Sample records for device notification sunquest

  1. The successful implementation of a licensed data management interface between a Sunquest(®) laboratory information system and an AB SCIEX™ mass spectrometer.

    PubMed

    French, Deborah; Terrazas, Enrique

    2013-01-01

    Interfacing complex laboratory equipment to laboratory information systems (LIS) has become a more commonly encountered problem in clinical laboratories, especially for instruments that do not have an interface provided by the vendor. Liquid chromatography-tandem mass spectrometry is a great example of such complex equipment, and has become a frequent addition to clinical laboratories. As the testing volume on such instruments can be significant, manual data entry will also be considerable and the potential for concomitant transcription errors arises. Due to this potential issue, our aim was to interface an AB SCIEX™ mass spectrometer to our Sunquest(®) LIS. WE LICENSED SOFTWARE FOR THE DATA MANAGEMENT INTERFACE FROM THE UNIVERSITY OF PITTSBURGH, BUT EXTENDED THIS WORK AS FOLLOWS: The interface was designed so that it would accept a text file exported from the AB SCIEX™ × 5500 QTrap(®) mass spectrometer, pre-process the file (using newly written code) into the correct format and upload it into Sunquest(®) via file transfer protocol. The licensed software handled the majority of the interface tasks with the exception of converting the output from the Analyst(®) software to the required Sunquest(®) import format. This required writing of a "pre-processor" by one of the authors which was easily integrated with the supplied software. We successfully implemented the data management interface licensed from the University of Pittsburgh. Given the coding that was required to write the pre-processor, and alterations to the source code that were performed when debugging the software, we would suggest that before a laboratory decides to implement such an interface, it would be necessary to have a competent computer programmer available.

  2. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

  3. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

  4. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

  5. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

  6. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

  7. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... transport devices commonly known as stairlifts. These devices are used to assist transfers of a mobility... behalf of Bruno Independent Living Aids, Inc., for powered patient transport devices (commonly known as...

  8. Cascading Policies Provide Fault Tolerance for Pervasive Clinical Communications.

    PubMed

    Williams, Rose; Jalan, Srikant; Stern, Edie; Lussier, Yves A

    2005-03-21

    We implemented an end-to-end notification system that pushed urgent clinical laboratory results to Blackberry 7510 devices over the Nextel cellular network. We designed our system to use user roles and notification policies to abstract and execute clinical notification procedures. We anticipated some problems with dropped and non-delivered messages when the device was out-of-network, however, we did not expect the same problems in other situations like device reconnection to the network. We addressed these problems by creating cascading "fault tolerance" policies to drive notification escalation when messages timed-out or delivery failed. This paper describes our experience in providing an adaptable, fault tolerant pervasive notification system for delivering secure, critical, time-sensitive patient laboratory results.

  9. The use of Food and Drug Administration 510(k) notifications in patent litigation.

    PubMed

    Tolomeo, Deborah E

    2004-01-01

    The U.S. Food and Drug Administration (FDA) 510(k) approval process provides medical device companies with the ability to market a device after the company establishes that the device to the marketed is "substantially equivalent" to one or more predicate devices. Companies that submit 510(k) notifications should be aware, however, that a 510(k) notification is a public document that may later reappear as evidence in patent litigation. Courts have considered 510(k) notifications to be relevant evidence in determining direct and contributory infringement, patent invalidity, and patent unenforceability due to inequitable conduct before the U.S. Patent and Trademark Office (USPTO). In one case, the court held that a substantial equivalence determination by FDA constituted evidence that can be "construed as an admission of infringement." The court also has relied on a 510(k) notification to support a finding of personal liability for a corporate officer who signed the 510(k) notification to be evidence of willful and deliberate conduct, and have awarded treble damages and reasonable attorney's fees to the prevailing party. The potential for increased risk in patent litigation is important for practitioners in the medical device industry, because more than seventy-five percent of medical devices are approved for marketing through the 510(k) process. This article reviews a number of patent cases in which a court has admitted a 510(k) notification as relevant evidence, and proposes general strategies for avoiding these situations.

  10. Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

    PubMed

    1998-11-03

    The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

  11. 21 CFR 810.15 - Communications concerning a cease distribution and notification or mandatory recall order.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810.15 Communications concerning a cease distribution and notification... promptly notifying each health professional, device user facility, consignee, or individual, as appropriate...

  12. 21 CFR 810.17 - Termination of a cease distribution and notification or mandatory recall order.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... that they have been instructed to cease use of the device and to take other appropriate action; or (2..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810.17 Termination of a cease distribution and notification or...

  13. Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

    PubMed

    2003-04-22

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

  14. 21 CFR 810.15 - Communications concerning a cease distribution and notification or mandatory recall order.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Communications concerning a cease distribution and..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810.15 Communications concerning a cease distribution and notification...

  15. 40 CFR 63.3400 - What notifications and reports must I submit?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... unknown causes. (I) The date of the latest CEMS and CPMS certification or audit. (J) A description of any... control device and you are required to conduct a performance test of the control device. This notification... of the control device determined during the performance test are maintained. Unless EPA objects to...

  16. Proactive authenticated notifications for health practitioners: two way human computer interaction through phone.

    PubMed

    Majeed, Raphael W; Stöhr, Mark R; Röhrig, Rainer

    2012-01-01

    Notifications and alerts play an important role in clinical daily routine. Rising prevalence of clinical decision support systems and electronic health records also result in increasing demands on notification systems. Failure adequately to communicate a critical value is a potential cause of adverse events. Critical laboratory values and changing vital data depend on timely notifications of medical staff. Vital monitors and medical devices rely on acoustic signals for alerting which are prone to "alert fatigue" and require medical staff to be present within audible range. Personal computers are unsuitable to display time critical notification messages, since the targeted medical staff are not always operating or watching the computer. On the other hand, mobile phones and smart devices enjoy increasing popularity. Previous notification systems sending text messages to mobile phones depend on asynchronous confirmations. By utilizing an automated telephony server, we provide a method to deliver notifications quickly and independently of the recipients' whereabouts while allowing immediate feedback and confirmations. Evaluation results suggest the feasibility of the proposed notification system for real-time notifications.

  17. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

    PubMed

    Yang, Brian W; Iorio, Matthew L; Day, Charles S

    2017-03-15

    The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

  18. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray... guidance entitled ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This draft... premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA...

  19. Mass Notification for Higher Education

    ERIC Educational Resources Information Center

    Schneider, Tod

    2010-01-01

    Mass notification is a high priority in educational institutions. As the number of electronic communication devices has diversified, so has the complexity of designing an effective mass notification system. Picking the right system, with the right features, support services and price, can be daunting. This publication, updated quarterly due to…

  20. 40 CFR Table 7 to Subpart Vvvv of... - Applicability and Timing of Notifications

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... § 63.9(e). b. A notification of the date for the continuous monitoring system performance evaluation as... control device performance test and continuous monitoring system performance evaluation. ... Notifications 7 Table 7 to Subpart VVVV of Part 63 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...

  1. Safety status system for operating room devices.

    PubMed

    Guédon, Annetje C P; Wauben, Linda S G L; Overvelde, Marlies; Blok, Joleen H; van der Elst, Maarten; Dankelman, Jenny; van den Dobbelsteen, John J

    2014-01-01

    Since the increase of the number of technological aids in the operating room (OR), equipment-related incidents have come to be a common kind of adverse events. This underlines the importance of adequate equipment management to improve the safety in the OR. A system was developed to monitor the safety status (periodic maintenance and registered malfunctions) of OR devices and to facilitate the notification of malfunctions. The objective was to assess whether the system is suitable for use in an busy OR setting and to analyse its effect on the notification of malfunctions. The system checks automatically the safety status of OR devices through constant communication with the technical facility management system, informs the OR staff real-time and facilitates notification of malfunctions. The system was tested for a pilot period of six months in four ORs of a Dutch teaching hospital and 17 users were interviewed on the usability of the system. The users provided positive feedback on the usability. For 86.6% of total time, the localisation of OR devices was accurate. 62 malfunctions of OR devices were reported, an increase of 12 notifications compared to the previous year. The safety status system was suitable for an OR complex, both from a usability and technical point of view, and an increase of reported malfunctions was observed. The system eases monitoring the safety status of equipment and is a promising tool to improve the safety related to OR devices.

  2. 24 CFR 3280.202 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-1995, Standard on Types of Building Construction. Smoke alarm: An alarm device that is responsive to smoke. Tactile notification appliance: A notification appliance that alerts by the sense of touch or...

  3. 24 CFR 3280.202 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...-1995, Standard on Types of Building Construction. Smoke alarm: An alarm device that is responsive to smoke. Tactile notification appliance: A notification appliance that alerts by the sense of touch or...

  4. 24 CFR 3280.202 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-1995, Standard on Types of Building Construction. Smoke alarm: An alarm device that is responsive to smoke. Tactile notification appliance: A notification appliance that alerts by the sense of touch or...

  5. 24 CFR 3280.202 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-1995, Standard on Types of Building Construction. Smoke alarm: An alarm device that is responsive to smoke. Tactile notification appliance: A notification appliance that alerts by the sense of touch or...

  6. 40 CFR Table 13 to Subpart Wwww of... - Applicability and Timing of Notifications

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... performance evaluation as specified in § 63.9(g) The date of submission of notification of intent to conduct a... days after the completion of the add-on control device performance test and CMS performance evaluation. ... Notifications 13 Table 13 to Subpart WWWW of Part 63 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...

  7. Natural Language Processing Accurately Calculates Adenoma and Sessile Serrated Polyp Detection Rates.

    PubMed

    Nayor, Jennifer; Borges, Lawrence F; Goryachev, Sergey; Gainer, Vivian S; Saltzman, John R

    2018-07-01

    ADR is a widely used colonoscopy quality indicator. Calculation of ADR is labor-intensive and cumbersome using current electronic medical databases. Natural language processing (NLP) is a method used to extract meaning from unstructured or free text data. (1) To develop and validate an accurate automated process for calculation of adenoma detection rate (ADR) and serrated polyp detection rate (SDR) on data stored in widely used electronic health record systems, specifically Epic electronic health record system, Provation ® endoscopy reporting system, and Sunquest PowerPath pathology reporting system. Screening colonoscopies performed between June 2010 and August 2015 were identified using the Provation ® reporting tool. An NLP pipeline was developed to identify adenomas and sessile serrated polyps (SSPs) on pathology reports corresponding to these colonoscopy reports. The pipeline was validated using a manual search. Precision, recall, and effectiveness of the natural language processing pipeline were calculated. ADR and SDR were then calculated. We identified 8032 screening colonoscopies that were linked to 3821 pathology reports (47.6%). The NLP pipeline had an accuracy of 100% for adenomas and 100% for SSPs. Mean total ADR was 29.3% (range 14.7-53.3%); mean male ADR was 35.7% (range 19.7-62.9%); and mean female ADR was 24.9% (range 9.1-51.0%). Mean total SDR was 4.0% (0-9.6%). We developed and validated an NLP pipeline that accurately and automatically calculates ADRs and SDRs using data stored in Epic, Provation ® and Sunquest PowerPath. This NLP pipeline can be used to evaluate colonoscopy quality parameters at both individual and practice levels.

  8. Military Interoperable Digital Hospital Testbed (MIDHT) Phase III

    DTIC Science & Technology

    2014-10-01

    silently changed, it is common knowledge  that some  Java  Development  Kit (JDK) implementations create slightly differently  formatted PEM and  DER...tracking software  JKS  Java  KeyStore  LDAP  Lightweight Directory Access Protocol  MHS  Military Health System  MIMC  Conemaugh Miners Medical... MySQL ~ Conemaugh Health System ’-J Common Access Layer (CAL) Interface I I t J J AIIScripts I I McKe-n J Sunque.st Horizon EHR Lab Patient

  9. New orthopedic devices and the FDA.

    PubMed

    Sheth, Ujash; Nguyen, Nhu-An; Gaines, Sean; Bhandari, Mohit; Mehlman, Charles T; Klein, Guy

    2009-01-01

    Each year the field of orthopedics is introduced to an influx of new medical devices. Each of these medical devices has faced certain hurdles prior to being approved for marketing by the U.S. Food and Drug Administration (FDA). Among the regulatory pathways available, the 510(k) premarket notification is by far the one most commonly used. The 510(k) premarket notification allows the manufacturer to receive prompt approval of their device by demonstrating that it is "substantially equivalent" to an existing legally marketed device. In most instances, this proof of substantial equivalence allows manufacturers of medical devices to bypass the use of clinical trials, which are a hallmark of the approval process for new drugs. As a result, most medical devices are approved without demonstrating safety or effectiveness. This article reviews the regulatory processes used by the FDA to evaluate new orthopedic devices.

  10. 21 CFR 862.1380 - Hydroxybutyric dehydrogenase test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  11. 21 CFR 862.1470 - Lipid (total) test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  12. 21 CFR 862.1805 - Vitamin A test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  13. 21 CFR 862.1605 - Pregnanediol test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  14. 21 CFR 862.1590 - Porphobilinogen test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  15. 21 CFR 862.1790 - Uroporphyrin test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  16. 21 CFR 862.1595 - Porphyrins test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  17. 21 CFR 862.1620 - Progesterone test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  18. 21 CFR 807.35 - Notification of registrant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... manufacture or process biological products (including devices licensed under section 351 of the Public Health... device activities described in § 807.20, validation of registration and the assignment of a device...

  19. 21 CFR 807.35 - Notification of registrant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... manufacture or process biological products (including devices licensed under section 351 of the Public Health... device activities described in § 807.20, validation of registration and the assignment of a device...

  20. 40 CFR 156.210 - Notification-to-workers statements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Notification-to-workers statements. 156.210 Section 156.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Worker Protection Statements § 156.210...

  1. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... inclined platform lifts and vertical platform lifts), classified under 21 CFR 890.3930. IV. Comments...

  2. 21 CFR 807.35 - Notification of registrant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... regulations. (b) Owners and operators of device establishments who also manufacture or process blood or drug... and device listing are required to engage in the device activities described in § 807.20, validation...

  3. 21 CFR 810.10 - Cease distribution and notification order.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810... usual name of the device; (iii) The model, catalog, or product code numbers of the device; and (iv) The... opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device...

  4. 21 CFR 810.10 - Cease distribution and notification order.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810... usual name of the device; (iii) The model, catalog, or product code numbers of the device; and (iv) The... opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device...

  5. 21 CFR 872.6570 - Impression tube.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  6. 78 FR 40427 - Foreign-Trade Zone (FTZ) 183-Austin, Texas; Notification of Proposed Production Activity; Samsung...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-05

    ..., Texas; Notification of Proposed Production Activity; Samsung Austin Semiconductor, LLC (Semiconductors); Austin, Texas Samsung Austin Semiconductor, LLC (Samsung), operator of Subzone 183B, submitted a... June 26, 2013. Samsung currently has authority to produce semiconductor memory devices for export...

  7. 21 CFR 886.4300 - Intraocular lens guide.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4300 Intraocular lens guide. (a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct... lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  8. 75 FR 77647 - Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-13

    ... consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The... reauthorization negotiations with the regulated industry. ADDRESSES: Submit notification of intention to... groups at least once every month during negotiations with the regulated industry to continue discussions...

  9. User-Wearable Devices that Monitor Exposure to Blue Light and Recommend Adjustments Thereto

    NASA Technical Reports Server (NTRS)

    Lee, Yong Jin (Inventor)

    2017-01-01

    Described herein are user-wearable devices that include an optical sensor, and methods for use therewith. In certain embodiments, an optical sensor of a user-wearable device (e.g., a wrist-worn device) is used to detect blue light that is incident on the optical sensor and to produce a blue light detection signal indicative thereof, and thus, indicative of the response of the user's intrinsically photosensitive Retinal Ganglion Cells (ipRGCs). In dependence on the blue light detection signal, there is a determination of a metric indicative of an amount of blue light detected by the optical sensor. The metric is compared to a corresponding threshold, and a user notification is triggered in dependence on results of the comparing, wherein the user notification informs a person wearing the user-wearable device to adjust their exposure to light.

  10. Gastroenterology-urology devices; reclassification of implanted blood access devices. Final rule.

    PubMed

    2014-07-25

    The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.

  11. 21 CFR 807.25 - Information required for device establishment registration and device listing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

  12. 21 CFR 807.25 - Information required for device establishment registration and device listing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

  13. 21 CFR 874.4100 - Epistaxis balloon.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  14. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... standards. (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended...

  15. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... standards. (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended...

  16. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... standards. (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended...

  17. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... standards. (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended...

  18. 21 CFR 810.14 - Cease distribution and notification or mandatory recall strategy.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... addition to written communications as required by § 810.15, i.e., personal visits, telephone calls, or a... recall strategy. 810.14 Section 810.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Device Recall Procedures § 810.14 Cease distribution and notification or mandatory recall strategy. (a...

  19. Using Mobile Devices to Display, Overlay, and Animate Geophysical Data and Imagery

    NASA Astrophysics Data System (ADS)

    Batzli, S.; Parker, D.

    2011-12-01

    A major challenge in mobile-device map application development is to offer rich content and features with simple and intuitive controls and fast performance. Our goal is to bring visualization, animation, and notifications of near real-time weather and earth observation information derived from satellite and sensor data to mobile devices. Our robust back-end processing infrastructure can deliver content in the form of images, shapes, standard descriptive formats (eg. KML, JSON) or raw data to a variety of desktop software, browsers, and mobile devices on demand. We have developed custom interfaces for low-bandwidth browsers (including mobile phones) and high-feature browsers (including smartphones), as well as native applications for Android and iOS devices. Mobile devices offer time- and location-awareness and persistent data connections, allowing us to tailor timely notifications and displays to the user's geographic and time context. This presentation includes a live demo of how our mobile apps deliver animation of standard and custom data products in an interactive map interface.

  20. 21 CFR 810.16 - Cease distribution and notification or mandatory recall order status reports.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory... professionals, device user facilities, consignees, or individuals who have responded to the communication and the quantity of the device on hand at these locations at the time they received the communication; (3...

  1. 76 FR 67465 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

    ... makes appropriate recommendations to the Commissioner. E. Molecular and Clinical Genetics Devices Panel... vitro devices for use in clinical laboratory medicine, including clinical and molecular genetics, and...

  2. 78 FR 15682 - Notification of Proposed Production Activity TTI, Inc.; Subzone 196A (Electromechanical and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    ... Activity TTI, Inc.; Subzone 196A (Electromechanical and Circuit Protection Devices Production/ Kitting... electromechanical and circuit protection device production/kitting for a variety of commercial, aerospace and... for crimping, insertion/extraction, and terminal removal, and electromechanical devices (duty rates...

  3. 21 CFR 807.93 - Content and format of a 510(k) statement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

  4. 21 CFR 807.93 - Content and format of a 510(k) statement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

  5. 21 CFR 807.93 - Content and format of a 510(k) statement.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

  6. 21 CFR 807.93 - Content and format of a 510(k) statement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

  7. 21 CFR 807.93 - Content and format of a 510(k) statement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

  8. 77 FR 71804 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... Representatives on the Device Good Manufacturing Practice Advisory Committee AGENCY: Food and Drug Administration... Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological... regarding good manufacturing practices governing the methods used in, and the facilities and controls used...

  9. 21 CFR 874.5840 - Antistammering device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  10. 75 FR 66382 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    .... Therapy Devices Panel. General and Plastic Surgery Devices September 1, 2011. Panel. A. NMQAAC The... review and make recommendations on specific issues or problems concerning the safety and effectiveness of...

  11. FleXConf: A Flexible Conference Assistant Using Context-Aware Notification Services

    NASA Astrophysics Data System (ADS)

    Armenatzoglou, Nikos; Marketakis, Yannis; Kriara, Lito; Apostolopoulos, Elias; Papavasiliou, Vicky; Kampas, Dimitris; Kapravelos, Alexandros; Kartsonakis, Eythimis; Linardakis, Giorgos; Nikitaki, Sofia; Bikakis, Antonis; Antoniou, Grigoris

    Integrating context-aware notification services to ubiquitous computing systems aims at the provision of the right information to the right users, at the right time, in the right place, and on the right device, and constitutes a significant step towards the realization of the Ambient Intelligence vision. In this paper, we present FlexConf, a semantics-based system that supports location-based, personalized notification services for the assistance of conference attendees. Its special features include an ontology-based representation model, rule-based context-aware reasoning, and a novel positioning system for indoor environments.

  12. Readability of "Dear Patient" device advisory notification letters created by a device manufacturer.

    PubMed

    Mueller, Luke A; Sharma, Arjun; Ottenberg, Abigale L; Mueller, Paul S

    2013-04-01

    In 2006, the Heart Rhythm Society (HRS) recommended that cardiovascular implantable electronic device (CIED) manufacturers use advisory notification letters to communicate with affected patients. To evaluate the readability of the HRS sample "patient device advisory notification" letter and those created by 1 CIED manufacturer. The HRS sample letter and 25 Boston Scientific Corporation letters dated from 2005 through 2011 were evaluated by using 6 readability tests. Readability (Flesch-Kincaid score) of the HRS sample letter was grade level 12.5, and median readability of the device manufacturer letters was grade level 12.8 (range 10.8-18.9). Similar results were obtained by using other readability scales. No letters had readability scores at the National Work Group on Literacy and Health's recommended reading level-fifth grade; the letters' readability exceeded this recommended level by an average of 7.7 grades (95% confidence interval 6.9-8.5; P<.001). Likewise, no letters had readability scores at the average reading level of US adults-eighth grade; the letters' readability exceeded this level by an average of 4.7 grades (95% confidence interval 3.9-5.5; P< .001). The readability of the HRS sample letter and those created by a CIED manufacturer significantly exceeded the recommended and average US adults' reading skill levels. Such letters are unlikely to be informative to many patients. CIED manufacturers should ensure that advisory letters are comprehensible to most affected patients. Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  13. Alaska 511 - Transportation & Public Facilities, State of Alaska.

    Science.gov Websites

    Service Stay connected Best app for IPhone mobile devices Get it on Google Play Feed Facebook Twitter GovDelivery for text and email notifications Best for low bandwidth users
    and mobile devices Site

  14. The PulsePoint Respond mobile device application to crowdsource basic life support for patients with out-of-hospital cardiac arrest: Challenges for optimal implementation.

    PubMed

    Brooks, Steven C; Simmons, Graydon; Worthington, Heather; Bobrow, Bentley J; Morrison, Laurie J

    2016-01-01

    PulsePoint Respond is a novel mobile device application that notifies citizens within 400 m (∼ 1/4 mile) of a suspected cardiac arrest to facilitate resuscitation. Our objectives were to (1) characterize users, and (2) understand their behavior after being sent a notification. We sought to identify challenges for optimal implementation of PulsePoint-mediated bystander resuscitation. PulsePoint Respond users who sent a notification between 04/07/2012 and 06/16/2014 were invited to participate in an online survey. At the beginning of our study, PulsePoint Respond was active in more than 600 US communities. There were 1274 completed surveys (response rate 1448/6777, 21.4%). Respondents were firefighters (28%), paramedics (18%), emergency medical technicians (9%), nurses (7%), MDs (1%), other health care professionals (12%), and non-health care professionals (42%). Of those who received a PulsePoint notification, only 23% (189/813) responded to the PulsePoint notification. Of those who responded, 28% (52/187) did not arrive on scene. Of those who did arrive on scene, only 32% (44/135) found a person unconscious and not breathing normally. Of those who arrived on scene prior to emergency medical services and found a cardiac arrest victim, 79% (11/14) performed bystander cardiopulmonary resuscitation. Challenges for optimal implementation of PulsePoint Respond include technical aspects of the notifications (audio volume, precision of location information), excessive activation radii, insufficient user density in the community, and suboptimal cardiac arrest notification specificity. PulsePoint Respond has the potential to improve the community response to cardiac arrest, with 80% of responders attempting basic life support when they found a cardiac arrest victim prior to EMS. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Protocol-driven remote monitoring of cardiac resynchronization therapy as part of a heart failure disease management strategy.

    PubMed

    Smeets, Christophe J P; Verbrugge, Frederik H; Vranken, Julie; Van der Auwera, Jo; Mullens, Wilfried; Dupont, Matthias; Grieten, Lars; De Cannière, Hélène; Lanssens, Dorien; Vandenberk, Thijs; Storms, Valerie; Thijs, Inge M; Vandervoort, Pieter

    2018-06-01

    Cardiac resynchronisation therapy (CRT) is an established treatment for heart failure (HF) with reduced ejection fraction. CRT devices are equipped with remote monitoring functions, which are pivotal in the detection of device problems, but may also facilitate disease management. The aim of this study was to provide a comprehensive overview of the clinical interventions taken based on remote monitoring. This is a single centre observational study of consecutive CRT patients (n = 192) participating in protocol-driven remote follow-up. Incoming technical- and disease-related alerts were analysed together with subsequently triggered interventions. During 34 ± 13 months of follow-up, 1372 alert-containing notifications were received (2.53 per patient-year of follow-up), comprising 1696 unique alerts (3.12 per patient-year of follow-up). In 60%, notifications resulted in a phone contact. Technical alerts constituted 8% of incoming alerts (0.23 per patient-year of follow-up). Rhythm (1.43 per patient-year of follow-up) and bioimpedance alerts (0.98 per patient-year of follow-up) were the most frequent disease-related alerts. Notifications included a rhythm alert in 39%, which triggered referral to the emergency room (4%), outpatient cardiology clinic (36%) or general practitioner (7%), or resulted in medication changes (13%). Sole bioimpedance notifications resulted in a telephone contact in 91%, which triggered outpatient evaluation in 8% versus medication changes in 10%. Clinical outcome was excellent with 97% 1-year survival. Remote CRT follow-up resulted in 0.23 technical- versus 2.64 disease-related alerts annually. Rhythm and bioimpedance notifications constituted the majority of incoming notifications which triggered an actual intervention in 22% and 15% of cases, respectively.

  16. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ...: General Requirements for Safety-- Collateral Standard: Electromagnetic Compatibility--Requirements and... electromagnetic compatibility and electrical safety. Firms are now exempt from 510(k) requirements for vertical... Equipment--Part 1-2: General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility...

  17. 21 CFR 862.1365 - Glutathione test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

  18. 21 CFR 862.1365 - Glutathione test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

  19. 21 CFR 862.1365 - Glutathione test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

  20. 21 CFR 821.1 - Scope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... patient. Effective tracking of devices from the manufacturing facility, through the distributor network..., and licensed practitioners) and, ultimately, to the patient is necessary for the effectiveness of remedies prescribed by the act, such as patient notification (section 518(a) of the act) or device recall...

  1. 21 CFR 821.1 - Scope.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... patient. Effective tracking of devices from the manufacturing facility, through the distributor network..., and licensed practitioners) and, ultimately, to the patient is necessary for the effectiveness of remedies prescribed by the act, such as patient notification (section 518(a) of the act) or device recall...

  2. 21 CFR 821.1 - Scope.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... patient. Effective tracking of devices from the manufacturing facility, through the distributor network..., and licensed practitioners) and, ultimately, to the patient is necessary for the effectiveness of remedies prescribed by the act, such as patient notification (section 518(a) of the act) or device recall...

  3. Ambulatory Seizure Monitoring: From Concept to Prototype Device.

    PubMed

    Myers, Mark H; Threatt, Madeline; Solies, Karsten M; McFerrin, Brent M; Hopf, Lindsey B; Birdwell, J Douglas; Sillay, Karl A

    2016-07-01

    The brain, made up of billions of neurons and synapses, is the marvelous core of human thought, action and memory. However, if neuronal activity manifests into abnormal electrical activity across the brain, neural behavior may exhibit synchronous neural firings known as seizures. If unprovoked seizures occur repeatedly, a patient may be diagnosed with epilepsy. The scope of this project is to develop an ambulatory seizure monitoring system that can be used away from a hospital, making it possible for the user to stay at home, and primary care personnel to monitor a patient's seizure activity in order to provide deeper analysis of the patient's condition and apply personalized intervention techniques. The ambulatory seizure monitoring device is a research device that has been developed with the objective of acquiring a portable, clean electroencephalography (EEG) signal and transmitting it wirelessly to a handheld device for processing and notification. This device is comprised of 4 phases: acquisition, transmission, processing and notification. During the acquisition stage, the EEG signal is detected using EEG electrodes; these signals are filtered and amplified before being transmitted in the second stage. The processing stage encompasses the signal processing and seizure prediction. A notification is sent to the patient and designated contacts, given an impending seizure. Each of these phases is comprised of various design components, hardware and software. The experimental findings illustrate that there may be a triggering mechanism through the phase lock value method that enables seizure prediction. The device addresses the need for long-term monitoring of the patient's seizure condition in order to provide the clinician a better understanding of the seizure's duration and frequency and ultimately provide the best remedy for the patient.

  4. Ambulatory Seizure Monitoring: From Concept to Prototype Device

    PubMed Central

    Myers, Mark H.; Threatt, Madeline; Solies, Karsten M.; McFerrin, Brent M.; Hopf, Lindsey B.; Birdwell, J. Douglas; Sillay, Karl A.

    2016-01-01

    Background The brain, made up of billions of neurons and synapses, is the marvelous core of human thought, action and memory. However, if neuronal activity manifests into abnormal electrical activity across the brain, neural behavior may exhibit synchronous neural firings known as seizures. If unprovoked seizures occur repeatedly, a patient may be diagnosed with epilepsy. Purpose The scope of this project is to develop an ambulatory seizure monitoring system that can be used away from a hospital, making it possible for the user to stay at home, and primary care personnel to monitor a patient's seizure activity in order to provide deeper analysis of the patient's condition and apply personalized intervention techniques. Methods The ambulatory seizure monitoring device is a research device that has been developed with the objective of acquiring a portable, clean electroencephalography (EEG) signal and transmitting it wirelessly to a handheld device for processing and notification. Result This device is comprised of 4 phases: acquisition, transmission, processing and notification. During the acquisition stage, the EEG signal is detected using EEG electrodes; these signals are filtered and amplified before being transmitted in the second stage. The processing stage encompasses the signal processing and seizure prediction. A notification is sent to the patient and designated contacts, given an impending seizure. Each of these phases is comprised of various design components, hardware and software. The experimental findings illustrate that there may be a triggering mechanism through the phase lock value method that enables seizure prediction. Conclusion The device addresses the need for long-term monitoring of the patient's seizure condition in order to provide the clinician a better understanding of the seizure's duration and frequency and ultimately provide the best remedy for the patient. PMID:27647960

  5. Selected Aspects of the eCall Emergency Notification System

    NASA Astrophysics Data System (ADS)

    Kaminski, Tomasz; Nowacki, Gabriel; Mitraszewska, Izabella; Niezgoda, Michał; Kruszewski, Mikołaj; Kaminska, Ewa; Filipek, Przemysław

    2012-02-01

    The article describes problems associated with the road collision detection for the purpose of the automatic emergency call. At the moment collision is detected, the eCall device installed in the vehicle will automatically make contact with Emergency Notification Centre and send the set of essential information on the vehicle and the place of the accident. To activate the alarm, the information about the deployment of the airbags will not be used, because connection of the eCall device might interfere with the vehicle’s safety systems. It is necessary to develop a method enabling detection of the road collision, similar to the one used in airbag systems, and based on the signals available from the acceleration sensors.

  6. 75 FR 10294 - Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-05

    ...] Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension...). In the notice, FDA requested comments on a number of identified challenges associated with the 510(k... premarket notification (or 510(k)) process for the review of medical devices. Specific questions for comment...

  7. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  8. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  9. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  10. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  11. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  12. 21 CFR 807.95 - Confidentiality of information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...: (1) Where the device is on the market, i.e., introduced or delivered for introduction into interstate commerce for commercial distribution; (2) Where the person submitting the premarket notification submission has disclosed, through advertising or any other manner, his intent to market the device to scientists...

  13. Field Tests of a Tractor Rollover Detection and Emergency Notification System.

    PubMed

    Liu, B; Koc, A B

    2015-04-01

    The objective of this research was to assess the feasibility of a rollover detection and emergency notification system for farm tractors using field tests. The emergency notification system was developed based on a tractor stability model and implemented on a mobile electronic device with the iOS operating system. A complementary filter was implemented to combine the data from the accelerometer and gyroscope sensors to improve their accuracies in calculating the roll and pitch angles and the roll and pitch rates. The system estimates a stability index value during tractor operation, displays feedback messages when the stability index is lower than a preset threshold value, and transmits emergency notification messages when an overturn happens. Ten tractor rollover tests were conducted on a field track. The developed system successfully monitored the stability of the tractor during all of the tests. The iOS application was able to detect rollover accidents and transmit emergency notifications in the form of a phone call and email when an accident was detected. The system can be a useful tool for training and education in safe tractor operation. The system also has potential for stability monitoring and emergency notification of other on-road and off-road motorized vehicles.

  14. Healthcare Blockchain System Using Smart Contracts for Secure Automated Remote Patient Monitoring.

    PubMed

    Griggs, Kristen N; Ossipova, Olya; Kohlios, Christopher P; Baccarini, Alessandro N; Howson, Emily A; Hayajneh, Thaier

    2018-06-06

    As Internet of Things (IoT) devices and other remote patient monitoring systems increase in popularity, security concerns about the transfer and logging of data transactions arise. In order to handle the protected health information (PHI) generated by these devices, we propose utilizing blockchain-based smart contracts to facilitate secure analysis and management of medical sensors. Using a private blockchain based on the Ethereum protocol, we created a system where the sensors communicate with a smart device that calls smart contracts and writes records of all events on the blockchain. This smart contract system would support real-time patient monitoring and medical interventions by sending notifications to patients and medical professionals, while also maintaining a secure record of who has initiated these activities. This would resolve many security vulnerabilities associated with remote patient monitoring and automate the delivery of notifications to all involved parties in a HIPAA compliant manner.

  15. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  16. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  17. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  18. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  19. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  20. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  1. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  2. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  3. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  4. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  5. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  6. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  7. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  8. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  9. 40 CFR 63.5180 - What reports must I submit?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 63.9(e) if you are complying with the emission standard using a control device. This notification and... specified in § 63.10(d)(2) if you are using a control device to comply with the emission standards and you..., shutdown, and malfunction reports as specified in § 63.10(d)(5) if you use a control device to comply with...

  10. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... for Safety--Collateral Standard: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and Stairway Chair Lifts'') must validate electromagnetic...: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and...

  11. 21 CFR 862.1720 - Triose phosphate isomerase test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

  12. 21 CFR 862.1720 - Triose phosphate isomerase test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

  13. 21 CFR 862.1720 - Triose phosphate isomerase test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

  14. 40 CFR 63.11397 - What General Provisions apply to this subpart?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Fibers Production Area Sources Other Requirements and Information § 63.11397 What General Provisions... vent system and control device, flare, or recovery device), fiber spinning line, AN storage tank..., your notification of compliance status required by § 63.9(h) must include the following information: (1...

  15. 40 CFR 63.11397 - What General Provisions apply to this subpart?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Fibers Production Area Sources Other Requirements and Information § 63.11397 What General Provisions... vent system and control device, flare, or recovery device), fiber spinning line, AN storage tank..., your notification of compliance status required by § 63.9(h) must include the following information: (1...

  16. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  17. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  18. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  19. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  20. 77 FR 7591 - Request for Notification From Consumer Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    .... Assurance--Knowledgeable in clinical practice, research specialization, or professional work that has a significant focus on mammography. Certain Panels of the Medical Devices Advisory Committee Clinical Chemistry... chemistry and toxicology in vitro diagnostic devices (IVDs); clinical use of related IVDs in laboratories...

  1. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  2. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  3. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  4. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  5. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  6. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  7. 21 CFR 810.10 - Cease distribution and notification order.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., including, where known: (i) The brand name of the device; (ii) The common name, classification name, or...) A copy of any written communication used by the person named in the order to notify health professionals and device user facilities; (7) A proposed strategy for complying with the cease distribution and...

  8. 21 CFR 810.10 - Cease distribution and notification order.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., including, where known: (i) The brand name of the device; (ii) The common name, classification name, or...) A copy of any written communication used by the person named in the order to notify health professionals and device user facilities; (7) A proposed strategy for complying with the cease distribution and...

  9. 21 CFR 810.10 - Cease distribution and notification order.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., including, where known: (i) The brand name of the device; (ii) The common name, classification name, or...) A copy of any written communication used by the person named in the order to notify health professionals and device user facilities; (7) A proposed strategy for complying with the cease distribution and...

  10. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and... devices that have established safety and effectiveness profiles and for which it believes 510(k) review is... 510(k) requirement through rulemaking that would reclassify the Class II devices and amend the...

  11. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  12. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  13. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  14. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  15. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  16. 21 CFR 807.81 - When a premarket notification submission is required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II. (2..., chemical composition, energy source, or manufacturing process. (ii) A major change or modification in the...

  17. 40 CFR 63.3000 - What notifications and reports must I submit?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... reporting period. (v) The date of the latest continuous parameter monitoring system certification or audit... parameter monitoring system, or add-on control device since the last semiannual reporting period. (4) No...-on control devices no later than 60 days after completing the tests as specified in § 63.10(d)(2...

  18. 21 CFR 830.110 - Application for accreditation as an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency.... (1) An applicant seeking initial FDA accreditation as an issuing agency shall notify FDA of its desire to be accredited by sending a notification by email to [email protected]fda.hhs.gov, or by correspondence to...

  19. 21 CFR 864.3300 - Cytocentrifuge.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  20. 21 CFR 864.3300 - Cytocentrifuge.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  1. 21 CFR 862.1560 - Urinary phenylketones (nonquantitative) test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  2. 21 CFR 872.3220 - Facebow.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... for use in denture fabrication to determine the spatial relationship between the upper and lower jaws.... Class I (general controls). The device is exempt from the premarket notification procedures in subpart E...

  3. 21 CFR 880.5475 - Jet lavage.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

  4. 21 CFR 880.5475 - Jet lavage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

  5. 21 CFR 886.3800 - Scleral shell.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  6. 21 CFR 886.3800 - Scleral shell.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  7. 21 CFR 886.3800 - Scleral shell.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  8. 21 CFR 874.1800 - Air or water caloric stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... vestibular function testing of a patient's body balance system. The vestibular stimulation of the...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  9. 21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

  10. 21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

  11. 21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

  12. 40 CFR 63.11564 - What are my notification, recordkeeping, and reporting requirements?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) through (b)(4) of this section. (1) If you are using a control device to comply with the emission limits... mixers, coaters). If you are not using a control device to comply with the emission limits, the... brief description of the CPMS. (xi) The date of the latest CPMS certification or audit. (xii) A...

  13. 40 CFR 63.11585 - What are my notification, recordkeeping, and reporting requirements?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... of the bag leak detector, parameter monitor, or CPMS. (ix) If a CPMS is used, the date of the latest...) Records of all inspections as required by § 63.11584(b) and pressure measurement device checks (if... according to § 63.11583(f). (viii) Records of particulate control device manufacturing specifications and...

  14. 40 CFR 63.4530 - What records must I keep?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Standards for Hazardous Air Pollutants for Surface Coating of Plastic Parts and Products Notifications... mass of organic HAP emission reduction by emission capture systems and add-on control devices using...

  15. 21 CFR 868.1575 - Gas collection vessel.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... for subsequent analysis. It does not include a sampling pump. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  16. 21 CFR 876.5160 - Urological clamp for males.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... temporarily. It is an external clamp. (b) Classification. Class I (general controls). Except when intended for internal use or use on females, the device is exempt from the premarket notification procedures in subpart...

  17. 21 CFR 876.4480 - Electrohydraulic lithotriptor.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode... special control for this device is FDA's “Guidance for the Content of Premarket Notifications for...

  18. 21 CFR 876.4480 - Electrohydraulic lithotriptor.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode... special control for this device is FDA's “Guidance for the Content of Premarket Notifications for...

  19. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  20. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  1. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  2. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  3. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  4. Regulatory issues relating to therapies for periodontal regeneration.

    PubMed

    Singleton, D G; Torres-Cabassa, A

    1997-03-01

    The Food and Drug Administration (FDA) has regulated medical devices since May 1976, when the Medical Device Amendments were enacted. The clinical trial requirements for the marketing of periodontal regeneration devices have been dependent, in part, on the degree of their similarity to devices marketed prior to the legislative enactment date in terms of materials, indication statements, and labeling claims. Nonresorbable barriers were allowed to be marketed based on their equivalence to devices marketed prior to the enactment date based on biocompatability and clinical trial data under the premarket notification requirements section of the law. Bone filling materials such as hydroxyapatite were first marketed based on the finding of equivalence to predicate devices. Newer technologies such as bioabsorbable barriers have also been reviewed under the premarket notification provisions of the law, but manufacturers have been required to provide more extensive safety and effectiveness data to establish equivalence to pre-Amendments devices. Data to answer questions related to the potential toxicity of breakdown products, period of absorption, and ultimate clinical effectiveness needed to be answered prior to marketing. New devices that incorporate technologies that are not substantially equivalent to predicate devices must proceed through the premarket approval route to marketing. For new devices considered a potential significant risk to the patient population, clinical trials are conducted via the investigational device exemption (IDE) requirements that specify the means by which trials will proceed in order to protect the rights of patients. New devices of organic origin, such as bone morphogenic protein, have followed the premarket approval route with IDE requirements instituted as a condition for their path to the marketplace. Issues associated with immediate and long-term contact including potential toxicity, tumorigenicity, and sensitization need to be addressed with appropriate animal models.

  5. 21 CFR 888.4800 - Template for clinical use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... cutting. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. [52 FR...

  6. Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.

    PubMed

    Tazawa, Yoshiaki

    2016-01-01

    On July 1st, 2013, the Ministry of Health, Labor and Welfare (MHLW) issued an official notification regarding the co-development of companion diagnostics (CDx) with a drug which requires any exclusive diagnostic test or medical device to predict efficacy or adverse reactions to the drug. The main frame and contents in the MHLW's notification are quite similar to the summaries in the final guidance issued by the US Food and Drug Administration (FDA) on August 6th, 2014 Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic Devices, [2014] ), and these recommend industries to develop, study and submit CDx and the corresponding drug contemporaneously as much as possible. Following the MHLW's notification, the Pharmaceutical and Medical Device Agency (PMDA) notified on December 26th, 2013, "the technical guidance for co-development of CDx and the drug" that mentioned the regulatory requirements for clinical trial of the drug and CDx as well as analytical validity of CDx required for the trials. These official notifications from the Ministry and the Agency may be useful for pharmaceutical and diagnostics makers to understand how they should co-develop and validate CDx for clinical trials and regulatory submission. However, since the most anticipated technologies such as the next generation sequencer (NGS) are more complex and its medical risks could be high level, the existing regulatory system focusing on only diagnostics reagents and devices that are developed and manufactured by in vitro diagnostics (IVD) makers may be no longer suitable for the characteristics of CDx for the future.As an increase of clinical needs for multiple biomarkers assay by DNA sequencer, on November 19th, 2013, the FDA cleared 510 K for NGS and its universal kit. On October 3rd, 2014, moreover, the agency notified two drafts of guidance (Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), [2014]; Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDT), [2014]) for oversight of laboratory developed tests (LDTs) with medium or high medical risks. These FDA's strategic decisions and new regulatory frameworks may allow the clinical laboratories to develop and perform more easily NGS-based CDx under the certification of Clinical Laboratory Improvement Amendments (CLIA). However, neither law nor regulated quality management system similar to the CLIA exists in Japan. To effectively validate LDTs and NGS for medical practice, Japan should learn more the current regulatory changes and initiatives in the US, as well as to reform the regulatory frameworks and create any regulated quality management system for clinical laboratory testing to be reimbursed.

  7. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... provides industry and agency staff with updated recommendations concerning 510(k) submissions for various... will be relevant for premarket notification (510(k)) submissions for these device types. Detection...

  8. Home security system using internet of things

    NASA Astrophysics Data System (ADS)

    Anitha, A.

    2017-11-01

    IoT refers to the infrastructure of connected physical devices which is growing at a rapid rate as huge number of devices and objects are getting associated to the Internet. Home security is a very useful application of IoT and we are using it to create an inexpensive security system for homes as well as industrial use. The system will inform the owner about any unauthorized entry or whenever the door is opened by sending a notification to the user. After the user gets the notification, he can take the necessary actions. The security system will use a microcontroller known as Arduino Uno to interface between the components, a magnetic Reed sensor to monitor the status, a buzzer for sounding the alarm, and a WiFi module, ESP8266 to connect and communicate using the Internet. The main advantages of such a system includes the ease of setting up, lower costs and low maintenance.

  9. A home automation based environmental sound alert for people experiencing hearing loss.

    PubMed

    Mielke, Matthias; Bruck, Rainer

    2016-08-01

    Different assistive technologies are available for deaf people (i.e. deaf, deafened, and hard of hearing). Besides the well-known hearing aid, devices for detection of sound events that occur at home or at work (e.g. doorbell, telephone) are available. Despite the technological progress in the last years and resulting new possibilities, the basic functions and concepts of such devices have not changed. The user still needs special assistive technology that is bound to the home or work environment. In this contribution a new concept for awareness of events in buildings is presented. In contrast to state-of-the-art assistive devices, it makes use of modern Information and Communication and home automation technology, and thus offers the prospect of cheap implementation and higher comfort for the user. In this concept events are indicated by notifications that are send over a Bluetooth Low Energy mesh network from a source to the user. The notifications are received by the user's smartwatch and the event is indicated by vibration and an icon representing its source.

  10. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics... applicable to all devices reviewed through the 510(k) notification process in CDRH and CBER and have been... draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is...

  11. 77 FR 21621 - Meeting of Notification of Citizens Coinage Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-10

    ... coin legends, mottos, dates, symbols and devices. Interested Persons Should Call the CCAC HOTLINE at (202) 354-7502 for the Latest Update on Meeting Time and Room Location In accordance with 31 U.S.C...

  12. [Analysis of an incident notification system and register in a critical care unit].

    PubMed

    Murillo-Pérez, M A; García-Iglesias, M; Palomino-Sánchez, I; Cano Ruiz, G; Cuenca Solanas, M; Alted López, E

    2016-01-01

    To analyse the incident communicated through a notification system and register in a critical care unit. A cross-sectional descriptive study was conducted by performing an analysis of the records of incidents communicated anonymously and voluntarily from January 2007 to December 2013 in a critical care unit of adult patients with severe trauma. incident type and class, professional reports, and suggestions for improvement measures. A descriptive analysis was performed on the variables. Out of a total of 275 incidents reported, 58.5% of them were adverse events. Incident distributed by classes: medication, 33.7%; vascular access-drainage-catheter-sensor, 19.6%; devices-equipment, 13.3%, procedures, 11.5%; airway tract and mechanical ventilation, 10%; nursing care, 4.1%; inter-professional communication, 3%; diagnostic test, 3%; patient identification, 1.1%, and transfusion 0.7%. In the medication group, administrative errors accounted for a total of 62%; in vascular access-drainage-catheter-sensor group, central venous lines, a total of 27%; in devices and equipment group, respirators, a total of 46.9%; in airway self-extubations, a total of 32.1%. As regards to medication errors, 62% were incidents without damage. Incident notification by profession: doctors, 43%, residents, 5.6%, nurses, 51%, and technical assistants, 0.4%. Adverse events are the most communicated incidents. The events related to medication administration are the most frequent, although most of them were without damage. Nurses and doctors communicate the incidents with the same frequency. In order to highlight the low incident notification despite it being an anonymous and volunteer system, therefore, it is suggested to study measurements to increase the level of communication. Copyright © 2016 Elsevier España, S.L.U. y SEEIUC. All rights reserved.

  13. Food and Drug Administration Regulation of in Vitro Diagnostic Devices

    PubMed Central

    Mansfield, Elizabeth; O’Leary, Timothy J.; Gutman, Steven I.

    2005-01-01

    The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation. PMID:15681468

  14. 40 CFR 63.8480 - What notifications must I submit and when?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... establish the values. (ii) For each APCD that includes a fabric filter, if a bag leak detection system is... specifications for bag leak detection systems in § 63.8450(e). (f) If you request a routine control device...

  15. Communication latencies of Apple push notification messages relevant for delivery of time-critical information to anesthesia providers.

    PubMed

    Rothman, Brian S; Dexter, Franklin; Epstein, Richard H

    2013-08-01

    Tablet computers and smart phones have gained popularity in anesthesia departments for educational and patient care purposes. VigiVU(™) is an iOS application developed at Vanderbilt University for remote viewing of perioperative information, including text message notifications delivered via the Apple Push Notification (APN) service. In this study, we assessed the reliability of the APN service. Custom software was written to send a message every minute to iOS devices (iPad(®), iPod Touch(®), and iPhone(®)) via wireless local area network (WLAN) and cellular pathways 24 hours a day over a 4-month period. Transmission and receipt times were recorded and batched by days, with latencies calculated as their differences. The mean, SEM, and the exact 95% upper confidence limits for the percent of days with ≥1 prolonged (>100 seconds) latency were calculated. Acceptable performance was defined as mean latency <30 seconds and ≤0.5% of latencies >100 seconds. Testing conditions included fixed locations of devices in high signal strength locations. Mean latencies were <1 second for iPad and iPod devices (WLAN), and <4 seconds for iPhone (cellular). Among >173,000 iPad and iPod latencies, none were >100 seconds. For iPhone latencies, 0.03% ± 0.01% were >100 seconds. The 95% upper confidence limits of days with ≥1 prolonged latency were 42% (iPhone) and 5% to 8% (iPad, iPod). The APN service was reliable for all studied devices over WLAN and cellular pathways, and performance was better than third party paging systems using Internet connections previously investigated using the same criteria. However, since our study was a best-case assessment, testing is required at individual sites considering use of this technology for critical messaging. Furthermore, since the APN service may fail due to Internet or service provider disruptions, a backup paging system is recommended if the APN service were to be used for critical messaging.

  16. Remote monitoring of a Fire Protection System

    NASA Astrophysics Data System (ADS)

    Bauman, Steven; Vermeulen, Tom; Roberts, Larry; Matsushige, Grant; Gajadhar, Sarah; Taroma, Ralph; Elizares, Casey; Arruda, Tyson; Potter, Sharon; Hoffman, James

    2011-03-01

    Some years ago CFHT proposed developing a Remote Observing Environment aimed at producing Science Observations at their Observatory Facility on Mauna Kea from their Headquarters facility in Waimea, HI. This Remote Observing Project commonly referred to as OAP (Observatory Automation Project) was completed at the end of January 2011 and has been providing the majority of Science Data since. My poster will discuss the upgrades to the existing fire alarm protection system. With no one at the summit during nightly operations, the observatory facility required automated monitoring of the facility for safety to personnel and equipment in the case of a fire. An addressable analog fire panel was installed which utilizes digital communication protocol (DCP), intelligent communication with other devices, and an RS-232 interface which provides feedback and real-time monitoring of the system. Using the interface capabilities of the panel, it provides notifications when heat detectors, smoke sensors, manual pull stations, or the main observatory computer room fire suppression system has been activated. The notifications are sent out as alerts to staff in the form of test massages and emails and the observing control GUI interface alerts the remote telescope operator with a map showing the location of the fire occurrence and type of device that has been triggered. And all of this was accomplished without the need for an outside vendor to monitor the system and facilitate warnings or notifications regarding the system.

  17. 40 CFR 63.129 - Transfer operations provisions-reporting and recordkeeping for performance tests and notification...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... or TOC achieved by the control device determined as specified in § 63.128(a) of this subpart, or the concentration of total organic HAP or TOC (parts per million by volume, by compound) determined as specified in...

  18. 77 FR 73035 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also... in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a...

  19. Therapeutic Devices for Epilepsy

    PubMed Central

    Fisher, Robert S.

    2011-01-01

    Therapeutic devices provide new options for treating drug-resistant epilepsy. These devices act by a variety of mechanisms to modulate neuronal activity. Only vagus nerve stimulation, which continues to develop new technology, is approved for use in the United States. Deep brain stimulation (DBS) of anterior thalamus for partial epilepsy recently was approved in Europe and several other countries. Responsive neurostimulation, which delivers stimuli to one or two seizure foci in response to a detected seizure, recently completed a successful multicenter trial. Several other trials of brain stimulation are in planning or underway. Transcutaneous magnetic stimulation (TMS) may provide a noninvasive method to stimulate cortex. Controlled studies of TMS split on efficacy, and may depend on whether a seizure focus is near a possible region for stimulation. Seizure detection devices in the form of “shake” detectors via portable accelerometers can provide notification of an ongoing tonic-clonic seizure, or peace of mind in the absence of notification. Prediction of seizures from various aspects of EEG is in early stages. Prediction appears to be possible in a subpopulation of people with refractory seizures and a clinical trial of an implantable prediction device is underway. Cooling of neocortex or hippocampus reversibly can attenuate epileptiform EEG activity and seizures, but engineering problems remain in its implementation. Optogenetics is a new technique that can control excitability of specific populations of neurons with light. Inhibition of epileptiform activity has been demonstrated in hippocampal slices, but use in humans will require more work. In general, devices provide useful palliation for otherwise uncontrollable seizures, but with a different risk profile than with most drugs. Optimizing the place of devices in therapy for epilepsy will require further development and clinical experience. PMID:22367987

  20. Unified web-based network management based on distributed object orientated software agents

    NASA Astrophysics Data System (ADS)

    Djalalian, Amir; Mukhtar, Rami; Zukerman, Moshe

    2002-09-01

    This paper presents an architecture that provides a unified web interface to managed network devices that support CORBA, OSI or Internet-based network management protocols. A client gains access to managed devices through a web browser, which is used to issue management operations and receive event notifications. The proposed architecture is compatible with both the OSI Management reference Model and CORBA. The steps required for designing the building blocks of such architecture are identified.

  1. 21 CFR 866.5735 - Prothrombin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  2. 78 FR 70531 - Foreign-Trade Zone (FTZ) 93-Raleigh/Durham, North Carolina; Notification of Proposed Production...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-26

    .... The finished products include devices such as respiratory placebo inhalers, Relenza anti-viral inhalers, Seretide/Advair, Serevent and Flovent diskus respiratory inhalers, Advair and Ventolin HFA respiratory inhalers, and the following tablets and capules--Lovaza antihyperlipidemic, Paxil depression...

  3. 21 CFR 1.101 - Notification and recordkeeping.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... products and devices regulated by the Center for Biologics Evaluation and Research—Division of Case... Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. (ii) For... Research—Division of New Drugs and Labeling Compliance, Center for Drug Evaluation and Research, Food and...

  4. 21 CFR 1.101 - Notification and recordkeeping.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... products and devices regulated by the Center for Biologics Evaluation and Research—Division of Case... Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. (ii) For... Research—Division of New Drugs and Labeling Compliance, Center for Drug Evaluation and Research, Food and...

  5. 40 CFR 63.2382 - What notifications must I submit and when and what information should be submitted?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... sampling and analysis procedures and quality assurance procedures. (iii) Descriptions of monitoring devices... ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS... compliance assessments, inspections and repairs, and calculations used to demonstrate initial compliance...

  6. Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial

    PubMed Central

    Atukunda, Esther C; Tumuhimbise, Wilson; Pisarski, Emily E; Tam, Melanie; Wyatt, Monique A; Ware, Norma C; Haberer, Jessica E

    2018-01-01

    Background Wireless electronic adherence monitors can detect antiretroviral therapy (ART) adherence lapses and trigger interventions in real time, thus potentially avoiding unnecessary HIV viremia. Evidence about the acceptability and feasibility of these monitors and associated interventions, however, is limited. Objective The aim of this study was to assess the acceptability and feasibility of real-time adherence monitoring linked to text messaging (short message service, SMS) reminders and notifications to support adherence among individuals living with HIV who are taking ART in rural southwestern Uganda. Methods Individuals living with HIV who were initiating ART were enrolled in a pilot randomized controlled trial and followed up for 9 months. Participants received a real-time adherence monitor and were randomized to one of the following study arms: (1) scheduled SMS, (2) SMS triggered by missed or delayed doses, or (3) no SMS. SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses in the scheduled SMS and triggered SMS arms. Study participants and social supporters participated in qualitative semistructured in-depth interviews on acceptability and feasibility of this technology. An inductive, content analytic approach, framed by the unified theory of acceptance and use of technology model, was used to analyze qualitative data. Quantitative feasibility data, including device functionality and SMS tracking data, were recorded based upon device metrics collected electronically and summarized descriptively. Results A total of 63 participants participated in the study. Participants reported that real-time monitoring intervention linked to SMS reminders and notifications are generally acceptable; the predominant feedback was perceived utility—the intervention was beneficial in motivating and reminding patients to take medication, as well as enabling provision of social support. The intervention was found to be technically feasible, as data were obtained from most participants as expected most of the time. Potential challenges included the impact of the technology on confidentiality, shared phone ownership, usability skills, and availability of electricity. Conclusions Real-time adherence monitoring integrated with SMS reminders and social support notifications is a generally acceptable (based primarily on perceived utility) and feasible intervention in a resource-limited country. Future efforts should focus on optimized device design, user training to overcome the challenges we encountered, cost effectiveness studies, as well as studying the monitoring aspect of the device without accompanying interventions. Trial Registration ClinicalTrials.gov NCT01957865; https://clinicaltrials.gov/ct2/show/NCT01957865 (Archived by WebCite at http://www.webcitation.org/6zFiDlXDa) PMID:29773527

  7. 78 FR 37203 - Authorization of Production Activity; Subzone 196A; TTI, Inc. (Electromechanical and Circuit...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-20-2013] Authorization of Production Activity; Subzone 196A; TTI, Inc. (Electromechanical and Circuit Protection Devices Production/Kitting); Fort Worth, Texas On February 13, 2013, TTI, Inc. submitted a notification of proposed production activity to the...

  8. 40 CFR 65.164 - Performance test and flare compliance determination notifications and reports.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONSOLIDATED FEDERAL AIR RULE Closed Vent Systems, Control Devices, and Routing to a Fuel Gas System or a Process § 65.164 Performance test and flare... complete test report shall include a brief process description, sampling site description, description of...

  9. 49 CFR 234.269 - Cut-out circuits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... EMERGENCY NOTIFICATION SYSTEMS Maintenance, Inspection, and Testing Inspections and Tests § 234.269 Cut-out... overrides the operation of automatic warning systems. This includes both switch cut-out circuits and devices... 49 Transportation 4 2013-10-01 2013-10-01 false Cut-out circuits. 234.269 Section 234.269...

  10. 49 CFR 234.269 - Cut-out circuits.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... EMERGENCY NOTIFICATION SYSTEMS Maintenance, Inspection, and Testing Inspections and Tests § 234.269 Cut-out... overrides the operation of automatic warning systems. This includes both switch cut-out circuits and devices... 49 Transportation 4 2014-10-01 2014-10-01 false Cut-out circuits. 234.269 Section 234.269...

  11. 49 CFR 234.269 - Cut-out circuits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... EMERGENCY NOTIFICATION SYSTEMS Maintenance, Inspection, and Testing Inspections and Tests § 234.269 Cut-out... overrides the operation of automatic warning systems. This includes both switch cut-out circuits and devices... 49 Transportation 4 2012-10-01 2012-10-01 false Cut-out circuits. 234.269 Section 234.269...

  12. 21 CFR 56.102 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... approval of a medical device for human use, described in section 515 of the act. (16) A product development... an infant formula when submitted as part of an infant formula notification under section 412(c) of....70 of this chapter. (23) Data and information from investigations involving children submitted in a...

  13. 21 CFR 56.102 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... approval of a medical device for human use, described in section 515 of the act. (16) A product development... an infant formula when submitted as part of an infant formula notification under section 412(c) of....70 of this chapter. (23) Data and information from investigations involving children submitted in a...

  14. 21 CFR 50.3 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

  15. 21 CFR 50.3 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

  16. 21 CFR 56.102 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... approval of a medical device for human use, described in section 515 of the act. (16) A product development... an infant formula when submitted as part of an infant formula notification under section 412(c) of....70 of this chapter. (23) Data and information from investigations involving children submitted in a...

  17. 21 CFR 56.102 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... approval of a medical device for human use, described in section 515 of the act. (16) A product development... an infant formula when submitted as part of an infant formula notification under section 412(c) of....70 of this chapter. (23) Data and information from investigations involving children submitted in a...

  18. 21 CFR 56.102 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... approval of a medical device for human use, described in section 515 of the act. (16) A product development... an infant formula when submitted as part of an infant formula notification under section 412(c) of....70 of this chapter. (23) Data and information from investigations involving children submitted in a...

  19. 21 CFR 50.3 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

  20. 21 CFR 50.3 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

  1. 21 CFR 50.3 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

  2. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  3. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  4. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  5. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  6. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  7. Think Visual

    ERIC Educational Resources Information Center

    Thomas, Lisa Carlucci

    2012-01-01

    Photographs tell a story and illustrate an experience more profoundly than words alone. Real-time, text-based communication is an increasingly normal part of daily life as mobile devices and social networks proliferate. Yet, in the steady stream of tweets, comments, status updates, notifications, and e-mail, the details are easily lost in the…

  8. 21 CFR 25.50 - General information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General information. 25.50 Section 25.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENVIRONMENTAL IMPACT... notifications for human drugs, animal drugs, biologic products, and devices are protected from disclosure under...

  9. 21 CFR 20.100 - Applicability; cross-reference to other regulations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of this chapter. (25) Cosmetic establishment registrations, in § 710.7 of this chapter. (26) Cosmetic product ingredient and cosmetic raw material composition statements, § 720.8 of this chapter. (27) Cosmetic product experience reports, in § 730.7 of this chapter. (28) Device premarket notification...

  10. 21 CFR 20.100 - Applicability; cross-reference to other regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of this chapter. (25) Cosmetic establishment registrations, in § 710.7 of this chapter. (26) Cosmetic product ingredient and cosmetic raw material composition statements, § 720.8 of this chapter. (27) Cosmetic product experience reports, in § 730.7 of this chapter. (28) Device premarket notification...

  11. 40 CFR 51.371 - On-road testing.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... inspection; notification may be by mailing in the case of remote sensing on-road testing or through immediate... information about the performance of in-use vehicles, by measuring on-road emissions through the use of remote sensing devices or by assessing vehicle emission performance through roadside pullovers including tailpipe...

  12. 40 CFR 51.371 - On-road testing.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... inspection; notification may be by mailing in the case of remote sensing on-road testing or through immediate... information about the performance of in-use vehicles, by measuring on-road emissions through the use of remote sensing devices or by assessing vehicle emission performance through roadside pullovers including tailpipe...

  13. 40 CFR 51.371 - On-road testing.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... inspection; notification may be by mailing in the case of remote sensing on-road testing or through immediate... information about the performance of in-use vehicles, by measuring on-road emissions through the use of remote sensing devices or by assessing vehicle emission performance through roadside pullovers including tailpipe...

  14. 40 CFR 51.371 - On-road testing.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... inspection; notification may be by mailing in the case of remote sensing on-road testing or through immediate... information about the performance of in-use vehicles, by measuring on-road emissions through the use of remote sensing devices or by assessing vehicle emission performance through roadside pullovers including tailpipe...

  15. 77 FR 50057 - Premerger Notification; Reporting and Waiting Period Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

    ... statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. If you want... an exclusive license to all of B's patent rights for all veterinary indications. B retains all patent... veterinary indications is an asset acquisition because A is receiving all rights to the patent for a...

  16. 78 FR 14963 - Foreign-Trade Zone 163-Ponce, Puerto Rico; Authorization of Production Activity; Zimmer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-80-2012] Foreign-Trade Zone 163--Ponce, Puerto Rico; Authorization of Production Activity; Zimmer Manufacturing BV (Medical Devices); Ponce, Puerto... Subzone 163A, in Ponce, Puerto Rico. The notification was processed in accordance with the regulations of...

  17. 21 CFR 876.5820 - Hemodialysis system and accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop..., dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the...

  18. 47 CFR 10.240 - Notification to new subscribers of non-participation in WEA.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... part or in whole, shall provide clear and conspicuous notice, which takes into account the needs of... messages at the point-of-sale. (b) The point-of-sale includes stores, kiosks, third party reseller... emergency alert capable devices, please ask a sales representative, or go to [[CMS provider's URL

  19. 47 CFR 10.240 - Notification to new subscribers of non-participation in CMAS.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... CMAS Alert Messages, in part or in whole, shall provide clear and conspicuous notice, which takes into... to provide Alert messages at the point-of-sale. (b) The point-of-sale includes stores, kiosks, third... availability of this service and wireless emergency alert capable devices, please ask a sales representative...

  20. 47 CFR 10.240 - Notification to new subscribers of non-participation in WEA.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... part or in whole, shall provide clear and conspicuous notice, which takes into account the needs of... messages at the point-of-sale. (b) The point-of-sale includes stores, kiosks, third party reseller... emergency alert capable devices, please ask a sales representative, or go to [[CMS provider's URL

  1. 47 CFR 10.240 - Notification to new subscribers of non-participation in CMAS.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... CMAS Alert Messages, in part or in whole, shall provide clear and conspicuous notice, which takes into... to provide Alert messages at the point-of-sale. (b) The point-of-sale includes stores, kiosks, third... availability of this service and wireless emergency alert capable devices, please ask a sales representative...

  2. 78 FR 10574 - Premerger Notification; Reporting and Waiting Period Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ..., patterns, devices, manufacturing processes, or customer names. If you would like the Commission to give... service. Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release... of a tender offer under Sec. 801.30, that the intention to make the tender offer has been publicly...

  3. 76 FR 78930 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology... profiles and for which it believes 510(k) review is not necessary to assure safety and effectiveness. While FDA intends to exempt these devices from the 510(k) requirement through rulemaking that would...

  4. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will notify...

  5. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I must conduct postmarket surveillance? We will send you a letter (the postmarket surveillance order) notifying...

  6. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will notify...

  7. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I must conduct postmarket surveillance? We will send you a letter (the postmarket surveillance order) notifying...

  8. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will notify...

  9. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will notify...

  10. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I must conduct postmarket surveillance? We will send you a letter (the postmarket surveillance order) notifying...

  11. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I must conduct postmarket surveillance? We will send you a letter (the postmarket surveillance order) notifying...

  12. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I must conduct postmarket surveillance? We will send you a letter (the postmarket surveillance order) notifying...

  13. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will notify...

  14. [Industry regulation and its relationship to the rapid marketing of medical devices].

    PubMed

    Matsuoka, Atsuko

    2012-01-01

    In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

  15. Mycobacterium chimaera Infections Associated With Contaminated Heater-Cooler Devices for Cardiac Surgery: Outbreak Management.

    PubMed

    Marra, Alexandre R; Diekema, Daniel J; Edmond, Michael B

    2017-08-15

    The global outbreak of Mycobacterium chimaera infections associated with heater-cooler devices (HCDs) presents several important, unique challenges for the infection prevention community. The primary focus of this article is to assist hospitals in establishing a rapid response for identification, notification, and evaluation of exposed patients, and management of HCDs with regard to placement and containment, environmental culturing, and disinfection. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  16. Learning Messages Notification System to Mobile Devices

    ERIC Educational Resources Information Center

    Jimenez, M. Lourdes

    2005-01-01

    The work presents a new method to send educational messages in e-learning systems. The communication tools are one of the main characteristics of the virtual formative actions, in addition of the contents and the evaluation. The system must help to motivate the students, mainly those who do not leave the formative action and continue it until the…

  17. 75 FR 37520 - Bureau of Political-Military Affairs: Directorate of Defense Trade Controls; Notifications to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-29

    ... support the HYLAS 2 Commercial Communication Satellite Program of the United Kingdom. The United States... (Transmittal No. 10-002) Hon. Nancy Pelosi, Speaker of the House of Representatives Dear Madam Speaker... the C-130 Air Crew Training Device Program for end use by the Royal Saudi Air Force. The United States...

  18. 77 FR 40701 - Notification of Petition for Approval; Informational Filing and Request for Waiver

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-10

    ... of the work requires UP to design procure and install: 1. Cab signal fixed equipment in an initial... warning devices by passenger trains operating in excess of 79 mph. In addition, the two-way communications...; Section 235.5, Changes requiring filing of application; Section 240.127, Criteria for examining skill...

  19. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... Memorandum titled ``Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3,'' a... achieves its intended goals. In September 2009, FDA's Center for Devices and Radiological Health (CDRH... regarding the strengths and challenges associated with the 510(k) program. In August 2010, CDRH published...

  20. 21 CFR 807.92 - Content and format of a 510(k) summary.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

  1. 21 CFR 807.92 - Content and format of a 510(k) summary.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

  2. 21 CFR 807.92 - Content and format of a 510(k) summary.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

  3. 21 CFR 807.92 - Content and format of a 510(k) summary.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

  4. 21 CFR 807.92 - Content and format of a 510(k) summary.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

  5. The Centrifugal Simulation of Blast Parameters.

    DTIC Science & Technology

    1983-12-01

    a is to be experimentally evaluated. The terms that remain in Equation (1) are not nondimensional; that is, they are not true i-terms. This does not...If necessary and identify by block number This study is concerned with the use oT a centrifuge as an experimental device on which free-field blast...5 SIMILITUDE. .. .. ..... ...... ...... ... 9 Ill. EXPERIMENTAL PROCEDURES .. .. ... ...... ........13 INTRODUCTION

  6. 21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate? (a) If you do not agree with...

  7. 21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate? (a) If you do not agree with...

  8. 21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate? (a) If you do not agree with...

  9. Market surveillance of in vitro diagnostics by the BfArM until end 2010: how safe are products for tumor diagnostics?

    PubMed

    Siekmeier, R; Wetzel, D

    2013-01-01

    The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) regulates the marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field corrective actions the manufacturers have to inform the responsible Competent Authorities (CA). In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD. In this study all notifications regarding IVD (tests, calibrators, kits, and control materials, except laboratory analyzers) for tumor diagnostics received by the BfArM between begin 1999 until end of 2010 were analyzed. All notifications were analyzed in respect to the type of product, the source of notification, the underlying product defects and the corrective actions performed. In the observation period, a total of 2,851 notifications were received of which 84 were related to IVD for tumor diagnostics included in this study (clinical chemistry - 63, histology - 6, molecular biology - 3, rapid tests - 12). Reports were received from manufacturers (68 cases), CA (8 cases), users (4 cases) and other sources (4 cases). In the group of IVD based on clinical chemistry means, the affected products were mostly those for the measurement of prostate specific antigen (PSA, 14 cases), human chorion gonadotropine (13 cases), carcino embryonic antigen (6 cases), CA 19-9 (6 cases), α(1)-fetoprotein (6 cases) and CA 125 (5 cases), whereas in test strips 9 out of the 12 notifications were related to PSA. Investigations of the manufacturers were able to identify the underlying root causes of product failures in 66 cases (78.6%). In 10 cases (11.9%) the root cause remained unclear and in 6 cases and 2 cases (7.1% and 2.4%) a product failure was excluded or a user error was the underlying cause. Most common root causes of product failures were material defects (24 cases) and manufacturing errors (15 cases). Corrective actions were performed by the manufacturers in 64 cases (76.2%) and were predominantly (multiple entries possible) customer information (62 cases, mandatory in case of a recall), recalls (45 cases), modifications in production or quality management (45 cases) and design changes (14 cases). The obtained results suggest that the system for post marketing surveillance of IVD is an established tool to enhance product safety and provides valuable information on product specific problems serving for improvement of product safety.

  10. Method and device for detecting impact events on a security barrier which includes a hollow rebar allowing insertion and removal of an optical fiber

    DOEpatents

    Pies, Ross E.

    2016-03-29

    A method and device for the detection of impact events on a security barrier. A hollow rebar is farmed within a security barrier, whereby the hollow rebar is completely surrounded by the security barrier. An optical fiber passes through the interior of the hollow rebar. An optical transmitter and an optical receiver are both optically connected to the optical fiber and connected to optical electronics. The optical electronics are configured to provide notification upon the detection of an impact event at the security barrier based on the detection of disturbances within the optical fiber.

  11. Dispatching function calls across accelerator devices

    DOEpatents

    Jacob, Arpith C.; Sallenave, Olivier H.

    2017-01-10

    In one embodiment, a computer-implemented method for dispatching a function call includes receiving, at a supervisor processing element (PE) and from an origin PE, an identifier of a target device, a stack frame of the origin PE, and an address of a function called from the origin PE. The supervisor PE allocates a target PE of the target device. The supervisor PE copies the stack frame of the origin PE to a new stack frame on a call stack of the target PE. The supervisor PE instructs the target PE to execute the function. The supervisor PE receives a notification that execution of the function is complete. The supervisor PE copies the stack frame of the target PE to the stack frame of the origin PE. The supervisor PE releases the target PE of the target device. The supervisor PE instructs the origin PE to resume execution of the program.

  12. Hematology and pathology devices; reclassification of the automated differential cell counter. Final rule.

    PubMed

    2002-01-14

    The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information submitted in a reclassification petition from the International Society for Laboratory Hematology (ISLH), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.

  13. A Trust-Based Secure Routing Scheme Using the Traceback Approach for Energy-Harvesting Wireless Sensor Networks.

    PubMed

    Tang, Jiawei; Liu, Anfeng; Zhang, Jian; Xiong, Neal N; Zeng, Zhiwen; Wang, Tian

    2018-03-01

    The Internet of things (IoT) is composed of billions of sensing devices that are subject to threats stemming from increasing reliance on communications technologies. A Trust-Based Secure Routing (TBSR) scheme using the traceback approach is proposed to improve the security of data routing and maximize the use of available energy in Energy-Harvesting Wireless Sensor Networks (EHWSNs). The main contributions of a TBSR are (a) the source nodes send data and notification to sinks through disjoint paths, separately; in such a mechanism, the data and notification can be verified independently to ensure their security. (b) Furthermore, the data and notification adopt a dynamic probability of marking and logging approach during the routing. Therefore, when attacked, the network will adopt the traceback approach to locate and clear malicious nodes to ensure security. The probability of marking is determined based on the level of battery remaining; when nodes harvest more energy, the probability of marking is higher, which can improve network security. Because if the probability of marking is higher, the number of marked nodes on the data packet routing path will be more, and the sink will be more likely to trace back the data packet routing path and find malicious nodes according to this notification. When data packets are routed again, they tend to bypass these malicious nodes, which make the success rate of routing higher and lead to improved network security. When the battery level is low, the probability of marking will be decreased, which is able to save energy. For logging, when the battery level is high, the network adopts a larger probability of marking and smaller probability of logging to transmit notification to the sink, which can reserve enough storage space to meet the storage demand for the period of the battery on low level; when the battery level is low, increasing the probability of logging can reduce energy consumption. After the level of battery remaining is high enough, nodes then send the notification which was logged before to the sink. Compared with past solutions, our results indicate that the performance of the TBSR scheme has been improved comprehensively; it can effectively increase the quantity of notification received by the sink by 20%, increase energy efficiency by 11%, reduce the maximum storage capacity needed by nodes by 33.3% and improve the success rate of routing by approximately 16.30%.

  14. A Trust-Based Secure Routing Scheme Using the Traceback Approach for Energy-Harvesting Wireless Sensor Networks

    PubMed Central

    Tang, Jiawei; Zhang, Jian; Zeng, Zhiwen; Wang, Tian

    2018-01-01

    The Internet of things (IoT) is composed of billions of sensing devices that are subject to threats stemming from increasing reliance on communications technologies. A Trust-Based Secure Routing (TBSR) scheme using the traceback approach is proposed to improve the security of data routing and maximize the use of available energy in Energy-Harvesting Wireless Sensor Networks (EHWSNs). The main contributions of a TBSR are (a) the source nodes send data and notification to sinks through disjoint paths, separately; in such a mechanism, the data and notification can be verified independently to ensure their security. (b) Furthermore, the data and notification adopt a dynamic probability of marking and logging approach during the routing. Therefore, when attacked, the network will adopt the traceback approach to locate and clear malicious nodes to ensure security. The probability of marking is determined based on the level of battery remaining; when nodes harvest more energy, the probability of marking is higher, which can improve network security. Because if the probability of marking is higher, the number of marked nodes on the data packet routing path will be more, and the sink will be more likely to trace back the data packet routing path and find malicious nodes according to this notification. When data packets are routed again, they tend to bypass these malicious nodes, which make the success rate of routing higher and lead to improved network security. When the battery level is low, the probability of marking will be decreased, which is able to save energy. For logging, when the battery level is high, the network adopts a larger probability of marking and smaller probability of logging to transmit notification to the sink, which can reserve enough storage space to meet the storage demand for the period of the battery on low level; when the battery level is low, increasing the probability of logging can reduce energy consumption. After the level of battery remaining is high enough, nodes then send the notification which was logged before to the sink. Compared with past solutions, our results indicate that the performance of the TBSR scheme has been improved comprehensively; it can effectively increase the quantity of notification received by the sink by 20%, increase energy efficiency by 11%, reduce the maximum storage capacity needed by nodes by 33.3% and improve the success rate of routing by approximately 16.30%. PMID:29494561

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

    PubMed

    Drum, Bruce

    2004-01-01

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

  16. Residual Network Data Structures in Android Devices

    DTIC Science & Technology

    2011-09-01

    Apple’s iOS, Google’s Android, RIM’s Blackberry and Nokia’s Symbian. Each Smartphone presents unique characteristics for forensic examiners. In...another. • Home Agent: A router on mobile node’s home network that tunnels traffic to mobile node when not on home network. Also maintains mobile nodes...Address notification to the Home Agent. When traffic arrives at the Home Agent for the mobile node, the Home Agent tunnels the traffic to the Care-of

  17. Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink).

    PubMed

    Brachmann, Johannes; Böhm, Michael; Rybak, Karin; Klein, Gunnar; Butter, Christian; Klemm, Hanno; Schomburg, Rolf; Siebermair, Johannes; Israel, Carsten; Sinha, Anil-Martin; Drexler, Helmut

    2011-07-01

    The Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink (OptiLink HF) study is designed to investigate whether OptiVol fluid status monitoring with an automatically generated wireless CareAlert notification via the CareLink Network can reduce all-cause death and cardiovascular hospitalizations in an HF population, compared with standard clinical assessment. Methods Patients with newly implanted or replacement cardioverter-defibrillator devices with or without cardiac resynchronization therapy, who have chronic HF in New York Heart Association class II or III and a left ventricular ejection fraction ≤35% will be eligible to participate. Following device implantation, patients are randomized to either OptiVol fluid status monitoring through CareAlert notification or regular care (OptiLink 'on' vs. 'off'). The primary endpoint is a composite of all-cause death or cardiovascular hospitalization. It is estimated that 1000 patients will be required to demonstrate superiority of the intervention group to reduce the primary outcome by 30% with 80% power. The OptiLink HF study is designed to investigate whether early detection of congestion reduces mortality and cardiovascular hospitalization in patients with chronic HF. The study is expected to close recruitment in September 2012 and to report first results in May 2014.

  18. Timeliness of notification systems for infectious diseases: A systematic literature review.

    PubMed

    Swaan, Corien; van den Broek, Anouk; Kretzschmar, Mirjam; Richardus, Jan Hendrik

    2018-01-01

    Timely notification of infectious diseases is crucial for prompt response by public health services. Adequate notification systems facilitate timely notification. A systematic literature review was performed to assess outcomes of studies on notification timeliness and to determine which aspects of notification systems are associated with timely notification. Articles reviewing timeliness of notifications published between 2000 and 2017 were searched in Pubmed and Scopus. Using a standardized notification chain, timeliness of reporting system for each article was defined as either sufficient (≥ 80% notifications in time), partly sufficient (≥ 50-80%), or insufficient (< 50%) according to the article's predefined timeframe, a standardized timeframe for all articles, and a disease specific timeframe. Electronic notification systems were compared with conventional methods (postal mail, fax, telephone, email) and mobile phone reporting. 48 articles were identified. In almost one third of the studies with a predefined timeframe (39), timeliness of notification systems was either sufficient or insufficient (11/39, 28% and 12/39, 31% resp.). Applying the standardized timeframe (45 studies) revealed similar outcomes (13/45, 29%, sufficient notification timeframe, vs 15/45, 33%, insufficient). The disease specific timeframe was not met by any study. Systems involving reporting by laboratories most often complied sufficiently with predefined or standardized timeframes. Outcomes were not related to electronic, conventional notification systems or mobile phone reporting. Electronic systems were faster in comparative studies (10/13); this hardly resulted in sufficient timeliness, neither according to predefined nor to standardized timeframes. A minority of notification systems meets either predefined, standardized or disease specific timeframes. Systems including laboratory reporting are associated with timely notification. Electronic systems reduce reporting delay, but implementation needs considerable effort to comply with notification timeframes. During outbreak threats, patient, doctors and laboratory testing delays need to be reduced to achieve timely detection and notification. Public health authorities should incorporate procedures for this in their preparedness plans.

  19. Reading, readability, and legibility research: implications for notification letters.

    PubMed

    Zimmerman, D E

    1993-01-01

    This article defines communication science and then briefly describes three research areas relevant to worker notifications: (1) receiving of notification messages, (2) reading and understanding of notification messages, and (3) influences or effects of notification messages on workers. Next, the article focuses on the reading and legibility research relevant to worker notifications and then provides 16 guidelines for drafting worker notifications. Finally, the article suggests evaluating draft notifications by using one or more of the following: skilled editorial reviews, readability scoring, Cloze techniques, signal stopping techniques, in-depth personal interviews, focus groups, and usability testing.

  20. The Effect of Timing and Frequency of Push Notifications on Usage of a Smartphone-Based Stress Management Intervention: An Exploratory Trial.

    PubMed

    Morrison, Leanne G; Hargood, Charlie; Pejovic, Veljko; Geraghty, Adam W A; Lloyd, Scott; Goodman, Natalie; Michaelides, Danius T; Weston, Anna; Musolesi, Mirco; Weal, Mark J; Yardley, Lucy

    2017-01-01

    Push notifications offer a promising strategy for enhancing engagement with smartphone-based health interventions. Intelligent sensor-driven machine learning models may improve the timeliness of notifications by adapting delivery to a user's current context (e.g. location). This exploratory mixed-methods study examined the potential impact of timing and frequency on notification response and usage of Healthy Mind, a smartphone-based stress management intervention. 77 participants were randomised to use one of three versions of Healthy Mind that provided: intelligent notifications; daily notifications within pre-defined time frames; or occasional notifications within pre-defined time frames. Notification response and Healthy Mind usage were automatically recorded. Telephone interviews explored participants' experiences of using Healthy Mind. Participants in the intelligent and daily conditions viewed (d = .47, .44 respectively) and actioned (d = .50, .43 respectively) more notifications compared to the occasional group. Notification group had no meaningful effects on percentage of notifications viewed or usage of Healthy Mind. No meaningful differences were indicated between the intelligent and non-intelligent groups. Our findings suggest that frequent notifications may encourage greater exposure to intervention content without deterring engagement, but adaptive tailoring of notification timing does not always enhance their use. Hypotheses generated from this study require testing in future work. ISRCTN67177737.

  1. Devices for Ambulatory Monitoring of Sleep-Associated Disorders in Children with Neurological Diseases.

    PubMed

    Ulate-Campos, Adriana; Tsuboyama, Melissa; Loddenkemper, Tobias

    2017-12-25

    Good sleep quality is essential for a child's wellbeing. Early sleep problems have been linked to the later development of emotional and behavioral disorders and can negatively impact the quality of life of the child and his or her family. Sleep-associated conditions are frequent in the pediatric population, and even more so in children with neurological problems. Monitoring devices can help to better characterize sleep efficiency and sleep quality. They can also be helpful to better characterize paroxysmal nocturnal events and differentiate between nocturnal seizures, parasomnias, and obstructive sleep apnea, each of which has a different management. Overnight ambulatory detection devices allow for a tolerable, low cost, objective assessment of sleep quality in the patient's natural environment. They can also be used as a notification system to allow for rapid recognition and prompt intervention of events like seizures. Optimal monitoring devices will be patient- and diagnosis-specific, but may include a combination of modalities such as ambulatory electroencephalograms, actigraphy, and pulse oximetry. We will summarize the current literature on ambulatory sleep devices for detecting sleep disorders in children with neurological diseases.

  2. The Effect of Timing and Frequency of Push Notifications on Usage of a Smartphone-Based Stress Management Intervention: An Exploratory Trial

    PubMed Central

    Hargood, Charlie; Pejovic, Veljko; Geraghty, Adam W. A.; Lloyd, Scott; Goodman, Natalie; Michaelides, Danius T.; Weston, Anna; Musolesi, Mirco; Weal, Mark J.; Yardley, Lucy

    2017-01-01

    Push notifications offer a promising strategy for enhancing engagement with smartphone-based health interventions. Intelligent sensor-driven machine learning models may improve the timeliness of notifications by adapting delivery to a user’s current context (e.g. location). This exploratory mixed-methods study examined the potential impact of timing and frequency on notification response and usage of Healthy Mind, a smartphone-based stress management intervention. 77 participants were randomised to use one of three versions of Healthy Mind that provided: intelligent notifications; daily notifications within pre-defined time frames; or occasional notifications within pre-defined time frames. Notification response and Healthy Mind usage were automatically recorded. Telephone interviews explored participants’ experiences of using Healthy Mind. Participants in the intelligent and daily conditions viewed (d = .47, .44 respectively) and actioned (d = .50, .43 respectively) more notifications compared to the occasional group. Notification group had no meaningful effects on percentage of notifications viewed or usage of Healthy Mind. No meaningful differences were indicated between the intelligent and non-intelligent groups. Our findings suggest that frequent notifications may encourage greater exposure to intervention content without deterring engagement, but adaptive tailoring of notification timing does not always enhance their use. Hypotheses generated from this study require testing in future work. Trial registration number: ISRCTN67177737 PMID:28046034

  3. 76 FR 20712 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... for OMB Review; Comment Request; Representative of Miners, Notification of Legal Identity, and... collection request (ICR) titled, ``Representative of Miners, Notification of Legal Identity, and Notification... representative, notification of mine owner and operator legal identity, and notification of commencement of...

  4. 47 CFR 17.7 - Antenna structures requiring notification to the FAA.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Antenna structures requiring notification to..., MARKING, AND LIGHTING OF ANTENNA STRUCTURES Federal Aviation Administration Notification Criteria § 17.7 Antenna structures requiring notification to the FAA. A notification to the Federal Aviation...

  5. 47 CFR 17.7 - Antenna structures requiring notification to the FAA.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 1 2013-10-01 2013-10-01 false Antenna structures requiring notification to..., MARKING, AND LIGHTING OF ANTENNA STRUCTURES Federal Aviation Administration Notification Criteria § 17.7 Antenna structures requiring notification to the FAA. A notification to the Federal Aviation...

  6. 47 CFR 17.7 - Antenna structures requiring notification to the FAA.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 1 2011-10-01 2011-10-01 false Antenna structures requiring notification to..., MARKING, AND LIGHTING OF ANTENNA STRUCTURES Federal Aviation Administration Notification Criteria § 17.7 Antenna structures requiring notification to the FAA. A notification to the Federal Aviation...

  7. 47 CFR 17.7 - Antenna structures requiring notification to the FAA.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 1 2012-10-01 2012-10-01 false Antenna structures requiring notification to..., MARKING, AND LIGHTING OF ANTENNA STRUCTURES Federal Aviation Administration Notification Criteria § 17.7 Antenna structures requiring notification to the FAA. A notification to the Federal Aviation...

  8. An overview of the regulatory aspects of medical devices from the viewpoint of research and device manufacturing.

    PubMed

    Patrick, J

    1993-01-01

    To review the Food and Drug Administration's regulatory requirements for bringing a new or substantially changed medical device to market in the United States, noting the history and current requirements for the continuous spinal catheter. The relevant laws and guidelines for classifying, testing, and submitting a device to Food and Drug Administration approval are reviewed. The Food and Drug Administration categorizes medical devices into three classes, based on potential risk for illness or injury presented by a malfunction or failure. Class III devices are the most critical ones, and require a Premarket Approval that includes clinical trials before market introduction. Classes I and II usually require a 510(k), or premarket notification, which usually does not need any clinical data. Testing requirements include biocompatibility testing; physical, functional, and packaging testing; and sterility testing. The continuous spinal catheter (25-32 gauge) was marketed under a 510(k) claiming substantial equivalence to the Bizzarri-Giuffrida 24-gauge catheter, which was a pre-Amendment device. After incidences of cauda equina syndrome were reported with use of the continuous spinal technique, the Food and Drug Administration reclassified the small-gauge catheters as Class III devices, which require a Premarket Approval before being marketed.

  9. 33 CFR 135.307 - Notification contents.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) MARINE POLLUTION FINANCIAL RESPONSIBILITY AND COMPENSATION OFFSHORE OIL POLLUTION COMPENSATION FUND Notification of Pollution Incidents § 135.307 Notification contents. (a) In each notification provided under...

  10. 33 CFR 135.307 - Notification contents.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) MARINE POLLUTION FINANCIAL RESPONSIBILITY AND COMPENSATION OFFSHORE OIL POLLUTION COMPENSATION FUND Notification of Pollution Incidents § 135.307 Notification contents. (a) In each notification provided under...

  11. 33 CFR 135.307 - Notification contents.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) MARINE POLLUTION FINANCIAL RESPONSIBILITY AND COMPENSATION OFFSHORE OIL POLLUTION COMPENSATION FUND Notification of Pollution Incidents § 135.307 Notification contents. (a) In each notification provided under...

  12. 33 CFR 135.307 - Notification contents.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) MARINE POLLUTION FINANCIAL RESPONSIBILITY AND COMPENSATION OFFSHORE OIL POLLUTION COMPENSATION FUND Notification of Pollution Incidents § 135.307 Notification contents. (a) In each notification provided under...

  13. 28 CFR 551.153 - Cancelling the notification request.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Cancelling the notification request. 551... MANAGEMENT MISCELLANEOUS Victim and/or Witness Notification § 551.153 Cancelling the notification request. (a... victim and/or witness that his or her request for notification has been cancelled. (b) Bureau of Prisons...

  14. 40 CFR 152.46 - Notification and non-notification changes to registrations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... cause unreasonable adverse effects to the environment may be accomplished by notification to the Agency... having no potential to cause unreasonable adverse effects to the environment may be accomplished without... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Notification and non-notification...

  15. Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration.

    PubMed

    Dodd, Erin M; Winter, Margo A; Hordinsky, Maria K; Sadick, Neil S; Farah, Ronda S

    2018-06-01

    The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded, and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. Patients increasingly seek the advice of dermatologists regarding the safety and efficacy of these hair loss treatments. The purpose of this guide was threefold: (1) to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia; (2) to review device design, features and existing clinical evidence; and (3) to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection. A search of the FDA 510(k) Premarket Notification database was conducted using product code "OAP" to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. Thirteen commercially available devices were identified and compared. Devices varied in shape, wavelength, light sources, technical features, price, and level of clinical evidence. To date, there are no head-to-head studies comparing the efficacy of these devices. Photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. However, long-term, high quality studies comparing these devices in diverse populations are lacking. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium. AGA, androgenetic alopecia; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; LED, light-emitting diode; PBMT, photobiomodulation therapy.

  16. Using digital notifications to improve attendance in clinic: systematic review and meta-analysis.

    PubMed

    Robotham, Dan; Satkunanathan, Safarina; Reynolds, John; Stahl, Daniel; Wykes, Til

    2016-10-24

    Assess the impact of text-based electronic notifications on improving clinic attendance, in relation to study quality (according to risk of bias), and to assess simple ways in which notifications can be optimised (ie, impact of multiple notifications). Systematic review, study quality appraisal assessing risk of bias, data synthesised in meta-analyses. MEDLINE, EMBASE, PsycINFO, Web of Science and Cochrane Database of Systematic Reviews (01.01.05 until 25.4.15). A systematic search to discover all studies containing quantitative data for synthesis into meta-analyses. Studies examining the effect of text-based electronic notifications on prescheduled appointment attendance in healthcare settings. Primary analysis included experimental studies where randomisation was used to define allocation to intervention and where a control group consisting of 'no reminders' was used. Secondary meta-analysis included studies comparing text reminders with voice reminders. Studies lacking sufficient information for inclusion (after attempting to contact study authors) were excluded. Primary outcomes were rate of attendance/non-attendance at healthcare appointments. Secondary outcome was rate of rescheduled and cancelled appointments. 26 articles were included. 21 included in the primary meta-analysis (8345 patients receiving electronic text notifications, 7731 patients receiving no notifications). Studies were included from Europe (9), Asia (7), Africa (2), Australia (2) and America (1). Patients who received notifications were 23% more likely to attend clinic than those who received no notification (risk ratio=1.23, 67% vs 54%). Those receiving notifications were 25% less likely to 'no show' for appointments (risk ratio=.75, 15% vs 21%). Results were similar when accounting for risk of bias, region and publication year. Multiple notifications were significantly more effective at improving attendance than single notifications. Voice notifications appeared more effective than text notifications at improving attendance. Electronic text notifications improve attendance and reduce no shows across healthcare settings. Sending multiple notifications could improve attendance further. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  17. Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink)

    PubMed Central

    Brachmann, Johannes; Böhm, Michael; Rybak, Karin; Klein, Gunnar; Butter, Christian; Klemm, Hanno; Schomburg, Rolf; Siebermair, Johannes; Israel, Carsten; Sinha, Anil-Martin; Drexler, Helmut

    2011-01-01

    Aims The Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink (OptiLink HF) study is designed to investigate whether OptiVol fluid status monitoring with an automatically generated wireless CareAlert notification via the CareLink Network can reduce all-cause death and cardiovascular hospitalizations in an HF population, compared with standard clinical assessment. Methods Patients with newly implanted or replacement cardioverter-defibrillator devices with or without cardiac resynchronization therapy, who have chronic HF in New York Heart Association class II or III and a left ventricular ejection fraction ≤35% will be eligible to participate. Following device implantation, patients are randomized to either OptiVol fluid status monitoring through CareAlert notification or regular care (OptiLink ‘on' vs. ‘off'). The primary endpoint is a composite of all-cause death or cardiovascular hospitalization. It is estimated that 1000 patients will be required to demonstrate superiority of the intervention group to reduce the primary outcome by 30% with 80% power. Conclusion The OptiLink HF study is designed to investigate whether early detection of congestion reduces mortality and cardiovascular hospitalization in patients with chronic HF. The study is expected to close recruitment in September 2012 and to report first results in May 2014. ClinicalTrials.gov Identifier: NCT00769457 PMID:21555324

  18. Smart Device-Based Notifications to Promote Healthy Behavior Related to Childhood Obesity and Overweight

    PubMed Central

    Brenes, Jose A.; Guerrero, Luis A.; Bravo, José

    2018-01-01

    Obesity is one of the most serious public health challenges of the 21st century and it is a threat to the life of people according to World Health Organization. In this scenario, family environment is important to establish healthy habits which help to reduce levels of obesity and control overweight in children. However, little efforts have been focused on helping parents to promote and have healthy lifestyles. In this paper, we present two smart device-based notification prototypes to promote healthy behavior with the aim of avoiding childhood overweight and obesity. The first prototype helps parents to follow a healthy snack routine, based on a nutritionist suggestion. Using a fridge magnet, parents receive graphical reminders of which snacks they and their children should consume. The second prototype provides a graphical reminder that prevents parents from forgetting the required equipment to practice sports. Prototypes were evaluated by nine nutritionists from three countries (Costa Rica, Mexico and Spain). Evaluations were based on anticipation of use and the ergonomics of human–system interaction according to the ISO 9241-210. Results show that the system is considered useful. Even though they might not be willing to use the system, they would recommend it to their patients. Based on the ISO 9241-210 the best ranked features were the system’s comprehensibility, the perceived effectiveness and clarity. The worst ranked features were the system’s suitability for learning and its discriminability. PMID:29346302

  19. Accelerating TB notification from the private health sector in Delhi, India.

    PubMed

    Kundu, Debashish; Chopra, Kamal; Khanna, Ashwani; Babbar, Neeti; Padmini, T J

    2016-01-01

    In India, almost half of all patients with tuberculosis (TB) seek care in the private sector as the first point of care. The national programme is unable to support such TB patients and facilitate effective treatment, as there is no information on TB and Multi or Extensively Drug Resistant TB (M/XDR-TB) diagnosis and treatment in private sector. To improve this situation, Government of India declared TB a notifiable disease for establishing TB surveillance system, to extend supportive mechanism for TB treatment adherence and standardised practices in the private sector. But TB notification from the private sector is a challenge and still a lot needs to be done to accelerate TB notification. Delhi State TB Control Programme had taken initiatives for improving notification of TB cases from the private sector in 2014. Key steps taken were to constitute a state level TB notification committee to oversee the progress of TB notification efforts in the state and direct 'one to one' sensitisation of private practitioners (PPs) (in single PP's clinic, corporate hospitals and laboratories) by the state notification teams with the help of available tools for sensitising the PP on TB notification - TB Notification Government Order, Guidance Tool for TB Notification and Standards of TB Care in India. As a result of focussed state level interventions, without much external support, there was an accelerated notification of TB cases from the private sector. TB notification cases from the private sector rose from 341 (in 2013) to 4049 (by the end of March 2015). Active state level initiatives have led to increase in TB case notification. Copyright © 2016 Tuberculosis Association of India. Published by Elsevier B.V. All rights reserved.

  20. Death notification: considerations for law enforcement personnel.

    PubMed

    Hart, C W; DeBernardo, Caren R

    2004-01-01

    Death notification is among the most unpleasant and uncomfortable tasks a law enforcement officer undertakes. For years, law enforcement officers have been performing notifications that involved life threatening injuries or death from tragedies including suicide. Unfortunately, many officers have performed this task without appropriate training. Performing notifications can be physically and emotionally exhausting. Expressing the right words, understanding families' emotions, and responding with empathy are paramount. The attitude, demeanor, professionalism, and sensitivity of law enforcement officers projected during a notification are critical. The delivery of a notification can remain etched in a family member's memory forever. Many notifications have left family members with the perception that law enforcement officers are callous, thoughtless, and insensitive. This negative perception can be overcome through training and practice. This article presents several factors that supervisors and officers should consider in the notification process and offers guidelines to consider to best serve your agency and the community.

  1. Outbreaks of health care-associated influenza-like illness in France: Impact of electronic notification.

    PubMed

    Munier-Marion, Elodie; Bénet, Thomas; Dananché, Cédric; Soing-Altach, Sophan; Maugat, Sylvie; Vaux, Sophie; Vanhems, Philippe

    2017-11-01

    Mandatory notification of health care-associated (HA) infections, including influenza-like illness (ILI) outbreaks, has been implemented in France since 2001. In 2012, the system moved to online electronic notification of HA infections (e-SIN). The objectives of this study are to describe ILI outbreak notifications to Santé publique France (SPF), the French national public health agency, and to evaluate the impact of notification dematerialization. All notifications of HA ILI outbreaks between July 2001 and June 2015 were included. Notifications before and after e-SIN implementation were compared regarding notification delay and information exhaustiveness. Overall, 506 HA ILI outbreaks were reported, accounting for 7,861 patients and health care professionals. Median delay between occurrence of the first case and notification was, respectively, 32 and 13 days before and after e-SIN utilization (P < .001). Information exhaustiveness was improved by electronic notification regarding HA status (8.5% of missing data before and 2.3% after e-SIN, P = .003), hypotheses of cause (25.4% of missing data before vs 8.0% after e-SIN, P < .001), and level of event control (23.7% of missing data before vs 7.5% after e-SIN, P < .001). HA influenza notifications, including HA ILI or influenza, to health authorities are essential to guide decisional instances and health care practices. Electronic notifications have improved the timeliness and quality of information transmitted. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  2. A multi-site evaluation of innovative approaches to increase tuberculosis case notification: summary results.

    PubMed

    Creswell, Jacob; Sahu, Suvanand; Blok, Lucie; Bakker, Mirjam I; Stevens, Robert; Ditiu, Lucica

    2014-01-01

    Globally, TB notifications have stagnated since 2007, and sputum smear positive notifications have been declining despite policies to improve case detection. We evaluate results of 28 interventions focused on improving TB case detection. We measured additional sputum smear positive cases treated, defined as the intervention area's increase in case notification during the project compared to the previous year. Projects were encouraged to select control areas and collect historical notification data. We used time series negative binomial regression for over-dispersed cross-sectional data accounting for fixed and random effects to test the individual projects' effects on TB notification while controlling for trend and control populations. Twenty-eight projects, 19 with control populations, completed at least four quarters of case finding activities, covering a population of 89.2 million. Among all projects sputum smear positive (SS+) TB notifications increased 24.9% and annualized notification rates increased from 69.1 to 86.2/100,000 (p = 0.0209) during interventions. Among the 19 projects with control populations, SS+TB case notifications increased 36.9% increase while in the control populations a 3.6% decrease was observed. Fourteen (74%) of the 19 projects' SS+TB notification rates in intervention areas increased from the baseline to intervention period when controlling for historical trends and notifications in control areas. Interventions were associated with large increases in TB notifications across many settings, using an array of interventions. Many people with TB are not reached using current approaches. Different methods and interventions tailored to local realities are urgently needed.

  3. Tuberculosis inequalities and socio-economic deprivation in Portugal.

    PubMed

    Apolinário, D; Ribeiro, A I; Krainski, E; Sousa, P; Abranches, M; Duarte, R

    2017-07-01

    To analyse the geographical distribution of tuberculosis (TB) in Portugal and estimate the association between TB and socio-economic deprivation. An ecological study at the municipality level using TB notifications for 2010-2014 was conducted. Spatial Bayesian models were used to calculate smoothed standardised notification rates, identify high- and low-risk areas and estimate the association between TB notification and the European Deprivation Index (EDI) for Portugal and its component variables. Standardised notification rates ranged from 4.41 to 76.44 notifications per 100 000 population. Forty-one high-risk and 156 low-risk municipalities were identified. There was no statistically significant association between TB notification rate and the EDI, but some of its variables, such as the proportion of manual workers and the percentage unemployed, were significantly and directly associated with TB notification, whereas the variable 'proportion of residents with low education level' showed an inverse relationship. Wide inequalities in TB notification rates were observed, and some areas continued to exhibit high TB notification rates. We found significant associations between TB and some socio-economic factors of the EDI.

  4. Regulatory perspectives and research activities at the FDA on the use of phantoms with in vivo diagnostic devices

    NASA Astrophysics Data System (ADS)

    Agrawal, Anant; Gavrielides, Marios A.; Weininger, Sandy; Chakrabarti, Kish; Pfefer, Joshua

    2008-02-01

    For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.

  5. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related...; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability,'' that... Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues...

  6. 75 FR 27362 - Supplemental Guidelines for Sex Offender Registration and Notification

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-14

    ...] RIN 1105-AB36 Supplemental Guidelines for Sex Offender Registration and Notification AGENCY: Department of Justice. ACTION: Notice; Proposed guidelines. SUMMARY: The Sex Offender Registration and Notification Act (SORNA) establishes minimum national standards for sex offender registration and notification...

  7. 76 FR 1630 - Supplemental Guidelines for Sex Offender Registration and Notification

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-11

    ...] RIN 1105-AB36 Supplemental Guidelines for Sex Offender Registration and Notification AGENCY: Department of Justice. ACTION: Final guidelines. SUMMARY: The Sex Offender Registration and Notification Act (SORNA), establishes minimum national standards for sex offender registration and notification. The...

  8. Effect of a checklist on advanced trauma life support workflow deviations during trauma resuscitations without pre-arrival notification.

    PubMed

    Kelleher, Deirdre C; Jagadeesh Chandra Bose, R P; Waterhouse, Lauren J; Carter, Elizabeth A; Burd, Randall S

    2014-03-01

    Trauma resuscitations without pre-arrival notification are often initially chaotic, which can potentially compromise patient care. We hypothesized that trauma resuscitations without pre-arrival notification are performed with more variable adherence to ATLS protocol and that implementation of a checklist would improve performance. We analyzed event logs of trauma resuscitations from two 4-month periods before (n = 222) and after (n = 215) checklist implementation. Using process mining techniques, individual resuscitations were compared with an ideal workflow model of 6 ATLS primary survey tasks performed by the bedside evaluator and given model fitness scores (range 0 to 1). Mean fitness scores and frequency of conformance (fitness = 1) were compared (using Student's t-test or chi-square test, as appropriate) for activations with and without notification both before and after checklist implementation. Multivariable linear regression, controlling for patient and resuscitation characteristics, was also performed to assess the association between pre-arrival notification and model fitness before and after checklist implementation. Fifty-five (12.6%) resuscitations lacked pre-arrival notification (23 pre-implementation and 32 post-implementation; p = 0.15). Before checklist implementation, resuscitations without notification had lower fitness (0.80 vs 0.90; p < 0.001) and conformance (26.1% vs 50.8%; p = 0.03) than those with notification. After checklist implementation, the fitness (0.80 vs 0.91; p = 0.007) and conformance (26.1% vs 59.4%; p = 0.01) improved for resuscitations without notification, but still remained lower than activations with notification. In multivariable analysis, activations without notification had lower fitness both before (b = -0.11, p < 0.001) and after checklist implementation (b = -0.04, p = 0.02). Trauma resuscitations without pre-arrival notification are associated with a decreased adherence to key components of the ATLS primary survey protocol. The addition of a checklist improves protocol adherence and reduces the effect of notification on task performance. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  9. 40 CFR 372.45 - Notification about toxic chemicals.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 27 2010-07-01 2010-07-01 false Notification about toxic chemicals..., EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW Supplier Notification Requirements § 372.45 Notification about toxic chemicals. (a) Except as...

  10. 40 CFR 372.45 - Notification about toxic chemicals.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 28 2011-07-01 2011-07-01 false Notification about toxic chemicals..., EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW Supplier Notification Requirements § 372.45 Notification about toxic chemicals. (a) Except as...

  11. 50 CFR 660.411 - Notification and publication procedures.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 50 Wildlife and Fisheries 9 2010-10-01 2010-10-01 false Notification and publication procedures. 660.411 Section 660.411 Wildlife and Fisheries FISHERY CONSERVATION AND MANAGEMENT, NATIONAL OCEANIC... West Coast Salmon Fisheries § 660.411 Notification and publication procedures. (a) Notification and...

  12. 40 CFR 372.45 - Notification about toxic chemicals.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 29 2012-07-01 2012-07-01 false Notification about toxic chemicals..., EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW Supplier Notification Requirements § 372.45 Notification about toxic chemicals. (a) Except as...

  13. 40 CFR 372.45 - Notification about toxic chemicals.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 29 2013-07-01 2013-07-01 false Notification about toxic chemicals..., EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW Supplier Notification Requirements § 372.45 Notification about toxic chemicals. (a) Except as...

  14. 40 CFR 372.45 - Notification about toxic chemicals.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 28 2014-07-01 2014-07-01 false Notification about toxic chemicals..., EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW Supplier Notification Requirements § 372.45 Notification about toxic chemicals. (a) Except as...

  15. 50 CFR 660.411 - Notification and publication procedures.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 50 Wildlife and Fisheries 13 2012-10-01 2012-10-01 false Notification and publication procedures. 660.411 Section 660.411 Wildlife and Fisheries FISHERY CONSERVATION AND MANAGEMENT, NATIONAL OCEANIC... West Coast Salmon Fisheries § 660.411 Notification and publication procedures. (a) Notification and...

  16. 76 FR 9665 - Designation, Reportable Quantities, and Notification; Notification Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-22

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 302 [EPA-HQ-SFUND-2010-1068; FRL-9268-8] Designation, Reportable Quantities, and Notification; Notification Requirements AGENCY: Environmental Protection Agency... knowledge of any release (other than a federally permitted release or application of a pesticide) for the...

  17. Unusual sex differences in tuberculosis notifications across Pakistan and the role of environmental factors.

    PubMed

    Khan, M S; Khan, M S; Hasan, R; Godfrey-Faussett, P

    2013-09-01

    In developing countries, only one-third of new tuberculosis cases notified are from women. It is not clear whether tuberculosis incidence is lower in women than men, or whether notification figures reflect under-detection of tuberculosis in women. Pakistan, however, presents an unusual pattern of sex differences in tuberculosis notifications. While 2 of the 4 provinces (Sindh and Punjab) report more notifications from men (female to male ratios 0.81 and 0.89 respectively in 2009), the other 2 provinces (Khyber-Pakhtunkhwa and Balochistan) consistently report higher numbers of smear-positive tuberculosis notifications from women than men (1.37 and 1.40). No other country is known to have such a large variation in the sex ratios of notifications across regions. Large variations in female to male smear-positive notification ratios in different settings across a single country may indicate that environmental factors, rather than endogenous biological factors, are important in influencing the observed sex differences in tuberculosis notifications.

  18. GSM module for wireless radiation monitoring system via SMS

    NASA Astrophysics Data System (ADS)

    Rahman, Nur Aira Abd; Hisyam Ibrahim, Noor; Lombigit, Lojius; Azman, Azraf; Jaafar, Zainudin; Arymaswati Abdullah, Nor; Hadzir Patai Mohamad, Glam

    2018-01-01

    A customised Global System for Mobile communication (GSM) module is designed for wireless radiation monitoring through Short Messaging Service (SMS). This module is able to receive serial data from radiation monitoring devices such as survey meter or area monitor and transmit the data as text SMS to a host server. It provides two-way communication for data transmission, status query, and configuration setup. The module hardware consists of GSM module, voltage level shifter, SIM circuit and Atmega328P microcontroller. Microcontroller provides control for sending, receiving and AT command processing to GSM module. The firmware is responsible to handle task related to communication between device and host server. It process all incoming SMS, extract, and store new configuration from Host, transmits alert/notification SMS when the radiation data reach/exceed threshold value, and transmits SMS data at every fixed interval according to configuration. Integration of this module with radiation survey/monitoring device will create mobile and wireless radiation monitoring system with prompt emergency alert at high-level radiation.

  19. 76 FR 23515 - Enhanced Weapons, Firearms Background Checks, and Security Event Notifications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-27

    ... material and would add new event notification requirements on the theft or loss of enhanced weapons...-2011-0017] RIN 3150-AI49 Enhanced Weapons, Firearms Background Checks, and Security Event Notifications... regulations governing security event notifications. These proposed regulations are consistent with the...

  20. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related... ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement...

  1. 30 CFR 41.12 - Changes; notification by operator.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Changes; notification by operator. 41.12 Section 41.12 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.12...

  2. 30 CFR 41.11 - Notification by operator.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.11 Notification by... of the legal identity of the operator in accordance with the applicable provisions of paragraph (b... proprietorship, partnership, or corporation, the operator shall state: (1) The nature and type, or legal identity...

  3. 30 CFR 41.11 - Notification by operator.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.11 Notification by... of the legal identity of the operator in accordance with the applicable provisions of paragraph (b...) the Federal mine identification numbers of all other mines in which any corporate officer has a 20...

  4. 30 CFR 41.11 - Notification by operator.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.11 Notification by... of the legal identity of the operator in accordance with the applicable provisions of paragraph (b...) the Federal mine identification numbers of all other mines in which any corporate officer has a 20...

  5. 30 CFR 41.11 - Notification by operator.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.11 Notification by... of the legal identity of the operator in accordance with the applicable provisions of paragraph (b...) the Federal mine identification numbers of all other mines in which any corporate officer has a 20...

  6. 29 CFR 2400.5 - Notification.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Notification. 2400.5 Section 2400.5 Labor Regulations... PRIVACY ACT § 2400.5 Notification. (a) Notification of systems. The following procedures permit.... See § 2400.6 for suggested form of request. (2) Upon establishing or revising a system of records...

  7. 29 CFR 2400.5 - Notification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 9 2011-07-01 2011-07-01 false Notification. 2400.5 Section 2400.5 Labor Regulations... PRIVACY ACT § 2400.5 Notification. (a) Notification of systems. The following procedures permit.... See § 2400.6 for suggested form of request. (2) Upon establishing or revising a system of records...

  8. 30 CFR 41.12 - Changes; notification by operator.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Changes; notification by operator. 41.12 Section 41.12 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.12...

  9. 30 CFR 41.11 - Notification by operator.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.11 Notification by... of the legal identity of the operator in accordance with the applicable provisions of paragraph (b... proprietorship, partnership, or corporation, the operator shall state: (1) The nature and type, or legal identity...

  10. 48 CFR 52.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 2 2013-10-01 2013-10-01 false Privacy Act Notification....224-1 Privacy Act Notification. As prescribed in 24.104, insert the following clause in solicitations... required to accomplish an agency function: Privacy Act Notification (APR 1984) The Contractor will be...

  11. 48 CFR 52.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 2 2012-10-01 2012-10-01 false Privacy Act Notification....224-1 Privacy Act Notification. As prescribed in 24.104, insert the following clause in solicitations... required to accomplish an agency function: Privacy Act Notification (APR 1984) The Contractor will be...

  12. 48 CFR 52.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 2 2011-10-01 2011-10-01 false Privacy Act Notification....224-1 Privacy Act Notification. As prescribed in 24.104, insert the following clause in solicitations... required to accomplish an agency function: Privacy Act Notification (APR 1984) The Contractor will be...

  13. 48 CFR 52.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 2 2014-10-01 2014-10-01 false Privacy Act Notification....224-1 Privacy Act Notification. As prescribed in 24.104, insert the following clause in solicitations... required to accomplish an agency function: Privacy Act Notification (APR 1984) The Contractor will be...

  14. 48 CFR 52.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Privacy Act Notification....224-1 Privacy Act Notification. As prescribed in 24.104, insert the following clause in solicitations... required to accomplish an agency function: Privacy Act Notification (APR 1984) The Contractor will be...

  15. 47 CFR 17.14 - Certain antenna structures exempt from notification to the FAA.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 1 2012-10-01 2012-10-01 false Certain antenna structures exempt from... CONSTRUCTION, MARKING, AND LIGHTING OF ANTENNA STRUCTURES Federal Aviation Administration Notification Criteria § 17.14 Certain antenna structures exempt from notification to the FAA. A notification to the Federal...

  16. 47 CFR 17.14 - Certain antenna structures exempt from notification to the FAA.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Certain antenna structures exempt from... CONSTRUCTION, MARKING, AND LIGHTING OF ANTENNA STRUCTURES Federal Aviation Administration Notification Criteria § 17.14 Certain antenna structures exempt from notification to the FAA. A notification to the Federal...

  17. 47 CFR 17.14 - Certain antenna structures exempt from notification to the FAA.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 1 2013-10-01 2013-10-01 false Certain antenna structures exempt from... CONSTRUCTION, MARKING, AND LIGHTING OF ANTENNA STRUCTURES Federal Aviation Administration Notification Criteria § 17.14 Certain antenna structures exempt from notification to the FAA. A notification to the Federal...

  18. 47 CFR 17.14 - Certain antenna structures exempt from notification to the FAA.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 1 2011-10-01 2011-10-01 false Certain antenna structures exempt from... CONSTRUCTION, MARKING, AND LIGHTING OF ANTENNA STRUCTURES Federal Aviation Administration Notification Criteria § 17.14 Certain antenna structures exempt from notification to the FAA. A notification to the Federal...

  19. 47 CFR 17.7 - Antenna structures requiring notification to the FAA.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 1 2014-10-01 2014-10-01 false Antenna structures requiring notification to..., MARKING, AND LIGHTING OF ANTENNA STRUCTURES Federal Aviation Administration Notification Criteria § 17.7 Antenna structures requiring notification to the FAA. Link to an amendment published at 79 FR 56986, Sept...

  20. Stop and Think: Exploring Mobile Notifications to Foster Reflective Practice on Meta-Learning

    ERIC Educational Resources Information Center

    Tabuenca, Bernardo; Kalz, Marco; Ternier, Stefaan; Specht, Marcus

    2015-01-01

    Nowadays, smartphone users are constantly receiving notifications from applications that provide feedback, as reminders, recommendations or announcements. Nevertheless, there is little research on the effects of mobile notifications to foster meta-learning. This paper explores the effectiveness of mobile notifications to foster reflection on…

  1. 48 CFR 1452.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Privacy Act Notification... Privacy Act Notification. (a) As prescribed in 1424.104, the clause at FAR 52.224-1, Privacy Act... the clause to read “Privacy Act Notification (JUL 1996) (Deviation)”; and (2) Adding the following...

  2. 48 CFR 1452.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Privacy Act Notification... Privacy Act Notification. (a) As prescribed in 1424.104, the clause at FAR 52.224-1, Privacy Act... the clause to read “Privacy Act Notification (JUL 1996) (Deviation)”; and (2) Adding the following...

  3. 48 CFR 1452.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Privacy Act Notification... Privacy Act Notification. (a) As prescribed in 1424.104, the clause at FAR 52.224-1, Privacy Act... the clause to read “Privacy Act Notification (JUL 1996) (Deviation)”; and (2) Adding the following...

  4. 48 CFR 1452.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Privacy Act Notification... Privacy Act Notification. (a) As prescribed in 1424.104, the clause at FAR 52.224-1, Privacy Act... the clause to read “Privacy Act Notification (JUL 1996) (Deviation)”; and (2) Adding the following...

  5. 48 CFR 1452.224-1 - Privacy Act Notification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Privacy Act Notification... Privacy Act Notification. (a) As prescribed in 1424.104, the clause at FAR 52.224-1, Privacy Act... the clause to read “Privacy Act Notification (JUL 1996) (Deviation)”; and (2) Adding the following...

  6. 10 CFR 75.44 - Timing of advance notification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Timing of advance notification. 75.44 Section 75.44 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT Advanced Notification and Expenses § 75.44 Timing of advance notification. (a) Except as provided...

  7. 10 CFR 75.44 - Timing of advance notification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Timing of advance notification. 75.44 Section 75.44 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT Advanced Notification and Expenses § 75.44 Timing of advance notification. (a) Except as provided...

  8. 7 CFR 1735.9 - USDA Rural Development State Director notification.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 11 2014-01-01 2014-01-01 false USDA Rural Development State Director notification....9 USDA Rural Development State Director notification. Applicants shall complete a notification form which will be a public document that the RUS provides to USDA Rural Development State Directors and...

  9. Direct memory access transfer completion notification

    DOEpatents

    Archer, Charles J [Rochester, MN; Blocksome, Michael A [Rochester, MN; Parker, Jeffrey J [Rochester, MN

    2011-02-15

    DMA transfer completion notification includes: inserting, by an origin DMA engine on an origin node in an injection first-in-first-out (`FIFO`) buffer, a data descriptor for an application message to be transferred to a target node on behalf of an application on the origin node; inserting, by the origin DMA engine, a completion notification descriptor in the injection FIFO buffer after the data descriptor for the message, the completion notification descriptor specifying a packet header for a completion notification packet; transferring, by the origin DMA engine to the target node, the message in dependence upon the data descriptor; sending, by the origin DMA engine, the completion notification packet to a local reception FIFO buffer using a local memory FIFO transfer operation; and notifying, by the origin DMA engine, the application that transfer of the message is complete in response to receiving the completion notification packet in the local reception FIFO buffer.

  10. Direct memory access transfer completion notification

    DOEpatents

    Archer, Charles J.; Blocksome, Michael A.; Parker, Jeffrey J.

    2010-08-17

    Methods, apparatus, and products are disclosed for DMA transfer completion notification that include: inserting, by an origin DMA engine on an origin compute node in an injection FIFO buffer, a data descriptor for an application message to be transferred to a target compute node on behalf of an application on the origin compute node; inserting, by the origin DMA engine, a completion notification descriptor in the injection FIFO buffer after the data descriptor for the message, the completion notification descriptor specifying an address of a completion notification field in application storage for the application; transferring, by the origin DMA engine to the target compute node, the message in dependence upon the data descriptor; and notifying, by the origin DMA engine, the application that the transfer of the message is complete, including performing a local direct put operation to store predesignated notification data at the address of the completion notification field.

  11. A data-management system using sensor technology and wireless devices for port security

    NASA Astrophysics Data System (ADS)

    Saldaña, Manuel; Rivera, Javier; Oyola, Jose; Manian, Vidya

    2014-05-01

    Sensor technologies such as infrared sensors and hyperspectral imaging, video camera surveillance are proven to be viable in port security. Drawing from sources such as infrared sensor data, digital camera images and processed hyperspectral images, this article explores the implementation of a real-time data delivery system. In an effort to improve the manner in which anomaly detection data is delivered to interested parties in port security, this system explores how a client-server architecture can provide protected access to data, reports, and device status. Sensor data and hyperspectral image data will be kept in a monitored directory, where the system will link it to existing users in the database. Since this system will render processed hyperspectral images that are dynamically added to the server - which often occupy a large amount of space - the resolution of these images is trimmed down to around 1024×768 pixels. Changes that occur in any image or data modification that originates from any sensor will trigger a message to all users that have a relation with the aforementioned. These messages will be sent to the corresponding users through automatic email generation and through a push notification using Google Cloud Messaging for Android. Moreover, this paper presents the complete architecture for data reception from the sensors, processing, storage and discusses how users of this system such as port security personnel can use benefit from the use of this service to receive secure real-time notifications if their designated sensors have detected anomalies and/or have remote access to results from processed hyperspectral imagery relevant to their assigned posts.

  12. Assessment of preventive measures for accidental blood exposure in operating theaters: a survey of 20 hospitals in Northern France.

    PubMed

    Tarantola, Arnaud; Golliot, Franck; L'Heriteau, François; Lebascle, Karin; Ha, Catherine; Farret, Danièle; Bignon, Sylvie; Smaïl, Amar; Doutrellot-Philippon, Catherine; Astagneau, Pascal; Bouvet, Elisabeth

    2006-08-01

    Accidental exposures to blood of body fluids (ABE) expose health care workers (HCW) to the risk of occupational infection. Our aim was to assess the prevention equipment available in the operating theater (OT) with reference to guidelines or recommendations and its use by the staff in that OT on that day and past history of ABE. Correspondents of the Centre de Coordination de la Lutte contre les Infections Nosocomiales (CCLIN) Paris-Nord ABE Surveillance Taskforce carried out an observational multicenter survey in 20 volunteer French hospitals. In total, 260 operating staff (including 151 surgeons) were investigated. Forty-nine of the 260 (18.8%) staff said they double-gloved for all patients and procedures, changing gloves hourly. Blunt-tipped suture needles were available in 49.1% of OT; 42 of 76 (55.3%) of the surgeons in these OT said they never used them. Overall, 60% and 64% of surgeons had never self-tested for HIV and hepatitis C virus (HCV), respectively. Fifty-five surgeons said they had sustained a total of 96 needlestick injuries during the month preceding the survey. Ten of these surgeons had notified of 1 needlestick injury each to the occupational health department of their hospital (notification rate, 10.4%). The occurrence of needlestick injury remained high in operating personnel in France in 2000. Although hospitals may improve access to protective devices, operating staff mindful of safety in the OT should increase their use of available devices, their knowledge of their own serostatus, and their ABE notification rate to guide well-targeted prevention efforts.

  13. 22 CFR 96.101 - Notification of temporary accreditation decisions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... uniform notification date to be established by the Secretary pursuant to § 96.58(a). On that date, the... accreditation decisions to any agency or to the public until the uniform notification date. If the Secretary requests information on the interim or final status of an agency prior to the uniform notification date...

  14. 43 CFR 29.8 - Notification and advertisement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Notification and advertisement. 29.8... LIABILITY FUND § 29.8 Notification and advertisement. (a) As soon as the person in charge of a vessel has... and the National Response Center, (800) 424-6802, of the incident. Notification under this section is...

  15. 28 CFR 72.3 - Applicability of the Sex Offender Registration and Notification Act.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Applicability of the Sex Offender...) SEX OFFENDER REGISTRATION AND NOTIFICATION § 72.3 Applicability of the Sex Offender Registration and Notification Act. The requirements of the Sex Offender Registration and Notification Act apply to all sex...

  16. 28 CFR 72.3 - Applicability of the Sex Offender Registration and Notification Act.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Applicability of the Sex Offender...) SEX OFFENDER REGISTRATION AND NOTIFICATION § 72.3 Applicability of the Sex Offender Registration and Notification Act. The requirements of the Sex Offender Registration and Notification Act apply to all sex...

  17. 28 CFR 72.3 - Applicability of the Sex Offender Registration and Notification Act.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Applicability of the Sex Offender...) SEX OFFENDER REGISTRATION AND NOTIFICATION § 72.3 Applicability of the Sex Offender Registration and Notification Act. The requirements of the Sex Offender Registration and Notification Act apply to all sex...

  18. 28 CFR 72.3 - Applicability of the Sex Offender Registration and Notification Act.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Applicability of the Sex Offender...) SEX OFFENDER REGISTRATION AND NOTIFICATION § 72.3 Applicability of the Sex Offender Registration and Notification Act. The requirements of the Sex Offender Registration and Notification Act apply to all sex...

  19. 28 CFR 72.3 - Applicability of the Sex Offender Registration and Notification Act.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Applicability of the Sex Offender...) SEX OFFENDER REGISTRATION AND NOTIFICATION § 72.3 Applicability of the Sex Offender Registration and Notification Act. The requirements of the Sex Offender Registration and Notification Act apply to all sex...

  20. 12 CFR 12.5 - Notification by agreement; alternative forms and times of notification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Notification by agreement; alternative forms and times of notification. 12.5 Section 12.5 Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY RECORDKEEPING AND CONFIRMATION REQUIREMENTS FOR SECURITIES TRANSACTIONS § 12.5...

  1. 40 CFR 63.1210 - What are the notification requirements?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... change in information already provided under § 63.9. 63.1206(b)(5)(i) Notification of changes in design...), 63.9(e) 63.9(g)(1) and (3) Notification of performance test and continuous monitoring system evaluation, including the performance test plan and CMS performance evaluation plan.1 63.1210(b) Notification...

  2. 40 CFR 63.1210 - What are the notification requirements?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... change in information already provided under § 63.9. 63.1206(b)(5)(i) Notification of changes in design...), 63.9(e) 63.9(g)(1) and (3) Notification of performance test and continuous monitoring system evaluation, including the performance test plan and CMS performance evaluation plan.1 63.1210(b) Notification...

  3. 20 CFR 367.7 - Change in notification to another government agency.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... AND PROCEDURES RECOVERY OF DEBTS OWED TO THE UNITED STATES GOVERNMENT BY ADMINISTRATIVE OFFSET § 367.7 Change in notification to another government agency. If, after submitting notification of liability for a... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false Change in notification to another government...

  4. 43 CFR 29.8 - Notification and advertisement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Notification and advertisement. 29.8... LIABILITY FUND § 29.8 Notification and advertisement. (a) As soon as the person in charge of a vessel has... and the National Response Center, (800) 424-6802, of the incident. Notification under this section is...

  5. 49 CFR 573.13 - Reimbursement for pre-notification remedies.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Reimbursement for pre-notification remedies. 573... RESPONSIBILITY AND REPORTS § 573.13 Reimbursement for pre-notification remedies. (a) Pursuant to 49 U.S.C. 30120... seeks reimbursement for the costs of a pre-notification remedy for which he or she paid. (3) Pre...

  6. 49 CFR 573.13 - Reimbursement for pre-notification remedies.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Reimbursement for pre-notification remedies. 573... RESPONSIBILITY AND REPORTS § 573.13 Reimbursement for pre-notification remedies. (a) Pursuant to 49 U.S.C. 30120... seeks reimbursement for the costs of a pre-notification remedy for which he or she paid. (3) Pre...

  7. 49 CFR 573.13 - Reimbursement for pre-notification remedies.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 7 2013-10-01 2013-10-01 false Reimbursement for pre-notification remedies. 573... RESPONSIBILITY AND REPORTS § 573.13 Reimbursement for pre-notification remedies. (a) Pursuant to 49 U.S.C. 30120... seeks reimbursement for the costs of a pre-notification remedy for which he or she paid. (3) Pre...

  8. 49 CFR 573.13 - Reimbursement for pre-notification remedies.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 7 2012-10-01 2012-10-01 false Reimbursement for pre-notification remedies. 573... RESPONSIBILITY AND REPORTS § 573.13 Reimbursement for pre-notification remedies. (a) Pursuant to 49 U.S.C. 30120... seeks reimbursement for the costs of a pre-notification remedy for which he or she paid. (3) Pre...

  9. 78 FR 13995 - Delegation of Authority To Submit to the Congress Certain Certifications, Reports, and Notifications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-01

    ...--Delegation of Authority To Submit to the Congress Certain Certifications, Reports, and Notifications #0; #0... Delegation of Authority To Submit to the Congress Certain Certifications, Reports, and Notifications... make all certifications, reports, and notifications to the Congress prior to entry into force of the...

  10. 77 FR 8245 - Commission Information Collection Activities (FERC-65, FERC-65A, and FERC-65B); Comment Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... collections, FERC-65, FERC-65A, and FERC-65B (Notification of Holding Company Status, Exemption Notification of Holding Company Status, and Waiver Notification of Holding Company Status). DATES: Comments on the... (202) 273-0873. SUPPLEMENTARY INFORMATION: Title: Notification of Holding Company Status (FERC-65...

  11. 48 CFR 52.222-29 - Notification of visa denial.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 2 2011-10-01 2011-10-01 false Notification of visa....222-29 Notification of visa denial. As prescribed in 22.810(g), insert the following clause: Notification of Visa Denial (JUN 2003) It is a violation of Executive Order 11246 for a Contractor to refuse to...

  12. 48 CFR 52.222-29 - Notification of visa denial.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 2 2014-10-01 2014-10-01 false Notification of visa....222-29 Notification of visa denial. As prescribed in 22.810(g), insert the following clause: Notification of Visa Denial (JUN 2003) It is a violation of Executive Order 11246 for a Contractor to refuse to...

  13. 48 CFR 52.222-29 - Notification of visa denial.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 2 2012-10-01 2012-10-01 false Notification of visa....222-29 Notification of visa denial. As prescribed in 22.810(g), insert the following clause: Notification of Visa Denial (JUN 2003) It is a violation of Executive Order 11246 for a Contractor to refuse to...

  14. 48 CFR 52.222-29 - Notification of visa denial.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 2 2013-10-01 2013-10-01 false Notification of visa....222-29 Notification of visa denial. As prescribed in 22.810(g), insert the following clause: Notification of Visa Denial (JUN 2003) It is a violation of Executive Order 11246 for a Contractor to refuse to...

  15. 48 CFR 52.222-29 - Notification of visa denial.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Notification of visa....222-29 Notification of visa denial. As prescribed in 22.810(g), insert the following clause: Notification of Visa Denial (JUN 2003) It is a violation of Executive Order 11246 for a Contractor to refuse to...

  16. 21 CFR 170.106 - Notification for a food contact substance formulation (NFCSF).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.106 Notification for a... accept an NFCSF, any food additive that is a component of the formulation must be authorized for its... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Notification for a food contact substance...

  17. 16 CFR 802.21 - Acquisitions of voting securities not meeting or exceeding greater notification threshold (as...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... meeting or exceeding greater notification threshold (as adjusted). 802.21 Section 802.21 Commercial... meeting or exceeding greater notification threshold (as adjusted). (a) An acquisition of voting securities... of the acquiring person to meet or exceed a notification threshold (as adjusted) greater than the...

  18. 16 CFR 802.21 - Acquisitions of voting securities not meeting or exceeding greater notification threshold (as...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... meeting or exceeding greater notification threshold (as adjusted). 802.21 Section 802.21 Commercial... meeting or exceeding greater notification threshold (as adjusted). (a) An acquisition of voting securities... of the acquiring person to meet or exceed a notification threshold (as adjusted) greater than the...

  19. 16 CFR 802.21 - Acquisitions of voting securities not meeting or exceeding greater notification threshold (as...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... meeting or exceeding greater notification threshold (as adjusted). 802.21 Section 802.21 Commercial... meeting or exceeding greater notification threshold (as adjusted). (a) An acquisition of voting securities... of the acquiring person to meet or exceed a notification threshold (as adjusted) greater than the...

  20. How complete and accurate is meningococcal disease notification?

    PubMed

    Breen, E; Ghebrehewet, S; Regan, M; Thomson, A P J

    2004-12-01

    Effective public health control of meningococcal disease (meningococcal meningitis and septicaemia) is dependent on complete, accurate and speedy notification. Using capture-recapture techniques this study assesses the completeness, accuracy and timeliness of meningococcal notification in a health authority. The completeness of meningococcal disease notification was 94.8% (95% confidence interval 93.2% to 96.2%); 91.2% of cases in 2001 were notified within 24 hours of diagnosis, but 28.0% of notifications in 2001 were false positives. Clinical staff need to be aware of the public health implications of a notification of meningococcal disease, and of failure of, or delay in notification. Incomplete or delayed notification not only leads to inaccurate data collection but also means that important public health measures may not be taken. A clinical diagnosis of meningococcal disease should be carefully considered between the clinician and the consultant in communicable disease control (CCDC). Otherwise, prophylaxis may be given unnecessarily, disease incidence inflated, and the benefits of control measures underestimated. Consultants in communicable disease control (CCDCs), in conjunction with clinical staff, should de-notify meningococcal disease if the diagnosis changes.

  1. Significance of Psychological Stress Response and Health-related Quality of Life in Spouses of Cancer Patients When Given Bad News

    PubMed Central

    Kugimoto, Toyoko; Katsuki, Ryo; Kosugi, Toshifumi; Ohta, Akihide; Sato, Hidetoshi

    2017-01-01

    Objective: This study illuminates the degree of psychological stress response experienced by spouses of cancer patients when given bad news at three different times (notification of the name of the disease, notification of recurrence, and notification of terminality) as well as the factors that influence the response and the health status of the spouse as measured by health-related quality of life (QOL). Methods: A total of 203 individuals (57 men and 146 women) who had received the three types of news were surveyed using a self-report questionnaire on psychological stress response, marital satisfaction, and health-related QOL scales. Results: The degree of the psychological stress response was the highest for notification of terminality, followed by notification of the name of the disease, and notification of recurrence. The influencing factors varied depending on the notification period. Although no significant difference was observed for health-related QOL among the three notification types, significant differences were observed for certain items when compared with national standard values. Conclusions: When a notification of terminality, which produced the highest psychological stress response, is given, providing care that considers health-related QOL is necessary not only for patients but also for their spouses. PMID:28503648

  2. Testing-adjusted chlamydia notification trends in New South Wales, Australia, 2000 to 2010.

    PubMed

    Cretikos, Michelle; Mayne, Darren; Reynolds, Roderick; Spokes, Paula; Madeddu, Daniel

    2014-01-01

    Between 2005 and 2010, Australian notification rates for chlamydia infection increased by 64% from 203 to 333 per 100 000 population. Interpreting this trend is difficult without examining rates and local patterns of testing. We examined the effect of adjusting for local testing rates on chlamydia notification trends in New South Wales (NSW), Australia from 2000 to 2010. We used testing data for NSW residents for Medicare Benefits Schedule items for chlamydia from 1 July 1999 to 30 June 2005 and 1 July 2007 to 30 June 2010. This data set excluded testing by public sector laboratories. We also obtained laboratory-confirmed genital chlamydia notifications in NSW residents for 1 July 1999 to 30 June 2010 and excluded notifications from public laboratories. We used negative binomial regression to assess trends in chlamydia notification rates by age and sex after adjusting for local government area (LGA)-level Medicare-funded testing rates, socioeconomic disadvantage, remoteness and Medicare provider density. Testing-adjusted rates of chlamydia notifications declined by 5.2% per annum (rate ratio [RR] = 0.95, 95% confidence interval (CI) = 0.93-0.96) for women overall, and 2.3% (RR = 0.98, 95% CI = 0.96-1.00) and 5.0% per annum (RR = 0.95, 95% CI = 0.93-0.98) for men in LGAs with moderate and high densities of Medicare providers, respectively. Notification rates remained stable for men in low Medicare provider density LGAs (RR = 1.01, 95% CI = 0.96-1.07). It is likely that increased testing for chlamydia has driven increases in chlamydia notification in NSW over the last decade. Notification data provide no evidence for a general increase in the prevalence of chlamydia in the NSW community for this period. Notification-based chlamydia surveillance should be routinely adjusted for local testing rates.

  3. Meat and meat products – analysis of the most common threats in the years 2011-2015 in Rapid Alert System for Food and Feed (RASFF)

    PubMed

    Kononiuk, Anna D.; Karwowska, Małgorzata

    The key tool used in the European Union in order to eliminate the risks associated with the consumption of potentially hazardous food is RASFF - Rapid Alert System for Food and Feed Safety. The RASFF was established to increase accountability and strengthening cooperation between states of the European Union in the field of food safety control. The aim of this study was to explore the trends and temporal and spatial distribution of notifications on food safety hazards between January 2011 and December 2015 with a special emphasis on meat and meat products on the basis of notification from RASFF. The study analyzed notifications on the annual reports of the RASFF published by the European Commission and requests added to the portal RASFF in the period 01.01.2011 - 31.12.2015 on the category of “meat and meat products (other than poultry) and “poultry meat and poultry meat products”. Analysis included detailed information on each notification, such as the classification and date, hazard category, notifying country, country origin. The most common classifications of notification were ‘alert’ and ‘border rejection’. Generally, basis of this notifications were ‘company’s own check’ and ‘official control on the market’. Pathogenic microorganisms were the most often hazard of category in which the higher number of notifications concerned with Salmonella spp. Alert notification which is the most dangerous for consumers were the most common type of classification for notifications on ‘meat and meat product’ category. The most of notifications in category ‘poultry meat and poultry meat products’ were the result of border control. Pathogenic microorganisms were the reason for the huge number of notifications in studied product categories. Many of notifications were associated with products which origin countries were outside RASFF member states.

  4. Communicable Diseases Network Australia National Arbovirus and Malaria Advisory Committee annual report, 2005-06.

    PubMed

    Liu, Conan; Johansen, Cheryl; Kurucz, Nina; Whelan, Peter

    2006-01-01

    This report describes the epidemiology of mosquito-borne disease in Australia for the mosquito-borne disease season 1 July 2005 to 30 June 2006, in which the second largest number of notifications since 1995-96 was reported. Ross River virus (RRV) infections (66%), Barmah Forest virus (BFV) infections (23%) and malaria (9%) were the most common mosquito-borne diseases reported in 2005-06. National RRV notifications were the fifth largest on record. The Northern Territory had the highest rate of RRV notifications and the peak notification rate (in January 2006) was the third highest since 2000. National BFV notification rates were the highest on record. The Northern Territory also reported the highest BFV notification rate this season, peaking in February-March 2006, which was the highest reported BFV notification rate on record. BFV notification rates were significantly higher in teenagers compared to previous seasons. There were 731 notifications of malaria in 2005-06 of which none was reported as locally acquired. This was the third highest reporting period for malaria notifications since 2000. In contrast to previous years in which Plasmodium vivax was the predominant species, Plasmodium falciparum was reported as the infecting species in 45 per cent of the malaria notifications and Plasmodium vivax for 42 per cent of cases. Young adults in the 20-24 year age group had the highest number of cases and children in the 5-9 year age group accounted for 22 per cent of notifications. There were two cases of Kunjin virus (KUNV) infection and one case of Murray Valley encephalitis virus (MVEV) infection reported in 2005-06, all from Western Australia. Sentinel chicken surveillance data for flaviviruses and sentinel pig surveillance data for Japanese encephalitis virus are reported. There were 200 notifications of dengue virus (DENV) infection in 2005-06, of which 46 per cent (n = 92) was reported as having been acquired overseas. Dengue serotypes 2 and 3 were detected in two outbreaks of locally-acquired dengue in Queensland this season.

  5. 30 CFR 50.10 - Immediate notification.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., ILLNESSES, EMPLOYMENT, AND PRODUCTION IN MINES NOTIFICATION, INVESTIGATION, REPORTS AND RECORDS OF ACCIDENTS, INJURIES, ILLNESSES, EMPLOYMENT, AND COAL PRODUCTION IN MINES Notification, Investigation, Preservation of...

  6. 30 CFR 50.10 - Immediate notification.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., ILLNESSES, EMPLOYMENT, AND PRODUCTION IN MINES NOTIFICATION, INVESTIGATION, REPORTS AND RECORDS OF ACCIDENTS, INJURIES, ILLNESSES, EMPLOYMENT, AND COAL PRODUCTION IN MINES Notification, Investigation, Preservation of...

  7. 30 CFR 50.10 - Immediate notification.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., ILLNESSES, EMPLOYMENT, AND PRODUCTION IN MINES NOTIFICATION, INVESTIGATION, REPORTS AND RECORDS OF ACCIDENTS, INJURIES, ILLNESSES, EMPLOYMENT, AND COAL PRODUCTION IN MINES Notification, Investigation, Preservation of...

  8. 30 CFR 50.10 - Immediate notification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., ILLNESSES, EMPLOYMENT, AND PRODUCTION IN MINES NOTIFICATION, INVESTIGATION, REPORTS AND RECORDS OF ACCIDENTS, INJURIES, ILLNESSES, EMPLOYMENT, AND COAL PRODUCTION IN MINES Notification, Investigation, Preservation of...

  9. 23 CFR 1215.6 - Review and notification of compliance status.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Review and notification of compliance status. 1215.6... FHWA will review appropriate State laws for compliance with 23 U.S.C. 153. States initially found to be... § 1215.6 Review and notification of compliance status. Review of each State's laws and notification of...

  10. 12 CFR Appendix C to Part 202 - Sample Notification Forms

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 2 2011-01-01 2011-01-01 false Sample Notification Forms C Appendix C to Part... CREDIT OPPORTUNITY ACT (REGULATION B) Pt. 202, App. C Appendix C to Part 202—Sample Notification Forms 1. This appendix contains ten sample notification forms. Forms C-1 through C-4 are intended for use in...

  11. 12 CFR Appendix C to Part 202 - Sample Notification Forms

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 2 2014-01-01 2014-01-01 false Sample Notification Forms C Appendix C to Part... CREDIT OPPORTUNITY ACT (REGULATION B) Pt. 202, App. C Appendix C to Part 202—Sample Notification Forms 1. This appendix contains ten sample notification forms. Forms C-1 through C-4 are intended for use in...

  12. Implementation of Epic Beaker Clinical Pathology at Stanford University Medical Center.

    PubMed

    Tan, Brent T; Fralick, Jennifer; Flores, William; Schrandt, Cary; Davis, Vicki; Bruynell, Tom; Wilson, Lisa; Christopher, John; Weber, Shirley; Shah, Neil

    2017-03-01

    To provide an account of implementation of the Epic Beaker 2014 clinical pathology module at Stanford University Medical Center and highlight strengths and weaknesses of the system. Based on a formal selection process, Stanford selected Epic Beaker to replace Sunquest as the clinical laboratory information system (LIS). The rationale included integration between the LIS and already installed Epic electronic medical record (EMR), reduction in the number of systems and interfaces, and positive patient identification (PPID). The build was significantly customized and included a first of its kind Epic-to-Epic interface. This was due to the clinical laboratory serving two hospitals (pediatric and adult) with independent instances of Epic. Test turnaround times showed improvement from historical baselines, mostly because of the implementation of PPID. PPID also resulted in significant reduction in mislabeled specimens. Epic 2014 Beaker clinical pathology is a viable LIS with adequate functionality for a large academic center. Strengths include PPID and integration with the EMR. Integration provides laboratory users with ready access to the patient's relevant clinical history to assist releasing of results and gives physician and nurse providers sophisticated add-on ordering and specimen collection workflows. Areas that could use further development include specimen aliquoting, quality control reporting, and maintenance tools. © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  13. School-based BMI and body composition screening and parent notification in California: methods and messages.

    PubMed

    Madsen, Kristine A; Linchey, Jennifer

    2012-06-01

    School-based body mass index (BMI) or body composition screening is increasing, but little is known about the process of parent notification. Since 2001, California has required annual screening of body composition via the FITNESSGRAM, with optional notification. This study sought to identify the prevalence of parental notification when screening is required but notification is optional, and the methods and messages used. Researchers conducted phone interviews with 851 school districts (89%) in California and reviewed notification materials from 54 districts. As of 2008, 53% of California districts notified parents of screening results. Many districts (24%) did not know the reason for their notification policy. Most districts notified parents via a letter mailed home (70%) or sent home with the child (18%). Whereas 79% of sample letters provided students' BMI, only 12% provided an explanation of BMI, and only half provided tips on what parents should do if concerned about their child's results. In California, where body composition screening is required but parent notification is not, approximately half of school districts elect to notify parents of results, most commonly via letter. Most letters do not explain BMI or percent body fat scores, nor do they suggest what parents should do for a child identified as at-risk. Further research to identify interpretable and actionable notification messages for parents will be critical if school-based BMI and body composition screening and notification is to reduce childhood obesity. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

  14. Patient preferences for partner notification.

    PubMed

    Apoola, A; Radcliffe, K W; Das, S; Robshaw, V; Gilleran, G; Kumari, B S; Boothby, M; Rajakumar, R

    2006-08-01

    To identify patient preferences for notification of sexual contacts when a sexually transmitted infection (STI) is diagnosed. A questionnaire survey of 2544 patients attending three large genitourinary clinics at Derby, Birmingham, and Coventry in the United Kingdom. The median age of the respondents was 24 with 1474 (57.9%) women, 1835 (72.1%) white, 1826 (71.8%) single. The most favoured method of partner notification was patient referral, which was rated a "good" method by 65.8% when they had to be contacted because a sexual partner has an STI. Notifying contacts by letter as a method of provider partner notification is more acceptable than phoning, text messaging, or email. Respondents with access to mobile telephones, private emails, and private letters were more likely to rate a method of partner notification using that mode of communication as "good" compared to those without. With provider referral methods of partner notification respondents preferred to receive a letter, email, or text message asking them to contact the clinic rather than a letter, email or text message informing them that they may have an STI. Most respondents think that being informed directly by a partner is the best method of being notified of the risk of an STI. Some of the newer methods may not be acceptable to all but a significant minority of respondents prefer these methods of partner notification. The wording of letters, emails, or text messages when used for partner notification has an influence on the acceptability of the method and may influence success of the partner notification method. Services should be flexible enough to utilise the patients' preferred method of partner notification.

  15. Advancing Partner Notification Through Electronic Communication Technology: A Review of Acceptability and Utilization Research.

    PubMed

    Pellowski, Jennifer; Mathews, Catherine; Kalichman, Moira O; Dewing, Sarah; Lurie, Mark N; Kalichman, Seth C

    2016-06-01

    A cornerstone of sexually transmitted infection (STI) prevention is the identification, tracing, and notification of sex partners of index patients. Although partner notification reduces disease burden and prevents new infections as well as reinfections, studies show that only a limited number of partners are ever notified. Electronic communication technologies, namely, the Internet, text messaging, and phone calls (i.e., e-notification), have the potential to expand partner services. We conducted a systematic review of studies that have investigated the acceptability and utility of e-notification. We identified 23 studies that met the following criteria: (a) 9 studies presented data on the acceptability of technology-based communications for contacting sex partner(s), and (b) 14 studies reported on the utilization of communication technologies for partner notification. Studies found high levels of interest in and acceptability of e-notification; however, there was little evidence for actual use of e-notification. Taken together, results suggest that electronic communications could have their greatest impact in notifying less committed partners who would otherwise be uninformed of their STI exposure. In addition, all studies to date have been conducted in resource-rich countries, although the low cost of e-notification may have its greatest impact in resource-constrained settings. Research is needed to determine the best practices for exploiting the opportunities afforded by electronic communications for expanding STI partner services.

  16. 50 CFR 665.803 - Notifications.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... notification of the trip type (either deep-setting or shallow-setting). (b) The permit holder, or designated... in processing an application, permit holders failing to receive important notifications, or sanctions...

  17. 78 FR 53774 - Guide for the Evaluation of Alert and Notification Systems for Nuclear Power Plants, FEMA-REP-10...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    ...] Guide for the Evaluation of Alert and Notification Systems for Nuclear Power Plants, FEMA-REP-10, Rev. 1... the Guide for the Evaluation of Alert and Notification Systems for Nuclear Power Plants, FEMA-REP-10... Agency (FEMA) issued FEMA-REP-10, Guide for the Evaluation of Alert and Notification Systems for Nuclear...

  18. Information Security and Data Breach Notification Safeguards

    DTIC Science & Technology

    2007-07-31

    for unauthorized purposes. Data breach notification requirements obligate covered entities to provide notice to affected persons (e.g., cardholders...customers) about the occurrence of a data security breach involving personally identifiable information. The first data breach notification law was...computerized personal information to disclose any breach of a resident’s personal information. S.B. 1386 was the model for subsequent data breach notification

  19. Federal Information Security and Data Breach Notification Laws

    DTIC Science & Technology

    2009-01-29

    The following report describes information security and data breach notification requirements included in the Privacy Act, the Federal Information...information for unauthorized purposes. Data breach notification laws typically require covered entities to implement a breach notification policy, and...Feinstein), S. 495 (Leahy), and S. 1178 (Inouye)--were reported favorably out of Senate committees. Those bills include information security and data

  20. Age differences in the takeover of vehicle control and engagement in non-driving-related activities in simulated driving with conditional automation.

    PubMed

    Clark, Hallie; Feng, Jing

    2017-09-01

    High-level vehicle automation has been proposed as a valuable means to enhance the mobility of older drivers, as older drivers experience age-related declines in many cognitive functions that are vital for safe driving. Recent research attempted to examine age differences in how engagement in non-driving-related activities impact driving performance, by instructing drivers to engage in mandatory pre-designed activities. While the mandatory engagement method allows a precise control of the timing and mental workload of the non-driving-related activities, it is different from how a driver would naturally engage in these activities. This study allowed younger (age 18-35, mean age=19.9years) and older drivers (age 62-81, mean age=70.4years) to freely decide when and how to engage in voluntarily chosen non-driving-related activities during simulated driving with conditional automation. We coded video recordings of participants' engagement in non-driving-related activities. We examined the effect of age, level of activity-engagement and takeover notification interval on vehicle control performance during the takeover, by comparing between the high and low engagement groups in younger and older drivers, across two takeover notification interval conditions. We found that both younger and older drivers engaged in various non-driving-related activities during the automated driving portion, with distinct preferences on the type of activity for each age group (i.e., while younger drivers mostly used an electronic device, older drivers tended to converse). There were also significant differences between the two age groups and between the two notification intervals on various driving performance measures. Older drivers benefited more than younger drivers from the longer interval in terms of response time to notifications. Voluntary engagement in non-driving-related activities did not impair takeover performance in general, although there was a trend of older drivers who were more engaged in non-driving-related activities braking harder than those with low activity-engagement during the takeover. Published by Elsevier Ltd.

  1. Stretchable Loudspeaker using Liquid Metal Microchannel

    PubMed Central

    Jin, Sang Woo; Park, Jeongwon; Hong, Soo Yeong; Park, Heun; Jeong, Yu Ra; Park, Junhong; Lee, Sang-Soo; Ha, Jeong Sook

    2015-01-01

    Considering the various applications of wearable and bio-implantable devices, it is desirable to realize stretchable acoustic devices for body-attached applications such as sensing biological signals, hearing aids, and notification of information via sound. In this study, we demonstrate the facile fabrication of a Stretchable Acoustic Device (SAD) using liquid metal coil of Galinstan where the SAD is operated by the electromagnetic interaction between the liquid metal coil and a Neodymium (Nd) magnet. To fabricate a liquid metal coil, Galinstan was injected into a micro-patterned elastomer channel. This fabricated SAD was operated simultaneously as a loudspeaker and a microphone. Measurements of the frequency response confirmed that the SAD was mechanically stable under both 50% uniaxial and 30% biaxial strains. Furthermore, 2000 repetitive applications of a 50% uniaxial strain did not induce any noticeable degradation of the sound pressure. Both voice and the beeping sound of an alarm clock were successfully recorded and played back through our SAD while it was attached to the wrist under repeated deformation. These results demonstrate the high potential of the fabricated SAD using Galinstan voice coil in various research fields including stretchable, wearable, and bio-implantable acoustic devices. PMID:26181209

  2. Stretchable Loudspeaker using Liquid Metal Microchannel

    NASA Astrophysics Data System (ADS)

    Jin, Sang Woo; Park, Jeongwon; Hong, Soo Yeong; Park, Heun; Jeong, Yu Ra; Park, Junhong; Lee, Sang-Soo; Ha, Jeong Sook

    2015-07-01

    Considering the various applications of wearable and bio-implantable devices, it is desirable to realize stretchable acoustic devices for body-attached applications such as sensing biological signals, hearing aids, and notification of information via sound. In this study, we demonstrate the facile fabrication of a Stretchable Acoustic Device (SAD) using liquid metal coil of Galinstan where the SAD is operated by the electromagnetic interaction between the liquid metal coil and a Neodymium (Nd) magnet. To fabricate a liquid metal coil, Galinstan was injected into a micro-patterned elastomer channel. This fabricated SAD was operated simultaneously as a loudspeaker and a microphone. Measurements of the frequency response confirmed that the SAD was mechanically stable under both 50% uniaxial and 30% biaxial strains. Furthermore, 2000 repetitive applications of a 50% uniaxial strain did not induce any noticeable degradation of the sound pressure. Both voice and the beeping sound of an alarm clock were successfully recorded and played back through our SAD while it was attached to the wrist under repeated deformation. These results demonstrate the high potential of the fabricated SAD using Galinstan voice coil in various research fields including stretchable, wearable, and bio-implantable acoustic devices.

  3. Improving sexually transmitted infection results notification via mobile phone technology.

    PubMed

    Reed, Jennifer L; Huppert, Jill S; Taylor, Regina G; Gillespie, Gordon L; Byczkowski, Terri L; Kahn, Jessica A; Alessandrini, Evaline A

    2014-11-01

    To improve adolescent notification of positive sexually transmitted infection (STI) tests using mobile phone technology and STI information cards. A randomized intervention among 14- to 21-year olds in a pediatric emergency department (PED). A 2 × 3 factorial design with replication was used to evaluate the effectiveness of six combinations of two factors on the proportion of STI-positive adolescents notified within 7 days of testing. Independent factors included method of notification (call, text message, or call + text message) and provision of an STI information card with or without a phone number to obtain results. Covariates for logistic regression included age, empiric STI treatment, days until first attempted notification, and documentation of confidential phone number. Approximately half of the 383 females and 201 males enrolled were ≥18 years of age. Texting only or type of card was not significantly associated with patient notification rates, and there was no significant interaction between card and notification method. For females, successful notification was significantly greater for call + text message (odds ratio, 3.2; 95% confidence interval, 1.4-6.9), and documenting a confidential phone number was independently associated with successful notification (odds ratio, 3.6; 95% confidence interval, 1.7-7.5). We found no significant predictors of successful notification for males. Of patients with a documented confidential phone number who received a call + text message, 94% of females and 83% of males were successfully notified. Obtaining a confidential phone number and using call + text message improved STI notification rates among female but not male adolescents in a pediatric emergency department. Copyright © 2014 Society for Adolescent Health and Medicine. All rights reserved.

  4. Anticipated Notification of Sexual Partners following STD Diagnosis among Men Who Have Sex with Men and Transgender Women in Lima, Peru: A Mixed Methods Analysis.

    PubMed

    Clark, Jesse L; Perez-Brumer, Amaya G; Segura, Eddy R; Salvatierra, Hector J; Sanchez, Jorge; Lama, Javier R

    New strategies to support partner notification (PN) are critical for STD control and require detailed understanding of how specific individual and partnership characteristics guide notification decisions. From 2011 to 2012, 397 MSM and TW recently diagnosed with HIV, syphilis, or another STD completed a survey on anticipated notification of recent sexual partners and associated factors. Qualitative interviews were conducted with a subset of participants to provide further depth to quantitative findings. Prevalence ratios and generalized estimating equation (GEE) models were used to analyze participant- and partner-level factors associated with anticipated PN. Among all partners reported, 52.5% were described as "Very Likely" or "Somewhat Likely" to be notified. Anticipated notification was more likely for main partners than casual (adjusted Prevalence Ratio [aPR], 95% CI: 0.63, 0.54-0.75) or commercial (aPR, 95% CI: 0.44, 0.31-0.62) partners. Other factors associated with likely notification included perception of the partner as an STD source (aPR, 95% CI: 1.27, 1.10-1.48) and anticipated future sexual contact with the partner (aPR, 95% CI: 1.30, 1.11-1.52). An HIV diagnosis was associated with a lower likelihood of notification than non-HIV STDs (aPR: 0.68, 0.55-0.86). Qualitative discussion of the barriers and incentives to PN reflected a similar differentiation of anticipated notification according to partnership type and type of HIV/STD diagnosis. Detailed attention to how partnership characteristics guide notification outcomes is essential to the development of new PN strategies. By accurately and thoroughly assessing the diversity of partnership interactions among individuals with HIV/STD, new notification techniques can be tailored to partner-specific circumstances.

  5. Feasibility of a real-time hand hygiene notification machine learning system in outpatient clinics.

    PubMed

    Geilleit, R; Hen, Z Q; Chong, C Y; Loh, A P; Pang, N L; Peterson, G M; Ng, K C; Huis, A; de Korne, D F

    2018-04-09

    Various technologies have been developed to improve hand hygiene (HH) compliance in inpatient settings; however, little is known about the feasibility of machine learning technology for this purpose in outpatient clinics. To assess the effectiveness, user experiences, and costs of implementing a real-time HH notification machine learning system in outpatient clinics. In our mixed methods study, a multi-disciplinary team co-created an infrared guided sensor system to automatically notify clinicians to perform HH just before first patient contact. Notification technology effects were measured by comparing HH compliance at baseline (without notifications) with real-time auditory notifications that continued till HH was performed (intervention I) or notifications lasting 15 s (intervention II). User experiences were collected during daily briefings and semi-structured interviews. Costs of implementation of the system were calculated and compared to the current observational auditing programme. Average baseline HH performance before first patient contact was 53.8%. With real-time auditory notifications that continued till HH was performed, overall HH performance increased to 100% (P < 0.001). With auditory notifications of a maximum duration of 15 s, HH performance was 80.4% (P < 0.001). Users emphasized the relevance of real-time notification and contributed to technical feasibility improvements that were implemented in the prototype. Annual running costs for the machine learning system were estimated to be 46% lower than the observational auditing programme. Machine learning technology that enables real-time HH notification provides a promising cost-effective approach to both improving and monitoring HH, and deserves further development in outpatient settings. Copyright © 2018 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  6. 40 CFR 172.46 - Submission of a notification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Biotechnology Notification Review. (c... that clearly identifies the EPA action supported as a Biotechnology Notification Review. (2) Five...

  7. 40 CFR 172.46 - Submission of a notification.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Biotechnology Notification Review. (c... that clearly identifies the EPA action supported as a Biotechnology Notification Review. (2) Five...

  8. 30 CFR 49.9 - Mine emergency notification plan.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... TRAINING MINE RESCUE TEAMS § 49.9 Mine emergency notification plan. (a) Each underground mine shall have a mine rescue notification plan outlining the procedures to follow in notifying the mine rescue teams...

  9. 30 CFR 49.9 - Mine emergency notification plan.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... TRAINING MINE RESCUE TEAMS § 49.9 Mine emergency notification plan. (a) Each underground mine shall have a mine rescue notification plan outlining the procedures to follow in notifying the mine rescue teams...

  10. New South Wales annual vaccine-preventable disease report, 2012

    PubMed Central

    Spokes, Paula; Gilmour, Robin

    2014-01-01

    We aim to describe the epidemiology of selected vaccine-preventable diseases in New South Wales (NSW) for 2012. Data from the NSW Notifiable Conditions Information Management System were analysed by: local health district of residence, age, Aboriginality, vaccination status and organism, where available. Risk factor and vaccination status data were collected by public health units for cases following notification under the NSW Public Health Act 2010. The largest outbreak of measles since 1998 was reported in 2012. Pacific Islander and Aboriginal people were at higher risk as were infants less than 12 months of age. Notifications of invasive pneumococcal disease (IPD) in children less than five years declined; however, the overall number of notifications for IPD increased. Mumps case notifications were also elevated. There were no Haemophilus influenzae type b case notifications in children less than five years of age for the first time since the vaccine was introduced. Invasive meningococcal disease case notifications were at their lowest rates since case notification began in 1991. Case notification rates for other selected vaccine-preventable diseases remained stable. Vaccine-preventable disease control is continually strengthening in NSW with notable successes in invasive bacterial infections. However, strengthening measles immunization in Pacific Islander and Aboriginal communities remains essential to maintain measles elimination. PMID:25077033

  11. New South Wales annual vaccine-preventable disease report, 2012.

    PubMed

    Rosewell, Alexander; Spokes, Paula; Gilmour, Robin

    2014-01-01

    We aim to describe the epidemiology of selected vaccine-preventable diseases in New South Wales (NSW) for 2012. Data from the NSW Notifiable Conditions Information Management System were analysed by: local health district of residence, age, Aboriginality, vaccination status and organism, where available. Risk factor and vaccination status data were collected by public health units for cases following notification under the NSW Public Health Act 2010. The largest outbreak of measles since 1998 was reported in 2012. Pacific Islander and Aboriginal people were at higher risk as were infants less than 12 months of age. Notifications of invasive pneumococcal disease (IPD) in children less than five years declined; however, the overall number of notifications for IPD increased. Mumps case notifications were also elevated. There were no Haemophilus influenzae type b case notifications in children less than five years of age for the first time since the vaccine was introduced. Invasive meningococcal disease case notifications were at their lowest rates since case notification began in 1991. Case notification rates for other selected vaccine-preventable diseases remained stable. Vaccine-preventable disease control is continually strengthening in NSW with notable successes in invasive bacterial infections. However, strengthening measles immunization in Pacific Islander and Aboriginal communities remains essential to maintain measles elimination.

  12. Asynchronous automated electronic laboratory result notifications: a systematic review.

    PubMed

    Slovis, Benjamin H; Nahass, Thomas A; Salmasian, Hojjat; Kuperman, Gilad; Vawdrey, David K

    2017-11-01

    To systematically review the literature pertaining to asynchronous automated electronic notifications of laboratory results to clinicians. PubMed, Web of Science, and the Cochrane Collaboration were queried for studies pertaining to automated electronic notifications of laboratory results. A title review was performed on the primary results, with a further abstract review and full review to produce the final set of included articles. The full review included 34 articles, representing 19 institutions. Of these, 19 reported implementation and design of systems, 11 reported quasi-experimental studies, 3 reported a randomized controlled trial, and 1 was a meta-analysis. Twenty-seven articles included alerts of critical results, while 5 focused on urgent notifications and 2 on elective notifications. There was considerable variability in clinical setting, system implementation, and results presented. Several asynchronous automated electronic notification systems for laboratory results have been evaluated, most from >10 years ago. Further research on the effect of notifications on clinicians as well as the use of modern electronic health records and new methods of notification is warranted to determine their effects on workflow and clinical outcomes. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  13. Foodborne Norovirus State of Affairs in the EU Rapid Alert System for Food and Feed

    PubMed Central

    Papapanagiotou, Elias P.

    2017-01-01

    The European Union Rapid Alert System for Food and Feed (EU RASFF) database is an invaluable instrument for analyzing notifications involving norovirus in food. The aim of this work was to carry out a thorough research of the alert and border rejection notifications submitted in the RASFF database from its onset until 31 August 2017. Some conclusions of interest were: (i) Denmark, France, Italy, the Netherlands and Norway have contributed the majority of alert notifications as notifying countries, (ii) France and Serbia have been cited more often in alert notifications as countries of origin, (iii) Italy and Spain have submitted the majority of border rejection notifications, (iv) Third Countries implicated more frequently in border rejection notifications for norovirus in bivalve molluscs were Vietnam and Tunisia, whereas in fruits and vegetables were China and Serbia, (v) “risk dispersion” from norovirus-contaminated food was narrow since, in just over half of all alert notifications and all of the border rejection notifications, only up to three countries were involved, and (vi) both raw (oysters and berries) and cooked (mussels) food products can present a health risk to consumers. The information retrieved from the RASFF database on norovirus-contaminated food could prove helpful in the planning of future norovirus risk analysis endeavors. PMID:29186840

  14. Gender and tuberculosis: a comparison of prevalence surveys with notification data to explore sex differences in case detection.

    PubMed

    Borgdorff, M W; Nagelkerke, N J; Dye, C; Nunn, P

    2000-02-01

    To explore whether lower tuberculosis notification rates among women are due to a reduced access to health care, particularly diagnostic services, for women. Age- and sex-specific tuberculosis prevalence rates of smear-positive tuberculosis were obtained from tuberculosis prevalence surveys reported to the WHO or published in the literature. Age- and sex-specific notification rates from the same countries in 1996 were used. Prevalence data and notifications from 29 surveys in 14 countries were used. Notification rates varied strongly among countries, but the female/male ratio was below 1 and decreased with increasing age in almost all. The female/male (F/M) prevalence ratios were less than 0.5 in surveys in the South-East Asia and Western Pacific Region, and approximately 1 in the African Region. In most countries the F/M sex ratio in prevalent cases was similar or lower than that in notified cases, suggesting that F/M differences in notification rates may be largely due to epidemiological differences and not to differential access to health care. However, available data are limited as the prevalence surveys in Africa were carried out many years ago, and in Asia notification rates may be distorted by a large private sector with deficiencies in notification.

  15. Personal annunciation device

    DOEpatents

    Angelo, Peter [Oak Ridge, TN; Younkin, James [Oak Ridge, TN; DeMint, Paul [Kingston, TN

    2011-01-25

    A personal annunciation device (PAD) providing, in an area of interest, compensatory annunciation of the presence of an abnormal condition in a hazardous area and accountability of the user of the PAD. Compensatory annunciation supplements primary annunciation provided by an emergency notification system (ENS). A detection system detects an abnormal condition, and a wireless transmission system transmits a wireless transmission to the PAD. The PAD has a housing enclosing the components of the PAD including a communication module for receiving the wireless transmission, a power supply, processor, memory, annunciation system, and RFID module. The RFID module has an RFID receiver that listens for an RFID transmission from an RFID reader disposed in a portal of an area of interest. The PAD identifies the transmission and changes its operating state based on the transmission. The RFID readers recognize, record, and transmit the state of the PAD to a base station providing accountability of the wearer.

  16. Dynamic defense and network randomization for computer systems

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Chavez, Adrian R.; Stout, William M. S.; Hamlet, Jason R.

    The various technologies presented herein relate to determining a network attack is taking place, and further to adjust one or more network parameters such that the network becomes dynamically configured. A plurality of machine learning algorithms are configured to recognize an active attack pattern. Notification of the attack can be generated, and knowledge gained from the detected attack pattern can be utilized to improve the knowledge of the algorithms to detect a subsequent attack vector(s). Further, network settings and application communications can be dynamically randomized, wherein artificial diversity converts control systems into moving targets that help mitigate the early reconnaissancemore » stages of an attack. An attack(s) based upon a known static address(es) of a critical infrastructure network device(s) can be mitigated by the dynamic randomization. Network parameters that can be randomized include IP addresses, application port numbers, paths data packets navigate through the network, application randomization, etc.« less

  17. 16 CFR 803.7 - Expiration of notification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... material if and when the proposed transaction is ever revived. A's notification expires July 15 of Year 2, eighteen months following the date of receipt of its notification. If A and B wish to revive their...

  18. 10 CFR 39.77 - Notification of incidents and lost sources; abandonment procedures for irretrievable sources.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., radiation overexposures, excessive levels and concentrations of radiation, and certain other accidents as... RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Security, Records, Notifications § 39.77 Notification of...

  19. 10 CFR 39.77 - Notification of incidents and lost sources; abandonment procedures for irretrievable sources.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., radiation overexposures, excessive levels and concentrations of radiation, and certain other accidents as... RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Security, Records, Notifications § 39.77 Notification of...

  20. 10 CFR 39.77 - Notification of incidents and lost sources; abandonment procedures for irretrievable sources.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., radiation overexposures, excessive levels and concentrations of radiation, and certain other accidents as... RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Security, Records, Notifications § 39.77 Notification of...

  1. 10 CFR 39.77 - Notification of incidents and lost sources; abandonment procedures for irretrievable sources.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., radiation overexposures, excessive levels and concentrations of radiation, and certain other accidents as... RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Security, Records, Notifications § 39.77 Notification of...

  2. 10 CFR 39.77 - Notification of incidents and lost sources; abandonment procedures for irretrievable sources.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., radiation overexposures, excessive levels and concentrations of radiation, and certain other accidents as... RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Security, Records, Notifications § 39.77 Notification of...

  3. Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery - United States.

    PubMed

    Perkins, Kiran M; Lawsin, Adrian; Hasan, Nabeeh A; Strong, Michael; Halpin, Alison L; Rodger, Rachael R; Moulton-Meissner, Heather; Crist, Matthew B; Schwartz, Suzanne; Marders, Julia; Daley, Charles L; Salfinger, Max; Perz, Joseph F

    2016-10-14

    In the spring of 2015, investigators in Switzerland reported a cluster of six patients with invasive infection with Mycobacterium chimaera, a species of nontuberculous mycobacterium ubiquitous in soil and water. The infected patients had undergone open-heart surgery that used contaminated heater-cooler devices during extracorporeal circulation (1). In July 2015, a Pennsylvania hospital also identified a cluster of invasive nontuberculous mycobacterial infections among open-heart surgery patients. Similar to the Swiss report, a field investigation by the Pennsylvania Department of Health, with assistance from CDC, used both epidemiologic and laboratory evidence to identify an association between invasive Mycobacterium avium complex, including M. chimaera, infections and exposure to contaminated Stöckert 3T heater-cooler devices, all manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) (2). M. chimaera was described as a distinct species of M. avium complex in 2004 (3). The results of the field investigation prompted notification of approximately 1,300 potentially exposed patients.* Although heater-cooler devices are used to regulate patients' blood temperature during cardiopulmonary bypass through water circuits that are closed, these reports suggest that aerosolized M. chimaera from the devices resulted in the invasive infections (1,2). The Food and Drug Administration (FDA) and CDC have issued alerts regarding the need to follow updated manufacturer's instructions for use of the devices, evaluate the devices for contamination, remain vigilant for new infections, and continue to monitor reports from the United States and overseas (2).

  4. 5 CFR 470.307 - Notification responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Section 470.307 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.307 Notification responsibilities. (a) 5 U.S.C. 4703 requires notification of...

  5. Ground Water Rule - Boil Water Advisory - Public Notification Template

    EPA Pesticide Factsheets

    The Ground Water Rule - Boil Water Advisory - Public Notification Template can be use to issue a Tier 1 Public Notification when it has been determined that source ground water is contaminated with E. Coli bacteria.

  6. Emergency Response Notification System (ERNS)

    EPA Science Inventory

    The Emergency Response Notification System (ERNS) is a database used to store information on notifications of oil discharges and hazardous substances releases. The ERNS program is a cooperative data sharing effort among the Environmental Protection Agency (EPA) Headquarters, the ...

  7. Improving the accuracy of birth notification data: lessons from the Birth to Ten study

    PubMed Central

    Ellison, GTH; Richter, LM; de Wet, T; Harris, HE; Griesel, RD; McIntyre, JA

    2007-01-01

    The aim of the present study was to evaluate the accuracy of birth notification data collected during Birth to Ten, a longitudinal birth cohort study based in the Soweto-Johannesburg Metropole. Photocopies of birth notification forms were obtained from three local health authorities (Soweto, Diepmeadow and Johannesburg) for 5 448 of the 5 460 singleton births that occurred during seven weeks between April and June 1990, to women resident in Soweto-Johannesburg. By comparing the data recorded on the three different types of notification forms used by delivery centres within the Metropole, it was possible to assess the consistency of data collected during birth notification. For 539 of the 2 120 births that occurred at Baragwanath Hospital in Soweto, it was possible to locate the original records of maternal age, gravidity, infant sex, date of birth, birth weight and gestational age at birth, contained in obstetric and neonatal hospital files. By comparing these records with information contained in the birth notification forms it was possible to assess the accuracy of birth notification data submitted for deliveries at Baragwanath Hospital. Each of the different notification forms contained a different selection of variables and failed to specify the precision with which continuous variables should be recorded. For 12 selected variables, the proportion of missing records ranged from 0.0% to 40.9%, and was highest for those variables (such as APGAR scores and parity) that were not required on all four forms. The percentage agreement between information recorded on these forms and the original hospital records was highest for the categorical variable infant sex (99.1%), while the accuracy of notification data for continuous variables ranged from 95.2% (maternal age) to 29.7% (gestational age at birth). The upper 95% confidence intervals for the mean absolute errors in gestational age at birth and birth weight were two to three times the units of measurement, at 2.4 weeks and 165 g, respectively. When these extremes of error were applied to data for all 539 children, the proportion classified as premature or post-term varied by up to 25.7%, while those classified as macrosomic, low or very low birth weight varied by 10.5%. This analysis illustrates the potential consequences of imprecise birth notification data on the apparent prevalence of premature and low birth weight babies, both of which are key indicators in maternal and child health. Improving the process of birth notification and standardising the format of birth notification forms would increase the consistency of birth notification data. Selecting variables that are established indicators of health status, and can be reliably measured, would help improve the utility and accuracy of birth notification data. PMID:19330041

  8. Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-07

    The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.

  9. An Efficient Power Saving Technique Based Location Alarm For Smart Phones

    NASA Astrophysics Data System (ADS)

    Saranya, G.; Lavanya, S.; Sivasankari, S.

    2018-04-01

    In today’s world it is not possible for everything to work at the scheduled time. Therefore it is necessary that our daily applications remind us on a particular location instead of a particular time. When the reminder is set, it continuously checks the distance from the destination. If it matches with the maximum distance entered it reminds the user that he/she is about to reach their destination. When the user enters the proximity radius that was set in the application, the user is notified. The application is set to work with availability of GPS as well as mobile network data in the users’ device which runs on android platform. The application also limits the impact of battery life of its device by bringing down the rate of updates and background services when the device battery is low and hence optimizing the battery usage for further important tasks. The location can be either a place or the GPS location of other user. The notification can be enabled on both the users and both the user can be notified based on the proximity radius set by them.

  10. Personalized and automated remote monitoring of atrial fibrillation.

    PubMed

    Rosier, Arnaud; Mabo, Philippe; Temal, Lynda; Van Hille, Pascal; Dameron, Olivier; Deléger, Louise; Grouin, Cyril; Zweigenbaum, Pierre; Jacques, Julie; Chazard, Emmanuel; Laporte, Laure; Henry, Christine; Burgun, Anita

    2016-03-01

    Remote monitoring of cardiac implantable electronic devices is a growing standard; yet, remote follow-up and management of alerts represents a time-consuming task for physicians or trained staff. This study evaluates an automatic mechanism based on artificial intelligence tools to filter atrial fibrillation (AF) alerts based on their medical significance. We evaluated this method on alerts for AF episodes that occurred in 60 pacemaker recipients. AKENATON prototype workflow includes two steps: natural language-processing algorithms abstract the patient health record to a digital version, then a knowledge-based algorithm based on an applied formal ontology allows to calculate the CHA2DS2-VASc score and evaluate the anticoagulation status of the patient. Each alert is then automatically classified by importance from low to critical, by mimicking medical reasoning. Final classification was compared with human expert analysis by two physicians. A total of 1783 alerts about AF episode >5 min in 60 patients were processed. A 1749 of 1783 alerts (98%) were adequately classified and there were no underestimation of alert importance in the remaining 34 misclassified alerts. This work demonstrates the ability of a pilot system to classify alerts and improves personalized remote monitoring of patients. In particular, our method allows integration of patient medical history with device alert notifications, which is useful both from medical and resource-management perspectives. The system was able to automatically classify the importance of 1783 AF alerts in 60 patients, which resulted in an 84% reduction in notification workload, while preserving patient safety. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  11. Heavy Metals in Notifications of Rapid Alert System for Food and Feed.

    PubMed

    Pigłowski, Marcin

    2018-02-20

    Heavy metals represent the fourth most often notified hazard category in the Rapid Alert System for Food and Feed (RASFF) from 1980-2016. The goal of the study was to examine the similarities in notifications of particular heavy metals within the RASFF year, product category, notifying country, country of origin, notification basis, notification type, distribution status, risk decision, and action taken, taking into account the particular product type, such as food, food contact material, and feed. The data originated from the RASFF database. Cluster analysis on pivot tables was applied using joining and two-way joining methods. Most notifications concerned food, in which the highest number were related to mercury, cadmium, chromium, lead, arsenic, and nickel. Notifications were mainly related to fish and food contact materials, in addition to fruits and vegetables, seafood, and dietetic food. The number of notifications decreased in 2015 and 2016. The majority of products were notified by Italy, Spain, Germany, and France. The notified products originated mainly from China and Spain. The notification was usually based on official controls on the market, as well as border controls. The notification types were mainly information, alert, and border rejections. Products were not frequently distributed due to distribution restriction to the notifying country or the possibility of distribution to the market. A risk decision was not usually made. The taken actions included re-dispatch of products, withdrawal from the market, or destruction. The data on heavy metals from the RASFF database can help European and national authorities in shaping public health.

  12. Death Notification: Someone Needs To Call the Family.

    PubMed

    Ombres, Rachel; Montemorano, Lauren; Becker, Daniel

    2017-06-01

    The death notification process can affect family grief and bereavement. It can also affect the well-being of involved physicians. There is no standardized process for making death notification phone calls. We assumed that residents are likely to be unprepared before and troubled after. We investigated current death notification practices to develop an evidence-based template for standardizing this process. We used results of a literature review and open-ended interviews with faculty, residents, and widows to develop a survey regarding resident training and experience in death notification by phone. We invited all internal medicine (IM) residents at our institution to complete the survey. Sixty-seven of 93 IM residents (72%) responded to the survey. Eighty-seven percent of responders reported involvement in a death that required notification by phone. Eighty percent of residents felt inadequately trained for this task. Over 25% reported that calls went poorly. Attendings were involved in 17% of cases. Primary care physicians were not involved. Nurses and chaplains were not involved. Respondents never delayed notification of death until family arrived at the hospital. There was no consistent approach to rehearsing or making the call, advising families about safe travel to the hospital, greeting families upon arrival, or following up with expressions of condolence. Poor communication skills during death notification may contribute to complicated grief for surviving relatives and stress among physicians. This study is the first to describe current practices of death notification by IM residents. More training is needed and could be combined with training in disclosure of medical error.

  13. Heavy Metals in Notifications of Rapid Alert System for Food and Feed

    PubMed Central

    Pigłowski, Marcin

    2018-01-01

    Heavy metals represent the fourth most often notified hazard category in the Rapid Alert System for Food and Feed (RASFF) from 1980–2016. The goal of the study was to examine the similarities in notifications of particular heavy metals within the RASFF year, product category, notifying country, country of origin, notification basis, notification type, distribution status, risk decision, and action taken, taking into account the particular product type, such as food, food contact material, and feed. The data originated from the RASFF database. Cluster analysis on pivot tables was applied using joining and two-way joining methods. Most notifications concerned food, in which the highest number were related to mercury, cadmium, chromium, lead, arsenic, and nickel. Notifications were mainly related to fish and food contact materials, in addition to fruits and vegetables, seafood, and dietetic food. The number of notifications decreased in 2015 and 2016. The majority of products were notified by Italy, Spain, Germany, and France. The notified products originated mainly from China and Spain. The notification was usually based on official controls on the market, as well as border controls. The notification types were mainly information, alert, and border rejections. Products were not frequently distributed due to distribution restriction to the notifying country or the possibility of distribution to the market. A risk decision was not usually made. The taken actions included re-dispatch of products, withdrawal from the market, or destruction. The data on heavy metals from the RASFF database can help European and national authorities in shaping public health. PMID:29461471

  14. Death Notification: Someone Needs To Call the Family

    PubMed Central

    Ombres, Rachel; Montemorano, Lauren

    2017-01-01

    Abstract Background: The death notification process can affect family grief and bereavement. It can also affect the well-being of involved physicians. There is no standardized process for making death notification phone calls. We assumed that residents are likely to be unprepared before and troubled after. Objective: We investigated current death notification practices to develop an evidence-based template for standardizing this process. Design: We used results of a literature review and open-ended interviews with faculty, residents, and widows to develop a survey regarding resident training and experience in death notification by phone. Setting/Subjects: We invited all internal medicine (IM) residents at our institution to complete the survey. Measurements: Sixty-seven of 93 IM residents (72%) responded to the survey. Eighty-seven percent of responders reported involvement in a death that required notification by phone. Results: Eighty percent of residents felt inadequately trained for this task. Over 25% reported that calls went poorly. Attendings were involved in 17% of cases. Primary care physicians were not involved. Nurses and chaplains were not involved. Respondents never delayed notification of death until family arrived at the hospital. There was no consistent approach to rehearsing or making the call, advising families about safe travel to the hospital, greeting families upon arrival, or following up with expressions of condolence. Conclusions: Poor communication skills during death notification may contribute to complicated grief for surviving relatives and stress among physicians. This study is the first to describe current practices of death notification by IM residents. More training is needed and could be combined with training in disclosure of medical error. PMID:28099046

  15. Public Notification Instructions and Templates for the Revised Total Coliform Rule (RTCR)

    EPA Pesticide Factsheets

    EPA has developed public notification (PN) templates to help with implementation of the PN Rule. This document aims to assist water systems with the Public Notification requirements specific to the Revised Total Coliform Rule (RTCR).

  16. 5 CFR 179.304 - Notification procedures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Notification procedures. 179.304 Section 179.304 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS CLAIMS COLLECTION STANDARDS Administrative Offset § 179.304 Notification procedures. Before collecting any debt...

  17. Ten years' work on the World Organisation for Animal Health (OIE) Worldwide Animal Disease Notification System.

    PubMed

    Jebara, Karim Ben; Cáceres, Paula; Berlingieri, Francesco; Weber-Vintzel, Laure

    2012-12-01

    This article gives an overview of the World Organisation for Animal Health (OIE) Worldwide Animal Disease Notification System and highlights the major achievements during the past decade. It describes the different types of disease notification reports received and processed by the OIE. It also evaluates the three strategies implemented by the OIE in the recent years aimed at improving disease notification: introduction and use of a secure online notification system World Animal Health Information System (WAHIS) and its database interface World Animal Health Information Database (WAHID); implementation of active search and verification procedures for non-official information; and enhanced building of capacity for animal disease notification to the OIE by Members Countries. The improvements are evidenced by the increasing number of reports submitted on an annual basis and the reduction in submission time together with an improvement in the quality and quantity of the immediate notifications and follow-up reports, six-monthly and annual reports submitted by Veterinary Authorities. In the recent years, the OIE's notification system provides an early warning system more sensitive and global. Consequently, there is a greater knowledge of animal diseases' distribution worldwide. As a result, it is possible to ensure better prevention, more accurate risk assessment and evaluation by diminishing the spread of known or newly emerging pathogens. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. Risk assessment, identification, and notification (RAIN) system : a novel approach for traffic management.

    DOT National Transportation Integrated Search

    2009-08-31

    Primary research focused on the design and development of an energy-efficient Risk Notification Message Dissemination Protocol (RNMDP) for vehicular ad hoc networks (VANETs). RNMDP propagates Risk Notification Messages (RNMs) from a location of origi...

  19. Intelligent transportation systems field operational test cross-cutting study : emergency notification and response.

    DOT National Transportation Integrated Search

    1998-09-01

    Emergency Notification and Response report summarizes and interprets the results of two Field Operational Tests (FOTs) that included emergency notification and response system components. The tests included in this report are: Colorado Mayday and Pug...

  20. 50 CFR 300.41 - Investigation notification.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 50 Wildlife and Fisheries 11 2012-10-01 2012-10-01 false Investigation notification. 300.41 Section 300.41 Wildlife and Fisheries INTERNATIONAL FISHING AND RELATED ACTIVITIES INTERNATIONAL FISHERIES REGULATIONS South Pacific Tuna Fisheries § 300.41 Investigation notification. Upon commencement of an...

  1. 50 CFR 300.41 - Investigation notification.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 50 Wildlife and Fisheries 11 2013-10-01 2013-10-01 false Investigation notification. 300.41 Section 300.41 Wildlife and Fisheries INTERNATIONAL FISHING AND RELATED ACTIVITIES INTERNATIONAL FISHERIES REGULATIONS South Pacific Tuna Fisheries § 300.41 Investigation notification. Upon commencement of an...

  2. 50 CFR 300.41 - Investigation notification.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 50 Wildlife and Fisheries 9 2011-10-01 2011-10-01 false Investigation notification. 300.41 Section 300.41 Wildlife and Fisheries INTERNATIONAL FISHING AND RELATED ACTIVITIES INTERNATIONAL FISHERIES REGULATIONS South Pacific Tuna Fisheries § 300.41 Investigation notification. Upon commencement of an...

  3. 50 CFR 300.41 - Investigation notification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Investigation notification. 300.41 Section 300.41 Wildlife and Fisheries INTERNATIONAL FISHING AND RELATED ACTIVITIES INTERNATIONAL FISHERIES REGULATIONS South Pacific Tuna Fisheries § 300.41 Investigation notification. Upon commencement of an...

  4. 50 CFR 300.41 - Investigation notification.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 50 Wildlife and Fisheries 11 2014-10-01 2014-10-01 false Investigation notification. 300.41 Section 300.41 Wildlife and Fisheries INTERNATIONAL FISHING AND RELATED ACTIVITIES INTERNATIONAL FISHERIES REGULATIONS South Pacific Tuna Fisheries § 300.41 Investigation notification. Upon commencement of an...

  5. 44 CFR 206.39 - Notification.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Notification. 206.39 Section 206.39 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE FEDERAL DISASTER ASSISTANCE The Declaration Process § 206.39 Notification. (a...

  6. 44 CFR 206.39 - Notification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Notification. 206.39 Section 206.39 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE FEDERAL DISASTER ASSISTANCE The Declaration Process § 206.39 Notification. (a...

  7. 44 CFR 206.39 - Notification.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Notification. 206.39 Section 206.39 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE FEDERAL DISASTER ASSISTANCE The Declaration Process § 206.39 Notification. (a...

  8. 44 CFR 206.39 - Notification.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Notification. 206.39 Section 206.39 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE FEDERAL DISASTER ASSISTANCE The Declaration Process § 206.39 Notification. (a...

  9. 44 CFR 206.39 - Notification.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Notification. 206.39 Section 206.39 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE FEDERAL DISASTER ASSISTANCE The Declaration Process § 206.39 Notification. (a...

  10. 24 CFR 290.11 - Notification requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., HUD acquires a project. (c) Methods of notification—(1) To tenants. Pre-disposition notification will... URBAN DEVELOPMENT HUD-OWNED PROPERTIES DISPOSITION OF MULTIFAMILY PROJECTS AND SALE OF HUD-HELD MULTIFAMILY MORTGAGES Disposition of Multifamily Projects § 290.11 Notification requirements. (a) In general...

  11. 47 CFR 76.917 - Notification of certification withdrawal.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Notification of certification withdrawal. 76.917 Section 76.917 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES MULTICHANNEL VIDEO AND CABLE TELEVISION SERVICE Cable Rate Regulation § 76.917 Notification of...

  12. 40 CFR 280.22 - Notification requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Section 280.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES... STORAGE TANKS (UST) UST Systems: Design, Construction, Installation and Notification § 280.22 Notification... to notify the designated state or local agency in accordance with the Hazardous and Solid Waste...

  13. 40 CFR 280.22 - Notification requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Section 280.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES... STORAGE TANKS (UST) UST Systems: Design, Construction, Installation and Notification § 280.22 Notification... to notify the designated state or local agency in accordance with the Hazardous and Solid Waste...

  14. 40 CFR 280.22 - Notification requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Section 280.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES... STORAGE TANKS (UST) UST Systems: Design, Construction, Installation and Notification § 280.22 Notification... to notify the designated state or local agency in accordance with the Hazardous and Solid Waste...

  15. 40 CFR 280.22 - Notification requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Section 280.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES... STORAGE TANKS (UST) UST Systems: Design, Construction, Installation and Notification § 280.22 Notification... to notify the designated state or local agency in accordance with the Hazardous and Solid Waste...

  16. 40 CFR 280.22 - Notification requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Section 280.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES... STORAGE TANKS (UST) UST Systems: Design, Construction, Installation and Notification § 280.22 Notification... to notify the designated state or local agency in accordance with the Hazardous and Solid Waste...

  17. Evaluating the Emergency Notification Systems of the NASA White Sands Test

    NASA Technical Reports Server (NTRS)

    Chavez, Alfred Paul

    2004-01-01

    The problem was that the NASA Fire and Emergency Services did not know if the current emergency notification systems on the NASA White Sands Test Facility were appropriate for alerting the employees of an emergency. The purpose of this Applied Research Project was to determine if the current emergency notification systems of the White Sands Test Facility are appropriate for alerting the employees of an emergency. This was a descriptive research project. The research questions were: 1) What are similar facilities using to alert the employees of an emergency?; 2) Are the current emergency notification systems suitable for the community hazards on the NASA White Sands Test Facility?; 3) What is the NASA Fire and Emergency Services currently using to measure the effectiveness of the emergency notification systems?; and 4) What are the current training methods used to train personnel to the emergency notification systems at the NASA White Sands Test Facility? The procedures involved were to research other established facilities, research published material from credible sources, survey the facility to determine the facility perception of the emergency notification systems, and evaluate the operating elements of the established emergency notification systems for the facility. The results were that the current systems are suitable for the type of hazards the facility may endure. The emergency notification systems are tested frequently to ensure effectiveness in the event of an emergency. Personnel are trained and participate in a yearly drill to make certain personnel are educated on the established systems. The recommendations based on the results were to operationally improve the existing systems by developing and implementing one system that can overall notify the facility of a hazard. Existing procedures and training should also be improved to ensure that all personnel are educated on what to do when the emergency notification systems are activated.

  18. Health information exchange in the wild: the association between organizational capability and perceived utility of clinical event notifications in ambulatory and community care.

    PubMed

    Vest, Joshua R; Ancker, Jessica S

    2017-01-01

    Event notifications are real-time, electronic, automatic alerts to providers of their patients' health care encounters at other facilities. Our objective was to examine the effects of organizational capability and related social/organizational issues upon users' perceptions of the impact of event notifications on quality, efficiency, and satisfaction. We surveyed representatives (n = 49) of 10 organizations subscribing to the Bronx Regional Health Information Organization's event notification services about organizational capabilities, notification information quality, perceived usage, perceived impact, and organizational and respondent characteristics. The response rate was 89%. Average item scores were used to create an individual domain summary score. The association between the impact of event notifications and organizational characteristics was modeled using random-intercept logistic regression models. Respondents estimated that organizations followed up on the majority (83%) of event notifications. Supportive organizational policies were associated with the perception that event notifications improved quality of care (odds ratio [OR] = 2.12; 95% CI, = 1.05, 4.45), efficiency (OR = 2.06; 95% CI = 1.00, 4.21), and patient satisfaction (OR = 2.56; 95% CI = 1.13, 5.81). Higher quality of event notification information was also associated with a perceived positive impact on quality of care (OR = 2.84; 95% CI = 1.31, 6.12), efficiency (OR = 3.04; 95% CI = 1.38, 6.69), and patient satisfaction (OR = 2.96; 95% CI = 1.25, 7.03). Health care organizations with appropriate processes, workflows, and staff may be better positioned to use event notifications. Additionally, information quality remains critical in users' assessments and perceptions. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. Anticipated Notification of Sexual Partners following STD Diagnosis among Men Who Have Sex with Men and Transgender Women in Lima, Peru: A Mixed Methods Analysis

    PubMed Central

    Clark, Jesse L.; Perez-Brumer, Amaya G.; Segura, Eddy R.; Salvatierra, Hector J.; Sanchez, Jorge; Lama, Javier R.

    2016-01-01

    Background New strategies to support partner notification (PN) are critical for STD control and require detailed understanding of how specific individual and partnership characteristics guide notification decisions. Methods From 2011 to 2012, 397 MSM and TW recently diagnosed with HIV, syphilis, or another STD completed a survey on anticipated notification of recent sexual partners and associated factors. Qualitative interviews were conducted with a subset of participants to provide further depth to quantitative findings. Prevalence ratios and generalized estimating equation (GEE) models were used to analyze participant- and partner-level factors associated with anticipated PN. Results Among all partners reported, 52.5% were described as “Very Likely” or “Somewhat Likely” to be notified. Anticipated notification was more likely for main partners than casual (adjusted Prevalence Ratio [aPR], 95% CI: 0.63, 0.54–0.75) or commercial (aPR, 95% CI: 0.44, 0.31–0.62) partners. Other factors associated with likely notification included perception of the partner as an STD source (aPR, 95% CI: 1.27, 1.10–1.48) and anticipated future sexual contact with the partner (aPR, 95% CI: 1.30, 1.11–1.52). An HIV diagnosis was associated with a lower likelihood of notification than non-HIV STDs (aPR: 0.68, 0.55–0.86). Qualitative discussion of the barriers and incentives to PN reflected a similar differentiation of anticipated notification according to partnership type and type of HIV/STD diagnosis. Discussion Detailed attention to how partnership characteristics guide notification outcomes is essential to the development of new PN strategies. By accurately and thoroughly assessing the diversity of partnership interactions among individuals with HIV/STD, new notification techniques can be tailored to partner-specific circumstances. PMID:27685158

  20. An Analysis of the Effects of Smartphone Push Notifications on Task Performance with regard to Smartphone Overuse Using ERP

    PubMed Central

    Kim, Seul-Kee; Kim, So-Yeong; Kang, Hang-Bong

    2016-01-01

    Smartphones are used ubiquitously worldwide and are essential tools in modern society. However, smartphone overuse is an emerging social issue, and limited studies have objectively assessed this matter. The majority of previous studies have included surveys or behavioral observation studies. Since a previous study demonstrated an association between increased push notifications and smartphone overuse, we investigated the effects of push notifications on task performance. We detected changes in brainwaves generated by smartphone push notifications using the N200 and P300 components of event-related potential (ERP) to investigate both concentration and cognitive ability. ERP assessment indicated that, in both risk and nonrisk groups, the lowest N200 amplitude and the longest latency during task performance were found when push notifications were delivered. Compared to the nonrisk group, the risk group demonstrated lower P300 amplitudes and longer latencies. In addition, the risk group featured a higher rate of error in the Go-Nogo task, due to the negative influence of smartphone push notifications on performance in both risk and nonrisk groups. Furthermore, push notifications affected subsequent performance in the risk group. PMID:27366147

  1. An Analysis of the Effects of Smartphone Push Notifications on Task Performance with regard to Smartphone Overuse Using ERP.

    PubMed

    Kim, Seul-Kee; Kim, So-Yeong; Kang, Hang-Bong

    2016-01-01

    Smartphones are used ubiquitously worldwide and are essential tools in modern society. However, smartphone overuse is an emerging social issue, and limited studies have objectively assessed this matter. The majority of previous studies have included surveys or behavioral observation studies. Since a previous study demonstrated an association between increased push notifications and smartphone overuse, we investigated the effects of push notifications on task performance. We detected changes in brainwaves generated by smartphone push notifications using the N200 and P300 components of event-related potential (ERP) to investigate both concentration and cognitive ability. ERP assessment indicated that, in both risk and nonrisk groups, the lowest N200 amplitude and the longest latency during task performance were found when push notifications were delivered. Compared to the nonrisk group, the risk group demonstrated lower P300 amplitudes and longer latencies. In addition, the risk group featured a higher rate of error in the Go-Nogo task, due to the negative influence of smartphone push notifications on performance in both risk and nonrisk groups. Furthermore, push notifications affected subsequent performance in the risk group.

  2. Emergency Notification Strategy

    ERIC Educational Resources Information Center

    Katsouros, Mark

    2014-01-01

    In higher education, the IT department is often the service provider for the institution's emergency notification system (ENS). For many institutions, the complexity of providing emergency notification to students, faculty, and staff makes using a local, on-premise solution unrealistic. But finding the right commercially hosted technical solution…

  3. 39 CFR 266.5 - Notification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... UNITED STATES POSTAL SERVICE ORGANIZATION AND ADMINISTRATION PRIVACY OF INFORMATION § 266.5 Notification... reasonable efforts to serve notice on an individual before any personal information on such individual is... request.) (d) Notification of New Use. Any newly intended use of personal information maintained by the...

  4. 39 CFR 266.5 - Notification.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... UNITED STATES POSTAL SERVICE ORGANIZATION AND ADMINISTRATION PRIVACY OF INFORMATION § 266.5 Notification... reasonable efforts to serve notice on an individual before any personal information on such individual is... request.) (d) Notification of New Use. Any newly intended use of personal information maintained by the...

  5. 39 CFR 266.5 - Notification.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... UNITED STATES POSTAL SERVICE ORGANIZATION AND ADMINISTRATION PRIVACY OF INFORMATION § 266.5 Notification... reasonable efforts to serve notice on an individual before any personal information on such individual is... request.) (d) Notification of New Use. Any newly intended use of personal information maintained by the...

  6. 39 CFR 266.5 - Notification.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... UNITED STATES POSTAL SERVICE ORGANIZATION AND ADMINISTRATION PRIVACY OF INFORMATION § 266.5 Notification... reasonable efforts to serve notice on an individual before any personal information on such individual is... request.) (d) Notification of New Use. Any newly intended use of personal information maintained by the...

  7. 39 CFR 266.5 - Notification.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... UNITED STATES POSTAL SERVICE ORGANIZATION AND ADMINISTRATION PRIVACY OF INFORMATION § 266.5 Notification... reasonable efforts to serve notice on an individual before any personal information on such individual is... request.) (d) Notification of New Use. Any newly intended use of personal information maintained by the...

  8. 20 CFR 633.205 - Notification of selection.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Notification of selection. 633.205 Section 633.205 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR MIGRANT AND SEASONAL FARMWORKER PROGRAMS Grant Planning and Application Procedures § 633.205 Notification of selection...

  9. 40 CFR 725.235 - Conditions of exemption for activities conducted inside a structure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... experiments subject to Institutional Biosafety Committee review, or notification simultaneous with initiation of the experiment, the information submitted for review or notification, along with standard... experiments exempt from Institutional Biosafety Committee review or notification simultaneous with initiation...

  10. 21 CFR 107.240 - Notification requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.240 Notification requirements. (a) Notification of a violative infant formula. A manufacturer shall promptly notify the Food and Drug..., and Cosmetic Act (the act)) that reasonably supports the conclusion that an infant formula that has...

  11. 78 FR 39736 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug... information entitled ``Food Labeling; Notification Procedures for Statements on Dietary Supplements'' to OMB... collection of information entitled ``Food Labeling; Notification Procedures for Statements on Dietary...

  12. 49 CFR 659.33 - Accident notification.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Accident notification. 659.33 Section 659.33 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION... Agency § 659.33 Accident notification. (a) The oversight agency must require the rail transit agency to...

  13. 49 CFR 659.33 - Accident notification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Accident notification. 659.33 Section 659.33 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION... Agency § 659.33 Accident notification. (a) The oversight agency must require the rail transit agency to...

  14. 40 CFR 141.201 - General public notification requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) WATER PROGRAMS (CONTINUED) NATIONAL PRIMARY DRINKING WATER REGULATIONS Public Notification of Drinking Water Violations § 141.201 General public notification requirements. Public water systems in States with primacy for the public water system supervision (PWSS) program must comply with the requirements in this...

  15. 40 CFR 141.201 - General public notification requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) WATER PROGRAMS (CONTINUED) NATIONAL PRIMARY DRINKING WATER REGULATIONS Public Notification of Drinking Water Violations § 141.201 General public notification requirements. Public water systems in States with primacy for the public water system supervision (PWSS) program must comply with the requirements in this...

  16. 40 CFR 141.201 - General public notification requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) WATER PROGRAMS (CONTINUED) NATIONAL PRIMARY DRINKING WATER REGULATIONS Public Notification of Drinking Water Violations § 141.201 General public notification requirements. Public water systems in States with primacy for the public water system supervision (PWSS) program must comply with the requirements in this...

  17. 40 CFR 141.201 - General public notification requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) WATER PROGRAMS (CONTINUED) NATIONAL PRIMARY DRINKING WATER REGULATIONS Public Notification of Drinking Water Violations § 141.201 General public notification requirements. Public water systems in States with primacy for the public water system supervision (PWSS) program must comply with the requirements in this...

  18. 33 CFR 135.305 - Notification procedures.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) MARINE POLLUTION FINANCIAL RESPONSIBILITY AND COMPENSATION OFFSHORE OIL POLLUTION COMPENSATION FUND Notification of Pollution Incidents § 135.305 Notification procedures. (a) The person in charge of a vessel or... oil pollution shall, as soon as that person has knowledge of the incident, immediately notify by...

  19. 33 CFR 135.305 - Notification procedures.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) MARINE POLLUTION FINANCIAL RESPONSIBILITY AND COMPENSATION OFFSHORE OIL POLLUTION COMPENSATION FUND Notification of Pollution Incidents § 135.305 Notification procedures. (a) The person in charge of a vessel or... oil pollution shall, as soon as that person has knowledge of the incident, immediately notify by...

  20. 33 CFR 135.305 - Notification procedures.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) MARINE POLLUTION FINANCIAL RESPONSIBILITY AND COMPENSATION OFFSHORE OIL POLLUTION COMPENSATION FUND Notification of Pollution Incidents § 135.305 Notification procedures. (a) The person in charge of a vessel or... oil pollution shall, as soon as that person has knowledge of the incident, immediately notify by...

  1. 49 CFR 383.35 - Notification of previous employment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... COMMERCIAL DRIVER'S LICENSE STANDARDS; REQUIREMENTS AND PENALTIES Notification Requirements and Employer Responsibilities § 383.35 Notification of previous employment. (a) Any person applying for employment as an... information specified in paragraph (c) of this section. (b) All employers shall request the information...

  2. 47 CFR 68.106 - Notification to provider of wireline telecommunications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 3 2011-10-01 2011-10-01 false Notification to provider of wireline telecommunications. 68.106 Section 68.106 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON... of Terminal Equipment § 68.106 Notification to provider of wireline telecommunications. (a) General...

  3. 47 CFR 68.106 - Notification to provider of wireline telecommunications.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 3 2010-10-01 2010-10-01 false Notification to provider of wireline telecommunications. 68.106 Section 68.106 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON... of Terminal Equipment § 68.106 Notification to provider of wireline telecommunications. (a) General...

  4. 40 CFR 152.117 - Notification to applicant.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Notification to applicant. 152.117 Section 152.117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Agency Review of Applications § 152.117 Notification to...

  5. 47 CFR 68.106 - Notification to provider of wireline telecommunications.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 3 2014-10-01 2014-10-01 false Notification to provider of wireline telecommunications. 68.106 Section 68.106 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON... of Terminal Equipment § 68.106 Notification to provider of wireline telecommunications. (a) General...

  6. 47 CFR 68.106 - Notification to provider of wireline telecommunications.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 3 2012-10-01 2012-10-01 false Notification to provider of wireline telecommunications. 68.106 Section 68.106 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON... of Terminal Equipment § 68.106 Notification to provider of wireline telecommunications. (a) General...

  7. 47 CFR 68.106 - Notification to provider of wireline telecommunications.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 3 2013-10-01 2013-10-01 false Notification to provider of wireline telecommunications. 68.106 Section 68.106 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON... of Terminal Equipment § 68.106 Notification to provider of wireline telecommunications. (a) General...

  8. 33 CFR 135.305 - Notification procedures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) MARINE POLLUTION FINANCIAL RESPONSIBILITY AND COMPENSATION OFFSHORE OIL POLLUTION COMPENSATION FUND Notification of Pollution Incidents § 135.305 Notification procedures. (a) The person in charge of a vessel or... oil pollution shall, as soon as that person has knowledge of the incident, immediately notify by...

  9. 33 CFR 135.305 - Notification procedures.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) MARINE POLLUTION FINANCIAL RESPONSIBILITY AND COMPENSATION OFFSHORE OIL POLLUTION COMPENSATION FUND Notification of Pollution Incidents § 135.305 Notification procedures. (a) The person in charge of a vessel or... oil pollution shall, as soon as that person has knowledge of the incident, immediately notify by...

  10. 40 CFR 63.1210 - What are the notification requirements?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...; (E) Waste minimization and emission control technique(s) effectiveness; (F) A description of the... National Emission Standards for Hazardous Air Pollutants from Hazardous Waste Combustors Notification...)(v) Notification of excessive particulate matter detection system exceedances. 63.1207(e), 63.9(e) 63...

  11. 40 CFR 279.73 - Notification.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 28 2012-07-01 2012-07-01 false Notification. 279.73 Section 279.73 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR THE MANAGEMENT OF USED OIL Standards for Used Oil Fuel Marketers § 279.73 Notification. (a...

  12. 40 CFR 279.73 - Notification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 27 2011-07-01 2011-07-01 false Notification. 279.73 Section 279.73 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR THE MANAGEMENT OF USED OIL Standards for Used Oil Fuel Marketers § 279.73 Notification. (a...

  13. 40 CFR 279.73 - Notification.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 27 2014-07-01 2014-07-01 false Notification. 279.73 Section 279.73 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR THE MANAGEMENT OF USED OIL Standards for Used Oil Fuel Marketers § 279.73 Notification. (a...

  14. 40 CFR 279.73 - Notification.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 28 2013-07-01 2013-07-01 false Notification. 279.73 Section 279.73 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR THE MANAGEMENT OF USED OIL Standards for Used Oil Fuel Marketers § 279.73 Notification. (a...

  15. 40 CFR 63.7189 - What applications and notifications must I submit and when?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Semiconductor Manufacturing Applications, Notifications, Reports, and Records § 63.7189 What applications and notifications...

  16. 14 CFR 1214.1107 - Notification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Notification. 1214.1107 Section 1214.1107 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT NASA Astronaut Candidate Recruitment and Selection Program § 1214.1107 Notification. Selectees and the appropriate military services...

  17. 14 CFR 1214.1107 - Notification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Notification. 1214.1107 Section 1214.1107 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT NASA Astronaut Candidate Recruitment and Selection Program § 1214.1107 Notification. Selectees and the appropriate military services...

  18. 77 FR 65189 - National Environmental Justice Advisory Council; Notification of Public Teleconference Meeting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-25

    ...; Notification of Public Teleconference Meeting and Public Comment AGENCY: Environmental Protection Agency (EPA). ACTION: Notification of public teleconference meeting and public comment. SUMMARY: The Environmental... National Environmental Justice Advisory Council (NEJAC) will host a public teleconference meeting on...

  19. 77 FR 30325 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Notification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-22

    ...] Agency Information Collection Activities: Proposed Collection; Comments Requested: Notification of Change... through the use of appropriate automated, electronic, mechanical, or other technological collection... currently approved collection. (2) Title of the Form/Collection: Notification of Change of Mailing or...

  20. 78 FR 45275 - Agency Information Collection Activities; Proposed collection; Comments Requested: Notification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-26

    ...] Agency Information Collection Activities; Proposed collection; Comments Requested: Notification of Change... technological collection techniques or other forms of information technology, e.g., permitting electronic... currently approved collection. (2) Title of the Form/Collection: Notification of Change of Mailing or...

  1. 28 CFR 540.13 - Notification of rejections.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Notification of rejections. 540.13 Section 540.13 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT CONTACT WITH PERSONS IN THE COMMUNITY Correspondence § 540.13 Notification of rejections. When...

  2. 40 CFR 725.235 - Conditions of exemption for activities conducted inside a structure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... experiments subject to Institutional Biosafety Committee review, or notification simultaneous with initiation of the experiment, the information submitted for review or notification, along with standard... experiments exempt from Institutional Biosafety Committee review or notification simultaneous with initiation...

  3. 40 CFR 725.235 - Conditions of exemption for activities conducted inside a structure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... experiments subject to Institutional Biosafety Committee review, or notification simultaneous with initiation of the experiment, the information submitted for review or notification, along with standard... experiments exempt from Institutional Biosafety Committee review or notification simultaneous with initiation...

  4. 40 CFR 725.235 - Conditions of exemption for activities conducted inside a structure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... experiments subject to Institutional Biosafety Committee review, or notification simultaneous with initiation of the experiment, the information submitted for review or notification, along with standard... experiments exempt from Institutional Biosafety Committee review or notification simultaneous with initiation...

  5. Potential impact and acceptability of Internet partner notification for men who have sex with men and transgender women recently diagnosed as having sexually transmitted disease in Lima, Peru.

    PubMed

    Clark, Jesse L; Segura, Eddy R; Perez-Brumer, Amaya G; Reisner, Sari L; Peinado, Jesus; Salvatierra, Hector J; Sanchez, Jorge; Lama, Javier R

    2014-01-01

    We assessed the potential impact of Internet partner notification among men who have sex with men and transgender women in Peru recently diagnosed as having sexually transmitted disease. Use of Internet partner notification was anticipated for 55.9% of recent partners, including 43.0% of partners not currently expected to be notified, a 20.6% increase in anticipated notification outcomes.

  6. Real-Time Multimission Event Notification System for Mars Relay

    NASA Technical Reports Server (NTRS)

    Wallick, Michael N.; Allard, Daniel A.; Gladden, Roy E.; Wang, Paul; Hy, Franklin H.

    2013-01-01

    As the Mars Relay Network is in constant flux (missions and teams going through their daily workflow), it is imperative that users are aware of such state changes. For example, a change by an orbiter team can affect operations on a lander team. This software provides an ambient view of the real-time status of the Mars network. The Mars Relay Operations Service (MaROS) comprises a number of tools to coordinate, plan, and visualize various aspects of the Mars Relay Network. As part of MaROS, a feature set was developed that operates on several levels of the software architecture. These levels include a Web-based user interface, a back-end "ReSTlet" built in Java, and databases that store the data as it is received from the network. The result is a real-time event notification and management system, so mission teams can track and act upon events on a moment-by-moment basis. This software retrieves events from MaROS and displays them to the end user. Updates happen in real time, i.e., messages are pushed to the user while logged into the system, and queued when the user is not online for later viewing. The software does not do away with the email notifications, but augments them with in-line notifications. Further, this software expands the events that can generate a notification, and allows user-generated notifications. Existing software sends a smaller subset of mission-generated notifications via email. A common complaint of users was that the system-generated e-mails often "get lost" with other e-mail that comes in. This software allows for an expanded set (including user-generated) of notifications displayed in-line of the program. By separating notifications, this can improve a user's workflow.

  7. Study of variables affecting critical value notification in a laboratory catering to tertiary care hospital.

    PubMed

    Agarwal, Rachna; Chhillar, Neelam; Tripathi, Chandra B

    2015-01-01

    During post-analytical phase, critical value notification to responsible caregiver in a timely manner has potential to improve patient safety which requires cooperative efforts between laboratory personnel and caregivers. It is widely accepted by hospital accreditors that ineffective notification can lead to diagnostic errors that potentially harm patients and are preventable. The objective of the study was to assess the variables affecting critical value notification, their role in affecting it's quality and approaches to improve it. In the present study 1,187 critical values were analysed in the Clinical Chemistry Laboratory catering to tertiary care hospital for neuropsychiatric diseases. During 25 months of study period, we evaluated critical value notification with respect to clinical care area, caregiver to whom it was notified and timeliness of notification. During the study period (25 months), the laboratory obtained 1,279 critical values in clinical chemistry. The analytes most commonly notified were sodium and potassium (20.97 & 20.8 % of total critical results). Analysis of critical value notification versus area of care showed that critical value notification was high in ICU and emergency area followed by inpatients and 64.61 % critical values were notified between 30 and 120 min after receiving the samples. It was found that failure to notify the responsible caregiver in timely manner represent an important patient safety issue and may lead to diagnostic errors. The major area of concern are notification of critical value for outpatient samples, incompleteness of test requisition forms regarding illegible writing, lack of information of treating physician and location of test ordering and difficulty in contacting the responsible caregiver.

  8. 47 CFR 10.260 - Timing of subscriber notification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Timing of subscriber notification. 10.260 Section 10.260 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMERCIAL MOBILE ALERT SYSTEM Election to Participate in Commercial Mobile Alert System § 10.260 Timing of subscriber notification. A CMS...

  9. 7 CFR 622.7 - Notification under Executive Order 12372.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 6 2011-01-01 2011-01-01 false Notification under Executive Order 12372. 622.7 Section 622.7 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE WATER RESOURCES WATERSHED PROJECTS General § 622.7 Notification...

  10. 7 CFR 622.7 - Notification under Executive Order 12372.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 6 2010-01-01 2010-01-01 false Notification under Executive Order 12372. 622.7 Section 622.7 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE WATER RESOURCES WATERSHED PROJECTS General § 622.7 Notification...

  11. 7 CFR 622.7 - Notification under Executive Order 12372.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 6 2012-01-01 2012-01-01 false Notification under Executive Order 12372. 622.7 Section 622.7 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE WATER RESOURCES WATERSHED PROJECTS General § 622.7 Notification...

  12. 7 CFR 622.7 - Notification under Executive Order 12372.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 6 2014-01-01 2014-01-01 false Notification under Executive Order 12372. 622.7 Section 622.7 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE WATER RESOURCES WATERSHED PROJECTS General § 622.7 Notification...

  13. 7 CFR 622.7 - Notification under Executive Order 12372.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 6 2013-01-01 2013-01-01 false Notification under Executive Order 12372. 622.7 Section 622.7 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE WATER RESOURCES WATERSHED PROJECTS General § 622.7 Notification...

  14. 48 CFR 970.4401-3 - Advance notification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... subcontracts relating to functions derived from the Atomic Energy Commission. (c) The advance notice shall... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Advance notification. 970... 970.4401-3 Advance notification. (a) Contracting officers shall assure that the written description of...

  15. 47 CFR 64.2011 - Notification of customer proprietary network information security breaches.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 3 2011-10-01 2011-10-01 false Notification of customer proprietary network information security breaches. 64.2011 Section 64.2011 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... Proprietary Network Information § 64.2011 Notification of customer proprietary network information security...

  16. 47 CFR 64.2011 - Notification of customer proprietary network information security breaches.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 3 2010-10-01 2010-10-01 false Notification of customer proprietary network information security breaches. 64.2011 Section 64.2011 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... Proprietary Network Information § 64.2011 Notification of customer proprietary network information security...

  17. 47 CFR 1.9060 - Amendments, waivers, and dismissals affecting spectrum leasing notifications and applications.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... spectrum leasing notifications and applications. 1.9060 Section 1.9060 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Spectrum Leasing General Policies and Procedures § 1.9060 Amendments, waivers, and dismissals affecting spectrum leasing notifications and applications. (a...

  18. 47 CFR 1.9060 - Amendments, waivers, and dismissals affecting spectrum leasing notifications and applications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... spectrum leasing notifications and applications. 1.9060 Section 1.9060 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Spectrum Leasing General Policies and Procedures § 1.9060 Amendments, waivers, and dismissals affecting spectrum leasing notifications and applications. (a...

  19. 10 CFR 20.1405 - Public notification and public participation.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Public notification and public participation. 20.1405 Section 20.1405 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiological Criteria for License Termination § 20.1405 Public notification and public participation. Upon the...

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