Sample records for labeling claims draft

  1. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

    PubMed

    2006-10-11

    This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably

  2. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

    PubMed Central

    2006-01-01

    This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably

  3. Current status of nutrition labelling and claims in the South-East Asian region: are we in harmony?

    PubMed

    Tee, E-Siong; Tamin, Suryani; Ilyas, Rosmulyati; Ramos, Adelisa; Tan, Wei-Ling; Lai, Darwin Kah-Soon; Kongchuntuk, Hataya

    2002-01-01

    This review includes the situation of nutrition labelling and claims in six countries in South-East Asia: Brunei, Indonesia, Malaysia, Philippines, Singapore and Thailand. With the exception of Malaysia, there is no mandatory nutrition labelling requirements for foods in these countries except for special categories of foods and when nutritional claims are made for fortified or enriched foods. Nevertheless, several food manufacturers, especially multinationals, do voluntarily label the nutritional content of a number of food products. There is, therefore, increasing interest among authorities in countries in the region to start formulating regulations for nutrition labelling for a wider variety of foods. Malaysia has proposed new regulations to make it mandatory to label a number of foodstuffs with the four core nutrients, protein, carbohydrate, fat and energy. Other countries have preferred to start with voluntary labelling by the manufacturers, but have spelt out the requirements for this voluntary labelling. The format and requirements for nutrition labelling differ widely for countries in the region. Some countries, such as Malaysia, closely follow the Codex guidelines on nutrition labelling in terms of format, components to be included and mode of expression. Other countries, such as the Philippines and Thailand, have drafted nutrition labelling regulations very similar to those of the Nutrition Labeling and Education Act (NLEA) of the United States. Nutrition and health claims are also not specifically permitted under food regulations that were enacted before 1998. However, various food products on the market have been carrying a variety of nutrition and health claims. There is concern that without proper regulations, the food industry may not be certain as to what claims can be made. Excessive and misleading claims made by irresponsible manufacturers would only serve to confuse and mislead the consumer. In recent years, there has been efforts in countries in

  4. 78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... container labels and carton labeling design, is the second in a series of three planned guidance documents...] Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To... entitled ``Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...

  5. Nutrition labelling, marketing techniques, nutrition claims and health claims on chip and biscuit packages from sixteen countries.

    PubMed

    Mayhew, Alexandra J; Lock, Karen; Kelishadi, Roya; Swaminathan, Sumathi; Marcilio, Claudia S; Iqbal, Romaina; Dehghan, Mahshid; Yusuf, Salim; Chow, Clara K

    2016-04-01

    Food packages were objectively assessed to explore differences in nutrition labelling, selected promotional marketing techniques and health and nutrition claims between countries, in comparison to national regulations. Cross-sectional. Chip and sweet biscuit packages were collected from sixteen countries at different levels of economic development in the EPOCH (Environmental Profile of a Community's Health) study between 2008 and 2010. Seven hundred and thirty-seven food packages were systematically evaluated for nutrition labelling, selected promotional marketing techniques relevant to nutrition and health, and health and nutrition claims. We compared pack labelling in countries with labelling regulations, with voluntary regulations and no regulations. Overall 86 % of the packages had nutrition labels, 30 % had health or nutrition claims and 87 % displayed selected marketing techniques. On average, each package displayed two marketing techniques and one health or nutrition claim. In countries with mandatory nutrition labelling a greater proportion of packages displayed nutrition labels, had more of the seven required nutrients present, more total nutrients listed and higher readability compared with those with voluntary or no regulations. Countries with no health or nutrition claim regulations had fewer claims per package compared with countries with regulations. Nutrition label regulations were associated with increased prevalence and quality of nutrition labels. Health and nutrition claim regulations were unexpectedly associated with increased use of claims, suggesting that current regulations may not have the desired effect of protecting consumers. Of concern, lack of regulation was associated with increased promotional marketing techniques directed at children and misleadingly promoting broad concepts of health.

  6. EPA Extends Comment Period for Draft Label Revisions on Respirators

    EPA Pesticide Factsheets

    Extending Comment Period for Draft Label Revisions on Respirators, Bring the respirator descriptions on pesticide labels into conformance with the current National Institute for Occupational Safety and Health (NIOSH) respirator language

  7. Food labeling: nutrient content claims, expansion of the nutrient content claim "lean". Final rule.

    PubMed

    2007-01-12

    The Food and Drug Administration (FDA) is amending its food labeling regulations for the expanded use of the nutrient content claim "lean" on the labels of foods categorized as "mixed dishes not measurable with a cup" that meet certain criteria for total fat, saturated fat, and cholesterol content. This final rule responds to a nutrient content claim petition submitted by Nestlé Prepared Foods Co. (Nestlé) under the Federal Food, Drug, and Cosmetic Act (the act). This action is also being taken to provide reliable information that would assist consumers in maintaining healthy dietary practices.

  8. 76 FR 14024 - Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ...] Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With...

  9. Patient-reported outcomes to support medical product labeling claims: FDA perspective.

    PubMed

    Patrick, Donald L; Burke, Laurie B; Powers, John H; Scott, Jane A; Rock, Edwin P; Dawisha, Sahar; O'Neill, Robert; Kennedy, Dianne L

    2007-01-01

    This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report coming directly from patients, without interpretation by physicians or others, about how they function or feel in relation to a health condition and its therapy. PRO instruments are used to measure these patient reports. PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known only to patients. Properly developed and evaluated PRO instruments also have the potential to provide more sensitive and specific measurements of the effects of medical therapies, thereby increasing the efficiency of clinical trials that attempt to measure the meaningful treatment benefits of those therapies. Poorly developed and evaluated instruments may provide misleading conclusions or data that cannot be used to support product labeling claims. We review selected major challenges from Food and Drug Administration's perspective in using PRO instruments, measures, and end points to support treatment benefit claims in product labeling. These challenges highlight the need for sponsors to formulate desired labeling claim(s) prospectively, to acquire and document information needed to support these claim(s), and to identify existing instruments or develop new and more appropriate PRO instruments for evaluating treatment benefit in the defined population in which they will seek claims.

  10. 78 FR 57394 - Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' The recommendations in the draft guidance are intended to help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

  11. 9 CFR 317.369 - Labeling applications for nutrient content claims.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

  12. 9 CFR 317.369 - Labeling applications for nutrient content claims.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

  13. 9 CFR 381.469 - Labeling applications for nutrient content claims.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

  14. 9 CFR 317.369 - Labeling applications for nutrient content claims.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

  15. 9 CFR 317.369 - Labeling applications for nutrient content claims.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

  16. 9 CFR 381.469 - Labeling applications for nutrient content claims.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

  17. 9 CFR 381.469 - Labeling applications for nutrient content claims.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

  18. 9 CFR 381.469 - Labeling applications for nutrient content claims.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

  19. 76 FR 4360 - Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-25

    ...] Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling...: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the... Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act...

  20. 78 FR 3418 - Pesticides; Draft Guidance for Pesticide Registrants on Web-Distributed Labeling for Pesticide...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ... with pesticide labeling requirements and thereby protecting human health and the environment from... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2012-0906; FRL-9374-4] Pesticides; Draft Guidance for Pesticide Registrants on Web- Distributed Labeling for Pesticide Products AGENCY: Environmental Protection...

  1. 75 FR 54347 - Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ...] Draft Guidance for Industry: Bar Code Label Requirements-- Questions and Answers (Question 12 Update... Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Bar... guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar...

  2. PRN 2001-X Draft: Spray and Dust Drift Label Statements for Pesticide Products

    EPA Pesticide Factsheets

    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.

  3. Australian consumers are sceptical about but influenced by claims about fat on food labels.

    PubMed

    Chan, C; Patch, C; Williams, P

    2005-01-01

    To explore the beliefs and attitudes of Australian consumers to claims about fat made on the labels of packaged food. Content analysis of transcripts from focus group discussions. A total of 26 female and 10 male participants aged 20-80 y, recruited by advertisement into six focus groups, stratified by age, sex and health status. Awareness of claims about fat was high in this sample of Australians and participants admitted that they influenced their purchase decisions. The most preferred form of claim was 'X% fat free'. Claims were considered most useful on foods that were high in fat. There was considerable scepticism about all nutrient claims, and consumers preferred to check claims about fat against the values in the nutrition information panel. Many claims were seen as advertising that could be misleading, deceptive or confusing. While claims about fat might prompt product trial, factors such as price, taste, naturalness, as well as other nutritional factors, also influenced purchase decisions. Some consumers believe low fat claims encourage over consumption of foods. Changes to regulations governing nutrition claims on food labels should be made to enhance their credibility and support their role in assisting consumers to make healthier food choices.

  4. List M: Registered Antimicrobial Products with Label Claims for Avian (Bird) Flu Disinfectants

    EPA Pesticide Factsheets

    These EPA disinfectant products are registered and labeled with a claim to inactivate Avian influenza A viruses on hard, non-porous surfaces. The label specifies the use sites (e.g., poultry houses and farm premises) for application of the product.

  5. 76 FR 82303 - Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... indication and risk information, post-marketing submission requirements) in their internet and social media... requests for off-label information, including those that firms may encounter on emerging electronic media...] Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About...

  6. Health claims in the labelling and marketing of food products:

    PubMed Central

    Asp, Nils-Georg; Bryngelsson, Susanne

    2007-01-01

    Since 1990 certain health claims in the labelling and marketing of food products have been allowed in Sweden within the food sector's Code of Practice. The rules were developed in close dialogue with the authorities. The legal basis was a decision by the authorities not to apply the medicinal products’ legislation to “foods normally found on the dinner table” provided the rules defined in the Code were followed. The Code of Practice lists nine well-established diet–health relationships eligible for generic disease risk reduction claims in two steps and general rules regarding nutrient function claims. Since 2001, there has also been the possibility for using “product-specific physiological claims (PFP)”, subject to premarketing evaluation of the scientific dossier supporting the claim. The scientific documentation has been approved for 10 products with PFP, and another 15 products have been found to fulfil the Code's criteria for “low glycaemic index”. In the third edition of the Code, active since 2004, conditions in terms of nutritional composition were set, i.e. “nutrient profiles”, with a general reference to the Swedish National Food Administration's regulation on the use of a particular symbol, i.e. the keyhole symbol. Applying the Swedish Code of practice has provided experience useful in the implementation of the European Regulation on nutrition and health claims made on foods, effective from 2007.

  7. A concept taxonomy and an instrument hierarchy: tools for establishing and evaluating the conceptual framework of a patient-reported outcome (PRO) instrument as applied to product labeling claims.

    PubMed

    Erickson, Pennifer; Willke, Richard; Burke, Laurie

    2009-01-01

    To facilitate development and evaluation of a PRO instrument conceptual framework, we propose two tools--a PRO concept taxonomy and a PRO instrument hierarchy. FDA's draft guidance on patient reported outcome (PRO) measures states that a clear description of the conceptual framework of an instrument is useful for evaluating its adequacy to support a treatment benefit claim for use in product labeling the draft guidance, however does not propose tools for establishing or evaluating a PRO instrument's conceptual framework. We draw from our review of PRO concepts and instruments that appear in prescription drug labeling approved in the United States from 1997 to 2007. We propose taxonomy terms that define relationships between PRO concepts, including "family,"compound concept," and "singular concept." Based on the range of complexity represented by the concepts, as defined by the taxonomy, we propose nine instrument orders for PRO measurement. The nine orders range from individual event counts to multi-item, multiscale instruments. This analysis of PRO concepts and instruments illustrates that the taxonomy and hierarchy are applicable to PRO concepts across a wide range of therapeutic areas and provide a basis for defining the instrument conceptual framework complexity. Although the utility of these tools in the drug development, review, and approval processes has not yet been demonstrated, these tools could be useful to improve communication and enhance efficiency in the instrument development and review process.

  8. Health-related claims on food labels in Australia: understanding environmental health officers' roles and implications for policy.

    PubMed

    Condon-Paoloni, Deanne; Yeatman, Heather R; Grigonis-Deane, Elizabeth

    2015-01-01

    Health and related claims on food labels can support consumer education initiatives that encourage purchase of healthier foods. A new food Standard on Nutrition, Health and Related Claims became law in January 2013. Implementation will need careful monitoring and enforcement to ensure that claims are truthful and have meaning. The current study explored factors that may impact on environmental health officers' food labelling policy enforcement practices. The study used a mixed-methods approach, using two previously validated quantitative questionnaire instruments that provided measures of the level of control that the officers exercised over their work, as well as qualitative, semi-structured, in-depth interviews. Local government; Australia. Thirty-seven officers in three Australian states participated in semi-structured in-depth interviews, as well as completing the quantitative questionnaires. Senior and junior officers, including field officers, participated in the study. The officers reported a high level of autonomy and control of their work, but also a heavy workload, dominated by concerns for public health and food safety, with limited time for monitoring food labels. Compliance of labels with proposed health claims regulations was not considered a priority. Lipsky's theory of street-level bureaucracy was used to enhance understanding of officers' work practices. Competing priorities affect environmental health officers' monitoring and enforcement of regulations. Understanding officers' work practices and their perceptions of enforcement is important to increase effectiveness of policy implementation and hence its capacity to augment education initiatives to optimize health benefits.

  9. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-11

    ... Product Container Is Not Made With Natural Rubber Latex.'' The purpose of this draft guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural... Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex...

  10. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  11. Health claims and other health-related statements in the labeling and advertising of alcohol beverages (99R-199P). Final rule, Treasury decision.

    PubMed

    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.

  12. Dietary supplement labeling and advertising claims: are clinical studies on the full product required?

    PubMed

    Villafranco, John E; Bond, Katie

    2009-01-01

    Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients--rather than the actual product--has caused a good deal of confusion. This confusion stems from the dearth of case law and the open-endedness of Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidance on this issue. Nevertheless, the relevant regulatory guidance, case law and self-regulatory case law--when assessed together--indicate that the law allows and even protects "key ingredient claims" (i.e., claims based on efficacy testing of key ingredients in the absence of full product testing). This article provides an overview of the relevant substantiation requirements for dietary supplement claims and then reviews FTC's and FDA's guidance on key ingredient claims; relevant case law; use of key ingredient claims in the advertising of other consumer products; and the National Advertising Division of the Better Business Bureau, Inc.'s (NAD's) approach to evaluating key ingredient claims for dietary supplements. This article concludes that key ingredient claims--provided they are presented in a truthful and non-deceptive manner--are permissible, and should be upheld in litigation and cases subject to industry self-regulation. This article further concludes that the NAD's approach to key ingredient claims provides practical guidance for crafting and substantiating dietary supplement key ingredient claims.

  13. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    ... can be sprinkled on soft foods and swallowed without chewing as an alternative administration... parameters are considered in this draft guidance as they relate to drug products labeled for sprinkle: (1... size differences between reference listed drugs and ANDAs and meet bioavailability (BA) or...

  14. 77 FR 55480 - Draft Compliance Policy Guide Sec. 690.150 on Labeling and Marketing of Nutritional Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-10

    ... for Use To Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats; Availability AGENCY..., Treat, or Prevent Disease in Dogs and Cats.'' This draft CPG is intended to provide guidance to FDA... marketing of dog and cat food products that are labeled and/or marketed as intending to diagnose, cure...

  15. Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized.

    PubMed

    Nichols, Peter D; Dogan, Lalen; Sinclair, Andrew

    2016-11-05

    We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n -3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%-136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%-119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized.

  16. Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized

    PubMed Central

    Nichols, Peter D.; Dogan, Lalen; Sinclair, Andrew

    2016-01-01

    We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n-3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%–136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%–119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized. PMID:27827947

  17. 21 CFR 101.71 - Health claims: claims not authorized.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: claims not authorized. 101.71 Section 101.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.71 Health...

  18. 21 CFR 101.71 - Health claims: claims not authorized.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Health claims: claims not authorized. 101.71 Section 101.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.71 Health...

  19. 21 CFR 101.71 - Health claims: claims not authorized.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Health claims: claims not authorized. 101.71 Section 101.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.71 Health...

  20. Do Health Claims and Front-of-Pack Labels Lead to a Positivity Bias in Unhealthy Foods?

    PubMed Central

    Talati, Zenobia; Pettigrew, Simone; Dixon, Helen; Neal, Bruce; Ball, Kylie; Hughes, Clare

    2016-01-01

    Health claims and front-of-pack labels (FoPLs) may lead consumers to hold more positive attitudes and show a greater willingness to buy food products, regardless of their actual healthiness. A potential negative consequence of this positivity bias is the increased consumption of unhealthy foods. This study investigated whether a positivity bias would occur in unhealthy variations of four products (cookies, corn flakes, pizzas and yoghurts) that featured different health claim conditions (no claim, nutrient claim, general level health claim, and higher level health claim) and FoPL conditions (no FoPL, the Daily Intake Guide (DIG), Multiple Traffic Lights (MTL), and the Health Star Rating (HSR)). Positivity bias was assessed via measures of perceived healthiness, global evaluations (incorporating taste, quality, convenience, etc.) and willingness to buy. On the whole, health claims did not produce a positivity bias, while FoPLs did, with the DIG being the most likely to elicit this bias. The HSR most frequently led to lower ratings of unhealthy foods than the DIG and MTL, suggesting that this FoPL has the lowest risk of creating an inaccurate positivity bias in unhealthy foods. PMID:27918426

  1. LCA-Based Product Claims

    EPA Science Inventory

    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...

  2. Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

    PubMed Central

    2014-01-01

    Background Metastatic castration-resistant prostate cancer (mCRPC) and its treatment significantly affect health-related quality of life (HRQOL). Our objectives were to evaluate and compare patient-reported outcome (PRO) claims granted by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for 5 recently approved mCRPC treatments and to examine key characteristics, development, and measurement properties of the PRO measures supporting these claims against current regulatory standards. Methods Five products approved for treatment of mCRPC by the FDA and the EMA (2010–2013) were examined: enzalutamide, abiraterone, sipuleucel-T, cabazitaxel, and radium Ra 223 dichloride. United States (US) drug approval packages and European Public Assessment Reports were reviewed. PRO claims in the US labels and European Summaries of Product Characteristics and supporting measures were identified. For PRO measures supporting claims, a targeted literature review was conducted to identify information on key characteristics and measurement properties; this information was compared against FDA PRO guidance criteria. Results Nine PRO “claims” were granted across 4 of 5 products reviewed. The EMA granted more claims (7 claims—4 for pain, 3 for HRQOL) than the FDA (2 claims, both for pain). The Brief Pain Inventory–Short Form (BPI-SF) worst pain item supported most pain claims and was the only measure supporting US claims. EMA pain claims were supported by BPI-SF worst pain (n = 2) and average pain (n = 1) items and the McGill Pain Questionnaire Present Pain Intensity component (n = 1). EMA HRQOL claims were supported by the Functional Assessment of Cancer Therapy–Prostate Module (n = 2) and the EuroQol 5 Dimensions with visual analogue scale (n = 1). Pain and prostate cancer–specific HRQOL measures supporting claims met US regulatory standards for construct validity, reliability, and responsiveness; these properties were strongest

  3. Consumers' knowledge, understanding, and attitudes toward health claims on food labels.

    PubMed

    Fullmer, S; Geiger, C J; Parent, C R

    1991-02-01

    The purpose of this study was to assess consumers' knowledge of current fiber recommendations and their attitudes, understanding, and awareness of health claims on breakfast cereal labels. An incidental sample of 241 respondents was drawn from four grocery stores of a local chain in Utah. Data were collected using a computerized interviewing system. The results suggested that consumers with higher education levels had a better understanding of diet-disease-related messages and a more positive attitude toward health messages on food labels. Knowledge of fiber was significantly correlated with positive attitudes toward health messages and understanding of health messages. Overall, attitudes toward placing diet-disease-related messages on food labels were positive. On a scale of 1 through 250, the mean score was 182.5 +/- 37.5 standard deviation (73%). Consumer knowledge of fiber was low. Out of 15 possible points, the mean score for fiber knowledge questions was 8.8 +/- 2.1 (59%). Consumers were more familiar with the role fiber may play in the prevention or treatment of certain diseases or conditions than with sources, classifications, and recommended intakes of fiber. Understanding of health messages was relatively low (45%). Whereas consumer attitudes toward health messages on food labels were positive, consumers (especially less-educated consumers) did not appear to understand the messages well. These results reiterate the concern for public policymakers to exercise caution and ensure that health messages on food labels are responsible and accurate. The results should also remind dietetic practitioners, who are the nutrition experts, of their continual role in providing and ensuring accurate nutrition education to the public.

  4. The role of nutrition labels and advertising claims in altering consumers' evaluation and choice.

    PubMed

    Bialkova, Svetlana; Sasse, Lena; Fenko, Anna

    2016-01-01

    Despite policy efforts, consumers' well-informed healthful choice is a challenge. Due to increasing number of benefit claims advertising taste or health front of pack (FOP), consumers face the dilemma to trade taste for health. To understand the mechanisms underlying food evaluation, this study investigates the health-pleasure trade-off and its effect on consumers' choice. 240 EU consumers took part in a taste experiment, after being presented with the product FOP. Half of the products carried a nutrition label FOP, respectively, reduced fat for potato chips, reduced sugar for cereal bars. Further, one third of the products carried health benefit claim, one third taste benefit claim, and one third no additional claim FOP. Attention to information and its effect on experienced taste, health perception and the buying intention were measured. The results show that the message displayed FOP altered consumers evaluation and choice. The effectiveness of the FOP message further depended on consumers' health motivation and the healthfulness perception of carrier products. The outcomes are summarized in a framework of health-pleasure trade-off. Current findings call for the establishment of standards to avoid the use of misleading information FOP. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. Electronic Submission of Labels

    EPA Pesticide Factsheets

    Pesticide registrants can provide draft and final labels to EPA electronically for our review as part of the pesticide registration process. The electronic submission of labels by registrants is voluntary but strongly encouraged.

  6. FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

    PubMed

    Drum, Bruce

    2004-01-01

    The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device.

  7. Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

    PubMed

    Revicki, Dennis A; Gnanasakthy, Ari; Weinfurt, Kevin

    2007-05-01

    The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints.

  8. Health claim evidence requirements in Japan.

    PubMed

    Yamada, Kazuhiko; Sato-Mito, Natsuko; Nagata, Junichi; Umegaki, Keizo

    2008-06-01

    In the early 1980s the Japanese scientific academy defined a functional food as a food having a tertiary or physiologically active function. The current Japanese "Food with Health Claims" include 2 categories. For the first category, "Food with Nutrient Function Claims," the label may be freely used if a product satisfies the standard for the minimum and maximum levels per daily portion usually consumed. The second category is defined as "Food for Specified Health Uses" (FOSHU). FOSHU foods are those that contain dietary ingredients that have beneficial effects on the physiological functions of the human body, maintain and promote health, and improve health-related conditions. Health claims on these foods correspond to the category of "other" function claims of the Codex Alimentarius. However, claims of disease-risk reduction are not currently allowed under FOSHU with an exception for calcium and folic acid. Manufacturers can emphasize the characteristics of their products and promote sales by labeling or claims. Therefore, the labeling should be clear and correct and avoid any chance of misinterpretation. The labeling of health claims on foods should always be based on scientific evidence. Any manufacturer who applies to the government for approval under the FOSHU code for its product must tabulate both published available publications and internal reports on the effectiveness of the product and/or its ingredients and provide a summary of each available publication or report. The tabulation must include in vitro metabolic and biochemical studies, in vivo studies, and randomized controlled trials on Japanese people. The overall philosophy of the Ministry is to maintain and improve the health status of people and to prevent chronic noncommunicable diseases through an approach that involves a well-balanced diet as well as through the use of "health foods" including "Food with Health Claims."

  9. Development of functional agricultural products utilizing the new health claim labeling system in Japan.

    PubMed

    Maeda-Yamamoto, Mari; Ohtani, Toshio

    2018-04-01

    In April 2015, Consumer Affairs Agency of Japan launched a new food labeling system known as "Foods with Function Claims (FFC)." Under this system, the food industry independently evaluates scientific evidence on foods and describes their functional properties. As of May 23, 2017, 1023 FFC containing 8 fresh foods have been launched. Meanwhile, to clarify the health-promoting effects of agricultural products, National Agriculture and Food Research Organization (NARO) implemented the "Research Project on Development of Agricultural Products" and demonstrated the risk reduction of osteoporosis of β-cryptoxanthin rich Satsuma mandarins and the anti-allergic effect of the O-methylated catechin rich tea cultivar Benifuuki. These foods were subsequently released as FFC. Moreover, NARO elucidated the health-promoting effects of various functional agricultural products (β-glucan rich barley, β-conglycinin rich soybean, quercetin rich onion, etc.) and a healthy boxed lunch. This review focuses on new food labeling system or research examining functional aspects of agricultural products.

  10. 78 FR 47154 - Food Labeling; Gluten-Free Labeling of Foods

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-05

    ...The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ``gluten-free'' for voluntary use in the labeling of foods. The final rule defines the term ``gluten-free'' to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ``no gluten,'' ``free of gluten,'' or ``without gluten'' in its labeling and fails to meet the requirements for a ``gluten-free'' claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ``wheat'' in the ingredient list or in a separate ``Contains wheat'' statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ``gluten-free'' will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ``gluten-free'' claim. Establishing a definition of the term ``gluten-free'' and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

  11. 40 CFR 152.108 - Review of labeling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Review of labeling. 152.108 Section... PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Agency Review of Applications § 152.108 Review of labeling. The Agency will review all draft labeling submitted with the application. If an applicant for...

  12. The regulation of patient-reported outcome claims: need for a flexible standard.

    PubMed

    Morris, Louis A; Miller, David W

    2002-01-01

    We review the FDA's policies for the regulation of patient-reported outcome (PRO) claims such as quality of life, productivity, satisfaction and symptom reports and suggest alternative standards for substantiation. We base our review on FDA regulatory activities and public statements in the field of advertising substantiation. We compare these activities to the FDA's label substantiation policies and policies for health-economic (HE) claim substantiation. There is an overt inconsistency between the FDA's policies for substantiation of PRO claims in product labels and substantiation for such claims in advertising materials. This results in a higher standard for PRO claims in promotional vehicles than in product labels. Rather than relying on a "substantial evidence" standard, the FDA should consider a more flexible standard, such as the one currently applied to information included in the Clinical Trials section of product labels, or adopting a "competent and reliable scientific evidence" standard as set forth in Section 114 of the Food and Drug Administration Modernization Act (FDAMA) for HE data. We conclude that there needs to be greater consistency for substantiation in product labels and promotional materials. Furthermore, reconceptualizing most PRO claims as benefit extrapolations as opposed to efficacy information suggests a less rigorous standard is necessary.

  13. 9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

  14. 9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

  15. 9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

  16. 9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

  17. 16 CFR 460.21 - Government claims.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

  18. 16 CFR 460.21 - Government claims.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

  19. 16 CFR 460.21 - Government claims.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

  20. 16 CFR 460.21 - Government claims.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

  1. 16 CFR 460.21 - Government claims.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

  2. Scenario-Testing: Decision Rules for Evaluating Conflicting Probabilistic Claims.

    ERIC Educational Resources Information Center

    Dudczak, Craig A.; Baker, David

    Evaluators of argument are frequently confronted by conflicting claims. While these claims are usually based on probabilities, they are often resolved with the accepted claim treated as though it were "true," while the rejected claim is treated as though it were "false." Scenario testing is the label applied to a set of…

  3. 9 CFR 412.1 - Label approval.

    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...

  4. Naturally good: Front-of-package claims as message cues.

    PubMed

    Skubisz, Christine

    2017-01-01

    Excess bodyweight is a significant public health problem in the United States, increasing the risk of adverse health conditions including hypertension, diabetes, heart disease, stroke, and cancer. Americans are consuming more calories than their bodies need each day and making purchasing decisions using heuristic cues, rather than caloric information. A recent trend in food and beverage labeling is the placement of a natural claim on a product's package. Unfortunately, the United States has not established clear requirements for natural claims and manufacturers are using this term liberally. Using models of information processing as a framework, the goal of this study was to predict the effects of natural claims on message processing and evaluations. It was predicted that natural claims would be perceived as heuristics for healthfulness. A 6 (product) x 2 (claim) experimental design was carried out. Support for the prediction that natural labeled products are evaluated as more healthful was found. Despite the fact that natural products contained the same number of calories as their regular counterparts, participants estimated that natural products contained 18% fewer calories. Implications of these findings for food labeling and public health are discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. 16 CFR 460.22 - Tax claims.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Tax claims. 460.22 Section 460.22 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.22 Tax claims. Do not say or imply that your product qualifies for a tax benefit unless it is true. ...

  6. 16 CFR 460.22 - Tax claims.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Tax claims. 460.22 Section 460.22 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.22 Tax claims. Do not say or imply that your product qualifies for a tax benefit unless it is true. ...

  7. A tale of three labels: translating the JUPITER trial data into regulatory claims.

    PubMed

    Ridker, Paul M

    2011-08-01

    Whether a pivotal randomized trial will be interpreted in a similar and consistent manner by different regulatory agencies is uncertain as policy perspectives may play a role in data interpretation and the translation of trial results into clinical practice. Using a contemporary example, to compare and contrast regulatory claims in the United States, Europe, and Canada that derive from a pivotal clinical trial. The recently completed JUPITER trial of rosuvastatin as compared to placebo conducted among 17,802 men and women with LDL-C <130 mg/dL and hsCRP ≥ 2 mg/L, provides the only available data on rosuvastatin for primary prevention of cardiovascular disease. Thus, the JUPITER trial provides an opportunity to compare and contrast how regulatory agencies in the United States, Canada, and Europe chose to interpret an identical database. Labeling indications based on earlier statin trials of primary and secondary prevention were also reviewed. JUPITER demonstrated a 44% reduction (p < 0.000001) in the trial pre-specified primary endpoint (nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, coronary revascularization, or cardiovascular death) with no evidence of heterogeneity across geographic regions. In response to these data, the US Food and Drug Administration label for rosuvastatin in primary prevention came closest to the actual JUPITER trial population by stipulating that those eligible for treatment should be older men and women with hsCRP >2 mg/L, plus one additional risk factor for heart disease. The Canadian label is silent on age and hsCRP (the major trial inclusion criterion), stipulating instead that treatment can be considered for those with 'at least two conventional risk factors for cardiovascular disease,' a group more inclusive than that studied. In contrast, the European Medicines Agency label limits treatment only to 'high risk individuals' ignoring hsCRP and using instead a post hoc definition of 'high risk

  8. 16 CFR 260.11 - Ozone-safe and ozone-friendly claims.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Ozone-safe and ozone-friendly claims. 260.11... THE USE OF ENVIRONMENTAL MARKETING CLAIMS § 260.11 Ozone-safe and ozone-friendly claims. It is... friendly to, the ozone layer or the atmosphere. Example 1: A product is labeled “ozone-friendly.” The claim...

  9. 16 CFR 260.11 - Ozone-safe and ozone-friendly claims.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Ozone-safe and ozone-friendly claims. 260.11... THE USE OF ENVIRONMENTAL MARKETING CLAIMS § 260.11 Ozone-safe and ozone-friendly claims. It is... friendly to, the ozone layer or the atmosphere. Example 1: A product is labeled “ozone-friendly.” The claim...

  10. A Critical Review of the Marketing Claims of Infant Formula Products in the United States.

    PubMed

    Belamarich, Peter F; Bochner, Risa E; Racine, Andrew D

    2016-05-01

    A highly competitive infant formula market has resulted in direct-to-consumer marketing intended to promote the sale of modified formulas that claim to ameliorate common infant feeding problems. The claims associated with these marketing campaigns are not evaluated with reference to clinical evidence by the Food and Drug Administration. We aimed to describe the language of claims made on formula labels and compare it with the evidence in systematic reviews. Of the 22 product labels we identified, 13 product labels included claims about colic and gastrointestinal symptoms. There is insufficient evidence to support the claims that removing or reducing lactose, using hydrolyzed or soy protein or adding pre-/probiotics to formula benefits infants with fussiness, gas, or colic yet claims like "soy for fussiness and gas" encourage parents who perceive their infants to be fussy to purchase modified formula. Increased regulation of infant formula claims is warranted. © The Author(s) 2015.

  11. 9 CFR 317.360 - Nutrient content claims for calorie content.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrient content claims for calorie content. 317.360 Section 317.360 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.360 Nutrient content claims for calorie content. (a) General requirements. A claim about the...

  12. 21 CFR 101.14 - Health claims: general requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

  13. 21 CFR 101.14 - Health claims: general requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

  14. 21 CFR 101.14 - Health claims: general requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

  15. 21 CFR 101.14 - Health claims: general requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

  16. 21 CFR 101.70 - Petitions for health claims.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

  17. 21 CFR 101.70 - Petitions for health claims.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

  18. 21 CFR 101.70 - Petitions for health claims.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

  19. 21 CFR 101.70 - Petitions for health claims.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

  20. 21 CFR 101.70 - Petitions for health claims.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

  1. Oncology patient-reported claims: maximising the chance for success.

    PubMed

    Kitchen, H; Rofail, D; Caron, M; Emery, M-P

    2011-01-01

    To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. "…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo") and equivalence (e.g. "no statistical differences were observed between treatment groups for global QoL"). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired language, claim, and target population are required. Practical

  2. 75 FR 14418 - Codex Alimentarius Commission: Meeting of the Codex Committee on Food Labeling

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

    ...) Proposed Draft Criteria and Principles for Legibility and Readability of Nutrition Labels (d) Discussion..., Physical Activity, and Health Guidelines for the Production, Processing, Labeling and Marketing of...

  3. 9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrient content claims for âgood... Nutrition Labeling § 317.354 Nutrient content claims for “good source,” “high,” and “more.” (a) General... nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in...

  4. 9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrient content claims for âgood... Nutrition Labeling § 381.454 Nutrient content claims for “good source,” “high,” and “more.” (a) General... nutrient content claims in § 381.413; and (3) The product for which the claim is made is labeled in...

  5. 21 CFR 101.65 - Implied nutrient content claims and related label statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with... the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that...

  6. 21 CFR 101.65 - Implied nutrient content claims and related label statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with... the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that...

  7. 21 CFR 101.65 - Implied nutrient content claims and related label statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with... the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that...

  8. Nutrition labelling: purpose, scientific issues and challenges.

    PubMed

    Van den Wijngaart, Annoek W E M

    2002-01-01

    Nutrition labels describe the nutrient content of a food and are intended to guide the consumer in food selection. The nutrition information provided must be selected on the basis of consistency with dietary recommendations. Selection of the specific nutrients or food components to be listed should further take into account label space, the analytical feasibility of measuring the particular nutritional component within the food matrix, and the relative costs of such analyses. Nutrition information provided on labels should be truthful and not mislead consumers. At the same time, labelling regulations should provide incentives to manufacturers to develop products that promote public health and assist consumers in following dietary recommendations. It is likely that in many countries, there would be some segments of the population that would benefit from information about the composition of foods. In these cases, countries should consider the need to provide for appropriate labelling and its presentation relative to existing guidelines and approaches. As nutrition-labelling efforts have evolved, different approaches and legal requirements have been established. These create difficulties in developing and harmonizing nutrition information listings, which have broad international applications. For these reasons, the Codex Guidelines on Nutrition Labeling play an important role to provide guidance to member countries when they want to develop or update their national regulations and to encourage harmonization of national standards with international standards. These Guidelines are based on the principle that no food should be described or presented in a manner that is false, misleading or deceptive. The Guidelines include provisions for voluntary nutrient declaration, calculation and presentation of nutrient information. The Guidelines on Claims establish general principles to be followed and leave the definition of specific claims to national regulations. Definitions

  9. 21 CFR 101.74 - Health claims: sodium and hypertension.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: sodium and hypertension. 101.74 Section 101.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.74 Health...

  10. 21 CFR 101.74 - Health claims: sodium and hypertension.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Health claims: sodium and hypertension. 101.74 Section 101.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.74 Health...

  11. Functional Drafting, Drafting--Intermediate: 9255.02.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course consists of six instructional blocks totaling 135 clock hours: (1) functional drafting, (2) threads and fasteners, (3) pictorial drawings, (4) introduction to electronic drafting, (5) introduction to piping drafting, and (6) Quinmester posttest. Mastery of skills indicated in Drafting-Basic--9255.01 is a prerequisite. In the functional…

  12. 9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 381.413; and (3) The product for which the claim is made is labeled in accordance with § 381.409. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

  13. 9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

  14. 9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

  15. 9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 381.413; and (3) The product for which the claim is made is labeled in accordance with § 381.409. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

  16. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ...] Draft Guidance for Industry and FDA Staff: Processing/ Reprocessing Medical Devices in Health Care... Devices in Health Care Settings: Validation Methods and Labeling.'' The recommendations in this guidance... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling...

  17. Comparison of the nutritional content of products, with and without nutrient claims, targeted at children in Brazil.

    PubMed

    Rodrigues, Vanessa Mello; Rayner, Mike; Fernandes, Ana Carolina; de Oliveira, Renata Carvalho; Proença, Rossana Pacheco da Costa; Fiates, Giovanna Medeiros Rataichesck

    2016-06-01

    Many children's food products highlight positive attributes on their front-of-package labels in the form of nutrient claims. This cross-sectional study investigated all retailed packaged foods (n 5620) in a major Brazilian supermarket, in order to identify the availability of products targeted at children, and to compare the nutritional content of products with and without nutrient claims on labels. Data on energy, carbohydrate, protein, fibre, Na and total and SFA content, along with the presence and type of nutrient claims, were obtained in-store from labels of all products. Products targeted at children were identified, divided into eight food groups and compared for their nutritional content per 100 g/ml and the presence of nutrient claims using the Mann-Whitney U test (P<0·05). Of the 535 food products targeted at children (9·5 % of all products), 270 (50·5 %) displayed nutrient claims on their labels. Children's products with nutrient claims had either a similar or worse nutritional content than their counterparts without nutrient claims. The major differences among groups were found in Group 8 (e.g. sauces and ready meals), in which children's products bearing nutrient claims had higher energy, carbohydrate, Na and total and SFA content per 100 g/ml than products without nutrient claims (P<0·05). This suggests that, to prevent misleading parents who are seeking healthier products for their children, the regulation on the use of nutrient claims should be revised, so that only products with appropriate nutrient profiles are allowed to display them.

  18. Consumer perceptions of graded, graphic and text label presentations for qualified health claims.

    PubMed

    Kapsak, Wendy Reinhardt; Schmidt, David; Childs, Nancy M; Meunier, John; White, Christy

    2008-03-01

    On December 18, 2002, the Food and Drug Administration (FDA) announced the Consumer Health Information for Better Nutrition Initiative. The initiative's goal is to make available more and better information about conventional foods and dietary supplements to help Americans improve their health and reduce risk of disease by making sound dietary decisions. It included a rating system to assess the "weight of the publicly available evidence." It assigns one of four ranked levels to the claim thus resulting in qualified health claims. Two phases of research were conducted by the International Food Information Council (IFIC) Foundation. Qualitative research to assess consumer understanding, vocabulary, and familiarity with claims helped with the design and orientation of the second quantitative research phase. The quantitative phase employed a Web-based survey. The claim formats included: report card graphic, report card text, embedded claim text, point-counterpoint, structure/function claim, and nutrient content claim. Respondents were asked to rate the product for perceived strength of scientific evidence provided to support the claim, and questions about the product's perceived healthfulness, quality, safety, and purchase intent. Consumers found it difficult to discriminate across four levels and showed inclination to project the scientific validity grade onto other product attributes. Consumers showed preference for simpler messages.

  19. Drafting Fundamentals. Drafting Module 1. Instructor's Guide.

    ERIC Educational Resources Information Center

    Missouri Univ., Columbia. Instructional Materials Lab.

    This Missouri Vocational Instruction Management System instructor's drafting guide has been keyed to the drafting competency profile developed by state industry and education professionals. The guide contains a cross-reference table of instructional materials. Ten units cover drafting fundamentals: (1) introduction to drafting; (2) general safety;…

  20. Oncology patient-reported claims: maximising the chance for success

    PubMed Central

    Kitchen, H; Rofail, D; Caron, M; Emery, M-P

    2011-01-01

    Objectives/purpose: To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. Methods: PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Results: Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. “…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo”) and equivalence (e.g. “no statistical differences were observed between treatment groups for global QoL”). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. Conclusions: PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired

  1. 9 CFR 317.309 - Nutrition label content.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

  2. 9 CFR 317.309 - Nutrition label content.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... only through a weight-control program qualify for nutrition claims. (3) The declaration of nutrient and...

  3. 9 CFR 317.309 - Nutrition label content.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... only through a weight-control program qualify for nutrition claims. (3) The declaration of nutrient and...

  4. 9 CFR 317.309 - Nutrition label content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

  5. Are foods with fat-related claims useful for weight management?

    PubMed

    Schermel, Alyssa; Wong, Christina L; L'Abbé, Mary R

    2016-01-01

    Many consumers believe that foods labelled with fat claims (e.g. low fat) are lower in calories than comparable regular foods and are therefore helpful for weight management. However, it is unknown whether such foods are actually lower in calories. Our aims were to determine 1) the relative proportion of foods carrying fat claims among various food categories within the Canadian marketplace; and 2) whether foods with fat claims are actually lower in calories than comparable foods without claims. The Food Label Information Program 2010, a database of Canadian foods developed at the University of Toronto, was used to compare the calorie content of products with and without fat claims within a given food subcategory, as defined by Schedule M of the Food and Drug Regulations. Median differences of 25% or greater were deemed nutritionally significant, as that is the minimum difference required for comparative claims such as "reduced" and "lower" in the Food and Drug Regulations. Fat claims were present on up to 68% of products in a given food subcategory. Products with fat claims were not significantly lower in both fat and calories compared to comparable products without fat claims in more than half of the subcategories (24 out of 40) analyzed. Conversely, in 16 subcategories, foods with fat claims were at least 25% lower in calories; however, for many of these foods, the absolute difference in calories was small, i.e., for 9 of the 16 subcategories, the absolute difference between foods with and without fat claims was <50 calories, even though the relative percent difference was high. This research suggests that foods with fat claims may be misleading consumers and undermining their efforts to manage body weight or prevent obesity. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. International investment agreements and public health: neutralizing a threat through treaty drafting

    PubMed Central

    2014-01-01

    Abstract The high profile investment claims filed by Philip Morris challenging Uruguayan and Australian measures that restrict advertising and logos on tobacco packaging awakened the public health community to the existence and potential detrimental impact of international investment agreements (IIAs). More recently, Eli Lilly challenged Canada’s invalidation of a pharmaceutical patent under an IIA. All of the cases claim that the intellectual property rights of the investor were infringed. As a result of these cases, many commentators and activists view IIAs as a threat to public health and have lobbied against their inclusion in ongoing trade negotiations. This article does not argue against IIAs. Instead, it seeks to demonstrate how more sophisticated treaty drafting can neutralize the threat to public health. In this regard, the article seeks to engage members of the public health community as campaigners not against IIAs but as advocates of better treaty drafting to ensure that IIAs do not infringe upon the right of a nation to take non-discriminatory measures for the promotion and protection of the health of their populations. PMID:25110377

  7. International investment agreements and public health: neutralizing a threat through treaty drafting.

    PubMed

    Mercurio, Bryan

    2014-07-01

    The high profile investment claims filed by Philip Morris challenging Uruguayan and Australian measures that restrict advertising and logos on tobacco packaging awakened the public health community to the existence and potential detrimental impact of international investment agreements (IIAs). More recently, Eli Lilly challenged Canada's invalidation of a pharmaceutical patent under an IIA. All of the cases claim that the intellectual property rights of the investor were infringed. As a result of these cases, many commentators and activists view IIAs as a threat to public health and have lobbied against their inclusion in ongoing trade negotiations. This article does not argue against IIAs. Instead, it seeks to demonstrate how more sophisticated treaty drafting can neutralize the threat to public health. In this regard, the article seeks to engage members of the public health community as campaigners not against IIAs but as advocates of better treaty drafting to ensure that IIAs do not infringe upon the right of a nation to take non-discriminatory measures for the promotion and protection of the health of their populations.

  8. Toward improved pregnancy labelling.

    PubMed

    Koren, Gideon; Sakaguchi, Sachi; Klieger, Chagit; Kazmin, Alex; Osadchy, Alla; Yazdani-Brojeni, Parvaneh; Matok, Ilan

    2010-01-01

    Information about the use of a medication in pregnancy is part of overall drug labelling as prepared by the pharmaceutical company and approved by the regulators. It is aimed at assisting clinicians in prescribing, however, very few drugs are labelled for specific indications in pregnancy, since there is rarely information about the use of a drug in this condition. Recently the FDA has drafted new guidelines for the labeling of drugs in pregnancy and breastfeeding, to replace the A,B,C,D,X system that was used for more than 30 years. Here we document the use of the new system through 3 different medications; each representing a different clinical situation in pregnancy--acute infection, chronic pain, and drug use during labor. Advantages and challenges in the new system are being highlighted.

  9. Korean consumers' perceptions of health/functional food claims according to the strength of scientific evidence

    PubMed Central

    Kim, Ji Yeon; Kang, Eun Jin; Kwon, Oran

    2010-01-01

    In this study, we investigated that consumers could differentiate between levels of claims and clarify how a visual aid influences consumer understanding of the different claim levels. We interviewed 2,000 consumers in 13 shopping malls on their perception of and confidence in different levels of health claims using seven point scales. The average confidence scores given by participants were 4.17 for the probable level and 4.07 for the possible level; the score for the probable level was significantly higher than that for the possible level (P < 0.05). Scores for confidence in claims after reading labels with and without a visual aid were 5.27 and 4.43, respectively; the score for labeling with a visual aid was significantly higher than for labeling without a visual aid (P < 0.01). Our results provide compelling evidence that providing health claims with qualifying language differentiating levels of scientific evidence can help consumers understand the strength of scientific evidence behind those claims. Moreover, when a visual aid was included, consumers perceived the scientific levels more clearly and had greater confidence in their meanings than when a visual aid was not included. Although this result suggests that consumers react differently to different claim levels, it is not yet clear whether consumers understand the variations in the degree of scientific support. PMID:21103090

  10. Updated Draft Protocol for the Evaluation of Bactericidal Activity of Hard, Non-porous Copper Containing Surface Products

    EPA Pesticide Factsheets

    This document describes the updated draft testing protocol recommended by the EPA to support the registration of copper-containing surface products (such as door knobs, or other items that are not intended for food contact) that bear sanitizer claims.

  11. 21 CFR 101.67 - Use of nutrient content claims for butter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

  12. 21 CFR 101.67 - Use of nutrient content claims for butter.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

  13. 21 CFR 101.67 - Use of nutrient content claims for butter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

  14. 21 CFR 101.67 - Use of nutrient content claims for butter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

  15. Influence of Food Labels on Adolescent Diet.

    ERIC Educational Resources Information Center

    Misra, Ranjita

    2002-01-01

    Provides information on food nutrition labels and discusses the benefits of adolescents' using them to plan healthy diets. Suggests that teachers and educators should encourage appropriate label reading education for adolescents to promote healthy eating practices. Provides definitions of nutrient content claims. (SG)

  16. Composition, disintegrative properties, and labeling compliance of commercially available taurine and carnitine dietary products.

    PubMed

    Bragg, Rebecca R; Freeman, Lisa M; Fascetti, Andrea J; Yu, Zengshou

    2009-01-15

    To test the quality, disintegration properties, and compliance with labeling regulations for representative commercially available taurine and carnitine dietary products. Evaluation study. 11 commercially available taurine and 10 commercially available carnitine products. For each product, the amount of taurine or carnitine was determined and compared with the label claim. All products were evaluated for concentrations of mercury, arsenic, and selenium. Disintegration properties of 5 taurine and 8 carnitine products were determined in vitro. Labels were evaluated for compliance with FDA guidelines. 10 of 11 taurine and 10 of 10 carnitine products were within 10% of the stated label claim. Three of 11 taurine and 6 of 10 carnitine products were within 5% of the stated label claim. The median percentage difference between laboratory analysis and label claim was -5.7% (range, -26.3% to 2.5%) for taurine and 3.6% (range, -2.6% to 8.8%) for carnitine. No substantial amount of contamination with mercury, arsenic, or selenium was found in any of the products. During disintegration testing, 1 of 5 taurine products and 5 of 8 carnitine products did not disintegrate within 45 minutes during at least 1 test. Disintegration time for those that did disintegrate ranged from 1.7 to 37.0 minutes. All product labels conformed with FDA regulations. Taurine and carnitine products evaluated in this study closely adhered to manufacturer claims and labeling guidelines. However, disintegration testing suggested high variability in some products, possibly limiting uptake and use by animals that receive them.

  17. The Basis of Structure/Function Claims of Nutraceuticals.

    PubMed

    Borchers, Andrea T; Keen, Carl L; Gershwin, M Eric

    2016-12-01

    In the United States, as in most of the world, there are large numbers of nutraceuticals that are sold and which people take to boost their immune response. There are, in addition, almost an equal number of products sold to reduce allergies. However, very few consumers, and indeed physicians, are aware of what a structure/function claim is. Structure/function claims are labeling claims that can be used to describe the potential effects of a dietary ingredient or similar substance on the structure or function of the human body. This category of claims was created by legislation contained in the Dietary Supplement Health and Education Act. The intent was to supply consumers with reasonably substantiated information that would allow them to make educated choices about their diet and health. They were not intended to have the same weight and substantiation as the claims made for conventional prescription pharmaceuticals. Rather, they were proposed to fill the gap between consumer desire for over-the-counter supplements and foods, and rigorous and generally more potent and potentially "toxic" prescription medications. The legally mandated disclaimer, stating that the U.S. Food and Drug Administration has not evaluated the structure/function claim, often leads to misinterpretation. While there should be a biologic premise underlying the claim, there is not an absolute requirement for a conventional rigorous placebo-controlled dose response trial. While this may not be the clinical standard that a typical scientific oriented society might desire, it reflects the attempts of the FDA to find common grounds and to allow consumers to use products that are generally considered as safe based on historical use and biologic comparisons. The logic of, indeed need for, structure/function claims is straightforward; however, of equal importance is that nutraceuticals should be properly labeled, have accuracy in their ingredients, be free of contamination, be safe, and have a

  18. 9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be... fat. (iv) A synonym for “___ percent fat free” is “___ percent lean.” (c) Fatty acid content claims...

  19. 9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be.... (iv) A synonym for “___ percent fat free” is “___ percent lean.” (c) Fatty acid content claims. (1...

  20. Consumer attitudes and understanding of cholesterol-lowering claims on food: randomize mock-package experiments with plant sterol and oat fibre claims.

    PubMed

    Wong, C L; Mendoza, J; Henson, S J; Qi, Y; Lou, W; L'Abbé, M R

    2014-08-01

    Few studies have examined consumer acceptability or comprehension of cholesterol-lowering claims on food labels. Our objective was to assess consumer attitudes and understanding of cholesterol-lowering claims regarding plant sterols (PS) and oat fibre (OF). We conducted two studies on: (1) PS claims and (2) OF claims. Both studies involved a randomized mock-packaged experiment within an online survey administered to Canadian consumers. In the PS study (n=721), we tested three PS-related claims (disease risk reduction claim, function claim and nutrient content claim) and a 'tastes great' claim (control) on identical margarine containers. Similarly, in the OF study (n=710), we tested three claims related to OF and a 'taste great' claim on identical cereal boxes. In both studies, participants answered the same set of questions on attitudes and understanding of claims after seeing each mock package. All claims that mentioned either PS or OF resulted in more positive attitudes than the taste control claim (P<0.0001), despite all products within each study having the same nutrition profile. How consumers responded to the nutrition claims between the two studies was influenced by contextual factors such as familiarity with the functional food/component and the food product that carried the claim. Permitted nutrition claims are approved based on physiological evidence and are allowed on any food product as long as it meets the associated nutrient criteria. However, it is difficult to generalize attitudes and understanding of claims when they are so highly dependent on contextual factors.

  1. Consumers' Exposure to Nutrition and Health Claims on Pre-Packed Foods: Use of Sales Weighting for Assessing the Food Supply in Slovenia.

    PubMed

    Pravst, Igor; Kušar, Anita

    2015-11-12

    Insights into the use of health-related information on foods are important for planning studies about the effects of such information on the consumer's understanding, purchasing, and consumption of foods, and also support further food policy decisions. We tested the use of sales data for weighting consumers' exposure to health-related labeling information in the Slovenian food supply. Food labeling data were collected from 6342 pre-packed foods available in four different food stores in Slovenia. Consumers' exposure was calculated as the percentage of available food products with particular food information in the food category. In addition, 12-month sales data were used to calculate sales weighted exposure as a percentage of sold food products with certain food information in the food category. The consumer's in-store and sales-weighted exposure to nutrition claims was 37% and 45%, respectively. Exposure to health claims was much lower (13%, 11% when sales-weighted). Health claims were mainly found in the form of general non-specific claims or function claims, while children's development and reduction of disease risk claims were present on only 0.1% and 0.2% of the investigated foods, respectively. Sales data were found very useful for establishing a reliable estimation of consumers' exposure to information provided on food labels. The high penetration of health-related information on food labels indicates that careful regulation of this area is appropriate. Further studies should focus on assessing the nutritional quality of foods labeled with nutrition and health claims, and understanding the importance of such labeling techniques for consumers' food preferences and choices.

  2. 21 CFR 101.82 - Health claims: Soy protein and risk of coronary heart disease (CHD).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: Soy protein and risk of coronary... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.82 Health claims: Soy protein and risk of coronary heart disease (CHD). (a...

  3. 9 CFR 381.409 - Nutrition label content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

  4. 9 CFR 381.409 - Nutrition label content.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... that are available only through a weight-control program qualify for nutrition claims. (3) The...

  5. 9 CFR 381.409 - Nutrition label content.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

  6. 9 CFR 381.409 - Nutrition label content.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... that are available only through a weight-control program qualify for nutrition claims. (3) The...

  7. An Assessment of the Political and Social Feasibility of a Peacetime Draft

    DTIC Science & Technology

    1988-12-01

    exists, individuals who possess the most lucrative job opportunities would be expected "to spend more to avoid payment of the conscript tax ." [Ref. 12...7 c. Social Equity --...- .....-.--.-..............--------- ----------- 8 2. The Draft and the Conscription Tax ------------------ 9 3. The AVF and...47 c. William Blackstone - ----------- ---------------47 3. The Erosion of Popular Acceptance of a Call to Arms------ 47 a. The Military Claim

  8. Evaluating promotional claims as false or misleading.

    PubMed

    Brushwood, David B; Knox, Caitlin A; Liu, Wei; Jenkins, Kevin A

    2013-11-01

    In light of the "false or misleading" standard resulting from the recent legal ruling, it can be concluded that a true claim is one that is both factually and analytically true. Factual truth could be based on the accuracy of the information and the sufficiency of the information. Analytical truth could be based on the scientific foundation for the claim and whether the information within the claim is presented in a balanced way. Regarding the assessment of whether a truthful claim is misleading, the evaluator could consider the relevance, consistency, and context of the information. Standards are important in medication use and medication regulation. Health care professionals who must decide whether a claim is truthful and not misleading will rely on guidance from FDA in determining how to evaluate promotional claims. As the court suggested in the case reviewed here, FDA could take the lead and provide guidance "in differentiating between misleading and false promotion, exaggerations and embellishments, and truthful or non-misleading information." Existing FDA regulations provide a foundation for such guidance. The next step for the agency would be to expand existing guidance to specifically describe how an off-label claim can be identified as either false or misleading.

  9. Medical-legal issues in headache: penal and civil Italian legislation, working claims, social security, off-label prescription.

    PubMed

    Aguggia, M; Cavallini, M; Varetto, L

    2006-05-01

    Primary headaches can be considered simultaneously as symptom and disease itself, while secondary headaches are expressions of a pathological process that can be systemic or locoregional. Because of its subjective features, headache is often difficult to assess and quantify by severity, frequency and invalidity rate, and for these reasons it has often been implicated in legal controversies. Headache has seldom been considered in the criminal law, except when it represents a typical symptom of a disease whose existence can be objectively assessed (i. e. raised intracranial pressure). Therefore, in civil legislation it is not yet coded to start claiming for invalidity compensation. In particular, one of the most debated medical-legal questions is represented by headaches occurring after head injury. Headache is often the principal symptom at the beginning of several toxic chronic syndromes, with many implications, especially in working claims, and, more recently, it may be referred to as one of the most frequent symptoms by victims of mobbing (i. e. psychological harassment in the workplace). The National Institute for Industrial Accident Insurance (INAIL) scales (instituted by the law 38/2000) mention the "Subjective cranial trauma syndrome" and give an invalidity rate evaluation. With reference to other headache forms, no legislation really exists at the present time, and headache is only considered as a symptom of a certain coded disease. Requests for invalidity social pension and the question of off-label prescriptions (drug prescription for a disease, without formal indication for it) are other controversial matters.

  10. 9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

  11. 9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

  12. Consumers’ Exposure to Nutrition and Health Claims on Pre-Packed Foods: Use of Sales Weighting for Assessing the Food Supply in Slovenia

    PubMed Central

    Pravst, Igor; Kušar, Anita

    2015-01-01

    Insights into the use of health-related information on foods are important for planning studies about the effects of such information on the consumer’s understanding, purchasing, and consumption of foods, and also support further food policy decisions. We tested the use of sales data for weighting consumers’ exposure to health-related labeling information in the Slovenian food supply. Food labeling data were collected from 6342 pre-packed foods available in four different food stores in Slovenia. Consumers’ exposure was calculated as the percentage of available food products with particular food information in the food category. In addition, 12-month sales data were used to calculate sales weighted exposure as a percentage of sold food products with certain food information in the food category. The consumer’s in-store and sales-weighted exposure to nutrition claims was 37% and 45%, respectively. Exposure to health claims was much lower (13%, 11% when sales-weighted). Health claims were mainly found in the form of general non-specific claims or function claims, while children’s development and reduction of disease risk claims were present on only 0.1% and 0.2% of the investigated foods, respectively. Sales data were found very useful for establishing a reliable estimation of consumers’ exposure to information provided on food labels. The high penetration of health-related information on food labels indicates that careful regulation of this area is appropriate. Further studies should focus on assessing the nutritional quality of foods labeled with nutrition and health claims, and understanding the importance of such labeling techniques for consumers’ food preferences and choices. PMID:26569301

  13. 9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to... level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of...

  14. 9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to... level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of...

  15. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  16. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 7 2012-10-01 2012-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  17. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  18. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  19. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 7 2013-10-01 2013-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  20. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  1. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 7 2011-10-01 2011-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  2. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  3. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  4. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 7 2014-10-01 2014-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  5. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.

    PubMed

    Boyce, Richard D; Horn, John R; Hassanzadeh, Oktie; Waard, Anita de; Schneider, Jodi; Luciano, Joanne S; Rastegar-Mojarad, Majid; Liakata, Maria

    2013-01-26

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug

  6. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

    PubMed Central

    2013-01-01

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug

  7. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 3 2013-10-01 2013-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  8. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 3 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  9. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 3 2014-10-01 2014-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  10. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 3 2012-10-01 2012-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  11. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 3 2011-10-01 2011-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  12. 16 CFR 460.20 - R-value per inch claims.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

  13. 16 CFR 460.20 - R-value per inch claims.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

  14. 16 CFR 460.20 - R-value per inch claims.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

  15. 16 CFR 460.20 - R-value per inch claims.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

  16. 16 CFR 260.9 - Free-of claims.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... intentionally to the product. Example 1: A package of t-shirts is labeled “Shirts made with a chlorine-free bleaching process.” The shirts, however, are bleached with a process that releases a reduced, but still... substantiated claim, however, that the shirts were “bleached with a process that releases 50% less of the...

  17. 16 CFR 260.9 - Free-of claims.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... intentionally to the product. Example 1: A package of t-shirts is labeled “Shirts made with a chlorine-free bleaching process.” The shirts, however, are bleached with a process that releases a reduced, but still... substantiated claim, however, that the shirts were “bleached with a process that releases 50% less of the...

  18. 77 FR 39710 - Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ...] Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and... Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use... enforcement discretion with regard to the liver warning required in the labeling. DATES: Although you can...

  19. Consumer attitudes and understanding of low-sodium claims on food: an analysis of healthy and hypertensive individuals.

    PubMed

    Wong, Christina L; Arcand, JoAnne; Mendoza, Julio; Henson, Spencer J; Qi, Ying; Lou, Wendy; L'Abbé, Mary R

    2013-06-01

    Sodium-related claims on food labels should facilitate lower-sodium food choices; however, consumer attitudes and understanding of such claims are unknown. We evaluated consumer attitudes and understanding of different types of sodium claims and the effect of having hypertension on responses to such claims. Canadian consumers (n = 506), with and without hypertension, completed an online survey that contained a randomized mock-package experiment, which tested 4 packages that differed only by the claims they carried as follows: 3 sodium claims (disease risk reduction, function, and nutrient-content claims) and a tastes-great claim (control). Participants answered the same questions on attitudes and understanding of claims after seeing each package. Food packages with any sodium claim resulted in more positive attitudes toward the claim and the product healthfulness than did packages with the taste control claim, although all mock packages were identical nutritionally. Having hypertension increased ratings related to product healthfulness and purchase intentions, but there was no difference in reported understanding between hypertensives and normotensives. In general, participants attributed additional health benefits to low-sodium products beyond the well-established relation of sodium and hypertension. Sodium claims have the potential to facilitate lower-sodium food choices. However, we caution that consumers do not seem to differentiate between different types of claims, but the nutritional profiles of foods that carry different sodium claims can potentially differ greatly in the current labeling environment. Additional educational efforts are needed to ensure that consumers do not attribute inappropriate health benefits to foods with low-sodium claims. This trial was registered at clinicaltrials.gov as NCT01764724.

  20. 9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

  1. 9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

  2. 9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

  3. 9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

  4. Drafting--Basic, Drafting--Intermediate: 9255.01.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course has no prerequisites, offers instruction in basic drafting room techniques and procedures, and also covers job opportunities and industrial methods in engineering. The student is introduced to and asked to perform fundamental drafting problems with working drawings, using multiview and auxiliary views and sections. The course also…

  5. Computer Assisted Drafting (CNC) Drawings. Drafting Module 6. Instructor's Guide.

    ERIC Educational Resources Information Center

    Missouri Univ., Columbia. Instructional Materials Lab.

    This Missouri Vocational Instruction Management System instructor's drafting guide has been keyed to the drafting competency profile developed by state industry and education professionals. This unit contains information on computer-assisted drafting drawings. The guide contains a cross-reference table of instructional materials and 20 worksheets.…

  6. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0305] Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  7. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 1 2014-10-01 2014-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  8. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 1 2011-10-01 2011-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  9. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  10. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 1 2013-10-01 2013-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  11. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 1 2012-10-01 2012-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  12. What's in a name: the Vermont Genetically Engineered Food Labeling Act

    PubMed Central

    McPherson, Malia J.

    2014-01-01

    On May 8, 2014, Vermont passed the Vermont Genetically Engineered Food Labeling Act (Act) requiring labels on certain genetically engineered foods. Once the bill takes effect July 1, 2016, all Vermont-retailed foods with more than 0.9% of their total weight in genetically modified ingredients must be labeled with language stating, “may be partially produced with genetic engineering.” As genetically engineered food are considered scientifically equivalent to their traditional counterparts and are not subject to federal labeling by the FDA, the Act presents several legal questions. Several of the legal questions have been raised in a recent lawsuit filed by the Grocery Manufactures Association that claims the Act violates the First Amendment, Supremacy Clause, and Commerce Clause. This paper will discuss why the Second Circuit could strike down the Act as unconstitutional as to each claim. PMID:27774175

  13. Focus on Food Labeling. An FDA Consumer Special Report.

    ERIC Educational Resources Information Center

    Food and Drug Administration (DHHS/PHS), Washington, DC.

    This special issue is designed for those who want to know all they can about the new federal requirements for nutrition information on food labels. Nine articles are included. "Good Reading for Good Eating" (Paula Kurtzweil) addresses mandatory nutrition labeling, the nutrition panel, nutrient content and health claims, and ingredient…

  14. Sunscreen sun protection factor claim based on in vivo interlaboratory variability.

    PubMed

    Miksa, S; Lutz, D; Guy, C; Delamour, E

    2016-12-01

    The SPF (sun protection factor) is the best known reference in the world for expressing UVB protection. The SPF is used for labelling purposes for consumer guidance. The determination of the SPF is often accomplished using an in vivo method that has been standardized. Only one in vivo SPF value from one laboratory is required for claiming an SPF value. The aim of this study was to determine the relevance of the in vivo SPF value in terms of interlaboratory variability for claiming purposes and to determine whether some minimum number of different in vivo SPF values from different laboratories would improve the reliability of the final SPF claimed. A large population of 44 different commercially available sunscreen formulations from the European market has been investigated, covering various product types. The majority of the SPF values claimed ranged from 15 to 50+. For each product, at least three different in vivo SPF values tested in different laboratories have been gathered, and a variety of statistical analyses have been performed. For each SPF category from the average of all samples, the minimum and maximum in vivo-measured SPF values from the different laboratories would lead to labels claiming different levels of SPF for the same product. Indeed, with coefficients of variation for in vivo SPF determinations that exceed 50% in some cases, as an example, the same product could in reality be claimed to be SPF 30, SPF 50 or SPF 50+. In this study, the authors demonstrated that using only one in vivo SPF value from one laboratory may actually challenge the reliability of the final SPF claim significantly. To reduce the consumer health risk by ensuring the reliability of the SPF claim, an average from at least 3 (ideally 4) different in vivo SPF values should be compulsory. © 2016 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

  15. Food claims and nutrition facts of commercial infant foods.

    PubMed

    Koo, Yu-Chin; Chang, Jung-Su; Chen, Yi Chun

    2018-01-01

    Composition claim, nutrition claim and health claim are often found on the commercial complementary food packaging. The introduction of complementary foods (CFs) to infants is a turning point in the development of their eating behavior, and their commercial use for Taiwanese infants is growing. In Taiwan, lots of the advertisements for CFs employed health or nutrition claims to promote the products, but the actual nutritional content of these CFs is not clear. The aim of this study was to compare the food claims of commercial complementary food products with their actual nutrition facts. A sample of 363 commercial CFs was collected from websites, local supermarkets, and other food stores, and their nutrition-related claims were classified into composition, nutrition, and health categories. Although the World Health Organization recommends that infants should be exclusively breastfed for the first 6 months, 48.2% of the commercial CFs were targeted at infants younger than 6 months. Therefore, marketing regulations should be implemented to curb early weaning as a result of products targeted at infants younger than 6 months. More than 50% of Taiwanese commercial CFs have high sugar content and more than 20% were high in sodium. Products with health claims, such as "provides good nutrition to children" or "improves appetite," have higher sodium or sugar content than do those without such claims. Moreover, products with calcium or iron content claims did not contain more calcium or iron than products without such claims. Additionally, a significantly greater proportion of the products with "no added sugar" claims were classified as having high sugar content as compared to those without such claims. Parents cannot choose the healthiest food products for their children by simply focusing on food claims. Government should regulate the labeling of nutrition facts and food claims for foods targeted at infants younger than 12 months.

  16. Food claims and nutrition facts of commercial infant foods

    PubMed Central

    Koo, Yu-Chin; Chang, Jung-Su

    2018-01-01

    Composition claim, nutrition claim and health claim are often found on the commercial complementary food packaging. The introduction of complementary foods (CFs) to infants is a turning point in the development of their eating behavior, and their commercial use for Taiwanese infants is growing. In Taiwan, lots of the advertisements for CFs employed health or nutrition claims to promote the products, but the actual nutritional content of these CFs is not clear. The aim of this study was to compare the food claims of commercial complementary food products with their actual nutrition facts. A sample of 363 commercial CFs was collected from websites, local supermarkets, and other food stores, and their nutrition-related claims were classified into composition, nutrition, and health categories. Although the World Health Organization recommends that infants should be exclusively breastfed for the first 6 months, 48.2% of the commercial CFs were targeted at infants younger than 6 months. Therefore, marketing regulations should be implemented to curb early weaning as a result of products targeted at infants younger than 6 months. More than 50% of Taiwanese commercial CFs have high sugar content and more than 20% were high in sodium. Products with health claims, such as “provides good nutrition to children” or “improves appetite,” have higher sodium or sugar content than do those without such claims. Moreover, products with calcium or iron content claims did not contain more calcium or iron than products without such claims. Additionally, a significantly greater proportion of the products with “no added sugar” claims were classified as having high sugar content as compared to those without such claims. Parents cannot choose the healthiest food products for their children by simply focusing on food claims. Government should regulate the labeling of nutrition facts and food claims for foods targeted at infants younger than 12 months. PMID:29489848

  17. 21 CFR 101.91 - Gluten-free labeling of food.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... that has not been processed to remove gluten (e.g., wheat flour); or (3) An ingredient that is derived... is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). (b) Requirements. (1) A food that... Nutrient Content Claims nor Health Claims § 101.91 Gluten-free labeling of food. (a) Definitions. (1) The...

  18. [Health claims made about foods: the new European regulation].

    PubMed

    Baelde, D

    2008-01-01

    Pursuant to the regulation harmonized relating to labelling, the presentation of the foodstuffs and publicity on them, the health claims made on these products should not be likely to mislead the consumer, must be able to be scientifically substantiated and it cannot be stated nor be evoked a property relating to the prevention, the treatment or the cure of a human disease. The recent publication of the European regulation concerning nutrition and health claims made on foods is a specific text, which supplements this device. The scientific evaluation of health claims allegations is centralized at the European Food Safety Authority and is preliminary to the launching of the food products. The food supplements, defined in the lawful plan in the field of the food right, are also subjected to these provisions.

  19. Regulatory science requirements of labeling of genetically modified food.

    PubMed

    Moghissi, A Alan; Jaeger, Lisa M; Shafei, Dania; Bloom, Lindsey L

    2018-05-01

    This paper provides an overview of the evolution of food labeling in the USA. It briefly describes the three phases of agricultural development consisting of naturally occurring, cross-bred, and genetically engineered, edited or modified crops, otherwise known as Genetically Modified Organisms (GMO). It uses the Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC) to evaluate the scientific validity of claims applicable to GMO and the Best Available Public Information (BAPI) to evaluate the pronouncements by public media and others. Subsequently claims on health risk, ecological risk, consumer choice, and corporate greed are evaluated based on BARS/MERSC and BAPI. The paper concludes by suggesting that labeling of food containing GMO should consider the consumer's choice, such as the food used by those who desire kosher and halal food. Furthermore, the consumer choice is already met by the exclusion of GMO in organic food.

  20. Toddler drinks, formulas, and milks: Labeling practices and policy implications.

    PubMed

    Pomeranz, Jennifer L; Romo Palafox, Maria J; Harris, Jennifer L

    2018-04-01

    Toddler drinks are a growing category of drinks marketed for young children 9-36 months old. Medical experts do not recommend them, and public health experts raise concerns about misleading labeling practices. In the U.S., the toddler drink category includes two types of products: transition formulas, marketed for infants and toddlers 9-24 months; and toddler milks, for children 12-36 months old. The objective of this study was to evaluate toddler drink labeling practices in light of U.S. food labeling policy and international labeling recommendations. In January 2017, we conducted legal research on U.S. food label laws and regulations; collected and evaluated toddler drink packages, including nutrition labels and claims; and compared toddler drink labels with the same brand's infant formula labels. We found that the U.S. has a regulatory structure for food labels and distinct policies for infant formula, but no laws specific to toddler drinks. Toddler drink labels utilized various terms and images to identify products and intended users; made multiple health and nutrition claims; and some stated there was scientific or expert support for the product. Compared to the same manufacturer's infant formula labels, most toddler drink labels utilized similar colors, branding, logos, and graphics. Toddler drink labels may confuse consumers about their nutrition and health benefits and the appropriateness of these products for young children. To support healthy toddler diets and well-informed decision-making by caregivers, the FDA can provide guidance or propose regulations clarifying permissible toddler drink labels and manufacturers should end inappropriate labeling practices. Copyright © 2018 Elsevier Inc. All rights reserved.

  1. Draft PRN 2006-A: Use of Antimicrobial Pesticide Products in Heating, Ventilation, Air Conditioning and Refrigeration Systems (HVAC&R)

    EPA Pesticide Factsheets

    This draft notice provides guidance to registrants of EPA-registered antimicrobial products whose labels bear general directions related to hard, non-porous or porous surfaces, but which are not but which are not specifically registered for HVAC uses.

  2. Simvastatin prescribing patterns before and after FDA dosing restrictions: a retrospective analysis of a large healthcare claims database.

    PubMed

    Tuchscherer, Rhianna M; Nair, Kavita; Ghushchyan, Vahram; Saseen, Joseph J

    2015-02-01

    Muscle-related events, or myopathies, are a commonly reported adverse event associated with statin use. In June 2011, the US FDA released a Drug Safety Communication that provided updated product labeling with dosing restrictions for simvastatin to minimize the risk of myopathies. Our objective was to describe prescribing patterns of simvastatin in combination with medications known to increase the risk of myopathies following updated product labeling dosing restrictions in June 2011. A retrospective observational analysis was carried out, in which administrative claims data were utilized to identify prescribing patterns of simvastatin in combination with calcium channel blockers (CCBs) and other pre-specified drug therapies. Prescribing patterns were analyzed on a monthly basis 24 months prior to and 9 months following product label changes. Incidence of muscle-related events was also analyzed. In June 2011, a total of 60% of patients with overlapping simvastatin-CCB claims and 94% of patients with overlapping simvastatin-non-CCB claims were prescribed an against-label combination. As of March 2012, a total of 41% and 93% of patients continued to be prescribed against-label simvastatin-CCB and simvastatin-non-CCB combinations, respectively. The most commonly prescribed dose of simvastatin was 20 mg (39%). Against-label combinations were most commonly prescribed at a simvastatin dose of 40 mg (56%). Amlodipine was the most commonly prescribed CCB in combination with simvastatin (70%) and the most common CCB prescribed against-label (67%). Despite improvements in prescribing practices, many patients are still exposed to potentially harmful simvastatin combinations. Aggressive changes in simvastatin prescribing systems and processes are needed to improve compliance with FDA labeling to improve medication and patient safety.

  3. Basic Drafting. Revised.

    ERIC Educational Resources Information Center

    Schertz, Karen

    This introductory module on drafting includes the technical content and tasks necessary for a student to be employed in an entry-level drafting occupation. The module contains 18 instructional units that cover the following topics: introduction to drafting; tools and equipment; supplies and materials; sketching; scales; drawing format; lettering;…

  4. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...

  5. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...

  6. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...

  7. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...

  8. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...

  9. 21 CFR 101.10 - Nutrition labeling of restaurant foods.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Nutrition labeling of restaurant foods. 101.10... restaurant foods. Nutrition labeling in accordance with § 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in § 101.13 or in subpart D of this...

  10. 77 FR 46518 - Draft Resource Management Plan/General Plan Draft Environmental Impact Statement/Revised Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-03

    ... DEPARTMENT OF THE INTERIOR Bureau of Reclamation Draft Resource Management Plan/General Plan Draft... Recreation Area, Merced County, California AGENCY: Bureau of Reclamation, Interior. ACTION: Notice of... California Department of Parks and Recreation was given the responsibility to plan, design, construct...

  11. Effects of alternative label formats on choice of high- and low-sodium products in a New Zealand population sample.

    PubMed

    McLean, Rachael; Hoek, Janet; Hedderley, Duncan

    2012-05-01

    Dietary sodium reduction is a cost-effective public health intervention to reduce chronic disease. In response to calls for further research into front-of-pack labelling systems, we examined how alternative sodium nutrition label formats and nutrition claims influenced consumers' choice behaviour and whether consumers with or without a diagnosis of hypertension differed in their choice patterns. An anonymous online experiment in which participants viewed ten choice sets featuring three fictitious brands of baked beans with varied label formats and nutritional profiles (high and low sodium) and indicated which brand in each set they would purchase if shopping for this product. Participants were recruited from New Zealand's largest online nationwide research panel. Five hundred people with self-reported hypertension and 191 people without hypertension aged 18 to 79 years. The addition of a front-of-pack label increased both groups' ability to discriminate between products with high and low sodium, while the Traffic Light label enabled better identification of the high-sodium product. Both front-of-pack formats enhanced discrimination in the presence of a reduced salt claim, but the Traffic Light label also performed better than the Percentage Daily Intake label in moderating the effect of the claim for the high-sodium product. Front-of-pack labels, particularly those with simple visual cues, enhance consumers' ability to discriminate between high- and low-sodium products, even when those products feature nutrition claims.

  12. Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

    PubMed

    Habibi, Roojin; Lexchin, Joel; Mintzes, Barbara; Holbrook, Anne

    2017-11-01

    This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P < 0.001. Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators. © 2017 The British Pharmacological Society.

  13. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  14. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  15. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  16. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  17. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  18. Electrical and Electronic Drafting, Drafting 3: 9257.01.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course covers the standards used in the electronic field, electrical drawings, electronic drafting, and parts of functional drafting. The student will become familiar with symbols used in these fields and become proficient with tools and reference material used in drawing schematics and mechanical details and in electrical and electronic…

  19. PRN 96-4: Label Statements Involving Product Efficacy and Potential for Harm to Property

    EPA Pesticide Factsheets

    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.

  20. Interpretive front-of-pack nutrition labels. Comparing competing recommendations.

    PubMed

    Maubach, Ninya; Hoek, Janet; Mather, Damien

    2014-11-01

    Many stakeholders support introducing an interpretive front-of-pack (FOP) nutrition label, but disagree over the form it should take. In late 2012, an expert working group established by the New Zealand government recommended the adoption of an untested summary rating system: a Star label. This study used a best-worst scaling choice experiment to estimate how labels featuring the new Star rating, the Multiple Traffic Light (MTL), Daily Intake Guide (DIG), and a no-FOP control affected consumers' choice behaviours and product perceptions. Nutrient-content and health claims were included in the design. We also assessed whether respondents who used more or less information during the choice tasks differed in their selection patterns. Overall, while respondents made broadly similar choices with respect to the MTL and Star labels, the MTL format had a significantly greater impact on depressing preference as a food's nutritional profile became less healthy. Health claims increased rankings of less nutritious options, though this effect was less pronounced when the products featured an MTL. Further, respondents were best able to differentiate products' healthiness with MTL labels. The proposed summary Stars system had less effect on choice patterns than an MTL label and our findings highlight the need for policy makers to ensure that decisions to introduce FOP labels are underpinned by robust research evidence. These results suggest that the proposed summary Stars system will have less effect on shifting food choice patterns than interpretive FOP nutrition label featuring traffic light ratings. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. 37 CFR 1.75 - Claim(s).

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Claim(s). 1.75 Section 1.75 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Specification § 1.75 Claim(s). (a...

  2. 37 CFR 1.75 - Claim(s).

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Claim(s). 1.75 Section 1.75 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Specification § 1.75 Claim(s). (a...

  3. 76 FR 41808 - Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ...] Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric Delivery..., announce the availability of the draft environmental impact statement and the draft Oncor Electric Delivery... Oncor Electric Delivery Company, LLC (Applicant; Oncor), and (2) That the Applicant has developed a...

  4. Mechanical Drafting.

    ERIC Educational Resources Information Center

    McClain, Gerald R.

    This publication, the third in a series on drafting, is intended to strengthen students' competence in the specialized field of mechanical drafting. The text consists of instructional materials for both teacher and students, written in terms of student performance using measurable objectives. The course includes 11 units. Each instructional unit…

  5. Architectural Drafting.

    ERIC Educational Resources Information Center

    Davis, Ronald; Yancey, Bruce

    Designed to be used as a supplement to a two-book course in basic drafting, these instructional materials consisting of 14 units cover the process of drawing all working drawings necessary for residential buildings. The following topics are covered in the individual units: introduction to architectural drafting, lettering and tools, site…

  6. 76 FR 59732 - Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ...] Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric Delivery... availability of the draft environmental impact statement (DEIS) and the draft Oncor Electric Delivery Company... announced that Oncor Electric Delivery Company, LLC, has applied under section 10(a)(1)(B) of the Endangered...

  7. General Drafting. Technical Manual.

    ERIC Educational Resources Information Center

    Department of the Army, Washington, DC.

    The manual provides instructional guidance and reference material in the principles and procedures of general drafting and constitutes the primary study text for personnel in drafting as a military occupational specialty. Included is information on drafting equipment and its use; line weights, conventions and formats; lettering; engineering charts…

  8. 9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 317.309(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

  9. 9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 381.409(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

  10. 9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 317.309(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

  11. 9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 381.409(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

  12. 37 CFR 1.75 - Claim(s).

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Claim(s). 1.75 Section 1.75... GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Specification § 1.75 Claim(s). (a.... (35 U.S.C. 6; 15 U.S.C. 1113, 1126) [31 FR 12922, Oct. 4, 1966, as amended at 36 FR 12690, July 3...

  13. Are Front of Pack Claims Indicators of Nutrition Quality? Evidence from 2 Product Categories.

    PubMed

    Schaefer, Debra; Hooker, Neal H; Stanton, John L

    2016-01-01

    American grocery shoppers face an array of front of pack (FOP) nutrition and health claims when making food selections. Such systems have been categorized as summary or nutrient specific. Either type should help consumers make judgments about the nutrition quality of a product. This research tests if the type or quantity of FOP claims are indeed good indicators of objective nutrition quality. Claim and nutrition information from more than 2200 breakfast cereals and prepared meals launched between 2006 and 2010 were analyzed using binary and multinomial logistic regression models. Results suggest that no type or number of front of pack claims could distinguish "healthy" foods. However, some types and frequencies of FOP claims were significant predictors of higher or lower levels of certain key nutrients. Given the complex and crowded label environment in which these FOP claims reside, one may be concerned that such cues are not closely related to objective measures of nutrition quality. © 2015 Institute of Food Technologists®

  14. 33 CFR 401.29 - Maximum draft.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 3 2012-07-01 2012-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) The draft...) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft...

  15. 33 CFR 401.29 - Maximum draft.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 3 2011-07-01 2011-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) The draft...) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft...

  16. 33 CFR 401.29 - Maximum draft.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) The draft...) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft...

  17. Working, Welding and Structural Drafting, Drafting--Intermediate: 9255.03.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course introduces the student to working welding drawings, both detail and assembly, as related to all fields of drafting and structural drafting, and provides him with the opportunity to work with various types of tools and equipment. Prior to entry in this course, the vocational student must display mastery of the skills indicated in…

  18. 76 FR 57760 - Notice of Availability of Draft Resource Management Plan and Draft Environmental Impact Statement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... Availability of Draft Resource Management Plan and Draft Environmental Impact Statement for the Colorado River... prepared a Draft Resource Management Plan (RMP) and Draft Environmental Impact Statement (EIS) for the... alternative) seeks to allocate limited resources among competing human interests, land uses, and conservation...

  19. Comparison of two data mining techniques in labeling diagnosis to Iranian pharmacy claim dataset: artificial neural network (ANN) versus decision tree model.

    PubMed

    Rezaei-Darzi, Ehsan; Farzadfar, Farshad; Hashemi-Meshkini, Amir; Navidi, Iman; Mahmoudi, Mahmoud; Varmaghani, Mehdi; Mehdipour, Parinaz; Soudi Alamdari, Mahsa; Tayefi, Batool; Naderimagham, Shohreh; Soleymani, Fatemeh; Mesdaghinia, Alireza; Delavari, Alireza; Mohammad, Kazem

    2014-12-01

    This study aimed to evaluate and compare the prediction accuracy of two data mining techniques, including decision tree and neural network models in labeling diagnosis to gastrointestinal prescriptions in Iran. This study was conducted in three phases: data preparation, training phase, and testing phase. A sample from a database consisting of 23 million pharmacy insurance claim records, from 2004 to 2011 was used, in which a total of 330 prescriptions were assessed and used to train and test the models simultaneously. In the training phase, the selected prescriptions were assessed by both a physician and a pharmacist separately and assigned a diagnosis. To test the performance of each model, a k-fold stratified cross validation was conducted in addition to measuring their sensitivity and specificity. Generally, two methods had very similar accuracies. Considering the weighted average of true positive rate (sensitivity) and true negative rate (specificity), the decision tree had slightly higher accuracy in its ability for correct classification (83.3% and 96% versus 80.3% and 95.1%, respectively). However, when the weighted average of ROC area (AUC between each class and all other classes) was measured, the ANN displayed higher accuracies in predicting the diagnosis (93.8% compared with 90.6%). According to the result of this study, artificial neural network and decision tree model represent similar accuracy in labeling diagnosis to GI prescription.

  20. 32 CFR 536.120 - Claims payable as maritime claims.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Claims payable as maritime claims. 536.120... ACCOUNTS CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.120 Claims payable as maritime claims. A claim is cognizable under this subpart if it arises in or on a maritime location, involves some...

  1. Mississippi Curriculum Framework for Drafting and Design Technology (Program CIP: 48.0102--Architectural Drafting Technology) (Program CIP: 48.0101--General Drafting). Postsecondary Programs.

    ERIC Educational Resources Information Center

    Mississippi Research and Curriculum Unit for Vocational and Technical Education, State College.

    This document, which is intended for use by community and junior colleges throughout Mississippi, contains curriculum frameworks for the two course sequences of the state's postsecondary-level drafting and design technology program: architectural drafting technology and drafting and design technology. Presented first are a program description and…

  2. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... your comment on this draft guidance before it begins work on the final version of the guidance, submit... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm...

  3. The potential clinical impact of the release of two drafts of the human proteome

    PubMed Central

    Ezkurdia, Iakes; Calvo, Enrique; Del Pozo, Angela; Vázquez, Jesús; Valencia, Alfonso; Tress, Michael L.

    2015-01-01

    The authors have carried out an investigation of the two “draft maps of the human proteome” published in 2014 in Nature. The findings include an abundance of poor spectra, low-scoring peptide-spectrum matches and incorrectly identified proteins in both these studies, highlighting clear issues with the application of false discovery rates. This noise means that the claims made by the two papers – the identification of high numbers of protein coding genes, the detection of novel coding regions and the draft tissue maps themselves – should be treated with considerable caution. The authors recommend that clinicians and researchers do not use the unfiltered data from these studies. Despite this these studies will inspire further investigation into tissue-based proteomics. As long as this future work has proper quality controls, it could help produce a consensus map of the human proteome and improve our understanding of the processes that underlie health and disease. PMID:26496066

  4. Drafting: Current Trends and Future Practices

    ERIC Educational Resources Information Center

    Jensen, C.

    1976-01-01

    Various research findings are reported on drafting trends which the author feels should be incorporated into teaching drafting: (1) true position and geometric tolerancing, (2) decimal and metric dimensioning, (3) functional drafting, (4) automated drafting, and (5) drawing reproductions. (BP)

  5. The motivational and informational basis of attitudes toward foods with health claims.

    PubMed

    Žeželj, Iris; Milošević, Jasna; Stojanović, Žaklina; Ognjanov, Galjina

    2012-12-01

    This research explored the effects of food choice motives, nutritional knowledge, and the use of food labels, on attitude toward food with health claims. Food with health claims was chosen as a relatively novel category of products designed to be beneficial for health. We identified eight motives served by food in general, and tested if they serve as motivations to positively evaluate functional food. Questionnaire was administered on nationally representative samples of 3085 respondents from six Western Balkan countries. We proposed two structural models relating an extensive list of eight and, alternatively, restricted list of three food-choice motives (health, mood and sensory appeal) to attitude toward functional food. We also expected the indirect association between the health motive and attitude, through nutritional knowledge and use of food labels. The results revealed highly positive, although undifferentiated attitude toward functional food, with no significant differences between the countries. The restricted model provided a better fit then the exhaustive model; the health motive was proven to have indirect influence on attitude through knowledge and label use. The implications of these findings for functional approach to attitudes, understanding the demand for functional food and overcoming barriers to dietary change are discussed. Copyright © 2012 Elsevier Ltd. All rights reserved.

  6. 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...

  7. EPA scientific integrity policy draft

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    2011-08-01

    The U.S. Environmental Protection Agency (EPA) issued its draft scientific integrity policy on 5 August. The draft policy addresses scientific ethical standards, communications with the public, the use of advisory committees and peer review, and professional development. The draft policy was developed by an ad hoc group of EPA senior staff and scientists in response to a December 2010 memorandum on scientific integrity from the White House Office of Science and Technology Policy. The agency is accepting public comments on the draft through 6 September; comments should be sent to osa.staff@epa.gov. For more information, see http://www.epa.gov/stpc/pdfs/draft-scientific-integrity-policy-aug2011.pdf.

  8. 78 FR 9688 - Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... Pesticide Registrants on Antimicrobial Pesticide Products With Mold-Related Label Claims; Notice of... Register issue of December 12, 2012, requesting comments on Guidance for Antimicrobial Pesticide Products... CONTACT: Melba S. Morrow, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental...

  9. FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.

    PubMed

    1995-02-01

    The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.

  10. 49 CFR 229.61 - Draft system.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A... absorbed by friction devices or draft gears that exceeds one-half inches. (5) A broken or cracked coupler...

  11. 49 CFR 229.61 - Draft system.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A... absorbed by friction devices or draft gears that exceeds one-half inches. (5) A broken or cracked coupler...

  12. 49 CFR 229.61 - Draft system.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A... absorbed by friction devices or draft gears that exceeds one-half inches. (5) A broken or cracked coupler...

  13. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 6 2014-07-01 2014-07-01 false Draft EIS. 989.19 Section 989.19 National... ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.19 Draft EIS. (a) Preliminary draft. The EPF supports the proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues...

  14. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 6 2012-07-01 2012-07-01 false Draft EIS. 989.19 Section 989.19 National... ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.19 Draft EIS. (a) Preliminary draft. The EPF supports the proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues...

  15. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 6 2013-07-01 2013-07-01 false Draft EIS. 989.19 Section 989.19 National... ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.19 Draft EIS. (a) Preliminary draft. The EPF supports the proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues...

  16. Mechnical Drawing/Drafting Curriculum Guide.

    ERIC Educational Resources Information Center

    Gregory, Margaret R.; Benson, Robert T.

    This curriculum guide consists of materials for teaching a course in mechanical drawing and drafting. Addressed in the individual units of the guide are the following topics: the nature and scope of drawing and drafting, visualization and spatial relationships, drafting tools and materials, linework, freehand lettering, geometric construction,…

  17. Healthfulness and nutritional composition of Canadian prepackaged foods with and without sugar claims.

    PubMed

    Bernstein, Jodi T; Franco-Arellano, Beatriz; Schermel, Alyssa; Labonté, Marie-Ève; L'Abbé, Mary R

    2017-11-01

    The objective of this study was to evaluate differences in calories, nutrient content, overall healthfulness, and use of sweetener ingredients between products with and without sugar claims. Consumers assume products with sugar claims are healthier and lower in calories. It is therefore important claims be found on comparatively healthier items. This study is a cross-sectional analysis of the University of Toronto's 2013 Food Label Database. Subcategories where at least 5% of products (and n ≥ 5) carried a sugar claim were included (n = 3048). Differences in median calorie content, nutrient content, and overall healthfulness, using the Food Standards Australia/New Zealand Nutrient Profiling Scoring criterion, between products with and without sugar claims, were determined. Proportion of products with and without claims that had excess free sugar levels (≥10% of calories from free sugar) and that contained sweeteners was also determined. Almost half (48%) of products with sugar claims contained excess free sugar, and a greater proportion contained sweeteners than products without such claims (30% vs 5%, χ 2 = 338.6, p < 0.0001). Overall, products with sugar claims were "healthier" and had lower median calorie, free sugar, total sugar, and sodium contents than products without claims. At the subcategory level, reductions in free sugar contents were not always met with similar reductions in calorie contents. This study highlights concerns with regards to the nutritional composition of products bearing sugar claims. Findings can support educational messaging to assist consumer interpretation of sugar claims and can inform changes in nutrition policies, for example, permitting sugar claims only on products with calorie reductions and without excess free sugar.

  18. 76 FR 57759 - Notice of Availability of Draft Resource Management Plan and Draft Environmental Impact Statement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... Availability of Draft Resource Management Plan and Draft Environmental Impact Statement for the Kremmling Field... Management Act of 1976 (FLPMA), as amended, the Bureau of Land Management (BLM) has prepared a Draft Resource... alternatives for future [[Page 57760

  19. Automatic draft reading based on image processing

    NASA Astrophysics Data System (ADS)

    Tsujii, Takahiro; Yoshida, Hiromi; Iiguni, Youji

    2016-10-01

    In marine transportation, a draft survey is a means to determine the quantity of bulk cargo. Automatic draft reading based on computer image processing has been proposed. However, the conventional draft mark segmentation may fail when the video sequence has many other regions than draft marks and a hull, and the estimated waterline is inherently higher than the true one. To solve these problems, we propose an automatic draft reading method that uses morphological operations to detect draft marks and estimate the waterline for every frame with Canny edge detection and a robust estimation. Moreover, we emulate surveyors' draft reading process for getting the understanding of a shipper and a receiver. In an experiment in a towing tank, the draft reading error of the proposed method was <1 cm, showing the advantage of the proposed method. It is also shown that accurate draft reading has been achieved in a real-world scene.

  20. 78 FR 19733 - Draft General Management Plan and Draft Environmental Impact Statement, Fort Raleigh National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... Management Plan (EIS/GMP) for Fort Raleigh National Historic Site, North Carolina. The draft describes and... announce the dates, times, and locations of public meetings on the draft EIS/GMP through the NPS Planning... delivery to the above address. Electronic copies of the Draft EIS/GMP will be available online at http...

  1. Labeling of trans fatty acid content in food, regulations and limits-the FDA view.

    PubMed

    Moss, Julie

    2006-05-01

    With the scientific evidence associating trans fatty acid (TFA) intake with an increased risk of coronary heart disease (CHD), the U.S. Food and Drug Administration (FDA) issued a final rule that requires the declaration of the amount of TFA present in foods, including dietary supplements, on the nutrition label by January 1, 2006. The addition of TFA to the nutrition label will lead to the prevention of 600 to 1200 cases of CHD and 240-480 deaths each year saving Dollars 900 million to Dollars 1.8 billion per year in medical costs, lost productivity, and pain and suffering. For the purpose of nutrition labeling, TFA are defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e. non-conjugated) double bonds in a trans configuration. There are many issues that FDA has yet to resolve: (1) defining nutrient content claims for "free" and "reduced" levels of trans fat, (2) placing limits on the amount of TFA in conjunction with saturated fat limits for nutrient content claims, health claims, and disclosure and disqualifying levels, (3) a daily value, and (4) a possible footnote or disclosure statement to enhance consumer understanding of cholesterol raising lipids. FDA issued an Advanced Notice of Proposed Rulemaking (ANPR) requesting comments on the unresolved issues. FDA will also be conducting consumer research to determine consumer understanding of various TFA labeling possibilities. Comments to the ANPR, results of consumer research and current science will be used by FDA to resolve these issues and to determine future rulemaking for TFA labeling.

  2. Mathematics for Drafting.

    ERIC Educational Resources Information Center

    Clary, Joseph R.; Nery, Karen P.

    This set of three modules was designed for use primarily to help teach and reinforce the basic mathematics skills in drafting classes. The modules are based on the needs of drafting students in beginning courses as determined by a survey of teachers across North Carolina. Each module consists of basic information and examples and problem sheets…

  3. FDA preemption of drug and device labeling: who should decide what goes on a drug label?

    PubMed

    Valoir, Tamsen; Ghosh, Shubha

    2011-01-01

    The Supreme Court decided an issue that is critical to consumer health and safety last year. In April 2009, the Supreme Court held that extensive FDA regulation of drugs did not preempt a state law claim that an additional warning on the label was necessary to make the drug reasonably safe for use. Thus, states--and even courts and juries--are now free to cast their vote on what a drug label should say. This is in direct contrast to medical devices, where the federal statute regulating medical devices expressly provides that state regulations are preempted. This Article discusses basic preemption principles and drugs, and explores the policy ramifications of pro- and anti-preemption policy in the healthcare industry.

  4. Interpreting labels of abuse-deterrent opioid analgesics.

    PubMed

    Webster, Lynn R

    To provide an overview of available abuse-deterrent opioids (ADOs) and the labeling text that describes abuse-deterrent (AD) properties. A nonsystematic review of ADO literature and regulatory documents guiding their development. A critical assessment and discussion of common routes of opioid abuse, AD methods and properties, US Food and Drug Administration (FDA) study requirements to achieve AD labeling, and brief guide to understanding AD labels. The FDA has issued guidance as incentive and direction to industry to develop ADOs as one component of a multi-pronged public-health strategy to combat opioid abuse and misuse. The guidance describes separate categories of premarket and postmarket studies and makes recommendations for claims that may be made based on study findings. Ten ADOs have FDA-approved labeling attesting to AD properties. Available formulations that fail to conform to FDA guidance in study and labeling recommendations cannot be considered ADO. Formulations with AD properties are expected to reduce risk compared to the same agents without AD properties but cannot prevent all abuse and adverse clinical outcomes.

  5. Effects of Categorical Labels on Similarity Judgments: A Critical Analysis of Similarity-Based Approaches

    ERIC Educational Resources Information Center

    Noles, Nicholaus S.; Gelman, Susan A.

    2012-01-01

    Our goal in the present study was to evaluate the claim that category labels affect children's judgments of visual similarity. We presented preschool children with discriminable and identical sets of animal pictures and asked them to make perceptual judgments in the presence or absence of labels. Our findings indicate that children who are asked…

  6. 10 CFR 51.74 - Distribution of draft environmental impact statement and supplement to draft environmental impact...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...

  7. 10 CFR 51.74 - Distribution of draft environmental impact statement and supplement to draft environmental impact...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...

  8. 10 CFR 51.74 - Distribution of draft environmental impact statement and supplement to draft environmental impact...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...

  9. 10 CFR 51.74 - Distribution of draft environmental impact statement and supplement to draft environmental impact...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...

  10. 10 CFR 51.74 - Distribution of draft environmental impact statement and supplement to draft environmental impact...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...

  11. Nutrition and health claims in products directed at children via television in Spain in 2012.

    PubMed

    Royo-Bordonada, Miguel Ángel; Bosqued-Estefanía, María José; Damián, Javier; López-Jurado, Lázaro; Moya-Geromini, María Ángeles

    2016-01-01

    To describe the use of nutrition and health claims in products directed at children via television in Spain and to analyse their nutrient profile. A cross-sectional study of television food advertisements over 7 days in five Spanish television channels popular among children. The products were classified as core, non-core or miscellaneous, and as either healthy or less healthy, according to the United Kingdom Nutrient Profile Model. We registered all claims contained on the product (packaging and labelling) and its advertisement. We calculated the frequency distributions of health and nutrition claims. During the 420hours of broadcasting, 169 food products were identified, 28.5% in the dairy group and 60.9% in the non-core category. A total of 53.3% of products contained nutrition claims and 26.6% contained health claims; 62.2% of the products with claims were less healthy. Low-fat dairy products were the food category containing the highest percentage of health and nutrition claims. Over half of all food products marketed to children via television in Spain made some type of nutrition or health claim. Most of these products were less healthy, which could mislead Spanish consumers. Copyright © 2016 SESPAS. Published by Elsevier Espana. All rights reserved.

  12. Comparison of Conventional and Computer-Aided Drafting Methods from the View of Time and Drafting Quality

    ERIC Educational Resources Information Center

    Ozkan, Aysen; Yildirim, Kemal

    2016-01-01

    Problem Statement: Drafting course is essential for students in the design disciplines for becoming more organized and for complying with standards in the educational system. Drafting knowledge is crucial, both for comprehension of the issues and for the implementation phase. In any design project, drafting performance and success are as important…

  13. Competency Reference for Computer Assisted Drafting.

    ERIC Educational Resources Information Center

    Oregon State Dept. of Education, Salem. Div. of Vocational Technical Education.

    This guide, developed in Oregon, lists competencies essential for students in computer-assisted drafting (CAD). Competencies are organized in eight categories: computer hardware, file usage and manipulation, basic drafting techniques, mechanical drafting, specialty disciplines, three dimensional drawing/design, plotting/printing, and advanced CAD.…

  14. Articulated Instruction Objectives Guide for Drafting. Final Document for Articulation of Drafting.

    ERIC Educational Resources Information Center

    Henderson, Wm. Edward, Jr.

    Intended for use in competency-based and criterion-referenced vocational programs, this articulated, performance-based instruction objectives guide for Drafting I is designed for reference use in the articulation of drafting programs at the secondary and postsecondary levels. It consists of a description of the development of the guide, 14…

  15. 78 FR 39253 - Notice of Extension of Comment Period for Draft Initial Comprehensive Plan and Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ...Pursuant to the Resources and Ecosystems Sustainability, Tourist Opportunities, and Revived Economies of the Gulf States Act (RESTORE Act), the Secretary of Commerce, as Chair of the Gulf Coast Ecosystem Restoration Council (Council), announces the extension of the public comment period for the Draft Initial Comprehensive Plan (Draft Plan) to restore and protect the Gulf Coast region and the Draft Programmatic Environmental Assessment (Draft PEA) for the Draft Plan. Council Members also have compiled preliminary lists of ecosystem restoration projects that are ``authorized but not yet commenced'' and the full Council is in the process of evaluating these lists; the Council announces the availability of these preliminary lists. If you previously submitted comments, please do not resubmit them because the Council has already incorporated them into the public record and will fully consider them.

  16. 46 CFR 151.03-35 - Limiting draft.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 5 2010-10-01 2010-10-01 false Limiting draft. 151.03-35 Section 151.03-35 Shipping... BULK LIQUID HAZARDOUS MATERIAL CARGOES Definitions § 151.03-35 Limiting draft. Maximum allowable draft to which a barge may be loaded. Limiting draft is a function of hull type and cargo specific gravity...

  17. 46 CFR 151.03-35 - Limiting draft.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 5 2012-10-01 2012-10-01 false Limiting draft. 151.03-35 Section 151.03-35 Shipping... BULK LIQUID HAZARDOUS MATERIAL CARGOES Definitions § 151.03-35 Limiting draft. Maximum allowable draft to which a barge may be loaded. Limiting draft is a function of hull type and cargo specific gravity...

  18. 46 CFR 151.03-35 - Limiting draft.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 5 2013-10-01 2013-10-01 false Limiting draft. 151.03-35 Section 151.03-35 Shipping... BULK LIQUID HAZARDOUS MATERIAL CARGOES Definitions § 151.03-35 Limiting draft. Maximum allowable draft to which a barge may be loaded. Limiting draft is a function of hull type and cargo specific gravity...

  19. 46 CFR 151.03-35 - Limiting draft.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 5 2011-10-01 2011-10-01 false Limiting draft. 151.03-35 Section 151.03-35 Shipping... BULK LIQUID HAZARDOUS MATERIAL CARGOES Definitions § 151.03-35 Limiting draft. Maximum allowable draft to which a barge may be loaded. Limiting draft is a function of hull type and cargo specific gravity...

  20. 46 CFR 151.03-35 - Limiting draft.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 5 2014-10-01 2014-10-01 false Limiting draft. 151.03-35 Section 151.03-35 Shipping... BULK LIQUID HAZARDOUS MATERIAL CARGOES Definitions § 151.03-35 Limiting draft. Maximum allowable draft to which a barge may be loaded. Limiting draft is a function of hull type and cargo specific gravity...

  1. Effect of low-carbohydrate claims on consumer perceptions about food products' healthfulness and helpfulness for weight management.

    PubMed

    Labiner-Wolfe, Judith; Jordan Lin, Chung-Tung; Verrill, Linda

    2010-01-01

    Evaluate effect of low-carbohydrate claims on consumer perceptions about food products' healthfulness and helpfulness for weight management. Experiment in which participants were randomly assigned 1 of 12 front-of-package claim conditions on bread or a frozen dinner. Seven of the 12 conditions also included Nutrition Facts (NF) information. Internet. 4,320 members of a national on-line consumer panel. Exposure to images of a food package. Ratings on Likert scales about perceived healthfulness, helpfulness for weight management, and caloric content. Mean ratings by outcome measure, condition, and product were calculated. Ratings were also used as the dependent measure in analysis of variance models. Participants who saw front-of-package-only conditions rated products bearing low-carbohydrate claims as more helpful for weight management and lower in calories than the same products without a claim. Those who saw the bread with low-carbohydrate claims also rated it as more healthful than those who saw no claim. When the NF label was available and products had the same nutrition profile, participants rated products with low-carbohydrate claims the same as those with no claim. Consumers who do not use the NF panel may interpret low-carbohydrate claims to have meaning beyond the scope of the claim itself. Published by Elsevier Inc.

  2. 31 CFR 515.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 515.406 Section 515.406 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY CUBAN ASSETS CONTROL REGULATIONS Interpretations §...

  3. 31 CFR 515.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 515.406 Section 515.406 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY CUBAN ASSETS CONTROL REGULATIONS Interpretations §...

  4. 31 CFR 515.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 515.406 Section 515.406 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY CUBAN ASSETS CONTROL REGULATIONS Interpretations §...

  5. 31 CFR 515.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 515.406 Section 515.406 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY CUBAN ASSETS CONTROL REGULATIONS Interpretations §...

  6. 31 CFR 515.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 515.406 Section 515.406 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY CUBAN ASSETS CONTROL REGULATIONS Interpretations §...

  7. 31 CFR 500.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 500.406 Section 500.406 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY FOREIGN ASSETS CONTROL REGULATIONS Interpretations § 50...

  8. 32 CFR 536.85 - Claims payable under the Federal Tort Claims Act.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 3 2013-07-01 2013-07-01 false Claims payable under the Federal Tort Claims Act... AND ACCOUNTS CLAIMS AGAINST THE UNITED STATES Claims Cognizable Under the Federal Tort Claims Act § 536.85 Claims payable under the Federal Tort Claims Act. (a) Unless otherwise prescribed, claims for...

  9. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 7 2011-07-01 2011-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall...

  10. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 7 2014-07-01 2014-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall...

  11. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 7 2012-07-01 2012-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall...

  12. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 7 2013-07-01 2013-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall...

  13. The ban on "off-label" pharmaceutical promotion: constitutionally permissible prophylaxis against false or misleading commercial speech?

    PubMed

    Greenwood, Kate

    2011-01-01

    Critics of the Food & Drug Administration's ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers' truthful speech about their legal--and beneficial--products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they "usually rest solely on the offensive assumption that the public will respond 'irrationally' to the truth." The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on "truthful speech to physicians" but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban's adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress' rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.

  14. 33 CFR 401.29 - Maximum draft.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 3 2014-07-01 2014-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) Notwithstanding any provision herein, the loading of cargo, draft and speed of a vessel in transit shall be...

  15. 33 CFR 401.29 - Maximum draft.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 3 2013-07-01 2013-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) Notwithstanding any provision herein, the loading of cargo, draft and speed of a vessel in transit shall be...

  16. Persistent use of against-label statin-fibrate combinations from 2003-2009 despite United States Food and Drug Administration dose restrictions.

    PubMed

    Alford, Julie C; Saseen, Joseph J; Allen, Richard R; Nair, Kavita V

    2012-07-01

    To describe the prevalence of prescribing against-label statin-fibrate combination therapy. Retrospective cohort study. Medstat MarketScan Commercial Claims and Encounter database. Adults (aged 18-89 yrs) who were prescribed statin-fibrate combination therapy between January 1, 2003, and June 30, 2009, had pharmacy claims demonstrating two or more concurrently filled prescriptions for a statin and a fibrate, and had continuous insurance enrollment for at least 12 months. Claims data were used to identify patients with dyslipidemia based on International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. National Drug Codes were used to describe concurrent statin-fibrate combination therapy. The primary outcome was recent use of against-label statin-fibrate combination therapy, defined as use during the last 18 months (January 1, 2008-June 30, 2009) of the study period. Patients were stratified according to statin and dosage to identify against-label combination use (e.g., simvastatin > 10 mg/day with gemfibrozil). Within the recent-use period, 131,394 patients were prescribed concurrent statin-fibrate combination therapy; of these patients, 13,420 (10.2%) had against-label therapy. Simvastatin-gemfibrozil accounted for 8978 (66.9%) of all against-label combinations. Of all 9877 simvastatin-gemfibrozil combinations prescribed in the recent-use period (both on-label and against-label use), 8978 (90.9%) were against label. The secondary outcome was prevalence of against-label statin-fibrate combination therapy on an annual basis: 15.5% in 2003, 18.7% in 2004, 9.1% in 2005, 8.3% in 2006, 9.2% in 2007, and 9.8% in 2008. Against-label statin-fibrate combination therapy continues to be prescribed despite established United States Food and Drug Administration (FDA) dose restrictions. Nearly every time the simvastatin-gemfibrozil combination was prescribed, it was against label because simvastatin exceeded the maximum dose restriction

  17. Decision for the Draft.

    ERIC Educational Resources Information Center

    Chambers, John Whiteclay, II

    2002-01-01

    Discusses why U.S. President Woodrow Wilson decided to institute the military draft. Provides background information on when Wilson changed from insisting on using volunteers in the military to his resolve for instituting the draft, due to a challenge of power by former U.S. President Theodore Roosevelt. (CMK)

  18. 7 CFR 1488.13 - CCC drafts.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false CCC drafts. 1488.13 Section 1488.13 Agriculture... Export Sales of Agricultural Commodities From Private Stocks Under CCC Export Credit Sales Program (GSM-5) Bank Obligations and Repayment § 1488.13 CCC drafts. CCC will draw one draft for each payment due under...

  19. 7 CFR 1488.13 - CCC drafts.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false CCC drafts. 1488.13 Section 1488.13 Agriculture... Export Sales of Agricultural Commodities From Private Stocks Under CCC Export Credit Sales Program (GSM-5) Bank Obligations and Repayment § 1488.13 CCC drafts. CCC will draw one draft for each payment due under...

  20. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 7 2010-07-01 2010-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations...) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall be built or means shall be taken to prevent cargo from falling from them. (b) Buckets and tubs used...

  1. 46 CFR 167.65-40 - Draft.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 7 2011-10-01 2011-10-01 false Draft. 167.65-40 Section 167.65-40 Shipping COAST GUARD... Requirements § 167.65-40 Draft. The master of every nautical school ship over 50 gross tons shall, whenever leaving port, enter the maximum draft of his nautical school ship in the log book. ...

  2. 46 CFR 167.65-40 - Draft.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Draft. 167.65-40 Section 167.65-40 Shipping COAST GUARD... Requirements § 167.65-40 Draft. The master of every nautical school ship over 50 gross tons shall, whenever leaving port, enter the maximum draft of his nautical school ship in the log book. ...

  3. 46 CFR 167.65-40 - Draft.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 7 2014-10-01 2014-10-01 false Draft. 167.65-40 Section 167.65-40 Shipping COAST GUARD... Requirements § 167.65-40 Draft. The master of every nautical school ship over 50 gross tons shall, whenever leaving port, enter the maximum draft of his nautical school ship in the log book. ...

  4. 46 CFR 167.65-40 - Draft.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 7 2013-10-01 2013-10-01 false Draft. 167.65-40 Section 167.65-40 Shipping COAST GUARD... Requirements § 167.65-40 Draft. The master of every nautical school ship over 50 gross tons shall, whenever leaving port, enter the maximum draft of his nautical school ship in the log book. ...

  5. 46 CFR 167.65-40 - Draft.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 7 2012-10-01 2012-10-01 false Draft. 167.65-40 Section 167.65-40 Shipping COAST GUARD... Requirements § 167.65-40 Draft. The master of every nautical school ship over 50 gross tons shall, whenever leaving port, enter the maximum draft of his nautical school ship in the log book. ...

  6. 7 CFR 1488.13 - CCC drafts.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false CCC drafts. 1488.13 Section 1488.13 Agriculture... Agricultural Commodities From Private Stocks Under CCC Export Credit Sales Program (GSM-5) Bank Obligations and Repayment § 1488.13 CCC drafts. CCC will draw one draft for each payment due under bank obligations. If any...

  7. 7 CFR 1488.13 - CCC drafts.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false CCC drafts. 1488.13 Section 1488.13 Agriculture... Agricultural Commodities From Private Stocks Under CCC Export Credit Sales Program (GSM-5) Bank Obligations and Repayment § 1488.13 CCC drafts. CCC will draw one draft for each payment due under bank obligations. If any...

  8. 7 CFR 1488.13 - CCC drafts.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false CCC drafts. 1488.13 Section 1488.13 Agriculture... Agricultural Commodities From Private Stocks Under CCC Export Credit Sales Program (GSM-5) Bank Obligations and Repayment § 1488.13 CCC drafts. CCC will draw one draft for each payment due under bank obligations. If any...

  9. A review of FDA warning letters and notices of violation issued for patient-reported outcomes promotional claims between 2006 and 2012.

    PubMed

    Symonds, Tara; Hackford, Claire; Abraham, Lucy

    2014-06-01

    To ascertain the frequency and types of patient-reported outcome (PRO) violations made in US pharmaceutical promotional materials between 2006 and 2012 and determine whether there were increases in violation warnings after issuance of the Food and Drug Administration (FDA) draft and final PRO Guidance. All warning letters (WLs) or notices of violation (NOVs) issued by the FDA's Office of Prescription Drug Promotion were reviewed for PRO violations (n = 213). Each letter containing a PRO violation was reviewed to determine the type of violation: 1) PRO measure not fit for purpose, 2) study design/interpretation of results, 3) statistical analysis, and 4) no treatment benefit. Forty-one (19%) letters contained information about PRO infringements. Noticeable spikes in letters were shown in 2007 (37%) and 2010 (31%) after the issuance of the draft and final PRO Guidance, respectively. The most common violation was PRO measure not fit for purpose (54%), specifically: use of individual items (45%), insufficient evidence of content validity (36%), and broadening of the claim beyond what the PRO measures (27%). Issues with study design/interpretation of results were also high (49%), particularly broadening of claim beyond what was measured in the trial (55%) and no PRO measure used (50%). A fifth of the letters issued to companies contained PRO violations, with most related to poor selection of the PRO measure used or trying to broaden the claim. More guidance from the Office of Prescription Drug Promotion about what is considered "substantial evidence" in this area could help reduce the number of letters issued. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  10. Basic Drafting: Book One.

    ERIC Educational Resources Information Center

    Davis, Ronald; And Others

    The first of a two-book course in drafting, this manual consists of 13 topics in the following units: introduction to drafting, general safety, basic tools and lines, major equipment, applying for a job, media, lettering, reproduction, drawing sheet layout, architect's scale usage, civil engineer's scale usage, mechanical engineer's scale usage,…

  11. Predicted percentage dissatisfied with ankle draft.

    PubMed

    Liu, S; Schiavon, S; Kabanshi, A; Nazaroff, W W

    2017-07-01

    Draft is unwanted local convective cooling. The draft risk model of Fanger et al. (Energy and Buildings 12, 21-39, 1988) estimates the percentage of people dissatisfied with air movement due to overcooling at the neck. There is no model for predicting draft at ankles, which is more relevant to stratified air distribution systems such as underfloor air distribution (UFAD) and displacement ventilation (DV). We developed a model for predicted percentage dissatisfied with ankle draft (PPD AD ) based on laboratory experiments with 110 college students. We assessed the effect on ankle draft of various combinations of air speed (nominal range: 0.1-0.6 m/s), temperature (nominal range: 16.5-22.5°C), turbulence intensity (at ankles), sex, and clothing insulation (<0.7 clo; lower legs uncovered and covered). The results show that whole-body thermal sensation and air speed at ankles are the dominant parameters affecting draft. The seated subjects accepted a vertical temperature difference of up to 8°C between ankles (0.1 m) and head (1.1 m) at neutral whole-body thermal sensation, 5°C more than the maximum difference recommended in existing standards. The developed ankle draft model can be implemented in thermal comfort and air diffuser testing standards. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. Defining hip fracture with claims data: outpatient and provider claims matter.

    PubMed

    Berry, S D; Zullo, A R; McConeghy, K; Lee, Y; Daiello, L; Kiel, D P

    2017-07-01

    Medicare claims are commonly used to identify hip fractures, but there is no universally accepted definition. We found that a definition using inpatient claims identified fewer fractures than a definition including outpatient and provider claims. Few additional fractures were identified by including inconsistent diagnostic and procedural codes at contiguous sites. Medicare claims data is commonly used in research studies to identify hip fractures, but there is no universally accepted definition of fracture. Our purpose was to describe potential misclassification when hip fractures are defined using Medicare Part A (inpatient) claims without considering Part B (outpatient and provider) claims and when inconsistent diagnostic and procedural codes occur at contiguous fracture sites (e.g., femoral shaft or pelvic). Participants included all long-stay nursing home residents enrolled in Medicare Parts A and B fee-for-service between 1/1/2008 and 12/31/2009 with follow-up through 12/31/2011. We compared the number of hip fractures identified using only Part A claims to (1) Part A plus Part B claims and (2) Part A and Part B claims plus discordant codes at contiguous fracture sites. Among 1,257,279 long-stay residents, 40,932 (3.2%) met the definition of hip fracture using Part A claims, and 41,687 residents (3.3%) met the definition using Part B claims. 4566 hip fractures identified using Part B claims would not have been captured using Part A claims. An additional 227 hip fractures were identified after considering contiguous fracture sites. When ascertaining hip fractures, a definition using outpatient and provider claims identified 11% more fractures than a definition with only inpatient claims. Future studies should publish their definition of fracture and specify if diagnostic codes from contiguous fracture sites were used.

  13. 46 CFR 196.15-5 - Drafts.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 7 2012-10-01 2012-10-01 false Drafts. 196.15-5 Section 196.15-5 Shipping COAST GUARD... Inspections § 196.15-5 Drafts. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and aft, in the official logbook when leaving port. (b) On...

  14. 46 CFR 196.15-5 - Drafts.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 7 2014-10-01 2014-10-01 false Drafts. 196.15-5 Section 196.15-5 Shipping COAST GUARD... Inspections § 196.15-5 Drafts. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and aft, in the official logbook when leaving port. (b) On...

  15. 46 CFR 196.15-5 - Drafts.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 7 2011-10-01 2011-10-01 false Drafts. 196.15-5 Section 196.15-5 Shipping COAST GUARD... Inspections § 196.15-5 Drafts. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and aft, in the official logbook when leaving port. (b) On...

  16. 46 CFR 196.15-5 - Drafts.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 7 2013-10-01 2013-10-01 false Drafts. 196.15-5 Section 196.15-5 Shipping COAST GUARD... Inspections § 196.15-5 Drafts. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and aft, in the official logbook when leaving port. (b) On...

  17. 46 CFR 196.15-5 - Drafts.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Drafts. 196.15-5 Section 196.15-5 Shipping COAST GUARD... Inspections § 196.15-5 Drafts. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and aft, in the official logbook when leaving port. (b) On...

  18. CURRENT PRACTICES OBSERVED IN DESIGN AND DRAFTING OCCUPATIONS.

    ERIC Educational Resources Information Center

    SQUIRES, CARL E.

    DATA WHICH HAD SIGNIFICANCE FOR DESIGN AND DRAFTING CURRICULUMS WERE COLLECTED BY DIRECT OBSERVATION OF 21 DESIGN AND DRAFTING FACTORS WITHIN 16 SELECTED INDUSTRIAL COMPANIES EMPLOYING 869 DESIGNERS AND DRAFTSMEN. OBSERVATIONS COVERED (1) THE NUMBER OF DESIGN AND DRAFTING EMPLOYEES, (2) THE SYSTEM OF DRAFTING ROOM ORGANIZATION, (3) JOB…

  19. Microbial status and product labelling of 58 original tattoo inks.

    PubMed

    Høgsberg, T; Saunte, D M; Frimodt-Møller, N; Serup, J

    2013-01-01

    European Council resolutions on tattoo ink introduce sterility and preservation of inks to protect customers. Inks used in Denmark are typically purchased over the internet from international suppliers and manufacturers from the US and the UK. In Denmark tattoo inks are regulated and labelled according to REACH as if they were plain chemicals. The objective of this study was to check the microbial product safety of unopened and opened tattoo ink stock bottles. Packaging, labelling, preservation, sterility and contamination with micro-organisms were studied. Physical inspection and culture of bacteria and fungi. Six of 58 unopened stock bottles (10%) were contaminated with bacteria and one of six samples (17%) of previously used stock bottles was contaminated. The bacterial species represented bacteria considered pathogenic in humans as well as non-pathogenic environmental bacteria. Yeast or moulds were detected in none of the samples. A total of 31% of the manufacturers informed only about the brand name. No information about content, sterility, risks or expiry date was indicated on the label. A total of 42% claimed sterility of their inks. A total of 54% labelled a maximum period of durability of typically 2-3 years. The physical sealing was leaking in 28% of the products. The European Council resolutions regarding safety of tattoo inks are not effective. Stock bottles of tattoo ink may contain bacteria pathogenic to humans and environmental bacteria, and packaging, labelling and preservation of inks are of inadequate quality. Claim of sterility can be erroneous. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

  20. Mississippi Curriculum Framework for General Drafting (Program CIP: 48.0101--Drafting, General). Secondary Programs.

    ERIC Educational Resources Information Center

    Mississippi Research and Curriculum Unit for Vocational and Technical Education, State College.

    This document, which reflects Mississippi's statutory requirement that instructional programs be based on core curricula and performance-based assessment, contains outlines of the instructional units required in local instructional management plans and daily lesson plans for two secondary-level courses in drafting: drafting I and II. Presented…

  1. Outstanding Questions In First Amendment Law Related To Food Labeling Disclosure Requirements For Health.

    PubMed

    Pomeranz, Jennifer L

    2015-11-01

    The federal and state governments are increasingly focusing on food labeling as a method to support good health. Many such laws are opposed by the food industry and may be challenged in court, raising the question of what is legally feasible. This article analyzes outstanding questions in First Amendment law related to commercial disclosure requirements and conducts legal analysis and policy evaluation for three current policies. These include the Food and Drug Administration's draft regulation requiring an added sugar disclosure on the Nutrition Facts panel, California's proposed sugar-sweetened beverage safety warning label bill, and Vermont's law requiring labels of genetically engineered food to disclose this information. I recommend several methods for policy makers to enact food labeling laws within First Amendment parameters, including imposing factual commercial disclosure requirements, disclosing the government entity issuing a warning, collecting evidence, and identifying legitimate governmental interests. Project HOPE—The People-to-People Health Foundation, Inc.

  2. Aeronautical Drafting, Drafting 3: 9257.02.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    Intended for students interested in the aircraft and missile field of engineering and drafting, the course covers fundamentals, working drawings, and auxiliary views and sections that are related to this field. Considered advanced training, a prerequisite for the course is mastery of the skills indicated in Electrical and Electronic…

  3. 76 FR 65744 - Draft Environmental Assessment and Draft Habitat Conservation Plan for Lower Colorado River...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ...] Draft Environmental Assessment and Draft Habitat Conservation Plan for Lower Colorado River Authority... of availability of documents and announcement of public hearings. SUMMARY: The Lower Colorado River... issuance of an incidental take permit (ITP) to Lower Colorado River Authority Transmission Services...

  4. 76 FR 9345 - Soule Hydro, LLC; Notice of Draft License Application and Preliminary Draft Environmental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ...] Soule Hydro, LLC; Notice of Draft License Application and Preliminary Draft Environmental Assessment (PDEA) and Request for Preliminary Terms and Conditions Take notice that the following hydroelectric... Project: With this notice the Commission is soliciting (1) preliminary terms, conditions, and...

  5. Legal and Public Health Considerations Affecting the Success, Reach, and Impact of Menu-Labeling Laws

    PubMed Central

    Pomeranz, Jennifer L.; Brownell, Kelly D.

    2008-01-01

    Because the rate of consumption of away-from-home meals has increased dramatically, the distinction between requiring nutrition information for packaged but not restaurant products is no longer reasonable. Public health necessitates that nutrition labels must be included with restaurant menus as a strategy to educate consumers and address the escalation of obesity. Menu-labeling laws are being considered at the local, state, and federal levels, but the restaurant industry opposes such action. We discuss the public health rationale and set forth the government’s legal authority for the enactment of menu-labeling laws. We further aim to educate the public health community of the potential legal challenges to such laws, and we set forth methods for governments to survive these challenges by drafting laws according to current legal standards. PMID:18633081

  6. Legal and public health considerations affecting the success, reach, and impact of menu-labeling laws.

    PubMed

    Pomeranz, Jennifer L; Brownell, Kelly D

    2008-09-01

    Because the rate of consumption of away-from-home meals has increased dramatically, the distinction between requiring nutrition information for packaged but not restaurant products is no longer reasonable. Public health necessitates that nutrition labels must be included with restaurant menus as a strategy to educate consumers and address the escalation of obesity. Menu-labeling laws are being considered at the local, state, and federal levels, but the restaurant industry opposes such action. We discuss the public health rationale and set forth the government's legal authority for the enactment of menu-labeling laws. We further aim to educate the public health community of the potential legal challenges to such laws, and we set forth methods for governments to survive these challenges by drafting laws according to current legal standards.

  7. Food labels, autonomy, and the right (not) to know.

    PubMed

    Bonotti, Matteo

    2014-12-01

    Food labelling has been overlooked in the emerging body of literature concerning the normative dimensions of food and drink policies. In this paper, I argue that arguments normally advanced in bioethics and medical ethics regarding the "right to know" and the "right not to know" can provide useful normative guidelines for critically assessing existing and proposed food labelling regimes. More specifically, I claim that food labelling ought to respect the legitimate interests and the autonomy of both consumers who seek knowledge about their food in order to make informed dietary choices and consumers who prefer to remain ignorant about the contents and effects of their food in order to avoid the emotional and psychological harm, or more simply the loss of enjoyment, which may result from receiving that information.

  8. Influence of time orientation on food choice: Case study with cookie labels.

    PubMed

    Tórtora, Giuliana; Ares, Gastón

    2018-04-01

    Time orientation can influence health-related behaviors, including food consumption. The aim of the present work was to study the influence of time orientation on food choice, using cookie labels as case study. A choice-conjoint task was designed using labels differing in type of cookie (chocolate chips vs. granola), front-of-pack nutrition information (nutritional warnings vs. Facts Up Front system) and nutritional claim (no claim vs. "0% cholesterol. 0% trans fat"). An online study was conducted, in which 155 participants evaluated 8 pairs of cookie labels and selected the one they would buy if they were in the supermarket. Then, they were asked to complete a consideration of future consequences scale (CFC) adapted to eating habits, as well as a questionnaire about socio-demographic characteristics. Time orientation influenced participants' choices of cookies labels; particularly the importance attached to type of cookie. Participants with greater consideration of future consequences preferred the granola cookies, associated with health, while those who prioritized immediate consequences preferred chocolate chip cookies. In addition, nutritional warnings discouraged choice regardless of participants' time orientation. Results from the present work provide additional evidence of the influence of time preferences on food choices and suggest that strategies to stimulate and generate a more future-oriented perspective on eating habits could contribute to more healthful food choices. Copyright © 2018 Elsevier Ltd. All rights reserved.

  9. Architectural Drafting, Drafting 2: 9255.04.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course covers the basic fundamentals of architectural drafting and is not intended to delve into the more advanced phases of architecture. The student is presented with standards and procedures, and will become proficient in layout of floor plans, electrical plans, roof construction, foundation plans, typical wall construction, plot plans, and…

  10. 76 FR 50490 - Draft Comprehensive Conservation Plan and Draft Environmental Impact Statement, Arctic National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... draft CCP and draft EIS'' in the subject line of the message. Fax: Attn: Sharon Seim, Planning Team Leader, (907) 456-0428. U.S. Mail: Sharon Seim, Planning Team Leader, Arctic National Wildlife Refuge... CONTACT: Sharon Seim, Planning Team Leader, at the address listed above, by phone at (907) 456-0501, or by...

  11. Small Claims Court.

    ERIC Educational Resources Information Center

    McKitric, Eloise; Davis, Janet

    The study examined individuals and companies who used small claims courts and the results of decisions reached in small claims cases. A review of studies including an empirical study of two Ohio small claims courts monitored for 12 months made it clear that small claims courts need to be examined to determine if utilization and accessibility to…

  12. 32 CFR 536.74 - Scope for claims under the Military Claims Act.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (normally a resident) of the United States at the time of the incident giving rise to the claim. See § 536... AND ACCOUNTS CLAIMS AGAINST THE UNITED STATES Claims Cognizable Under the Military Claims Act § 536.74... claims against the United States for death or personal injury, or damage to, or loss or destruction of...

  13. 32 CFR 536.74 - Scope for claims under the Military Claims Act.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (normally a resident) of the United States at the time of the incident giving rise to the claim. See § 536... AND ACCOUNTS CLAIMS AGAINST THE UNITED STATES Claims Cognizable Under the Military Claims Act § 536.74... claims against the United States for death or personal injury, or damage to, or loss or destruction of...

  14. Hip Arthroplasty Malpractice Claims in the Netherlands: Closed Claim Study 2000-2012.

    PubMed

    Zengerink, Imme; Reijman, Max; Mathijssen, Nina M C; Eikens-Jansen, Manon P; Bos, P Koen

    2016-09-01

    A total hip arthroplasty (THA) is a successful and reliable operation with few complications. These complications however, do form a potential source for compensation claims. In the Netherlands, there are no studies available concerning filed claims after THA. The aim of this study was to determine the incidence of claims related to THAs in the Netherlands and the reasons to claim, which claims lead to compensation, the costs involved for the insurer, and the demographics of the claimants. In this observational study, we analyzed all closed claims from 2000 to 2012 from the national largest insurer of medical liability and compared it to data from our national implant registry in the Netherlands. With the intention to contribute to prevention, we have identified the demographics of the claimant, the reasons for filing claims, and the outcome of claims. Overall, 516 claims were expressed in 280 closed claim files after THA. Claims were most often related to sciatic nerve injury (19.6%). Most claimants were women (71.6%) with an average age of 63.1 years. The median cost per compensated claim is €5.921. The claimant is more likely to be female and to be younger than the average patient receiving a THA. The incidence of a claim after a THA is 0.14%-0.30%. Nerve damage is the most common reason to file for compensation. The distribution in reasons to claim does not resemble the complication rate in literature after a THA. The outcome of this study can be used to improve patient care, safety, and costs. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  16. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  17. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  18. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  19. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  20. Testing consumer perception of nutrient content claims using conjoint analysis.

    PubMed

    Drewnowski, Adam; Moskowitz, Howard; Reisner, Michele; Krieger, Bert

    2010-05-01

    The US Food and Drug Administration (FDA) proposes to establish standardized and mandatory criteria upon which front-of-pack (FOP) nutrition labelling must be based. The present study aimed to estimate the relative contribution of declared amounts of different nutrients to the perception of the overall 'healthfulness' of foods by the consumer. Protein, fibre, vitamin A, vitamin C, calcium and iron were nutrients to encourage. Total fat, saturated fat, cholesterol, total and added sugar, and sodium were the nutrients to limit. Two content claims per nutrient used the FDA-approved language. An online consumer panel (n 320) exposed to multiple messages (n 48) rated the healthfulness of each hypothetical food product. Utility functions were constructed using conjoint analysis, based on multiple logistic regression and maximum likelihood estimation. Consumer perception of healthfulness was most strongly driven by the declared presence of protein, fibre, calcium and vitamin C and by the declared total absence of saturated fat and sodium. For this adult panel, total and added sugar had lower utilities and contributed less to the perception of healthfulness. There were major differences between women and men. Conjoint analysis can lead to a better understanding of how consumers process information about the full nutrition profile of a product, and is a powerful tool for the testing of nutrient content claims. Such studies can help the FDA develop science-based criteria for nutrient profiling that underlies FOP and shelf labelling.

  1. 1 CFR 21.1 - Drafting.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 1 General Provisions 1 2011-01-01 2011-01-01 false Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...

  2. 1 CFR 21.1 - Drafting.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 1 General Provisions 1 2010-01-01 2010-01-01 false Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...

  3. 1 CFR 21.1 - Drafting.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 1 General Provisions 1 2013-01-01 2012-01-01 true Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...

  4. 1 CFR 21.1 - Drafting.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 1 General Provisions 1 2012-01-01 2012-01-01 false Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...

  5. 1 CFR 21.1 - Drafting.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 1 General Provisions 1 2014-01-01 2012-01-01 true Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...

  6. Nutritional quality of packaged foods targeted at children in Brazil: which ones should be eligible to bear nutrient claims?

    PubMed

    Rodrigues, V M; Rayner, M; Fernandes, A C; de Oliveira, R C; Proença, R P C; Fiates, G M R

    2017-01-01

    This study aimed to assess the nutritional quality of food products marketed at children, with and without nutrient claims, using two different approaches. Analyses were performed based on a data set with food composition and labelling data from every packaged food marketed at children sold in a major Brazilian supermarket (n=535). Foods were classified as 'healthier' and 'less healthy' according to the UK/Ofcom nutrient profile model and to the NOVA classification based on the level of food processing. Pearson's χ 2 test was used to compare proportions between models. Agreement was assessed using Cohen's κ-statistic (P<0.05). The NOVA model was stricter than the UK/Ofcom model, classifying more products as 'less healthy' (91.4%) compared with the nutrient profile-based model (75.0%; P<0.001). Agreement between models was 79.4% (k=0.30), because 72.9% (n=390) of products were categorised as 'less healthy' by both models, and 6.5% (n=35) as 'healthier'. Half of the food products marketed at children from the database (270; 50.5%) bore nutrient claims. From these products with nutrient claims, 95.9% (92.8-98.0) were classified as 'less healthy' by the NOVA model, whereas this percentage was 74.1% (68.4-79.2) according to the UK/Ofcom model (P<0.05). The high number of foods with low nutritional quality being marketed at children via product packaging and nutrient claims should be of concern to policy makers wanting to improve children's diets and to tackle childhood obesity. The implementation of nutritional quality criteria to ensure that foods targeted at children should be eligible to bear nutrient claims on their labels could avoid a situation where claims mask the overall nutritional status of a food.

  7. New FDA draft guidance on immunogenicity.

    PubMed

    Parenky, Ashwin; Myler, Heather; Amaravadi, Lakshmi; Bechtold-Peters, Karoline; Rosenberg, Amy; Kirshner, Susan; Quarmby, Valerie

    2014-05-01

    A "Late Breaking" session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss the US Food and Drug Administration's (FDA) 2013 draft guidance on Immunogenicity Assessment for Therapeutic Protein Products. The session was initiated by a presentation from the FDA which highlighted several key aspects of the 2013 draft guidance pertaining to immunogenicity risk, the potential impact on patient safety and product efficacy, and risk mitigation. This was followed by an open discussion on the draft guidance which enabled delegates from biopharmaceutical companies to engage the FDA on topics that had emerged from their review of the draft guidance. The multidisciplinary audience fostered an environment that was conducive to scientific discussion on a broad range of topics such as clinical impact, immune mitigation strategies, immune prediction and the role of formulation, excipients, aggregates, and degradation products in immunogenicity. This meeting report highlights several key aspects of the 2013 draft guidance together with related dialog from the session.

  8. IRIS Toxicological Review of Ammonia (Revised External Review Draft)

    EPA Science Inventory

    In August 2013, EPA submitted a revised draft IRIS assessment of ammonia to the agency's Science Advisory Board (SAB) and posted this draft on the IRIS website. EPA had previously released a draft of the assessment for public comment, held a public meeting about the draft, and ...

  9. Teaching Legislative Drafting: A Simulation Approach.

    ERIC Educational Resources Information Center

    Stern, Barry Jeffrey

    1988-01-01

    An approach to teaching legislative drafting uses limited traditional classroom instruction and intensive exposure to the process of legislative drafting through a classroom simulation in which students revise the Massachusetts criminal code. (MSE)

  10. 49 CFR 230.92 - Draw gear and draft systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Draw gear and draft systems. 230.92 Section 230.92 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Tenders Draw Gear and Draft Systems § 230.92 Draw gear and draft systems. Couplers, draft gear and...

  11. 49 CFR 230.92 - Draw gear and draft systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Draw gear and draft systems. 230.92 Section 230.92 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Tenders Draw Gear and Draft Systems § 230.92 Draw gear and draft systems. Couplers, draft gear and...

  12. 49 CFR 230.92 - Draw gear and draft systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false Draw gear and draft systems. 230.92 Section 230.92 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Tenders Draw Gear and Draft Systems § 230.92 Draw gear and draft systems. Couplers, draft gear and...

  13. 49 CFR 230.92 - Draw gear and draft systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Draw gear and draft systems. 230.92 Section 230.92 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Tenders Draw Gear and Draft Systems § 230.92 Draw gear and draft systems. Couplers, draft gear and...

  14. 49 CFR 230.92 - Draw gear and draft systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Draw gear and draft systems. 230.92 Section 230.92 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Tenders Draw Gear and Draft Systems § 230.92 Draw gear and draft systems. Couplers, draft gear and...

  15. Assessment of health claims, content, and safety of herbal supplements containing Ginkgo biloba

    PubMed Central

    Fransen, Heidi P.; Pelgrom, Sylvia M.G.J.; Stewart-Knox, Barbara; de Kaste, Dries; Verhagen, Hans

    2010-01-01

    Background European Regulation 1924/2006 states that all health claims made on foods need to be substantiated scientifically. Objective To apply the PASSCLAIM criteria for the scientific substantiation of health claims on foods to herbal supplements containing Ginkgo biloba. Evaluation of three selected claimed health effects for G. biloba (improvement of blood circulation, improvement of symptoms of old age, and improvement of memory) was achieved through review of publicly available scientific data. A total of 35 human intervention studies were evaluated. Commercially available products claimed to contain mainly G. biloba (N=29) were randomly sampled in the Netherlands and analyzed for their content on ginkgo extract. Also, a toxicological risk assessment was performed. Results The three selected health claims investigated could not be substantiated. This was mainly because of a lack of data from studies in healthy volunteers. In most studies results performed with a 24% standardized G. biloba extract were described. However, our chemical analysis showed that 25 of the 29 sampled products did not contain the required minimum 24% standardized extract. Moreover, in most preparations the content of substances typical for G. biloba did not conform to what was declared on the label. Since toxicity data for G. biloba are very limited, a safety limit could not be established. Conclusions Evidence is lacking for three health claims of herbal products with G. biloba. Neither safety nor efficacy can be guaranteed at the recommended daily dose. The multidisciplinary approach described in this paper provides good insight into issues that are relevant for the evaluation of health claims for herbal food supplements. PMID:20927202

  16. 75 FR 3760 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-22

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0018] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory...) is issuing for public comment a draft guide in the agency's ``Regulatory Guide'' series. This series...

  17. 75 FR 20645 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0158] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory... draft guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make...

  18. 77 FR 33489 - Draft Offender Tracking System Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... Tracking System Standard AGENCY: National Institute of Justice. ACTION: Notice of Draft Offender Tracking System Standard, Selection and Application Guide, and Certification Program Requirements. SUMMARY: In an...) A draft standard entitled, ``Offender Tracking System Standard'' (2) a draft companion document...

  19. Computer Aided Drafting. Instructor's Guide.

    ERIC Educational Resources Information Center

    Henry, Michael A.

    This guide is intended for use in introducing students to the operation and applications of computer-aided drafting (CAD) systems. The following topics are covered in the individual lessons: understanding CAD (CAD versus traditional manual drafting and care of software and hardware); using the components of a CAD system (primary and other input…

  20. Pediatric radiology malpractice claims - characteristics and comparison to adult radiology claims.

    PubMed

    Breen, Micheál A; Dwyer, Kathy; Yu-Moe, Winnie; Taylor, George A

    2017-06-01

    Medical malpractice is the primary method by which people who believe they have suffered an injury in the course of medical care seek compensation in the United States and Canada. An increasing body of research demonstrates that failure to correctly diagnose is the most common allegation made in malpractice claims against radiologists. Since the 1994 survey by the Society of Chairmen of Radiology in Children's Hospitals (SCORCH), no other published studies have specifically examined the frequency or clinical context of malpractice claims against pediatric radiologists or arising from pediatric imaging interpretation. We hypothesize that the frequency, character and outcome of malpractice claims made against pediatric radiologists differ from those seen in general radiology practice. We searched the Controlled Risk Insurance Co. (CRICO) Strategies' Comparative Benchmarking System (CBS), a private repository of approximately 350,000 open and closed medical malpractice claims in the United States, for claims related to pediatric radiology. We further queried these cases for the major allegation, the clinical environment in which the claim arose, the clinical severity of the alleged injury, indemnity paid (if payment was made), primary imaging modality involved (if applicable) and primary International Classification of Diseases, 9th revision (ICD-9) diagnosis underlying the claim. There were a total of 27,056 fully coded claims of medical malpractice in the CBS database in the 5-year period between Jan. 1, 2010, and Dec. 31, 2014. Of these, 1,472 cases (5.4%) involved patients younger than 18 years. Radiology was the primary service responsible for 71/1,472 (4.8%) pediatric cases. There were statistically significant differences in average payout for pediatric radiology claims ($314,671) compared to adult radiology claims ($174,033). The allegations were primarily diagnosis-related in 70% of pediatric radiology claims. The most common imaging modality implicated in

  1. 75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0148] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

  2. 75 FR 45166 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0265] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

  3. 76 FR 6086 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... NUCLEAR REGULATORY COMMISSION 10 CFR Part 73 [NRC-2011-0015] RIN 3150-AI49 Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Availability of Draft... comment Draft Regulatory Guide, DG-5020, ``Applying for Enhanced Weapons Authority, Applying for...

  4. 78 FR 77027 - Overhead Clearance (Air-Draft) Accidents

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-20

    ... No. USCG-2013-0466] Overhead Clearance (Air-Draft) Accidents AGENCY: Coast Guard, DHS. ACTION... clearance (air-draft) accidents. In its petition, which calls for vessel masters to be provided with accurate vertical air draft information, a maritime organization has described 16 overhead clearance...

  5. 76 FR 6085 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ...-2011-0014] RIN 3150-AI49 Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice Availability of Draft Regulatory Guide. SUMMARY: The U.S. Nuclear Regulatory Commission (Commission or NRC) is issuing for public comment Draft Regulatory Guide, DG-5019, ``Reporting and...

  6. Investigation of Improper Disclosure of For Official Use Only Information from the Comprehensive Review Working Group Draft Report

    DTIC Science & Technology

    2011-04-08

    and sealed in brown envelopes and the envelopes bound together with a large rubber band. The top envelope had an affixed label printed in 25 font ...red text with the words "EYES ONLY" and the name of the recipient in 18 font red text, all underlined. In addition to the draft Report and...Marine Corps, Retired Commander two copies. One from Mr. Paul & :Mr. Juan Garcia Captain Copy made by Executive Asst to Mr. Robert Work USMC Colonel

  7. Effects of Categorical Labels on Similarity Judgments: A Critical Evaluation of a Critical Analysis--Comment on Noles and Gelman (2012)

    ERIC Educational Resources Information Center

    Sloutsky, Vladimir M.; Fisher, Anna V.

    2012-01-01

    Noles and Gelman (2012) attempt to critically reevaluate the claim that linguistic labels affect children's judgments of visual similarity. They report results of an experiment that used a modified version of Sloutsky and Fisher's (2004) task and conclude that "labels do not generally affect children's perceptual similarity judgments; rather,…

  8. Cluster: Drafting. Course: Architectural Drafting. Research Project.

    ERIC Educational Resources Information Center

    Sanford - Lee County Schools, NC.

    The sequence of 10 units is designed for use with an instructor in architectural drafting, and is also keyed to other texts. Each unit contains several task packages specifying prerequisites, rationale for learning, objectives, learning activities to be supervised by the instructor, and learning practice. The units cover: architectural lettering…

  9. Modeling number of claims and prediction of total claim amount

    NASA Astrophysics Data System (ADS)

    Acar, Aslıhan Şentürk; Karabey, Uǧur

    2017-07-01

    In this study we focus on annual number of claims of a private health insurance data set which belongs to a local insurance company in Turkey. In addition to Poisson model and negative binomial model, zero-inflated Poisson model and zero-inflated negative binomial model are used to model the number of claims in order to take into account excess zeros. To investigate the impact of different distributional assumptions for the number of claims on the prediction of total claim amount, predictive performances of candidate models are compared by using root mean square error (RMSE) and mean absolute error (MAE) criteria.

  10. Origins of the prohibition against off-label promotion.

    PubMed

    Coleman, Terry S

    2014-01-01

    The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretations and regulatory provisions relied on by the government to take enforcement action against off-label promotion are the incidental by-products of initiatives undertaken by FDA through administrative action and litigation early in its implementation of the Federal Food, Drug, and Cosmetic Act. The actions were designed to obtain FDA authority over therapeutic claims made in advertising, even though Congress had assigned authority over advertising to the Federal Trade Commission, and to establish a prescription-only drug system, even though FDA lacked statutory authority for such a system. The principal purpose of both efforts was to prevent inappropriate self-medication. This article describes the history of those strategies, including expansion of the definition of the term "labeling" to encompass matter that was initially regarded as advertising; creation of the rule that the labeling of drugs must have adequate directions for all "intended" uses; and construction of the prescription-only drug system in a manner that allowed FDA to use the statutory requirement for labeling to have "adequate directions for use" to prohibit the off-label promotion of prescription drugs.

  11. Food label usage and reported difficulty with following a gluten-free diet among individuals in the USA with coeliac disease and those with noncoeliac gluten sensitivity.

    PubMed

    Verrill, L; Zhang, Y; Kane, R

    2013-10-01

    Individuals with coeliac disease (CD) and those with noncoeliac gluten sensitivity (GS) have reported difficulty following a gluten-free diet (GFD); however, few studies have explored the link between the food label, gluten-free (GF) claims and the difficulty associated with following a GFD. The present study surveyed adults with CD (n = 1,583) and adults with GS (n = 797) about their reported difficulty following a GFD, including assessing the role of food labels and GF claims, as well as other factors known to contribute to this difficulty. A two-sample t-test and chi-squared tests for equality of means or proportions were used for the descriptive data and ordinal logistic regression (OLR) was used to model associations. On average, individuals with GS reported slightly more difficulty following the GFD than did participants with CD. According to the OLR results, reading the food label often was significantly associated with less reported difficulty following a GFD, whereas consuming packaged processed foods and looking for GF claims more often were significantly associated with more reported difficulty for both respondent groups. Individuals with GS may rely more heavily on the GF claim for information about a product's gluten content. Individuals with CD, on the other hand, may be more experienced food label readers and may rely more on the ingredient list for finding GF foods. More studies are needed aiming to understand the role of the food label in facilitating consumers' ability to follow a GFD. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

  12. 23 CFR 771.123 - Draft environmental impact statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 23 Highways 1 2013-04-01 2013-04-01 false Draft environmental impact statements. 771.123 Section... ENVIRONMENT ENVIRONMENTAL IMPACT AND RELATED PROCEDURES § 771.123 Draft environmental impact statements. (a) A draft EIS shall be prepared when the Administration determines that the action is likely to cause...

  13. 23 CFR 771.123 - Draft environmental impact statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 23 Highways 1 2012-04-01 2012-04-01 false Draft environmental impact statements. 771.123 Section... ENVIRONMENT ENVIRONMENTAL IMPACT AND RELATED PROCEDURES § 771.123 Draft environmental impact statements. (a) A draft EIS shall be prepared when the Administration determines that the action is likely to cause...

  14. 23 CFR 771.123 - Draft environmental impact statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 23 Highways 1 2014-04-01 2014-04-01 false Draft environmental impact statements. 771.123 Section... ENVIRONMENT ENVIRONMENTAL IMPACT AND RELATED PROCEDURES § 771.123 Draft environmental impact statements. (a) A draft EIS shall be prepared when the Administration determines that the action is likely to cause...

  15. Ambulatory care and the law: lien claims where none exist as of right.

    PubMed

    Balko, G A

    1995-01-01

    The health care provider, whether an individual or an institution, needs to pay attention to appropriate mechanisms to ensure payment for services or repayment for benefits provided. While statutes provide some protection for large institutions, including health care providers, individual health care providers often are left to their own devices. The employment of a well drafted voluntary lien agreement can not only secure a right of recover against a patient, but where the patient pursues a personal injury claim through an attorney, can also give the health care provider recourse to patient's attorney. Knowing how to assert these liens, what funds are reachable by these lien, and what time factors must be adhered to in order to make the liens effective, are vital to a health care provider's financial well-being.

  16. 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...

  17. Drafting.

    ERIC Educational Resources Information Center

    Hughes, Larry R.

    This guide to teaching drafting, one in a series of instructional materials for junior high industrial arts education, is designed to assist teachers as they plan and implement new courses of study and as they make revisions and improvements in existing courses in order to integrate classroom learning with real-life experiences. This drafting…

  18. Revision of Electro-Mechanical Drafting Program to Include CAD/D (Computer-Aided Drafting/Design). Final Report.

    ERIC Educational Resources Information Center

    Snyder, Nancy V.

    North Seattle Community College decided to integrate computer-aided design/drafting (CAD/D) into its Electro-Mechanical Drafting Program. This choice necessitated a redefinition of the program through new curriculum and course development. To initiate the project, a new industrial advisory council was formed. Major electronic and recruiting firms…

  19. Automated drafting system uses computer techniques

    NASA Technical Reports Server (NTRS)

    Millenson, D. H.

    1966-01-01

    Automated drafting system produces schematic and block diagrams from the design engineers freehand sketches. This system codes conventional drafting symbols and their coordinate locations on standard size drawings for entry on tapes that are used to drive a high speed photocomposition machine.

  20. Cluster: Drafting. Course: Introduction to Technical Drafting.

    ERIC Educational Resources Information Center

    Sanford - Lee County Schools, NC.

    The set of 10 units is designed for use with an instructor as an introduction to technical drafting, and is also keyed to other texts. Each unit contains several task packages specifying prerequisites, rationale for learning, objectives, learning activities to be supervised by the instructor, and learning practice. The units cover: drafting…

  1. 19 CFR 207.63 - Circulation of draft questionnaires.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 19 Customs Duties 3 2012-04-01 2012-04-01 false Circulation of draft questionnaires. 207.63... SUBSIDIZED EXPORTS TO THE UNITED STATES Five-Year Reviews § 207.63 Circulation of draft questionnaires. (a) The Director shall circulate draft questionnaires to the parties for comment in each full review. (b...

  2. 19 CFR 207.63 - Circulation of draft questionnaires.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 19 Customs Duties 3 2011-04-01 2011-04-01 false Circulation of draft questionnaires. 207.63... SUBSIDIZED EXPORTS TO THE UNITED STATES Five-Year Reviews § 207.63 Circulation of draft questionnaires. (a) The Director shall circulate draft questionnaires to the parties for comment in each full review. (b...

  3. 19 CFR 207.63 - Circulation of draft questionnaires.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 19 Customs Duties 3 2013-04-01 2013-04-01 false Circulation of draft questionnaires. 207.63... SUBSIDIZED EXPORTS TO THE UNITED STATES Five-Year Reviews § 207.63 Circulation of draft questionnaires. (a) The Director shall circulate draft questionnaires to the parties for comment in each full review. (b...

  4. 19 CFR 207.63 - Circulation of draft questionnaires.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 19 Customs Duties 3 2014-04-01 2014-04-01 false Circulation of draft questionnaires. 207.63... SUBSIDIZED EXPORTS TO THE UNITED STATES Five-Year Reviews § 207.63 Circulation of draft questionnaires. (a) The Director shall circulate draft questionnaires to the parties for comment in each full review. (b...

  5. 19 CFR 207.63 - Circulation of draft questionnaires.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Circulation of draft questionnaires. 207.63... SUBSIDIZED EXPORTS TO THE UNITED STATES Five-Year Reviews § 207.63 Circulation of draft questionnaires. (a) The Director shall circulate draft questionnaires to the parties for comment in each full review. (b...

  6. "Off Label" Use of FDA-Approved Devices and Digital Breast Tomosynthesis.

    PubMed

    Kopans, Daniel B

    2015-11-01

    The purpose of this article is to clarify for radiologists the meaning of U.S. Food and Drug Administration (FDA) approval with respect to Digital Breast Tomosynthesis (DBT). DBT is a major improvement over 2D mammography in the detection of cancers (sensitivity) and the reduction in recalls resulting from screening (specificity). Most imaging systems that have been approved by the FDA are used "off label" for breast imaging. Although the FDA determines which claims a manufacturer can make for a device, physicians may use approved devices, such as DBT, off label to provide better patient care.

  7. 10 CFR 51.86 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.86 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and any...

  8. 10 CFR 51.81 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.81 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and...

  9. 10 CFR 51.86 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.86 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and any...

  10. 10 CFR 51.86 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.86 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and any...

  11. 10 CFR 51.81 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.81 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and...

  12. 10 CFR 51.81 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.81 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and...

  13. 10 CFR 51.81 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.81 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and...

  14. 10 CFR 51.81 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.81 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and...

  15. 10 CFR 51.86 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.86 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and any...

  16. 10 CFR 51.86 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.86 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and any...

  17. The Physics of Bump Drafting in Car Racing

    ERIC Educational Resources Information Center

    Fiolhais, Miguel C. N.; Amor dos Santos, Susana

    2014-01-01

    The technique of bump drafting, also known as two-car drafting in motorsports, is analysed in the framework of Newtonian mechanics and simple aerodynamic drag forces. As an apparent unnatural effect that often pleases the enthusiasts of car racing, bump drafting provides a unique pedagogical opportunity for students to gain insights into the…

  18. 49 CFR 238.433 - Draft system.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Draft system. 238.433 Section 238.433 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Equipment § 238.433 Draft system. (a) Leading and trailing automatic couplers of trains shall be compatible...

  19. 49 CFR 238.433 - Draft system.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Draft system. 238.433 Section 238.433 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Equipment § 238.433 Draft system. (a) Leading and trailing automatic couplers of trains shall be compatible...

  20. 49 CFR 238.433 - Draft system.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Draft system. 238.433 Section 238.433 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Equipment § 238.433 Draft system. (a) Leading and trailing automatic couplers of trains shall be compatible...

  1. 49 CFR 238.433 - Draft system.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false Draft system. 238.433 Section 238.433 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Equipment § 238.433 Draft system. (a) Leading and trailing automatic couplers of trains shall be compatible...

  2. 49 CFR 238.433 - Draft system.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Draft system. 238.433 Section 238.433 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Equipment § 238.433 Draft system. (a) Leading and trailing automatic couplers of trains shall be compatible...

  3. 10 CFR 51.80 - Draft environmental impact statement-materials license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-materials license. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.80 Draft environmental impact statement—materials license. (a) The NRC staff will either prepare a draft environmental...

  4. 10 CFR 51.80 - Draft environmental impact statement-materials license.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Draft environmental impact statement-materials license. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.80 Draft environmental impact statement—materials license. (a) The NRC staff will either prepare a draft environmental...

  5. 10 CFR 51.80 - Draft environmental impact statement-materials license.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Draft environmental impact statement-materials license. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.80 Draft environmental impact statement—materials license. (a) The NRC staff will either prepare a draft environmental...

  6. 10 CFR 51.80 - Draft environmental impact statement-materials license.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Draft environmental impact statement-materials license. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.80 Draft environmental impact statement—materials license. (a) The NRC staff will either prepare a draft environmental...

  7. 10 CFR 51.80 - Draft environmental impact statement-materials license.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Draft environmental impact statement-materials license. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.80 Draft environmental impact statement—materials license. (a) The NRC staff will either prepare a draft environmental...

  8. Orientation, Sketching, Mechanical Drawing, Drafting--Basic: 9253.01.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course introduces the student to the drafting trade, freehand sketching, and basic mechanical drawing. The course has no prerequisites and will guide the student into drafting concepts and serve as a foundation for further study in vocational drafting. Requiring a total of 45 class hours, eight hours are utilized in orientation, 15 hours are…

  9. 46 CFR 131.510 - Draft and loadline markings.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Draft and loadline markings. 131.510 Section 131.510..., Drills, and Inspections § 131.510 Draft and loadline markings. (a) The master of each vessel on an ocean or coastwise voyage shall enter in the vessel's logbook the drafts of the vessel, forward and aft...

  10. 46 CFR 131.510 - Draft and loadline markings.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Draft and loadline markings. 131.510 Section 131.510..., Drills, and Inspections § 131.510 Draft and loadline markings. (a) The master of each vessel on an ocean or coastwise voyage shall enter in the vessel's logbook the drafts of the vessel, forward and aft...

  11. 46 CFR 131.510 - Draft and loadline markings.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Draft and loadline markings. 131.510 Section 131.510..., Drills, and Inspections § 131.510 Draft and loadline markings. (a) The master of each vessel on an ocean or coastwise voyage shall enter in the vessel's logbook the drafts of the vessel, forward and aft...

  12. "Organic," "natural," and "additive-free" cigarettes: Comparing the effects of advertising claims and disclaimers on perceptions of harm.

    PubMed

    Baig, Sabeeh A; Byron, M Justin; Lazard, Allison J; Brewer, Noel T

    2018-02-26

    The U.S. Tobacco Control Act restricts advertising or labeling that suggests one tobacco product is less harmful than another. We sought to examine how "organic," "natural," and "additive-free" advertising claims and corresponding disclaimers affect perceptions of cigarettes' harm. Participants were a national probability sample of adults in the U.S. (n = 1,114, including 344 smokers). We conducted a 5 (claim) × 2 (disclaimer) between-subjects factorial experiment. Participants viewed a Natural American Spirit cigarettes ad claiming they were "organic," "natural," "additive-free," "light," or "regular;" and with or without a corresponding disclaimer. The outcome was perceived harm of the advertised cigarettes. Among smokers, we also assessed interest in switching within their current brand to cigarettes with this characteristic (e.g., "additive-free"). Claims in the ad had a large effect on perceived harm (Cohen's d = 0.87, 95% CI: 0.47-1.29). Claims of cigarettes being "organic," "natural," or "additive-free" reduced perceived harm from the advertised cigarettes, as compared to "regular" and "light" claims. Disclaimers had a small effect, increasing perceived harm (d = 0.25, 95% CI: 0.08-0.41). The problematic claims also increased smokers' interest in switching. Disclaimers had no effect on smokers' interest in switching. "Organic," "natural," and "additive-free" claims may mislead people into thinking that the advertised cigarettes are less harmful than other cigarettes. Disclaimers did not offset misperceptions of harm created by false claims. The U.S. Food and Drug Administration should restrict the use of these misleading claims in tobacco advertising.

  13. 46 CFR 108.661 - Unit markings: Draft marks.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Unit markings: Draft marks. 108.661 Section 108.661... AND EQUIPMENT Equipment Markings and Instructions § 108.661 Unit markings: Draft marks. (a) Each unit must have draft marks for each foot of immersion— (1) If the unit is a surface unit, on both the port...

  14. 46 CFR 108.661 - Unit markings: Draft marks.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Unit markings: Draft marks. 108.661 Section 108.661... AND EQUIPMENT Equipment Markings and Instructions § 108.661 Unit markings: Draft marks. (a) Each unit must have draft marks for each foot of immersion— (1) If the unit is a surface unit, on both the port...

  15. 46 CFR 108.661 - Unit markings: Draft marks.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Unit markings: Draft marks. 108.661 Section 108.661... AND EQUIPMENT Equipment Markings and Instructions § 108.661 Unit markings: Draft marks. (a) Each unit must have draft marks for each foot of immersion— (1) If the unit is a surface unit, on both the port...

  16. 46 CFR 108.661 - Unit markings: Draft marks.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Unit markings: Draft marks. 108.661 Section 108.661... AND EQUIPMENT Equipment Markings and Instructions § 108.661 Unit markings: Draft marks. (a) Each unit must have draft marks for each foot of immersion— (1) If the unit is a surface unit, on both the port...

  17. 46 CFR 108.661 - Unit markings: Draft marks.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Unit markings: Draft marks. 108.661 Section 108.661... AND EQUIPMENT Equipment Markings and Instructions § 108.661 Unit markings: Draft marks. (a) Each unit must have draft marks for each foot of immersion— (1) If the unit is a surface unit, on both the port...

  18. 32 CFR 750.8 - Claims: Responsibility of the Tort Claims Unit Norfolk.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... received in proper form. (c) Adjudicating the claim. (1) The Tort Claims Unit Norfolk shall evaluate and... is a narrative summary of the facts upon which the suit is based and has as enclosures the claims...

  19. 32 CFR 750.8 - Claims: Responsibility of the Tort Claims Unit Norfolk.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... received in proper form. (c) Adjudicating the claim. (1) The Tort Claims Unit Norfolk shall evaluate and... is a narrative summary of the facts upon which the suit is based and has as enclosures the claims...

  20. Banning front-of-package food labels: first Amendment constraints on public health policy.

    PubMed

    Lytton, Timothy D

    2011-06-01

    In recent months, the FDA has begun a crackdown on misleading nutrition and health claims on the front of food packages by issuing warning letters to manufacturers and promising to develop stricter regulatory standards. Leading nutrition policy experts Marion Nestle and David Ludwig have called for an even tougher approach: a ban on all nutrition and health claims on the front of food packages. Nestle and Ludwig argue that most of these claims are scientifically unsound and misleading to consumers and that eliminating them would 'aid educational efforts to encourage the public to eat whole or minimally processed foods and to read the ingredients list on processed foods'. Nestle and Ludwig are right to raise concerns about consumer protection and public health when it comes to front-of-package food labels, but an outright ban on front-of-package nutrition and health claims would violate the First Amendment. As nutrition policy experts develop efforts to regulate front-of-package nutrition and health claims, they should be mindful of First Amendment constraints on government regulation of commercial speech.

  1. Pipe Drafting with CAD. Teacher Edition.

    ERIC Educational Resources Information Center

    Smithson, Buddy

    This teacher's guide contains nine units of instruction for a course on computer-assisted pipe drafting. The course covers the following topics: introduction to pipe drafting with CAD (computer-assisted design); flow diagrams; pipe and pipe components; valves; piping plans and elevations; isometrics; equipment fabrication drawings; piping design…

  2. 10 CFR 51.85 - Draft environmental impact statement-rulemaking.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-rulemaking. 51.85... Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.85 Draft environmental impact... Commission has determined to prepare an environmental impact statement. ...

  3. 18 CFR 281.212 - Draft tariff and index of entitlements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Draft tariff and index... Rule § 281.212 Draft tariff and index of entitlements. (a) Each interstate pipeline shall prepare draft tariff sheets or sections and a draft index of entitlements in accordance with this subpart. (b) The...

  4. 18 CFR 281.212 - Draft tariff and index of entitlements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Draft tariff and index... Rule § 281.212 Draft tariff and index of entitlements. (a) Each interstate pipeline shall prepare draft tariff sheets or sections and a draft index of entitlements in accordance with this subpart. (b) The...

  5. 18 CFR 281.212 - Draft tariff and index of entitlements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Draft tariff and index... Rule § 281.212 Draft tariff and index of entitlements. (a) Each interstate pipeline shall prepare draft tariff sheets or sections and a draft index of entitlements in accordance with this subpart. (b) The...

  6. 18 CFR 281.212 - Draft tariff and index of entitlements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Draft tariff and index... Rule § 281.212 Draft tariff and index of entitlements. (a) Each interstate pipeline shall prepare draft tariff sheets or sections and a draft index of entitlements in accordance with this subpart. (b) The...

  7. 18 CFR 281.212 - Draft tariff and index of entitlements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Draft tariff and index... Rule § 281.212 Draft tariff and index of entitlements. (a) Each interstate pipeline shall prepare draft tariff sheets or sections and a draft index of entitlements in accordance with this subpart. (b) The...

  8. Assessing risk of draft survey by AHP method

    NASA Astrophysics Data System (ADS)

    Xu, Guangcheng; Zhao, Kuimin; Zuo, Zhaoying; Liu, Gang; Jian, Binguo; Lin, Yan; Fan, Yukun; Wang, Fei

    2018-04-01

    The paper assesses the risks of vessel floating in the seawater for draft survey by using the analytic hierarchy process. On this basis, the paper established draft survey risk index from the view of draft reading, ballast water, fresh water, and calculation process and so on. Then the paper proposes the method to deal with risk assessment using one concrete sample.

  9. Introduction to MacDraft. High-Technology Training Module.

    ERIC Educational Resources Information Center

    Traxler, Gene

    This training module on MacDraft is part of a computer drafting skills unit on communications technology for grades 9-12. The objective is for each student to complete a drawing on the MacIntosh computer using the MacDraft software program. This drawing is to be dimensioned with a dual system and is to include a border and title block. This module…

  10. Socioeconomic Representativeness and the Draft

    DTIC Science & Technology

    1980-06-01

    l that the quality of recruits who enter the services ( especiall the Army) is of lover caliber than historically experienced. Proponents of...the "quality" of recruits who enter the services ( especially the Army) is of lower caliber than historically experienced. Proponents of conscription...draft, especially when considering peacetime conscrip- tion. The strength of the argument for the draft was held to be that all eligible men would serve

  11. Teaching Drafting 101: What Comes First?

    ERIC Educational Resources Information Center

    Carkhuff, Don

    2006-01-01

    Employers require pristine drawings that convey clarity and precision for the production of goods. Can a change in sequence of instruction be expeditious and help teachers better prepare their students for the workplace? Research suggests that combining traditional drafting and computer-aided drafting (CAD) instruction makes sense. It is analogous…

  12. Model Machine Shop for Drafting Instruction.

    ERIC Educational Resources Information Center

    Jackson, Carl R.

    The development and implementation of a two-year interdisciplinary course integrating a machine shop and drafting curriculum are described in the report. The purpose of the course is to provide a learning process in industrial drafting featuring identifiable orientation in skills that will enable the student to develop competencies that are…

  13. Malpractice claims for endoscopy

    PubMed Central

    Hernandez, Lyndon V; Klyve, Dominic; Regenbogen, Scott E

    2013-01-01

    AIM: To summarize the magnitude and time trends of endoscopy-related claims and to compare total malpractice indemnity according to specialty and procedure. METHODS: We obtained data from a comprehensive database of closed claims from a trade association of professional liability insurance carriers, representing over 60% of practicing United States physicians. Total payments by procedure and year were calculated, and were adjusted for inflation (using the Consumer Price Index) to 2008 dollars. Time series analysis was performed to assess changes in the total value of claims for each type of procedure over time. RESULTS: There were 1901 endoscopy-related closed claims against all providers from 1985 to 2008. The specialties include: internal medicine (n = 766), gastroenterology (n = 562), general surgery (n = 231), general and family practice (n = 101), colorectal surgery (n = 87), other specialties (n = 132), and unknown (n = 22). Colonoscopy represented the highest frequencies of closed claims (n = 788) and the highest total indemnities ($54 093 000). In terms of mean claims payment, endoscopic retrograde cholangiopancreatography (ERCP) ranked the highest ($374  794) per claim. Internists had the highest number of total claims (n = 766) and total claim payment ($70  730  101). Only total claim payments for colonoscopy and ERCP seem to have increased over time. Indeed, there was an average increase of 15.5% per year for colonoscopy and 21.9% per year for ERCP after adjusting for inflation. CONCLUSION: There appear to be differences in malpractice coverage costs among specialties and the type of endoscopic procedure. There is also evidence for secular trend in total claim payments, with colonoscopy and ERCP costs rising yearly even after adjusting for inflation. PMID:23596540

  14. 10 CFR 51.85 - Draft environmental impact statement-rulemaking.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Draft environmental impact statement-rulemaking. 51.85 Section 51.85 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR... Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.85 Draft environmental impact...

  15. 10 CFR 51.85 - Draft environmental impact statement-rulemaking.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Draft environmental impact statement-rulemaking. 51.85 Section 51.85 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR... Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.85 Draft environmental impact...

  16. 10 CFR 51.85 - Draft environmental impact statement-rulemaking.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Draft environmental impact statement-rulemaking. 51.85 Section 51.85 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR... Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.85 Draft environmental impact...

  17. 10 CFR 51.85 - Draft environmental impact statement-rulemaking.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Draft environmental impact statement-rulemaking. 51.85 Section 51.85 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR... Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.85 Draft environmental impact...

  18. Mechanical Drafting with CAD. Teacher Edition.

    ERIC Educational Resources Information Center

    McClain, Gerald R.

    This instructor's manual contains 13 units of instruction for a course on mechanical drafting with options for using computer-aided drafting (CAD). Each unit includes some or all of the following basic components of a unit of instruction: objective sheet, suggested activities for the teacher, assignment sheets and answers to assignment sheets,…

  19. Claims to the benefits of clinical supervision: A critique of the policy development process and outcomes in New South Wales, Australia.

    PubMed

    White, Edward

    2017-02-01

    The historical development of clinical supervision has been variously interpreted in the international literature. Creditable evidence has accumulated, particularly over the past two decades, to show that clinical supervision has a positive demonstrable effect on supervisees. However, comparatively little research evidence has entered the public domain on any effect that clinical supervision might have on other nominated outcomes. In Australia, developments in clinical supervision were recently prompted by initiatives at national and state levels. Since 2010, lead agencies for these have sought feedback from professional bodies and organizations on a number of inter-related draft policy documents. The present article tracked changes over time between the draft and final versions of these documents in New South Wales, and reviewed the original sources of literature cited within them. The strength of evidence upon which the final published versions were reportedly predicated was scrutinized. Upon examination, claims to the wider benefits of clinical supervision were found to be unconvincingly supported, not least because the examples selected by the agencies from the international literature and cited in their respective documents were either silent, parsimonious, or contradictory. Many claims remain at the level of folklore/hypothetical propositions, therefore, and stay worthy of rigorous empirical testing and faithful public reporting. Such investigations have been acknowledged as notoriously difficult to conduct. The present article identified noteworthy examples in the contemporary literature that signpost robust ways forward for empirical outcomes-orientated research, the findings from which might strengthen the evidence base of future policy documents. © 2017 Australian College of Mental Health Nurses Inc.

  20. Consumer awareness of salt and sodium reduction and sodium labeling.

    PubMed

    Kim, M K; Lopetcharat, K; Gerard, P D; Drake, M A

    2012-09-01

    Reduction of dietary sodium by reduction of sodium in foods is a current industry target. Quantitative information on consumer knowledge of sodium and reduction of dietary sodium is limited. The objectives of this study were to characterize consumer knowledge and awareness of sodium and salt reduction in foods. Consumers (n = 489) participated in a quantitative internet survey designed to gather knowledge and attitudes towards dietary sodium, sodium in foods, and health. Eating habits and food consumption characteristics, knowledge of salt and sodium, and interest in health and wellness were probed. Saltiness believe and sodium knowledge indices were calculated based on correct responses to salt levels in food products. Kano analysis was conducted to determine the role of nutrition labels and satisfaction/dissatisfaction of foods. Consumers were aware of the presence of sodium in "salty" foods, and that sodium was part of salt. People who had a family history of certain diseases associated with a higher intake of dietary sodium did not necessarily have more knowledge of the relationship between sodium intake and a specific disease compared to consumers with no family history. Sodium content on the food label panel did not influence consumer dissatisfaction; however, sodium content did not necessarily increase consumer product satisfaction either. The addition of a healthy nutrient (that is, whole grain, fiber) into a current food product was appealing to consumers. For nutrient labeling, a "reduced" claim was more appealing to consumers than a "free" claim for "unhealthy" nutrients such as fat, sodium, and sugar. This study demonstrated the current state of consumer knowledge on sodium and salt reduction, and consumer perception of the relationship between diets high in sodium and many chronic diseases. Information that may contribute to consumer satisfaction on nutrition panel labeling was also determined. © 2012 Institute of Food Technologists®

  1. Scope of claim coverage in patents of fufang Chinese herbal drugs: Substitution of ingredients

    PubMed Central

    2011-01-01

    Herbal ingredients in a Chinese fufang prescription are often replaced by one or several other herbal combinations. As there have been very few Chinese herbal patent infringement cases, it is still unclear how the Doctrine of Equivalents should be applied to determine the scope of 'equivalents' in Chinese fufang prescriptions. Case law principles from cases in other technical areas such as chemical patents and biological drug patents can be borrowed to ascertain a precise scope of a fufang patent. This article summarizes and discusses several chemical and biopharmaceutical patent cases. In cases where a certain herbal ingredient is substituted by another herb or a combination of herbs, accused infringers are likely to relate herbal drug patents to chemical drug patents with strict interpretation whereas patent owners may take advantage of the liberal application of Doctrine of Equivalence in biopharmaceutical patents by analogizing the complex nature of herbal drugs with biological drugs. Therefore, consideration should be given to the purpose of an ingredient in a patent, the qualities when combined with the other ingredients and the intended function. The scope of equivalents also depends on the stage of the prior art. Moreover, it is desirable to disclose any potential substitutes when drafting the application. Claims should be drafted in such a way that all foreseeable modifications are encompassed for the protection of the patent owner's intellectual property. PMID:21854570

  2. Scope of claim coverage in patents of fufang Chinese herbal drugs: Substitution of ingredients.

    PubMed

    Wang, Xinsheng; Tian, Jiaher; Chan, Albert Wai-Kit

    2011-08-19

    Herbal ingredients in a Chinese fufang prescription are often replaced by one or several other herbal combinations. As there have been very few Chinese herbal patent infringement cases, it is still unclear how the Doctrine of Equivalents should be applied to determine the scope of 'equivalents' in Chinese fufang prescriptions. Case law principles from cases in other technical areas such as chemical patents and biological drug patents can be borrowed to ascertain a precise scope of a fufang patent. This article summarizes and discusses several chemical and biopharmaceutical patent cases. In cases where a certain herbal ingredient is substituted by another herb or a combination of herbs, accused infringers are likely to relate herbal drug patents to chemical drug patents with strict interpretation whereas patent owners may take advantage of the liberal application of Doctrine of Equivalence in biopharmaceutical patents by analogizing the complex nature of herbal drugs with biological drugs. Therefore, consideration should be given to the purpose of an ingredient in a patent, the qualities when combined with the other ingredients and the intended function. The scope of equivalents also depends on the stage of the prior art. Moreover, it is desirable to disclose any potential substitutes when drafting the application. Claims should be drafted in such a way that all foreseeable modifications are encompassed for the protection of the patent owner's intellectual property.

  3. IRIS Toxicological Review of Trimethylbenzenes (Revised External Review Draft)

    EPA Science Inventory

    In August 2013, EPA submitted a revised draft IRIS assessment of trimethylbenzenes to the agency's Science Advisory Board (SAB) and posted this draft on the IRIS website. EPA had previously released a draft of the assessment for public comment, held a public meeting about the dr...

  4. 10 CFR 51.70 - Draft environmental impact statement-general.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-general. 51.70... Implementing Section 102(2) Environmental Impact Statements § 51.70 Draft environmental impact statement—general. (a) The NRC staff will prepare a draft environmental impact statement as soon as practicable...

  5. 10 CFR 51.71 - Draft environmental impact statement-contents.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-contents. 51.71... Implementing Section 102(2) Environmental Impact Statements § 51.71 Draft environmental impact statement—contents. (a) Scope. The draft environmental impact statement will be prepared in accordance with the scope...

  6. 40 CFR 1502.9 - Draft, final, and supplemental statements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 34 2012-07-01 2012-07-01 false Draft, final, and supplemental... IMPACT STATEMENT § 1502.9 Draft, final, and supplemental statements. Except for proposals for legislation... supplemented. (a) Draft environmental impact statements shall be prepared in accordance with the scope decided...

  7. 10 CFR 51.70 - Draft environmental impact statement-general.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Draft environmental impact statement-general. 51.70... Implementing Section 102(2) Environmental Impact Statements § 51.70 Draft environmental impact statement—general. (a) The NRC staff will prepare a draft environmental impact statement as soon as practicable...

  8. 10 CFR 51.70 - Draft environmental impact statement-general.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Draft environmental impact statement-general. 51.70... Implementing Section 102(2) Environmental Impact Statements § 51.70 Draft environmental impact statement—general. (a) The NRC staff will prepare a draft environmental impact statement as soon as practicable...

  9. 10 CFR 51.70 - Draft environmental impact statement-general.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Draft environmental impact statement-general. 51.70... Implementing Section 102(2) Environmental Impact Statements § 51.70 Draft environmental impact statement—general. (a) The NRC staff will prepare a draft environmental impact statement as soon as practicable...

  10. 40 CFR 1502.9 - Draft, final, and supplemental statements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 33 2011-07-01 2011-07-01 false Draft, final, and supplemental... IMPACT STATEMENT § 1502.9 Draft, final, and supplemental statements. Except for proposals for legislation... supplemented. (a) Draft environmental impact statements shall be prepared in accordance with the scope decided...

  11. 10 CFR 51.70 - Draft environmental impact statement-general.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Draft environmental impact statement-general. 51.70... Implementing Section 102(2) Environmental Impact Statements § 51.70 Draft environmental impact statement—general. (a) The NRC staff will prepare a draft environmental impact statement as soon as practicable...

  12. 40 CFR 1502.9 - Draft, final, and supplemental statements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Draft, final, and supplemental... IMPACT STATEMENT § 1502.9 Draft, final, and supplemental statements. Except for proposals for legislation... supplemented. (a) Draft environmental impact statements shall be prepared in accordance with the scope decided...

  13. 40 CFR 1502.9 - Draft, final, and supplemental statements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 33 2014-07-01 2014-07-01 false Draft, final, and supplemental... IMPACT STATEMENT § 1502.9 Draft, final, and supplemental statements. Except for proposals for legislation... supplemented. (a) Draft environmental impact statements shall be prepared in accordance with the scope decided...

  14. 40 CFR 1502.9 - Draft, final, and supplemental statements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 34 2013-07-01 2013-07-01 false Draft, final, and supplemental... IMPACT STATEMENT § 1502.9 Draft, final, and supplemental statements. Except for proposals for legislation... supplemented. (a) Draft environmental impact statements shall be prepared in accordance with the scope decided...

  15. Accuracy of professional sports drafts in predicting career potential.

    PubMed

    Koz, D; Fraser-Thomas, J; Baker, J

    2012-08-01

    The forecasting of talented players is a crucial aspect of building a successful sports franchise and professional sports invest significant resources in making player choices in sport drafts. The current study examined the relationship between career performance (i.e. games played) and draft round for the National Football League, National Hockey League, National Basketball League, and Major League Baseball for players drafted from 1980 to 1989 (n = 4874) against the assumption of a linear relationship between performance and draft round (i.e. that players with the most potential will be selected before players of lower potential). A two-step analysis revealed significant differences in games played across draft rounds (step 1) and a significant negative relationship between draft round and games played (step 2); however, the amount of variance accounted for was relatively low (less than 17%). Results highlight the challenges of accurately evaluating amateur talent. © 2011 John Wiley & Sons A/S.

  16. 32 CFR 538.6 - Claims.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 3 2014-07-01 2014-07-01 false Claims. 538.6 Section 538.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY CLAIMS AND ACCOUNTS MILITARY PAYMENT CERTIFICATES § 538.6 Claims. Claims for conversion of military payment certificates, as well as claims arising out of...

  17. Cluster: Drafting. Course: Basic Technical Drafting. Research Project.

    ERIC Educational Resources Information Center

    Sanford - Lee County Schools, NC.

    The set of six units is designed for use with an instructor in basic technical drafting and is also keyed to other texts. Each unit contains several task packages specifying prerequisites, rationale for learning, objectives, learning activities to be supervised by the instructor, and learning practice. The units cover: pictorial drawing; screw…

  18. 49 CFR 229.61 - Draft system.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... D&E couplers. (2) A crack or break in the side wall or pin bearing bosses outside of the shaded... or draft gears that exceeds one-half inches. (5) A broken or cracked coupler carrier. (6) A broken or cracked yoke. (7) A broken draft gear. (b) A device shall be provided under the lower end of all drawbar...

  19. 49 CFR 229.61 - Draft system.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... D&E couplers. (2) A crack or break in the side wall or pin bearing bosses outside of the shaded... or draft gears that exceeds one-half inches. (5) A broken or cracked coupler carrier. (6) A broken or cracked yoke. (7) A broken draft gear. (b) A device shall be provided under the lower end of all drawbar...

  20. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... an exhaustive review of labeling claims made for drugs marketed under new-drug and antibiotic drug... classification in lieu of the Academy's classification. (d) For new drugs and antibiotics, supplements to provide... purchaser or prescriber is not misled by being left unaware through the sponsor's silence that a basic...

  1. Framing and Claiming: How Information-Framing Affects Expected Social Security Claiming Behavior.

    PubMed

    Brown, Jeffrey R; Kapteyn, Arie; Mitchell, Olivia S

    2016-03-01

    This paper provides evidence that Social Security benefit claiming decisions are strongly affected by framing and are thus inconsistent with expected utility theory. Using a randomized experiment that controls for both observable and unobservable differences across individuals, we find that the use of a "breakeven analysis" encourages early claiming. Respondents are more likely to delay when later claiming is framed as a gain, and the claiming age is anchored at older ages. Additionally, the financially less literate, individuals with credit card debt, and those with lower earnings are more influenced by framing than others.

  2. 32 CFR 536.120 - Claims payable as maritime claims.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... claim is cognizable under this subpart if it arises in or on a maritime location, involves some... scope of employment. This class of claims includes, but is not limited to: (a) Damage to a ship, boat, barge, or other watercraft; (b) An injury that involves a ship, boat, barge, or other watercraft; (c...

  3. 32 CFR 536.120 - Claims payable as maritime claims.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... claim is cognizable under this subpart if it arises in or on a maritime location, involves some... scope of employment. This class of claims includes, but is not limited to: (a) Damage to a ship, boat, barge, or other watercraft; (b) An injury that involves a ship, boat, barge, or other watercraft; (c...

  4. 32 CFR 536.120 - Claims payable as maritime claims.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... claim is cognizable under this subpart if it arises in or on a maritime location, involves some... scope of employment. This class of claims includes, but is not limited to: (a) Damage to a ship, boat, barge, or other watercraft; (b) An injury that involves a ship, boat, barge, or other watercraft; (c...

  5. Internal Federal Railroad Administration draft rulemaking document

    DOT National Transportation Integrated Search

    1993-03-08

    THIS DOCUMENT IS A DRAFTOF THE RULE FOR PARTICULAR APPLICABILITY : FOR THE ORLANDO MAGLEV SYSTEM - IT IS STILL A WORKING DRAFT AND : IS BEING DISTRIBUTED SO THAT EVERYONE THAT IS PART OF DRAFTING : THIS RULE CAN HAVE ONE MORE OPPORTUNITY TO REVIEW BO...

  6. 78 FR 19632 - Administrative Claims Under the Federal Tort Claims Act and Related Statutes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... Administration 20 CFR Parts 638 and 670 RIN 1290-AA25 Administrative Claims Under the Federal Tort Claims Act and... governing administrative claims under the Federal Tort Claims Act and related statutes. DATES: Effective... (this is not a toll-free number). Individuals with hearing or speech impairments may access this...

  7. 75 FR 21145 - Availability of the Draft Environmental Impact Statement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

    ... DEPARTMENT OF TRANSPORTATION Federal Highway Administration Availability of the Draft... availability of the Draft Environmental Impact Statement. SUMMARY: The FHWA, on behalf of the California Department of Transportation (Caltrans), announces the availability of the Draft Environmental Impact...

  8. 76 FR 49707 - Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ...; (8) allow for the use of the health claim on phytosterol ester-containing dietary supplements (esterified with food- grade fatty acids) but not on nonesterified phytosterol-containing dietary supplements... regarding the cholesterol- lowering efficacy of nonesterified phytosterols in dietary supplements. FDA did...

  9. 46 CFR 32.56-45 - Draft stops-T/ALL.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 1 2013-10-01 2013-10-01 false Draft stops-T/ALL. 32.56-45 Section 32.56-45 Shipping....56-45 Draft stops—T/ALL. (a) Where ceilings or linings are fitted in accommodation, service, or... if draft stops of “B” Class construction are fitted between the ceiling or lining and the deck or...

  10. 46 CFR 32.56-45 - Draft stops-T/ALL.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 1 2014-10-01 2014-10-01 false Draft stops-T/ALL. 32.56-45 Section 32.56-45 Shipping....56-45 Draft stops—T/ALL. (a) Where ceilings or linings are fitted in accommodation, service, or... if draft stops of “B” Class construction are fitted between the ceiling or lining and the deck or...

  11. 46 CFR 32.56-45 - Draft stops-T/ALL.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 1 2012-10-01 2012-10-01 false Draft stops-T/ALL. 32.56-45 Section 32.56-45 Shipping....56-45 Draft stops—T/ALL. (a) Where ceilings or linings are fitted in accommodation, service, or... if draft stops of “B” Class construction are fitted between the ceiling or lining and the deck or...

  12. Managing the Drafting Process: Creating a New Model for the Workplace.

    ERIC Educational Resources Information Center

    Shwom, Barbara L.; Hirsch, Penny L.

    1994-01-01

    Discusses the development of a pragmatic model of the writing process in the workplace, focusing on the importance of "drafting" as part of that process. Discusses writers' attitudes about drafting and the structures of the workplace that drafting has to accommodate. Introduces a drafting model and discusses results of using this model…

  13. 77 FR 27478 - Notice of Availability of the Draft Environmental Impact Statement and Draft Proposed California...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ...In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) has prepared a Draft Proposed California Desert Conservation Area (CDCA) Plan Amendment and a Draft Environmental Impact Statement (EIS) for the Haiwee Geothermal Leasing Area (HGLA), Inyo County, California, and by this notice is announcing the opening of the comment period.

  14. Framing and Claiming: How Information-Framing Affects Expected Social Security Claiming Behavior

    PubMed Central

    Brown, Jeffrey R.; Kapteyn, Arie; Mitchell, Olivia S.

    2017-01-01

    This paper provides evidence that Social Security benefit claiming decisions are strongly affected by framing and are thus inconsistent with expected utility theory. Using a randomized experiment that controls for both observable and unobservable differences across individuals, we find that the use of a “breakeven analysis” encourages early claiming. Respondents are more likely to delay when later claiming is framed as a gain, and the claiming age is anchored at older ages. Additionally, the financially less literate, individuals with credit card debt, and those with lower earnings are more influenced by framing than others. PMID:28579641

  15. IRIS Toxicological Review of Methanol (Noncancer) (Interagency Science Discussion Draft)

    EPA Science Inventory

    On May 3, 2013, the Toxicological Review of Methanol (noncancer) (Revised External Review Draft) was posted for public review and comment. Subsequently, the draft Toxicological Review, Appendices, and draft IRIS Summary were reviewed internally by EPA and by other federal agenci...

  16. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

    ...] Draft Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production... entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the draft guidance). The draft guidance, when finalized, will provide guidance to egg producers...

  17. Influence of Label Design on Children's Perception of 2 Snack Foods.

    PubMed

    Arrúa, Alejandra; Vidal, Leticia; Antúnez, Lucía; Machín, Leandro; Martínez, Joseline; Curutchet, María Rosa; Giménez, Ana; Ares, Gastón

    2017-03-01

    To evaluate the influence of label design on children's perception of 2 popular snack foods across 3 income levels. Labels of 2 snack products (yogurt and sponge cake) were designed using a fractional factorial design with 3 2-level variables: cartoon character, nutrition claims, and front-of-package nutritional information. A total of 221 children (aged 9-13 years) from Montevideo, Uruguay, with different income levels, participated in the study. Children's attitude toward and liking of 2 food products. Low-income children showed a more positive attitude toward the products than did middle- and high-income children. The inclusion of a cartoon character in sponge cake labels significantly affected hedonic expectations regardless of income. Middle- and high-income children tended to use the term funny more frequently and the term boring less frequently to describe labels that included the cartoon character, compared with those that did not. Results showed that the inclusion of cartoon characters on food labels is associated with fun. Low-income children seem more susceptible to the marketing strategies of food companies than do middle- and high-income children. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  18. Normalized Legal Drafting and the Query Method.

    ERIC Educational Resources Information Center

    Allen, Layman E.; Engholm, C. Rudy

    1978-01-01

    Normalized legal drafting, a mode of expressing ideas in legal documents so that the syntax that relates the constituent propositions is simplified and standardized, and the query method, a question-asking activity that teaches normalized drafting and provides practice, are examined. Some examples are presented. (JMD)

  19. In Brief: Geoengineering draft statement

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    2009-04-01

    The American Meteorological Society (AMS) has prepared a draft policy statement on geoengineering the climate system, which the AMS Council is considering for approval. The statement notes, “Geoengineering will not substitute for either aggressive mitigation or proactive adaptation. It could contribute to a comprehensive risk management strategy to slow climate change and alleviate its negative impacts, but the potential for adverse and unintended consequences implies a need for adequate research, appropriate regulation, and transparent consideration.” The statement, if adopted, indicates that AMS recommends enhanced research on the scientific and technological potential for geoengineering the climate system; additional study of the historical, ethical, legal, political, and societal aspects of the geoengineering issues; and the development and analysis of policy options to promote transparency and international cooperation in exploring geoengineering options along with restrictions on reckless efforts to manipulate the climate system. AMS is accepting comments on the draft statement until 23 April. For more information, visit http://ametsoc.org/policy/draftstatements/index.html#draft.

  20. 44 CFR 62.20 - Claims appeals.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Claims appeals. 62.20 Section... OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.20 Claims appeals. (a.... Decision means the insurer's final claim determination, which is the insurer's written denial, in whole or...

  1. 44 CFR 62.20 - Claims appeals.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Claims appeals. 62.20 Section... OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.20 Claims appeals. (a.... Decision means the insurer's final claim determination, which is the insurer's written denial, in whole or...

  2. 44 CFR 62.20 - Claims appeals.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Claims appeals. 62.20 Section... OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.20 Claims appeals. (a.... Decision means the insurer's final claim determination, which is the insurer's written denial, in whole or...

  3. Impact of Health Labels on Flavor Perception and Emotional Profiling: A Consumer Study on Cheese

    PubMed Central

    Schouteten, Joachim J.; De Steur, Hans; De Pelsmaeker, Sara; Lagast, Sofie; De Bourdeaudhuij, Ilse; Gellynck, Xavier

    2015-01-01

    The global increase of cardiovascular diseases is linked to the shift towards unbalanced diets with increasing salt and fat intake. This has led to a growing consumers’ interest in more balanced food products, which explains the growing number of health-related claims on food products (e.g., “low in salt” or “light”). Based on a within-subjects design, consumers (n = 129) evaluated the same cheese product with different labels. Participants rated liking, saltiness and fat flavor intensity before and after consuming four labeled cheeses. Even though the cheese products were identical, inclusion of health labels influenced consumer perceptions. Cheese with a “light” label had a lower overall expected and perceived liking compared to regular cheese. Although cheese with a “salt reduced” label had a lower expected liking compared to regular cheese, no lower liking was found when consumers actually consumed the labeled cheese. All labels also influenced the perceived intensities of the attributes related to these labels, e.g., for example salt intensity for reduced salt label. While emotional profiles of the labeled cheeses differed before tasting, little differences were found when actual tasting these cheeses. In conclusion, this study shows that health-related labels might influence the perceived flavor and emotional profiles of cheese products. PMID:26690211

  4. Materials and Manufacturing, Drafting 3: 9257.03.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    Designed for students interested in engineering fields pertaining to mechanical and electronic drafting, the course covers several types of drawings in the mechanical and electronic drafting field and many types of machine shop operations. The student will become familiar with stress, loading, safety factors, and manufacturing processes. The…

  5. 32 CFR 842.5 - Claims forms.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... certain is sufficient to file a claim. The claimant should use these forms when filing a claim: (a) Claim... of or Damage to Personal Property Incident to Service, or DD Forms 1842, Claim for Personal Property Against the United States, and 1844, Schedule of Property and Claim Analysis Chart, to file the claim. (b...

  6. 32 CFR 842.5 - Claims forms.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... certain is sufficient to file a claim. The claimant should use these forms when filing a claim: (a) Claim... of or Damage to Personal Property Incident to Service, or DD Forms 1842, Claim for Personal Property Against the United States, and 1844, Schedule of Property and Claim Analysis Chart, to file the claim. (b...

  7. 10 CFR 51.77 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.77 Distribution of draft environmental impact statement. (a) In addition to the distribution...

  8. 10 CFR 51.77 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.77 Distribution of draft environmental impact statement. (a) In addition to the distribution...

  9. 10 CFR 51.77 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.77 Distribution of draft environmental impact statement. (a) In addition to the distribution...

  10. 77 FR 44610 - Notice of Availability of Draft Environmental Assessment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-30

    .... 12968-001-CT] Notice of Availability of Draft Environmental Assessment FirstLight Hydro Generating...). Staff prepared a draft environmental assessment (EA), which analyzes the potential environmental effects... human environment. A copy of the draft EA is available for review at the Commission in the Public...

  11. 10 CFR 51.77 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.77 Distribution of draft environmental impact statement. (a) In addition to the distribution...

  12. 10 CFR 51.77 - Distribution of draft environmental impact statement.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.77 Distribution of draft environmental impact statement. (a) In addition to the distribution...

  13. 75 FR 22400 - Draft Test Guidelines; Reopening of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2009-0681; FRL-8822-3] Draft Test Guidelines... draft test guidelines for product performance of public health uses of antimicrobial agents. EPA...-8437-2). In that document, EPA announced the availability of four draft test guidelines for product...

  14. The nutritional quality of foods carrying health-related claims in Germany, The Netherlands, Spain, Slovenia and the United Kingdom

    PubMed Central

    Kaur, A; Scarborough, P; Hieke, S; Kusar, A; Pravst, I; Raats, M; Rayner, M

    2016-01-01

    Backgroung/Objectives: Compares the nutritional quality of pre-packaged foods carrying health-related claims with foods that do not carry health-related claims. Subject/Methods: Cross-sectional survey of pre-packaged foods available in Germany, The Netherlands, Spain, Slovenia and the United Kingdom in 2013. A total of 2034 foods were randomly sampled from three food store types (a supermarket, a neighbourhood store and a discounter). Nutritional information was taken from nutrient declarations present on food labels and assessed through a comparison of mean levels, regression analyses and the application of a nutrient profile model currently used to regulate health claims in Australia and New Zealand (Food Standards Australia New Zealand's Nutrient Profiling Scoring Criterion, FSANZ NPSC). Results: Foods carrying health claims had, on average, lower levels, per 100 g, of the following nutrients, energy—29.3 kcal (P<0.05), protein—1.2 g (P<0.01), total sugars—3.1 g (P<0.05), saturated fat—2.4 g (P<0.001), and sodium—842 mg (P<0.001), and higher levels of fibre—0.8 g (P<0.001). A similar pattern was observed for foods carrying nutrition claims. Forty-three percent (confidence interval (CI) 41%, 45%) of foods passed the FSANZ NPSC, with foods carrying health claims more likely to pass (70%, CI 64%, 76%) than foods carrying nutrition claims (61%, CI 57%, 66%) or foods that did not carry either type of claim (36%, CI 34%, 38%). Conclusions: Foods carrying health-related claims have marginally better nutrition profiles than those that do not carry claims; these differences would be increased if the FSANZ NPSC was used to regulate health-related claims. It is unclear whether these relatively small differences have significant impacts on health. PMID:27406158

  15. Formalizing Probabilistic Safety Claims

    NASA Technical Reports Server (NTRS)

    Herencia-Zapana, Heber; Hagen, George E.; Narkawicz, Anthony J.

    2011-01-01

    A safety claim for a system is a statement that the system, which is subject to hazardous conditions, satisfies a given set of properties. Following work by John Rushby and Bev Littlewood, this paper presents a mathematical framework that can be used to state and formally prove probabilistic safety claims. It also enables hazardous conditions, their uncertainties, and their interactions to be integrated into the safety claim. This framework provides a formal description of the probabilistic composition of an arbitrary number of hazardous conditions and their effects on system behavior. An example is given of a probabilistic safety claim for a conflict detection algorithm for aircraft in a 2D airspace. The motivation for developing this mathematical framework is that it can be used in an automated theorem prover to formally verify safety claims.

  16. Debate on the Draft--Helping Students Decide Where They Stand.

    ERIC Educational Resources Information Center

    Victory, James

    1981-01-01

    Presents four exercises to help secondary school social studies students understand the complex issues of the draft. Students participate in a mock draft lottery, analyze Phil Och's Draft Dodger Rag, examine how individual experiences affect attitudes, and compare writings by Bill Mauldin and Ron Kovic. (KC)

  17. 32 CFR 536.75 - Claims payable under the Military Claims Act.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., acting within the scope of their employment, that is determined to be negligent or wrongful; or (2..., chapter 11. (c) Maritime claims. Claims that arise on the high seas or within the territorial waters of a...

  18. 32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... subpart C claims. (i) Interpretation of meanings and construction of questions of law under the MCA will... 32 National Defense 3 2011-07-01 2009-07-01 true Applicable law for claims under the Military Claims Act. 536.77 Section 536.77 National Defense Department of Defense (Continued) DEPARTMENT OF THE...

  19. 75 FR 52996 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-30

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0287] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Draft Regulatory Guide, DG-8035, ``Administrative Practices in Radiation Surveys and Monitoring.'' FOR FURTHER...

  20. The National Football League Combine: performance differences between drafted and nondrafted players entering the 2004 and 2005 drafts.

    PubMed

    Sierer, S Patrick; Battaglini, Claudio L; Mihalik, Jason P; Shields, Edgar W; Tomasini, Nathan T

    2008-01-01

    The purpose of this study was to examine performance differences between drafted and nondrafted athletes (N = 321) during the 2004 and 2005 National Football League (NFL) Combines. We categorized players into one of 3 groups: Skill, Big skill, and Linemen. Skill players (SP) consisted of wide receivers, cornerbacks, free safeties, strong safeties, and running backs. Big skill players (BSP) included fullbacks, linebackers, tight ends, and defensive ends. Linemen (LM) consisted of centers, offensive guards, offensive tackles, and defensive tackles. We analyzed player height and mass, as well as performance on the following combine drills: 40-yard dash, 225-lb bench press test, vertical jump, broad jump, pro-agility shuttle, and the 3-cone drill. Student t-tests compared performance on each of these measures between drafted and nondrafted players. Statistical significance was found between drafted and nondrafted SP for the 40-yard dash (P < 0.001), vertical jump (P = 0.003), pro-agility shuttle (P < 0.001), and 3-cone drill (P < 0.001). Drafted and nondrafted BSP performed differently on the 40-yard dash (P = 0.002) and 3-cone drill (P = 0.005). Finally, drafted LM performed significantly better than nondrafted LM on the 40-yard dash (P = 0.016), 225-lb bench press (P = 0.003), and 3-cone drill (P = 0.005). Certified strength and conditioning specialists will be able to utilize the significant findings to help better prepare athletes as they ready themselves for the NFL Combine.

  1. 76 FR 26284 - Draft Integrated Science Assessment for Lead (Pb)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9302-5; Docket ID No. EPA-HQ-ORD-2011-0051] Draft Integrated... the availability of a document titled, ``First External Review Draft Integrated Science Assessment for Lead'' (EPA/600/R-10/075A). This draft document was prepared by the National Center for Environmental...

  2. Evaluating a Surprising Claim

    NASA Astrophysics Data System (ADS)

    Hayden, Howard C.

    2013-11-01

    A television advertisement and a website present an interesting question: can rail company CSX really move a ton of freight 468 miles on a gallon of fuel, or is the claim preposterous? Let us examine the claim, first by understanding what is meant, looking at their data, and then converting units to examine the claim quantitatively.

  3. Evaluating a Surprising Claim

    ERIC Educational Resources Information Center

    Hayden, Howard C.

    2013-01-01

    A television advertisement and a website present an interesting question: can rail company CSX "really" move a ton of freight 468 miles on a gallon of fuel, or is the claim preposterous? Let us examine the claim, first by understanding what is meant, looking at their data, and then converting units to examine the claim quantitatively.

  4. 32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) The United States will only be liable for the portion of loss or damage attributable to the fault of... preparation and presentation of the claim. (vi) Punitive or exemplary damages are not payable. (vii) Claims... will be considered as an element of damages under paragraph (b)(3)(ii) of this section. Claims for...

  5. 32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) The United States will only be liable for the portion of loss or damage attributable to the fault of... preparation and presentation of the claim. (vi) Punitive or exemplary damages are not payable. (vii) Claims... will be considered as an element of damages under paragraph (b)(3)(ii) of this section. Claims for...

  6. 32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) The United States will only be liable for the portion of loss or damage attributable to the fault of... preparation and presentation of the claim. (vi) Punitive or exemplary damages are not payable. (vii) Claims... will be considered as an element of damages under paragraph (b)(3)(ii) of this section. Claims for...

  7. Computer-Aided Drafting. Education for Technology Employment.

    ERIC Educational Resources Information Center

    Northern Illinois Univ., De Kalb. Dept. of Technology.

    This computer-aided drafting (CAD) curriculum was developed to provide drafting instructors in Illinois with a useful guide for relating an important new technological advance to the vocational classroom. The competency-based learning activity guides are written to be used with any CAD system being used at the secondary and postsecondary levels.…

  8. Reinstate the Draft? Target Report No. 15.

    ERIC Educational Resources Information Center

    Orleans, Bill, Comp.

    Position papers collected by the United States Student Association (USSA) outlining objections to the reimposition of a selective service draft are presented. The USSA believes that a draft is unnecessary because: total active military strength is maintained even when voluntary enlistment falls short of its goal; it would increase military costs;…

  9. 46 CFR 169.755 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Section 169.755 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS SAILING SCHOOL VESSELS Vessel Control, Miscellaneous Systems, and Equipment Markings § 169.755 Draft marks and... projections of the marks onto a vertical plane are of uniform height equal to the vertical spacing between...

  10. 46 CFR 169.755 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Section 169.755 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS SAILING SCHOOL VESSELS Vessel Control, Miscellaneous Systems, and Equipment Markings § 169.755 Draft marks and... projections of the marks onto a vertical plane are of uniform height equal to the vertical spacing between...

  11. 46 CFR 169.755 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Section 169.755 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS SAILING SCHOOL VESSELS Vessel Control, Miscellaneous Systems, and Equipment Markings § 169.755 Draft marks and... projections of the marks onto a vertical plane are of uniform height equal to the vertical spacing between...

  12. 46 CFR 169.755 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Section 169.755 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS SAILING SCHOOL VESSELS Vessel Control, Miscellaneous Systems, and Equipment Markings § 169.755 Draft marks and... projections of the marks onto a vertical plane are of uniform height equal to the vertical spacing between...

  13. 46 CFR 169.755 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Section 169.755 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS SAILING SCHOOL VESSELS Vessel Control, Miscellaneous Systems, and Equipment Markings § 169.755 Draft marks and... projections of the marks onto a vertical plane are of uniform height equal to the vertical spacing between...

  14. 10 CFR 51.72 - Supplement to draft environmental impact statement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Supplement to draft environmental impact statement. 51.72... Implementing Section 102(2) Environmental Impact Statements § 51.72 Supplement to draft environmental impact statement. (a) The NRC staff will prepare a supplement to a draft environmental impact statement for which a...

  15. 10 CFR 51.72 - Supplement to draft environmental impact statement.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Supplement to draft environmental impact statement. 51.72... Implementing Section 102(2) Environmental Impact Statements § 51.72 Supplement to draft environmental impact statement. (a) The NRC staff will prepare a supplement to a draft environmental impact statement for which a...

  16. 18 CFR 5.25 - Applications requiring a draft NEPA document.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... a draft NEPA document. 5.25 Section 5.25 Conservation of Power and Water Resources FEDERAL ENERGY... APPLICATION PROCESS § 5.25 Applications requiring a draft NEPA document. (a) If the Commission determines that a license application will be processed with an environmental impact statement, or a draft and final...

  17. 10 CFR 51.72 - Supplement to draft environmental impact statement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Supplement to draft environmental impact statement. 51.72... Implementing Section 102(2) Environmental Impact Statements § 51.72 Supplement to draft environmental impact statement. (a) The NRC staff will prepare a supplement to a draft environmental impact statement for which a...

  18. 10 CFR 51.72 - Supplement to draft environmental impact statement.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Supplement to draft environmental impact statement. 51.72... Implementing Section 102(2) Environmental Impact Statements § 51.72 Supplement to draft environmental impact statement. (a) The NRC staff will prepare a supplement to a draft environmental impact statement for which a...

  19. 18 CFR 5.25 - Applications requiring a draft NEPA document.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... a draft NEPA document. 5.25 Section 5.25 Conservation of Power and Water Resources FEDERAL ENERGY... APPLICATION PROCESS § 5.25 Applications requiring a draft NEPA document. (a) If the Commission determines that a license application will be processed with an environmental impact statement, or a draft and final...

  20. 18 CFR 5.25 - Applications requiring a draft NEPA document.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... a draft NEPA document. 5.25 Section 5.25 Conservation of Power and Water Resources FEDERAL ENERGY... APPLICATION PROCESS § 5.25 Applications requiring a draft NEPA document. (a) If the Commission determines that a license application will be processed with an environmental impact statement, or a draft and final...