having concentrations >1,000 ppm. An additional 67% of chocolate bars with a "traces of milk" statement contained 3 to 6,700 ppm of milk. Fifteen percent of chocolates labeled dairy free or lactose free and 25% labeled vegan were positive for milk, all with concentrations >1,000 ppm. Even for chocolates with no reference to milk on the label, 33% of these products contained 60 to 3,400 ppm of milk. The survey of chocolate products for peanuts revealed that 8% of products with an advisory statement contained peanut, with the highest concentration of 550 ppm. All nine chocolates bearing the peanut-free or allergen-free statement were negative for peanut, but 17% of chocolates with no label statement for peanut were positive for peanut at concentrations of 9 to 170 ppm. Evaluation of multiple lots of four chocolate products revealed that milk was consistently present or absent for the products investigated, but mixed results were obtained when multiple lots were tested for peanut. This study indicates that a large proportion of dark chocolate bars contain undeclared milk. The type of advisory statement or the absence of a milk advisory statement on products did not predict the amount or absence of milk protein. In contrast, a lower proportion of chocolates containing undeclared peanut was found. Consumers with food allergies should be cautious when purchasing dark chocolate products, particularly those that have an advisory label statement.
A Critique of the New Statement on Labeling
ERIC Educational Resources Information Center
Hitchcock, Leonard A.
2006-01-01
In this paper, the 2005 revision of ALA's position document on labeling and rating systems is closely examined and assessed, not only in comparison with the previous version of the document, but also in terms of its adequacy as a statement of library principles and as a practical guide for library practice. It is found to be ambiguous in meaning,…
9 CFR 381.125 - Special handling label requirements.
Code of Federal Regulations, 2010 CFR
2010-01-01
... consumers, hotels, restaurants, or similar institutions and shall appear on the label. The information shall... such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as...
40 CFR 156.210 - Notification-to-workers statements.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Notification-to-workers statements. 156.210 Section 156.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Worker Protection Statements § 156.210...
27 CFR 4.62 - Mandatory statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
..., type, and distinctive designation. The advertisement shall contain a conspicuous statement of the class, type, or distinctive designation to which the product belongs, corresponding with the statement of class, type, or distinctive designation which is required to appear on the label of the product. (c...
40 CFR 205.55-4 - Labeling-compliance.
Code of Federal Regulations, 2011 CFR
2011-07-01
... PROGRAMS TRANSPORTATION EQUIPMENT NOISE EMISSION CONTROLS Medium and Heavy Trucks § 205.55-4 Labeling... contrasts with the background of the label: (i) The label heading: Vehicle Noise Emission Control...) The statement: This Vehicle Conforms to U.S. EPA Regulations for Noise Emission Applicable to Medium...
27 CFR 4.32 - Mandatory label information.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Mandatory label information. (a) There shall be stated on the brand label: (1) Brand name, in accordance... the bottle. (c) There shall be stated on the brand label or on a back label a statement that the... the Office of Management and Budget under Control Number 1512-0469) [T.D. 6521, 25 FR 13835, Dec. 29...
Robust label-free biosensing using microdisk laser arrays with on-chip references.
Wondimu, S F; Hippler, M; Hussal, C; Hofmann, A; Krämmer, S; Lahann, J; Kalt, H; Freude, W; Koos, C
2018-02-05
Whispering-gallery mode (WGM) microdisk lasers show great potential for highly sensitive label-free detection in large-scale sensor arrays. However, when used in practical applications under normal ambient conditions, these devices suffer from temperature fluctuations and photobleaching. Here we demonstrate that these challenges can be overcome by a novel referencing scheme that allows for simultaneous compensation of temperature drift and photobleaching. The technique relies on reference structures protected by locally dispensed passivation materials, and can be scaled to extended arrays of hundreds of devices. We prove the viability of the concept in a series of experiments, demonstrating robust and sensitive label-free detection over a wide range of constant or continuously varying temperatures. To the best of our knowledge, these measurements represent the first demonstration of biosensing in active WGM devices with simultaneous compensation of both photobleaching and temperature drift.
Code of Federal Regulations, 2014 CFR
2014-07-01
...). In addition, the following human health hazard statement shall appear on each label as specified at... they are true and do not alter the meaning of the required statement. Human health hazard statements...
Code of Federal Regulations, 2012 CFR
2012-07-01
...). In addition, the following human health hazard statement shall appear on each label as specified at... they are true and do not alter the meaning of the required statement. Human health hazard statements...
27 CFR 4.39 - Prohibited practices.
Code of Federal Regulations, 2010 CFR
2010-04-01
... substance found within the wine, and health benefits or effects on health. The term includes both specific... OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.39 Prohibited practices. (a) Statements on labels. Containers of wine, or any label on such containers, or any...
76 FR 251 - Country of Origin Labeling of Packed Honey
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-04
...-AC89 Country of Origin Labeling of Packed Honey AGENCY: Agricultural Marketing Service, USDA. ACTION... addressing country of origin labeling for packed honey bearing any official USDA mark or statement. Also, the... origin labeling requirements are not met for packages of honey containing official USDA grade marks or...
40 CFR 168.65 - Pesticide export label and labeling requirements.
Code of Federal Regulations, 2010 CFR
2010-07-01
... toxic pesticides. If the pesticide, device or active ingredient is highly toxic to humans, the skull and... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Pesticide export label and labeling...) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for...
40 CFR 168.65 - Pesticide export label and labeling requirements.
Code of Federal Regulations, 2011 CFR
2011-07-01
... toxic pesticides. If the pesticide, device or active ingredient is highly toxic to humans, the skull and... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Pesticide export label and labeling...) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for...
40 CFR 168.65 - Pesticide export label and labeling requirements.
Code of Federal Regulations, 2012 CFR
2012-07-01
... toxic pesticides. If the pesticide, device or active ingredient is highly toxic to humans, the skull and... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Pesticide export label and labeling...) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for...
21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...
21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...
21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...
21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...
27 CFR 7.54 - Prohibited statements.
Code of Federal Regulations, 2012 CFR
2012-04-01
..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...
27 CFR 7.54 - Prohibited statements.
Code of Federal Regulations, 2013 CFR
2013-04-01
..., DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...
27 CFR 7.54 - Prohibited statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...
27 CFR 7.54 - Prohibited statements.
Code of Federal Regulations, 2014 CFR
2014-04-01
..., DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...
27 CFR 7.54 - Prohibited statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...
40 CFR 156.66 - Child hazard warning.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
40 CFR 156.66 - Child hazard warning.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
40 CFR 156.66 - Child hazard warning.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
40 CFR 156.66 - Child hazard warning.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
40 CFR 156.66 - Child hazard warning.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-03
... technology. Infant Formula Label Statements Experimental Study--(OMB Control Number 0910-NEW) FDA is planning... Statements Experimental Study will collect information from four groups: Pregnant women, mothers of infants... Statements Experimental Study AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
40 CFR 156.206 - General statements.
Code of Federal Regulations, 2011 CFR
2011-07-01
... (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall...
40 CFR 156.206 - General statements.
Code of Federal Regulations, 2013 CFR
2013-07-01
... (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall...
40 CFR 156.206 - General statements.
Code of Federal Regulations, 2014 CFR
2014-07-01
... (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall...
40 CFR 156.206 - General statements.
Code of Federal Regulations, 2012 CFR
2012-07-01
... (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall...
21 CFR 352.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...
21 CFR 347.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...
21 CFR 352.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...
21 CFR 352.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...
21 CFR 347.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...
21 CFR 347.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...
PRN 97-5: Use of Common Names for Active Ingredients on Pesticide Labeling
This notice announces EPA policy to expand the use of common names on pesticide labeling. EPA will permit the use of common names approved by ANSI in the label ingredients statement without the accompanying scientific chemical name.
16 CFR 500.4 - Statement of identity.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...
27 CFR 5.40 - Statements of age and percentage.
Code of Federal Regulations, 2011 CFR
2011-04-01
... Distilled Spirits § 5.40 Statements of age and percentage. (a) Statements of age and percentage for whisky. In the case of straight whisky bottled in conformity with the bottled in bond labeling requirements and of domestic or foreign whisky, whether or not mixed or blended, all of which is 4 years old or...
27 CFR 5.40 - Statements of age and percentage.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Distilled Spirits § 5.40 Statements of age and percentage. (a) Statements of age and percentage for whisky. In the case of straight whisky bottled in conformity with the bottled in bond labeling requirements and of domestic or foreign whisky, whether or not mixed or blended, all of which is 4 years old or...
16 CFR 500.4 - Statement of identity.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...
16 CFR 500.4 - Statement of identity.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...
16 CFR 500.4 - Statement of identity.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...
16 CFR 500.4 - Statement of identity.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...
40 CFR 156.206 - General statements.
Code of Federal Regulations, 2010 CFR
2010-07-01
... AGRICULTURAL USE REQUIREMENTS in the labeling. (e) Spanish warning statements. If the product is classified as... appear in Spanish in addition to English followed by the statement, “Si Usted no entiende la etiqueta... some one to explain it to you in detail.)” The Spanish signal word “PELIGRO” shall be used for products...
16 CFR 1500.123 - Condensation of label information.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...
16 CFR 1500.123 - Condensation of label information.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...
16 CFR 1500.123 - Condensation of label information.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...
16 CFR 1500.123 - Condensation of label information.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...
Khuda, Sefat E; Sharma, Girdhari M; Gaines, Dennis; Do, Andrew B; Pereira, Marion; Chang, Michael; Ferguson, Martine; Williams, Kristina M
2016-08-01
A comprehensive study was designed to determine the frequency and levels of soy allergen in packaged bakery and snack food products. A representative sample of products with no soy allergen disclosed on the label was analysed using two widely used enzyme-linked immunosorbent assay (ELISA) methods. Samples were chosen that either had no soy identified on the product label or which had a soy precautionary statement. Among 558 bakery and snack products, soy protein was detected in 17% of the products using the Neogen (NE) kit and 11% of the products using the Elisa Systems (ES) kit. The disagreement rates between kits were 8.8% for bakery products and 3.3% for snack products. Overall soy protein was detected at higher frequency in bakery products than in snack foods. Among 284 bakery samples, soy protein was detected in 25% of the samples with no precautionary statement and 19% of the samples which had a precautionary statement. Among 274 snack samples, soy protein was detected in 11% of the samples with no precautionary statement and 9% of the samples which had a precautionary statement. The sample repeatability was at an acceptable level (< 9%) for each method and food commodity. The reproducibility between kits was 23% for bakery foods and 36% for snack foods. None of the bakery (21) and snack (6) products without precautionary labelling (measured level > 5 ppm) had a higher level of soy protein per serving compared with the eliciting dose10 (ED10) of 10.6 mg for soy allergic patients. But the level of soy protein per serving may be clinically relevant to a subpopulation of soy allergic patients if a more stringent eliciting dose is applied. These findings emphasise that suitable detection methodologies and references doses are crucial for labelling accuracy and the safety of soy allergic consumers.
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.17 Food labeling..., or are sold for use in food service establishments, may be provided on cartons or in labeling, e.g... the Public Health Service Act (PHS Act), any State or locality that is willing and able to assist the...
21 CFR 701.11 - Identity labeling.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Identity labeling. 701.11 Section 701.11 Food and... COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...
Code of Federal Regulations, 2011 CFR
2011-01-01
... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...
Code of Federal Regulations, 2010 CFR
2010-01-01
... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...
27 CFR 4.38 - General requirements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... mandatory information required on labels by this part, except the alcoholic content statement, shall be in... OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.38... descriptive or explanatory information, the script, type, or printing of the mandatory information shall be of...
40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...
40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...
16 CFR § 1500.123 - Condensation of label information.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Condensation of label information. § 1500.123 Section § 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS... § 1500.123 Condensation of label information. Whenever the statement of the principal hazard or hazards...
Code of Federal Regulations, 2011 CFR
2011-07-01
... label. (e) For engines requiring ULSD, create a separate label with the statement: “ULTRA LOW SULFUR... power (in kW), and power density (in kW/L) as needed to determine the emission standards for the engine family. You may specify displacement, maximum engine power, or power density as a range consistent with...
76 FR 19237 - Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-06
... exemption from nutrition labeling for food that is served in restaurants or other establishments in which... the selection button that includes a clear and conspicuous statement disclosing the number of calories... Act also requires certain restaurants and similar retail food establishments to provide calorie and...
21 CFR 701.11 - Identity labeling.
Code of Federal Regulations, 2014 CFR
2014-04-01
... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...
21 CFR 701.11 - Identity labeling.
Code of Federal Regulations, 2011 CFR
2011-04-01
... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...
21 CFR 701.11 - Identity labeling.
Code of Federal Regulations, 2013 CFR
2013-04-01
... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...
21 CFR 701.11 - Identity labeling.
Code of Federal Regulations, 2012 CFR
2012-04-01
... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...
Evaluative communications between affectively ill and well mothers and their children.
Inoff-Germain, G; Nottelmann, E D; Radke-Yarrow, M
1992-04-01
Earlier research suggests that the natural verbal discourse of mothers with their children can be important in clarifying, verifying, and evaluating the behavior in which a child is engaged, in attributing qualities to the child, and in influencing the child's self-perceptions. We investigated the potential influences of parental affective illness (bipolar affective disorder and unipolar depression in contrast to no history of psychiatric illness) on such "labeling" behavior in a sample of 61 mothers and their older (school-age) and younger (preschool-age) children. It was hypothesized that the dispositions characterizing affective illness (specifically, negativity and disengagement) would be reflected in the labeling statements of mothers with a diagnosis as they interacted with their children. Based on videotaped interactions during a visit to a home-like laboratory apartment, labeling statements were identified in terms of speaker and person being labeled ("addressee") and coded (positive, negative, mixed, or neutral) for judgmental and affective quality of the statement and reaction of the addressee. Data were analyzed (a) by family unit and (b) my mother to child statements. The general pattern of findings indicated, in relative terms, an excess of negativity on the part of family members in the bipolar group and a dearth of negative affect for mothers in the unipolar group. Negativity in the bipolar group appeared to be especially likely when the setting involved mothers and two male children. Additionally, findings are discussed in terms of sex differences in vulnerability to depression.
16 CFR § 1500.15 - Labeling of fire extinguishers.
Code of Federal Regulations, 2013 CFR
2013-01-01
... the statement of hazard “Dangerous gas formed when used to extinguish flame or on contact with heat... in § 1500.3(c)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when...
21 CFR 201.51 - Declaration of net quantity of contents.
Code of Federal Regulations, 2014 CFR
2014-04-01
... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...
21 CFR 201.51 - Declaration of net quantity of contents.
Code of Federal Regulations, 2013 CFR
2013-04-01
... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...
21 CFR 201.51 - Declaration of net quantity of contents.
Code of Federal Regulations, 2012 CFR
2012-04-01
... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-18
...; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION... dietary supplements to notify us that they are marketing a dietary supplement product that bears on its... supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a...
21 CFR 201.51 - Declaration of net quantity of contents.
Code of Federal Regulations, 2011 CFR
2011-04-01
... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...
21 CFR 201.51 - Declaration of net quantity of contents.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...
10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.
Code of Federal Regulations, 2014 CFR
2014-01-01
.... (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (B) The...
10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.
Code of Federal Regulations, 2010 CFR
2010-01-01
... can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS...
10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.
Code of Federal Regulations, 2012 CFR
2012-01-01
... can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS...
10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.
Code of Federal Regulations, 2011 CFR
2011-01-01
... can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS...
10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.
Code of Federal Regulations, 2013 CFR
2013-01-01
.... (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (B) The...
21 CFR 331.30 - Labeling of antacid products.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....” (d) Drug interaction precaution. The labeling of the product contains the following statement “Ask a...
21 CFR 331.30 - Labeling of antacid products.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....” (d) Drug interaction precaution. The labeling of the product contains the following statement “Ask a...
21 CFR 312.6 - Labeling of an investigational new drug.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Section 312.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION General Provisions § 312.6 Labeling of... human use shall bear a label with the statement “Caution: New Drug—Limited by Federal (or United States...
PRN 2001-1: First Aid Statements on Pesticide Product Labels
This PR notice is intended to provide guidance for what the Agency believes is the most updated appropriate first aid language for pesticide product labels to ensure that they continue to adequately protect the public.
PRN 94-2: Recycling Empty Aerosol Pesticide Containers
This notice offers registrants use of an optional label statement permitting recycling as an alternative to instructions to dispose of aerosol pesticide containers. Registrants may add a label reference to recycling the empty aerosol pesticide container.
21 CFR 344.52 - Labeling of ear drying aid drug products.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) Indications. The labeling of the product states, under the heading “Use,” the following: “dries water in the...] washing the hair”). Other truthful and nonmisleading statements, describing only the indications for use...
16 CFR 1500.15 - Labeling of fire extinguishers.
Code of Federal Regulations, 2011 CFR
2011-01-01
... hazard “Dangerous gas formed when used to extinguish flame or on contact with heat” are required labeling...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...
16 CFR 1500.15 - Labeling of fire extinguishers.
Code of Federal Regulations, 2014 CFR
2014-01-01
... hazard “Dangerous gas formed when used to extinguish flame or on contact with heat” are required labeling...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...
16 CFR 1500.15 - Labeling of fire extinguishers.
Code of Federal Regulations, 2012 CFR
2012-01-01
... hazard “Dangerous gas formed when used to extinguish flame or on contact with heat” are required labeling...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...
Code of Federal Regulations, 2010 CFR
2010-07-01
...)(vi), (a)(5)(vii), (a)(6)(i), (a)(6)(ii), and (c). (ii) Hazard communication program. Requirements as...). In addition, the following human health hazard statement shall appear on each label as specified at... they are true and do not alter the meaning of the required statement. Human health hazard statements...
2013-01-01
Background The goal of many proteomics experiments is to determine the abundance of proteins in biological samples, and the variation thereof in various physiological conditions. High-throughput quantitative proteomics, specifically label-free LC-MS/MS, allows rapid measurement of thousands of proteins, enabling large-scale studies of various biological systems. Prior to analyzing these information-rich datasets, raw data must undergo several computational processing steps. We present a method to address one of the essential steps in proteomics data processing - the matching of peptide measurements across samples. Results We describe a novel method for label-free proteomics data alignment with the ability to incorporate previously unused aspects of the data, particularly ion mobility drift times and product ion information. We compare the results of our alignment method to PEPPeR and OpenMS, and compare alignment accuracy achieved by different versions of our method utilizing various data characteristics. Our method results in increased match recall rates and similar or improved mismatch rates compared to PEPPeR and OpenMS feature-based alignment. We also show that the inclusion of drift time and product ion information results in higher recall rates and more confident matches, without increases in error rates. Conclusions Based on the results presented here, we argue that the incorporation of ion mobility drift time and product ion information are worthy pursuits. Alignment methods should be flexible enough to utilize all available data, particularly with recent advancements in experimental separation methods. PMID:24341404
Benjamin, Ashlee M; Thompson, J Will; Soderblom, Erik J; Geromanos, Scott J; Henao, Ricardo; Kraus, Virginia B; Moseley, M Arthur; Lucas, Joseph E
2013-12-16
The goal of many proteomics experiments is to determine the abundance of proteins in biological samples, and the variation thereof in various physiological conditions. High-throughput quantitative proteomics, specifically label-free LC-MS/MS, allows rapid measurement of thousands of proteins, enabling large-scale studies of various biological systems. Prior to analyzing these information-rich datasets, raw data must undergo several computational processing steps. We present a method to address one of the essential steps in proteomics data processing--the matching of peptide measurements across samples. We describe a novel method for label-free proteomics data alignment with the ability to incorporate previously unused aspects of the data, particularly ion mobility drift times and product ion information. We compare the results of our alignment method to PEPPeR and OpenMS, and compare alignment accuracy achieved by different versions of our method utilizing various data characteristics. Our method results in increased match recall rates and similar or improved mismatch rates compared to PEPPeR and OpenMS feature-based alignment. We also show that the inclusion of drift time and product ion information results in higher recall rates and more confident matches, without increases in error rates. Based on the results presented here, we argue that the incorporation of ion mobility drift time and product ion information are worthy pursuits. Alignment methods should be flexible enough to utilize all available data, particularly with recent advancements in experimental separation methods.
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. Senate Committee on Labor and Human Resources.
This hearing on the Nutrition Labeling and Education Act of 1989, S. 1425, which requires mandatory nutrition labels on all food products regulated by the Food and Drug Administration, covered specific details on labeling procedures which will enable consumers to make intelligent choices on food selection. Prepared statements are included from…
PRN 87-1: Label Improvement Program for Pesticides Applied through Irrigation Systems (Chemigation)
This Notice requires registrants of pesticide products registered under FIFRA and applied through irrigation systems to revise the labeling for such products to include additional use directions and other statements described in this Notice.
Conflict of Interest Disclosure in Off-Label Oncology Clinical Trials
Irwin, Blair; Hirsch, Bradford R.; Samsa, Gregory P.; Abernethy, Amy P.
2012-01-01
Purpose: We sought to determine the prevalence, reliability, and predictors of conflict of interest (COI) and funding disclosure statements for studies of anticancer targeted therapies conducted in the off-label prescribing setting. Methods: As a part of a federally funded systematic review, manuscripts were included in the analysis if they were used to support one of 19 indications for cancer targeted therapies that were off-label but reimbursable according to compendia published in 2006 or before. Studies were categorized according to trial design, trial results, average impact factor of journals, and presence of COI and funding disclosure statements. Results: Among the 69 included studies, prevalence of COI and funding disclosures was low, at 33% and 58% respectively; time trends showed some improvement between 2002 to 2007, but only 60% of studies had disclosures by 2007. Predictors of COI disclosure were publication in high-impact-factor journals (P < .001), large study sample size (P = .001), enrollment exclusively in the United States (P = .04), and study of the targeted therapy in combination with other agents as opposed to the study drug alone (P = .03). Conclusion: Disclosure of potential sources of bias in COI and funding statements in studies of off-label indications for anticancer targeted therapies was low and did not increase substantially over time. PMID:23277767
Code of Federal Regulations, 2011 CFR
2011-04-01
... dandruff, seborrheic dermatitis, or psoriasis. 358.750 Section 358.750 Food and Drugs FOOD AND DRUG... Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established...
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.
Code of Federal Regulations, 2012 CFR
2012-04-01
... any other labeling. (e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts... concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of...
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.
Code of Federal Regulations, 2014 CFR
2014-04-01
... any other labeling. (e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts... concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of...
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.
Code of Federal Regulations, 2013 CFR
2013-04-01
... any other labeling. (e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts... concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of...
Code of Federal Regulations, 2010 CFR
2010-04-01
... dandruff, seborrheic dermatitis, or psoriasis. 358.750 Section 358.750 Food and Drugs FOOD AND DRUG... Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established...
Zollanvari, Amin; Dougherty, Edward R
2016-12-01
In classification, prior knowledge is incorporated in a Bayesian framework by assuming that the feature-label distribution belongs to an uncertainty class of feature-label distributions governed by a prior distribution. A posterior distribution is then derived from the prior and the sample data. An optimal Bayesian classifier (OBC) minimizes the expected misclassification error relative to the posterior distribution. From an application perspective, prior construction is critical. The prior distribution is formed by mapping a set of mathematical relations among the features and labels, the prior knowledge, into a distribution governing the probability mass across the uncertainty class. In this paper, we consider prior knowledge in the form of stochastic differential equations (SDEs). We consider a vector SDE in integral form involving a drift vector and dispersion matrix. Having constructed the prior, we develop the optimal Bayesian classifier between two models and examine, via synthetic experiments, the effects of uncertainty in the drift vector and dispersion matrix. We apply the theory to a set of SDEs for the purpose of differentiating the evolutionary history between two species.
Roberts, Steven O; Ho, Arnold K; Gelman, Susan A
2017-06-01
Children use descriptive regularities of social groups (what is) to generate prescriptive judgments (what should be). We examined whether this tendency held when the regularities were introduced through group presence, category labels, or generic statements. Children (ages 4-9years, N=203) were randomly assigned to one of four conditions that manipulated how descriptive group regularities were presented: group presence (e.g., "These ones [a group of three individuals] eat this kind of berry"), category labels (e.g., "This [individual] Hibble eats this kind of berry"), generic statements (e.g., [showing an individual] "Hibbles eat this kind of berry"), or control (e.g., "This one [individual] eats this kind of berry"). Then, children saw conforming and non-conforming individuals and were asked to evaluate their behavior. As predicted, children evaluated non-conformity negatively in all conditions except the control condition. Together, these results suggest that minimal perceptual and linguistic cues provoke children to treat social groups as having normative force. Copyright © 2016 Elsevier Inc. All rights reserved.
Code of Federal Regulations, 2010 CFR
2010-04-01
... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
Code of Federal Regulations, 2013 CFR
2013-04-01
... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
Code of Federal Regulations, 2014 CFR
2014-04-01
... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
Code of Federal Regulations, 2011 CFR
2011-04-01
... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
Code of Federal Regulations, 2012 CFR
2012-04-01
... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
77 FR 51110 - Submission for OMB Review; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-23
... approved collection. Title: Labeling and Advertising Requirements Under the Federal Alcohol Administration... standards include minimum mandatory labeling and advertising statements. Affected Public: Private Sector...: Extension without change of a currently approved collection. Title: Beer for Exportation. Form: TTB F 5130...
21 CFR 501.3 - Identity labeling of animal food in package form.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...
21 CFR 501.3 - Identity labeling of animal food in package form.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...
21 CFR 501.3 - Identity labeling of animal food in package form.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...
Code of Federal Regulations, 2014 CFR
2014-01-01
... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...
Code of Federal Regulations, 2010 CFR
2010-01-01
... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...
Code of Federal Regulations, 2011 CFR
2011-01-01
... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...
Code of Federal Regulations, 2013 CFR
2013-01-01
... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...
Survey of peanut levels in selected Irish food products bearing peanut allergen advisory labels.
Robertson, Orla N; Hourihane, Jonathan O'B; Remington, Benjamin C; Baumert, Joseph L; Taylor, Steve L
2013-01-01
Peanut allergy affects up to 2% of consumers and is responsible for the majority of fatalities caused by food-induced anaphylaxis. Peanut-containing products must be clearly labelled. Manufacturers are not legally required to label peanut if its inclusion resulted from unintentional cross contact with foods manufactured in the same facility. However, the use of allergen advisory statements alerting consumers of the potential presence of peanut allergen has increased in recent years. In previous studies, the vast majority of foods with precautionary allergen statements did not contain detectable levels of peanut, but no data are available on Irish food products. Thirty-eight food products bearing peanut/nut allergen-related statements were purchased from multiple locations in the Republic of Ireland and analysed for the presence of peanut. Peanut was detected in at least one lot in 5.3% (2 of 38) of the products tested. The doses of peanut detected ranged from 0.14 mg to 0.52 mg per suggested serving size (0.035-0.13 mg peanut protein). No detectable levels of peanut were found in the products that indicated peanut/nuts as a minor ingredient. Quantitative risk assessment, based on the known distribution of individual threshold doses for peanut, indicates that only a very small percentage of the peanut-allergic population would be likely to experience an allergic reaction to those products while the majority of products with advisory labels appear safe for the peanut-allergic population. Food manufacturers should be encouraged to analyse products manufactured in shared facilities and even on shared equipment with peanuts for peanut residues to determine whether sufficient risk exists to warrant the use of advisory labelling. Although it appears that the majority of food products bearing advisory nut statements are in fact free of peanut contamination, advice to peanut allergy sufferers to avoid said foods should continue in Ireland and therefore in the wider European Union.
Quantitative risk assessment of foods containing peanut advisory labeling.
Remington, Benjamin C; Baumert, Joseph L; Marx, David B; Taylor, Steve L
2013-12-01
Foods with advisory labeling (i.e. "may contain") continue to be prevalent and the warning may be increasingly ignored by allergic consumers. We sought to determine the residual levels of peanut in various packaged foods bearing advisory labeling, compare similar data from 2005 and 2009, and determine any potential risk for peanut-allergic consumers. Of food products bearing advisory statements regarding peanut or products that had peanut listed as a minor ingredient, 8.6% and 37.5% contained detectable levels of peanut (>2.5 ppm whole peanut), respectively. Peanut-allergic individuals should be advised to avoid such products regardless of the wording of the advisory statement. Peanut was detected at similar rates and levels in products tested in both 2005 and 2009. Advisory labeled nutrition bars contained the highest levels of peanut and an additional market survey of 399 products was conducted. Probabilistic risk assessment showed the risk of a reaction to peanut-allergic consumers from advisory labeled nutrition bars was significant but brand-dependent. Peanut advisory labeling may be overused on some nutrition bars but prudently used on others. The probabilistic approach could provide the food industry with a quantitative method to assist with determining when advisory labeling is most appropriate. Copyright © 2013 Elsevier Ltd. All rights reserved.
21 CFR 347.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... sections of the applicable OTC drug monographs. For a combination drug product that does not have an... combination, as established in the statement of identity sections of the applicable OTC drug monographs. (b... monographs, unless otherwise stated in this paragraph (b). Other truthful and nonmisleading statements...
21 CFR 347.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... sections of the applicable OTC drug monographs. For a combination drug product that does not have an... combination, as established in the statement of identity sections of the applicable OTC drug monographs. (b... monographs, unless otherwise stated in this paragraph (b). Other truthful and nonmisleading statements...
40 CFR 156.200 - Scope and applicability.
Code of Federal Regulations, 2010 CFR
2010-07-01
... this chapter. These statements refer to specific workplace practices designed to reduce or eliminate... 170 of this chapter. The requirements addressed in these statements are designed to reduce the risk of... shall be distributed or sold without amended labeling by any registrant after April 21, 1994, or by any...
21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c). ...
21 CFR 740.11 - Cosmetics in self-pressurized containers.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...
21 CFR 740.11 - Cosmetics in self-pressurized containers.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...
21 CFR 740.11 - Cosmetics in self-pressurized containers.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...
21 CFR 740.11 - Cosmetics in self-pressurized containers.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...
21 CFR 740.11 - Cosmetics in self-pressurized containers.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...
21 CFR 369.20 - Drugs; recommended warning and caution statements.
Code of Federal Regulations, 2014 CFR
2014-04-01
..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...
21 CFR 369.20 - Drugs; recommended warning and caution statements.
Code of Federal Regulations, 2012 CFR
2012-04-01
..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...
21 CFR 369.20 - Drugs; recommended warning and caution statements.
Code of Federal Regulations, 2013 CFR
2013-04-01
..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...
21 CFR 369.20 - Drugs; recommended warning and caution statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...
2015-09-30
1 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. Langmuir Turbulence Eric A. D’Asaro, Ramsey Harcourt...definitive experimental tests of the hypothesis that Langmuir Turbulence , specifically the equations of motion with the addition of the Craik-Leibovich...vortex force and advection by the surface wave Stokes drift, can accurately describe turbulence in the upper ocean boundary layer under conditions of
9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2014 CFR
2014-01-01
... criteria set forth for such foods in § 381.460. (d) “Reduced calorie” foods and other comparative claims. A... misleading, and the product is labeled “low calorie” or “reduced calorie” or bears another comparative...
Code of Federal Regulations, 2014 CFR
2014-01-01
... foreign language or printing labels that bear a statement of the quantity of contents in accordance with... Policy Book, (except for “natural” and negative claims (e.g., “gluten free”)), health claims, ingredient and processing method claims (e.g., high-pressure processing), structure-function claims, claims...
9 CFR 112.7 - Special additional requirements.
Code of Federal Regulations, 2010 CFR
2010-01-01
... a biological product containing inactivated rabies virus, carton labels, enclosures, and all but... biological product containing modified live rabies virus, the carton labels, enclosures, and all but very... Any Other Animal!” (2) For other vaccines containing modified live rabies virus, the statement “For...
21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2010 CFR
2010-04-01
... because of usefulness in reducing or maintaining body weight shall bear: (1) Nutrition labeling in... in § 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as “diet... “diet” that clearly shows that the food is offered solely for a dietary use other than regulating body...
21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2014 CFR
2014-04-01
... because of usefulness in reducing or maintaining body weight shall bear: (1) Nutrition labeling in... in § 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as “diet... “diet” that clearly shows that the food is offered solely for a dietary use other than regulating body...
21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2012 CFR
2012-04-01
... because of usefulness in reducing or maintaining body weight shall bear: (1) Nutrition labeling in... in § 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as “diet... “diet” that clearly shows that the food is offered solely for a dietary use other than regulating body...
40 CFR 172.25 - Administration of State programs.
Code of Federal Regulations, 2010 CFR
2010-07-01
... sufficient information, including a confidential statement of formula for any new product, to enable the... and this subpart. (c) Labeling. (1) New products shall bear labeling satisfying the requirements of... distributed with the product. (2) The designated State agency may permit an EPA or State registered pesticide...
Zurzolo, G A; Peters, R L; Koplin, J J; de Courten, M; Mathai, M L; Tye-Din, J A; Tang, M L K; Campbell, D E; Ponsonby, A-L; Prescott, S L; Gurrin, L; Dharmage, S C; Allen, K J
2017-07-01
The precautionary allergen labelling (PAL) and Voluntary Incidental Trace Allergen Labelling (VITAL ® ) tools were designed by industry to assist consumers with selecting safe foods for consumption. However, a sizeable proportion of food products bear no label, and it is unclear whether these products are free from allergens and therefore safe to consume or have simply not undergone a risk assessment and therefore remain unlabelled for that reason. To assess the prevalence of unlabelled products that have undergone a risk assessment process and to examine the factors influencing industry's uptake of the VITAL ® process. A web-based questionnaire was distributed to Australasian food and grocery manufacturers. One hundred and thirty-seven Australasian manufacturers were contacted, and 59 questionnaires were returned (response rate: 43%). The respondents represented 454 different manufacturing sites. Manufacturers reported that 23% (95% CI 19-28) of products (n=102/434) that had been through the VITAL ® risk assessment process had no PAL statement on the label. 34% (95% CI 30-38), (n=204/600) of products that had undergone another (non-VITAL ® ) risk assessment process had no PAL statement. In examining the factors that influenced industry's uptake of the VITAL ® process, 25 manufacturers reported on factors that influenced the uptake of the VITAL ® process, 76% (CI 95% 55-91) reported that VITAL ® was an effective tool because it was based on science; 52% (CI 95% 31-72) reported that it was too time-consuming and 36% (CI 95% 18-57) identified a concern with it not being endorsed by the government. Currently, we estimate that at least 30% of products may have been through a risk assessment process and yet bear no PAL statement on the label. Permissive labelling could be incorporated onto these products if they have been assessed to be safe for consumption. © 2017 John Wiley & Sons Ltd.
21 CFR 201.6 - Drugs; misleading statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... representation with respect to another drug or a device or a food or cosmetic. (b) The labeling of a drug which... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS...
ERIC Educational Resources Information Center
Tuncay, Busra; Yilmaz-Tuzun, Ozgul; Tuncer-Teksoz, Gaye
2011-01-01
The aim of the present study was to investigate the relationship between environmental moral reasoning patterns and environmental attitudes of 120 pre-service science teachers. Content analysis was carried out on participants' written statements regarding their concerns about the presented environmental problems and the statements were labeled as…
21 CFR 101.15 - Food; prominence of required statements.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...
21 CFR 101.15 - Food; prominence of required statements.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...
21 CFR 101.15 - Food; prominence of required statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...
21 CFR 101.15 - Food; prominence of required statements.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...
21 CFR 101.15 - Food; prominence of required statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...
21 CFR 201.16 - Drugs; Spanish-language version of certain required statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs; Spanish-language version of certain...; Spanish-language version of certain required statements. An increasing number of medications restricted to... where Spanish is the predominant language. Such labeling is authorized under § 201.15(c). One required...
21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where...
21 CFR 201.16 - Drugs; Spanish-language version of certain required statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; Spanish-language version of certain...; Spanish-language version of certain required statements. An increasing number of medications restricted to prescription use only are being labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico...
The Effect of Cancer Warning Statements on Alcohol Consumption Intentions
ERIC Educational Resources Information Center
Pettigrew, Simone; Jongenelis, Michelle I.; Glance, David; Chikritzhs, Tanya; Pratt, Iain S.; Slevin, Terry; Liang, Wenbin; Wakefield, Melanie
2016-01-01
In response to increasing calls to introduce warning labels on alcoholic beverages, this study investigated the potential effectiveness of alcohol warning statements designed to increase awareness of the alcohol-cancer link. A national online survey was administered to a diverse sample of Australian adult drinkers (n = 1,680). Along with…
10 CFR Appendix A to Subpart S of... - Compliance Statement for Metal Halide Lamp Ballasts
Code of Federal Regulations, 2011 CFR
2011-01-01
... Equipment: Metal Halide Lamp Ballasts Manufacturer's or Private Labeler's Name and Address: [Company name] (“the company”) submits this Compliance Statement under 10 CFR Part 431 (Energy Efficiency Program for... Reports submitted by or on behalf of this company. All information in such Certification Report(s) and in...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Merkley, Eric D.; Baker, Erin S.; Crowell, Kevin L.
2013-02-20
Chemical cross-linking of proteins followed by proteolysis and mass spectrometric analysis of the resulting cross-linked peptides can provide insights into protein structure and protein-protein interactions. However, cross-linked peptides are by necessity of low stoichometry and have different physicochemical properties than linear peptides, routine unambiguous identification of the cross-linked peptides has remained difficult. To address this challenge, we demonstrated the use of liquid chromatography and ion mobility separations coupled with mass spectrometry in combination with a heavy-isotope labeling method. The combination of mixed-isotope cross-linking and ion mobility provided unique and easily interpretable spectral multiplet features for the intermolecular cross-linked peptides. Applicationmore » of the method to two different homodimeric proteins - SrfN, a virulence factor from Salmonella Typhimurium and SO_2176, a protein of unknown function from Shewanella oneidensis- revealed several cross-linked peptides from both proteins that were identified with a low false discovery rate (estimated using a decoy approach). A greater number of cross-linked peptides were identified using ion mobility drift time information in the analysis than when the data were summed across the drift time dimension before analysis. The identified cross-linked peptides migrated more quickly in the ion mobility drift tube than the unmodified peptides.« less
21 CFR 352.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... statement of identity sections of the applicable OTC drug monographs. For a combination drug product that... applicable OTC drug monographs. (b) Indications. The labeling of the product states, under the heading “Uses... the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and...
21 CFR 352.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... statement of identity sections of the applicable OTC drug monographs. For a combination drug product that... applicable OTC drug monographs. (b) Indications. The labeling of the product states, under the heading “Uses... the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and...
21 CFR 333.160 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... combination, as established in the statement of identity sections of the applicable OTC drug monographs. For a... sections of the applicable OTC drug monographs. (b) Indications. The labeling of the product states, under... the “Indications” sections of the applicable OTC drug monographs, unless otherwise stated in this...
21 CFR 812.5 - Labeling of investigational devices.
Code of Federal Regulations, 2012 CFR
2012-04-01
... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...
21 CFR 812.5 - Labeling of investigational devices.
Code of Federal Regulations, 2011 CFR
2011-04-01
... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...
21 CFR 812.5 - Labeling of investigational devices.
Code of Federal Regulations, 2014 CFR
2014-04-01
... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...
21 CFR 812.5 - Labeling of investigational devices.
Code of Federal Regulations, 2010 CFR
2010-04-01
... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...
21 CFR 812.5 - Labeling of investigational devices.
Code of Federal Regulations, 2013 CFR
2013-04-01
... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-06
... products in the SNS that are approved, licensed, or cleared for marketing.\\2\\ Labels on investigational... the implementation of this rule, when investigational products were ultimately approved for marketing... that any statements concerning preemption can be justified under legal principles governing preemption...
16 CFR 1500.15 - Labeling of fire extinguishers.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling of fire extinguishers. 1500.15 Section 1500.15 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...
Child Nutrition Labeling for Meat and Poultry Products.
ERIC Educational Resources Information Center
Wade, Cheryl; And Others
Prepared for food manufacturers, this publication contains instructions for calculating the contribution that a meat or poultry product makes toward the meal pattern requirements of child nutrition programs. It also contains instructions on how to apply for and obtain the approval for a label containing a child nutrition statement. These…
Code of Federal Regulations, 2010 CFR
2010-04-01
... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.70 Labeling. (a) In addition to the... container of Source Plasma: (1) The proper name of the product. (2) The statement “Caution: For... size and type of print as the proper name. If the Source Plasma has a reactive screening test for...
Code of Federal Regulations, 2011 CFR
2011-04-01
... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.70 Labeling. (a) In addition to the... container of Source Plasma: (1) The proper name of the product. (2) The statement “Caution: For... size and type of print as the proper name. If the Source Plasma has a reactive screening test for...
40 CFR 600.306-08 - Labeling requirements.
Code of Federal Regulations, 2011 CFR
2011-07-01
... required to bear range values as required by paragraph (b) of this section, or determined by the... minimum tax-free value, the following statement must appear on the specific label: “[Manufacturer's name... sold or not or whether the vehicle has been relabeled or not. (b) Fuel economy range of comparable...
21 CFR 201.309 - Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
Code of Federal Regulations, 2010 CFR
2010-04-01
... investigation of reports of possible toxic effects and renal damage due to misuse of the drug acetophenetidin..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Specific Labeling Requirements... Drugs, in December 1963, appointed an ad hoc Advisory Committee of Inquiry on Possible Nephrotoxicity...
Thonusin, Chanisa; IglayReger, Heidi B; Soni, Tanu; Rothberg, Amy E; Burant, Charles F; Evans, Charles R
2017-11-10
In recent years, mass spectrometry-based metabolomics has increasingly been applied to large-scale epidemiological studies of human subjects. However, the successful use of metabolomics in this context is subject to the challenge of detecting biologically significant effects despite substantial intensity drift that often occurs when data are acquired over a long period or in multiple batches. Numerous computational strategies and software tools have been developed to aid in correcting for intensity drift in metabolomics data, but most of these techniques are implemented using command-line driven software and custom scripts which are not accessible to all end users of metabolomics data. Further, it has not yet become routine practice to assess the quantitative accuracy of drift correction against techniques which enable true absolute quantitation such as isotope dilution mass spectrometry. We developed an Excel-based tool, MetaboDrift, to visually evaluate and correct for intensity drift in a multi-batch liquid chromatography - mass spectrometry (LC-MS) metabolomics dataset. The tool enables drift correction based on either quality control (QC) samples analyzed throughout the batches or using QC-sample independent methods. We applied MetaboDrift to an original set of clinical metabolomics data from a mixed-meal tolerance test (MMTT). The performance of the method was evaluated for multiple classes of metabolites by comparison with normalization using isotope-labeled internal standards. QC sample-based intensity drift correction significantly improved correlation with IS-normalized data, and resulted in detection of additional metabolites with significant physiological response to the MMTT. The relative merits of different QC-sample curve fitting strategies are discussed in the context of batch size and drift pattern complexity. Our drift correction tool offers a practical, simplified approach to drift correction and batch combination in large metabolomics studies. Copyright © 2017 Elsevier B.V. All rights reserved.
Use of Symbols in Labeling. Final rule.
2016-06-15
The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement "Rx only" or "[rx] only" in the labeling for prescription devices.
21 CFR 501.15 - Animal food; prominence of required statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Animal food; prominence of required statements. 501.15 Section 501.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.15 Animal food; prominence of required...
40 CFR 86.1807-01 - Vehicle labeling.
Code of Federal Regulations, 2014 CFR
2014-07-01
... statement: “This Vehicle Conforms to U.S. EPA Regulations Applicable to XXX-Fueled 20XX Model Year New Motor... Applicable to XXX-Fueled 20XX Model Year New Light-Duty Trucks.” (C) For medium-duty passenger vehicles, the statement: “This Vehicle Conforms to U.S. EPA Regulations Applicable to XXX-fueled 20XX Model Year New...
40 CFR 600.307-08 - Fuel economy label format requirements.
Code of Federal Regulations, 2010 CFR
2010-07-01
....210-08(c), located directly above the arrow. (iv) The statement “This Vehicle” directly above the... “This Vehicle” statement, and centered above the bar, in two lines, if needed. (C) For dedicated natural... alternate fuel, in a size and format specified in Appendix V of this part. (c) The city mpg number shall be...
40 CFR 600.307-08 - Fuel economy label format requirements.
Code of Federal Regulations, 2011 CFR
2011-07-01
....210-08(c), located directly above the arrow. (iv) The statement “This Vehicle” directly above the... “This Vehicle” statement, and centered above the bar, in two lines, if needed. (C) For dedicated natural... alternate fuel, in a size and format specified in appendix V of this part. (c) The city mpg number shall be...
21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.
Code of Federal Regulations, 2010 CFR
2010-04-01
... general pharmacological category(ies) or the principal intended action(s) of the drug or, where the drug... actions of each active ingredient. When an OTC drug monograph contains a statement of identity, the pharmacological action described in the statement of identity shall also be stated as the purpose of the active...
Healthy Breakfasts for Kids: It's All about Balance
... Nutrition Facts label and ingredient statement when you shop. “The label makes it easy to determine the amounts of nutrients your kids are getting and to compare one product to another,” Adler says. Make sure your ... & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco ...
27 CFR 19.646 - Age of whisky containing no neutral spirits.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Age of whisky containing... Label Requirements Bottle Label Requirements § 19.646 Age of whisky containing no neutral spirits. In the case of whisky containing no neutral spirits, statements of age and percentage shall be stated on...
47 CFR 95.1217 - Labeling requirements.
Code of Federal Regulations, 2011 CFR
2011-10-01
... programmer/control transmitters shall be labeled as provided in part 2 of this chapter and shall bear the... where it is not feasible to place the statement on the device. (b) Where a MedRadio programmer/control... specified in this section is required to be affixed only to the main control unit. (c) MedRadio transmitters...
78 FR 14046 - Proposed Establishment of the Moon Mountain District Sonoma County Viticultural Area
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-04
..., which is composed of sedimentary and metamorphic rocks of the Jurassic and Cretaceous Periods..., among other things, prohibit consumer deception and the use of misleading statements on labels, and... use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the...
Alsop, David C.; Detre, John A.; Golay, Xavier; Günther, Matthias; Hendrikse, Jeroen; Hernandez-Garcia, Luis; Lu, Hanzhang; MacIntosh, Bradley J.; Parkes, Laura M.; Smits, Marion; van Osch, Matthias J. P.; Wang, Danny JJ; Wong, Eric C.; Zaharchuk, Greg
2014-01-01
This article provides a summary statement of recommended implementations of arterial spin labeling (ASL) for clinical applications. It is a consensus of the ISMRM Perfusion Study Group and the European ‘ASL in Dementia’ consortium, both of whom met to reach this consensus in October 2012 in Amsterdam. Although ASL continues to undergo rapid technical development, we believe that current ASL methods are robust and ready to provide useful clinical information, and that a consensus statement on recommended implementations will help the clinical community to adopt a standardized approach. In this article we describe the major considerations and tradeoffs in implementing an ASL protocol, and provide specific recommendations for a standard approach. Our conclusions are that, as an optimal default implementation we recommend: pseudo-continuous labeling, background suppression, a segmented 3D readout without vascular crushing gradients, and calculation and presentation of both label/control difference images and cerebral blood flow in absolute units using a simplified model. PMID:24715426
Diagnosing developmental problems in children: parents and professionals negotiate bad news.
Abrams, E Z; Goodman, J F
1998-04-01
To examine how parents and professionals engage in a process of negotiation over what labels to use and what developmental meaning to ascribe to those labels when imparting a diagnosis of mental disability to parents of young children. We performed a sociolinguistic analysis of 10 feedback sessions with parents whose children had been diagnosed by a clinical team as developmentally disabled. Professionals shied away from explicit use of labels; they preferred to describe children's deficits with rate descriptors (e.g., "slow"). Parties to the sessions see-sawed between optimistic and pessimistic statements. That is, when parents seemed despairing, professionals would try to hold out hope; when parents were unrealistic, professionals gave more blunt statements. Parents who received the most ambiguous interpretations seemed left with diagnostic questions still unanswered; those who received more forthright information appeared better able to move on to issues of prognosis. Diagnoses of developmental disabilities are jointly constructed by parents and professionals. We recommend larger and more controlled studies on the relationship between negotiation and labeling in diagnostic feedback interviews and the impact of these processes on parental satisfaction and adaptation.
21 CFR 133.178 - Pasteurized neufchatel cheese spread with other foods.
Code of Federal Regulations, 2013 CFR
2013-04-01
... mixture of two or more of the following: A vinegar, acetic acid, lactic acid, citric acid, phosphoric acid... ingredient appears on the label (other than in an ingredient statement as specified in paragraph (d) of this... least the same size as the type used in such word or statement. (d) Each of the ingredients used in the...
21 CFR 133.178 - Pasteurized neufchatel cheese spread with other foods.
Code of Federal Regulations, 2014 CFR
2014-04-01
... mixture of two or more of the following: A vinegar, acetic acid, lactic acid, citric acid, phosphoric acid... ingredient appears on the label (other than in an ingredient statement as specified in paragraph (d) of this... least the same size as the type used in such word or statement. (d) Each of the ingredients used in the...
21 CFR 133.178 - Pasteurized neufchatel cheese spread with other foods.
Code of Federal Regulations, 2012 CFR
2012-04-01
... mixture of two or more of the following: A vinegar, acetic acid, lactic acid, citric acid, phosphoric acid... ingredient appears on the label (other than in an ingredient statement as specified in paragraph (d) of this... least the same size as the type used in such word or statement. (d) Each of the ingredients used in the...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Haque, Ahsanul; Khan, Latifur; Baron, Michael
2015-09-01
Most approaches to classifying evolving data streams either divide the stream of data into fixed-size chunks or use gradual forgetting to address the problems of infinite length and concept drift. Finding the fixed size of the chunks or choosing a forgetting rate without prior knowledge about time-scale of change is not a trivial task. As a result, these approaches suffer from a trade-off between performance and sensitivity. To address this problem, we present a framework which uses change detection techniques on the classifier performance to determine chunk boundaries dynamically. Though this framework exhibits good performance, it is heavily dependent onmore » the availability of true labels of data instances. However, labeled data instances are scarce in realistic settings and not readily available. Therefore, we present a second framework which is unsupervised in nature, and exploits change detection on classifier confidence values to determine chunk boundaries dynamically. In this way, it avoids the use of labeled data while still addressing the problems of infinite length and concept drift. Moreover, both of our proposed frameworks address the concept evolution problem by detecting outliers having similar values for the attributes. We provide theoretical proof that our change detection method works better than other state-of-the-art approaches in this particular scenario. Results from experiments on various benchmark and synthetic data sets also show the efficiency of our proposed frameworks.« less
16 CFR 502.102 - “Economy size.”
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 1 2010-01-01 2010-01-01 false âEconomy size.â 502.102 Section 502.102 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENT OF GENERAL POLICY OR INTERPRETATION AND EXEMPTIONS UNDER THE FAIR PACKAGING AND LABELING ACT REGULATIONS UNDER SECTION 5(C) OF THE FAIR PACKAGING AND LABELING ACT Retail Sale...
21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.
Code of Federal Regulations, 2010 CFR
2010-04-01
... drug by those who do not require it for medical purposes. Additionally, comment included a great deal... unless the labeling on or within the package from which the drug is to be dispensed bears adequate... its label bears the statement “Rx only.” (c) Regulatory proceedings may be initiated with regard to...
21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.
Code of Federal Regulations, 2011 CFR
2011-04-01
... drug by those who do not require it for medical purposes. Additionally, comment included a great deal... unless the labeling on or within the package from which the drug is to be dispensed bears adequate... its label bears the statement “Rx only.” (c) Regulatory proceedings may be initiated with regard to...
21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.
Code of Federal Regulations, 2013 CFR
2013-04-01
... drug by those who do not require it for medical purposes. Additionally, comment included a great deal... unless the labeling on or within the package from which the drug is to be dispensed bears adequate... its label bears the statement “Rx only.” (c) Regulatory proceedings may be initiated with regard to...
21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.
Code of Federal Regulations, 2012 CFR
2012-04-01
... drug by those who do not require it for medical purposes. Additionally, comment included a great deal... unless the labeling on or within the package from which the drug is to be dispensed bears adequate... its label bears the statement “Rx only.” (c) Regulatory proceedings may be initiated with regard to...
21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.
Code of Federal Regulations, 2014 CFR
2014-04-01
... drug by those who do not require it for medical purposes. Additionally, comment included a great deal... unless the labeling on or within the package from which the drug is to be dispensed bears adequate... its label bears the statement “Rx only.” (c) Regulatory proceedings may be initiated with regard to...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Net contents. 4.37 Section 4.37 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.37 Net contents. (a) Statement of net contents. The net...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Net contents. 4.37 Section 4.37 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.37 Net contents. (a) Statement of net contents. The net...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Net contents. 4.37 Section 4.37 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.37 Net contents. (a) Statement of net contents. The net...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Net contents. 4.37 Section 4.37 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.37 Net contents. (a) Statement of net contents. The net...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Net contents. 4.37 Section 4.37 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.37 Net contents. (a) Statement of net contents. The net...
76 FR 70866 - Expansions of the Russian River Valley and Northern Sonoma Viticultural Areas
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-16
... deception and the use of misleading statements on labels, and ensure that labels provide the consumer with... CFR part 4) allows the establishment of definitive viticultural areas and the use of their names as.... Petitioners may use the same procedure to request changes involving existing viticultural areas. Section 9.12...
75 FR 42601 - Establishment of the Sierra Pelona Valley Viticultural Area (2010R-004P)
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-22
... metamorphic rocks, mostly gneiss and other metamorphic rocks with granitic intrusions. The petition notes that... deception and the use of misleading statements on labels, and ensure that labels provide the consumer with... CFR part 4) allows the establishment of definitive viticultural areas and the use of their names as...
40 CFR 600.307-86 - Fuel economy label format requirements.
Code of Federal Regulations, 2011 CFR
2011-07-01
... § 600.209 (a) and (b), (iii) The fuel pump logo, and (iv) The phrase “Compare this [vehicle/truck] to... the next higher integer value. (iii)(A) A statement: “For comparison shopping, all [vehicles/trucks...) If manufacturer chooses to enlarge the label from that depicted in appendix VIII the logo and the...
21 CFR 701.13 - Declaration of net quantity of contents.
Code of Federal Regulations, 2012 CFR
2012-04-01
... (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.13 Declaration of net quantity of contents. (a) The label of a cosmetic in package form shall bear a declaration of the net quantity of contents. This... weight or measure. The statement shall be in terms of fluid measure if the cosmetic is liquid or in terms...
Spinks, Jean; Mortimer, Duncan
2015-01-01
It has been suggested that complementary medicines are currently 'under-regulated' in some countries due to their potential for harm as a direct result from side-effects or interactions; from delaying more effective care; or from the economic cost of purchasing an ineffective or inappropriate treatment. The requirement of additional labelling on complementary medicine products has been suggested in Australia and may provide additional information to consumers at the point of purchase. This paper details a unique way of testing the potential effects on consumer behaviour of including either a traffic light logo or regulatory statement on labels. Using a discrete choice experiment, data were collected in 2012 in a sample of 521 Australians with either type 2 diabetes or cardiovascular disease. We find that additional labelling can affect consumer behaviour, but in unpredictable ways. The results of this experiment are informative to further the dialogue concerning possible regulatory mechanisms. Copyright © 2014 Elsevier Ltd. All rights reserved.
Y chromosome diversity, human expansion, drift, and cultural evolution
Chiaroni, Jacques; Underhill, Peter A.; Cavalli-Sforza, Luca L.
2009-01-01
The relative importance of the roles of adaptation and chance in determining genetic diversity and evolution has received attention in the last 50 years, but our understanding is still incomplete. All statements about the relative effects of evolutionary factors, especially drift, need confirmation by strong demographic observations, some of which are easier to obtain in a species like ours. Earlier quantitative studies on a variety of data have shown that the amount of genetic differentiation in living human populations indicates that the role of positive (or directional) selection is modest. We observe geographic peculiarities with some Y chromosome mutants, most probably due to a drift-related phenomenon called the surfing effect. We also compare the overall genetic diversity in Y chromosome DNA data with that of other chromosomes and their expectations under drift and natural selection, as well as the rate of fall of diversity within populations known as the serial founder effect during the recent “Out of Africa” expansion of modern humans to the whole world. All these observations are difficult to explain without accepting a major relative role for drift in the course of human expansions. The increasing role of human creativity and the fast diffusion of inventions seem to have favored cultural solutions for many of the problems encountered in the expansion. We suggest that cultural evolution has been subrogating biologic evolution in providing natural selection advantages and reducing our dependence on genetic mutations, especially in the last phase of transition from food collection to food production. PMID:19920170
Y chromosome diversity, human expansion, drift, and cultural evolution.
Chiaroni, Jacques; Underhill, Peter A; Cavalli-Sforza, Luca L
2009-12-01
The relative importance of the roles of adaptation and chance in determining genetic diversity and evolution has received attention in the last 50 years, but our understanding is still incomplete. All statements about the relative effects of evolutionary factors, especially drift, need confirmation by strong demographic observations, some of which are easier to obtain in a species like ours. Earlier quantitative studies on a variety of data have shown that the amount of genetic differentiation in living human populations indicates that the role of positive (or directional) selection is modest. We observe geographic peculiarities with some Y chromosome mutants, most probably due to a drift-related phenomenon called the surfing effect. We also compare the overall genetic diversity in Y chromosome DNA data with that of other chromosomes and their expectations under drift and natural selection, as well as the rate of fall of diversity within populations known as the serial founder effect during the recent "Out of Africa" expansion of modern humans to the whole world. All these observations are difficult to explain without accepting a major relative role for drift in the course of human expansions. The increasing role of human creativity and the fast diffusion of inventions seem to have favored cultural solutions for many of the problems encountered in the expansion. We suggest that cultural evolution has been subrogating biologic evolution in providing natural selection advantages and reducing our dependence on genetic mutations, especially in the last phase of transition from food collection to food production.
Code of Federal Regulations, 2012 CFR
2012-01-01
... Section 317.17 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar... thermally processed to Fo 3 or more; they have been fermented or pickled to pH of 4.6 or less; or they have...
Code of Federal Regulations, 2014 CFR
2014-01-01
... Section 317.17 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar... thermally processed to Fo 3 or more; they have been fermented or pickled to pH of 4.6 or less; or they have...
Code of Federal Regulations, 2013 CFR
2013-01-01
... Section 317.17 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar... thermally processed to Fo 3 or more; they have been fermented or pickled to pH of 4.6 or less; or they have...
What's in a Name? Evaluating the Effects of the "Sex Offender" Label on Public Opinions and Beliefs.
Harris, Andrew J; Socia, Kelly M
2016-10-01
Particularly over the past two decades, the terms sex offender and juvenile sex offender (JSO) have attained increasingly common usage in media and public policy discourse. Although often applied as factual descriptors, the labels may evoke strong subconscious associations with a population commonly presumed to be compulsive, at high risk of re-offense, and resistant to rehabilitation. Such associations, in turn, may exert considerable impact on expressions of support for certain policies as well as public beliefs and opinions about adults and youth who have perpetrated sexual offenses. The current study systematically evaluated the impact of the "sex offender" and "JSO" labels through series of items administered to a nationally stratified and matched sample from across the United States. The study employed an experimental design, in which one group of participants (n = 498) ranked their levels of agreement with a series of statements utilizing these labels, and a control group (n = 502) responded to a matched set of statements substituting the labels with more neutral descriptive language. Findings support the hypothesis that use of the "sex offender" label strengthens public support for policies directed at those who have perpetrated sexual crimes, including public Internet disclosure, residency restrictions, and social networking bans. The "JSO" label is demonstrated to produce particularly robust effects, enhancing support for policies that subject youth to public Internet notification and affecting beliefs about youths' propensity to re-offend as adults. Implications for public policy, media communication, and research are explored and discussed. © The Author(s) 2014.
Individual Differences in the Rubber Hand Illusion Are Related to Sensory Suggestibility.
Marotta, Angela; Tinazzi, Michele; Cavedini, Clelia; Zampini, Massimiliano; Fiorio, Mirta
2016-01-01
In the rubber hand illusion (RHI), watching a rubber hand being stroked in synchrony with one's own hidden hand may induce a sense of ownership over the rubber hand. The illusion relies on bottom-up multisensory integration of visual, tactile, and proprioceptive information, and on top-down processes through which the rubber hand is incorporated into pre-existing representations of the body. Although the degree of illusory experience varies largely across individuals, the factors influencing individual differences are unknown. We investigated whether sensory suggestibility might modulate susceptibility to the RHI. Sensory suggestibility is a personality trait related to how individuals react to sensory information. Because of its sensory nature, this trait could be relevant for studies using the RHI paradigm. Seventy healthy volunteers were classified by Sensory Suggestibility Scale (SSS) scores as having high or low suggestibility and assigned to either a high- (High-SSS) or a low-suggestibility (Low-SSS) group. Two components of the RHI were evaluated in synchronous and asynchronous stroking conditions: subjective experience of sense of ownership over the rubber hand via a 9-statement questionnaire, and proprioceptive drift as measured with a ruler. The High-SSS group was generally more susceptible to the subjective component; in the synchronous condition, they rated the statement assessing the sense of ownership higher than the Low-SSS group. The scores for this statement significantly correlated with the total SSS score, indicating that the higher the sensory suggestibility, the stronger the sense of ownership. No effect of sensory suggestibility on proprioceptive drift was observed, suggesting that the effect is specific for the subjective feeling of ownership. This study demonstrates that sensory suggestibility may contribute to participants' experience of the illusion and should be considered when using the RHI paradigm.
Individual Differences in the Rubber Hand Illusion Are Related to Sensory Suggestibility
Marotta, Angela; Tinazzi, Michele; Cavedini, Clelia; Zampini, Massimiliano
2016-01-01
In the rubber hand illusion (RHI), watching a rubber hand being stroked in synchrony with one’s own hidden hand may induce a sense of ownership over the rubber hand. The illusion relies on bottom-up multisensory integration of visual, tactile, and proprioceptive information, and on top-down processes through which the rubber hand is incorporated into pre-existing representations of the body. Although the degree of illusory experience varies largely across individuals, the factors influencing individual differences are unknown. We investigated whether sensory suggestibility might modulate susceptibility to the RHI. Sensory suggestibility is a personality trait related to how individuals react to sensory information. Because of its sensory nature, this trait could be relevant for studies using the RHI paradigm. Seventy healthy volunteers were classified by Sensory Suggestibility Scale (SSS) scores as having high or low suggestibility and assigned to either a high- (High-SSS) or a low-suggestibility (Low-SSS) group. Two components of the RHI were evaluated in synchronous and asynchronous stroking conditions: subjective experience of sense of ownership over the rubber hand via a 9-statement questionnaire, and proprioceptive drift as measured with a ruler. The High-SSS group was generally more susceptible to the subjective component; in the synchronous condition, they rated the statement assessing the sense of ownership higher than the Low-SSS group. The scores for this statement significantly correlated with the total SSS score, indicating that the higher the sensory suggestibility, the stronger the sense of ownership. No effect of sensory suggestibility on proprioceptive drift was observed, suggesting that the effect is specific for the subjective feeling of ownership. This study demonstrates that sensory suggestibility may contribute to participants’ experience of the illusion and should be considered when using the RHI paradigm. PMID:27977783
Toxicology of Perfluorodecanoic Acid
1990-11-01
Perfluorodecanoic Acid ( PFOA ) and Thyroid Status. A. Statement of Problem: 1. Toxic doses of PFDA result in reduction of feed intake, body weight, serum...hypophagia and body weight loss). ii. Perfluoroaecanoic Acid ( PFOA ) and Lipid Metabolism in the Rat. A. Statement of Problem: 1. PFDA in a dose... perfluorinated acids are not available commercially. B. Objectives: 1. To synthesize perfluoro -n-decanoic acid ( PFDA ) with 14C-labeling in the C-I position. 2. To
Message on a bottle: are alcohol warning labels about cancer appropriate?
Miller, Emma R; Ramsey, Imogen J; Baratiny, Genevieve Y; Olver, Ian N
2016-02-11
Although most Australians are unaware of the risk, there is strong evidence for a direct link between alcohol consumption and many types of cancer. Warning labels on alcohol products have been proposed as a cost-effective strategy to inform the community of this health risk. We aimed to identify how Australians might respond to such an approach. We conducted a national online survey canvassing responses to four separate cancer warning messages on labels. The graphically presented messages were informed by qualitative data from a series of focus groups among self-identified 'light-to-moderate' drinkers. For each label, participants were asked their level of agreement with impact statements about raising awareness, prompting conversation, influencing drinking behaviour and educating others about cancer risk. We analysed responses according to demographic and other factors, including self-reported drinking behaviour (using the 3-item Alcohol Use Disorder Test - AUDIT-C - scores). Approximately 1600 participants completed the survey, which was open to all Australian adults over a period of 1 month in 2014. Overall, the labels were well received, with the majority (>70 %) agreeing all labels could raise awareness and prompt conversations about the cancer risk associated with alcohol. Around 50 % or less agreed that the labels could influence drinking behaviour, but larger proportions agreed that the labels would prompt them to discuss the issue with family and friends. Although sex, AUDIT-C score and age were significantly associated with agreement on bivariate analysis, multivariate analyses demonstrated that being inclined to act upon warning label recommendations in general was the most important predictor of agreement with all of the impact statements. Having a low AUDIT-C score also predicted agreement that the labels might prompt behaviour change in friends. The findings suggest that providing detailed warnings about cancer risk on alcohol products is a viable means of increasing public awareness of the health risks associated with alcohol consumption. Further research is needed to explore the ability of such warnings to influence behavioural intentions and actual drinking behaviour.
Nunes, Maria Antónia; Rodrigues, Francisca; Alves, Rita C; Oliveira, Maria Beatriz P P
2017-10-01
Herbs have been used from ancient times for infusion preparation based on their potential health effects. In particular, the consumption of Hibiscus sabdariffa L., Crataegus spp. and Panax spp. has been largely associated to cardiovascular benefits. In this work, the label information of 52 herbal products for infusion preparation containing the referred herbs was analyzed and discussed, taking into consideration the European Union regulation for herbal products, which intends to protect public health and harmonize the legal framework in Member States. Details about the cardiovascular-related statements and warning notifications about consumption were considered. Also, regulatory issues and possible herb-drug interactions were explored and discussed. A total of 14 of the 52 herbal products selected presented health claims/statements on the label. Hibiscus was present in the majority of the products and, in some cases, it was mentioned only in the ingredients list and not on the product front-of-pack. Despite the promising outcomes of these plants to modulate cardiovascular risk markers, consumers with some sort of cardiovascular dysfunction and/or under medication treatments should be aware to carefully analyze the labels and consult additional information related to these herbal products. Manufacturers have also a huge responsibility to inform consumers by presenting awareness statements. Lastly, health professionals must advise and alert their patients about possible interactions that could occur between the concomitant consumption of drugs and herbs. Overall, there is still a real need of additional studies and clinical trials to better understand herbs effects and establish a science-based guidance to assess their safety. Copyright © 2017 Elsevier Ltd. All rights reserved.
Ferguson, J Connor; Chechetto, Rodolfo G; O'Donnell, Chris C; Dorr, Gary J; Moore, John H; Baker, Greg J; Powis, Kevin J; Hewitt, Andrew J
2016-08-01
Previous research has sought to adopt the use of drift-reducing technologies (DRTs) for use in field trials to control diamondback moth (DBM) Plutella xylostella (L.) (Lepidoptera: Plutellidae) in canola (Brassica napus L.). Previous studies observed no difference in canopy penetration from fine to coarse sprays, but the coverage was higher for fine sprays. DBM has a strong propensity to avoid sprayed plant material, putting further pressure on selecting technologies that maximise coverage, but often this is at the expense of a greater drift potential. This study aims to examine the addition of a DRT oil that is labelled for control of DBM as well and its effect on the drift potential of the spray solution. The objectives of the study are to quantify the droplet size spectrum and spray drift potential of each nozzle type to select technologies that reduce spray drift, to examine the effect of the insecticide tank mix at both (50 and 100 L ha(-1) ) application rates on droplet size and spray drift potential across tested nozzle type and to compare the droplet size results of each nozzle by tank mix against the drift potential of each nozzle. The nozzle type affected the drift potential the most, but the spray solution also affected drift potential. The fine spray quality (TCP) resulted in the greatest drift potential (7.2%), whereas the coarse spray quality (AIXR) resulted in the lowest (1.3%), across all spray solutions. The spray solutions mixed at the 100 L ha(-1) application volume rate resulted in a higher drift potential than the same products mixed at the 50 L ha(-1) mix rate. The addition of the paraffinic DRT oil was significant in reducing the drift potential of Bacillus thuringiensis var. kurstkai (Bt)-only treatments across all tested nozzle types. The reduction in drift potential from the fine spray quality to the coarse spray quality was up to 85%. The addition of a DRT oil is an effective way to reduce the spray solution drift potential across all nozzle types and tank mixes evaluated in this study. The greatest reduction in drift potential can be achieved by changing nozzle type, which can reduce the losses of the spray to the surrounding environment. Venturi nozzles greatly reduce the drift potential compared with standard nozzles by as much as 85% across all three insecticide spray solutions. Results suggest that a significant reduction in drift potential can be achieved by changing the nozzle type, and can be achieved without a loss in control of DBM. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.
21 CFR 201.100 - Prescription drugs for human use.
Code of Federal Regulations, 2011 CFR
2011-04-01
..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...
21 CFR 201.100 - Prescription drugs for human use.
Code of Federal Regulations, 2014 CFR
2014-04-01
..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...
21 CFR 201.100 - Prescription drugs for human use.
Code of Federal Regulations, 2012 CFR
2012-04-01
..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...
21 CFR 201.100 - Prescription drugs for human use.
Code of Federal Regulations, 2013 CFR
2013-04-01
..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...
21 CFR 201.100 - Prescription drugs for human use.
Code of Federal Regulations, 2010 CFR
2010-04-01
..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...
21 CFR 740.12 - Feminine deodorant sprays.
Code of Federal Regulations, 2010 CFR
2010-04-01
... all over the body. (b) The label of a feminine deodorant spray shall bear the following statement... itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should...
9 CFR 381.133 - Generically approved labeling.
Code of Federal Regulations, 2010 CFR
2010-01-01
... addition, deletion, or amendment of a dated or undated coupon, a cents-off statement, cooking instructions... addition, deletion, or amendment of recipe suggestions for the product; (x) Any change in punctuation; (xi...
2007-12-19
The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all over-the-counter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These warning statements will advise consumers that vaginal contraceptives/spermicides containing N9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings and labeling information will also advise consumers that use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS virus (HIV) from an infected partner. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, and all relevant data and information on N9 that have come to our attention.
U.S. EPA, Pesticide Product Label, SCOTTS "ALL-OUT" SPOT WEEDER, 03/15/1968
2011-04-14
... drift lH" ill'l'lic;,'i.'11 to I'l';lr1>)" t'.an:<'11 [>1<'11 •..• , fJfl\\·:vrs lll' ~hnd.:. COlltl'llt~; l'Il,I,)' pr"".:urc, !)o !lot 1I,;l' 1I"'lr firl' (II' U\\,l'll fLil'l', S(1)',· in ...
PRN 66 Federal Registration of Economic Poisons
The Federal Insecticide, Fungicide, and Rodenticide Act, and the regulations promulgated thereunder, provide that an economic poison is misbranded if its labeling bears any statement, graphic representation, or design which is false or misleading.
16 CFR 500.20 - Conspicuousness.
Code of Federal Regulations, 2010 CFR
2010-01-01
..., color, embossing, or molding) to other matter on the package; except that a statement of net quantity blown, embossed, or molded on a glass or plastic surface is permissible when all label information is so...
Code of Federal Regulations, 2013 CFR
2013-04-01
... CONSUMPTION INFANT FORMULA Labeling § 107.30 Exemptions. When containers of ready-to-feed infant formula, to... container includes the statement “This Unit Not Intended For Individual Sale” in type size not less than one...
Code of Federal Regulations, 2012 CFR
2012-04-01
... CONSUMPTION INFANT FORMULA Labeling § 107.30 Exemptions. When containers of ready-to-feed infant formula, to... container includes the statement “This Unit Not Intended For Individual Sale” in type size not less than one...
21 CFR 520.2520g - Trichlorfon, phenothiazine, and piperazine dihydrochloride powder.
Code of Federal Regulations, 2013 CFR
2013-04-01
.... Labeling shall bear the following statements: The drug is a cholinesterase inhibitor. Do not use this..., neuromuscular depolarizing agents (e.g., succinylcholine) or to cholinesterase-inhibiting drugs, pesticides, or...
Product environmental claims include a wide range of marketing claims, labels, declarations, statements and reports that are generally intended to distinguish a product as environmentally friendly or ‘green’. They differ from organizational environmental claims in the...
Identifying Key Attributes for Protein Beverages.
Oltman, A E; Lopetcharat, K; Bastian, E; Drake, M A
2015-06-01
This study identified key attributes of protein beverages and evaluated effects of priming on liking of protein beverages. An adaptive choice-based conjoint study was conducted along with Kano analysis to gain insight on protein beverage consumers (n = 432). Attributes evaluated included label claim, protein type, amount of protein, carbohydrates, sweeteners, and metabolic benefits. Utility scores for levels and importance scores for attributes were determined. Subsequently, two pairs of clear acidic whey protein beverages were manufactured that differed by age of protein source or the amount of whey protein per serving. Beverages were evaluated by 151 consumers on two occasions with or without priming statements. One priming statement declared "great flavor," the other priming statement declared 20 g protein per serving. A two way analysis of variance was applied to discern the role of each priming statement. The most important attribute for protein beverages was sweetener type, followed by amount of protein, followed by type of protein followed by label claim. Beverages with whey protein, naturally sweetened, reduced sugar and ≥15 g protein per serving were most desired. Three consumer clusters were identified, differentiated by their preferences for protein type, sweetener and amount of protein. Priming statements positively impacted concept liking (P < 0.05) but had no effect on overall liking (P > 0.05). Consistent with trained panel profiles of increased cardboard flavor with higher protein content, consumers liked beverages with 10 g protein more than beverages with 20 g protein (6.8 compared with 5.7, P < 0.05). Protein beverages must have desirable flavor for wide consumer appeal. © 2015 Institute of Food Technologists®
1989-09-27
a run is always the @RUN statement, which can specify user-id, account number, and project-id. The @ PASSWD statement specifies password and security...Every-Page-Label Options PASSWD password for batch; F36 User-id validation chang for demand; comp, nent set for batch LEV change Clearance Level F33...clearance level @@PASS Change password F36 Current valid password must @@ PASSWD be specified @@SEND Display a print file F16 Sym to user-id or site-id that is
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-24
...; Comparative Safety Statements for Pesticide Product Labeling; and Public Health Work Group. Discussion topics... Century Science and Integrated Testing and Assessment Strategies: Transitioning Research to Regulatory...
PRN 93-5: Labeling Requirements of the Clean Air Act
A regulation under the Clean Air Act requires a warning statement on products (including pesticide products) manufactured with or containing Class I ozone-depleting substances, including chlorofluorocarbons, methyl chloroform and carbon tetrachloride.
2011-12-30
The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.
Improved semi-supervised online boosting for object tracking
NASA Astrophysics Data System (ADS)
Li, Yicui; Qi, Lin; Tan, Shukun
2016-10-01
The advantage of an online semi-supervised boosting method which takes object tracking problem as a classification problem, is training a binary classifier from labeled and unlabeled examples. Appropriate object features are selected based on real time changes in the object. However, the online semi-supervised boosting method faces one key problem: The traditional self-training using the classification results to update the classifier itself, often leads to drifting or tracking failure, due to the accumulated error during each update of the tracker. To overcome the disadvantages of semi-supervised online boosting based on object tracking methods, the contribution of this paper is an improved online semi-supervised boosting method, in which the learning process is guided by positive (P) and negative (N) constraints, termed P-N constraints, which restrict the labeling of the unlabeled samples. First, we train the classification by an online semi-supervised boosting. Then, this classification is used to process the next frame. Finally, the classification is analyzed by the P-N constraints, which are used to verify if the labels of unlabeled data assigned by the classifier are in line with the assumptions made about positive and negative samples. The proposed algorithm can effectively improve the discriminative ability of the classifier and significantly alleviate the drifting problem in tracking applications. In the experiments, we demonstrate real-time tracking of our tracker on several challenging test sequences where our tracker outperforms other related on-line tracking methods and achieves promising tracking performance.
9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2010 CFR
2010-01-01
... other comparative claims. A product purporting to be “reduced calorie” or otherwise containing fewer... bears another comparative calorie claim in compliance with the applicable provisions in this subpart. (2...
9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2014 CFR
2014-01-01
... other comparative claims. A product purporting to be “reduced calorie” or otherwise containing fewer... bears another comparative calorie claim in compliance with the applicable provisions in this subpart. (2...
21 CFR 1.24 - Exemptions from required label statements.
Code of Federal Regulations, 2014 CFR
2014-04-01
... skimmed milk, vitamin D milk and milk products, fortified milk and milk products, homogenized milk... food package shall be exempt from regulations of section 403 (e)(1), (g)(2), (i)(2), (k), and (q) of...
21 CFR 1.24 - Exemptions from required label statements.
Code of Federal Regulations, 2013 CFR
2013-04-01
... skimmed milk, vitamin D milk and milk products, fortified milk and milk products, homogenized milk... food package shall be exempt from regulations of section 403 (e)(1), (g)(2), (i)(2), (k), and (q) of...
21 CFR 1.24 - Exemptions from required label statements.
Code of Federal Regulations, 2012 CFR
2012-04-01
... skimmed milk, vitamin D milk and milk products, fortified milk and milk products, homogenized milk... food package shall be exempt from regulations of section 403 (e)(1), (g)(2), (i)(2), (k), and (q) of...
40 CFR 1045.135 - How must I label and identify the engines I produce?
Code of Federal Regulations, 2014 CFR
2014-07-01
... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM SPARK-IGNITION PROPULSION MARINE ENGINES AND... California standards). You may include this information by adding it to the statement we specify or by...
21 CFR 201.310 - Phenindione; labeling of drug preparations intended for use by man.
Code of Federal Regulations, 2012 CFR
2012-04-01
... fatalities). There are also reports implicating the drug in cases of hepatitis and hypersensitivity reactions... statement to the following effect: “Warning: Agranulocytosis and hepatitis have been associated with the use...
21 CFR 201.310 - Phenindione; labeling of drug preparations intended for use by man.
Code of Federal Regulations, 2013 CFR
2013-04-01
... fatalities). There are also reports implicating the drug in cases of hepatitis and hypersensitivity reactions... statement to the following effect: “Warning: Agranulocytosis and hepatitis have been associated with the use...
16 CFR 307.6 - Requirements for disclosure on the label.
Code of Federal Regulations, 2010 CFR
2010-01-01
..., plug of chewing tobacco, or dispenser of individual packages of smokeless tobacco that may be purchased... plug of chewing tobacco—Eight point type, provided that if the warning statement is printed in one line...
Sargeant, J M; O'Connor, A M; Cullen, J N; Makielski, K M; Jones-Bitton, A
2017-07-01
Study design labels are used to identify relevant literature to address specific clinical and research questions and to aid in evaluating the evidentiary value of research. Evidence from the human healthcare literature indicates that the label "case series" may be used inconsistently and inappropriately. Our primary objective was to determine the proportion of studies in the canine and feline veterinary literature labeled as case series that actually corresponded to descriptive cohort studies, population-based cohort studies, or other study designs. Our secondary objective was to identify the proportion of case series in which potentially inappropriate inferential statements were made. Descriptive evaluation of published literature. One-hundred published studies (from 19 journals) labeled as case series. Studies were identified by a structured literature search, with random selection of 100 studies from the relevant citations. Two reviewers independently characterized each study, with disagreements resolved by consensus. Of the 100 studies, 16 were case series. The remaining studies were descriptive cohort studies (35), population-based cohort studies (36), or other observational or experimental study designs (13). Almost half (48.8%) of the case series or descriptive cohort studies, with no control group and no formal statistical analysis, included inferential statements about the efficacy of treatment or statistical significance of potential risk factors. Authors, peer-reviewers, and editors should carefully consider the design elements of a study to accurately identify and label the study design. Doing so will facilitate an understanding of the evidentiary value of the results. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.
40 CFR 82.110 - Form of label bearing warning statement.
Code of Federal Regulations, 2012 CFR
2012-07-01
... contrast are: black letters on a dark blue or dark green background, dark red letters on a light red background, light red letters on a reflective silver background, and white letters on a light gray or tan...
40 CFR 82.110 - Form of label bearing warning statement.
Code of Federal Regulations, 2013 CFR
2013-07-01
... contrast are: black letters on a dark blue or dark green background, dark red letters on a light red background, light red letters on a reflective silver background, and white letters on a light gray or tan...
40 CFR 1054.135 - How must I label and identify the engines I produce?
Code of Federal Regulations, 2014 CFR
2014-07-01
... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... meet (such as California standards). You may include this information by adding it to the statement we...
40 CFR 1054.135 - How must I label and identify the engines I produce?
Code of Federal Regulations, 2011 CFR
2011-07-01
... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... meet (such as California standards). You may include this information by adding it to the statement we...
40 CFR 1054.135 - How must I label and identify the engines I produce?
Code of Federal Regulations, 2010 CFR
2010-07-01
... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... meet (such as California standards). You may include this information by adding it to the statement we...
40 CFR 1054.135 - How must I label and identify the engines I produce?
Code of Federal Regulations, 2013 CFR
2013-07-01
... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... meet (such as California standards). You may include this information by adding it to the statement we...
40 CFR 1054.135 - How must I label and identify the engines I produce?
Code of Federal Regulations, 2012 CFR
2012-07-01
... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... meet (such as California standards). You may include this information by adding it to the statement we...
Code of Federal Regulations, 2010 CFR
2010-07-01
... expressed in the statement of formula. These data include information on the starting materials, production... product. (ii) Product composition data are compared to the composition of materials used in required... restrictions, labeling requirements, or special packaging requirements may be imposed. (iii) Product...
21 CFR 74.1705 - FD&C Yellow No. 5.
Code of Federal Regulations, 2014 CFR
2014-04-01
..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
21 CFR 74.1705 - FD&C Yellow No. 5.
Code of Federal Regulations, 2013 CFR
2013-04-01
..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
21 CFR 74.1705 - FD&C Yellow No. 5.
Code of Federal Regulations, 2010 CFR
2010-04-01
..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
21 CFR 74.1705 - FD&C Yellow No. 5.
Code of Federal Regulations, 2011 CFR
2011-04-01
..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
21 CFR 74.1705 - FD&C Yellow No. 5.
Code of Federal Regulations, 2012 CFR
2012-04-01
..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
Efficacy and consumer preferences for different approaches to calorie labeling on menus.
Pang, Jocelyn; Hammond, David
2013-01-01
To evaluate the efficacy and consumer preferences of calorie labeling on menus. Between-group experiment. Participants were randomized to view menu items according to 1 of 4 experimental conditions: no calorie information, calorie-only information, calorie plus health statement (HS), and calorie plus the Physical Activity Scale. Participants selected a snack and then rated menus from all conditions on the level of understanding and perceived effectiveness. University of Waterloo, Canada. A total of 213 undergraduate university students recruited from classrooms. The calorie amount of menu selection and ratings of understandability and perceived effectiveness. Linear regression models and chi-square tests. Participants who selected items from menus without calorie information selected snacks with higher calorie amounts than participants in the calorie-only condition (P = .002) and the calorie plus HS condition (P = .001). The calorie plus HS menu was perceived as most understandable and the calorie plus calorie plus Physical Activity Scale menu was perceived as most effective in helping to promote healthy eating. Calorie labeling on menus may assist consumers in making healthier choices, with consumer preference for menus that include contextual health statements. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.
Untested pesticide mitigation requirements: ecological, agricultural, and legal implications
Vyas, Nimish B.
2013-01-01
Every pesticide sold in the United States must have a U.S. Environmental Agency approved label on its container. The label provides directions for the pesticide’s use and is legally enforceable under the Federal Insecticide, Fungicide and Rodenticide Act. For a pesticide with high ecological risks, mitigation statements may be included on the label to reduce the pesticide’s risks and to support its registration. Many mitigation mandates are easy to implement and are effective, however, at times, well-intentioned but novel and untested mitigation requirements, though theoretically sound, may not be perceived by the pesticide users to be practical under operational settings. Courts of law recognize the pesticide label as a legal document, therefore it is imperative that the label mitigation mandates be achievable. I use the rodenticide Rozol label to illustrate how an untested risk mitigation mandate may be considered too burdensome by pesticide users whereby the mitigation action may not be implemented in the field, resulting in label violation and unreasonable risks to the environment.
Citrome, Leslie
2009-09-01
Pharmaceutical product labeling as approved by regulatory agencies include statements of adverse event risk. Product labels include descriptive statements such as whether events are uncommon or rare, as well as percentage occurrence for more common events. In addition tables are provided with the frequencies of the latter events for both product and placebo as observed in clinical trials. Competing products are not mentioned in a specific drug's product labeling but indirect comparisons can be made using the corresponding label information for the alternate product. Two types of tools are easily used for this purpose: absolute measures such as number needed to harm (NNH), and relative measures such as relative risk increase (RRI). The calculations for both of these types of quantitative measures are presented using as examples the oral first-line second-generation antipsychotic medications. Among three sample outcomes selected a priori, akathisia, weight gain, and discontinuation from a clinical trial because of an adverse reaction, there appears to be differences among the different antipsychotics versus placebo. Aripiprazole was associated with the highest risk for akathisia, particularly when used as adjunctive treatment of major depressive disorder (NNH 5, 95% CI 4-7; RRI 525%, 95% CI 267%-964%). Although insufficient information was available in product labeling to calculate the CI, olanzapine was associated with the highest risk for weight gain of at least 7% from baseline (NNH 6, RRI 640% for adults; NNH 4, RRI 314% for adolescents), and quetiapine for the indication of bipolar depression was associated with the highest risk of discontinuation from a clinical trial because of an adverse reaction (NNH 8, RRI 265% for 600 mg/d; NNH 15, RRI 137% for 300 mg/d). In conclusion, with certain limitations, it is possible for the clinician to extract information from medication product labeling regarding the frequency with which certain adverse reactions can be expected. This supplements, but does not replace, information reported directly in clinical trial reports.
Genetic drift at expanding frontiers promotes gene segregation
Hallatschek, Oskar; Hersen, Pascal; Ramanathan, Sharad; Nelson, David R.
2007-01-01
Competition between random genetic drift and natural selection play a central role in evolution: Whereas nonbeneficial mutations often prevail in small populations by chance, mutations that sweep through large populations typically confer a selective advantage. Here, however, we observe chance effects during range expansions that dramatically alter the gene pool even in large microbial populations. Initially well mixed populations of two fluorescently labeled strains of Escherichia coli develop well defined, sector-like regions with fractal boundaries in expanding colonies. The formation of these regions is driven by random fluctuations that originate in a thin band of pioneers at the expanding frontier. A comparison of bacterial and yeast colonies (Saccharomyces cerevisiae) suggests that this large-scale genetic sectoring is a generic phenomenon that may provide a detectable footprint of past range expansions. PMID:18056799
7 CFR 205.505 - Statement of agreement.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... qualities of products labeled as organically produced; (3) Conduct an annual performance evaluation of all... certification decisions and implement measures to correct any deficiencies in certification services; (4) Have...
12 CFR 1026.37 - Content of disclosures for certain mortgage transactions (Loan Estimate).
Code of Federal Regulations, 2014 CFR
2014-01-01
... (labeled “Email” and “Phone,” respectively). (l) Comparisons. Under the master heading, “Additional... “Comparisons” along with the statement “Use these measures to compare this loan with other loans”: (1) In five...
76 FR 36627 - Required Warnings for Cigarette Packages and Advertisements
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-22
...The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.
Required warnings for cigarette packages and advertisements. Final rule.
2011-06-22
The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.
Bailey, Timothy S; Grunberger, George; Bode, Bruce W; Handelsman, Yehuda; Hirsch, Irl B; Jovanovič, Lois; Roberts, Victor Lawrence; Rodbard, David; Tamborlane, William V; Walsh, John
2016-02-01
This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.
AUTOMATED FLOWCHART SYSTEM FROM TEXAS A&M UNIVERSITY
NASA Technical Reports Server (NTRS)
Woodford, W.
1994-01-01
An accurate flowchart is an important part of the documentation for any computer program. The flowchart offers the user an easy to follow overview of program operation and the maintenance programmer an effective debugging tool. The TAMU FLOWCHART System was developed to flowchart any program written in the FORTRAN language. It generates a line printer flowchart which is representative of the program logic. This flowchart provides the user with a detailed representation of the program action taken as each program statement is executed. The TAMU FLOWCHART System should prove to be a valuable aid to groups working with complex FORTRAN programs. Each statement in the program is displayed within a symbol which represents the program action during processing of the enclosed statement. Symbols available include: subroutine, function, and entry statements; arithmetic statements; input and output statements; arithmetical and logical IF statements; subroutine calls with or without argument list returns; computed and assigned GO TO statements; DO statements; STOP and RETURN statements; and CONTINUE and ASSIGN statements. Comment cards within the source program may be suppressed or displayed and associated with a succeeding source statement. Each symbol is annotated with a label (if present in the source code), a block number, and the statement sequence number. Program flow and options within the program are represented by line segments and direction indicators connecting symbols. The TAMU FLOWCHART System should be able to accurately flowchart any working FORTRAN program. This program is written in COBOL for batch execution and has been implemented on an IBM 370 series computer with an OS operating system and with a central memory requirement of approximately 380K of 8 bit bytes. The TAMU FLOWCHART System was developed in 1977.
27 CFR 5.63 - Mandatory statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Advertising of Distilled... and address of the permittee responsible for its publication or broadcast. Street number and name may... specific brand name advertised. (2) On consumer specialty items, the only information necessary is the...
21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2013 CFR
2013-04-01
...) “Reduced calorie” foods and other comparative calorie claims. A food purporting to be “reduced calorie” or... comparative calorie claim in compliance with part 101 of this chapter and this section. (2) Paragraph (e)(1...
21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) “Reduced calorie” foods and other comparative calorie claims. A food purporting to be “reduced calorie” or... comparative calorie claim in compliance with part 101 of this chapter and this section. (2) Paragraph (e)(1...
WaterSense Specification for Commercial Pre-Rinse Spray Valves Supporting Statement
The U.S. Environmental Protection Agency’s (EPA’s) WaterSense program released a specification for PRSVs to earn the WaterSense label on September 19, 2013, in order to further improve the nation’s water and energy efficiency.
16 CFR 502.101 - Introductory offers.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENT OF GENERAL POLICY OR... FAIR PACKAGING AND LABELING ACT Retail Sale Price Representations § 502.101 Introductory offers. (a... retail sale at a price lower than the anticipated ordinary and customary retail sale price. (b) The...
America, you are digging your grave with your spoon--should the FDA tell you that on food labels?
Card, Melissa M
2013-01-01
R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.
Random Walk on a Perturbation of the Infinitely-Fast Mixing Interchange Process
NASA Astrophysics Data System (ADS)
Salvi, Michele; Simenhaus, François
2018-05-01
We consider a random walk in dimension d≥ 1 in a dynamic random environment evolving as an interchange process with rate γ >0. We prove that, if we choose γ large enough, almost surely the empirical velocity of the walker X_t/t eventually lies in an arbitrary small ball around the annealed drift. This statement is thus a perturbation of the case γ =+∞ where the environment is refreshed between each step of the walker. We extend three-way part of the results of Huveneers and Simenhaus (Electron J Probab 20(105):42, 2015), where the environment was given by the 1-dimensional exclusion process: (i) We deal with any dimension d≥1; (ii) We treat the much more general interchange process, where each particle carries a transition vector chosen according to an arbitrary law μ ; (iii) We show that X_t/t is not only in the same direction of the annealed drift, but that it is also close to it.
Vujić, Mario; Pollak, Lea
2015-12-01
The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.
Obesity and Pediatric Drug Development.
Vaughns, Janelle D; Conklin, Laurie S; Long, Ying; Zheng, Panli; Faruque, Fahim; Green, Dionna J; van den Anker, John N; Burckart, Gilbert J
2018-05-01
There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies. FDA labels were also reviewed for statements addressing obesity in pediatric patients. Forty-five drugs studied in pediatric patients under the FDA Amendments Act were found to have statements and key words in the medical and clinical pharmacology reviews and labels related to obesity. Forty-four products were identified similarly with pediatric studies under FDASIA. Of the 89 product labels identified, none provided dosing information related to obesity. The effect of body mass index on drug pharmacokinetics was mentioned in only 4 labels. We conclude that there is little information presently available to provide guidance related to dosing in obese pediatric patients. Moving forward, regulators, clinicians, and the pharmaceutical industry should consider situations in drug development in which the inclusion of obese patients in pediatric trials is necessary to facilitate the safe and effective use of new drug products in the obese pediatric population. © 2018, The American College of Clinical Pharmacology.
Bayesian Normalization Model for Label-Free Quantitative Analysis by LC-MS
Nezami Ranjbar, Mohammad R.; Tadesse, Mahlet G.; Wang, Yue; Ressom, Habtom W.
2016-01-01
We introduce a new method for normalization of data acquired by liquid chromatography coupled with mass spectrometry (LC-MS) in label-free differential expression analysis. Normalization of LC-MS data is desired prior to subsequent statistical analysis to adjust variabilities in ion intensities that are not caused by biological differences but experimental bias. There are different sources of bias including variabilities during sample collection and sample storage, poor experimental design, noise, etc. In addition, instrument variability in experiments involving a large number of LC-MS runs leads to a significant drift in intensity measurements. Although various methods have been proposed for normalization of LC-MS data, there is no universally applicable approach. In this paper, we propose a Bayesian normalization model (BNM) that utilizes scan-level information from LC-MS data. Specifically, the proposed method uses peak shapes to model the scan-level data acquired from extracted ion chromatograms (EIC) with parameters considered as a linear mixed effects model. We extended the model into BNM with drift (BNMD) to compensate for the variability in intensity measurements due to long LC-MS runs. We evaluated the performance of our method using synthetic and experimental data. In comparison with several existing methods, the proposed BNM and BNMD yielded significant improvement. PMID:26357332
Concept Mapping as an Approach to Facilitate Participatory Intervention Building.
L Allen, Michele; Schaleben-Boateng, Dane; Davey, Cynthia S; Hang, Mikow; Pergament, Shannon
2015-01-01
A challenge to addressing community-defined need through community-based participatory intervention building is ensuring that all collaborators' opinions are represented. Concept mapping integrates perspectives of individuals with differing experiences, interests, or expertise into a common visually depicted framework, and ranks composite views on importance and feasibility. To describe the use of concept mapping to facilitate participatory intervention building for a school-based, teacher-focused, positive youth development (PYD) promotion program for Latino, Hmong, and Somali youth. Particiants were teachers, administrators, youth, parents, youth workers, and community and university researchers on the projects' community collaborative board. We incorporated previously collected qualitative data into the process. In a mixed-methods process we 1) generated statements based on key informant interview and focus group data from youth workers, teachers, parents, and youth in multiple languages regarding ways teachers promote PYD for Somali, Latino and Hmong youth; 2) guided participants to individually sort statements into meaningful groupings and rate them by importance and feasibility; 3) mapped the statements based on their relation to each other using multivariate statistical analyses to identify concepts, and as a group identified labels for each concept; and 4) used labels and statement ratings to identify feasible and important concepts as priorities for intervention development. We identified 12 concepts related to PYD promotion in schools and prioritized 8 for intervention development. Concept mapping facilitated participatory intervention building by formally representing all participants' opinions, generating visual representation of group thinking, and supporting priority setting. Use of prior qualitative work increased the diversity of viewpoints represented.
Futile and Potentially Inappropriate Interventions: Semantics Matter.
Kon, Alexander A
2018-01-01
In 1997, the Society for Critical Care Medicine (SCCM) published a statement regarding futile and inadvisable treatments. Recently, five critical care organizations published a consensus statement supporting and expanding upon the 1997 SCCM statement, and the SCCM issued a companion statement defining futile and potentially inappropriate interventions. In all of these statements, there is agreement that the term futile should be used only when an intervention cannot accomplish the intended physiologic goal. The organizations provide recommendations for optimizing communication, however even when clinicians use excellent communication techniques, there are times when competing ethical considerations mean that a surrogate persists in requesting an intervention that the clinician does not believe is justified. In such cases, clinicians should not label the requested intervention as futile, because doing so is disrespectful to patients and families, overly empowers clinicians, and stifles communication. When clinicians believe that they are justified in declining such a request due to differences in values or beliefs, they should refer to the requested treatment as "potentially inappropriate," indicating that the disagreement is based on values, and that any decision to withhold the requested intervention is preliminary until reviewed through a fair process.
78 FR 14264 - Submission for OMB Review; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-05
..., filing of petitions and applications and agency #0;statements of organization and functions are examples... Service Title: Mandatory Country of Origin Labeling of All Covered Commodities. OMB Control Number: 0581.... Frequency of Responses: Recordkeeping. Total Burden Hours: 31,437,002. Agricultural Marketing Service Title...
This guidance proposes to use an organism hierarchy to identify effective products for use with emerging pathogens and to permit registrants to make limited statements against such pathogens. It provides general guidance to interested parties.
75 FR 69523 - Required Warnings for Cigarette Packages and Advertisements
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-12
...The Food and Drug Administration (FDA) is proposing to amend its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany the nine new textual warning statements that will be required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This proposed rule, once finalized, would specify the color graphics that must accompany each of the nine new textual warning statements.
Hallersten, Anna; Fürst, Walter; Mezzasalma, Riccardo
2016-06-01
In the European Union, labels (Summaries of Product Characteristics, SmPCs) of biosimilars and their reference products are in many instances almost identical (following a generic approach) despite different data requirements for the authorization of biosimilars and generics. To understand physicians' preferences on type and detail of information in the biosimilar label and their use of information sources when prescribing biologics including biosimilars, EuropaBio surveyed 210 physicians across seven European countries. Among surveyed physicians, 90.5% use the label frequently or occasionally as an information source and 87.2% deemed a clear statement on the origin of data helpful or very helpful. When comparing excerpts from the label of an authorized biosimilar and modified texts with additional information, 78.1-82.9% preferred the samples with additional information. This survey shows that the label is an appropriate vehicle for providing physicians with information about biologics and that physicians prefer more product-specific information in the biosimilar label. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
16 CFR 501.2 - Christmas tree ornaments.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Christmas tree ornaments. 501.2 Section 501.2 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENT OF GENERAL POLICY OR... PROHIBITIONS UNDER PART 500 § 501.2 Christmas tree ornaments. Christmas tree ornaments packaged and labeled for...
PR Notice 94-4 MOU on Regulation of Liquid Chemical Germicides Intended for Use on Medical Devices
This MOU between EPA and FDA establishes roles for regulation of liquid chemical germicides intended for use on medical devices. An amendment revises the disclaimer statement for labels of all liquid chemical germicides, other than FDA-approved sterilants.
21 CFR 81.32 - Limitation of certificates.
Code of Federal Regulations, 2010 CFR
2010-04-01
... SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS... use of these color additives in drugs and cosmetics in any other manner will result in adulteration. Each of these color additives shall bear a label statement of the tolerance and use limitations...
21 CFR 522.914 - Fenprostalene solution.
Code of Federal Regulations, 2010 CFR
2010-04-01
... this chapter. (d) Special considerations. Labeling shall bear the following statements: Women of.... Feedlot heifers to induce abortion, single dose. Beef or nonlactating dairy cattle for estrus synchronization, a single dose or two doses 11 to 13 days apart. Do not use in pregnant animals unless abortion is...
Garber, Alan J; Abrahamson, Martin Julian; Barzilay, Joshua I; Blonde, Lawrence; Bloomgarden, Zachary T; Bush, Michael A; Dagogo-Jack, Samuel; Davidson, Michael B; Einhorn, Daniel; Garber, Jeffrey R; Garvey, W Timothy; Grunberger, George; Handelsman, Yehuda; Hirsch, Irl B; Jellinger, Paul S; McGill, Janet B; Mechanick, Jeffrey I; Rosenblit, Paul David; Umpierrez, Guillermo E
2015-12-01
This document represents the official position of the American Association of Clinical Endocrinologists and the American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.
Vinik, Aaron I; Camacho, Pauline M; Davidson, Jaime A; Handelsman, Yehuda; Lando, Howard M; Leddy, Anne L; Reddy, Sethu K; Cook, Richard; Spallone, Vicenza; Tesfaye, Solomon; Ziegler, Dan
2017-12-01
This document represents the official position of the American Association of Clinical Endocrinologists and the American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.
Goodman, Neil; Guay, Andre; Dandona, Paresh; Dhindsa, Sandeep; Faiman, Charles; Cunningham, Glenn R
2015-09-01
This document represents the official position of the American Association of Clinical Endocrinologists and the American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.
Implicitly-Defined Neural Networks for Sequence Labeling
2016-09-09
this is to improve performance on long-range dependencies, and to improve stability (solution drift) in NLP tasks. We choose an implicit neural network...there have been NLP tasks, and there are many effective approaches to dealing with them. In the context of HMMs, there are the “Forward-Backward...Malyska for interesting discussion of related work, and Liz Salesky for NLP application suggestions! Tagger WSJ Accuracy Word vectors only 0.9626 Single
Biuw, Martin; McConnell, Bernie; Bradshaw, Corey J A; Burton, Harry; Fedak, Mike
2003-10-01
Elephant seals regularly perform dives during which they spend a large proportion of time drifting passively through the water column. The rate of vertical change in depth during these "drift" dives is largely a result of the proportion of lipid tissue in the body, with fatter seals having higher (more positive or less negative) drift rates compared with leaner seals. We examined the temporal changes in drift rates of 24 newly weaned southern elephant seal (Mirounga leonina) pups during their first trip to sea to determine if this easily recorded dive characteristic can be used to continuously monitor changes in body composition of seals throughout their foraging trips. All seals demonstrated a similar trend over time: drift rates were initially positive but decreased steadily over the first 30-50 days after departure (Phase 1), corresponding to seals becoming gradually less buoyant. Over the following approximately 100 days (Phase 2), drift rates again increased gradually, while during the last approximately 20-45 days (Phase 3) drift rates either remained constant or decreased slightly. The daily rate of change in drift rate was negatively related to the daily rate of horizontal displacement (daily travel rate), and daily travel rates of more than approximately 80 km were almost exclusively associated with negative changes in drift rate. We developed a mechanistic model based on body compositions and morphometrics measured in the field, published values for the density of seawater and various body components, and values of drag coefficients for objects of different shapes. We used this model to examine the theoretical relationships between drift rate and body composition and carried out a sensitivity analysis to quantify errors and biases caused by varying model parameters. While variations in seawater density and uncertainties in estimated body surface area and volume are unlikely to result in errors in estimated lipid content of more than +/-2.5%, variations in drag coefficient can lead to errors of >or =10%. Finally, we compared the lipid contents predicted by our model with the lipid contents measured using isotopically labelled water and found a strong positive correlation. The best-fitting model suggests that the drag coefficient of seals while drifting passively is between approximately 0.49 (roughly corresponding to a sphere-shaped object) and 0.69 (a prolate spheroid), and we were able to estimate relative lipid content to within approximately +/-2% lipid. Our results suggest that this simple method can be used to estimate the changes in lipid content of free-ranging seals while at sea and may help improve our understanding of the foraging strategies of these important marine predators.
Wang, An-Li; Shi, Zhenhao; Fairchild, Victoria P; Aronowitz, Catherine A; Langleben, Daniel D
2018-04-26
Graphic warning labels (GWLs) on cigarette packages, that combine textual warnings with emotionally salient images depicting the adverse health consequences of smoking, have been adopted in most European countries. In the US, the courts deemed the evidence justifying the inclusion of emotionally salient images in GWLs insufficient and put the implementation on hold. We conducted a controlled experimental study examining the effect of emotional salience of GWL's images on the recall of their text component. Seventy-three non-treatment-seeking daily smokers received cigarette packs carrying GWLs for a period of 4 weeks. Participants were randomly assigned to receive packs with GWLs previously rated as eliciting high or low level of emotional reaction (ER). The two conditions differed in respect to images but used the same textual warning statements. Participants' recognition of GWL images and statements were tested separately at baseline and again after the 4-week repetitive exposure. Textual warning statements were recognized more accurately when paired with high ER images than when paired with low ER images, both at baseline and after daily exposure to GWLs over a 4-week period. The results suggest that emotional salience of GWLs facilitates cognitive processing of the textual warnings, resulting in better remembering of the information about the health hazards of smoking. Thus, high emotional salience of the pictorial component of GWLs is essential for their overall effectiveness.
21 CFR 341.85 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... combination, as established in the statement of identity sections of the applicable OTC drug monographs. If... drug monographs, unless otherwise stated in this paragraph (a). (1) For permitted combinations... established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this...
27 CFR 7.52 - Mandatory statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages § 7... broadcast. Street number and name may be omitted in the address. (b) Class. The advertisement shall contain... where only one type of malt beverage is marketed under the specific brand name advertised. (2) On...
The Emotional Components of Jealousy: A Multivariate Investigation.
ERIC Educational Resources Information Center
Ray, Lisa
To investigate the emotional parameters of jealousy and to examine the differences between male and female labeling of jealousy, 288 college undergraduates completed the Emotional Parameters of Jealousy Questionnaire. The questionnaire consists of 59 statements that refer to emotions experienced by a person in a situation in which he/she feels…
21 CFR 163.130 - Milk chocolate.
Code of Federal Regulations, 2010 CFR
2010-04-01
... used: (1) Cacao fat; (2) Nutritive carbohydrate sweeteners; (3) Spices, natural and artificial... name of the specific neutralizing agent used in the food. (3) When one or more of the spices... label shall bear an appropriate statement, e.g., “Spice added”, “Flavored with ___”, or “With ___ added...
21 CFR 514.106 - Approval of supplemental applications.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Approval of supplemental applications. 514.106 Section 514.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... labeling (color, style, format, addition, deletion, or revision of certain statements, e.g., trade name...
21 CFR 514.106 - Approval of supplemental applications.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Approval of supplemental applications. 514.106 Section 514.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... labeling (color, style, format, addition, deletion, or revision of certain statements, e.g., trade name...
21 CFR 514.106 - Approval of supplemental applications.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Approval of supplemental applications. 514.106 Section 514.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... labeling (color, style, format, addition, deletion, or revision of certain statements, e.g., trade name...
... is the equipment can be used for both foods and leads to "cross-contamination." That's the same thing that happens in your own house if someone spreads peanut butter on a sandwich and dips that same knife ... to nuts also have to avoid foods with these statements on the label. Some of ...
40 CFR 205.158 - Labeling requirements.
Code of Federal Regulations, 2010 CFR
2010-07-01
... requirements of ___ (noise emission standard) dBA at ___ (closing rpm) rpm by the Federal test procedure...-letter manufacturer abbreviation as soon as reasonably practical after his existence is known to the... section with the statement; “For Export Only”. (c) Any competition motorcycle as defined in § 205.151(a)(3...
40 CFR 205.158 - Labeling requirements.
Code of Federal Regulations, 2011 CFR
2011-07-01
... requirements of ___ (noise emission standard) dBA at ___ (closing rpm) rpm by the Federal test procedure...-letter manufacturer abbreviation as soon as reasonably practical after his existence is known to the... section with the statement; “For Export Only”. (c) Any competition motorcycle as defined in § 205.151(a)(3...
21 CFR 105.62 - Hypoallergenic foods.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Hypoallergenic foods. 105.62 Section 105.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.62 Hypoallergenic foods. If a...
21 CFR 105.62 - Hypoallergenic foods.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Hypoallergenic foods. 105.62 Section 105.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.62 Hypoallergenic foods. If a...
21 CFR 105.62 - Hypoallergenic foods.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Hypoallergenic foods. 105.62 Section 105.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.62 Hypoallergenic foods. If a...
21 CFR 105.62 - Hypoallergenic foods.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Hypoallergenic foods. 105.62 Section 105.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.62 Hypoallergenic foods. If a...
21 CFR 105.62 - Hypoallergenic foods.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Hypoallergenic foods. 105.62 Section 105.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.62 Hypoallergenic foods. If a...
27 CFR 4.64 - Prohibited practices.
Code of Federal Regulations, 2010 CFR
2010-04-01
... found within the wine, and health benefits or effects on health. The term includes both specific health... OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Advertising of Wine § 4.64 Prohibited practices. (a) Restrictions. The advertisement of wine shall not contain: (1) Any statement that is false or...
40 CFR 747.115 - Mixed mono and diamides of an organic acid.
Code of Federal Regulations, 2010 CFR
2010-07-01
... warning statement shall be no smaller than six point type. All required label text shall be of sufficient..., commerce, importer, impurity, Inventory, manufacturer, person, process, processor, and small quantities... control of the processor. (ii) Distribution in commerce is limited to purposes of export. (iii) The...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Exports. 16.31 Section 16... TREASURY LIQUORS ALCOHOLIC BEVERAGE HEALTH WARNING STATEMENT General Provisions § 16.31 Exports. The..., bottled, or labeled for export from the United States, or for delivery to a vessel or aircraft, as...
21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.
Code of Federal Regulations, 2010 CFR
2010-04-01
....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for processing, repacking, or...
40 CFR 721.1612 - Substituted 2-nitro- and 2-aminobenzesulfonamide.
Code of Federal Regulations, 2014 CFR
2014-07-01
...) TOXIC SUBSTANCES CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Significant New Uses for... statements shall appear on each label and MSDS required by this paragraph: This substance may be toxic to terrestrial organisms and plants. Notice to user: Release to water restrictions apply. (ii) Disposal...
40 CFR 721.1612 - Substituted 2-nitro- and 2-aminobenzesulfonamide.
Code of Federal Regulations, 2010 CFR
2010-07-01
...) TOXIC SUBSTANCES CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Significant New Uses for... statements shall appear on each label and MSDS required by this paragraph: This substance may be toxic to terrestrial organisms and plants. Notice to user: Release to water restrictions apply. (ii) Disposal...
40 CFR 721.1612 - Substituted 2-nitro- and 2-aminobenzesulfonamide.
Code of Federal Regulations, 2013 CFR
2013-07-01
...) TOXIC SUBSTANCES CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Significant New Uses for... statements shall appear on each label and MSDS required by this paragraph: This substance may be toxic to terrestrial organisms and plants. Notice to user: Release to water restrictions apply. (ii) Disposal...
40 CFR 721.1612 - Substituted 2-nitro- and 2-aminobenzesulfonamide.
Code of Federal Regulations, 2012 CFR
2012-07-01
...) TOXIC SUBSTANCES CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Significant New Uses for... statements shall appear on each label and MSDS required by this paragraph: This substance may be toxic to terrestrial organisms and plants. Notice to user: Release to water restrictions apply. (ii) Disposal...
40 CFR 721.1612 - Substituted 2-nitro- and 2-aminobenzesulfonamide.
Code of Federal Regulations, 2011 CFR
2011-07-01
...) TOXIC SUBSTANCES CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Significant New Uses for... statements shall appear on each label and MSDS required by this paragraph: This substance may be toxic to terrestrial organisms and plants. Notice to user: Release to water restrictions apply. (ii) Disposal...
21 CFR 133.176 - Pasteurized cheese spread with fruits, vegetables, or meats.
Code of Federal Regulations, 2013 CFR
2013-04-01
..., or meats. 133.176 Section 133.176 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Requirements for Specific Standardized Cheese and Related Products § 133.176 Pasteurized cheese spread with... the requirements for label statement of ingredients, prescribed for pasteurized cheese spread by § 133...
21 CFR 163.130 - Milk chocolate.
Code of Federal Regulations, 2011 CFR
2011-04-01
... used: (1) Cacao fat; (2) Nutritive carbohydrate sweeteners; (3) Spices, natural and artificial... name of the specific neutralizing agent used in the food. (3) When one or more of the spices... label shall bear an appropriate statement, e.g., “Spice added”, “Flavored with ___”, or “With ___ added...
9 CFR 381.126 - Date of packing and date of processing; contents of cans.
Code of Federal Regulations, 2010 CFR
2010-01-01
... explanatory statement, as provided in § 381.129(c)(2). (b) The immediate container for dressed poultry shall..., DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Labeling and...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-24
... Consumer Products Other Than Automobiles. The Energy Conservation Program for Consumer Products Other Than Automobiles consists of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and... Program for Consumer Products Other Than Automobiles DOE requires that manufacturers: (1) Submit...
16 CFR 502.100 - “Cents-off” representations.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 502.100 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENT OF GENERAL POLICY... 5(C) OF THE FAIR PACKAGING AND LABELING ACT Retail Sale Price Representations § 502.100 “Cents-off... being offered for sale at a price lower than the ordinary and customary retail sale price. (b) Except as...
9 CFR 381.125 - Special handling label requirements.
Code of Federal Regulations, 2011 CFR
2011-01-01
... immediate containers for products that are frozen during distribution and intended to be thawed prior to or... frozen. Thaw in refrigerator or microwave. (Any portion of this statement that is in conflict with the product's specific handling instructions may be omitted, e.g., instructions to cook without thawing.) (A...
40 CFR 1036.150 - Interim provisions.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 34 2012-07-01 2012-07-01 false Interim provisions. 1036.150 Section... 13 CFR 121.201 are not subject to the greenhouse gas emission standards in § 1036.108. Qualifying... small business under 13 CFR 121.201. You must label your excluded vehicles with the statement: “THIS...
40 CFR 1036.150 - Interim provisions.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 33 2014-07-01 2014-07-01 false Interim provisions. 1036.150 Section... 13 CFR 121.201 are not subject to the greenhouse gas emission standards in § 1036.108. Qualifying... small business under 13 CFR 121.201. You must label your excluded engines with the statement: “THIS...
Evelyn, B.; Toigo, T.; Banks, D.; Pohl, D.; Gray, K.; Robins, B.; Ernat, J.
2001-01-01
Few recent data are available from formal evaluations of approved new drug applications to address perceptions that racial and ethnic groups are under-represented in clinical trials of new drugs. This study reviews racial and ethnic group participation in clinical trials and race-related labeling for new molecular entities approved during a five-year period by the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). This was a retrospective review of FDA medical officers' reviews of clinical trial protocols and product labeling for 185 new molecular entities (NME's) approved by CDER between January 1,1995, and December 31, 1999. Enrollment data were obtained from the reviews and tabulated according to race/ethnicity. The approved product labeling was searched for statements related to product testing in various racial/ethnic groups. All data were compiled and analyzed using Microsoft Access. This study quantifies the participation of racial/ethnic groups in clinical trials by year and therapeutic category. Additionally, the study categorizes labeling based on the types of effects described as related to race/ethnicity. Racial and ethnic groups appear to participate in clinical trials to varying degrees. African Americans participated in trials to the greatest extent; however, their participation steadily declined from 12% in 1995 to 6% in 1999. Among trials known to be conducted only in the U.S., African-American participation is comparable to their representation in the U.S. population. In all cases, participants designated as Hispanic appear to be far below their representation in the population. Some differences in participation for all racial and ethnic groups are seen when comparisons from year-to-year or among drug classes are made. Labeling for 45% (84/185) of the products contained some statement about race, although in only 8% (15/185) were differences related to race described. Fifty percent (50%) of the effects were pharmacokinetic, 39% were efficacy, and 11% were safety. One product label recommended a change in dosage based on racial differences. Images Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 7 PMID:11798060
Effect of lie labelling on children's evaluation of selfish, polite, and altruistic lies.
Cheung, Him; Chan, Yawen; Tsui, Wan Chi Gigi
2016-09-01
This study investigates how 5- and 6-year-olds' evaluations of selfish, polite, and altruistic lies change as a result of whether these false statements are explicitly labelled as lies. We are also interested in how interpretive theory of mind may correlate with such evaluations with and without a lie label. Our results showed that labelling lowered children's evaluations for the polite and altruistic lies, but not for the selfish lies. Interpretive theory of mind correlated positively with the evaluation difference between the polite and altruistic lies and that between the selfish and altruistic lies in the label, but not in the non-label condition. Correlation between the selfish and altruistic lies and that between the polite and altruistic lies were stronger with than without labelling, after controlling for age, and verbal and non-verbal intelligence. We conclude that lie labelling biases children towards more negative evaluations for non-selfish lies and makes them see lies of different motives as more similar. If a lie label is applied, whether lies of different motives are still evaluated differently depends on interpretive theory of mind, which reflects the child's ability to represent and allow different interpretations of an ambiguous reality. © 2016 The British Psychological Society.
Object Manifold Alignment for Multi-Temporal High Resolution Remote Sensing Images Classification
NASA Astrophysics Data System (ADS)
Gao, G.; Zhang, M.; Gu, Y.
2017-05-01
Multi-temporal remote sensing images classification is very useful for monitoring the land cover changes. Traditional approaches in this field mainly face to limited labelled samples and spectral drift of image information. With spatial resolution improvement, "pepper and salt" appears and classification results will be effected when the pixelwise classification algorithms are applied to high-resolution satellite images, in which the spatial relationship among the pixels is ignored. For classifying the multi-temporal high resolution images with limited labelled samples, spectral drift and "pepper and salt" problem, an object-based manifold alignment method is proposed. Firstly, multi-temporal multispectral images are cut to superpixels by simple linear iterative clustering (SLIC) respectively. Secondly, some features obtained from superpixels are formed as vector. Thirdly, a majority voting manifold alignment method aiming at solving high resolution problem is proposed and mapping the vector data to alignment space. At last, all the data in the alignment space are classified by using KNN method. Multi-temporal images from different areas or the same area are both considered in this paper. In the experiments, 2 groups of multi-temporal HR images collected by China GF1 and GF2 satellites are used for performance evaluation. Experimental results indicate that the proposed method not only has significantly outperforms than traditional domain adaptation methods in classification accuracy, but also effectively overcome the problem of "pepper and salt".
Optimized protocol for combined PALM-dSTORM imaging.
Glushonkov, O; Réal, E; Boutant, E; Mély, Y; Didier, P
2018-06-08
Multi-colour super-resolution localization microscopy is an efficient technique to study a variety of intracellular processes, including protein-protein interactions. This technique requires specific labels that display transition between fluorescent and non-fluorescent states under given conditions. For the most commonly used label types, photoactivatable fluorescent proteins and organic fluorophores, these conditions are different, making experiments that combine both labels difficult. Here, we demonstrate that changing the standard imaging buffer of thiols/oxygen scavenging system, used for organic fluorophores, to the commercial mounting medium Vectashield increased the number of photons emitted by the fluorescent protein mEos2 and enhanced the photoconversion rate between its green and red forms. In addition, the photophysical properties of organic fluorophores remained unaltered with respect to the standard imaging buffer. The use of Vectashield together with our optimized protocol for correction of sample drift and chromatic aberrations enabled us to perform two-colour 3D super-resolution imaging of the nucleolus and resolve its three compartments.
Merrick, S; Farrell, D
2012-07-01
Head and neck cancer patients are at high risk of malnutrition and its complications and therefore often undergo non-oral nasogastric or percutaneous endoscopic gastrostomy (PEG) nutrition support. However, there is little evidence that either approach is effective in this group. While one possible explanation for these findings relates to the relationship between artificial tube feeding and poor quality of life, there is little research that examines the patient's subjective experience of nutrition support. This study investigated the experiences of PEG tube feeding in head and neck cancer patients undergoing radical treatment. Conventional Q-methodology was used with 15 head and neck cancer patients, who rank-ordered 36 statements according to the extent to which these reflected their experiences of PEG tube feeding. The sorted statements were factor-analysed case-wise to provide clusters of similar experiences. Three perspectives emerged. Factor 1, labelled 'Constructive cognitive appraisal', focused around positive adaptation to, and acceptance of, PEG feeding. Factor 2, labelled 'Cognitive-affective dissonance', reflected ambivalence between cognitive acceptance and affective rejection of the PEG tube. Factor 3, labelled 'Emotion-focused appraisal', was characterised by tube-focused anxiety and fear. The findings broadly confirm Levanthal et al.'s Self-Regulatory Model of coping and support the need for genuine and individualised patient-centred nutritional care. © 2012 Blackwell Publishing Ltd.
Roses, Jonathan B
2011-01-01
In 2004, Congress mandated labeling of food allergens on packaged foods for the first time by passing the Food Allergen Labeling and Consumer Protection Act (FALCPA). FALCPA requires that manufacturers of foods containing one of the eight major allergens responsible for 90 percent of food allergies either state on the food's packaging that the food contains the allergen, or refers to the allergen by a name easily understandable by consumers in the ingredients listing. Despite this important first step in protecting consumers with food allergies, FALCPA left unregulated the use of conditional precautionary statements (e.g., "may contain [allergen]"), which many manufacturers have used as a low-cost shield to liability. Further, FALCPA applies only to packaged foods, and does not mandate listing of food allergen ingredients in restaurants. This article discusses the history of food allergen litigation in the United States, highlighting the problems plaintiffs have faced in seeking recovery for allergic reactions to a defendants' food product, and some of the practical difficulties still extant due to the lack of regulation of precautionary statements. Also presented is a review of the Massachusetts Food Allergy Awareness Act, the first state legislation requiring restaurants to take an active role in educating employees and consumers about the presence and dangers of food allergens.
21 CFR 814.118 - Denial of approval or withdrawal of approval of an HDE.
Code of Federal Regulations, 2010 CFR
2010-04-01
... contains an untrue statement of material fact, or omits material information; (5) The device's labeling... in compliance with the good laboratory practice regulations in part 58 of this chapter and no reason... conducting the study and the good laboratory practice regulations do not support the validity of the study...
21 CFR 101.93 - Certain types of statements for dietary supplements.
Code of Federal Regulations, 2011 CFR
2011-04-01
... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...
21 CFR 101.93 - Certain types of statements for dietary supplements.
Code of Federal Regulations, 2014 CFR
2014-04-01
... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...
21 CFR 101.93 - Certain types of statements for dietary supplements.
Code of Federal Regulations, 2013 CFR
2013-04-01
... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...
21 CFR 101.93 - Certain types of statements for dietary supplements.
Code of Federal Regulations, 2012 CFR
2012-04-01
... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...
27 CFR 7.71 - Alcoholic content.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Alcoholic content. 7.71 Section 7.71 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Interim Regulations for Alcoholic Content Statements § 7.71 Alcoholic content. ...
27 CFR 7.71 - Alcoholic content.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Alcoholic content. 7.71 Section 7.71 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF MALT BEVERAGES Interim Regulations for Alcoholic Content Statements § 7.71 Alcoholic content. ...
27 CFR 7.71 - Alcoholic content.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Alcoholic content. 7.71 Section 7.71 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF MALT BEVERAGES Interim Regulations for Alcoholic Content Statements § 7.71 Alcoholic content. ...
27 CFR 7.71 - Alcoholic content.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Alcoholic content. 7.71 Section 7.71 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Interim Regulations for Alcoholic Content Statements § 7.71 Alcoholic content. ...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Infant foods. 105.65 Section 105.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.65 Infant foods. (a) If a food (other than a...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Infant foods. 105.65 Section 105.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.65 Infant foods. (a) If a food (other than a...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Infant foods. 105.65 Section 105.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.65 Infant foods. (a) If a food (other than a...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Infant foods. 105.65 Section 105.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.65 Infant foods. (a) If a food (other than a...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Infant foods. 105.65 Section 105.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOODS FOR SPECIAL DIETARY USE Label Statements § 105.65 Infant foods. (a) If a food (other than a...
Code of Federal Regulations, 2013 CFR
2013-04-01
... or in a water carrier, but the amount added does not exceed 0.5 percent of the weight of the frozen eggs. If a water carrier is used, it shall contain not less than 50 percent by weight of such... paragraph (b) of this section is used, the label shall bear the statement “Monosodium phosphate (or...
Code of Federal Regulations, 2012 CFR
2012-04-01
... or in a water carrier, but the amount added does not exceed 0.5 percent of the weight of the frozen eggs. If a water carrier is used, it shall contain not less than 50 percent by weight of such... paragraph (b) of this section is used, the label shall bear the statement “Monosodium phosphate (or...
Code of Federal Regulations, 2014 CFR
2014-04-01
... or in a water carrier, but the amount added does not exceed 0.5 percent of the weight of the frozen eggs. If a water carrier is used, it shall contain not less than 50 percent by weight of such... paragraph (b) of this section is used, the label shall bear the statement “Monosodium phosphate (or...
Psychological Problems in Mental Deficiency.
ERIC Educational Resources Information Center
Sarason, Seymour B.; Doris, John
A statement of goals and the rationale for organization precede a historical discussion of mental deficiency and society. The problem of labels like IQ and brain injured and the consequences of the diagnostic process are illustrated by case histories; case studies are also used to examine the criteria used to decide who is retarded and to discuss…
27 CFR 7.71 - Alcoholic content.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Alcoholic content. 7.71 Section 7.71 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Interim Regulations for Alcoholic Content Statements § 7.71 Alcoholic content. ...
16 CFR 307.5 - Language requirements.
Code of Federal Regulations, 2010 CFR
2010-01-01
... regulations shall be set out in the English language. If the label of a smokeless tobacco product contains a required warning in a language other than English, the required warning must also appear in English. In the... publication that is not in English, the warning statement shall appear in the predominant language of the...
Code of Federal Regulations, 2014 CFR
2014-04-01
..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...
Code of Federal Regulations, 2013 CFR
2013-04-01
..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...
Code of Federal Regulations, 2012 CFR
2012-04-01
..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...
Code of Federal Regulations, 2010 CFR
2010-04-01
..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...
Code of Federal Regulations, 2011 CFR
2011-04-01
..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...
21 CFR 139.125 - Vegetable macaroni products.
Code of Federal Regulations, 2012 CFR
2012-04-01
... requirements for label statement of ingredients prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), and (g), except that: (1) Tomato (of any red variety), artichoke, beet, carrot, parsley, or spinach is added in such quantity that the solids thereof are not less than 3 percent by weight of the finished...
21 CFR 139.125 - Vegetable macaroni products.
Code of Federal Regulations, 2011 CFR
2011-04-01
... requirements for label statement of ingredients prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), and (g), except that: (1) Tomato (of any red variety), artichoke, beet, carrot, parsley, or spinach is added in such quantity that the solids thereof are not less than 3 percent by weight of the finished...
21 CFR 139.125 - Vegetable macaroni products.
Code of Federal Regulations, 2010 CFR
2010-04-01
... requirements for label statement of ingredients prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), and (g), except that: (1) Tomato (of any red variety), artichoke, beet, carrot, parsley, or spinach is added in such quantity that the solids thereof are not less than 3 percent by weight of the finished...
21 CFR 139.125 - Vegetable macaroni products.
Code of Federal Regulations, 2014 CFR
2014-04-01
... requirements for label statement of ingredients prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), and (g), except that: (1) Tomato (of any red variety), artichoke, beet, carrot, parsley, or spinach is added in such quantity that the solids thereof are not less than 3 percent by weight of the finished...
21 CFR 139.125 - Vegetable macaroni products.
Code of Federal Regulations, 2013 CFR
2013-04-01
... requirements for label statement of ingredients prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), and (g), except that: (1) Tomato (of any red variety), artichoke, beet, carrot, parsley, or spinach is added in such quantity that the solids thereof are not less than 3 percent by weight of the finished...
Pieretti, Mariah M; Chung, Danna; Pacenza, Robert; Slotkin, Todd; Sicherer, Scott H
2009-08-01
The Food Allergy Labeling and Consumer Protection Act became effective January 1, 2006, and mandates disclosure of the 8 major allergens in plain English and as a source of ingredients in the ingredient statement. It does not regulate advisory labels. We sought to determine the frequency and language used in voluntary advisory labels among commercially available products and to identify labeling ambiguities affecting consumers with allergy. Trained surveyors performed a supermarket survey of 20,241 unique manufactured food products (from an original assessment of 49,604 products) for use of advisory labels. A second detailed survey of 744 unique products evaluated additional labeling practices. Overall, 17% of 20,241 products surveyed contain advisory labels. Chocolate candy, cookies, and baking mixes were the 3 categories of 24 with the greatest frequency (> or = 40%). Categorically, advisory warnings included "may contain" (38%), "shared equipment" (33%), and "within plant" (29%). The subsurvey disclosed 25 different types of advisory terminology. Nonspecific terms, such as "natural flavors" and "spices," were found on 65% of products and were not linked to a specific ingredient for 83% of them. Additional ambiguities included unclear sources of soy (lecithin vs protein), nondisclosure of sources of gelatin and lecithin, and simultaneous disclosure of "contains" and "may contain" for the same allergen, among others. Numerous products have advisory labeling and ambiguities that present challenges to consumers with food allergy. Additional allergen labeling regulation could improve safety and quality of life for individuals with food allergy.
de Groot, Ronald; Brekelmans, Pieter; Herremans, Joke; Meulenbelt, Jan
2010-01-01
The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN-GHS) is developed to harmonize the criteria for hazard communication worldwide. The European Regulation on classification, labeling, and packaging of substances and mixtures [CLP Regulation (European Commission, EC) No 1272/2008] will align the existing European Union (EU) legislation to the UN-GHS. This CLP Regulation entered into force on January 20, 2009, and will, after a transitional period, replace the current rules on classification, labeling, and packaging for supply and use in Europe. Both old and new classifications will exist simultaneously until 2010 for substances and until 2015 for mixtures. The new hazard classification will introduce new health hazard classes and categories, with associated new hazard pictograms, signal words, Hazard (H)-statements, and Precautionary (P)-statements as labeling elements. Furthermore, the CLP Regulation will affect the notification of product information on hazardous products to poisons information centers (PICs). At this moment product notification widely varies in procedures and requirements across EU Member States. Article 45 of the CLP Regulation contains a provision stating that the EC will (by January 20, 2012) review the possibility of harmonizing product notification. The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) is recognized as an important stakeholder. For cosmetic products, the new Cosmetics Regulation will directly implement a new procedure for electronic cosmetic product notification in all EU Member States. Both the CLP Regulation and the Cosmetics Regulation will develop their own product notification procedure within different time frames. Harmonization of notification procedures for both product groups, especially a common electronic format, would be most effective from a cost-benefit viewpoint and would be welcomed by PICs.
Drift in Neural Population Activity Causes Working Memory to Deteriorate Over Time.
Schneegans, Sebastian; Bays, Paul M
2018-05-23
Short-term memories are thought to be maintained in the form of sustained spiking activity in neural populations. Decreases in recall precision observed with increasing number of memorized items can be accounted for by a limit on total spiking activity, resulting in fewer spikes contributing to the representation of each individual item. Longer retention intervals likewise reduce recall precision, but it is unknown what changes in population activity produce this effect. One possibility is that spiking activity becomes attenuated over time, such that the same mechanism accounts for both effects of set size and retention duration. Alternatively, reduced performance may be caused by drift in the encoded value over time, without a decrease in overall spiking activity. Human participants of either sex performed a variable-delay cued recall task with a saccadic response, providing a precise measure of recall latency. Based on a spike integration model of decision making, if the effects of set size and retention duration are both caused by decreased spiking activity, we would predict a fixed relationship between recall precision and response latency across conditions. In contrast, the drift hypothesis predicts no systematic changes in latency with increasing delays. Our results show both an increase in latency with set size, and a decrease in response precision with longer delays within each set size, but no systematic increase in latency for increasing delay durations. These results were quantitatively reproduced by a model based on a limited neural resource in which working memories drift rather than decay with time. SIGNIFICANCE STATEMENT Rapid deterioration over seconds is a defining feature of short-term memory, but what mechanism drives this degradation of internal representations? Here, we extend a successful population coding model of working memory by introducing possible mechanisms of delay effects. We show that a decay in neural signal over time predicts that the time required for memory retrieval will increase with delay, whereas a random drift in the stored value predicts no effect of delay on retrieval time. Testing these predictions in a multi-item memory task with an eye movement response, we identified drift as a key mechanism of memory decline. These results provide evidence for a dynamic spiking basis for working memory, in contrast to recent proposals of activity-silent storage. Copyright © 2018 Schneegans and Bays.
Kesselheim, Aaron S.; Wang, Bo; Studdert, David M.; Avorn, Jerry
2012-01-01
Background Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author. Methods and Findings We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996–2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, journal impact factor, citation count/year). We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15%) of which contained an adequate disclosure statement. Most articles had no disclosure (43%) or did not mention the pharmaceutical company (40%). Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02–0.67, p = 0.02). Over half of the authors (22/39, 56%) made no adequate disclosures in their articles. However, four of six authors with ≥25 articles disclosed in about one-third of articles (range: 10/36–8/25 [28%–32%]). Conclusions One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is a much lower rate of adequate disclosure than has been identified in previous studies. The non-disclosure patterns suggest shortcomings with authors and the rigor of journal practices. Please see later in the article for the Editors' Summary PMID:22899894
Kesselheim, Aaron S; Wang, Bo; Studdert, David M; Avorn, Jerry
2012-01-01
Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author. We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996-2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, journal impact factor, citation count/year). We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15%) of which contained an adequate disclosure statement. Most articles had no disclosure (43%) or did not mention the pharmaceutical company (40%). Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02-0.67, p = 0.02). Over half of the authors (22/39, 56%) made no adequate disclosures in their articles. However, four of six authors with ≥ 25 articles disclosed in about one-third of articles (range: 10/36-8/25 [28%-32%]). One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is a much lower rate of adequate disclosure than has been identified in previous studies. The non-disclosure patterns suggest shortcomings with authors and the rigor of journal practices. Please see later in the article for the Editors' Summary.
On tide-induced Lagrangian residual current and residual transport: 1. Lagrangian residual current
Feng, Shizuo; Cheng, Ralph T.; Pangen, Xi
1986-01-01
Residual currents in tidal estuaries and coastal embayments have been recognized as fundamental factors which affect the long-term transport processes. It has been pointed out by previous studies that it is more relevant to use a Lagrangian mean velocity than an Eulerian mean velocity to determine the movements of water masses. Under weakly nonlinear approximation, the parameter k, which is the ratio of the net displacement of a labeled water mass in one tidal cycle to the tidal excursion, is assumed to be small. Solutions for tides, tidal current, and residual current have been considered for two-dimensional, barotropic estuaries and coastal seas. Particular attention has been paid to the distinction between the Lagrangian and Eulerian residual currents. When k is small, the first-order Lagrangian residual is shown to be the sum of the Eulerian residual current and the Stokes drift. The Lagrangian residual drift velocity or the second-order Lagrangian residual current has been shown to be dependent on the phase of tidal current. The Lagrangian drift velocity is induced by nonlinear interactions between tides, tidal currents, and the first-order residual currents, and it takes the form of an ellipse on a hodograph plane. Several examples are given to further demonstrate the unique properties of the Lagrangian residual current.
Ramachandra, Ranjan; Bouwer, James C; Mackey, Mason R; Bushong, Eric; Peltier, Steven T; Xuong, Nguyen-Huu; Ellisman, Mark H
2014-06-01
Energy filtered transmission electron microscopy techniques are regularly used to build elemental maps of spatially distributed nanoparticles in materials and biological specimens. When working with thick biological sections, electron energy loss spectroscopy techniques involving core-loss electrons often require exposures exceeding several minutes to provide sufficient signal to noise. Image quality with these long exposures is often compromised by specimen drift, which results in blurring and reduced resolution. To mitigate drift artifacts, a series of short exposure images can be acquired, aligned, and merged to form a single image. For samples where the target elements have extremely low signal yields, the use of charge coupled device (CCD)-based detectors for this purpose can be problematic. At short acquisition times, the images produced by CCDs can be noisy and may contain fixed pattern artifacts that impact subsequent correlative alignment. Here we report on the use of direct electron detection devices (DDD's) to increase the signal to noise as compared with CCD's. A 3× improvement in signal is reported with a DDD versus a comparably formatted CCD, with equivalent dose on each detector. With the fast rolling-readout design of the DDD, the duty cycle provides a major benefit, as there is no dead time between successive frames.
Robust online tracking via adaptive samples selection with saliency detection
NASA Astrophysics Data System (ADS)
Yan, Jia; Chen, Xi; Zhu, QiuPing
2013-12-01
Online tracking has shown to be successful in tracking of previously unknown objects. However, there are two important factors which lead to drift problem of online tracking, the one is how to select the exact labeled samples even when the target locations are inaccurate, and the other is how to handle the confusors which have similar features with the target. In this article, we propose a robust online tracking algorithm with adaptive samples selection based on saliency detection to overcome the drift problem. To deal with the problem of degrading the classifiers using mis-aligned samples, we introduce the saliency detection method to our tracking problem. Saliency maps and the strong classifiers are combined to extract the most correct positive samples. Our approach employs a simple yet saliency detection algorithm based on image spectral residual analysis. Furthermore, instead of using the random patches as the negative samples, we propose a reasonable selection criterion, in which both the saliency confidence and similarity are considered with the benefits that confusors in the surrounding background are incorporated into the classifiers update process before the drift occurs. The tracking task is formulated as a binary classification via online boosting framework. Experiment results in several challenging video sequences demonstrate the accuracy and stability of our tracker.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Zocco, A.; Plunk, G. G.; Xanthopoulos, P.
The effects of a non-axisymmetric (3D) equilibrium magnetic field on the linear ion-temperature-gradient (ITG) driven mode are investigated. We consider the strongly driven, toroidal branch of the instability in a global (on the magnetic surface) setting. Previous studies have focused on particular features of non-axisymmetric systems, such as strong local shear or magnetic ripple, that introduce inhomogeneity in the coordinate along the magnetic field. In contrast, here we include non-axisymmetry explicitly via the dependence of the magnetic drift on the field line label α, i.e., across the magnetic field, but within the magnetic flux surface. We consider the limit wheremore » this variation occurs on a scale much larger than that of the ITG mode, and also the case where these scales are similar. Close to axisymmetry, we find that an averaging effect of the magnetic drift on the flux surface causes global (on the surface) stabilization, as compared to the most unstable local mode. In the absence of scale separation, we find destabilization is also possible, but only if a particular resonance occurs between the magnetic drift and the mode, and finite Larmor radius effects are neglected. We discuss the relative importance of surface global effects and known radially global effects.« less
40 CFR 86.1807-01 - Vehicle labeling.
Code of Federal Regulations, 2011 CFR
2011-07-01
... Conforms to U.S. EPA Regulations Applicable to XXX-Fueled 20XX Model Year New Motor Vehicles.” (B) For light-duty trucks, the statement: “This Vehicle Conforms to U.S. EPA Regulations Applicable to XXX...: “This Vehicle Conforms to U.S. EPA Regulations Applicable to XXX-fueled 20XX Model Year New Medium-Duty...
40 CFR 86.1807-01 - Vehicle labeling.
Code of Federal Regulations, 2013 CFR
2013-07-01
... Conforms to U.S. EPA Regulations Applicable to XXX-Fueled 20XX Model Year New Motor Vehicles.” (B) For light-duty trucks, the statement: “This Vehicle Conforms to U.S. EPA Regulations Applicable to XXX...: “This Vehicle Conforms to U.S. EPA Regulations Applicable to XXX-fueled 20XX Model Year New Medium-Duty...
40 CFR 86.1807-01 - Vehicle labeling.
Code of Federal Regulations, 2012 CFR
2012-07-01
... XXX-Fueled 20XX Model Year New Motor Vehicles.” (B) For light-duty trucks, the statement: “This Vehicle Conforms to U.S. EPA Regulations Applicable to XXX-Fueled 20XX Model Year New Light-Duty Trucks... Applicable to XXX-fueled 20XX Model Year New Medium-Duty Passenger Vehicles.” (D) For heavy-duty vehicles...
Code of Federal Regulations, 2012 CFR
2012-07-01
...: “This engine has been certified to meet U.S. EPA standards for a useful-life period of XXX miles or XXX... statement: “This engine has a primary intended service application as a XXX heavy-duty engine.” (The primary... regulations which apply to XXX-fueled heavy-duty vehicles. (F) Vehicles granted final admission under § 85...
Code of Federal Regulations, 2011 CFR
2011-04-01
... established in the statement of identity sections of the applicable OTC drug monographs. (1) Combinations of... ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this... established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use...
Code of Federal Regulations, 2010 CFR
2010-04-01
... established in the statement of identity sections of the applicable OTC drug monographs. (1) Combinations of... ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this... established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use...
16 CFR 503.3 - Name and place of business of manufacturer, packer, or distributor.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Name and place of business of manufacturer... LABELING ACT STATEMENTS OF GENERAL POLICY OR INTERPRETATION § 503.3 Name and place of business of manufacturer, packer, or distributor. To clarify the identity of a manufacturer, packer, or distributor for the...
21 CFR 101.65 - Implied nutrient content claims and related label statements.
Code of Federal Regulations, 2011 CFR
2011-04-01
..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... that is useful in creating a diet that is consistent with dietary recommendations if: (i) The food... must contain... (A) A raw fruit or vegetable Low fat as defined in § 101.62(b)(2) Low saturated fat as...
78 FR 36693 - Rules and Regulations Under the Fur Products Labeling Act
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-19
... Rules currently do, a statement that the guarantor's printed name and address will meet the signature... to section 301.47: ``Note: The printed name and address on the invoice or other document will suffice... Band Employee Benefit Plan v. Smith Barney Shearson, Inc., 76 F.3d 1245 (1st Cir. 1996) (upholding...
Code of Federal Regulations, 2013 CFR
2013-07-01
..., the statement “This refrigerant is FLAMMABLE. Take appropriate precautions.” b. This label must be... Narrowed Use Limits: Streaming Agents Application Substitute Decision Comments Halon 1211 CF3 I Acceptable in non-residential uses only Streaming Agents Aerosols—Proposed Acceptable Subject to Use Conditions...
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... bear the following warning: WARNING—Avoid spraying in eyes. Contents under pressure. Do not puncture or... warning required by paragraph (a)(1) of this section. (4) The words “Avoid spraying in eyes” may be... containing dry or incompletely hydrated psyllium husk, also known as psyllium seed husk, and bearing a health...
No herbicide residues found in smoke from prescribed fires
Charles K. McMahon; Parshall B. Bush
1992-01-01
Some concerns have been expressed by workers conducting prescribed burns on forest lands treated with herbicides.The major concern has based on speculation that hazardous levels of airborne herbicide residues may be present in the smoke near breathing zones of forest workers. Much of this speculation is based on fire hazard caution statements found on product labels...
21 CFR 101.3 - Identity labeling of food in packaged form.
Code of Federal Regulations, 2014 CFR
2014-04-01
... establishing a nutritional quality guideline pursuant to part 104 of this chapter), and which complies with all... subpart B of part 102 of this chapter. (g) Dietary supplements shall be identified by the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and...
21 CFR 101.3 - Identity labeling of food in packaged form.
Code of Federal Regulations, 2012 CFR
2012-04-01
... establishing a nutritional quality guideline pursuant to part 104 of this chapter), and which complies with all... subpart B of part 102 of this chapter. (g) Dietary supplements shall be identified by the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and...
21 CFR 101.3 - Identity labeling of food in packaged form.
Code of Federal Regulations, 2013 CFR
2013-04-01
... establishing a nutritional quality guideline pursuant to part 104 of this chapter), and which complies with all... subpart B of part 102 of this chapter. (g) Dietary supplements shall be identified by the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and...
40 CFR 156.204 - Modification and waiver of requirements.
Code of Federal Regulations, 2012 CFR
2012-07-01
... accordance with § 154.25(c) of this chapter that a pesticide should be placed in Special Review because the pesticide meets or exceeds the criteria for human health effects of § 154.7(a)(1)(2) or (6) of this chapter...) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Worker Protection Statements § 156.204...
40 CFR 156.204 - Modification and waiver of requirements.
Code of Federal Regulations, 2013 CFR
2013-07-01
... accordance with § 154.25(c) of this chapter that a pesticide should be placed in Special Review because the pesticide meets or exceeds the criteria for human health effects of § 154.7(a)(1)(2) or (6) of this chapter...) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Worker Protection Statements § 156.204...