Sample records for draft product labeling
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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 The purpose of this draft guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural...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...
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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...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' The recommendations in the draft guidance are intended to help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
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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 ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2012-0906; FRL-9374-4] Pesticides; Draft Guidance for Pesticide Registrants on Web- Distributed Labeling for Pesticide Products AGENCY: Environmental Protection...
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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 parameters are considered in this draft guidance as they relate to drug products labeled for sprinkle: (1...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...
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PRN 2001-X Draft: Spray and Dust Drift Label Statements for Pesticide Products
This Notice sets forth the U.S. Environmental Protection Agency's (EPA or Agency) draft guidance for labeling statements for controlling spray drift and dust drift from application sites and for implementing these statements for risk mitigation.
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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...
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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...
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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.
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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...
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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...
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Electronic Submissions of Pesticide Applications
Applications for pesticide registration can be submitted electronically, including forms, studies, and draft product labeling. Applicants need not submit multiple electronic copies of any pieces of their applications.
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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...
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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...
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EPA Extends Comment Period for Draft Label Revisions on Respirators
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
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-12
...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is intended to assist applicants and reviewers in drafting the ``Warnings and Precautions, Contraindications, and Boxed Warning'' sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-23
...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and in complying with the requirements in the final rule on the content and format of labeling for prescription drug and biological products. This guidance is intended to help applicants select information for inclusion in the ``Dosage and Administration'' section of labeling and to help them organize that information.
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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...
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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...
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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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-28
... Prescription Drug and Biological Products Labeling; Availability AGENCY: Food and Drug Administration, HHS... (BPCA) and the Pediatric Research Equity Act (PREA), as amended by the Food and Drug Administration... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...
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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...
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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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-03
... Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that..., Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Pl., Rockville, MD... seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V...
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Electronic Submission of Labels
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.
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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.
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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
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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.
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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...
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Commercial Economic Poisons Applicators Licensing Manual, Rough Draft.
ERIC Educational Resources Information Center
Michigan State Dept. of Agriculture, Lansing, Div. of Plant Industry.
This pesticide manual gives information on types of pest management, labels and labeling of pesticide containers, safety, types of pesticides (including chapters on insecticides, fungicides, herbicides, and nematicides), spray equipment, identification of pests (including weeds, plant diseases, and vertebrates), and environmental considerations.…
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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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-14
...] Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance provides... Products: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-19
...] Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability...) is announcing the availability of a draft guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-22
...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...
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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...
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Atkinson, Thomas M; Mendoza, Tito R; Sit, Laura; Passik, Steven; Scher, Howard I; Cleeland, Charles; Basch, Ethan
2010-03-01
In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance outlines psychometric aspects that should be considered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect clinically meaningful score changes. When finalized, it may provide a blueprint for evaluations of PRO measures that can be considered by sponsors and investigators involved in PRO research and drug registration trials. In this review we examine the short form of the Brief Pain Inventory (BPI) and particularly the "pain at its worst in the last 24 hours" item in the context of the FDA draft guidance, to assess its utility in clinical trials that include pain as a PRO endpoint. After a systematic evaluation of the psychometric aspects of the BPI, we conclude that the BPI and its "pain at its worst in the last 24 hours" item generically satisfy most key recommendations outlined in the draft guidance for assessing a pain-reduction treatment effect. Nonetheless, when the BPI is being considered for assessment of pain endpoints in a registration trial, sponsors and investigators should consult with the appropriate FDA division early during research design to discuss whether there is sufficient precedent to use the instrument in the population of interest or whether additional evaluations of measurement properties are advisable.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-25
...] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and... Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in...
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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...
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Fisher, B E
1999-01-01
The organic foods industry is booming: by one estimate, the market for organic foods is worth $4 billion annually and is expected to grow at a rate of more than 24% per year. Faced with the threat of pesticide exposures and other food safety problems, many consumers are turning to organic foods in hopes of finding a healthy alternative, but there is currently no consistency in organic food labeling and no guarantee that foods labeled as organic are actually grown and processed in a purely organic fashion. There is also controversy about whether the label "organic" covers such new technologies as irradiation and genetic engineering. As part of the 1990 Farm Bill, the U.S. Department of Agriculture (USDA) is working to develop a proposed rule on organic foods. The rule would regulate the allowable methods, practices, and substances used in producing and handling crops and their processed products. The first draft of the proposed rule, released in December 1997, met with unprecedented opposition, which centered around the fact that the proposal appeared to virtually ignore the recommendations of a standards board formed to assist in the rule's development. Other criticism opposed three practices put forward for comment by the USDA: irradiation, genetic engineering, and the use of sewage sludge in farming. Due to the vehemence of the opposition to its original proposal, the USDA has decided to rewrite the proposed rule. In preparation for that proposal, the USDA Agricultural Marketing Service released three issue papers in October 1998 for public comment. The 10,000-plus comments received in response to those papers will be incorporated into the second draft proposal, due out later this year. PMID:10064558
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-13
... document, which addresses safety achieved through drug product design, is the first in a series of planned...] Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors... Considerations for Product Design to Minimize Medication Errors.'' The draft guidance provides sponsors of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-14
... Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-17
...; formerly Docket No. 2007D-0290] Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of Draft Guidance...: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-26
...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion...
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Okello, Walter O; Muhanguzi, Dennis; MacLeod, Ewan T; Welburn, Susan C; Waiswa, Charles; Shaw, Alexandra P
2015-11-05
A study was conducted in Tororo District in eastern Uganda to assess the socio-economic contribution of draft cattle to rural livelihoods. The aim of the study was to empirically quantify the economic value of draft cattle thus contributing to understanding the impact of endemic parasitic diseases of cattle on livestock productivity and subsequently household income, labor and food security. A total of 205 draft cattle keeping households (n = 205) were randomly selected and structured household questionnaires were administered, focusing on work oxen use, productivity, inputs and outputs. The data obtained was analyzed using standard statistical methods and used to calculate the gross margin from the draft cattle enterprise. Secondary data were obtained from focus group discussions and key informant interviews and these were analyzed using Bayesian methods. The study showed that, apart from being labor saving, the use of animal traction is highly profitable with the gross margin per year from the use of draft cattle amounting to 245 United States dollars per work oxen owning household. The cash obtained from hiring out draft animals was equivalent to nearly a quarter of the average local household's monetary receipts. It also revealed that endemic bovine parasitic diseases such as trypanosomiasis and tick-borne diseases reduced draft cattle output by 20.9 % and potential household income from the use of draft oxen by 32.2 %. The presence of endemic cattle diseases in rural Uganda is adversely affecting the productivity of draft cattle, which in turn affects household income, labor and ultimately food security. This study highlights the contribution of draft cattle to rural livelihoods, thus increasing the expected impact of cost-effective control strategies of endemic production limiting livestock diseases in Uganda.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-04
...] Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing... Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft... human drug compounders that choose to register as outsourcing facilities (outsourcing facilities). DATES...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1295] Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for... draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound...
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Transportation of Hazardous Evidentiary Material.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Osborn, Douglas.
2005-06-01
This document describes the specimen and transportation containers currently available for use with hazardous and infectious materials. A detailed comparison of advantages, disadvantages, and costs of the different technologies is included. Short- and long-term recommendations are also provided.3 DraftDraftDraftExecutive SummaryThe Federal Bureau of Investigation's Hazardous Materials Response Unit currently has hazardous material transport containers for shipping 1-quart paint cans and small amounts of contaminated forensic evidence, but the containers may not be able to maintain their integrity under accident conditions or for some types of hazardous materials. This report provides guidance and recommendations on the availability of packages for themore » safe and secure transport of evidence consisting of or contaminated with hazardous chemicals or infectious materials. Only non-bulk containers were considered because these are appropriate for transport on small aircraft. This report will addresses packaging and transportation concerns for Hazardous Classes 3, 4, 5, 6, 8, and 9 materials. If the evidence is known or suspected of belonging to one of these Hazardous Classes, it must be packaged in accordance with the provisions of 49 CFR Part 173. The anthrax scare of several years ago, and less well publicized incidents involving unknown and uncharacterized substances, has required that suspicious substances be sent to appropriate analytical laboratories for analysis and characterization. Transportation of potentially hazardous or infectious material to an appropriate analytical laboratory requires transport containers that maintain both the biological and chemical integrity of the substance in question. As a rule, only relatively small quantities will be available for analysis. Appropriate transportation packaging is needed that will maintain the integrity of the substance, will not allow biological alteration, will not react chemically with the substance being shipped, and will otherwise maintain it as nearly as possible in its original condition.The recommendations provided are short-term solutions to the problems of shipping evidence, and have considered only currently commercially available containers. These containers may not be appropriate for all cases. Design, testing, and certification of new transportation containers would be necessary to provide a container appropriate for all cases.Table 1 provides a summary of the recommendations for each class of hazardous material.Table 1: Summary of RecommendationsContainerCost1-quart paint can with ArmlockTM seal ringLabelMaster(r)%242.90 eachHazard Class 3, 4, 5, 8, or 9 Small ContainersTC Hazardous Material Transport ContainerCurrently in Use4 DraftDraftDraftTable 1: Summary of Recommendations (continued)ContainerCost55-gallon open or closed-head steel drumsAll-Pak, Inc.%2458.28 - %2473.62 eachHazard Class 3, 4, 5, 8, or 9 Large Containers95-gallon poly overpack LabelMaster(r)%24194.50 each1-liter glass container with plastic coatingLabelMaster(r)%243.35 - %243.70 eachHazard Class 6 Division 6.1 Poisonous by Inhalation (PIH) Small ContainersTC Hazardous Material Transport ContainerCurrently in Use20 to 55-gallon PIH overpacksLabelMaster(r)%24142.50 - %24170.50 eachHazard Class 6 Division 6.1 Poisonous by Inhalation (PIH) Large Containers65 to 95-gallon poly overpacksLabelMaster(r)%24163.30 - %24194.50 each1-liter transparent containerCurrently in UseHazard Class 6 Division 6.2 Infectious Material Small ContainersInfectious Substance ShipperSource Packaging of NE, Inc.%24336.00 eachNone Commercially AvailableN/AHazard Class 6 Division 6.2 Infectious Material Large ContainersNone Commercially Available N/A5« less
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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 and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006.
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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 and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration- February 2006. PMID:17034633
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Stoll, Elaine
2010-01-01
Congress passed the Family Smoking Prevention and Tobacco Control Act in 2009 with the aim of reducing tobacco-related illnesses and deaths by curbing tobacco's appeal to and use by children and adolescents. Legislators considered provisions of the FSPTCA restricting tobacco advertising and labeling key to realizing the law's intended health benefits. But a lawsuit now before the U.S. Court of Appeals for the Sixth Circuit challenges the tobacco marketing restrictions as impermissible restraints on tobacco companies' commercial speech rights under the First Amendment. This article analyzes the constitutionality of each FSPTCA tobacco advertising and labeling restriction in light of U.S. Supreme Court decisions defining the extent of First Amendment protection for commercial speech, prior efforts to restrict tobacco marketing, and the outcomes of legal challenges to some of the prior marketing restrictions. Several of the FSPTCA tobacco advertising and labeling restrictions were drafted with insufficient accommodations for tobacco companies' First Amendment right to convey and consumers' First Amendment right to receive truthful information about lawful tobacco products and are therefore unconstitutional as currently written.
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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
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0286] Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or... Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-06
... irradiation, and (3) alternative sites for Pa'ina's irradiator. DATES: The public comment period on the Draft...'s irradiator, (2) electron-beam technology as an alternative to cobalt-60 irradiation, and (3... be used for the production and research irradiation of food, cosmetic, and pharmaceutical products...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-14
...] Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological... entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This revised draft... industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-13
... or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI 209; Availability AGENCY: Food and Drug... availability of a draft guidance for industry (draft GFI 213) entitled ``New Animal Drugs and New Animal Drug...
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New FDA draft guidance on immunogenicity.
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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-13
... Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to... exploration and verification of drug effects under epidemic and pandemic conditions. A draft notice of...
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10 CFR 51.76 - Draft environmental impact statement-limited work authorization.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Draft environmental impact statement-limited work...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.76 Draft environmental impact statement—limited work authorization. The NRC will prepare a...
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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...
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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...
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10 CFR 51.76 - Draft environmental impact statement-limited work authorization.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Draft environmental impact statement-limited work...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.76 Draft environmental impact statement—limited work authorization. The NRC will prepare a...
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10 CFR 51.76 - Draft environmental impact statement-limited work authorization.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Draft environmental impact statement-limited work...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.76 Draft environmental impact statement—limited work authorization. The NRC will prepare a...
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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...
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10 CFR 51.76 - Draft environmental impact statement-limited work authorization.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Draft environmental impact statement-limited work...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.76 Draft environmental impact statement—limited work authorization. The NRC will prepare a...
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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...
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10 CFR 51.76 - Draft environmental impact statement-limited work authorization.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-limited work...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.76 Draft environmental impact statement—limited work authorization. The NRC will prepare a...
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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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-02
... Classification of Materials and Materials for Organic Crop Production AGENCY: Agricultural Marketing Service... organic crop production, livestock production, and handling. The second set of draft guidance documents, NOP 5034, provides clarification regarding materials for use in organic crop production. These...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-17
... Pesticide Registrants on False or Misleading Pesticide Product Brand Names; Extension of Comment Period... Pesticide Product Brand Names.'' This document extends the comment period for 60 days, from June 18, 2010... draft Pesticide Registration Notice (PR Notice) entitled ``False or Misleading Pesticide Product Brand...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-31
...] Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment... support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It... Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),'' published in...
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Santos, Viviane Cristina dos; Ferraz, Marcos Bosi
2013-01-01
The Federal Constitution of 1988 allowed the National Congress to contribute towards formulation of new public policies. The objective of this study was to analyze the legislative production that dealt with health issues that was in passage in the National Congress between January 2007 and December 2008. Descriptive-exploratory cross-sectional study with quantitative and qualitative approaches, conducted in a federal university. The analysis material for the study comprised 144 draft bills that were classified and subsequently randomly evaluated by 155 professionals working within the healthcare system. The analysis showed that the Workers' Party (PT) and Brazilian Democratic Movement Party (PMDB) were the parties that presented the largest proportions of the draft bills (12.5% and 11.1%); 25.4% of the draft bills were presented by congress members with academic qualifications within healthcare and only 1.4% of the draft bills became transformed into legal regulations. In questionnaire responses, 51.5% of the evaluators did not consider the draft bills to be viable, 40.6% did not consider them to be relevant and 52.5% said that if the draft bills were not approved it would not be harmful to Brazilian society. In analyzing the data from this study, it was noted that the legislative production relating to healthcare was low and the transformation rate from draft bill to legal regulation was negligible. The results from the evaluation showed that the quality of legislative production was impaired.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-12
... Products (VICH). This draft VICH guidance document is intended to provide study design recommendations... Products; Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal...
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Current status of nutrition labelling and claims in the South-East Asian region: are we in harmony?
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 the region to enact regulations on nutrition claims. Recently enacted regulations or amendments to existing regulations of almost all the countries reviewed have included provisions for nutrition claims. Malaysia is in the process of gazetting regulations to clearly stipulate the permitted nutrition claims and the conditions required to make these claims along the guidelines of Codex Alimentarius Commission. Only two countries in the region permit health claims to be made - Indonesia and Philippines. Other countries in the region are following developments in Codex and examining the need for allowing these claims. There are more differences than similarities in the regulations on nutrition labelling and claims among countries in the South-East Asian region as no previous efforts have been made to address these. Hopefully, through this first regional meeting, countries can initiate closer interaction, with a view to working towards greater harmonization of nutrition labelling and health claims in the region.
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Toward improved pregnancy labelling.
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.
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PRN 2002-X Draft: False or Misleading Pesticide Product Brand Name
This notice provides guidance to registrants and distributors on pesticide product brand names that may be false or misleading, either by themselves or in association with particular company names or trademarks. It is a draft.
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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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-13
... Production (NOP 5021); Wild Crop Harvesting (NOP 5022); Outdoor Access for Organic Poultry (NOP 5024); Commingling and Contamination Prevention in Organic Production and Handling (NOP 5025); and The Use of Chlorine Materials in Organic Production and Handling (NOP 5026). These draft guidance documents are...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-20
... such as Internet promotion, social media, emails, CD-ROMs, and DVDs. Following issuance of the guidance... materials. The recommendations in the draft guidance pertain to product names in traditional print media...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-07
... Health's (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final... products, FDA headquarters and field personnel, and the public of CDRH's proposed approach on the safety of... limits. While this rulemaking process is ongoing, CDRH encourages manufacturers to keep children's toy...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-11
... by Blood and Blood Products,'' Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...CJD) by Blood and Blood Products'' dated May 2010 (2010 CJD/vCJD guidance). When finalized, the... Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products' '' dated April 2012. The draft...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-01
... Agriculture AGENCY: Environmental Protection Agency (EPA). ACTION: Notification to the Secretary of Agriculture. SUMMARY: This document notifies the public that the Administrator of EPA has forwarded to the Secretary of Agriculture a draft proposed rule as required by section 25(a) of the Federal Insecticide...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-08
... Notification of Submission to the Secretary of Agriculture; Pesticides; Regulation To Clarify Labeling of... the Secretary of Agriculture. SUMMARY: This document notifies the public as required by the Federal... of the U.S. Department of Agriculture (USDA) a draft final rule concerning the revision of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0082... effectiveness and adverse effects). Genetic variations can also influence the exposure- response (E/R... overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-25
...) requires certain chain restaurants and similar retail food establishments with 20 or more locations... operators'') to disclose calories for articles of food. Restaurants and similar retail food establishments... restaurants can help people make healthier choices (Refs. 1 and 2). Responding to this demand for information...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-22
... Design, Data Analysis, and Impact on Dosing and Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0133...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-16
...) Organizations and two associated draft QA Handbooks; 1) draft Handbook for Preparing Quality Management Plans... Availability and Comment Period for the Draft Quality Standard for Environmental Data Collection, Production, and Use by Non-EPA (External) Organizations and Two Associated QA Handbooks; Correction AGENCY...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-13
...] Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma Contamination... Detection of Mycoplasma Contamination.'' This draft guideline identifies stages of manufacture where... contamination. Because the guidelines apply to final product and master seed/cell testing in veterinary vaccines...
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75 FR 4380 - Draft Test Guidelines; Notice of Availability and Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-27
... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2009-0681; FRL-8437-2] Draft Test Guidelines; Notice...: Notice. SUMMARY: EPA is announcing the availability of four draft test guidelines for Product Performance... holidays. The Docket Facility telephone number is (703) 305-5805. Electronic access to the OPPTS Test...
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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…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-15
...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
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The purpose of this product is to make accessible the information about the 1,173 hydraulic fracturing-related chemicals that were listed in the external review draft of the Hydraulic Fracturing Drinking Water Assessment that was released recently. The product consists of a serie...
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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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-24
... Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and... Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access)'' (the draft guidance). The document provides guidance to egg producers on...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-13
..., Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation... Eggs During Production, Storage, and Transportation'' (the draft guidance). The draft guidance provides guidance to egg producers and other persons who are covered by FDA's final rule entitled ``Prevention of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-08
... Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-14
... Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-22
... Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-31
..., including Source Plasma, with recommendations intended to assist with determining which reporting mechanism... final version of the guidance, submit either electronic or written comments on the draft guidance by... INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the...
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This draft Geographic Information System (GIS) tool can be used to generate scenarios of housing-density changes and calculate impervious surface cover for the conterminous United States. A draft User’s Guide accompanies the tool. This product distributes the population project...
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EPA is releasing a draft report "Next Generation Risk Assessment: I... -
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-09
...] Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products... the availability of a draft guidance for industry entitled ``Submission of Warning Plans for... submitting warning plans to FDA under the Comprehensive Smokeless Tobacco Health Education Act, as amended by...
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Introduction to Production/Manufacturing Drafting. Drafting Module 8. Instructor's Guide.
ERIC Educational Resources Information Center
Missouri Univ., Columbia. Instructional Materials Lab.
This module, 1 of 10 in the Drafting curriculum guide developed in Missouri, contains 3 units of study that include some or all of the following components: performance objectives, lesson plans, information sheets, transparency masters, handouts, assignment sheets, job sheets, a unit test, and answers to the unit test. Special instructions on…
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1993-01-01
The set of documents discusses the new draft methods (EPA method 551, EPA method 552) for the analysis of disinfection byproducts contained in drinking water. The methods use the techniques of liquid/liquid extraction and gas chromatography with electron capture detection.
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Tumwine, Jacqueline
2011-11-01
To describe, as of July 2011, the status of tobacco control legislation in Africa in three key areas of the Framework Convention on Tobacco Control (FCTC)-(1) Protection from exposure to tobacco smoke, (2) Packaging and labelling of tobacco products, and (3) Tobacco advertising, promotion and sponsorship. Review and analysis of tobacco control legislation in Africa, media reports, journal articles, tobacco industry documents and data published in the 2011 WHO Report on the Global Tobacco Epidemic. Modest progress in FCTC implementation in Africa with many countries having legislation or policies on the protection from exposure to tobacco smoke, however, only a handful of countries meet the standards of the FCTC Article 8 and its Guidelines particularly with regards to designated smoking areas. Little progress on packaging and labelling of tobacco products, with few countries having legislation meeting the minimum standards of the FCTC Article 11 and its Guidelines. Mauritius is the only African country with graphic or pictorial health warnings in place and has the largest warning labels in Africa. Slightly better progress in banning tobacco advertising, promotion and sponsorship has been shown by African countries, although the majority of legislation falls short of the standards of the FCTC Article 13 and its Guidelines. Despite their efforts, African countries' FCTC implementation at national level has not matched the strong regional commitment demonstrated during the FCTC treaty negotiations. This study highlights the need for Africa to step up efforts to adopt and implement effective tobacco control legislation that is fully compliant with the FCTC. In order to achieve this, countries should prioritise resources for capacity building for drafting strong FCTC compliant legislation, research to inform policy and boost political will, and countering the tobacco industry which is a major obstacle to FCTC implementation in Africa.
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Beyond Reason: The Media, Politics, and Public Discourse. Draft.
ERIC Educational Resources Information Center
Dorman, William A.
The media have a lot to do with how people think and what people think about. The line between popular culture and news has virtually disappeared, giving rise to what some have labeled "infotainment." At the same time, "fake news" in the form of publicity that promoters provide to media outlets under the guise of legitimate…
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21 CFR 314.105 - Approval of an application and an abbreviated application.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...
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21 CFR 314.105 - Approval of an application and an abbreviated application.
Code of Federal Regulations, 2010 CFR
2010-04-01
... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...
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21 CFR 314.105 - Approval of an application and an abbreviated application.
Code of Federal Regulations, 2014 CFR
2014-04-01
... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...
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21 CFR 314.105 - Approval of an application and an abbreviated application.
Code of Federal Regulations, 2013 CFR
2013-04-01
... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...
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21 CFR 314.105 - Approval of an application and an abbreviated application.
Code of Federal Regulations, 2012 CFR
2012-04-01
... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-14
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... Evaluation and Research (HFD-170), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3160... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0045...
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DRAFT one year extension of the short-term national product waiver for stainless steel nuts and bolts used in pipe couplings, restraints, joints, flanges and saddles for State Revolving Fund projects.
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EPA is announcing the final (third) review draft report entitled Synthesis and Assessment Product 4.4: Preliminary Review of Adaptation Options for Climate Sensitive Ecosystems and Resources. This Synthesis and Assessment Product 4.4 (SAP 4.4) analyzes information on the ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-2955] (formerly Docket No. 1999D-4071) Draft Revised Guidance for Industry on Residual Solvents in New Veterinary...) entitled ``Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-02
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0618] Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-25
... Potassium (multiple RLDs) Aripiprazole Aspirin; Butalbital; Caffeine (multiple RLDs) Aspirin; Dipyridamole Aspirin; Oxycodone Aspirin; Butalbital; Caffeine; Codeine Phosphate Atovaquone Auranofin Azelaic Acid...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-23
...] Draft Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Products for Treatment... topics regarding irritable bowel syndrome (IBS) sign and symptom assessment for IBS with diarrhea (IBS-D... IBS. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0429] Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-07
... copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research..., Silver Spring, MD 20993- 0002, 301-796-8510. Regarding human drug products: Solomon Iyasu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm...
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Engineering Documentation and Data Control
NASA Technical Reports Server (NTRS)
Matteson, Michael J.; Bramley, Craig; Ciaruffoli, Veronica
2001-01-01
Mississippi Space Services (MSS) the facility services contractor for NASA's John C. Stennis Space Center (SSC), is utilizing technology to improve engineering documentation and data control. Two identified improvement areas, labor intensive documentation research and outdated drafting standards, were targeted as top priority. MSS selected AutoManager(R) WorkFlow from Cyco software to manage engineering documentation. The software is currently installed on over 150 desctops. The outdated SSC drafting standard was written for pre-CADD drafting methods, in other words, board drafting. Implementation of COTS software solutions to manage engineering documentation and update the drafting standard resulted in significant increases in productivity by reducing the time spent searching for documents.
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Hammerl, J A; Lasch, P; Nitsche, A; Dabrowski, P W; Hahmann, H; Wicke, A; Kleta, S; Al Dahouk, S; Dieckmann, R
2015-07-23
In 2013, contaminated liquid soap was detected by routine microbiological monitoring of consumer products through state health authorities. Because of its high load of Klebsiella oxytoca, the liquid soap was notified via the European Union Rapid Alert System for Dangerous Non-Food Products (EU-RAPEX) and recalled. Here, we present two draft genome sequences and a summary of their general features. Copyright © 2015 Hammerl et al.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-28
... Tobacco Control Act amends the FD&C Act and grants FDA authority to regulate the manufacture, marketing... (PMTA) under section 910(b) of the FD&C Act and receive a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act prior to marketing the product. The draft guidance is intended to...
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78 FR 26616 - Draft NOAA Five Year Research and Development Plan
Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-07
... understanding among NOAA's leadership, workforce, partners, constituents, and Congress on how the agency's R&D... learn from its experiences. ADDRESSES: The draft can be found at http://nrc.noaa.gov/CouncilProducts...
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76 FR 57031 - Draft Harmonized Test Guidelines; Notice of Availability and Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-15
...EPA is announcing the availability of the draft test guidelines for Series 810--Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents, concerning specifically air, textiles, and water.
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Draft Genome Sequence of Marinobacter sp. Strain ANT_B65, Isolated from Antarctic Marine Sponge.
de França, Paula; Camilo, Esther; Fantinatti-Garboginni, Fabiana
2018-01-04
Marinobacter sp. strain ANT_B65 was isolated from sponge collected in King George Island, Antarctica. The draft genome of 4,173,840 bp encodes 3,743 protein-coding open reading frames. The genome will provide insights into the strain's potential use in the production of natural products. Copyright © 2018 de França et al.
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Draft Genome Sequence of Bacillus stratosphericus LAMA 585, Isolated from the Atlantic Deep Sea
Cabral, Alencar; Andreote, Fernando Dini; Cavalett, Angélica; Pessatti, Marcos Luiz; Dini-Andreote, Francisco; da Silva, Marcus Adonai Castro
2013-01-01
Bacillus stratosphericus LAMA 585 was isolated from the Mid-Atlantic-Ridge seafloor (5,500-m depth). This bacterium presents the capacity for cellulase, xylanase, and lipase production when growing aerobically in marine-broth media. Genes involved in the tolerance of oligotrophic and extreme conditions and prospection of biotechnological products were annotated in the draft genome (3.7 Mb). PMID:23640380
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Draft Genome Sequence of a Red-Pigmented Janthinobacterium sp. Native to the Hudson Valley Watershed
O’Brien, Kelsey
2018-01-01
ABSTRACT Water samples from the Hudson Valley watershed indicate that the area is host to many violacein-producing bacterial isolates. Here, we report the draft whole-genome sequence of Janthinobacterium sp. strain BJB412, an isolate lacking violacein production yet containing genes responsible for prodigiosin, biofilm production, and quorum sensing, like its purple-pigmented counterparts. PMID:29301893
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-23
... per 12 ounces: (1) Sports drinks (this term is used by industry and has not been defined by the Agency), (2) bottled water and water beverages, (3) soft drinks and diet soft drinks, (4) energy drinks (this term is used by industry and has not been defined by the Agency), and (5) ready-to- drink teas. The CPG...
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Zhang, Ya; Kitajima, Masaaki; Whittle, Andrew J.; Liu, Wen-Tso
2017-01-01
The occurrence of pathogenic bacteria in drinking water distribution systems (DWDSs) is a major health concern, and our current understanding is mostly related to pathogenic species such as Legionella pneumophila and Mycobacterium avium but not to bacterial species closely related to them. In this study, genomic-based approaches were used to characterize pathogen-related species in relation to their abundance, diversity, potential pathogenicity, genetic exchange, and distribution across an urban drinking water system. Nine draft genomes recovered from 10 metagenomes were identified as Legionella (4 draft genomes), Mycobacterium (3 draft genomes), Parachlamydia (1 draft genome), and Leptospira (1 draft genome). The pathogenicity potential of these genomes was examined by the presence/absence of virulence machinery, including genes belonging to Type III, IV, and VII secretion systems and their effectors. Several virulence factors known to pathogenic species were detected with these retrieved draft genomes except the Leptospira-related genome. Identical clustered regularly interspaced short palindromic repeats-CRISPR-associated proteins (CRISPR-Cas) genetic signatures were observed in two draft genomes recovered at different stages of the studied system, suggesting that the spacers in CRISPR-Cas could potentially be used as a biomarker in the monitoring of Legionella related strains at an evolutionary scale of several years across different drinking water production and distribution systems. Overall, metagenomics approach was an effective and complementary tool of culturing techniques to gain insights into the pathogenic characteristics and the CRISPR-Cas signatures of pathogen-related species in DWDSs. PMID:29097994
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Dennis, J E
1997-12-01
Federal law requires that all laser products that are imported into or introduced into commerce in the United States comply with the performance standard published in the Code of Federal Regulations (CRF), Title 21, Parts 1040.10 and 1040.11, administered by the Center for Devices and Radiological Health (CDRH), US Food and Drug Administration. Although it contains somewhat different requirements for hazard classification, engineering controls and labeling, the ANSI Z136.1 standard defers to the CDRH standard. The CDRH standard became effective in August, 1976 and was amended, in 1978 and also in 1985. In the early 1990s, US experts met to formulate an approach to bring the requirements of the CDRH standard and those of the International Electrotechnical Commission (IEC) standard, IEC 825, into closer agreement in order to lower barriers to international trade and to remove any excessive compliance burdens on manufacturers. In 1993, the CDRH published, formally in the Federal Register and informally, a Notice of Intent to amend the CDRH standard. Responses to those notices have now been analyzed and informal draft amendments were distributed in 1996. This draft is now being prepared for formal issuance as a Notice of Proposed Rulemaking. Meanwhile, the IEC standard was amended in 1993 and republished as IEC 825-1; these amendments created considerable controversy since they resulted in over classification of the hazard of many products, especially light emitting diodes (LEDs) that have a large divergence and increased source dimensions. Additional amendments are now being developed to correct this problem. The CDRH has carefully monitored developments in the IEC and actively participated in its proceedings as a guide in developing its own proposal. This paper describes the major changes that are being proposed for the CDRH standard and presents some rationale for the major changes. The more significant changes include expansion of applicability to include LEDs, reduced emission durations for classification, revised measurement for hazard classification, reduced performance requirements for lower power visible radiation products, and revised requirements for medical products.
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Drafting standards on cognitive accessibility: a global collaboration.
Steel, Emily J; Janeslätt, Gunnel
2017-05-01
The International Organization for Standardization (ISO) is working on accessibility of products to support people with cognitive impairment. Working Group 10, within the technical committee 173 (assistive products for persons with disability) was formed in 2014 to draft standards for assistive products that support people with cognitive impairment. This article explains the scope and purpose of the working group and the context for its formation, and describes the plans and process for drafting and publishing new international standards. The proposed suite of standards is presented, with examples from a draft standard on daily time management. It draws on international research evidence for the effectiveness of assistive products designed to support time management in people with cognitive impairment. Examples of assistive products and their key features are provided based on domains of time as defined in the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY). The proposed standards will provide design recommendations for features and functions that increase the accessibility of products used by people with cognitive impairment. They are intended to be used by designers, manufactures, educators and services providers, to facilitate their commitment to inclusion and demonstrate their willingness to work with accessibility regulation. Implications for Rehabilitation New standards based on universal design (UD) principles can guide the design of more user-friendly assistive products for people with cognitive impairment. Greater usability of assistive products, whether mainstream or specially-designed, will make it easier for practitioners to find and introduce assistive solutions to individuals with cognitive impairment. Greater usability of assistive products for daily time management can decrease the need for user training and support and enable participation.
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Mundt, Kenneth A; Gentry, P Robinan; Dell, Linda D; Rodricks, Joseph V; Boffetta, Paolo
2018-02-01
Shortly after the International Agency for Research on Cancer (IARC) determined that formaldehyde causes leukemia, the United States Environmental Protection Agency (EPA) released its Draft IRIS Toxicological Review of Formaldehyde ("Draft IRIS Assessment"), also concluding that formaldehyde causes leukemia. Peer review of the Draft IRIS Assessment by a National Academy of Science committee noted that "causal determinations are not supported by the narrative provided in the draft" (NRC 2011). They offered recommendations for improving the Draft IRIS assessment and identified several important research gaps. Over the six years since the NRC peer review, significant new science has been published. We identify and summarize key recommendations made by NRC and map them to this new science, including extended analysis of epidemiological studies, updates of earlier occupational cohort studies, toxicological experiments using a sensitive mouse strain, mechanistic studies examining the role of exogenous versus endogenous formaldehyde in bone marrow, and several critical reviews. With few exceptions, new findings are consistently negative, and integration of all available evidence challenges the earlier conclusions that formaldehyde causes leukemia. Given formaldehyde's commercial importance, environmental ubiquity and endogenous production, accurate hazard classification and risk evaluation of whether exposure to formaldehyde from occupational, residential and consumer products causes leukemia are critical. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-14
...] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... Controls (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products... documentation to submit to support the CMC information for fermentation-derived intermediates, drug substances...
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Tuck, Geoffrey N; Whitten, Athol R
2013-01-01
Annual draft systems are the principal method used by teams in major sporting leagues to recruit amateur players. These draft systems frequently take one of three forms: a lottery style draft, a weighted draft, or a reverse-order draft. Reverse-order drafts can create incentives for teams to deliberately under-perform, or tank, due to the perceived gain from obtaining quality players at higher draft picks. This paper uses a dynamic simulation model that captures the key components of a win-maximising sporting league, including the amateur player draft, draft choice error, player productivity, and between-team competition, to explore how competitive balance and incentives to under-perform vary according to league characteristics. We find reverse-order drafts can lead to some teams cycling between success and failure and to other teams being stuck in mid-ranking positions for extended periods of time. We also find that an incentive for teams to tank exists, but that this incentive decreases (i) as uncertainty in the ability to determine quality players in the draft increases, (ii) as the number of teams in the league reduces, (iii) as team size decreases, and (iv) as the number of teams adopting a tanking strategy increases. Simulation models can be used to explore complex stochastic dynamic systems such as sports leagues, where managers face difficult decisions regarding the structure of their league and the desire to maintain competitive balance.
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Tuck, Geoffrey N.; Whitten, Athol R.
2013-01-01
Annual draft systems are the principal method used by teams in major sporting leagues to recruit amateur players. These draft systems frequently take one of three forms: a lottery style draft, a weighted draft, or a reverse-order draft. Reverse-order drafts can create incentives for teams to deliberately under-perform, or tank, due to the perceived gain from obtaining quality players at higher draft picks. This paper uses a dynamic simulation model that captures the key components of a win-maximising sporting league, including the amateur player draft, draft choice error, player productivity, and between-team competition, to explore how competitive balance and incentives to under-perform vary according to league characteristics. We find reverse-order drafts can lead to some teams cycling between success and failure and to other teams being stuck in mid-ranking positions for extended periods of time. We also find that an incentive for teams to tank exists, but that this incentive decreases (i) as uncertainty in the ability to determine quality players in the draft increases, (ii) as the number of teams in the league reduces, (iii) as team size decreases, and (iv) as the number of teams adopting a tanking strategy increases. Simulation models can be used to explore complex stochastic dynamic systems such as sports leagues, where managers face difficult decisions regarding the structure of their league and the desire to maintain competitive balance. PMID:24312243
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Tumwine, Jacqueline
2011-01-01
Objective To describe, as of July 2011, the status of tobacco control legislation in Africa in three key areas of the Framework Convention on Tobacco Control (FCTC)—(1) Protection from exposure to tobacco smoke, (2) Packaging and labelling of tobacco products, and (3) Tobacco advertising, promotion and sponsorship. Methods Review and analysis of tobacco control legislation in Africa, media reports, journal articles, tobacco industry documents and data published in the 2011 WHO Report on the Global Tobacco Epidemic. Results Modest progress in FCTC implementation in Africa with many countries having legislation or policies on the protection from exposure to tobacco smoke, however, only a handful of countries meet the standards of the FCTC Article 8 and its Guidelines particularly with regards to designated smoking areas. Little progress on packaging and labelling of tobacco products, with few countries having legislation meeting the minimum standards of the FCTC Article 11 and its Guidelines. Mauritius is the only African country with graphic or pictorial health warnings in place and has the largest warning labels in Africa. Slightly better progress in banning tobacco advertising, promotion and sponsorship has been shown by African countries, although the majority of legislation falls short of the standards of the FCTC Article 13 and its Guidelines. Despite their efforts, African countries’ FCTC implementation at national level has not matched the strong regional commitment demonstrated during the FCTC treaty negotiations. Conclusion This study highlights the need for Africa to step up efforts to adopt and implement effective tobacco control legislation that is fully compliant with the FCTC. In order to achieve this, countries should prioritise resources for capacity building for drafting strong FCTC compliant legislation, research to inform policy and boost political will, and countering the tobacco industry which is a major obstacle to FCTC implementation in Africa. PMID:22163209
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Draft Genome Sequence of the Dimorphic Yeast Yarrowia lipolytica Strain W29
DOE Office of Scientific and Technical Information (OSTI.GOV)
Pomraning, Kyle R.; Baker, Scott E.
Here, we present the draft genome sequence of the dimorphic ascomycete yeastYarrowia lipolyticastrain W29 (ATCC 20460).Y. lipolyticais a commonly employed model for the industrial production of lipases, small molecules, and more recently for its ability to accumulate lipids.
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Draft Genome Sequence of Lactobacillus helveticus ATCC 12046
2018-01-01
ABSTRACT Lactobacillus helveticus is a lactic acid bacterium used traditionally in the dairy industry, especially in the manufacture of cheeses. We present here the 2,141,841-bp draft genome sequence of L. helveticus strain ATCC 12046, a potential starter strain for improving cheese production. PMID:29449405
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ISO radiation sterilization standards
NASA Astrophysics Data System (ADS)
Lambert, Byron J.; Hansen, Joyce M.
1998-06-01
This presentation provides an overview of the current status of the ISO radiation sterilization standards. The ISO standards are voluntary standards which detail both the validation and routine control of the sterilization process. ISO 11137 was approved in 1994 and published in 1995. When reviewing the standard you will note that less than 20% of the standard is devoted to requirements and the remainder is guidance on how to comply with the requirements. Future standards developments in radiation sterilization are being focused on providing additional guidance. The guidance that is currently provided in informative annexes of ISO 11137 includes: device/packaging materials, dose setting methods, and dosimeters and dose measurement, currently, there are four Technical Reports being developed to provide additional guidance: 1. AAMI Draft TIR, "Radiation Sterilization Material Qualification" 2. ISO TR 13409-1996, "Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches" 3. ISO Draft TR, "Sterilization of health care products — Radiation sterilization Selection of a sterilization dose for a single production batch" li]4. ISO Draft TR, "Sterilization of health care products — Radiation sterilization-Product Families, Plans for Sampling and Frequency of Dose Audits."
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Introduction to Pesticide Labels
Pesticide product labels provide critical information about how to safely and legally handle and use pesticide products. Unlike most other types of product labels, pesticide labels are legally enforceable. Learn about pesticide product labels.
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76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-23
... draft guidance does not apply to egg producers and other persons who are covered by FDA's final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The... eggs) and direct-human-contact animal foods, and the interpretation of test results, when the presence...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
...) Organizations and two associated draft QA Handbooks; 1) draft Handbook for Preparing Quality Management Plans... Data Collection, Production, and Use by Non-EPA (External) Organizations and two associated QA Handbooks AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability & request for...
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Close, Dan; Ojumu, John O.; Zhang, Gui X.
2016-11-03
Cryptococcus terricola JCM 24523 has recently been identified as an oleaginous yeast capable of converting starch into fatty acids. Here, this draft genome sequence provides a platform for elucidating its fatty acid production potential and supporting comparisons with other oleaginous species.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Close, Dan; Ojumu, John O.; Zhang, Gui X.
Cryptococcus terricola JCM 24523 has recently been identified as an oleaginous yeast capable of converting starch into fatty acids. Here, this draft genome sequence provides a platform for elucidating its fatty acid production potential and supporting comparisons with other oleaginous species.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-12
... humans. ``Fungistats'' are antimicrobial pesticides intended for aesthetic or cosmetic purposes and only... to improve protection of public health through proper use of mold-related pesticides. III. Do PR... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2010-0539; FRL-9362-3] Pesticides; Draft Guidance for...
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9 CFR 439.5 - Applications for accreditation.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Section 439.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE..., for each accreditation sought, submit a check, bank draft, or money order in the amount specified in 9... are payable upon receipt by check, bank draft, or money order made payable to the U.S. Department of...
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Draft Genome Sequence of Lactobacillus helveticus ATCC 12046.
Palomino, María Mercedes; Burguener, Germán F; Campos, Josefina; Allievi, Mariana; Fina-Martin, Joaquina; Prado Acosta, Mariano; Fernández Do Porto, Darío A; Ruzal, Sandra M
2018-02-15
Lactobacillus helveticus is a lactic acid bacterium used traditionally in the dairy industry, especially in the manufacture of cheeses. We present here the 2,141,841-bp draft genome sequence of L. helveticus strain ATCC 12046, a potential starter strain for improving cheese production. Copyright © 2018 Palomino et al.
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USDA-ARS?s Scientific Manuscript database
Vinylglycines are non-proteinogenic amino acids that inhibit amino acid metabolism and ethylene production. In this report, we describe the draft genome sequences of seven isolates of Pseudomonas that produce 4-formylaminooxyvinylglycine, a compound known to inhibit the germination of grasses and t...
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Draft Genome Sequence of the Putrescine-Producing Strain Lactococcus lactis subsp. lactis 1AA59
del Rio, Beatriz; Linares, Daniel M.; Fernandez, María; Mayo, Baltasar; Martín, M. Cruz
2015-01-01
We report here the 2,576,542-bp genome annotated draft assembly sequence of Lactococcus lactis subsp. lactis 1AA59. This strain—isolated from a traditional cheese—produces putrescine, one of the most frequently biogenic amines found in dairy products. PMID:26089428
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9 CFR 381.400 - Nutrition labeling of poultry products.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition labeling of poultry products. (a) Nutrition labeling shall be provided for all poultry products intended...
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9 CFR 381.400 - Nutrition labeling of poultry products.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition labeling of poultry products. (a) Nutrition labeling must be provided for all poultry products intended for...
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9 CFR 381.400 - Nutrition labeling of poultry products.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition labeling of poultry products. (a) Nutrition labeling must be provided for all poultry products intended for...
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NASA Astrophysics Data System (ADS)
Wilhelm, S.; Balarac, G.; Métais, O.; Ségoufin, C.
2016-11-01
Flow prediction in a bulb turbine draft tube is conducted for two operating points using Unsteady RANS (URANS) simulations and Large Eddy Simulations (LES). The inlet boundary condition of the draft tube calculation is a rotating two dimensional velocity profile exported from a RANS guide vane- runner calculation. Numerical results are compared with experimental data in order to validate the flow field and head losses prediction. Velocity profiles prediction is improved with LES in the center of the draft tube compared to URANS results. Moreover, more complex flow structures are obtained with LES. A local analysis of the predicted flow field using the energy balance in the draft tube is then introduced in order to detect the hydrodynamic instabilities responsible for head losses in the draft tube. In particular, the production of turbulent kinetic energy next to the draft tube wall and in the central vortex structure is found to be responsible for a large part of the mean kinetic energy dissipation in the draft tube and thus for head losses. This analysis is used in order to understand the differences in head losses for different operating points. The numerical methodology could then be improved thanks to an in-depth understanding of the local flow topology.
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Gujar, Vaibhav V; Fuke, Priya; Khardenavis, Anshuman A; Purohit, Hemant J
2018-02-01
In this study, we have characterized a novel set of extracellular enzymes produced by Penicillium chrysogenum strain HKF2. A draft genome data of 31.5 Mbp was generated and annotation suggested a total of 11,243 protein-coding genes out of which 609 were CAZymes, majority of which were found to have homology with Penicillium rubens, Penicillium chrysogenum followed by Penicillium expansum and Penicillium roqueforti . The prominent CAZyme genes identified in the draft genome encoded for enzymes involved in the production of prebiotics such as inulo-oligosaccharides and fructo-oligosaccharides. Corresponding enzyme assay indicated that the isolate possessed the potential to produce 11.8 and 3.8 U/mL of β-fructofuranosidase and inulinase, respectively. This study highlights the significance of Effluent Treatment Plants as novel and under-explored niche for isolation of fungi having the potential for production of prebiotics synthesizing enzymes.
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USDA-ARS?s Scientific Manuscript database
Intense artificial selection over the last 100 years has produced elite maize (Zea mays) inbred lines that combine to produce high-yielding hybrids. To further our understanding of how genome and transcriptome variation contribute to the production of high-yielding hybrids, we generated a draft geno...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Starkenburg, S. R.; Polle, J. E. W.; Hovde, B.
ABSTRACT The green alga Scenedesmus obliquus is an emerging platform species for the industrial production of biofuels. Here, we report the draft assembly and annotation for the nuclear, plastid, and mitochondrial genomes of S. obliquus strain DOE0152z.
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Incorporating CAD Instruction into the Drafting Curriculum.
ERIC Educational Resources Information Center
Yuen, Steve Chi-Yin
1990-01-01
If education is to meet the challenged posed by the U.S. productivity crisis and the large number of computer-assisted design (CAD) workstations forecast as necessary in the future, schools must integrate CAD into the drafting curriculum and become aggressive in providing CAD training. Teachers need to maintain close contact with local industries…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability AGENCY: Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... Products, Questions and Answers.'' Because of increases in the number and complexity of ANDAs and FDA's...
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Draft genome sequence of the oleaginous yeast Cryptococcus curvatus ATCC 20509
DOE Office of Scientific and Technical Information (OSTI.GOV)
Close, Dan; Ojumu, John O.
Cryptococcus curvatus ATCC 20509 is a commonly used nonmodel oleaginous yeast capable of converting a variety of carbon sources into fatty acids. In addition, we present the draft genome sequence of this popular organism to provide a means for more in-depth studies of its fatty acid production potential.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-02
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver... the review of 351(k) applications and general scientific principles in conducting comparative analyses... specific, on the scientific considerations, Q&A, and quality considerations draft guidances. For example...
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ICLUS Tools and Datasets (Version 1.2) and User's Manual ...
This draft Geographic Information System (GIS) tool can be used to generate scenarios of housing-density changes and calculate impervious surface cover for the conterminous United States. A draft User’s Guide accompanies the tool. This product distributes the population projections and creates land use data described in the 2009 EPA report
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Draft genome sequence of the oleaginous yeast Cryptococcus curvatus ATCC 20509
Close, Dan; Ojumu, John O.
2016-11-03
Cryptococcus curvatus ATCC 20509 is a commonly used nonmodel oleaginous yeast capable of converting a variety of carbon sources into fatty acids. In addition, we present the draft genome sequence of this popular organism to provide a means for more in-depth studies of its fatty acid production potential.
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USDA-ARS?s Scientific Manuscript database
Potential Extraintestinal pathogenic Escherichia coli isolates DP254, WH333, WH398, F356, FEX675 and FEX725 were isolated from retail chicken meat products. Here, we report the draft genome sequences for these six E. coli isolates, which are currently being used in food safety research....
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Starkenburg, S. R.; Polle, J. E. W.; Hovde, B.; ...
2017-08-10
ABSTRACT The green alga Scenedesmus obliquus is an emerging platform species for the industrial production of biofuels. Here, we report the draft assembly and annotation for the nuclear, plastid, and mitochondrial genomes of S. obliquus strain DOE0152z.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-28
... research and marketing applications for medical devices. This draft guidance is not final nor is it in... FDA-regulated products (21 CFR 58.1). The draft guidance provides clarification on GLP terminology, the types of medical device research or marketing applications that are subject to the GLP regulation...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-06
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7520 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-20
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-22
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver..., Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-17
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...
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Coutouné, Natalia; Mulato, Aline Tieppo Nogueira
2017-01-01
ABSTRACT Here, we present the draft genome sequence of Saccharomyces cerevisiae BG-1, a Brazilian industrial strain widely used for bioethanol production from sugarcane. The 11.7-Mb genome sequence consists of 216 scaffolds and harbors 5,607 predicted protein-coding genes. PMID:28360170
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Inferring product healthfulness from nutrition labelling. The influence of reference points.
van Herpen, Erica; Hieke, Sophie; van Trijp, Hans C M
2014-01-01
Despite considerable research on nutrition labelling, it has proven difficult to find a front-of-pack label which is informative about product healthfulness across various situations. This study examines the ability of different types of nutrition labelling schemes (multiple traffic light label, nutrition table, GDA, logo) to communicate product healthfulness (a) across different product categories, (b) between options from the same product category, and (c) when viewed in isolation and in comparison with another product. Results of two experiments in Germany and The Netherlands show that a labelling scheme with reference point information at the nutrient level (e.g., the traffic light label) can achieve all three objectives. Although other types of labelling schemes are also capable of communicating healthfulness, labelling schemes lacking reference point information (e.g., nutrition tables) are less effective when no comparison product is available, and labelling schemes based on overall product healthfulness within the category (e.g., logos) can diminish consumers' ability to differentiate between categories, leading to a potential misinterpretation of product healthfulness. None of the labels affected food preferences.
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Inferring Product Healthfulness from Nutrition Labelling: The Influence of Reference Points.
Herpen, Erica van; Hieke, Sophie; van Trijp, Hans C M
2013-10-25
Despite considerable research on nutrition labelling, it has proven difficult to find a front-of-pack label which is informative about product healthfulness across various situations. This study examines the ability of different types of nutrition labelling schemes (multiple traffic light label, nutrition table, GDA, logo) to communicate product healthfulness (a) across different product categories, (b) between options from the same product category, and (c) when viewed in isolation and in comparison with another product. Results of two experiments in Germany and The Netherlands show that a labelling scheme with reference point information at the nutrient level (e.g., the traffic light label) can achieve all three objectives. Although other types of labelling schemes are also capable of communicating healthfulness, labelling schemes lacking reference point information (e.g., nutrition tables) are less effective when no comparison product is available, and labelling schemes based on overall product healthfulness within the category (e.g., logos) can diminish consumers' ability to differentiate between categories, leading to a potential misinterpretation of product healthfulness. None of the labels affected food preferences. Copyright © 2013. Published by Elsevier Ltd.
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Ni Mhurchu, Cliona; Eyles, Helen; Jiang, Yannan; Blakely, Tony
2018-02-01
There are few objective data on how nutrition labels are used in real-world shopping situations, or how they affect dietary choices and patterns. The Starlight study was a four-week randomised, controlled trial of the effects of three different types of nutrition labels on consumer food purchases: Traffic Light Labels, Health Star Rating labels, or Nutrition Information Panels (control). Smartphone technology allowed participants to scan barcodes of packaged foods and receive randomly allocated labels on their phone screen, and to record their food purchases. The study app therefore provided objectively recorded data on label viewing behaviour and food purchases over a four-week period. A post-hoc analysis of trial data was undertaken to assess frequency of label use, label use by food group, and association between label use and the healthiness of packaged food products purchased. Over the four-week intervention, study participants (n = 1255) viewed nutrition labels for and/or purchased 66,915 barcoded packaged products. Labels were viewed for 23% of all purchased products, with decreasing frequency over time. Shoppers were most likely to view labels for convenience foods, cereals, snack foods, bread and bakery products, and oils. They were least likely to view labels for sugar and honey products, eggs, fish, fruit and vegetables, and meat. Products for which participants viewed the label and subsequently purchased the product during the same shopping episode were significantly healthier than products where labels were viewed but the product was not subsequently purchased: mean difference in nutrient profile score -0.90 (95% CI -1.54 to -0.26). In a secondary analysis of a nutrition labelling intervention trial, there was a significant association between label use and the healthiness of products purchased. Nutrition label use may therefore lead to healthier food purchases. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.
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Relation Extraction with Weak Supervision and Distributional Semantics
2013-05-01
country is no longer a member of the organization), a player and an event, a team and a sport, etc. Multiple meanings of a relation phrase are success ...Zimbabwe, the Commonwealth> <force, country> <American forces, Vietnam>; <Roman Legions, Britain> < player , event> <Brandon Bass, the NBA draft>; <Agassi...training data. We found that dealing with incorrectly labeled examples is critical for its success . We develop a latent Bayesian framework for this
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Hahnel, Ulf J J; Arnold, Oliver; Waschto, Michael; Korcaj, Liridon; Hillmann, Karen; Roser, Damaris; Spada, Hans
2015-01-01
Green products are appealing. Thus, labeling products as environmentally friendly is an effective strategy to increase sales. However, the labels often promise more than the products can actually deliver. In the present research, we examined the expectation that consumers with high ecological motivation have strong preferences for green-labeled products - even when presented product information contradicts the label's image. This unsettling hypothesis is grounded in the labels' potential to create a cognitive match between the labeled product and consumers' motives. For labels indicating environmental friendliness (green product labels), this link should be strongest when consumers' ecological motivation is high. Findings in a series of three experiments support our assumption, showing that consumers with high ecological motivation had strong preferences (i.e., product evaluations, purchase intentions, and simulated purchase decisions) for green-labeled products as compared to consumers with low ecological motivation (Studies 1-3). Crucially, these preferences were robust, despite contradicting environmental product information (Studies 1 and 2). We extended our findings by additionally examining the impact of product labels and motivation on moral self-regulation processes. This was established by assessing participants' pro-social behavior after the purchase task: participants with high ecological motivation acted, consistent with their motives, more pro-socially in post-decision occasions. In accordance with moral cleansing effects, pro-social behavior was intensified after purchasing conventional products (Studies 2 and 3). Green labels protected participants with high ecological motivation from moral threats due to the purchase, thus making pro-social behavior less likely. Findings suggest that highly ecologically motivated consumers are most susceptible to green labels, which may override detailed product information.
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Draft Plan for Characterizing Commercial Data Products in Support of Earth Science Research
NASA Technical Reports Server (NTRS)
Ryan, Robert E.; Terrie, Greg; Berglund, Judith
2006-01-01
This presentation introduces a draft plan for characterizing commercial data products for Earth science research. The general approach to the commercial product verification and validation includes focused selection of a readily available commercial remote sensing products that support Earth science research. Ongoing product verification and characterization will question whether the product meets specifications and will examine its fundamental properties, potential and limitations. Validation will encourage product evaluation for specific science research and applications. Specific commercial products included in the characterization plan include high-spatial-resolution multispectral (HSMS) imagery and LIDAR data products. Future efforts in this process will include briefing NASA headquarters and modifying plans based on feedback, increased engagement with the science community and refinement of details, coordination with commercial vendors and The Joint Agency Commercial Imagery Evaluation (JACIE) for HSMS satellite acquisitions, acquiring waveform LIDAR data and performing verification and validation.
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Two Draft Genome Sequences of Chromobacterium violaceum Isolates from the Rio Negro.
da Gama, Auricélia Matos; de Almeida, Luiz Gustavo; Yamane, Tetsuo; Spira, Beny
2018-01-04
The draft genome sequences of two Chromobacterium violaceum strains isolated from the Rio Negro are reported here. These bacteria carry most genetic systems associated with the production of bioactive compounds, but unlike other C. violaceum strains, they lack a dedicated operon for arsenic resistance. Copyright © 2018 da Gama et al.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-03
...] Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug... and FDA staff entitled ``Glass Syringes for Delivering Drug and Biological Products: Technical... supplemental data are necessary for FDA to ensure the safe and effective use of glass syringes that comply with...
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ERIC Educational Resources Information Center
Pollard, Jim
This report reviews software packages for Apple Macintosh and Apple II computers available to secondary schools to teach computer-aided drafting (CAD). Products for the report were gathered through reviews of CAD periodicals, computers in education periodicals, advertisements, and teacher recommendations. The first section lists the primary…
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USDA-ARS?s Scientific Manuscript database
Shiga toxin-producing Escherichia coli is a foodborne and waterborne pathogen and is responsible for outbreaks of human gastroenteritis. This report documents the draft genome sequences of seven O113:H21 strains recovered from livestock, wildlife, and soil samples collected in a major agricultural r...
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Draft Genome Sequence of Amycolatopsis mediterranei DSM 40773, a Tangible Antibiotic Producer
Mukherjee, Udita; Saxena, Anjali; Kumari, Rashmi; Singh, Priya
2014-01-01
Amycolatopsis mediterranei DSM 40773 has been of special interest as successors of this strain are in use for the commercial production of rifamycin B. Here we present the draft genome sequence (~10 Mb) of this strain, which contains 108 contigs, 9,198 genes, and has a G+C content of 71.3%. PMID:25081263
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Xu, Aixia; Johnson, James R.; Sheen, Shiowshuh; Needleman, David S.
2018-01-01
ABSTRACT Potential extraintestinal pathogenic Escherichia coli strains DP254, WH333, WH398, F356, FEX675, and FEX725 were isolated from retail chicken meat products. Here, we report the draft genome sequences for these six E. coli isolates, which are currently being used in food safety research. PMID:29798928
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-03
... medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for... assist that office in processing your request, or fax your request to CDRH at (301) 847-8149. The draft... parts 862 through 892)) have been the basis for the CDRH's Classification Product Code structure and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-03
... appropriate scientific and medical experts, on the design and conduct of studies required for the assessment... functions, including the design and conduct of research, the oversight of specific studies, and the... any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft...
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Draft Genome Sequence of Chryseobacterium sp. JV274 Isolated from Maize Rhizosphere
Vacheron, Jordan; Dubost, Audrey; Chapulliot, David; Prigent-Combaret, Claire
2017-01-01
ABSTRACT We report the draft genome sequence of Chryseobacterium sp. JV274. This strain was isolated from the rhizosphere of maize during a greenhouse experiment. JV274 harbors genes involved in flexirubin production (darA and darB genes), bacterial competition (type VI secretion system), and gliding (bacterial motility; type IX secretion system). PMID:28408666
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9 CFR 317.300 - Nutrition labeling of meat or meat food products.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Nutrition labeling of meat or meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat or meat food products. (a) Nutrition labeling shall be...
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9 CFR 317.300 - Nutrition labeling of meat and meat food products.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition labeling of meat and meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat and meat food products. (a) Nutrition labeling must be...
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9 CFR 317.300 - Nutrition labeling of meat and meat food products.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition labeling of meat and meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat and meat food products. (a) Nutrition labeling must be...
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Hahnel, Ulf J. J.; Arnold, Oliver; Waschto, Michael; Korcaj, Liridon; Hillmann, Karen; Roser, Damaris; Spada, Hans
2015-01-01
Green products are appealing. Thus, labeling products as environmentally friendly is an effective strategy to increase sales. However, the labels often promise more than the products can actually deliver. In the present research, we examined the expectation that consumers with high ecological motivation have strong preferences for green-labeled products – even when presented product information contradicts the label’s image. This unsettling hypothesis is grounded in the labels’ potential to create a cognitive match between the labeled product and consumers’ motives. For labels indicating environmental friendliness (green product labels), this link should be strongest when consumers’ ecological motivation is high. Findings in a series of three experiments support our assumption, showing that consumers with high ecological motivation had strong preferences (i.e., product evaluations, purchase intentions, and simulated purchase decisions) for green-labeled products as compared to consumers with low ecological motivation (Studies 1–3). Crucially, these preferences were robust, despite contradicting environmental product information (Studies 1 and 2). We extended our findings by additionally examining the impact of product labels and motivation on moral self-regulation processes. This was established by assessing participants’ pro-social behavior after the purchase task: participants with high ecological motivation acted, consistent with their motives, more pro-socially in post-decision occasions. In accordance with moral cleansing effects, pro-social behavior was intensified after purchasing conventional products (Studies 2 and 3). Green labels protected participants with high ecological motivation from moral threats due to the purchase, thus making pro-social behavior less likely. Findings suggest that highly ecologically motivated consumers are most susceptible to green labels, which may override detailed product information. PMID:26441767
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16 CFR 1211.24 - Product certification and labeling by manufacturers.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by manufacturers. 1211.24 Section 1211.24 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... § 1211.24 Product certification and labeling by manufacturers. (a) Form of permanent label of...
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21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...
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21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...
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21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...
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21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...
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9 CFR 317.308 - Labeling of meat or meat food products with number of servings.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of meat or meat food products... SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY... Nutrition Labeling § 317.308 Labeling of meat or meat food products with number of servings. The label of...
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9 CFR 317.308 - Labeling of meat or meat food products with number of servings.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Labeling of meat or meat food products... SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY... Nutrition Labeling § 317.308 Labeling of meat or meat food products with number of servings. The label of...
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9 CFR 381.400 - Nutrition labeling of poultry products.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition labeling of poultry products. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. (a) Nutrition...
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Lance, Philip T; Greenaway, Ruth V; Edwards, Brian
2018-01-01
The US Food and Drug Administration (FDA) put out a call for comments on new draft guidance for industry "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA." This call for comments elicited 7 submissions from various organizations in the field of health care products. This article reports on a review conducted on these 7 submissions. The purpose of this review was to identify any commonalities across the different submissions and determine if there was consensus on any point or aspect of the draft guidance. To identify any commonalities, a heat map plotting the lines of the draft guidance that had raised a comment/suggestion was produced. Also, a thematic analysis was conducted on the comments/suggestions. In total the 7 submissions produced 137 suggestions. The heat map revealed that these suggestions did not focus on any single part of the guidance but were spread throughout the guidance. The thematic analysis conducted on the suggestions found a number of distinct trends. These trends were grouped into 10 primary themes, each with a number of subthemes. It was concluded that guidance from the FDA on this matter is warranted and would be appreciated. However, it was also concluded that based on the distinct trends identified in the suggestions, there are issues that the FDA may wish to consider before publishing their final guidance.
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21 CFR 333.150 - Labeling of first aid antibiotic drug products.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of first aid antibiotic drug products... First Aid Antibiotic Drug Products § 333.150 Labeling of first aid antibiotic drug products. (a... identifies the product as a “first aid antibiotic.” (b) Indications. The labeling of the product states...
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Khmelenina, Valentina N.; Beck, David A. C.; Munk, Christine; Davenport, Karen; Daligault, Hajnalka; Erkkila, Tracy; Goodwin, Lynne; Gu, Wei; Lo, Chien-Chi; Scholz, Matthew; Teshima, Hazuki; Xu, Yan; Chain, Patrick; Bringel, Francoise; Vuilleumier, Stéphane; DiSpirito, Alan; Dunfield, Peter; Jetten, Mike S. M.; Klotz, Martin G.; Knief, Claudia; Murrell, J. Colin; Op den Camp, Huub J. M.; Sakai, Yasuyoshi; Semrau, Jeremy; Svenning, Mette; Stein, Lisa Y.; Trotsenko, Yuri A.
2013-01-01
Robust growth of the gammaproteobacterium Methylomicrobium buryatense strain 5G on methane makes it an attractive system for CH4-based biocatalysis. Here we present a draft genome sequence of the strain that will provide a valuable framework for metabolic engineering of the core pathways for the production of valuable chemicals from methane. PMID:23814105
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Draft Genome Sequence of the Tyramine Producer Enterococcus durans Strain IPLA 655
Ladero, Victor; Linares, Daniel M.; del Rio, Beatriz; Fernandez, Maria; Martin, M. Cruz
2013-01-01
We here report a 3.059-Mbp draft assembly for the genome of Enterococcus durans strain IPLA 655. This dairy isolate provides a model for studying the regulation of the biosynthesis of tyramine (a toxic compound). These results should aid our understanding of tyramine production and allow tyramine accumulation in food to be reduced. PMID:23682153
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9 CFR 381.500 - Exemption from nutrition labeling.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. (a) The following poultry products are exempt from nutrition labeling: (1...
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9 CFR 381.500 - Exemption from nutrition labeling.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. (a) The following poultry products are exempt from nutrition labeling: (1...
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9 CFR 381.500 - Exemption from nutrition labeling.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. (a) The following poultry products are exempt from nutrition labeling: (1...
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PRN Notice 96-6: Pet Pesticide Product Label Statements
This notice specifies statements that should be added to the labels of pesticide products registered for use on dogs and/or cats. These label statements will help to ensure that products bear labeling to reduce the potential for misuse of pet products.
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9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...
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9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...
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9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...
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9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...
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9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...
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9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...
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9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...
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9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...
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76 FR 57682 - Petition Requesting Regulations Restricting Cadmium in Children's Products
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-16
... Requesting Regulations Restricting Cadmium in Children's Products AGENCY: Consumer Product Safety Commission...'') has received a petition requesting standards restricting cadmium in children's products, especially... to begin drafting a proposed rule unless a voluntary standard for cadmium in children's jewelry is...
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Roseman, Mary G; Joung, Hyun-Woo; Littlejohn, Emily I
2018-05-01
Front-of-package (FOP) labels are increasing in popularity on retail products. Reductive FOP labels provide nutrient-specific information, whereas evaluative FOP labels summarize nutrient information through icons. Better understanding of consumer behavior regarding FOP labels is beneficial to increasing consumer use of nutrition labeling when making grocery purchasing decisions. We aimed to determine FOP label format effectiveness in aiding consumers at assessing nutrient density of food products. In addition, we sought to determine relationships between FOP label use and attitude toward healthy eating, diet self-assessment, self-reported health and nutrition knowledge, and label and shopping behaviors. A between-subjects experimental design was employed. Participants were randomly assigned to one of four label conditions: Facts Up Front, Facts Up Front Extended, a binary symbol, and no-label control. One hundred sixty-one US primary grocery shoppers, aged 18 to 69 years. Participants were randomly invited to the online study. Participants in one of four label condition groups viewed three product categories (cereal, dairy, and snacks) with corresponding questions. Adults' nutrition assessment of food products based on different FOP label formats, along with label use and attitude toward healthy eating, diet self-assessment, self-reported health and nutrition knowledge, and label and shopping behaviors. Data analyses included descriptive statistics, χ 2 tests, and logistical regression. Significant outcomes were set to α=.05. Participants selected the more nutrient-dense product in the snack food category when it contained an FOP label. Subjective health and nutrition knowledge and frequency of selecting food for healthful reasons were associated with FOP label use (P<0.01 and P<0.05, respectively). Both Facts Up Front (reductive) and binary (evaluative) FOP labels appear effective for nutrition assessment of snack products compared with no label. Specific attitude and behavior factors were associated with label use. Copyright © 2018 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.
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Uhl, Kathleen; Kennedy, Dianne L; Kweder, Sandra L
2002-01-01
Drugs that carry a concern for teratogenicity are often classified as pregnancy category X in the drug label and contraindicated for use during pregnancy. Many drug labels can be found in the Physicians' Desk Reference (PDR), a widely used source of drug information by American clinicians and patients. To review product labelling in the electronic PDR for the pregnancy category X products for pregnancy prevention risk management components in labelling. The electronic version of the 2001 and 2002 PDR was searched for 'pregnancy category X' products using the full text search feature. All product labels identified were retrieved and reviewed for trade name, generic name, manufacturer and indication. Product labels were manually searched for any pregnancy prevention risk management strategies included in labelling. Those labels that had specific pregnancy prevention risk management strategies were further evaluated. One hundred and seventeen pregnancy category X products were obtained from 2249 products searched in the 2001 PDR database and 124 pregnancy category X products were obtained from the 2150 products in the 2002 PDR database. All pregnancy category X products identified were drug products. The label/package insert for each drug was reviewed to identify risk management strategies for pregnancy prevention. The majority of the labels include as the sole risk management strategy either a black box warning and/or a contraindication for use in women who are or may become pregnant. Only 13 drugs contained specific pregnancy prevention risk management strategies in the label directing the clinician and/or patient, e.g. frequency of pregnancy testing, number and type of contraception methods. Two drugs, bexarotene capsules and gel, were only included in the 2001 PDR. Three drugs, isotretinoin, acitretin, and thalidomide, have formal pregnancy prevention risk management programmes. This study demonstrates the varied risk management approaches in labelling for pregnancy prevention for pregnancy category X drugs. There is a need for consistency in the classification of pregnancy category X products and the pregnancy prevention risk management strategies utilised in the labelling for them.
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7 CFR 205.303 - Packaged products labeled “100 percent organic” or “organic.”
Code of Federal Regulations, 2010 CFR
2010-01-01
..., verifying organic certification of the operations producing such ingredients, and: Provided further, That... (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Labels, Labeling, and Market Information § 205.303 Packaged products labeled “100 percent organic” or “organic.” (a) Agricultural products...
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9 CFR 381.400 - Nutrition labeling of poultry products.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition... was delayed until Mar. 1, 2012, at 76 FR 76890, Dec. 9, 2011. (a) Nutrition labeling shall be provided...
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Consumer involvement: effects on information processing from over-the-counter medication labels.
Sansgiry, S S; Cady, P S; Sansgiry, S
2001-01-01
The objective of this study was to evaluate the effects of consumer involvement on information processing from over-the-counter (OTC) medication labels. A sample of 256 students evaluated simulated OTC product labels for two product categories (headache and cold) in random order. Each participant evaluated labels after reading a scenario to simulate high and low involvement respectively. A questionnaire was used to collect data on variables such as label comprehension, attitude-towards-product label, product evaluation, and purchase intention. The results indicate that when consumers are involved in their purchase of OTC medications they are significantly more likely to understand information from the label and evaluate it accordingly. However, involvement does not affect attitude-towards-product label nor does it enhance purchase intention.
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O'Hair, Joshua A.; Li, Hui; Thapa, Santosh; Scholz, Matthew B.
2017-01-01
ABSTRACT Novel cellulolytic microorganisms can potentially influence second-generation biofuel production. This paper reports the draft genome sequence of Bacillus licheniformis strain YNP1-TSU, isolated from hydrothermal-vegetative microbiomes inside Yellowstone National Park. The assembled sequence contigs predicted 4,230 coding genes, 66 tRNAs, and 10 rRNAs through automated annotation. PMID:28254968
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ERIC Educational Resources Information Center
Poehls, Eddie; And Others
This course guide for a design/drafting course is one of four developed for the graphic communications area in the North Dakota senior high industrial arts education program. (Eight other guides are available for two other areas of Industrial Arts--energy/power and production.) Part 1 provides such introductory information as a definition and…
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ERIC Educational Resources Information Center
Flores, Alina L.; Prue, Christine E.; Panissidi, Paula
2010-01-01
Objective: This article presents the results of testing draft folic acid educational materials with key gatekeepers, leading to the development of a Spanish-language print advertisement, poster, and radio public service announcement (PSA) aimed at promoting folic acid consumption among 18- to 25-year-old young Latina adults, as well as a…
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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.
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9 CFR 317.300 - Nutrition labeling of meat or meat food products.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition labeling of meat or meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat or meat food products. Link to an amendment published at 75...
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9 CFR 317.300 - Nutrition labeling of meat or meat food products.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition labeling of meat or meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat or meat food products. Link to an amendment published at 75...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-25
...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for human prescription drug and biological products (71 FR 3922), which appeared in the Federal Register of January 24, 2006. The rule is commonly referred to as the ``Physician Labeling Rule'' (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care practitioners.
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Berlin, Robert J
2009-09-01
I examined the relationship between the Food and Drug Administration's (FDA's) use of special regulatory designations and the frequency with which labels of oncology drugs are revised to explore how the FDA's designation of products relates to product development and refinement. One hundred oncology drugs, designated by the FDA as accelerated approval, priority review, orphan drug, or traditional review, were identified from publicly available information. Drug information for each product was evaluated to assess the rate at which manufacturers revised product labeling. Rates were compared between specially categorized products and traditional review products (e.g., orphan vs nonorphan drugs) to produce revision rate ratios for each special category. Labeling for accelerated approval and priority review products are revised significantly more frequently than are labels for traditional products. Accelerated approval products are approved based on surrogate endpoints; this approval process anticipates subsequent labeling refinement. Priority review products, however, are approved through a process that is ostensibly as rigorous as traditional review. Their higher than expected label revision rate may suggest deficiencies in the FDA's current priority review evaluation processes.
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Eyles, Helen; Choi, Yeun-Hyang
2017-01-01
Interpretive, front-of-pack (FOP) nutrition labels may encourage reformulation of packaged foods. We aimed to evaluate the effects of the Health Star Rating (HSR), a new voluntary interpretive FOP labelling system, on food reformulation in New Zealand. Annual surveys of packaged food and beverage labelling and composition were undertaken in supermarkets before and after adoption of HSR i.e., 2014 to 2016. Outcomes assessed were HSR uptake by food group star ratings of products displaying a HSR label; nutritional composition of products displaying HSR compared with non-HSR products; and the composition of products displaying HSR labels in 2016 compared with their composition prior to introduction of HSR. In 2016, two years after adoption of the voluntary system, 5.3% of packaged food and beverage products surveyed (n = 807/15,357) displayed HSR labels. The highest rates of uptake were for cereals, convenience foods, packaged fruit and vegetables, sauces and spreads, and ‘Other’ products (predominantly breakfast beverages). Products displaying HSR labels had higher energy density but had significantly lower mean saturated fat, total sugar and sodium, and higher fibre, contents than non-HSR products (all p-values < 0.001). Small but statistically significant changes were observed in mean energy density (−29 KJ/100 g, p = 0.002), sodium (−49 mg/100 g, p = 0.03) and fibre (+0.5 g/100 g, p = 0.001) contents of HSR-labelled products compared with their composition prior to adoption of HSR. Reformulation of HSR-labelled products was greater than that of non-HSR-labelled products over the same period, e.g., energy reduction in HSR products was greater than in non-HSR products (−1.5% versus −0.4%), and sodium content of HSR products decreased by 4.6% while that of non-HSR products increased by 3.1%. We conclude that roll-out of the voluntary HSR labelling system is driving healthier reformulation of some products. Greater uptake across the full food supply should improve population diets. PMID:28829380
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Mhurchu, Cliona Ni; Eyles, Helen; Choi, Yeun-Hyang
2017-08-22
Interpretive, front-of-pack (FOP) nutrition labels may encourage reformulation of packaged foods. We aimed to evaluate the effects of the Health Star Rating (HSR), a new voluntary interpretive FOP labelling system, on food reformulation in New Zealand. Annual surveys of packaged food and beverage labelling and composition were undertaken in supermarkets before and after adoption of HSR i.e., 2014 to 2016. Outcomes assessed were HSR uptake by food group star ratings of products displaying a HSR label; nutritional composition of products displaying HSR compared with non-HSR products; and the composition of products displaying HSR labels in 2016 compared with their composition prior to introduction of HSR. In 2016, two years after adoption of the voluntary system, 5.3% of packaged food and beverage products surveyed ( n = 807/15,357) displayed HSR labels. The highest rates of uptake were for cereals, convenience foods, packaged fruit and vegetables, sauces and spreads, and 'Other' products (predominantly breakfast beverages). Products displaying HSR labels had higher energy density but had significantly lower mean saturated fat, total sugar and sodium, and higher fibre, contents than non-HSR products (all p -values < 0.001). Small but statistically significant changes were observed in mean energy density (-29 KJ/100 g, p = 0.002), sodium (-49 mg/100 g, p = 0.03) and fibre (+0.5 g/100 g, p = 0.001) contents of HSR-labelled products compared with their composition prior to adoption of HSR. Reformulation of HSR-labelled products was greater than that of non-HSR-labelled products over the same period, e.g., energy reduction in HSR products was greater than in non-HSR products (-1.5% versus -0.4%), and sodium content of HSR products decreased by 4.6% while that of non-HSR products increased by 3.1%. We conclude that roll-out of the voluntary HSR labelling system is driving healthier reformulation of some products. Greater uptake across the full food supply should improve population diets.
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21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...
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21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...
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21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...
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21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...
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21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...
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9 CFR 112.2 - Final container label, carton label, and enclosure.
Code of Federal Regulations, 2010 CFR
2010-01-01
... carton; (10) In the case of a product which contains an antibiotic added during the production process... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Final container label, carton label, and enclosure. 112.2 Section 112.2 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION...
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Nanomaterial Case Study: A Comparison of Multiwalled ...
The draft document is intended to be used as part of a process to identify what is known and, more importantly, what is not yet known that could be of value in assessing the broad implications of specific nanomaterials. Like previous case studies (see History/ Chronology below), this draft case study on multiwalled carbon nanotubes (MWCNTs) is based on the comprehensive environmental assessment (CEA) approach, which consists of both a framework and a process. Unlike previous case studies this case study incorporates information about a traditional (i.e., “non-nano-enabled”) product, against which the MWCNT flame-retardant coating applied to upholstery textiles (i.e., the “nano-enabled” product) can be compared. The comparative element serves dual-purposes: 1) to provide a more robust database that facilitates identification of data gaps related to the nano-enabled product and 2) to provide a context for identifying key factors and data gaps for future efforts to evaluate risk-related trade-offs between a nano-enabled and non-nano-enabled product. This draft case study does not represent a completed or even a preliminary assessment of MWCNTs; rather, it uses the CEA framework to structure information from available literature and other resources (e.g., government reports) on the product life cycle, fate and transport processes in various environmental media, exposure-dose characterization, and impacts in human, ecological, and environmental receptors.
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[International trend of guidance for nanomaterial risk assessment].
Hirose, Akihiko
2013-01-01
In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0584... Products.'' This guidance updates recommendations regarding degradation products and updates the draft... information on listing of degradation products, setting acceptance criteria, and qualifying degradation...
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Safety and efficacy of drugs in pregnancy.
Knoppert, David
2011-01-01
Although most drugs are used to treat chronic or pregnancy-induced conditions during pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The information we have on drugs taken during pregnancy and lactation is usually obtained after market approval through published case reports or case series and from pregnancy exposure or retrospective birth defect registries. Furthermore, generic drugs approved for use in this vulnerable population may be approved based on results from a male trial population. This disregards the changes that can occur during pregnancy which can affect the pharmacokinetics of drugs. In an effort to improve the information provided to prescribers, in 2008 the United States Food and Drug Administration proposed a change in product labelling where information from pregnancy exposure registries would be required. As of 2009, European Medicines Agency requires additional statements on use during pregnancy within drug labelling information. In Canada, it is anticipated that the efficacy and safety of drugs in pregnancy will be included under the Drug Safety and Effectiveness Network initiative, and that this will offer a unified approach for such assessments. Pregmedic, a non-profit organization for the advancement of safe and effective use of drugs in pregnancy, has presented a number of proposals and draft guidelines to Health Canada on the inclusion of pregnant women in pharmacokinetic studies and the establishment of registries for women who take drugs during pregnancy. Pregmedic advocates for ensuring that drugs indicated for women are studied in women.
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A Comparison of the Sodium Content of Supermarket Private-Label and Branded Foods in Australia.
Trevena, Helen; Neal, Bruce; Dunford, Elizabeth; Haskelberg, Hila; Wu, Jason H Y
2015-08-21
Supermarket private-label products are perceived to be lower quality than their branded counterparts. Excess dietary sodium in foods contributes to high blood pressure and cardiovascular disease. Sodium concentrations in products are an important indicator of quality. We compared the sodium content of 15,680 supermarket private-label and branded products, available in four Australian supermarkets between 2011-2013, overall and for 15 food categories. Mean sodium values were compared for: (1) all products in 2013; (2) products in both 2011 and 2013; and (3) products only in 2013. Comparisons were made using paired and unpaired t tests. In each year the proportion of supermarket private-label products was 31%-32%, with overall mean sodium content 17% (12%-23%) lower than branded products in 2013 (p ≤ 0.001). For products available in both 2011 and 2013 there was a ≤2% (1%-3%) mean sodium reduction overall with no difference in reformulation between supermarket private-label and branded products (p = 0.73). New supermarket private-label products in 2013 were 11% lower in sodium than their branded counterparts (p = 0.02). Supermarket private-label products performed generally better than branded in terms of their sodium content. Lower sodium intake translates into lower blood pressure; some supermarket private-label products may be a good option for Australians needing to limit their sodium intake.
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A Comparison of the Sodium Content of Supermarket Private-Label and Branded Foods in Australia
Trevena, Helen; Neal, Bruce; Dunford, Elizabeth; Haskelberg, Hila; Wu, Jason H. Y.
2015-01-01
Supermarket private-label products are perceived to be lower quality than their branded counterparts. Excess dietary sodium in foods contributes to high blood pressure and cardiovascular disease. Sodium concentrations in products are an important indicator of quality. We compared the sodium content of 15,680 supermarket private-label and branded products, available in four Australian supermarkets between 2011–2013, overall and for 15 food categories. Mean sodium values were compared for: (1) all products in 2013; (2) products in both 2011 and 2013; and (3) products only in 2013. Comparisons were made using paired and unpaired t tests. In each year the proportion of supermarket private-label products was 31%–32%, with overall mean sodium content 17% (12%–23%) lower than branded products in 2013 (p ≤ 0.001). For products available in both 2011 and 2013 there was a ≤2% (1%–3%) mean sodium reduction overall with no difference in reformulation between supermarket private-label and branded products (p = 0.73). New supermarket private-label products in 2013 were 11% lower in sodium than their branded counterparts (p = 0.02). Supermarket private-label products performed generally better than branded in terms of their sodium content. Lower sodium intake translates into lower blood pressure; some supermarket private-label products may be a good option for Australians needing to limit their sodium intake. PMID:26308047
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-09
.... FSIS-2005-0018] Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry... (FSIS) is delaying the effective date of the final regulations that require nutrition labeling of the... December 29, 2010, FSIS published the final rule, ``Nutrition Labeling of Single-Ingredient Products and...
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Pieretti, Mariah M; Chung, Danna; Pacenza, Robert; Slotkin, Todd; Sicherer, Scott H
2009-08-01
The Food Allergy Labeling and Consumer Protection Act became effective January 1, 2006, and mandates disclosure of the 8 major allergens in plain English and as a source of ingredients in the ingredient statement. It does not regulate advisory labels. We sought to determine the frequency and language used in voluntary advisory labels among commercially available products and to identify labeling ambiguities affecting consumers with allergy. Trained surveyors performed a supermarket survey of 20,241 unique manufactured food products (from an original assessment of 49,604 products) for use of advisory labels. A second detailed survey of 744 unique products evaluated additional labeling practices. Overall, 17% of 20,241 products surveyed contain advisory labels. Chocolate candy, cookies, and baking mixes were the 3 categories of 24 with the greatest frequency (> or = 40%). Categorically, advisory warnings included "may contain" (38%), "shared equipment" (33%), and "within plant" (29%). The subsurvey disclosed 25 different types of advisory terminology. Nonspecific terms, such as "natural flavors" and "spices," were found on 65% of products and were not linked to a specific ingredient for 83% of them. Additional ambiguities included unclear sources of soy (lecithin vs protein), nondisclosure of sources of gelatin and lecithin, and simultaneous disclosure of "contains" and "may contain" for the same allergen, among others. Numerous products have advisory labeling and ambiguities that present challenges to consumers with food allergy. Additional allergen labeling regulation could improve safety and quality of life for individuals with food allergy.
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Cantrill, Richard C
2008-01-01
Methods of analysis for products of modern biotechnology are required for national and international trade in seeds, grain and food in order to meet the labeling or import/export requirements of different nations and trading blocks. Although many methods were developed by the originators of transgenic events, governments, universities, and testing laboratories, trade is less complicated if there exists a set of international consensus-derived analytical standards. In any analytical situation, multiple methods may exist for testing for the same analyte. These methods may be supported by regional preferences and regulatory requirements. However, tests need to be sensitive enough to determine low levels of these traits in commodity grain for regulatory purposes and also to indicate purity of seeds containing these traits. The International Organization for Standardization (ISO) and its European counterpart have worked to produce a suite of standards through open, balanced and consensus-driven processes. Presently, these standards are approaching the time for their first review. In fact, ISO 21572, the "protein standard" has already been circulated for systematic review. In order to expedite the review and revision of the nucleic acid standards an ISO Technical Specification (ISO/TS 21098) was drafted to set the criteria for the inclusion of precision data from collaborative studies into the annexes of these standards.
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Woo, Hannah L.; DeAngelis, Kristen M.; Teshima, Hazuki; ...
2017-05-04
In this paper, we report the high-quality draft genome sequences of four phylogenetically diverse lignocellulose-degrading bacteria isolated from tropical soil ( Gordonia sp., Paenibacillus sp., Variovorax sp., and Vogesella sp.) to elucidate the genetic basis of their ability to degrade lignocellulose. These isolates may provide novel enzymes for biofuel production.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Woo, Hannah L.; DeAngelis, Kristen M.; Teshima, Hazuki
In this paper, we report the high-quality draft genome sequences of four phylogenetically diverse lignocellulose-degrading bacteria isolated from tropical soil ( Gordonia sp., Paenibacillus sp., Variovorax sp., and Vogesella sp.) to elucidate the genetic basis of their ability to degrade lignocellulose. These isolates may provide novel enzymes for biofuel production.
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Wu, Xiaoqin; Deutschbauer, Adam M.; Kazakov, Alexey E.; Wetmore, Kelly M.; Cwick, Bryson A.; Walker, Robert M.; Novichkov, Pavel S.; Arkin, Adam P.
2017-01-01
ABSTRACT We present here the draft genome sequences of two Janthinobacterium lividum strains, GW456P and GW458P, isolated from groundwater samples collected from a background site at the Oak Ridge Field Research Center. Production of a purple pigment by these two strains was observed when grown on diluted (1/10) LB agar plates. PMID:28663297
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Draft Whole-Genome Sequence of Bacillus altitudinis Strain B-388, a Producer of Extracellular RNase.
Shah Mahmud, Raihan; Ulyanova, Vera; Malanin, Sergey; Dudkina, Elena; Vershinina, Valentina; Ilinskaya, Olga
2015-01-29
Here, we present a draft genome sequence of Bacillus altitudinis strain B-388, including a putative plasmid. The strain was isolated from the intestine of Indian meal moth, a common pest of stored grains, and it is characterized by the production of extracellular RNase, similar to binase, which is of interest for comparative studies and biotechnology. Copyright © 2015 Shah Mahmud et al.
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Presta, Luana; Bosi, Emanuele; Fondi, Marco; Maida, Isabel; Perrin, Elena; Miceli, Elisangela; Maggini, Valentina; Bogani, Patrizia; Firenzuoli, Fabio; Di Pilato, Vincenzo; Rossolini, Gian Maria; Mengoni, Alessio; Fani, Renato
2016-05-05
We announce here the draft genome sequence of Pseudomonas sp. strain EpS/L25, isolated from the stem/leaves of the medicinal plant Echinacea purpurea This genome will allow for comparative genomics in order to identify genes associated with the production of bioactive compounds and antibiotic resistance. Copyright © 2016 Presta et al.
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Letter from the Organic Arsenical Products Task Force expressing concern about aspects of the Science Advisory Board Workgroup's review of a draft document Toxicological Review of Inorganic Arsenic: In Support of the Summary Information on the Integrated Risk Information System (IRIS) and decision not to grant more time to prepare for meeting.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-11
... for Therapeutic Protein Products.'' Therapeutic protein products may elicit immune responses, and... evaluate and mitigate immune responses that may adversely affect their safety and efficacy. DATES: Although... these factors that may reduce the likelihood that these products will generate an immune response. In...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-21
... Monographs for ortho-Toluidine and Pentachlorophenol and By-Products of Its Synthesis; Availability of... candidate substance is defined as ``pentachlorophenol and by-products of its synthesis.'' During synthesis of pentachlorophenol, several additional chlorinated molecules are formed as by-products. In addition...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-03
...] Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY... announcing the availability of a guidance for industry entitled ``Label Comprehension Studies for Nonprescription Drug Products.'' The guidance provides recommendations on the design of label comprehension...
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1993-08-03
The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.
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Ferreira, Dalila Souza Santos; Kato, Rodrigo Bentes; Miranda, Fábio Malcher; da Costa Pinheiro, Kenny; Fonseca, Paula Luize Camargos; Tomé, Luiz Marcelo Ribeiro; Vaz, Aline Bruna Martins; Badotti, Fernanda; Ramos, Rommel Thiago Jucá; Brenig, Bertram; Azevedo, Vasco Ariston de Carvalho; Benevides, Raquel Guimarães; Góes-Neto, Aristóteles
2018-06-01
Herein, we present the draft genome of Trametes villosa isolate CCMB561, a wood-decaying Basidiomycota commonly found in tropical semiarid climate. The genome assembly was 57.98 Mb in size with an L50 of 691. A total of 16,711 putative protein-encoding genes was predicted, including 590 genes coding for carbohydrate-active enzymes (CAZy), directly involved in the decomposition of lignocellulosic materials. This is the first genome of this species of high interest in bioenergy research. The draft genome of Trametes villosa isolate CCMB561 will provide an important resource for future investigations in biofuel production, bioremediation and other green technologies.
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21 CFR 336.50 - Labeling of antiemetic drug products.
Code of Federal Regulations, 2011 CFR
2011-04-01
... labeled for use in adults and for those products that can be and are labeled for use in children under 12... enlargement of the prostate gland.” (ii) For those products that can be and are labeled only for children under 12 years of age. “Do not give this product to children who have a breathing problem such as...
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21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...
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21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...
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21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...
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21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...
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Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.
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-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market.
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Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness
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-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market. PMID:23351881
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9 CFR 112.10 - Special packaging and labeling.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Special packaging and labeling. 112.10... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING § 112.10 Special packaging and labeling. A biological product, which requires special packaging and/or...
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Lundeberg, Pamela J; Graham, Dan J; Mohr, Gina S
2018-06-01
Front-of-package (FOP) nutrition labels are increasingly used to present nutritional information to consumers. A variety of FOP nutrition schemes exist for presenting condensed nutrition information. The present study directly compared two symbolic FOP labeling systems - traffic light and star-based schemes - with specific regard to healthfulness perception and purchase intention for a variety of products. Additionally, this study investigated which method of message framing (gain, loss, gain + loss) would best enable individuals to effectively utilize the FOP labels. College students (n = 306) viewed food packages featuring either star or traffic light FOP labels and rated the healthfulness of each product and their likelihood of purchasing the product. Within each label type, participants were presented with differently-framed instructions regarding how to use the labels. Participants who viewed the star labels rated products with the lowest healthfulness as significantly less healthful and rated products with the highest healthfulness as significantly more healthful compared to participants who viewed those same products with traffic light labels. Purchase intention did not differ by label type. Additionally, including any type of framing (gain, loss, or gain + loss) assisted consumers in differentiating between foods with mid-range vs. low nutritional value. Star-based labels led more healthful foods to be seen as even more healthful and less healthful foods to be seen as even less healthful compared to the same foods with traffic light labels. Additionally, results indicate a benefit of including framing information for FOP nutrition label instructions; however, no individual frame led to significantly different behavior compared to the other frames. While ratings of product healthfulness were influenced by the framing and the label type, purchase intention was not impacted by either of these factors. Copyright © 2018 Elsevier Ltd. All rights reserved.
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9 CFR 381.115 - Containers of inspected and passed poultry products required to be labeled.
Code of Federal Regulations, 2010 CFR
2010-01-01
... poultry products required to be labeled. 381.115 Section 381.115 Animals and Animal Products FOOD SAFETY... AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Labeling and Containers § 381.115 Containers of inspected and passed poultry products required to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-19
... perceptions regarding such products. The survey will gather information on the characteristics and usage... Activities; Proposed Collection; Comment Request; Durable Nursery Products Exposure Survey AGENCY: Consumer... draft survey regarding ownership and use characteristics of durable infant or toddler products. DATES...
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Impact of Health Labels on Flavor Perception and Emotional Profiling: A Consumer Study on Cheese
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
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21 CFR 211.42 - Design and construction features.
Code of Federal Regulations, 2014 CFR
2014-04-01
... product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and... withholding from use of components, drug product containers, closures, and labeling, pending the appropriate...
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21 CFR 211.42 - Design and construction features.
Code of Federal Regulations, 2012 CFR
2012-04-01
... product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and... withholding from use of components, drug product containers, closures, and labeling, pending the appropriate...
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21 CFR 211.42 - Design and construction features.
Code of Federal Regulations, 2013 CFR
2013-04-01
... product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and... withholding from use of components, drug product containers, closures, and labeling, pending the appropriate...
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21 CFR 211.42 - Design and construction features.
Code of Federal Regulations, 2011 CFR
2011-04-01
... product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and... withholding from use of components, drug product containers, closures, and labeling, pending the appropriate...
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16 CFR 1211.25 - Product certification and labeling by importers.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by importers. 1211.25 Section 1211.25 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... § 1211.25 Product certification and labeling by importers. (a) General. The importer of any automatic...
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Iraq: Oil and Gas Legislation, Revenue Sharing, and U.S. Policy
2007-07-25
production and open to international oil companies or the INOC , and Annex 4 delineated 65 exploration blocks. The KRG posted its analysis of the draft...Oil Company ( INOC ). Under the hydrocarbon framework law, the responsibilities and authorities of the Ministry of Oil and the INOC would be altered...significantly, and the draft Ministry and INOC laws are necessary to ensure proper oversight, accountability, and separation of powers between the two
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Wu, Xiaoqin; Deutschbauer, Adam M; Kazakov, Alexey E; Wetmore, Kelly M; Cwick, Bryson A; Walker, Robert M; Novichkov, Pavel S; Arkin, Adam P; Chakraborty, Romy
2017-06-29
We present here the draft genome sequences of two Janthinobacterium lividum strains, GW456P and GW458P, isolated from groundwater samples collected from a background site at the Oak Ridge Field Research Center. Production of a purple pigment by these two strains was observed when grown on diluted (1/10) LB agar plates. Copyright © 2017 Wu et al.
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Mori, Kazuki; Mutaguchi, Yuta; Tashiro, Kosuke; Fujino, Yasuhiro; Ohmori, Taketo; Kuhara, Satoru; Ohshima, Toshihisa
2013-01-01
Lactobacillus otakiensis strain JCM 15040T was isolated from an unsalted pickling solution used in the production of sunki, a traditional Japanese pickle. Here, we prepared a draft genome sequence for this strain consisting of 40 contigs containing a total of 2,347,132 bp, 2,310 predicted coding sequences, and a G+C content of 42.4%. PMID:23929467
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Richard Haynes; Darius Adams; Ralph Alig; David Brooks; Irene Durbak; James Howard; Peter Ince; David McKeever; John Mills; Ken Skog; Xiaoping Zhou
2001-01-01
The Draft RPA Timber Assessment projects, over the next 50 years, the likelihood of increasing abundance of softwoods in the South and decreasing abundance of hardwoods in the South. These trends in supply, along with projected contributions from the North and West, imply U.S. consumption needs could be met without increasing net product imports and would not increase...
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Maggini, Valentina; Presta, Luana; Miceli, Elisangela; Fondi, Marco; Bosi, Emanuele; Chiellini, Carolina; Fagorzi, Camilla; Bogani, Patrizia; Di Pilato, Vincenzo; Rossolini, Gian Maria; Mengoni, Alessio; Firenzuoli, Fabio; Perrin, Elena; Fani, Renato
2017-05-18
In this announcement, we detail the draft genome sequence of the Pseudomonas sp. strain Ep R1, isolated from the roots of the medicinal plant Echinacea purpurea The elucidation of this genome sequence may allow the identification of genes associated with the production of antimicrobial compounds. Copyright © 2017 Maggini et al.
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Maggini, Valentina; Presta, Luana; Miceli, Elisangela; Fondi, Marco; Bosi, Emanuele; Chiellini, Carolina; Fagorzi, Camilla; Bogani, Patrizia; Di Pilato, Vincenzo; Rossolini, Gian Maria; Mengoni, Alessio; Firenzuoli, Fabio; Perrin, Elena
2017-01-01
ABSTRACT In this announcement, we detail the draft genome sequence of the Pseudomonas sp. strain Ep R1, isolated from the roots of the medicinal plant Echinacea purpurea. The elucidation of this genome sequence may allow the identification of genes associated with the production of antimicrobial compounds. PMID:28522712
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Compilation of Physicochemical and Toxicological Information ...
The purpose of this product is to make accessible the information about the 1,173 hydraulic fracturing-related chemicals that were listed in the external review draft of the Hydraulic Fracturing Drinking Water Assessment that was released recently. The product consists of a series of spreadsheets with physicochemical and toxicological information pulled from several sources of information, including: EPI Suite, LeadScope, QikiProp, Reaxys, IRIS, PPRTV, ATSDR, among other sources. The spreadsheets also contain background information about how the list of chemicals were compiled, what the different sources of chemical information are, and definitions and descriptions of the values presented. The purpose of this product is to compile and make accessible information about the 1,173 hydraulic fracturing-related chemicals listed in the external review draft of the Hydraulic Fracturing Drinking Water Assessment.
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9 CFR 112.2 - Final container label, carton label, and enclosure.
Code of Federal Regulations, 2013 CFR
2013-01-01
... biological product which name shall be identical with that shown in the product license under which such... container label if complete descriptive terms appear on a carton label and enclosures; (2) If the biological... if the biological product is prepared in a foreign country, the name and address of the permittee and...
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9 CFR 112.2 - Final container label, carton label, and enclosure.
Code of Federal Regulations, 2012 CFR
2012-01-01
... biological product which name shall be identical with that shown in the product license under which such... container label if complete descriptive terms appear on a carton label and enclosures; (2) If the biological... if the biological product is prepared in a foreign country, the name and address of the permittee and...
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9 CFR 112.2 - Final container label, carton label, and enclosure.
Code of Federal Regulations, 2014 CFR
2014-01-01
... biological product which name shall be identical with that shown in the product license under which such... container label if complete descriptive terms appear on a carton label and enclosures; (2) If the biological... if the biological product is prepared in a foreign country, the name and address of the permittee and...
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16 CFR 300.15 - Labeling of containers or packaging of wool products.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Labeling of containers or packaging of wool products. 300.15 Section 300.15 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.15...
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9 CFR 112.2 - Final container label, carton label, and enclosure.
Code of Federal Regulations, 2011 CFR
2011-01-01
... biological product which name shall be identical with that shown in the product license under which such... container label if complete descriptive terms appear on a carton label and enclosures; (2) If the biological... if the biological product is prepared in a foreign country, the name and address of the permittee and...
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Soil Fumigant Labels - Dimethyl Disulfide (DMDS)
Search by EPA registration number, product name, or company and follow the link to the Pesticide Product Labeling System (PPLS) for label details. Updated labels include new safety requirements for buffer zones and related measures.
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Czoli, Christine D; Goniewicz, Maciej L; Palumbo, Mary; White, Christine M; Hammond, David
2018-05-04
Although several countries, including Canada, have prohibited the sale of nicotine-containing e-cigarettes, there is little evidence examining the impact of such regulatory measures on nicotine content and labelling. E-cigarettes were systematically purchased at 80 retail outlets across 4 cities in Ontario, Canada in January-February 2015. Products' nicotine content and labelling accuracy were assessed using gas chromatography. A total of 166 e-cigarette products were purchased, including disposable products (33%), refillable products (14%), and e-liquids (53%). Similar proportions of products were labelled as 'without nicotine' (41%), and 'with nicotine' (44%), while 15% of products were unlabelled. Analyses revealed that almost half the products (48%) contained nicotine. With respect to the presence of nicotine, 10 products (6%) were mislabelled. Just over one-quarter (27%) of products labelled as 'with nicotine' (n = 73) fell outside their labelled concentration. All of the mislabelled products were e-liquids (100%) and the vast majority were sold in vape shops (90%). Despite a prohibition, nicotine-containing e-cigarettes are commonly sold in Canada. While many e-cigarettes were correctly labelled, inaccuracies were common, particularly among nicotine-containing products sold in vape shops. The findings reflect limitations regarding the design and enforcement of the current e-cigarette regulatory framework. Copyright © 2018 Elsevier B.V. All rights reserved.
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9 CFR 590.950 - Labeling of containers of eggs or egg products for importation.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of containers of eggs or egg... SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Imports § 590.950 Labeling of containers of eggs or egg products for importation...
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9 CFR 590.950 - Labeling of containers of eggs or egg products for importation.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Labeling of containers of eggs or egg... SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Imports § 590.950 Labeling of containers of eggs or egg products for importation...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-25
... filling out form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect... Drug Reaction, Lack of Effectiveness, Product Defect Report.'' II. Significance of Guidance This level...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-10
... Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products; Availability AGENCY: Food... in the Label, Labeling, or Advertising of Tobacco Products.'' This guidance provides information on... the use of ``light,'' ``mild,'' ``low,'' or similar descriptors in the label, labeling, or advertising...
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9 CFR 317.400 - Exemption from nutrition labeling.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...
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9 CFR 317.400 - Exemption from nutrition labeling.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...
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9 CFR 317.400 - Exemption from nutrition labeling.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-19
... Pesticide Registrants on False or Misleading Pesticide Product Brand Names AGENCY: Environmental Protection... Pesticide Product Brand Names.'' PR Notices are issued by the Office of Pesticide Programs (OPP) to inform... concerning pesticide product brand names that may be false or misleading, either by themselves or in...
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Soil Fumigant Labels - Methyl Bromide
Search soil fumigant pesticide labels by EPA registration number, product name, or company, and follow the link to The Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.
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Clinically relevant safety issues associated with St. John's wort product labels.
Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C
2008-07-17
St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0-8) for 23.9% completeness. The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements.
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Clinically relevant safety issues associated with St. John's wort product labels
Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C
2008-01-01
Background St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0–8) for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements. PMID:18637192
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Shemilt, Ian; Hendry, Vivien; Marteau, Theresa M
2017-01-12
Explicit labelling of lower strength alcohol products could reduce alcohol consumption by attracting more people to buy and drink such products instead of higher strength ones. Alternatively, it may lead to more consumption due to a 'self-licensing' mechanism. Equivalent labelling of food or tobacco (for example "Low fat" or "Low tar") could influence consumption of those products by similar mechanisms. This systematic review examined the effects of 'Low alcohol' and equivalent labelling of alcohol, food and tobacco products on selection, consumption, and perceptions of products among adults. A systematic review was conducted based on Cochrane methods. Electronic and snowball searches identified 26 eligible studies. Evidence from 12 randomised controlled trials (all on food) was assessed for risk of bias, synthesised using random effects meta-analysis, and interpreted in conjunction with evidence from 14 non-randomised studies (one on alcohol, seven on food and six on tobacco). Outcomes assessed were: quantities of the product (i) selected or (ii) consumed (primary outcomes - behaviours), (iii) intentions to select or consume the product, (iv) beliefs associated with it consumption, (v) product appeal, and (vi) understanding of the label (secondary outcomes - cognitions). Evidence for impacts on the primary outcomes (i.e. amounts selected or consumed) was overall of very low quality, showing mixed effects, likely to vary by specific label descriptors, products and population characteristics. Overall very low quality evidence suggested that exposure to 'Low alcohol' and equivalent labelling on alcohol, food and tobacco products can shift consumer perceptions of products, with the potential to 'self-licence' excess consumption. Considerable uncertainty remains about the effects of labels denoting low alcohol, and equivalent labels, on alcohol, food and tobacco selection and consumption. Independent, high-quality studies are urgently needed to inform policies on labelling regulations.
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Labelling of household products and prevention of unintentional poisoning.
de Presgrave, Rosaura Farias; Alves, Eloisa Nunes; Camacho, Luiz Antônio Bastos; Bôas, Maria Helena Simões Villas
2008-04-01
Unintentional poisoning occurs mainly in childhood due to ingestion of common household products. A decisive factor is the lack of knowledge concerning the potential toxicity of these products. A random study of 158 labels of cleaning products was conducted at the National Institute of Quality Control in Health--Brazil. Health hazard warnings, first aid in case of poisoning and storage instructions were evaluated to assess the quality of information provided to the consumer regarding the risks inherent in these products. Among these labels, 75% were considered inadequate since they did not provide all cautionary information necessary to avoid the health hazards associated with these products. First aid instructions in the case of inhalation were missing on more than 50% of labels studied and 47% did not recommend taking the label to a health professional in case of accident. Furthermore, the labels did not provide other important warnings such as "read before use" and "keep in original container': The results indicate that the labelling of cleaning products does not provide all safety information recommended for consumers.
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9 CFR 317.343 - Significant participation for voluntary nutrition labeling.
Code of Federal Regulations, 2011 CFR
2011-01-01
... voluntary nutrition labeling. 317.343 Section 317.343 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 317.343 Significant participation for voluntary nutrition labeling. Link to an... nutrition labeling, FSIS will consider only the major cuts of single-ingredient, raw meat products, as...
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9 CFR 381.443 - Significant participation for voluntary nutrition labeling.
Code of Federal Regulations, 2011 CFR
2011-01-01
... voluntary nutrition labeling. 381.443 Section 381.443 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 381.443 Significant participation for voluntary nutrition labeling. Link to an... nutrition labeling, FSIS will consider only the major cuts of single-ingredient, raw poultry products, as...
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When zero is greater than one: consumer misinterpretations of nutrition labels.
Graham, Dan J; Mohr, Gina S
2014-12-01
Front-of-package (FOP) nutrition labels are increasingly used by food manufacturers. A call to regulate the content and format of these labels resulted in recommendations by the Institute of Medicine (IOM) for standardized FOP labels that clearly communicate packaged foods' healthfulness. It is currently unclear how consumers would interpret and use these proposed labels. This research addresses psychological factors affecting the efficacy of FOP label use. It was hypothesized that IOM's proposed 0- to 3-point rating scale would produce the zero-comparison effect, leading to more favorable evaluations than are warranted for the least healthful products (i.e., those earning zero nutritional points). In two studies (Study 1, n = 68; Study 2, n = 101), participants evaluated products containing FOP labels on the basis of IOM recommendations. Primary outcomes were perceived product healthfulness and purchase intentions. Study 1 demonstrated that less-healthful products were rated by study participants to be equally healthful as more-healthful products. The relationship between FOP rating and purchase intentions was mediated by perceived healthfulness. Biases in product healthfulness ratings were exacerbated for consumers with higher (vs. lower) health concern. Study 2 demonstrated that by changing the rating scale from 0-3 to 1-4, consumers avoid the zero-comparison effect and accurately evaluate products' healthfulness. This research has implications for theory and policy in the domains of nutrition labeling and consumer health. Specifically, FOP labels can help consumers identify healthful options, but products receiving zero nutritional points may be misidentified as healthful; a simple label modification can prevent this confusion.
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Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition labeling of single... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.345 Nutrition....301. (a)(1) Nutrition information on the major cuts of single-ingredient, raw meat products identified...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition labeling of single... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.345 Nutrition....301. (a)(1) Nutrition information on the major cuts of single-ingredient, raw meat products identified...
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Drugs and Diseases Interacting with Cigarette Smoking in US Prescription Drug Labelling.
Li, Haibo; Shi, Qiang
2015-05-01
The US Food and Drug Administration (FDA) draft guidance for industry on drug interaction studies recommends, but does not mandate, that both cigarette smokers and non-smokers can be used to study drug metabolism in clinical trials, and that important results related to smoking should be included in drug labelling to guide medication usage. This study aimed to provide a comprehensive review of drugs or diseases interacting with smoking, as presented in all US drug labelling. The 62,857 drug labels deposited in the FDA Online Label Repository were searched using the keywords 'smoke', 'smoker(s)', 'smoking', 'tobacco' and 'cigarette(s)' on 19 June 2014. The resultant records were refined to include only human prescription drug labelling, for manual examination. For 188 single-active-ingredient drugs and 36 multiple-active-ingredient drugs, the labelling was found to contain smoking-related information. The pharmacokinetics of 29 and 21 single-active-ingredient drugs were affected and unaffected, respectively, by smoking. For the remaining drugs, the provided information related to smoking affecting efficacy, safety or diseases but not pharmacokinetics. Depending on the nature of specific drugs, the perturbation in pharmacokinetic parameters in smokers ranged from 13 to 500%, in comparison with non-smokers. Dosage modifications in smokers are necessary for four drugs and may be necessary for six drugs, but are unnecessary for seven drugs although the pharmacokinetic parameters of four of them are affected by smoking. Cigarette smoking is a risk factor for 16 types of diseases or adverse drug reactions. For one single-active-ingredient contraceptive drug and 10 multiple-active-ingredient contraceptive drugs, a black box warning (the FDA's strongest safety warning) is included in the labelling for increased risks of heart attacks and strokes in female smokers, and "women are strongly advised not to smoke" when using these drugs. This study presents the first comprehensive overview of cigarette smoking interacting with drugs and/or diseases, as presented in US drug labelling.
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Hamlin, Robert P; McNeill, Lisa S; Moore, Vanessa
2015-08-01
The present research was an experimental test that aimed to quantify the impact of two dominant front-of-pack (FOP) nutritional label formats on consumer evaluations of food products that carried them. The two FOP label types tested were the traffic light label and the Percentage Daily Intake. A 4×5 partially replicated Latin square design was used that allowed the impact of the FOP labels to be isolated from the effects of the product and the consumers who were performing the evaluations. The experiment was conducted on campus at the University of Otago, New Zealand. The participants were 250 university students selected at random who met qualifying criteria of independent living and regular purchase of the products used in the research. They were not aware of the purpose of the research. The presence of FOP labels led to significant and positive changes in consumer purchase intentions towards the products that carried them. These changes were not affected by the nature of FOP labels used, their size or the product nutritional status (good/bad) that they were reporting. The result is consistent with the participants paying attention to the FOP label and then using it as an adimensional cue indicating product desirability. As such, it represents a complete functional failure of both of these FOP label types in this specific instance. This result supports calls for further research on the performance of these FOP labels before any move to compulsory deployment is made.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-08
... 1107 Testing and Labeling Pertaining to Product Certification Regarding Representative Samples for... [CPSC Docket No. CPSC-2011-0082] Testing and Labeling Pertaining to Product Certification Regarding... to Product Certification.'' The proposed rule was intended to implement what was then known as...
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7 CFR 205.303 - Packaged products labeled “100 percent organic” or “organic.”
Code of Federal Regulations, 2011 CFR
2011-01-01
... Information § 205.303 Packaged products labeled “100 percent organic” or “organic.” (a) Agricultural products... product, the following: (1) The term, “100 percent organic” or “organic,” as applicable, to modify the name of the product; (2) For products labeled “organic,” the percentage of organic ingredients in the...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Harper, J.A.; Abel, K.D.; Piotrowski, R.G.
Ten cross sections were completed and drafted, and blueline copies were sent to DOE, Morgantown, WV, for review. These cross sections were used as the basis with which all other logs in the study area were correlated. The data has been encoded from 228 logs that were used. Two isopach, 2 structure contour, and 3 lithofacies maps have been completed and are awaiting drafting. A production and show map has been drafted and blueline copies were sent to DOE, Morgantown, WV, for review. The schedule of work was delayed due to the state budget problems the need to correct workmore » previously completed and sent to DOE, Morgantown, WV, and lack of a reproduction contract.« less
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Packaging and labeling of pharmaceutical products obtained from the internet.
Veronin, Michael
2011-02-15
For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.
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Allergen labelling in meat, dairy and cereal products from the Serbian market
NASA Astrophysics Data System (ADS)
Spirić, D.; Nikolić, D.; Ćirić, J.; Janković, S.; Stefanović, S.; Janković, V.; Teodorović, V.
2017-09-01
Allergens in food are a great health risk, because of the ratio of severity of problems compared to small amounts of ingested allergen. Since 2014, Serbian producers and importers of food have been obliged to declare allergens from the list of Codex Alimentarius on the product packaging. Surveillance of different meat, diary, and cereal product took place in 2016, with aim of checking if the Serbian regulatory requirements for labelling of allergens in food are being fulfilled. Out of 68 different meat products, 20 were not labelled for allergens. Thirty-six labels of various dairy products were examined revealing that allergen information was included on 27 of them. Only one of eight examined cereal products did not have allergen labelling.
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Improved High-Quality Draft Genome Sequence and Annotation of Burkholderia contaminans LMG 23361T.
Jung, Ji Young; Ahn, Youngbeom; Kweon, Ohgew; LiPuma, John J; Hussong, David; Marasa, Bernard S; Cerniglia, Carl E
2017-04-20
Burkholderia contaminans LMG 23361 is the type strain of the species isolated from the milk of a dairy sheep with mastitis. Some pharmaceutical products contain disinfectants such as benzalkonium chloride (BZK) and previously we reported that B. contaminans LMG 23361 T possesses the ability to inactivate BZK with high biodegradation rates. Here, we report an improved high-quality draft genome sequence of this strain. Copyright © 2017 Jung et al.
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Draft Genome Sequences of Four Enterococcus faecium Strains Isolated from Argentine Cheese
Martino, Gabriela P.; Quintana, Ingrid M.; Espariz, Martín; Blancato, Victor S.; Gallina Nizo, Gabriel; Esteban, Luis
2016-01-01
We report the draft genome sequences of four Enterococcus faecium strains isolated from Argentine regional cheeses. These strains were selected based on their technological properties, i.e., their ability to produce aroma compounds (diacetyl, acetoin, and 2,3-butanediol) from citrate. The goal of our study is to provide further genetic evidence for the rational selection of enterococci strains based on their pheno- and genotype in order to be used in cheese production. PMID:26847907
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-05
...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.
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Nicotine Concentrations in Electronic Cigarette Refill and Do-It-Yourself Fluids
Davis, Barbara; Dang, Michael; Kim, Jisoo
2015-01-01
Introduction: We evaluated the accuracy of nicotine concentration labeling on electronic cigarette refill products. Methods: The nicotine concentration of 71 electronic cigarette refill fluid products and 1 related do-it-yourself (DIY) product was quantified using high-performance liquid chromatography. Quantified data were compared with manufacturers labeled concentrations. Duplicate refill fluid products purchased at different times were evaluated by visual comparison of fluid coloration and quantified nicotine concentration. Results: Thirty-five of the 54 nicotine-containing fluids had quantified nicotine concentrations that deviated by more than ±10% from the manufacturer labels, with 46 of 50 being in excess of labeled values. Refill fluids labeled as 0 nicotine had no detectable nicotine. Of the 5 products that were unlabeled for nicotine concentration, 3 contained no detectable nicotine, whereas the remaining 2 contained nicotine in excess of 100mg/ml and may have been intended for DIY use. Sixteen of the 18 duplicate bottles of refill fluid varied greatly in their nicotine concentrations. One of the 5 companies showed significant improvement in labeling accuracy among the most recently purchased products. Of the 23 total duplicate pairs, 15 of 23 varied in coloration from their mates. Conclusions: Nicotine concentration labeling on electronic cigarette refill products was often inaccurate but showed improvement recently in products from 1 company. To ensure the safety of refill fluids and DIY products, it is necessary to establish quality control guidelines for the manufacturing and labeling and to monitor products longitudinally. PMID:24862971
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-18
... Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k)] Submissions--0910-NEW...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Products for foreign commerce... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. Labels to be affixed to packages of products for foreign commerce may be...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Products for foreign commerce... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. Labels to be affixed to packages of products for foreign commerce may be...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Products for foreign commerce... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. Labels to be affixed to packages of products for foreign commerce may be...
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Fact sheet provides information on labeling foam products. Products imported or manufactured after January 1, 2015 that contain or were manufactured with an HCFC must bear a warning label before they can be introduced into interstate commerce.
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16 CFR 1203.34 - Product certification and labeling by manufacturers (including importers).
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by....34 Product certification and labeling by manufacturers (including importers). (a) Form of permanent... the requirements of this subpart has been performed by or for the foreign manufacturer of the product...
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40 CFR 211.104 - Label content.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...
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40 CFR 211.104 - Label content.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...
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40 CFR 211.104 - Label content.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...
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40 CFR 211.104 - Label content.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...
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40 CFR 211.104 - Label content.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 25 2011-07-01 2011-07-01 false Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... shipping or storage of raw or processed agricultural products labeled as â100 percent organic,â âorganic,â... containers used for only shipping or storage of raw or processed agricultural products labeled as “100...) Nonretail containers used only to ship or store raw or processed agricultural product labeled as containing...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... shipping or storage of raw or processed agricultural products labeled as â100 percent organic,â âorganic,â... containers used for only shipping or storage of raw or processed agricultural products labeled as “100...) Nonretail containers used only to ship or store raw or processed agricultural product labeled as containing...
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Miranda-Ackerman, Marco A; Azzaro-Pantel, Catherine
2017-12-15
New consumer awareness is shifting industry towards more sustainable practices, creating a virtuous cycle between producers and consumers enabled by eco-labelling. Eco-labelling informs consumers of specific characteristics of products and has been used to market greener products. Eco-labelling in the food industry has yet been mostly focused on promoting organic farming, limiting the scope to the agricultural stage of the supply chain, while carbon labelling informs on the carbon footprint throughout the life cycle of the product. These labelling strategies help value products in the eyes of the consumer. Because of this, decision makers are motivated to adopt more sustainable models. In the food industry, this has led to important environmental impact improvements at the agricultural stage, while most other stages in the Food Supply Chain (FSC) have continued to be designed inefficiently. The objective of this work is to define a framework showing how carbon labelling can be integrated into the design process of the FSC. For this purpose, the concept of Green Supply Chain Network Design (GSCND) focusing on the strategic decision making for location and allocation of resources and production capacity is developed considering operational, financial and environmental (CO 2 emissions) issues along key stages in the product life cycle. A multi-objective optimization strategy implemented by use of a genetic algorithm is applied to a case study on orange juice production. The results show that the consideration of CO 2 emission minimization as an objective function during the GSCND process together with techno-economic criteria produces improved FSC environmental performance compared to both organic and conventional orange juice production. Typical results thus highlight the importance that carbon emissions optimization and labelling may have to improve FSC beyond organic labelling. Finally, CO 2 emission-oriented labelling could be an important tool to improve the effects eco-labelling has on food product environmental impact going forward. Copyright © 2017 Elsevier Ltd. All rights reserved.
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Packaging and Labeling of Pharmaceutical Products Obtained from the Internet
2011-01-01
Background For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. Objective The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. Methods During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Results Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Conclusions Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety. PMID:21324833
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Pandey, Abhishek; Kreimeyer, Kory; Foster, Matthew; Botsis, Taxiarchis; Dang, Oanh; Ly, Thomas; Wang, Wei; Forshee, Richard
2018-01-01
Structured Product Labels follow an XML-based document markup standard approved by the Health Level Seven organization and adopted by the US Food and Drug Administration as a mechanism for exchanging medical products information. Their current organization makes their secondary use rather challenging. We used the Side Effect Resource database and DailyMed to generate a comparison dataset of 1159 Structured Product Labels. We processed the Adverse Reaction section of these Structured Product Labels with the Event-based Text-mining of Health Electronic Records system and evaluated its ability to extract and encode Adverse Event terms to Medical Dictionary for Regulatory Activities Preferred Terms. A small sample of 100 labels was then selected for further analysis. Of the 100 labels, Event-based Text-mining of Health Electronic Records achieved a precision and recall of 81 percent and 92 percent, respectively. This study demonstrated Event-based Text-mining of Health Electronic Record's ability to extract and encode Adverse Event terms from Structured Product Labels which may potentially support multiple pharmacoepidemiological tasks.
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Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of drug products for the control of... DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic...
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Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of drug products for the control of... DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic...
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Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of drug products for the control of... DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic...
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Code of Federal Regulations, 2014 CFR
2014-01-01
... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...
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21 CFR 357.850 - Labeling of deodorant drug products for internal use.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...
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21 CFR 357.850 - Labeling of deodorant drug products for internal use.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...
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21 CFR 357.850 - Labeling of deodorant drug products for internal use.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...
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21 CFR 357.850 - Labeling of deodorant drug products for internal use.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...
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21 CFR 357.850 - Labeling of deodorant drug products for internal use.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-16
... Request; Bar Code Label Requirement for Human Drug and Biological Products AGENCY: Food and Drug... and clearance. Bar Code Label Requirement for Human Drug and Biological Products--(OMB Control Number... that required human drug product and biological product labels to have bar codes. The rule required bar...
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9 CFR 381.445 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Guidelines for voluntary nutrition... INSPECTION REGULATIONS Nutrition Labeling § 381.445 Guidelines for voluntary nutrition labeling of single-ingredient, raw products. (a) Nutrition information on the cuts of single-ingredient, raw poultry products...
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9 CFR 317.345 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Guidelines for voluntary nutrition... DEVICES, AND CONTAINERS Nutrition Labeling § 317.345 Guidelines for voluntary nutrition labeling of single-ingredient, raw products. (a) Nutrition information on the cuts of single-ingredient, raw meat products...
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40 CFR 763.171 - Labeling requirements.
Code of Federal Regulations, 2010 CFR
2010-07-01
... placed for sale, shipment, or storage. If the product has more than one layer of external wrapping or packaging, the label must be attached to the innermost layer adjacent to the product. If the innermost layer... product's innermost layer of product wrapping or packaging, or a label must be attached to the next outer...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA Center...
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Asioli, Daniele; Aschemann-Witzel, Jessica; Caputo, Vincenzina; Vecchio, Riccardo; Annunziata, Azzurra; Næs, Tormod; Varela, Paula
2017-09-01
Consumers in industrialized countries are nowadays much more interested in information about the production methods and components of the food products that they eat, than they had been 50years ago. Some production methods are perceived as less "natural" (i.e. conventional agriculture) while some food components are seen as "unhealthy" and "unfamiliar" (i.e. artificial additives). This phenomenon, often referred to as the "clean label" trend, has driven the food industry to communicate whether a certain ingredient or additive is not present or if the food has been produced using a more "natural" production method (i.e. organic agriculture). However, so far there is no common and objective definition of clean label. This review paper aims to fill the gap via three main objectives, which are to a) develop and suggest a definition that integrates various understandings of clean label into one single definition, b) identify the factors that drive consumers' choices through a review of recent studies on consumer perception of various food categories understood as clean label with the focus on organic, natural and 'free from' artificial additives/ingredients food products and c) discuss implications of the consumer demand for clean label food products for food manufacturers as well as policy makers. We suggest to define clean label, both in a broad sense, where consumers evaluate the cleanliness of product by assumption and through inference looking at the front-of-pack label and in a strict sense, where consumers evaluate the cleanliness of product by inspection and through inference looking at the back-of-pack label. Results show that while 'health' is a major consumer motive, a broad diversity of drivers influence the clean label trend with particular relevance of intrinsic or extrinsic product characteristics and socio-cultural factors. However, 'free from' artificial additives/ingredients food products tend to differ from organic and natural products. Food manufacturers should take the diversity of these drivers into account in developing new products and communication about the latter. For policy makers, it is important to work towards a more homogenous understanding and application of the term of clean label and identify a uniform definition or regulation for 'free from' artificial additives/ingredients food products, as well as work towards decreasing consumer misconceptions. Finally, multiple future research avenues are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.
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Fassett, James E.; Condon, Steven M.; Huffman, A. Curtis; Taylor, David J.
1997-01-01
Introduction: This study was commissioned by a consortium consisting of the Bureau of Land Management, Durango Office; the Colorado Oil and Gas Conservation Commission; La Plata County; and all of the major gas-producing companies operating in La Plata County, Colorado. The gas-seep study project consisted of four parts; 1) detailed surface mapping of Fruitland Formation coal outcrops in the above listed seep areas, 2) detailed measurement of joint and fracture patterns in the seep areas, 3) detailed coal-bed correlation of Fruitland coals in the subsurface adjacent to the seep areas, and 4) studies of deep-seated seismic patterns in those seep areas where seismic data was available. This report is divided into three chapters labeled 1, 2, and 3. Chapter 1 contains the results of the subsurface coal-bed correla-tion study, chapter 2 contains the results of the surface geologic mapping and joint measurement study, and chapter 3, contains the results of the deep-seismic study. A preliminary draft of this report was submitted to the La Plata County Group in September 1996. All of the members of the La Plata Group were given an opportunity to critically review the draft report and their comments were the basis for revising the first draft to create this final version of a geologic report on the major La Plata County gas seeps located north of the Southern Ute Indian Reservation.
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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.
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Garrido, Leandro Maza; Alves, João Marcelo Pereira; Oliveira, Liliane Santana; Gruber, Arthur; Padilla, Gabriel; Araújo, Welington Luiz
2016-11-17
Herein, we report a draft genome sequence of the endophytic Curtobacterium sp. strain ER1/6, isolated from a surface-sterilized Citrus sinensis branch, and it presented the capability to control phytopathogens. Functional annotation of the ~3.4-Mb genome revealed 3,100 protein-coding genes, with many products related to known ecological and biotechnological aspects of this bacterium. Copyright © 2016 Garrido et al.
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Emerging Role of the Army Family Physician in Primary Health Care Delivery.
1976-12-13
practice in the civilian community and had handled a variety of primary care problems. They volunteered to come into the Army , joined training pro ...the end of the draft came and with it the reality that adequate numbers of General Medical Officers ( GMO ’s) were no longer available. The typical... GMO , a product of the draft, came into the Army at the end of his year of internship. He was usually assigned all the unpleasant and mundane duties that
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Matsuzawa, Tomohiko; Koike, Hideaki; Saika, Azusa; Fukuoka, Tokuma; Sato, Shun; Habe, Hiroshi; Kitamoto, Dai
2015-01-01
The yeast Starmerella bombicola NBRC10243 is an excellent producer of sophorolipids (SLs) from various feedstocks. Here, we report the draft genome sequence of S. bombicola NBRC10243. Analysis of the sequence may provide insight into the properties of this yeast that make it superior for use in the production of functional glycolipids and biomolecules, leading to the further development of S. bombicola NBRC10243 for industrial applications. PMID:25814600
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Draft Genome Sequences of Four Enterococcus faecium Strains Isolated from Argentine Cheese.
Martino, Gabriela P; Quintana, Ingrid M; Espariz, Martín; Blancato, Victor S; Gallina Nizo, Gabriel; Esteban, Luis; Magni, Christian
2016-02-04
We report the draft genome sequences of four Enterococcus faecium strains isolated from Argentine regional cheeses. These strains were selected based on their technological properties, i.e., their ability to produce aroma compounds (diacetyl, acetoin, and 2,3-butanediol) from citrate. The goal of our study is to provide further genetic evidence for the rational selection of enterococci strains based on their pheno- and genotype in order to be used in cheese production. Copyright © 2016 Martino et al.
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Soil Fumigant Labels - Dazomet
Updated labels include new safety requirements for buffer zones and related measures. Find information from the Pesticide Product Labeling System (PPLS) for products such as Basamid G, manufactured by Amvac.
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9 CFR 381.128 - Labels in foreign languages.
Code of Federal Regulations, 2010 CFR
2010-01-01
... AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Labeling and Containers § 381.128 Labels in foreign languages. Any label to be affixed to a container of any dressed poultry or other poultry...
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List M: Registered Antimicrobial Products with Label Claims for Avian (Bird) Flu Disinfectants
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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-06
... final product requirements) Proposed Food Additive Provisions in Standards for Fish and Fishery Products... (held at Step 7) Section 4 Food Additives Draft Standard for Quick Frozen Scallop Adductor Muscle Meat... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2012-0035] Codex...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-20
... and Gene Therapy Products; Extension of Comment Period AGENCY: Food and Drug Administration, HHS...: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' that... sponsors of Investigational New Drug Applications for cellular therapy (CT) and gene therapy (GT) products...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-16
... for violations of access, advertising, and promotion restrictions issued under section 906(d) of the... product, including restrictions on the access to, and the advertising and promotion of, the tobacco... products, as well as restrictions on advertising and promotion of such products, to curb the appeal of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-12
... Monographs for ortho-Toluidine and Pentachlorophenol and By-products of Its Synthesis; Availability of... and By-products of its Synthesis (hereafter referred to as ``pentachlorophenol''). These documents were prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology...
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Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition labeling of single... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.445 Nutrition... § 381.401. (a)(1) Nutrition information on the major cuts of single-ingredient, raw poultry products...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition labeling of single... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.445 Nutrition... § 381.401. (a)(1) Nutrition information on the major cuts of single-ingredient, raw poultry products...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. 809.11... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Labeling § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. 809.11... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Labeling § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic...
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19 CFR 11.12b - Labeling textile fiber products.
Code of Federal Regulations, 2010 CFR
2010-04-01
... pursuant to § 141.113 of this chapter shall demand the immediate return of the involved products to customs... 19 Customs Duties 1 2010-04-01 2010-04-01 false Labeling textile fiber products. 11.12b Section 11... THE TREASURY PACKING AND STAMPING; MARKING Marking § 11.12b Labeling textile fiber products. (a...
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Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
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Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
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Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
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Comparative analysis of the labelling of nanotechnologies across four stakeholder groups
NASA Astrophysics Data System (ADS)
Capon, Adam; Gillespie, James; Rolfe, Margaret; Smith, Wayne
2015-08-01
Societies are constantly challenged to develop policies around the introduction of new technologies, which by their very nature contain great uncertainty. This uncertainty gives prominence to varying viewpoints which are value laden and have the ability to drastically shift policy. The issue of nanotechnologies is a prime example. The labelling of products that contain new technologies has been one policy tool governments have used to address concerns around uncertainty. Our study develops evidence regarding opinions on the labelling of products made by nanotechnologies. We undertook a computer-assisted telephone (CATI) survey of the Australian public and those involved in nanotechnologies from the academic, business and government sectors using a standardised questionnaire. Analysis was undertaken using descriptive and logistic regression techniques. We explored reluctance to purchase as a result of labelling products which contained manufactured nanomaterials both generally and across five broad products (food, cosmetics/sunscreens, medicines, pesticides, tennis racquets/computers) which represent the broad categories of products regulated by differing government agencies in Australia. We examined the relationship between reluctance to purchase and risk perception, trust, and familiarity. We found irrespective of stakeholder, most supported the labelling of products which contained manufactured nanomaterials. Perception of risk was the main driver of reluctance to purchase, while trust and familiarity were likely to have an indirect effect through risk perception. Food is likely to be the greatest product impacted by labelling. Risk perception surrounding nanotechnologies and label `framing' on the product are key issues to be addressed in the implementation of a labelling scheme.
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Toddler drinks, formulas, and milks: Labeling practices and policy implications.
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.
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27 CFR 5.32 - Mandatory label information.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Mandatory label information. 5.32 Section 5.32 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF DISTILLED SPIRITS Labeling Requirements for...
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Code of Federal Regulations, 2014 CFR
2014-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Label. 18.55 Section 18.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL PRODUCTION OF VOLATILE FRUIT-FLAVOR CONCENTRATE Operations § 18.55 Label. Each container...
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Code of Federal Regulations, 2012 CFR
2012-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Label. 18.55 Section 18.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS PRODUCTION OF VOLATILE FRUIT-FLAVOR CONCENTRATE Operations § 18.55 Label. Each container...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Label. 18.55 Section 18.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS PRODUCTION OF VOLATILE FRUIT-FLAVOR CONCENTRATE Operations § 18.55 Label. Each container...
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Code of Federal Regulations, 2013 CFR
2013-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Label. 18.55 Section 18.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL PRODUCTION OF VOLATILE FRUIT-FLAVOR CONCENTRATE Operations § 18.55 Label. Each container...
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The US FDA pregnancy lactation and labeling rule - Implications for maternal immunization.
Gruber, Marion F
2015-11-25
The FDA has responsibility for ensuring that prescription drug and biological products including vaccines are accompanied by labeling that summarizes scientific information concerning their safe and effective use. As part of a broader effort to improve the content and format of prescription drug labeling FDA published a final rule, the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the "Pregnancy and Lactation Labeling Rule (PLLR)." The most significant change to be implemented by this Rule is the removal of the letter risk categories A, B, C, D and X from all labeling, replacing them with a narrative summary of the risks of using a drug or biological product including vaccines during pregnancy. The PLLR requires an evaluation of available information about a product's use in pregnancy and provides an opportunity to update labeling when new information about use of a vaccine in pregnancy becomes available. Implementation of the provisions articulated in the PLLR, as they apply to vaccine product labeling, will require close collaboration between FDA and the vaccine manufacturer for both currently licensed vaccines and those in development. Copyright © 2015 The Author. Published by Elsevier Ltd.. All rights reserved.
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Kim, Sungroul; Goniewicz, Maciej L.; Yu, Sol; Kim, Bokyeong; Gupta, Ribhav
2015-01-01
Background: In South Korea, the consumption of liquid nicotine used in electronic cigarettes has dramatically increased from 4310 L in 2012 to 7220 L in 2013. This study aimed to examine the level of heterogeneity of contents of the labels and discrepancy of the nicotine content between that indicated on the label and the actual values for electronic cigarette liquid refill products in South Korea. Methods: We purchased 32 electronic cigarette liquid refill products (17 Korean domestic, 15 imported ones) and one pure nicotine product at six different electronic cigarette retail stores in Seoul between May and June 2014. The actual nicotine concentrations of each product were measured by a blinded analyst at Roswell Park Cancer Institute, Buffalo, NY, USA. Results: Three out of 15 imported liquid refill products provided manufacturing dates, while expiration dates were available on eight products. The range of nicotine concentration was from “not detected” to 17.5 mg/mL. Labeling discrepancies of the concentrations ranged from −32.2% to 3.3% among electronic cigarette liquid refill products. The highest concentration (150.3 ± 7.9 mg/mL) was found in a sample labeled as “pure nicotine”. Conclusions: There is no standardization of labelling among electronic cigarette liquids sampled from retail stores and the labels did not accurately reflect the content. One product labeled “pure nicotine” raises concerns, since it may be poisonous to consumers, especially to children. This study revealed the urgent need for the development of product regulations in South Korea. PMID:25950652
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CAR: contig assembly of prokaryotic draft genomes using rearrangements.
Lu, Chin Lung; Chen, Kun-Tze; Huang, Shih-Yuan; Chiu, Hsien-Tai
2014-11-28
Next generation sequencing technology has allowed efficient production of draft genomes for many organisms of interest. However, most draft genomes are just collections of independent contigs, whose relative positions and orientations along the genome being sequenced are unknown. Although several tools have been developed to order and orient the contigs of draft genomes, more accurate tools are still needed. In this study, we present a novel reference-based contig assembly (or scaffolding) tool, named as CAR, that can efficiently and more accurately order and orient the contigs of a prokaryotic draft genome based on a reference genome of a related organism. Given a set of contigs in multi-FASTA format and a reference genome in FASTA format, CAR can output a list of scaffolds, each of which is a set of ordered and oriented contigs. For validation, we have tested CAR on a real dataset composed of several prokaryotic genomes and also compared its performance with several other reference-based contig assembly tools. Consequently, our experimental results have shown that CAR indeed performs better than all these other reference-based contig assembly tools in terms of sensitivity, precision and genome coverage. CAR serves as an efficient tool that can more accurately order and orient the contigs of a prokaryotic draft genome based on a reference genome. The web server of CAR is freely available at http://genome.cs.nthu.edu.tw/CAR/ and its stand-alone program can also be downloaded from the same website.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-17
... intended approach to enforcement for certain OTC sunscreen products prior to an effective final monograph... establish a final monograph for OTC sunscreen products. These products are not yet the subject of an effective final monograph. \\1\\ See section 505 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355...
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Pesticide Labeling Questions & Answers
Pesticide manufacturers, applicators, state regulatory agencies, and other stakeholders raise questions or issues about pesticide labels. The questions on this page are those that apply to multiple products or address inconsistencies among product labels.
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7 CFR 205.670 - Inspection and testing of agricultural product to be sold or labeled “organic.”
Code of Federal Regulations, 2011 CFR
2011-01-01
... agricultural product to be sold or labeled “organic.” (a) All agricultural products that are to be sold... product to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic... 7 Agriculture 3 2011-01-01 2011-01-01 false Inspection and testing of agricultural product to be...
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9 CFR 381.500 - Exemption from nutrition labeling.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82167, Dec. 29, 2010. (a) The...
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9 CFR 381.500 - Exemption from nutrition labeling.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82167, Dec. 29, 2010. This amendment...
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27 CFR 4.32 - Mandatory label information.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Mandatory label information. 4.32 Section 4.32 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.32...
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27 CFR 4.32 - Mandatory label information.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Mandatory label information. 4.32 Section 4.32 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.32...
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[Academic production on food labeling in Brazil].
Câmara, Maria Clara Coelho; Marinho, Carmem Luisa Cabral; Guilam, Maria Cristina; Braga, Ana Maria Cheble Bahia
2008-01-01
To review and discuss academic production (theses and dissertations) on the topic of labeling of prepackaged foods in Brazil. A search of the database maintained by the Coordination for the Development of Higher Education Professionals (CAPES), one of the two Brazilian government research funding and support agencies, was conducted on the following keywords: "rotulagem" (labeling), "rotulagem nutricional" (food labeling) and "rótulo de alimentos" (food labels). The search covered the years 1987 (earliest year available) to 2004. We identified 49 studies on this topic. Content analysis identified three major themes: the extent to which food labels meet specific legal requirements (57.2%); the degree to which consumers understand the information on labels (22.4%); and the labeling of transgenic or genetically-modified foods (20.4%). Food labeling is a frequent topic and is adequately covered by the Brazilian academic production. In most of the studies, ineffective law enforcement appears to be the main factor in the lack of compliance with and disrespect for the food labeling rules and regulations in Brazil.
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Nicotine concentrations in electronic cigarette refill and do-it-yourself fluids.
Davis, Barbara; Dang, Michael; Kim, Jisoo; Talbot, Prue
2015-02-01
We evaluated the accuracy of nicotine concentration labeling on electronic cigarette refill products. The nicotine concentration of 71 electronic cigarette refill fluid products and 1 related do-it-yourself (DIY) product was quantified using high-performance liquid chromatography. Quantified data were compared with manufacturers labeled concentrations. Duplicate refill fluid products purchased at different times were evaluated by visual comparison of fluid coloration and quantified nicotine concentration. Thirty-five of the 54 nicotine-containing fluids had quantified nicotine concentrations that deviated by more than ± 10% from the manufacturer labels, with 46 of 50 being in excess of labeled values. Refill fluids labeled as 0 nicotine had no detectable nicotine. Of the 5 products that were unlabeled for nicotine concentration, 3 contained no detectable nicotine, whereas the remaining 2 contained nicotine in excess of 100mg/ml and may have been intended for DIY use. Sixteen of the 18 duplicate bottles of refill fluid varied greatly in their nicotine concentrations. One of the 5 companies showed significant improvement in labeling accuracy among the most recently purchased products. Of the 23 total duplicate pairs, 15 of 23 varied in coloration from their mates. Nicotine concentration labeling on electronic cigarette refill products was often inaccurate but showed improvement recently in products from 1 company. To ensure the safety of refill fluids and DIY products, it is necessary to establish quality control guidelines for the manufacturing and labeling and to monitor products longitudinally. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-18
... of Surveys in Developing Improved Labeling for Insect Repellent Products AGENCY: Environmental... of Surveys in Developing Improved Labeling for Insect Repellent Products'' and identified by EPA ICR... insect repellent products. Title: Use of Surveys in Developing Improved Labeling for Insect Repellent...
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40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...
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40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...
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16 CFR 305.16 - Labeling and marking for plumbing products.
Code of Federal Regulations, 2011 CFR
2011-01-01
... CONGRESS RULE CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Labeling and marking for plumbing products...
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16 CFR 305.16 - Labeling and marking for plumbing products.
Code of Federal Regulations, 2013 CFR
2013-01-01
... CONGRESS RULE CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Labeling and marking for plumbing products...
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16 CFR 305.16 - Labeling and marking for plumbing products.
Code of Federal Regulations, 2012 CFR
2012-01-01
... CONGRESS RULE CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Labeling and marking for plumbing products...
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9 CFR 112.5 - Review and approval of labeling.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...
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9 CFR 112.5 - Review and approval of labeling.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...
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9 CFR 112.5 - Review and approval of labeling.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...
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9 CFR 112.5 - Review and approval of labeling.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...
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9 CFR 112.5 - Review and approval of labeling.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...
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7 CFR 205.670 - Inspection and testing of agricultural product to be sold or labeled “organic.”
Code of Federal Regulations, 2012 CFR
2012-01-01
...), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM... agricultural product to be sold or labeled “organic.” (a) All agricultural products that are to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients...
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Draft genome sequence and genetic transformation of the oleaginous alga Nannochloropis gaditana
Radakovits, Randor; Jinkerson, Robert E.; Fuerstenberg, Susan I.; Tae, Hongseok; Settlage, Robert E.; Boore, Jeffrey L.; Posewitz, Matthew C.
2012-01-01
The potential use of algae in biofuels applications is receiving significant attention. However, none of the current algal model species are competitive production strains. Here we present a draft genome sequence and a genetic transformation method for the marine microalga Nannochloropsis gaditana CCMP526. We show that N. gaditana has highly favourable lipid yields, and is a promising production organism. The genome assembly includes nuclear (~29 Mb) and organellar genomes, and contains 9,052 gene models. We define the genes required for glycerolipid biogenesis and detail the differential regulation of genes during nitrogen-limited lipid biosynthesis. Phylogenomic analysis identifies genetic attributes of this organism, including unique stramenopile photosynthesis genes and gene expansions that may explain the distinguishing photoautotrophic phenotypes observed. The availability of a genome sequence and transformation methods will facilitate investigations into N. gaditana lipid biosynthesis and permit genetic engineering strategies to further improve this naturally productive alga. PMID:22353717
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Draft genome sequence and genetic transformation of the oleaginous alga Nannochloropis gaditana.
Radakovits, Randor; Jinkerson, Robert E; Fuerstenberg, Susan I; Tae, Hongseok; Settlage, Robert E; Boore, Jeffrey L; Posewitz, Matthew C
2012-02-21
The potential use of algae in biofuels applications is receiving significant attention. However, none of the current algal model species are competitive production strains. Here we present a draft genome sequence and a genetic transformation method for the marine microalga Nannochloropsis gaditana CCMP526. We show that N. gaditana has highly favourable lipid yields, and is a promising production organism. The genome assembly includes nuclear (~29 Mb) and organellar genomes, and contains 9,052 gene models. We define the genes required for glycerolipid biogenesis and detail the differential regulation of genes during nitrogen-limited lipid biosynthesis. Phylogenomic analysis identifies genetic attributes of this organism, including unique stramenopile photosynthesis genes and gene expansions that may explain the distinguishing photoautotrophic phenotypes observed. The availability of a genome sequence and transformation methods will facilitate investigations into N. gaditana lipid biosynthesis and permit genetic engineering strategies to further improve this naturally productive alga.
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Impact of front-of-pack 'traffic-light' nutrition labelling on consumer food purchases in the UK.
Sacks, Gary; Rayner, Mike; Swinburn, Boyd
2009-12-01
Front-of-pack 'traffic-light' nutrition labelling has been widely proposed as a tool to improve public health nutrition. This study examined changes to consumer food purchases after the introduction of traffic-light labels with the aim of assessing the impact of the labels on the 'healthiness' of foods purchased. The study examined sales data from a major UK retailer in 2007. We analysed products in two categories ('ready meals' and sandwiches), investigating the percentage change in sales 4 weeks before and after traffic-light labels were introduced, and taking into account seasonality, product promotions and product life-cycle. We investigated whether changes in sales were related to the healthiness of products. All products that were not new and not on promotion immediately before or after the introduction of traffic-light labels were selected for the analysis (n = 6 for ready meals and n = 12 for sandwiches). For the selected ready-meals, sales increased (by 2.4% of category sales) in the 4 weeks after the introduction of traffic-light labels, whereas sales of the selected sandwiches did not change significantly. Critically, there was no association between changes in product sales and the healthiness of the products. This short-term study based on a small number of ready meals and sandwiches found that the introduction of a system of four traffic-light labels had no discernable effect on the relative healthiness of consumer purchases. Further research on the influence of nutrition signposting will be needed before this labelling format can be considered a promising public health intervention.
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Arrúa, Alejandra; Machín, Leandro; Curutchet, María Rosa; Martínez, Joseline; Antúnez, Lucía; Alcaire, Florencia; Giménez, Ana; Ares, Gastón
2017-09-01
Warnings have recently been proposed as a new type of directive front-of-pack (FOP) nutrition labelling scheme to flag products with high content of key nutrients. In the present work, this system was compared with the two most common FOP nutrition labelling schemes (Guideline Daily Amounts (GDA) and traffic-light system) in terms of goal-directed attention, influence on perceived healthfulness and ability to differentiate between products. Design/Setting/Subjects Goal-directed attention to FOP labels was evaluated using a visual search task in which participants were presented with labels on a computer screen and were asked to indicate whether labels with high sodium content were present or absent. A survey with 387 participants was also carried out, in which the influence of FOP labels on perceived healthfulness and ability to identify the healthful alternative were evaluated. Warnings improved consumers' ability to correctly identify a product with high content of a key nutrient within a set of labels compared with GDA and received the highest goal-directed attention. In addition, products with high energy, saturated fat, sugar and/or sodium content that featured warnings on the label were perceived as less healthful than those featuring the GDA or traffic-light system. Warnings and the traffic-light system performed equally well in the identification of the most healthful product. Results from the present work suggest that warnings have potential as directive FOP nutrition labels to improve consumer ability to identify unhealthful products and highlight advantages compared with the traffic-light system.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-15
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0588] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic...
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Bennike, N H; Oturai, N B; Müller, S; Kirkeby, C S; Jørgensen, C; Christensen, A B; Zachariae, C; Johansen, J D
2018-01-01
More than 25% of the adult European population suffers from contact allergy, with fragrance substances recognized as one of the main causes. Since 2005, 26 fragrance contact allergens have been mandatory to label in cosmetic products within the EU if present at 10 ppm or above in leave-on and 100 ppm or above in wash-off cosmetics. To examine exposure, based on ingredient labelling, to the 26 fragrances in a sample of 5588 fragranced cosmetic products. The investigated products were identified through a novel, non-profit smartphone application (app), designed to provide information to consumers about chemical substances in cosmetic products. Products registered through the app between December 2015 and October 2016 were label checked according to International Nomenclature of Cosmetic Ingredients (INCI) for the presence of the 26 fragrance substances or the wording 'fragrance/parfum/aroma'. The largest product categories investigated were 'cream, lotion and oil' (n = 1192), 'shampoo and conditioner' (n = 968) and 'deodorants' (n = 632). Among cosmetic products labelled to contain at least one of the 26 fragrances, 85.5% and 73.9% contained at least two and at least three of the 26 fragrances, respectively. Linalool (49.5%) and limonene (48.5%) were labelled most often among all investigated products. Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC/Lyral ® ) was found in 13.5% of deodorants. Six of the 26 fragrance substances were labelled on less than one per cent of all products, including the natural extracts Evernia furfuracea (tree moss) and Evernia prunastri (oak moss). A total of 329 (5.9%) products had one or more of the 26 fragrance substances labelled but did not have 'parfum/fragrance/aroma' listed on the label. Consumers are widely exposed to, often multiple, well-established fragrance contact allergens through various cosmetic products intended for daily use. Several fragrance substances that are common causes of contact allergy were rarely labelled in this large sample of cosmetic products. © 2017 European Academy of Dermatology and Venereology.
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Bialkova, Svetlana; Grunert, Klaus G; Juhl, Hans Jørn; Wasowicz-Kirylo, Grazyna; Stysko-Kunkowska, Malgorzata; van Trijp, Hans C M
2014-05-01
In two eye-tracking studies, we explored whether and how attention to nutrition information mediates consumers' choice. Consumers had to select either the healthiest option or a product of their preference within an assortment. On each product a particular label (Choices logo, monochrome GDA label, or color-coded GDA label) communicated the product's nutrient profile. In study 1, participants had to select from 4 products differentiated, in addition to the nutrition information, by flavor (strawberry, muesli, apple, chocolate; varied within participants) and brand (local vs. global, varied between participants). Study 2 further explored brand effect within-participants, and thus only 2 flavors (strawberry, chocolate) were presented within an assortment. Actual choice made, response time and eye movements were recorded. Respondents fixated longer and more often on products with color-coded GDAs label than on products with monochrome GDAs or Choices logo. A health goal resulted in longer and more frequent fixations in comparison to a preference goal. Products with color-coded and monochrome GDAs had the highest likelihood of being chosen, and this effect was related to the attention-getting property of the label (irrespective of brand and flavor effects). The product fixated most had the highest likelihood of being chosen. These results suggest that attention mediates the effect of nutrition labels on choice. Copyright © 2014 Elsevier Ltd. All rights reserved.
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Soil Fumigant Labels - Metam Sodium/Potassium
Search by EPA registration number, product name, or company; and follow the link to the Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Thomadsen, Bruce R.; Thompson, Heaton H. II; Jani, Shirish K.
Medical products (devices, drugs, or biologics) contain information in their labeling regarding the manner in which the manufacturer has determined that the products can be used in a safe and effective manner. The Food and Drug Administration (FDA) approves medical products for use for these specific indications which are part of the medical product's labeling. When medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use canmore » be confusing. Although the responsibility and, ultimately, the liability for off-label use often rests with the prescribing physician, medical physicists and others are also responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is important for medical physicists to understand their responsibilities. In the United States, medical products can only be marketed if officially cleared, approved, or licensed by the FDA; they can be used if they are not subject to or specifically exempt from FDA regulations, or if they are being used in research with the appropriate regulatory safeguards. Medical devices are either cleared or approved by FDA's Center for Devices and Radiological Health. Drugs are approved by FDA's Center for Drug Evaluation and Research, and biological products such as vaccines or blood are licensed under a biologics license agreement by FDA's Center for Biologics Evaluation and Research. For the purpose of this report, the process by which the FDA eventually clears, approves, or licenses such products for marketing in the United States will be referred to as approval. This report summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the United States, and includes a discussion of the approval process, along with manufacturers' responsibilities, labeling, marketing and promotion, and off-label use. This is an educational and descriptive report and does not contain prescriptive recommendations. This report addresses the role of the medical physicist in clinical situations involving off-label use. Case studies in radiation therapy are presented. Any mention of commercial products is for identification only; it does not imply recommendations or endorsements of any of the authors or the AAPM. The full report, containing extensive background on off-label use with several appendices, is available on the AAPM website (http://www.aapm.org/pubs/reports/).« less
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Ducrot, Pauline; Méjean, Caroline; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Fezeu, Léopold; Hercberg, Serge; Péneau, Sandrine
2015-01-01
To date, no consensus has emerged on the most appropriate front-of-pack (FOP) nutrition label to help consumers in making informed choices. We aimed to compare the effectiveness of the label formats currently in use: nutrient-specific, graded and simple summary systems, in a large sample of adults. The FOP label effectiveness was assessed by measuring the label acceptability and understanding among 13,578 participants of the NutriNet-Santé cohort study, representative of the French adult population. Participants were exposed to five conditions, including four FOP labels: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick), and a "no label" condition. Acceptability was evaluated by several indicators: attractiveness, liking and perceived cognitive workload. Objective understanding was assessed by the percentage of correct answers when ranking three products according to their nutritional quality. Five different product categories were tested: prepared fish dishes, pizzas, dairy products, breakfast cereals, and appetizers. Differences among the label effectiveness were compared with chi-square tests. The 5-CNL was viewed as the easiest label to identify and as the one requiring the lowest amount of effort and time to understand. GDA was considered as the least easy to identify and to understand, despite being the most attractive and liked label. All FOP labels were found to be effective in ranking products according to their nutritional quality compared with the "no label" situation, although they showed differing levels of effectiveness (p<0.0001). Globally, the 5-CNL performed best, followed by MTL, GDA and Tick labels. The graded 5-CNL label was considered as easy to identify, simple and rapid to understand; it performed well when comparing the products' nutritional quality. Therefore, it is likely to present advantages in real shopping situations where choices are usually made quickly.
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Zhou, Haihong; Wang, Sheng-Ping; Herath, Kithsiri; Kasumov, Takhar; Sadygov, Rovshan G.; Kelley, David E.
2015-01-01
The synthesis of various molecules can be estimated by measuring the incorporation of a labeled precursor into a product of interest. Unfortunately, a central problem in many studies has been an inability to estimate the intracellular dilution of the precursor and therein correctly calculate the synthesis of the product; it is generally assumed that measuring the true product labeling is straightforward. We initiated a study to examine liver collagen synthesis and identified an apparent problem with assumptions regarding measurements of the product labeling. Since it is well known that collagen production is relatively slow, we relied on the use of [2H]H2O labeling (analogous to a primed infusion) and sampled animals over the course of 16 days. Although the water labeling (the precursor) remained stable and we observed the incorporation of labeled amino acids into collagen, the asymptotic protein labeling was considerably lower than what would be expected based on the precursor labeling. Although this observation is not necessarily surprising (i.e., one might expect that a substantial fraction of the collagen pool would appear “inert” or turn over at a very slow rate), its implications are of interest in certain areas. Herein, we discuss a novel situation in which tracers are used to quantify rates of flux under conditions where a product may not undergo complete replacement. We demonstrate how heterogeneity in the product pool can lead one to the wrong conclusions regarding estimates of flux, and we outline an approach that may help to minimize errors surrounding data interpretation. PMID:26015435
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-24
...] Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and... industry entitled ``Necessity of the Use of Food Product Categories in Food Facility Registrations and... made available a draft guidance entitled ``Guidance for Industry: Necessity of the Use of Food [[Page...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-27
... Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products... Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated January 2002 (2002 guidance), and the...CJD) by Blood and Blood Products''' dated August 2006 (2006 draft guidance). DATES: Submit electronic...
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The draft genome sequence of cork oak
Ramos, António Marcos; Usié, Ana; Barbosa, Pedro; Barros, Pedro M.; Capote, Tiago; Chaves, Inês; Simões, Fernanda; Abreu, Isabl; Carrasquinho, Isabel; Faro, Carlos; Guimarães, Joana B.; Mendonça, Diogo; Nóbrega, Filomena; Rodrigues, Leandra; Saibo, Nelson J. M.; Varela, Maria Carolina; Egas, Conceição; Matos, José; Miguel, Célia M.; Oliveira, M. Margarida; Ricardo, Cândido P.; Gonçalves, Sónia
2018-01-01
Cork oak (Quercus suber) is native to southwest Europe and northwest Africa where it plays a crucial environmental and economical role. To tackle the cork oak production and industrial challenges, advanced research is imperative but dependent on the availability of a sequenced genome. To address this, we produced the first draft version of the cork oak genome. We followed a de novo assembly strategy based on high-throughput sequence data, which generated a draft genome comprising 23,347 scaffolds and 953.3 Mb in size. A total of 79,752 genes and 83,814 transcripts were predicted, including 33,658 high-confidence genes. An InterPro signature assignment was detected for 69,218 transcripts, which represented 82.6% of the total. Validation studies demonstrated the genome assembly and annotation completeness and highlighted the usefulness of the draft genome for read mapping of high-throughput sequence data generated using different protocols. All data generated is available through the public databases where it was deposited, being therefore ready to use by the academic and industry communities working on cork oak and/or related species. PMID:29786699
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The draft genome sequence of cork oak.
Ramos, António Marcos; Usié, Ana; Barbosa, Pedro; Barros, Pedro M; Capote, Tiago; Chaves, Inês; Simões, Fernanda; Abreu, Isabl; Carrasquinho, Isabel; Faro, Carlos; Guimarães, Joana B; Mendonça, Diogo; Nóbrega, Filomena; Rodrigues, Leandra; Saibo, Nelson J M; Varela, Maria Carolina; Egas, Conceição; Matos, José; Miguel, Célia M; Oliveira, M Margarida; Ricardo, Cândido P; Gonçalves, Sónia
2018-05-22
Cork oak (Quercus suber) is native to southwest Europe and northwest Africa where it plays a crucial environmental and economical role. To tackle the cork oak production and industrial challenges, advanced research is imperative but dependent on the availability of a sequenced genome. To address this, we produced the first draft version of the cork oak genome. We followed a de novo assembly strategy based on high-throughput sequence data, which generated a draft genome comprising 23,347 scaffolds and 953.3 Mb in size. A total of 79,752 genes and 83,814 transcripts were predicted, including 33,658 high-confidence genes. An InterPro signature assignment was detected for 69,218 transcripts, which represented 82.6% of the total. Validation studies demonstrated the genome assembly and annotation completeness and highlighted the usefulness of the draft genome for read mapping of high-throughput sequence data generated using different protocols. All data generated is available through the public databases where it was deposited, being therefore ready to use by the academic and industry communities working on cork oak and/or related species.
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Soil Fumigant Labels - Chloropicrin
Search by EPA registration number, product name, or company name, and follow the link to the Pesticide Product Label System (PPLS) for details on each fumigant. Updated labels include new safety requirements for buffer zones and related measures.
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Logos and Graphics on Pesticide Product Labels
There are several logos that pesticide companies can add to their labels with EPA approval. The requirements and process vary, so review the guidance carefully before applying to add a logo to a product label.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-23
...The Commission amends the Energy Labeling Rule (``Rule'') by updating comparability ranges and unit energy costs for many EnergyGuide labels. The Commission also issues a conditional exemption and amendments for modified refrigerator and clothes washer labels to help consumers compare the labels for these products after the implementation of upcoming changes to the Department of Energy (``DOE'') test procedures.
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9 CFR 317.345 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Guidelines for voluntary nutrition... DEVICES, AND CONTAINERS Nutrition Labeling § 317.345 Guidelines for voluntary nutrition labeling of single-ingredient, raw products. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. (a) Nutrition...
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9 CFR 381.445 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Guidelines for voluntary nutrition... INSPECTION REGULATIONS Nutrition Labeling § 381.445 Guidelines for voluntary nutrition labeling of single-ingredient, raw products. Link to an amendment published at 75 FR 82166, Dec. 29, 2010. (a) Nutrition...
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21 CFR 340.50 - Labeling of stimulant drug products.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of stimulant drug products. 340.50 Section 340.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 340.50...
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21 CFR 331.30 - Labeling of antacid products.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....” (d) Drug interaction precaution. The labeling of the product contains the following statement “Ask a...
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21 CFR 331.30 - Labeling of antacid products.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....” (d) Drug interaction precaution. The labeling of the product contains the following statement “Ask a...
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The product is the presentation - a draft set of slides is attached. The presentation is organized around a comprehensive framework for nanomaterial evaluation published last year (Boyes et al., 2017). The framework considers nanomaterial enabled products across their life span...
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Current Over-the-Counter Medicine Label: Take a Look
... of OTC medicines sometimes make changes to their products or labeling (new ingredients, dosages, or warnings). Make sure to read the label each time you use the product. Always look for special "flags" or "banners" on ...
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Poirier, Simon; Coeuret, Gwendoline; Champomier-Vergès, Marie-Christine; Chaillou, Stéphane
2018-06-14
In this study, we present the draft genome sequences of nine strains from various psychrotrophic species identified in meat products and being recognized as important emerging food spoilers. Many of these species have only one or few strains being sequenced, and this work will contribute to the improvement of the overall genomic knowledge about them. Copyright © 2018 Poirier et al.
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Castro, Daniel B.A.; Pereira, Letícia Bianca; Silva, Marcus Vinícius M. e; Silva, Bárbara P. da; Palermo, Bruna Rafaella Z.; Carlos, Camila; Belgini, Daiane R.B.; Limache, Elmer Erasmo G.; Lacerda, Gileno V. Jr; Nery, Mariana B.P.; Gomes, Milene B.; Souza, Salatiel S. de; Silva, Thiago M. da; Rodrigues, Viviane D.; Paulino, Luciana C.; Vicentini, Renato; Ferraz, Lúcio F.C.; Ottoboni, Laura M.M.
2015-01-01
An actinobacterial strain, designated SO9-6, was isolated from a copper iron sulfide mineral. The organism is Gram-positive, facultatively anaerobic, and coccoid. Chemotaxonomic and phylogenetic properties were consistent with its classification in the genus Kocuria. Here, we report the first draft genome sequence of Kocuria marina SO9-6 under accession JROM00000000 (http://www.ncbi.nlm.nih.gov/nuccore/725823918), which provides insights for heavy metal bioremediation and production of compounds of biotechnological interest. PMID:26484219
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A Draft Test Protocol for Detecting Possible Biohazards in Martian Samples Returned to Earth
NASA Technical Reports Server (NTRS)
Rummel, John D. (Editor); Race, Margaret S.; DeVincenzi, Donald L.; Schad, P. Jackson; Stabekis, Pericles D.; Viso, Michel; Acevedo, Sara E.
2002-01-01
This document presents the first complete draft of a protocol for detecting possible biohazards in Mars samples returned to Earth: it is the final product of the Mars Sample Handling Protocol Workshop Series. convened in 2000-2001 by NASA's Planetary Protection Officer. The goal of the five-workshop Series vas to develop a comprehensive protocol by which returned martian sample materials could be assessed k r the presence of any biological hazard(s) while safeguarding the purity of the samples from possible terrestrial contamination.
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Draft Plan to Develop Non-Intrusive Load Monitoring Test Protocols
DOE Office of Scientific and Technical Information (OSTI.GOV)
Mayhorn, Ebony T.; Sullivan, Greg P.; Petersen, Joseph M.
2015-09-29
This document presents a Draft Plan proposed to develop a common test protocol that can be used to evaluate the performance requirements of Non-Intrusive Load Monitoring. Development on the test protocol will be focused on providing a consistent method that can be used to quantify and compare the performance characteristics of NILM products. Elements of the protocols include specifications for appliances to be used, metrics, instrumentation, and a procedure to simulate appliance behavior during tests. In addition, three priority use cases for NILM will be identified and their performance requirements will specified.
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Graham, Dan J; Lucas-Thompson, Rachel G; Mueller, Megan P; Jaeb, Melanie; Harnack, Lisa
2017-04-01
The present study investigated whether parent/child pairs would select more healthful foods when: (i) products were labelled with front-of-package (FOP) nutrition labels relative to packages without labels; (ii) products were labelled with colour-coded Multiple Traffic Light (MTL) FOP labels relative to monochromatic Facts up Front (FuF) FOP labels; and (iii) FOP labels were explained via in-aisle signage v. unexplained. Participants were randomly assigned to one of five conditions: (i) FuF labels with in-aisle signs explaining the labels; (ii) FuF labels, no signage; (iii) MTL labels with in-aisle signage; (iv) MTL labels, no signage; (v) control group, no labels/signage. Saturated fat, sodium, sugar and energy (calorie) content were compared across conditions. The study took place in a laboratory grocery aisle. Parent/child pairs (n 153) completed the study. Results did not support the hypothesis that MTL labels would lead to more healthful choices than FuF labels. The presence of FOP labels did little to improve the healthfulness of selected foods, with few exceptions (participants with v. without access to FOP labels selected lower-calorie cereals, participants with access to both FOP labels and in-aisle explanatory signage selected products with less saturated fat v. participants without explanatory signage). Neither MTL nor FuF FOP labels led to food choices with significantly lower saturated fat, sodium or sugar. In-aisle signs explaining the FOP labels were somewhat helpful to consumers in making more healthful dietary decisions. New FOP labelling programmes could benefit from campaigns to increase consumer awareness and understanding of the labels.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-26
... FEDERAL TRADE COMMISSION 16 CFR Part 305 [3084-AB15] Energy and Water Use Labeling for Consumer Products Under the Energy Policy and Conservation Act (``Energy Labeling Rule'') AGENCY: Federal Trade... to the Energy Labeling Rule (``Rule'') to require a new Department of Energy (DOE) test procedure for...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... requirements for human drug products held by the Strategic National Stockpile. 201.26 Section 201.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.26 Exceptions or alternatives to labeling requirements for human...
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Menthol Content in U.S. Marketed Cigarettes
Ai, Jiu; Taylor, Kenneth M.; Lisko, Joseph G.; Tran, Hang; Watson, Clifford H.; Holman, Matthew R.
2015-01-01
Introduction In 2011 menthol cigarettes accounted for 32 percent of the market in the United States, but there are few literature reports that provide measured menthol data for commercial cigarettes. To assess current menthol application levels in the U.S. cigarette market, menthol levels in cigarettes labeled or not labeled to contain menthol was determined for a variety of contemporary domestic cigarette products. Method We measured the menthol content of 45whole cigarettes using a validated gas chromatography/mass spectrometry method (GC/MS). Results In 23 cigarette brands labeled as menthol products, the menthol levels of the whole cigarette ranged from 2.9 to 19.6 mg/cigarette, with three products having higher levels of menthol relative to the other menthol products. The menthol levels for 22 cigarette products not labeled to contain menthol ranged from 0.002 to 0.07 mg/cigarette. The type of packaging (soft vs. hard pack) for a given cigarette product does not appear to affect menthol levels based on the current limited data. Conclusion Menthol levels in cigarette products labeled as containing menthol are approximately 50 to 5,000-fold higher than those in cigarette products not labeled as containing menthol. In general, menthol content appears to occur within discrete ranges for both mentholated and non-mentholated cigarettes. PMID:26259988
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Compliance and Verification of Standards and Labelling Programs in China: Lessons Learned
DOE Office of Scientific and Technical Information (OSTI.GOV)
Saheb, Yamina; Zhou, Nan; Fridley, David
2010-06-11
After implementing several energy efficiency standards and labels (30 products covered by MEPS, 50 products covered by voluntary labels and 19 products by mandatory labels), the China National Institute of Standardization (CNIS) is now implementing verification and compliance mechanism to ensure that the energy information of labeled products comply with the requirements of their labels. CNIS is doing so by organizing check testing on a random basis for room air-conditioners, refrigerators, motors, heaters, computer displays, ovens, and self -ballasted lamps. The purpose of the check testing is to understand the implementation of the Chinese labeling scheme and help local authoritiesmore » establishing effective compliance mechanisms. In addition, to ensure robustness and consistency of testing results, CNIS has coordinated a round robin testing for room air conditioners. Eight laboratories (Chinese (6), Australian (1) and Japanese (1)) have been involved in the round robin testing and tests were performed on four sets of samples selected from manufacturer?s production line. This paper describes the methodology used in undertaking both check and round robin testing, provides analysis of testing results and reports on the findings. The analysis of both check and round robin testing demonstrated the benefits of a regularized verification and monitoring system for both laboratories and products such as (i) identifying the possible deviations between laboratories to correct them, (ii) improving the quality of testing facilities, (iii) ensuring the accuracy and reliability of energy label information in order to strength the social credibility of the labeling program and the enforcement mechanism in place.« less
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Compliance and Verification of Standards and Labeling Programs in China: Lessons Learned
DOE Office of Scientific and Technical Information (OSTI.GOV)
Saheb, Yamina; Zhou, Nan; Fridley, David
2010-08-01
After implementing several energy efficiency standards and labels (30 products covered by MEPS, 50 products covered by voluntary labels and 19 products by mandatory labels), the China National Institute of Standardization (CNIS) is now implementing verification and compliance mechanism to ensure that the energy information of labeled products comply with the requirements of their labels. CNIS is doing so by organizing check testing on a random basis for room air-conditioners, refrigerators, motors, heaters, computer displays, ovens, and self -ballasted lamps. The purpose of the check testing is to understand the implementation of the Chinese labeling scheme and help local authoritiesmore » establishing effective compliance mechanisms. In addition, to ensure robustness and consistency of testing results, CNIS has coordinated a round robin testing for room air conditioners. Eight laboratories (Chinese (6), Australian (1) and Japanese (1)) have been involved in the round robin testing and tests were performed on four sets of samples selected from manufacturer's production line. This paper describes the methodology used in undertaking both check and round robin testing, provides analysis of testing results and reports on the findings. The analysis of both check and round robin testing demonstrated the benefits of a regularized verification and monitoring system for both laboratories and products such as (i) identifying the possible deviations between laboratories to correct them, (ii) improving the quality of testing facilities, (iii) ensuring the accuracy and reliability of energy label information in order to strength the social credibility of the labeling program and the enforcement mechanism in place.« less
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Code of Federal Regulations, 2011 CFR
2011-04-01
... dandruff, seborrheic dermatitis, or psoriasis. 358.750 Section 358.750 Food and Drugs FOOD AND DRUG... Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established...
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Code of Federal Regulations, 2012 CFR
2012-04-01
... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...
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Code of Federal Regulations, 2014 CFR
2014-04-01
... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...
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Code of Federal Regulations, 2013 CFR
2013-04-01
... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... dandruff, seborrheic dermatitis, or psoriasis. 358.750 Section 358.750 Food and Drugs FOOD AND DRUG... Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established...
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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...
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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...
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Willy, Mary E; Li, Zili
2004-04-01
The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States. We searched the Physicians' Desk Reference-2000 for prescription drugs with hepatic failure and/or hepatic necrosis listed in the labeling. We used a six-item checklist to evaluate the 'informativeness' and consistency of the labeling content. An informativeness score equaled the proportion of checklist items present in each drug's labeling. Ninety-five prescription drugs were included in the study. Eleven (12%) of the drugs had information related to hepatic failure in a Black Boxed Warning, 52 (54%) in the Warnings section and 32 (34%) in the Adverse Reactions section of the label. The mean informativeness score was 35%; the score was significantly higher, 61%, when the risk was perceived to be high. The informativeness of labeling was not affected by the time of the labeling, but differed across the Center for Drug Evaluation and Research (CDER) Review Division responsible for the labeling. The information provided in labeling is variable and affected by many factors, including the perceived level of risk and review division strategy. Product labeling may benefit from current FDA initiatives to improve the consistency of risk-related labeling.
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Cloud draft structure and trace gas transport
NASA Technical Reports Server (NTRS)
Scala, John R.; Tao, Wei-Kuo; Thompson, Anne M.; Simpson, Joanne; Garstang, Michael; Pickering, Kenneth E.; Browell, Edward V.; Sachse, Glen W.; Gregory, Gerald L.; Torres, Arnold L.
1990-01-01
During the second Amazon Boundary Layer Experiment (ABLE 2B), meteorological observations, chemical measurements, and model simulations are utilized in order to interpret convective cloud draft structure and to analyze its role in transport and vertical distribution of trace gases. One-dimensional photochemical model results suggest that the observed poststorm changes in ozone concentration can be attributed to convective transports rather than photochemical production and the results of a two-dimensional time-dependent cloud model simulation are presented for the May 6, 1987 squall system. The mesoscale convective system exhibited evidence of significant midlevel detrainment in addition to transports to anvil heights. Chemical measurements of O3 and CO obtained in the convective environment are used to predict photochemical production within the troposphere and to corroborate the cloud model results.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-14
... Nanotechnology; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... ``Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology''. This guidance is... nanomaterials or otherwise involve the application of nanotechnology. The points to consider are intended to be...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-13
... Stock in Organic Crop Production (NOP 5029)''; and ``Evaluating Allowed Ingredients and Sources of... finalized, these guidance documents will be available from the NOP through ``The Program Handbook: Guidance... ``Seeds, Annual Seedlings, and Planting Stock in Organic Crop Production (NOP 5029)'', and ``Evaluating...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-15
... reference product for the purpose of submitting a marketing application through an abbreviated licensure... submitting a marketing application through the abbreviated licensure pathway under section 351(k) of the... FDA will use to review applications for biosimilar products; and General scientific principles in...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-22
...] (formerly Docket No. 2005D-0106) Guidance for Industry on Systemic Lupus Erythematosus--Developing Medical... entitled ``Systemic Lupus Erythematosus--Developing Medical Products for Treatment.'' This guidance... medical devices for the treatment of systemic lupus erythematosus (SLE). This guidance finalizes the draft...
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40 CFR 763.171 - Labeling requirements.
Code of Federal Regulations, 2011 CFR
2011-07-01
... ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos-Containing Products; Labeling Requirements § 763.171 Labeling requirements. (a) After August 27, 1990, manufacturers, importers, and processors of all asbestos-containing products that are...
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16 CFR 1615.5 - Labeling requirements.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE.... (a) Care labels. All items of children's sleepwear shall be labeled with precautionary instructions... accordance with rules and regulations established by the Consumer Product Safety Commission. (b) [Reserved...
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Khuda, Sefat E; Sharma, Girdhari M; Gaines, Dennis; Do, Andrew B; Pereira, Marion; Chang, Michael; Ferguson, Martine; Williams, Kristina M
2016-08-01
Since the number of recalls involving undeclared allergens is commonly associated with bakery and snack foods, we aimed to determine the frequency of egg allergens in a large number of these products using two commercial enzyme-linked immunosorbent assay (ELISA) methods. Samples were chosen that either had no egg identified on the product label or which had an egg precautionary statement. Among all samples, egg protein was detected in 5% of products using a Morinaga (MO) kit and 1% of products using a R-Biopharm (RB) kit. For bakery samples, egg protein was detected in 6% of 363 samples with no precautionary labelling (6% by MO and 1% by RB kit) and 12% of 80 samples which had precautionary labelling. For snack samples, egg protein was detected in 2% of 371 samples with no precautionary labelling (2% by MO and < 1% by RB kit) and 5% of 21 samples which had precautionary labelling. The disagreement rates between two methods were 5.2% for bakery products and 2.6% for snack products. The sample repeatability was at an acceptable level for bakery (< 12.5%) and snack foods (< 7.5%) for each method. The relative standard deviation between test kits was high (103.1%) for bakery foods. Four bakery products without precautionary labelling had a higher level of egg protein per serving compared with the eliciting dose (ED10 of 3.7 mg protein) for egg allergic patients. These results highlight the fact that detection methodology plays a vital role for accurate labelling control and mitigation of risk for egg allergic consumers.
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Penetration of nutrition information on food labels across the EU-27 plus Turkey
Storcksdieck genannt Bonsmann, S; Celemín, L Fernández; Larrañaga, A; Egger, S; Wills, J M; Hodgkins, C; Raats, M M
2010-01-01
Objectives: The European Union (EU)-funded project Food Labelling to Advance Better Education for Life (FLABEL) aims to understand how nutrition information on food labels affects consumers' dietary choices and shopping behaviour. The first phase of this study consisted of assessing the penetration of nutrition labelling and related information on various food products in all 27 EU Member States and Turkey. Methods: In each country, food products were audited in three different types of retailers to cover as many different products as possible within five food and beverage categories: sweet biscuits, breakfast cereals, pre-packed chilled ready meals, carbonated soft drinks and yoghurts. Results: More than 37 000 products were audited in a total of 84 retail stores. On average, 85% of the products contained back-of-pack (BOP) nutrition labelling or related information (from 70% in Slovenia to 97% in Ireland), versus 48% for front-of-pack (FOP) information (from 24% in Turkey to 82% in the UK). The most widespread format was the BOP tabular or linear listing of nutrition content. Guideline daily amounts labelling was the most prevalent form of FOP information, showing an average penetration of 25% across all products audited. Among categories, breakfast cereals showed the highest penetration of nutrition-related information, with 94% BOP penetration and 70% FOP penetration. Conclusions: Nutrition labelling and related information was found on a large majority of products audited. These findings provide the basis for subsequent phases of FLABEL involving attention, reading, liking, understanding and use by consumers of different nutrition labelling formats. PMID:20808336
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Maison, Dominika; Marchlewska, Marta; Syarifah, Dewi; Zein, Rizqy A; Purba, Herison P
2018-01-01
Halal refers to what is permissible in traditional Islamic law. Food that meets halal requirements is marked by a halal label on the packaging and should be especially attractive to those Muslims who follow the set of dietary laws outlined in the Quran. This research examines the role of the halal label (explicit cue) and the country-of-origin (COO) (implicit cue) in predicting positive product perceptions among Muslim consumers. We hypothesized that when an explicit sign of "halalness" (i.e., halal label) relating to a particular product is accompanied by an implicit sign of anti - "halalness" (i.e., non-Islamic COO information), Muslim consumers who pay attention to the dietary laws of Islam would have negative perceptions of such a product. We tested our assumptions in an experiment conducted among Indonesian participants who declared themselves as Muslims ( n = 444). We manipulated: (a) exposure to the halal label, and (b) the COO information. Religion-based purchase behavior was measured as a moderator variable. Positive product perceptions were measured as a dependent variable. The results showed that the halal label itself had limited influence on product perceptions. However, we found that positive product perceptions significantly decreased among people who were high in religion-based purchase behavior in response to exposure to non-Islamic COO information accompanied by a halal label. In conclusion, people who are high (vs. low) in religion-based purchase behavior do not seem to trust halal-labeled food produced in a country with other than an Islamic tradition.
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Maison, Dominika; Marchlewska, Marta; Syarifah, Dewi; Zein, Rizqy A.; Purba, Herison P.
2018-01-01
Halal refers to what is permissible in traditional Islamic law. Food that meets halal requirements is marked by a halal label on the packaging and should be especially attractive to those Muslims who follow the set of dietary laws outlined in the Quran. This research examines the role of the halal label (explicit cue) and the country-of-origin (COO) (implicit cue) in predicting positive product perceptions among Muslim consumers. We hypothesized that when an explicit sign of “halalness” (i.e., halal label) relating to a particular product is accompanied by an implicit sign of anti-“halalness” (i.e., non-Islamic COO information), Muslim consumers who pay attention to the dietary laws of Islam would have negative perceptions of such a product. We tested our assumptions in an experiment conducted among Indonesian participants who declared themselves as Muslims (n = 444). We manipulated: (a) exposure to the halal label, and (b) the COO information. Religion-based purchase behavior was measured as a moderator variable. Positive product perceptions were measured as a dependent variable. The results showed that the halal label itself had limited influence on product perceptions. However, we found that positive product perceptions significantly decreased among people who were high in religion-based purchase behavior in response to exposure to non-Islamic COO information accompanied by a halal label. In conclusion, people who are high (vs. low) in religion-based purchase behavior do not seem to trust halal-labeled food produced in a country with other than an Islamic tradition. PMID:29623061
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Niederdeppe, Jeff; Frosch, Dominick L
2009-05-01
The Food and Drug Administration mandated that food products list the amount of trans fat per serving on nutrition facts labels by January 1, 2006. There have been no coordinated efforts to raise awareness about trans fat since the policy went into effect, but news coverage may promote informed decisions about food purchases. This paper assesses whether news coverage influenced sales of products containing trans fat, between December 13, 2004, and June 24, 2007, both before and after the labeling policy went into effect. Sales data for products containing trans fat from a major grocery store chain with stores throughout Los Angeles County were merged with news coverage data from LexisNexis and ProQuest. Cross-sectional time-series regression was conducted in 2008 to assess the effect of news coverage on weekly unit sales volume for seven trans-fat products across 11,997 store-weeks. News coverage effects were apparent for sales of two of the seven trans-fat products in the year before the trans-fat nutrition facts labeling policy went into effect (p<0.05 with Bonferroni correction). News coverage effects were observed for sales of six of the seven trans-fat products in the post-labeling period (p<0.05 with Bonferroni correction). For most products, effects were strongest at concurrent and 1-week lags, and they dissipated over time. News coverage about trans fat, combined with labeling information, appears to influence consumer behavior in the short term. News coverage and product labeling may not be sufficient to promote sustained changes in trans-fat purchases.
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76 FR 82296 - Environmental Impacts Statements; Notice of Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-30
.... 20110431, Draft EIS, USFS, NV, Geothermal Leasing on the Humboldt-Toiyabe National Forest, To Facilitate the Development and Production of Geothermal Energy, Ely, Austin, Tonopah and Bridgeport Ranger...
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Inconsistencies in emergency instructions on common household product labels.
Cantrell, F Lee; Nordt, Sean Patrick; Krauss, Jamey R
2013-10-01
Human exposures to non-pharmaceutical products often results in serious injury and death annually in the United States. Studies performed more than 25 years ago described inadequate first aid advice on the majority of household products. The current study evaluates contemporary non-pharmaceutical products with respect to location, uniformity and type of their first aid and emergency contact instructions. A random, convenience sample of commercial product label information was obtained from local retail stores over an 8 month period. Twelve common non-pharmaceutical product categories, with large numbers of annual human exposures, were identified from National Poison Data Systems data. A minimum of 10 unique products for each category utilized. The following information identified: product name and manufacturer, location on container, presence and type of route-specific treatment, medical assistance referral information. A total of 259 product labels were examined. First aid/contact information was located on container: rear 162 (63 %), side 28 (11 %), front 3 (1 %), bottom 2 (0.77 %), behind label 14 (5 %), missing entirely 50 (19 %). Fifty-five products (21 %) lacked any first aid instructions. Suggested contacts for accidental poisoning: none listed 75 (29 %), physician 144 (56 %), poison control centers 102 (39 %), manufacturer 44 (17 %), "Call 911" 10 (4 %). Suggested contacts for unintentional exposure and content of first aid instructions on household products were inconsistent, frequently incomplete and at times absent. Instruction locations similarly lacked uniformity. Household product labels need to provide concise, accurate first aid and emergency contact instructions in easy-to-understand language in a universal format on product labels.
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PRN 93-8: Labeling Statement Prohibiting Application to Water; Amendment to PR Notice 93-3
This notice adds one paragraph to P.R. Notice 93-3, which requested registrants to amend product labeling to include a new labeling statement prohibiting application of a pesticide to water for certain products.
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Developing a Community of Critically Literate Consumers . . . One Close Label-Reading at a Time
ERIC Educational Resources Information Center
Reissman, Rose Cherie
2012-01-01
This article focuses on middle school students analyzing product labels. The labels were analyzed in terms of which facts they purported to impart and to what extent these so-called facts tallied with actual data and scientific/health analyses of the products. Students then reworded the labels to include only documented facts. They also shared the…
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7 CFR 70.50 - Approval of official identification and wording on labels.
Code of Federal Regulations, 2011 CFR
2011-01-01
... INSPECTION ACT (CONTINUED) VOLUNTARY GRADING OF POULTRY PRODUCTS AND RABBIT PRODUCTS Grading of Poultry Products and Rabbit Products Identifying and Marking Products § 70.50 Approval of official identification... CFR part 381. Poultry Products Inspection Regulations. Labeling requirements for ready-to-cook rabbits...
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Calendar Year 2007 Program Benefits for U.S. EPA Energy Star Labeled Products: Expanded Methodology
DOE Office of Scientific and Technical Information (OSTI.GOV)
Sanchez, Marla; Homan, Gregory; Lai, Judy
2009-09-24
This report provides a top-level summary of national savings achieved by the Energy Star voluntary product labeling program. To best quantify and analyze savings for all products, we developed a bottom-up product-based model. Each Energy Star product type is characterized by product-specific inputs that result in a product savings estimate. Our results show that through 2007, U.S. EPA Energy Star labeled products saved 5.5 Quads of primary energy and avoided 100 MtC of emissions. Although Energy Star-labeled products encompass over forty product types, only five of those product types accounted for 65percent of all Energy Star carbon reductions achieved tomore » date, including (listed in order of savings magnitude)monitors, printers, residential light fixtures, televisions, and furnaces. The forecast shows that U.S. EPA?s program is expected to save 12.2 Quads of primary energy and avoid 215 MtC of emissions over the period of 2008?2015.« less
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Activity-based assay for ricin-like toxins
Keener, William K.; Ward, Thomas E.
2007-02-06
A method of detecting N-glycosylase activity in a sample involves incubating an oligodeoxyribonucleotide substrate containing a deoxyadenosine or deoxyuridine residue with the sample to be tested such that the N-glycosylase, if present, hydrolyzes the deoxyadenosine or deoxyuridine residue to result in an N-glycosylase product having an abasic site. A primer is annealed to the N-glycosylase product, and the primer is extended with a DNA polymerase, such as Taq DNA polymerase, that pauses at abasic sites. The resulting extension products are melted from the N-glycosylase product, allowed to form hairpins due to self-complementarity, and further extended in the presence of labeled precursors to result in labeled products. Extension products synthesized from undigested substrate as template do not result in labeled products. Thus, detection of labeled products results in detection of N-glycosylase activity. Oligodeoxyribonucleotide substrates, primer, and positive controls and a kit for N-glycosylase assay are also disclosed.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-05
... Commission Act for including a dolphin-safe label on tuna product in the United States that fails to meet the.... 130221153-3153-01] RIN 0648-BC78 Enhanced Document Requirements To Support Use of the Dolphin Safe Label on Tuna Products AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric...
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American Power Act (Discussion of Draft)
To secure the energy future of the United States, to provide incentives for the domestic production of clean energy technology, to achieve meaningful pollution reductions, to create jobs, and for other purposes.
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Antelmi, Annarita; Bruze, Magnus; Zimerson, Erik; Engfeldt, Malin; Young, Ewa; Persson, Lena; Foti, Caterina; Sörensen, Östen; Svedman, Cecilia
2017-04-01
Hair dyes contain strong allergens and are widely available. Correct labelling is a necessity in order to provide information about the contents. To compare the labelling and content of hair dyes. In total, 52 hair dyes, from 11 different countries, were bought over the counter. High-pressure liquid chromatography was used for the analysis of p-phenylenediamine (PPD), toluene-2,5-diamine (2,5-TDA), and three oxidation products of PPD. There was good agreement between labelling and content, although seven of the 52 products (13.5%) studied were incorrectly labelled. There were differences in the geographical use of PPD and 2,5-TDA; 2,5-TDA was more common in European products, while PPD was more common in products purchased outside Europe and was present in higher concentrations. All dyes purchased in Europe contained PPD and 2,5-TDA at levels within the limits defined by European legislation, however, levels were higher in some products purchased outside Europe. Only a small group of hair dyes sold in Europe were mislabelled. Further improvement in labelling, by providing the concentration of chemicals, may facilitate products to be purchased both locally and within the global market, when travelling or on the internet.
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The history and impact of the New York City menu labeling law.
Bernell, Brent
2010-01-01
As a result of the recent federal health care legislation, all restaurants in the United States that are part of a chain with twenty or more locations serving substantially the same menu items will be required to post the calorie information of the food they serve directly on menus and menu boards. This development represents the culmination of a regulatory initiative to combat the growth of obesity that only began in 2006 with the decision by the New York City Board of Health to require calorie posting in New York City chain restaurants. That initiative, Regulation 81.50, was the first of its kind in the United States; and yet, less than four years later, the idea has become a national standard. This paper tracks the history of New York City's landmark regulation, detailing the drafting of the law, the initial legal victory for the restaurant association challenging it, and the ultimate triumph of the City in winning legal validation of its calorie posting mandate. In doing so, this paper will also use the New York City regulation as a launching point to discuss the rationale behind menu labeling, to examine the potential legal pitfalls of menu labeling laws, to track the development of the initiative from New York City to a national standard, and finally, to evaluate the preliminary data on whether or not menu labeling is actually effective in achieving its ultimate goal: changing consumer eating habits and reducing obesity.
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16 CFR 1500.133 - Extremely flammable contact adhesives; labeling.
Code of Federal Regulations, 2011 CFR
2011-01-01
... under the Consumer Product Safety Act extremely flammable contact adhesives covered by this labeling... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Extremely flammable contact adhesives; labeling. 1500.133 Section 1500.133 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL...
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16 CFR 1500.133 - Extremely flammable contact adhesives; labeling.
Code of Federal Regulations, 2014 CFR
2014-01-01
... under the Consumer Product Safety Act extremely flammable contact adhesives covered by this labeling... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Extremely flammable contact adhesives; labeling. 1500.133 Section 1500.133 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL...
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Objective Understanding of Front-of-Package Nutrition Labels among Nutritionally At-Risk Individuals
Ducrot, Pauline; Méjean, Caroline; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Fezeu, Léopold K.; Hercberg, Serge; Péneau, Sandrine
2015-01-01
In the ongoing debate about front-of-package (FOP) nutrition labels, little data exist regarding nutritionally at-risk populations, although they are critical targets of prevention programs. This study aimed to compare the impact of FOP labels on the ability to rank products according to their nutritional quality among French adults potentially at risk of poor dietary quality (N = 14,230). Four labels were evaluated: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick), along with a reference without label. Mixed models were used to assess how individual characteristics and FOP labels were associated with the ability to rank products. Older participants and those with a lower educational level, income, nutritional knowledge, and likelihood of reading nutrition facts were less skilled at ranking food products according to nutritional quality. Compared with individual characteristics, nutrition labels had an increased impact on food product ranking ability. Overall, 5-CNL corresponded to the highest rate of correct responses, followed by MTL, GDA, and Tick (p < 0.0001). The strongest impact of 5-CNL was observed among individuals with no nutritional knowledge (odds ratio (OR): 20.24; 95% confidence interval (CI): 13.19–31.06). Therefore, 5-CNL appeared to be effective at informing consumers, including those who are nutritionally at-risk, about the nutritional quality of food products. PMID:26305255
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Ducrot, Pauline; Méjean, Caroline; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Fezeu, Léopold K; Hercberg, Serge; Péneau, Sandrine
2015-08-24
In the ongoing debate about front-of-package (FOP) nutrition labels, little data exist regarding nutritionally at-risk populations, although they are critical targets of prevention programs. This study aimed to compare the impact of FOP labels on the ability to rank products according to their nutritional quality among French adults potentially at risk of poor dietary quality (N = 14,230). Four labels were evaluated: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick), along with a reference without label. Mixed models were used to assess how individual characteristics and FOP labels were associated with the ability to rank products. Older participants and those with a lower educational level, income, nutritional knowledge, and likelihood of reading nutrition facts were less skilled at ranking food products according to nutritional quality. Compared with individual characteristics, nutrition labels had an increased impact on food product ranking ability. Overall, 5-CNL corresponded to the highest rate of correct responses, followed by MTL, GDA, and Tick (p < 0.0001). The strongest impact of 5-CNL was observed among individuals with no nutritional knowledge (odds ratio (OR): 20.24; 95% confidence interval (CI): 13.19-31.06). Therefore, 5-CNL appeared to be effective at informing consumers, including those who are nutritionally at-risk, about the nutritional quality of food products.
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Digital pathology: DICOM-conform draft, testbed, and first results.
Zwönitzer, Ralf; Kalinski, Thomas; Hofmann, Harald; Roessner, Albert; Bernarding, Johannes
2007-09-01
Hospital information systems are state of the art nowadays. Therefore, Digital Pathology, also labelled as Virtual Microscopy, has gained increased attention. Triggered by radiology, standardized information models and workflows were world-wide defined based on DICOM. However, DICOM-conform integration of Digital Pathology into existing clinical information systems imposes new problems requiring specific solutions concerning the huge amount of data as well as the special structure of the data to be managed, transferred, and stored. We implemented a testbed to realize and evaluate the workflow of digitized slides from acquisition to archiving. The experiences led to the draft of a DICOM-conform information model that accounted for extensions, definitions, and technical requirements necessary to integrate digital pathology in a hospital-wide DICOM environment. Slides were digitized, compressed, and could be viewed remotely. Real-time transfer of the huge amount of data was optimized using streaming techniques. Compared to a recent discussion in the DICOM Working Group for Digital Pathology (WG26) our experiences led to a preference of a JPEG2000/JPIP-based streaming of the whole slide image. The results showed that digital pathology is feasible but strong efforts by users and vendors are still necessary to integrate Digital Pathology into existing information systems.
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Tassinari, Melissa S; Sahin, Leyla; Yao, Lynne P
2015-08-01
Obtaining human pregnancy data to inform product labeling is important for drug and biological products. Collection and analyses of safety data on their use during pregnancy is usually performed after approval. The Centers for Disease Control National Birth Defects Prevention Study has provided important data on the relationship between drug use in pregnancy and birth defects. The Pregnancy and Lactation Labeling Rule will set new and improved standards for the inclusion of information about the use of prescription drugs and biological products during pregnancy; the National Birth Defects Prevention Study, along with other data sources, will be critical for providing safety data to inform product labeling. © 2015 Wiley Periodicals, Inc.
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9 CFR 381.408 - Labeling of poultry products with number of servings.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of poultry products with... SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS...
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Chen, Chaoyang; Sun, Chongran; Wu, Yi-Rui
2018-03-21
A wild-type solventogenic strain Clostridium diolis WST, isolated from mangrove sediments, was characterized to produce high amount of butanol and acetone with negligible level of ethanol and acids from glucose via a unique acetone-butanol (AB) fermentation pathway. Through the genomic sequencing, the assembled draft genome of strain WST is calculated to be 5.85 Mb with a GC content of 29.69% and contains 5263 genes that contribute to the annotation of 5049 protein-coding sequences. Within these annotated genes, the butanol dehydrogenase gene (bdh) was determined to be in a higher amount from strain WST compared to other Clostridial strains, which is positively related to its high-efficient production of butanol. Therefore, we present a draft genome sequence analysis of strain WST in this article that should facilitate to further understand the solventogenic mechanism of this special microorganism.
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An Exploratory Study: Assessment of Modeled Dioxin ...
EPA has released an external review draft entitled, An Exploratory Study: Assessment of Modeled Dioxin Exposure in Ceramic Art Studios(External Review Draft). The public comment period and the external peer-review workshop are separate processes that provide opportunities for all interested parties to comment on the document. In addition to consideration by EPA, all public comments submitted in accordance with this notice will also be forwarded to EPA’s contractor for the external peer-review panel prior to the workshop. EPA has realeased this draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. The purpose of this report is to describe an exploratory investigation of potential dioxin exposures to artists/hobbyists who use ball clay to make pottery and related products.
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Readability of product ingredient labels can be improved by simple means: an experimental study.
Yazar, Kerem; Seimyr, Gustaf Ö; Novak, Jiri A; White, Ian R; Lidén, Carola
2014-10-01
Ingredient labels on products used by consumers and workers every day, such as food, cosmetics, and detergents, can be difficult to read and understand. To assess whether typographical design and ordering of ingredients can improve the readability of product ingredient labels. The study subjects (n = 16) had to search for two target ingredients in 30 cosmetic product labels and three alternative formats of each. Outcome measures were completion time (reading speed), recognition rate, eye movements, task load and subjective rating when the reading of ingredient labels was assessed by video recording, an eye tracking device, and questionnaires. The completion time was significantly lower (p < 0.001) when subjects were reading all alternative formats than when they were reading the original. The recognition rate was generally high, and improved slightly with the alternative formats. The eye movement measures confirmed that the alternative formats were easier to read than the original product labels. Mental and physical demand and effort were significantly lower (p < 0.036) and experience rating was higher (p < 0.042) for the alternative formats. There were also differences between the alternative formats. Simple adjustments in the design of product ingredient labels would significantly improve their readability, benefiting the many allergic individuals and others in their daily struggle to avoid harmful or unwanted exposure. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
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Ciociola, A A; Sirgo, M A; Pappa, K A; McGuire, J A; Fung, K
2001-01-01
A study of the consumer's understanding of the product label instructions and the resulting product use were conducted to support the switch of a product from prescription to nonprescription status. H2 receptor antagonists have recently been approved for nonprescription use. This study evaluated the consumer's understanding of the product label for ranitidine hydrochloride (Zantac 75) and the product usage pattern in the treatment of episodic heartburn. Our objectives were to evaluate each aspect of the communication of labeled indications, contraindications, and directions for use of two label formats (old and new) for a new nonprescription preparation of ranitidine (Zantac) and to evaluate nonprescription consumers' use of ranitidine 75-mg tablets (as Zantac 75) in a medically unsupervised, at-home setting to observe whether these consumers used the product appropriately and followed directions as written on the package label. Adult male and female consumers (n = 1405) in a shopping mall environment who were attracted to a poster asking, "Do you have stomach problems?" were recruited for the label comprehension phase (two different label formats) and the 3-week usage phase if after reading the Zantac 75 package label they decided the product was appropriate for them. No instructions regarding the use of Zantac 75 were provided beyond what was printed on the package label. Subjects recorded use in a diary and tablet counts were performed at the end of the study period. A medical history was also taken at this time and an assessment of product use was performed by a physician. In at least 84% of all subjects, both formats were effective in the communication of label objectives for the contraindication against concurrent prescription stomach ulcer medication, maximum daily dose, and maximum duration of dosing at maximum daily doses. The direction to take one tablet per dose was adhered to by 90% of consumers, and 90% of consumers followed the instructions to take no more than two tablets in 24 hours. Ninety-six percent of consumers complied with the direction not to take the maximum daily dose for more than 14 consecutive days. Notably, the maximum daily dose was taken for < or =3 consecutive days by 79% of consumers. The most frequently reported adverse events were headache, acute nasopharyngitis, upper respiratory tract infection, diarrhea, nausea, and menstrual cramps. The study demonstrated that the vast majority of a large sample of unsupervised consumers understood the package label and fully complied with the package directions by not exceeding the maximum daily dosage and length of use. Nonprescription consumers safely used Zantac 75 without medical supervision.
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9 CFR 590.410 - Shell eggs and egg products required to be labeled.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Shell eggs and egg products required..., DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Identifying and Marking Product § 590.410 Shell eggs and egg products required to be labeled...
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9 CFR 590.410 - Shell eggs and egg products required to be labeled.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Shell eggs and egg products required..., DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Identifying and Marking Product § 590.410 Shell eggs and egg products required to be labeled...
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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...
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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...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) COUNTRY OF ORIGIN LABELING FOR FISH AND SHELLFISH General Provisions Country of Origin Notification § 60.300 Labeling. (a) Country of origin declarations and method of production (wild and/or farm-raised) designations can either...
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Code of Federal Regulations, 2014 CFR
2014-01-01
... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) COUNTRY OF ORIGIN LABELING FOR FISH AND SHELLFISH General Provisions Country of Origin Notification § 60.300 Labeling. (a) Country of origin declarations and method of production (wild and/or farm-raised) designations can either...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) COUNTRY OF ORIGIN LABELING FOR FISH AND SHELLFISH General Provisions Country of Origin Notification § 60.300 Labeling. (a) Country of origin declarations and method of production (wild and/or farm-raised) designations can either...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) COUNTRY OF ORIGIN LABELING FOR FISH AND SHELLFISH General Provisions Country of Origin Notification § 60.300 Labeling. (a) Country of origin declarations and method of production (wild and/or farm-raised) designations can either...
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Rodu, Brad; Plurphanswat, Nantaporn; Hughes, John R; Fagerström, Karl
2016-05-01
The US Food and Drug Administration can require changes in warning statements for modified risk tobacco products. We report an independent analysis of a consumer perception survey sponsored by Swedish Match as part of a Modified Risk Tobacco Product application to change warning labels for Swedish snus products. The survey exposed each of 4324 daily exclusive cigarette smokers, 1033 daily smokeless tobacco users, 1205 daily other tobacco users, 726 former users, and 5915 triers/never users to one of four current warnings and two proposed relative-risk labels (No tobacco product is safe, but this product presents lower risks to health than cigarettes, or No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes) for snus. Descriptive and logistic regression analyses examined four outcomes: believability, harmfulness, motivation to use, and intention to buy snus. Compared with the current not-safe-alternative warning, adult tobacco users who viewed the proposed labels perceived them as less believable, perceived snus as less harmful and were more likely to use and buy snus. The proposed labels had no impact on former smokers' likelihood to use and buy snus; triers/never users viewing the substantially lower risk label were more likely to buy snus. Tobacco users viewing the proposed labels perceived snus as less harmful than cigarettes and may be more likely to use and buy snus. If labeling changes lead to increased snus use and cigarette reduction or abstinence, public health may benefit. If the opposite occurs, public health could suffer. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Ergin, Ahmet; Hatipoğlu, Celile; Bozkurt, Ali Ihsan; Erdoğan, Aslı; Güler, Serdar; Ince, Gülberat; Kavurgacı, Nuran; Oz, Ahmet; Yeniay, Mustafa K
2013-01-01
The aim of this study was to determine the compliance status of product labels regarding Article 9 of the International Code on Marketing of Breast-milk Substitutes (the Code) in Denizli province, Turkey. A cross-sectional study design was employed to determine the compliance status. The product labels were obtained from a convenience sample of five supermarkets, one store and 5 pharmacies in the City centre and district of Honaz. Using a data collection form prepared by previously published studies, data were collected between July 26, 2010 and August 06, 2010. Data collection form included 13 criteria. In addition, we checked the boxes for the availability of a Turkish written label. Forty product labels of 7 companies were reached and evaluated. These products consisted of 83.0% of the products marketed by these companies in Turkey. Thirty seven (92.5%) of the labels violated Article 9 of the Code in terms of one or more criteria. Thirty four (85.0%) of the labels had photos or pictures idealizing the use of infant formula. Nine (22.5%) had a photo, a picture or any representation of an infant, and five (12.5%) had text which idealize the use of infant formula or discouraging breastfeeding. Eight (20%) did not state that breastfeeding is the best. Four (10%) had a term such as 'similar to breast milk or human milk'. In conclusion, the majority of the product labels of breast milk substitutes marketed in our country violate the Code. It is appropriate that the Turkish Ministry of Health, medical organizations, companies, and NGOs work more actively to increase awareness of this issue.
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Lando, Amy M; Lo, Serena C
2013-02-01
The Food and Drug Administration is considering changes to the Nutrition Facts label to help consumers make more healthful choices. To examine the effects of modifications to the Nutrition Facts label on foods that can be listed as having 1 or 2 servings per container, but are reasonably consumed at a single eating occasion. Participants were randomly assigned to study conditions that varied on label format, product, and nutrition profile. Data were collected via an online consumer panel. Adults aged 18 years and older were recruited from Synovate's online household panel. Data were collected during August 2011. A total of 32,897 invitations were sent for a final sample of 9,493 interviews. Participants were randomly assigned to one of 10 label formats classified into three groups: listing 2 servings per container with a single column, listing 2 servings per container with a dual column, and listing a single serving per container. Within these groups there were versions that enlarged the font size for "calories," removed "calories from fat," and changed the wording for serving size declaration. The single product task measured product healthfulness, the amount of calories and various nutrients per serving and per container, and label perceptions. The product comparison task measured ability to identify the healthier product and the product with fewer calories per container and per serving. Analysis of covariance models with Tukey-Kramer tests were used. Covariates included general label use, age, sex, level of education, and race/ethnicity. Single-serving and dual-column formats performed better and scored higher on most outcome measures. For products that contain 2 servings but are customarily consumed at a single eating occasion, using a single-serving or dual-column labeling approach may help consumers make healthier food choices. Published by Elsevier Inc.
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9 CFR 317.9 - Labeling of equine products.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of equine products. 317.9 Section 317.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY...
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Quantitative risk assessment of foods containing peanut advisory labeling.
Remington, Benjamin C; Baumert, Joseph L; Marx, David B; Taylor, Steve L
2013-12-01
Foods with advisory labeling (i.e. "may contain") continue to be prevalent and the warning may be increasingly ignored by allergic consumers. We sought to determine the residual levels of peanut in various packaged foods bearing advisory labeling, compare similar data from 2005 and 2009, and determine any potential risk for peanut-allergic consumers. Of food products bearing advisory statements regarding peanut or products that had peanut listed as a minor ingredient, 8.6% and 37.5% contained detectable levels of peanut (>2.5 ppm whole peanut), respectively. Peanut-allergic individuals should be advised to avoid such products regardless of the wording of the advisory statement. Peanut was detected at similar rates and levels in products tested in both 2005 and 2009. Advisory labeled nutrition bars contained the highest levels of peanut and an additional market survey of 399 products was conducted. Probabilistic risk assessment showed the risk of a reaction to peanut-allergic consumers from advisory labeled nutrition bars was significant but brand-dependent. Peanut advisory labeling may be overused on some nutrition bars but prudently used on others. The probabilistic approach could provide the food industry with a quantitative method to assist with determining when advisory labeling is most appropriate. Copyright © 2013 Elsevier Ltd. All rights reserved.
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Becoming an "Authorised" Postgraduate Research Writer
ERIC Educational Resources Information Center
James, Bronwyn
2012-01-01
Within the context of postgraduate research education and training in the higher education sector, drafting might be understood as "not quite the final product" produced by the student who is "not yet the final product" of the university. In this paper, I turn this assumption "off centre" to argue instead that writing and subjectivity are mutually…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-27
...-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to... existing mandates and government standards and ecolabels. [For illustration purposes, ``product category x...
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40 CFR 147.2906 - Emergency permits.
Code of Federal Regulations, 2010 CFR
2010-07-01
... substantial delay in oil or gas production, and injection will not result in movement of fluid into an USDW... permits to avoid a substantial delay in oil or gas production shall be issued only after a complete permit... notice procedure for a draft permit within 10 days after issuance. (3) An emergency permit may be oral or...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-20
... related to operations and maintenance of storage and distribution facilities for petroleum products within the Colton and Colton North Terminals, and with habitat restoration and management on a proposed on... maintenance of storage and distribution facilities for petroleum products on approximately 20 acres (ac) (8...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-18
... requirements described in Sec. 211.100(b); and standard operating procedures should be reviewed and revised or..., and update. The draft guidance also encourages manufacturers to include a procedure in their Plan for... as which drug products will be manufactured under altered procedures, which products will have...
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Energy Gain. Teacher's Guide and Student Guide. Net Energy Unit. Draft.
ERIC Educational Resources Information Center
McLeod, Richard J.
This module focuses on gains and losses of energy as society processes resources for energy production. It particularly focuses on the end point of energy conversion and addresses decisions which society must make concerning benefits and costs of various energy production methods and generating facilities. One class period is needed to implement…