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FDA, CE mark or something else?—Thinking fast and slow Sundeep Mishra Show more https://doi.org/10.1016/j.ihj.2016.11.327
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Open Access funded by Cardiological Society of India Under a Creative Commons license
Abstract There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: “substantial equivalence,” “PMDA,” “CE mark,” “Notified body,” “510K” and “PMA” but the actual approval process can also be very tardy, inconsistent and expensive.
Keywords Device regulation; Substantial equivalence; MDA; PMDA; CE mark; EC type examination; Notified body; 510K ; PMA; STED; Harmonization of regulatory approvals
1. Introduction “Developing a medical device that will be subject to scrutiny by FDA often strikes fear in the hearts of design engineers” The regulation of medical devices is a relatively recent phenomenon unlike drug regulation which commenced in the late 60s, a knee jerk response to thalidomide tragedy. In US the Bureau of Medical Devices and Diagnostic Products was established in 1974 and Medical Device Amendments to the Food, Drug, and Cosmetic Act were enacted, to assure safety and effectiveness of medical devices in 1976. The formal regulation of medical devices in the Europe only began much later (in the mid 1990s).1 However, device regulation has been distinguished from drug regulation only very recently. Despite global efforts to harmonize regulation of medical devices via groups such as the Global Harmonization Task Force (GHTF), there is a huge discrepancy among regulators all over the world. The differences lie in the concept, the classification of devices, the overall process, the quickness of approvals, their applicability across regions and the expense involved. Currently US contribute to 38% of medical device market, Europe ~ 25%, China ~ 21%.2
2. PIP breast implant scandal The “PIP Breast Implant Scandal” brought the field of device regulation to the fore. Greater emphasis on physical appearance has led to a growing number of breast augmentation procedures among women in developed countries. As a matter of fact, breast implantation has become the second most common surgery performed in USA. Poly Implant Prothèse (PIP) was a French company that produced silicone gel breast implants. However, the company was preemptively liquidated following the revelation that they had been manufacturing and selling breast implants made from cheaper industrial-grade silicone (instead of the mandated medical-grade silicone they had previously used). The hundreds of thousands of implants sold globally by PIP from 2001 to 2010 were found to have a 500% higher risk of rupturing or leaking (than approved models), as well as being implicated in several deaths due to systemic toxicity and even cases of induced breast cancer.3 The scandal, which produced fears of a massive health disaster, prompted a full recall of the company's implants by the French health ministry in 2010. All these “dangerous” implants had a CE mark on them but they had not been awarded a FDA approval yet because of “healthy ambivalence” among FDA regulators. Was this a failure of regulation or something else? This scandal brought to fore dialectic that while CE mark (vs. FDA approval) was quicker and easier to procure, was it safe enough?
3. Is CE mark directly comparable to US FDA or Japanese PMDA? The simple answer is no. Conceptually, each of these regulatory processes differ in the aims of regulation and the process involved: 3.1. Aim of regulation Essentially, the CE marking process focuses primarily on safety, but also on reinforced manufacturer obligation with respect to device claims i.e. to ensure that the device does what it claims to do. The FDA does this too, but has the additional requirement of evaluating efficacy. Once efficacy is evaluated, its value is also determined. In other words it also answers the question: ‘does healthcare really need this device?' Finally, all this is indirectly but ultimately linked to healthcare reimbursements. Japanese PMDA also looks at the quality, efficacy and safety of the device. The CE relies more on self-regulation and conformity assessment whereas FDA relies more on approval by regulatory bodies. 3.2. Process of regulation The regulatory process for CE mark is rather simple. It involves following the medical device directive (93/42/EEC) to identify conformity assessment procedures for that particular product. For Class III devices (implantable devices, which require highest assurance of safety and effectiveness before they can be used in clinical setting) essentially there can be two conformity assessment routes: 1. EC type examination (Module B) by a notified body followed by either device verification or production quality assurance audit by the notified body. 2.
Full quality assurance (Module H) and design dossier examination by notified body.
Based on requirements of conformity assessment route chosen, a technical file is compiled and certification is obtained by a notified body. Subsequently the device manufacturer has to declare conformity and appoint an Authorized Representative.4 Finally, CE Mark can be affixed to the product and/or its packaging and accompanying literature. After marketing the manufacturers are responsible for post-marketing surveillance. In devices Class I or Class II devices the regulatory process is even simpler. 3.2.1. Notified bodies Notified bodies are standards organizations/companies supervised, audited and designated in each Member State of the European Union by the relevant Devices Agency (Competent Authority) of each country. They are the premarketing assessors responsible for the higher risk devices, overseen and audited by the National Agencies. The Notified Bodies check the development and the designs of the device by manufacturing plant visits and audits. They also review the clinical studies, which have been undertaken, monitor the quality control procedures and the production of the device.1 3.2.2. EC-type examination EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of the legislative instrument that apply to it. It may be carried out in either of the following manner: — examination of a specimen, representative of the production envisaged, of the complete product (production type), — assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence with/without examination of specimens. 3.2.3. Post-market surveillance The EU relies more on post-marketing surveillance than on pre-marketing one. For example British Medical Device Agency (MDA), through its two complimentary schemes of Vigilance reporting and the Adverse Incident Scheme undertakes the process of surveillance. The first is mandatory for the manufacturer and concerns serious adverse incidents, whilst the second is voluntary and directed towards users. The regulatory process with FDA, on the other hand is rather cumbersome. If the device manufacturer claims equivalence to a pre-existing approved device in market, it can go for pre-market notification [510(k)]. The philosophy of this process involves proving substantial equivalence between the new device and the predicate (legally marketed) device, rather than an independent demonstration of the new devices’safety and effectiveness. The substantial equivalence should be not only in terms of technological and design characteristics but also on performance data and should have same intended use as the predicate device. If substantial equivalence cannot be established the device is categorized as Class III and generally requires pre-market approval (PMA). 3.2.4. Process of pre-market notification [510(k)]5 1.
Pre-market notification submission made by the device manufacturer (at least 90 days before device introduction into market). The submission includes information on description of device, explanation of how the device functions, scientific concepts that form the basis of this device and significant physical and performance characteristics.
FDA classifies the device in appropriate device category.
If device is classified
Technological characteristics (materials, design, and specifications).
Non-clinical bench performance or analytical studies- these may include a variety of tests − i)
mechanical, electrical, and biological engineering performance, such as fatigue, wear, tensile strength, compression, flow-rate, burst pressure;
other forms of non-clinical, including device-specific.
Non-clinical animal and/or biocompatibility studies are typically requested when other forms of non-clinical bench performance testing are not sufficient to demonstrate substantial equivalence.
Clinical performance data − When analytical or non-clinical bench performance testing data, or non-clinical animal and/or biocompatibility studies are insufficient, or available scientific methods are not acceptable, e.g., the scientific methods are deemed unacceptable because they are not clinically validated or are not supported by a valid scientific rationale, FDA may request clinical performance data to support a substantial equivalence determination.
FDA can request for additional performance data on any of these aspects and keep the notification on hold (till it is satisfied with the data).
If FDA is convinced that data is unable to prove substantial equivalence it can refuse notification and categorize it as Class III device.
3.2.5. FDA pre-market approval A Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the class III device. There are administrative elements of a PMA application, but good science and scientific writing is a key to the approval of PMA application.6 Conceptually, the review of a PMA is a four-step review process (details of this process are given in Table 2) consisting of: • Administrative and limited scientific review by FDA staff to determine completeness (acceptance and filing reviews); •
In-depth scientific, regulatory, and Quality System review by appropriate FDA personnel (substantive review);
Review and recommendation by the appropriate advisory committee (panel review); and
Final deliberations, documentation, and notification of the FDA decision.
Table 2. Steps in the PMA Application Process.
ODE (Office of Device Evaluation) filing review
OSB (Office of Surveillance and Biometrics) statistical review for filing
OC (Office of Compliance) review of manufacturing information for compliance with the Quality System regulation (21 CFR 820).
PMA filing decision
Quality System Inspection(s) by the FDA field personnel. An FDA manufacturing inspection is conducted for all original PMAs and may be conducted for PMA supplements requesting approval of alternate or additional manufacturing and sterilization facilities.
Bioresearch Monitoring (BIMO) Audit (audit of clinical study data)
Substantive review coordination and completion in areas such as:
Preparation of FDA Summary of Safety and Effectiveness Data (SSED)
Panel Meeting Decision and Mailing (if panel meeting is appropriate)
Panel Date (if appropriate)
Transcripts Received, Reviewed and Placed in Administrative Record
Final Response from OC for GMP/BIMO
Final ODE Decision Memo
Approval Order, SSED, Final Draft Labeling
3.2.6. Data requirements Stringent data requirements are to be met before approval can be considered. The data requirements pertain to technical sections, non-clinical laboratory studies and clinical investigations. Table 3. Generally clinical studies should be conducted in US. However, a study conducted under an investigational device exemption (IDE) outside the United States and submitted in support of a PMA must comply with the IDE regulation (21 CFR 812). Table 3. Data Requirements.
Technical Sections: The technical sections containing data and information which should allow FDA to determine whether to approve or disapprove the application.
Non-clinical Laboratory Studies Section: Non-clinical laboratory studies section includes information on microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests.
Clinical Investigations Section: Clinical investigations section includes study protocols, safety and effectiveness data, adverse reactions and complications, device failures and replacements, patient information, patient complaints, tabulations of data from all individual subjects, results of statistical analyses, and any other information from the clinical investigations
3.2.7. Panel review (21 CFR 814.44) FDA may refer the PMA to an outside panel of experts (advisory committee). In general, all PMAs for the first-of-a-kind device are taken before the appropriate advisory panel for review and recommendation. 3.2.8. Japan PMDA Traditionally, Japanese had the slowest approval process. However with the institution of an Action Program there has been a significant progress.7 An essential component of this plan is an accelerated review process which involves review of prior assessment, readiness for introduction of risk-management plan and utilization of medical information database. This Action Program also focuses on increasing the number of PMDA reviewers, increasing review fees, outsourcing designated Class II device reviews to registered certification bodies, a three-track review process, semiannual evaluation of review performances based on objective measures and an overall reorganization of the review department within Pharmaceuticals and Medical Devices Agency (PMDA). The Japanese approval process is essentially approval of two aspects: 1. Device – This involves review against essential principals and summary technical documentation (STED) data subsets. 2.
3.2.9. Essential principles in Japan It is a checklist of conformity to the essential principles (EP) specified in “the Standards for medical devices” as stipulated by the Japanese law. Broadly these EPs pertain to design and manufacture (toxicity, compatibility, hardness, wear and degree of fatigue, handling, etc), risk management, performance and function, durability, transport and storage and benefits of device. 3.2.10. STED Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) is a practical method to harmonize device regulation and bring Japan in line with other international regulatory bodies.8 Similar in principle to FDA 510(k) it attempts show equivalence of a new device with a predicate device. It attempts to develop a common regulatory format for all the major regulatory bodies.
4. Regulatory bodies in developed world In Canada, the Medical Devices Bureau of the Therapeutic Products Directorate is the regulatory body which requires Class III and IV device manufacturers to submit a Premarket Review Document (a summary of safety, effectiveness and clinical studies). The Therapeutic Goods Administration (TGA) is medical device regulator in Australia, where device approval is similar to Europe. Korea’s regulatory authority is the Korea Food and Drug Administration (KFDA) which requires higher risk device manufacturers to submit a Technical File followed by type testing by a third party and clinical study data as part of the submission. Korean Good Manufacturing Practices certification is also to be obtained (via a third party organization which works together with KFDA) by conducting a compliance evaluation. Currently, Singapore also requires product registration but devices which are already approved in another market such as the U.S., Canada, or Europe may follow an abbreviated registration process.
5. Regulatory bodies in less industrialized world In many parts of developing world, regulation of devices is still evolving. Western regulatory bodies rely on data from clinical studies performed in West. They generally include Caucasian populations, but have very few participants from other races, with typically <1% Asian population. Furthermore, even if population differences are not considered, the practice environment in West is much different from many parts of the World.8 Thus there is a healthy on-going debate whether West developed regulations are sufficient for this part of world as well or country specific clinical studies are required (enrolling population from index area). A pragmatic approach to this issue may be to apply the principle of “substantial equivalence” here as well. If the index population can be shown to be equivalent (with respect to given outcomes) to the “predicate” population, there may be no need to undertake a fresh study −“to re-invent the wheel.” However, despite this, the differences in practice environment will have to be considered and applying the principle of substantial equivalence may be warranted, here as well. A good solution to circumvent this problem could be to enroll a diverse population all over the world in the “initial” study itself. Thus there is a need to relook whether Western guidelines and regulatory framework developed in context of these guidelines is applicable to vast majority of population swath all over the world. In China the medical device regulatory authority is the State Food and Drug Administration (SFDA), The approval requires submission of a dossier to the SFDA as well as type testing. Class III products (manufactured outside of China) are subject to an onsite product audit and are also likely to require clinical studies conducted in China prior to approval, in particular for devices which contact the central nervous system. In context of Latin American (LATAM) countries there are efforts to harmonize regulations, so that now regulatory process in most countries is broadly similar. The basic features are: • Require a Technical File or Report similar to a CE Technical File (technical description, device safety test results, biocompatibility data, labeling, etc). •
A Certificate of Free Sale (CFS) issued by the public health authority in the country of origin, which demonstrates that the device is cleared for sale in origin country.
Product registration for 5 years (in most countries)
Devices are classified into four risk classes (I, II, III, and IV), ranging from low risk to high risk.
Most countries require certain regulatory documents to be translated into local language, and notarized.
However, there are some differences. In Brazil (the largest medical device market in LATAM) the approval process is most meticulous but also notoriously lengthy and submission costs are the most expensive in entire LATAM. In Mexico on the other hand, the devices that are cleared for sale in the U.S. or in Canada can undergo a fast track process where the only requirement is to get the technical documents translated into Spanish and notarized. Hong Kong does not currently require medical devices to be registered in order to be commercialized and registration is voluntary. New Zealand’s medical device regulator is called MedSafe under Ministry of Health. Devices must be registered on MedSafe’s database. There is no pre-market approval process in New Zealand. A local sponsor that has the legal responsibility for the medical device must be identified by the manufacturer.
6. Tips to regulatory process Among all the regulatory processes the quickest and the cheapest is 510(k). Thus if the new device is similar to some existing, approved device and it is possible to prove substantial equivalence to it, it may quickly get an approval. Once US pre-approval notification is achieved it would be easier to go for Japanese PMDA approval (STED route) and simultaneously apply for CE Mark. On the other hand if substantial equivalence is not possible/cannot be proved, then it may be easier to go for CE Mark as also plan a US clinical study in guidance with US FDA. In the initial international study, it could be a good idea to enroll some patients from India, China and other countries as well so that this study can be used in regulatory processes of these countries as well.
7. Advantages and limitations of current regulatory bodies CE Mark certifies that the medical device conforms to the European Standard of electronic engineering and that its use is considered reasonably safe. The process is simpler, less expensive and it relies more on self regulation (the onus is on the manufacturer) and post-marketing surveillance. However, CE is only half-way mark because re-imbursement approval will still be needed for each individual country. Regarding FDA approval, 510(k) is simpler and quicker and relies on proving substantial equivalence. With 510(k), the quality management system assessment may be delayed and the device placed on market (whereas quality management system assessment happens before approval in CE mark) for some time. FDA inspects to 21 CFR 820 only sometime after 510(k) clearance is given, even a year or so later. However, if substantial equivalence cannot be proved the approval process i.e. PMA could be lengthy, expensive, in-consistent (instances of early recall) and generally requires a clinical study conducted in USA. On the brighter side, once achieved, it is directly applicable to not only in all US (38% of world market), but also in Mexico and indirectly to many other countries of the world. Japanese PMDA now relies on accelerated review process and is also working on the concept of substantial equivalence particularly with FDA approved devices. Comparison of three regulatory bodies is discussed in Table 4. An issue with all these regulatory processes is that even if some of them look at efficacy (FDA, PMDA), they certify to only a threshold of efficacy. In other words it confirms a certain level of quality but is unable to differentiate/discriminate between value of approved products i.e. unable to determine the relative usefulness of product and thus its fair re-imbursement price. Another major limitation of these regulatory bodies is that there is no mechanism of recall (once approved) even after a product has outlived its usefulness and has even become obsolete.9 Table 4. Comparison among regulators.
Safety, Efficacy and Device consistency
Only Safety and Device consistency
Safety, Efficacy and Device consistency
Tedious and inconsistent
Simple and consistent
Simple and consistent
Speed of Approval
Slow if PMA required
Both Manufacturer and Regulator
Both Manufacturer and Regulator
Whole of US, Mexico
EU but approval by individual country still required
8. Harmonization of regulatory approvals Harmonizing regulatory approval processes is the need of the hour and may benefit not only device industry but individual country as well (by allowing a beneficial innovation to reach quickly to the needy and at a cheaper cost). The idea is to have a standardized format and submit essentially the same documentation to more than one Regulatory Authority or Conformity Assessment Body (in all regulatory classes). In 1992 GHTF, a voluntary partnership between government and industry representatives from the US, Australia, Canada, the EU and Japan joined together to promote international harmonization in the regulation of medical devices. Subsequently, countries such as Japan, Australia and Canada have adopted this harmonized approach as an acceptable format and content, within their regulatory framework. There is also a Japan–US “Harmonization-By-Doing” (HBD) Pilot Program which was launched in December 2003 to develop harmonized clinical trials and clinical trial requirements between Japan and the US along with a focus on regulatory convergence.10
9. Back to PIP breast implant scandal At the peak of the PIP scandal it was considered a failure of EU regulation. However, it has to be appreciated that this is not a failure of regulation, rather an illegal activity, substituting an approved clinical grade material with industrial grade material, a case for law enforcing agencies rather than regulators.
10. Conclusions There are multiple regulatory bodies all over the world with a different aim, process and application. This creates a lot of confusion in the minds of manufacturers. There is a need for harmonization, rationalization and standardization of submission process. "When a man cannot choose, he ceases to be a man" Recommended articles
Citing articles (1)
D.B. Jeffreyes The regulation of medical devices and the role of the Medical Devices Agency Br. J. Clin. Pharmacol., 52 (Sepetember (3)) (2001), pp. 229-235
J. Cunningham, B. Dolan, D. Kelly Chris Young Medical Device Sectoral Overview http://galwaydashboard.ie/publications/medical-sector.pdf
Breast Implant Scandal https://www.theguardian.com/world/2013/may/09/pip-breast-implant-report-questioned
How to achieve CE mark approval, CE testing and meet all CE mark requirements, for my product? file:///D:/IHJ%20Assignments/My%20Editorials/FDA%20or%20CE/CE%20Marking_%20CE%20mark%20approval,%20CE%20testing,%20CE%20mark%20requirements,%20how%20achie ve%20them%20all%20for%20my%20product_html.
The 510(k) Program, Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. htttp://www.fda.gov/downloads/MedicalDevices/…/UCM284443.pdf.


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All the sponsors stood proudly outside Reading train station. Credit: Pete Bloodworth/getreading
A celebration of all things that make the town what it is, the Pride of Reading awards have launched for the 15th year.
Even bigger and better than before, the theme for the annual ceremony is International Reading, in recognition of the town's worldwide links through business, communities and culture.
Sir John Madejski, patron of the awards, was among the special guests at the launch on Friday, May 11 at Mal Maison in Station Road.
The launch officially opens the nominations, with 17 categories to choose from including this year's newest award, Stronger Together Employer of the Year.
The ceremony hosted by Chris Tarrant, will take place on Friday, November 2 at the Royal Berkshire Conference Centre in Reading, Berkshire.
A panel of judges will decide the shortlisted nominees who will all be invited to special lunch at the end of the year where the winners will be announced.
Chris Tarrant will be back to host the 2018 awards. Credit: getreading
The judges' decision on whether a nominee is shortlisted is based on each individual story, rather than the number of nominations each person or organisation receives, so only one nomination is needed to put them in the running.
Take a look at the categories below to find out what they each represent and how to nominate.
Chris Tarrant Award
Ben Spiller (centre) winner of the Chris Tarrant Award 2017. Credit: getreading
Someone from Reading who deserves special recognition.
Volunteer/s of the Year
Reading Park Run organisers Paul (third from left) and Teresa Caswell (fourth from left) picked up the Volunteer of the Year Award. Credit: getreading
An individual or team engaged in diverse and challenging tasks, or simply who have stepped up when needed.
Employee of the Year
PC Graham Benham won Employee of the Year. Credit: getreading
An employee who goes the extra mile for their firm or customer.
Stronger Together Employer of The Year
A new category for firms that help unemployed people (aged 25 or over) who need support to get into work or vocational training, or to move closer to either of these goals.
Elizabeth Munro and PC Liz Cole won the Local Hero Award. Credit: getreading
Someone who, through a special act of kindness or bravery has made a positive difference to their community.
Health Worker of the Year Kath O'Hagan with Chris Tarrant. Credit: getreading
From nurses to hospital porters, GPs to special care staff, this category celebrates the health professional or team that takes caring to another level.
Toby Davies of Reading Between the Lines collecting the Cultural Contribution Award at the Pride of Reading Awards 2017. Credit: getreading
To raise the profile of, and give recognition to the projects, people, and organisations that contribute to the cultural life of Reading, covering music, drama, art and heritage.
Child of Courage
At the Pride of Reading awards with the Child of Courage winner Callum Taylor and X Factor's Danyl Johnson. Credit: getreading
The town's bravest youngster. There are many times when a childs' courage shines through.
Some become heroic lifesavers, others demonstrate courage through battling illness or other difficult circumstances. We want to hear about these amazing under 16-year-olds.
School of the Year
Headteacher Sarah East picked up the School of the Year Award for Springfield Primary in Tilehurst. Pictured with Lisa Harper who nominated the school for the support it showed her after the death of her son Byron Want. Credit: getreading
For exceptional achievement, open to nursery, primary, secondary and special schools in Reading.
Charity of the Year
Ken Deeks picked up Charity of the Year for his event Byte Night. Credit: getreading
Recognising a local charity or community group that has made an amazing impact to our community through partnership working with businesses, other charities and the public sector to further its cause.
Young Person of the Year
Carly Newman, 20, won Young Person of the Year Award at the Pride of Reading Awards 2017.
Credit: Pete Bloodworth/getreading
An inspirational young person, under 21, who has shown outstanding community spirit, drive and ambition.
Fundraiser of the Year
Iain Wright with his children Nicole and Joel collecting the Fundraiser of the Year Award, won posthumously by Vanessa Wright, with Vanessa's niece Karly and Chris Tarrant. Credit: getreading
An individual or organisation that has shown outstanding skills or dedication to fundraising.
Family of the Year
Lauren Heath's family - Millie Hensley, David Heath, Sherrie Gregory and Daniel Heath collect the Family of the Year Award from Chris Tarrant. Credit: getreading
A family that deserves special recognition.
Smile of the Year
A story that has made Reading smile. We want to hear about the acts of kindness or amusing tales which have bought happiness to the town.
Entrepreneur of the Year
Enterprise Award for an individual or group with a business venture in Reading.
Foster carer for 30 years, Iris Pridham, picked up Community Champion Award, and is pictured with Chris Tarrant and Candice Chambers and Graham Mountford from Broad Street Mall. Credit: getreading
Someone who works tirelessly in their community as an individual, in the voluntary sector, as a carer, for a community group or in public service who devotes their time for others.
Business in Action
Adam (second from left), Adrienne and Ian from Jacobs the Jewellers collect their prize for Business in Action (small business) from Chris Tarrant Credit: getreading
Companies, large or small, who get involved in community work. There are two awards for firms with under 50 and over 50 employees.
To nominate a person or business for one of these awards all you need to do is fill out the form below and wait for our reporter to be in touch.
**Nominations are now closed!
Thank you for all your fantastic stories.
**The judges will consider all the nomination stories by the end of September. **
**Only shortlisted nominees will be invited to attend the awards ceremony on November 2. **
If you haven't been contacted by mid-October then sadly you will not have been shortlisted.
The winners will be announced on the day.

domain: news


Works to secure Gosforth mine shaft collapse complete
A mine shaft that caused a ground collapse near homes and garages in Gosforth has been made safe for residents by the Coal Authority’s public safety team.
The team designed a permanent solution which required over 65 cubic metres of reinforced concrete to repair an area in Craster Square which collapsed at the end of last year.
The mine shaft, known as Coxlodge Colliery Jubilee Shaft, was operational during the 1820s and is nearly 200 years old. The mine was recorded as being closed in 1891, but the Coal Authority’s investigations showed that the shaft was left open after this time to help ventilate other mine workings in the area.
The permanent solution for local residents
Tim Marples, Head of Public Safety and Subsidence at the Coal Authority, said: “When the ground collapse occurred we immediately fenced off the area and filled the void to make it safe.
“We then carried out ground investigations which included drilling boreholes to investigate the mine shaft’s structure and fill materials, as well as the conditions underground.
“The results of these investigations gave our engineers the information they needed to design a permanent solution for the site.
“We’ve completed the construction of a hexagonal, steel reinforced concrete slab to cover the mine shaft, which now sits two metres below the ground.
“Underneath it we’ve injected 35 cubic metres of resin grout into the shaft to ensure the area is completely stabilised.
“This approach means that the mine shaft is now safe and local residents are protected.”


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Bob McCully’s review published on Letterboxd:
Panos Cosmatos outing for Guillermo Del Toro's Cabinet of Curiosities is some seriously decadent camp and gnarlified body horror. A full-on cosmic hangout flick as one of the most inventive casts is assembled for a mysterious get-together at a gorgeous pad. We're talking Eric Andre, Charlene Yi, Steve Agee and someone my wife said we saw play Peter Pan at the Stratford Theatre Festival in 2010 all filling the shoes of various selected characters. They're invited to Peter Weller and Sofia Boutella's secret Jodorowskian spherical lounge to do drugs and let loose.
Considering how much this is draped in curvaceous neon hues, whimsical lens flares, and that velvety Daniel "Oneohtrix Point Never" Lopatin synth score, I was pretty much sold on that aesthetic and the Jim Jarmusch-ian comedy of these 6 delightful performers hanging out and getting stooooooned. I started to wonder though... wasn't this supposed to be a horror tale?
I don't want to spoil it, because you absolutely need to watch this and enjoy the hell out of it, but shit gets real melty and real nasty right when you were ready for a bombastic climax. Easily one of the most impressive/believable CGI monsters I've ever seen. Gives me hope for the future of CGI in horror films (no shiny werewolves to be seen). As long as Panos is doing it.
Surprisingly exactly what I wanted for 1 hour - didn't need any more or any less - I just want more from Panos. Get that guy to huff on his intergalactic bong and start churning out more flicks ASAP.

domain: artistic


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Jonathan Butler Joins Jay Edwards On Jazz Tones
Jonathan Butler is in town May 22 at Cobb Energy Performing Arts Center as part of the Jazz Roots Series, performing with David Sanborn. The South African guitar and vocal artist is known across the globe for his music and his spirituality.
Jay Edwards will talk with Butler about his music, his influences, and what fans and newbies alike can expect at the May 22 performance.
From Jay: Jonathan Butler is a World Class Citizen from Cape Town South Africa residing in California. His musicianship was cultivated by being exposed to all kinds of rhythms, beats and harmonies at age 7.
Traveling with a circus at that early stage of life set a precedent for Jonathan's future. My intimate conversation about his life revealed the fact not being formally educated did not hinder him from being a world class performer.
Branded as a vocalist and guitarist with romantic, R&B and spiritual lyrics has captured the world's attention. He has released 25 records and is a multiple Grammy nominee. Butler is sensitive to society's ills and global dysfunctions.
Jonathan Butler's new release " Grace and Mercy" expresses his Christian roots and his musical versatility.
He will appear at Cobb Energy Center May 22,2013 with David Sanborn and provide not only entertainment but give a inspiring performance.
To get tickets to David Sanborn and Jonathan Butler, click here.
For more about Jonathan Butler, visit his site here.


A few not-so-shocking giveaways about this week’s new movie releases, including Justice League and Frank Serpico
Matthew Lickona 6 p.m., Nov. 17
According to a story in the Los Angeles Times, Judy Meier, longtime editor of the Borrego Sun newspaper, was found dead in her home today (Oct. 11). She was found in the kitchen and her estranged husband, Jim Meier, was found dead on a couch in the living room. The couple had recently filed for divorce. Authorities believe that Jim Meier, who had been a ranger at Anza-Borrrego State Park, killed Judy Meier and then committed suicide, according to the Times. A gun was found near his body. She had been quoted on this blog several times as the Reader followed events in Borrego, including Copley Newspapers selling off its assets. The paper had once belonged to Copley Newspapers.


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Michael Dappah take us on the Red Carpet outside the O2 Arena in London
Check out which country took Gold, Silver and Bronze at the FIBA Eurobasket 2017
Five of the Oklahoma City side played professionally in Spain before joining the NBA.
James Harden puts on a fantastic display in the two NBA pre-season games in Shanghai against the Pelicans.
Watch James Hardens best plays as he shines at point guard in the Rockets win against the Pelicans.

domain: sports


Horford helps Hawks down Thunder
Oklahoma City, OK – Al Horford netted 23 points and ripped down 12 rebounds as the Atlanta Hawks held off the Oklahoma City Thunder, 104-95, on Sunday at Chesapeake Energy Arena.
Louis Williams scored 19 points, including 14 in the final quarter, while Jeff Teague helped the cause with 16 points on 7-of-12 shooting to go with five assists.
Ivan Johnson contributed 10 points in a 12-plus minute run off the bench for the Hawks, who won their third consecutive road opener.
"We're a good team and we're getting to know each other, so this is big for us," Horford said. "To win on the road gives us a lot of confidence."
Kevin Martin dropped in a game-high 28 points, Kevin Durant was a pair of assists shy of his first career triple-double, finishing with 22 points, 12 rebounds and eight assists.
Russell Westbrook and Serge Ibaka donated 14 points each for the Thunder, who turned the ball over 21 times.
"We shouldn't be going back and forth with them," Durant said. "We're a defensive team and our defense let us down tonight."
Trailing 81-79 with 7:56 on the clock, the Hawks took control of the game for good as Williams netted 10 straight points during a 12-3 run, allowing the Hawks to open a 91-84 advantage with 4:44 left.
A deep 3-pointer by Martin with 4:06 to go pulled the Thunder within two, but they did not get any closer as Atlanta held on for the victory.
Down by five, 16-11, midway through the first quarter, the Hawks went on an 11-0 run. Teague tallied the final six points to give Atlanta a 22-16 lead. The Hawks took a 30-22 margin into the second stanza.
A layup by Zaza Pachulia with 5:38 left in the second frame gave the Hawks a 42-33 lead, but the defending Western Conference champs closed the first half with an 18-5 surge to take a 51-47 lead at the break.
Ibaka nailed a floater early in the third quarter to put the Thunder ahead, 57-48, but the visitors answered with an 11-2 push to tie the game at 59.
Back-to-back treys by Westbrook made it a six-point game, but again the Hawks had an answer as a Horford layup capped a mini 7-1 push to lock things up at 66 with 3:46 remaining in the third.
It stayed a one-possession game the rest of the quarter as the Hawks took a 75-74 lead courtesy of a Williams jumper with 21 seconds left.
Atlanta improved to 14-31 all-time in road lid-lifters ... Atlanta forward Josh Smith missed the game with a right ankle sprain ... Westbrook suffered a left shoulder contusion in the first quarter, but stayed in the game ... The Hawks shot just 14-of-20 from the free throw line.


Spokesperson for the UN High Commissioner for Human Rights: Rupert Colville Date: 7 June 2019Location: Geneva Subject: (1) Libya(1) Libya We are deeply concerned about the ghastly conditions in which migrants and refugees are being held in detention in Libya – with some 22 having died of tuberculosis and other illnesses in the Zintan detention facility since September 2018 – as well as ongoing reports of disappearances and human trafficking after people were intercepted at sea by the Libyan Coast Guard.
So far this year, a total of more than 2,300 people have been picked up off the coast of Libya and put in detention facilities.
Some 432 Eritreans detained in the facility – 132 of them children – reportedly receive only half of this amount.
Libya is notoriously perilous for refugees, asylum seekers, and migrants, who often suffer a litany of abuses, including at the country’s numerous detention facilities.Conditions at these facilities, many of which are under the control of militias, are deplorable.There are frequent shortages of water and food; over-crowding is endemic; detainees can experience physical mistreatment and torture; forced labour and slavery are rife; and there is a stark absence of oversight and regulation.Nevertheless, Italy and the European Union continue to strike controversial migration control deals with various actors in Libya aimed at reducing flows across the Mediterranean.During a recent visit to the Zintan Detention Centre, where 654 refugees and migrants are held, we found them severely malnourished, lacking water, locked in overcrowded warehouses reeking with the smell of rubbish and waste from overflowing latrines.
Those held in the facilities reportedly receive only one meal of 200 grams of plain pasta per day.
However, the Al-Khoms facility reports that there are currently only 30 migrants present.
This is particularly worrying given reports that migrants are being sold for forced labour or to smugglers promising transit to Europe.
A rescue operation, carried by the Libyan Coast Guard and local fisherman, has been underway since this morning and is ongoing.
“We must not simply accept these tragedies as inevitable,” said Vincent Cochetel, UNHCR Special Envoy for the Central Mediterranean.
We remind the Government that when a person dies in custody, there is a presumption of State responsibility.


Ahead of the rumoured launch of Apple’s video streaming service, the tech giant secretly announced two new iPads – the iPad Air and iPad Mini – right under your nose. With the two devices, Apple promises to offer 'dramatic power and capability.'
HERE’S WHAT WE KNOW
Starting at INR 44,900, the 10.5 inch iPad Air is powered by A12 Bionic processor with a second-generation Netural Engine coprocessor – used in the latest iPhones. With this, users can expect a 70 per cent improvement in the performance level compared to its predecessor. With 20 per cent larger display, the iPad Air has the capacity to handle heavy games, video editing and, cutting-edge 3D modelling. While we aren’t quite sure of the battery size, the 2019 iPad Air is claimed to last for a good 10 hours. What’s really impressive is that you can still use first-generation Apple pen on this device.
The 2019 iPad Mini is 25 per cent brighter than its predecessor. The 7.5 inch device comes with a laminated display, giving users a refined visibility. Staring at INR 34,900, this device is also compatible with the first-gen Apple pencil (you will have to buy it separately). You can, more or less, expect the same battery life the iPad Air offers.
Apparently, both the devices do not come with the FaceID recognition system. With 64GB and 256GB options available, both the devices will arrive in Gold, Space Grey, and Silver variants and will run on iOS 12.
According to Apple, “The new iPad models are available to order starting today from apple.com and in the Apple Store app in Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, the UAE, UK and US. Starting next week, the new iPad models will be available in those countries and regions, as well as in China (Wi-Fi models only), Macau (Wi-Fi models only) and Mexico with more countries and regions to follow soon, including Colombia, Greece, India, Israel, Russia, Saudi Arabia, South Africa, Thailand (Wi-Fi models only) and Turkey.”
While we are yet to get our hands on the other probable features of the two devices, we are quite happy with the estimated price range. If you think the 2019 iPad Pro is too expensive for your taste, you can get yourself one of the two devices (or both). The only major difference between the two devices is the size.
Image Courtesy: Apple


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- 6 slice
- bread, crust removed, cut into 1/2 inch squares
- 4 Tbsp
- butter, cut into 1/4" squares
- 2 c
- 2 c
- green chilies (chopped)
- salt and pepper
- 1 1/2 c
- monterey jack cheese
How to Make Overnight Chile Eggs
- 1In a large bowl, beat the eggs slightly. Add the bread, butter, milk, chilies, grated cheese, salt and pepper. Mix together and pour into a large rectangular baking pan that has been well greased.
- 2Refrigerate covered overnight. Bake, uncovered in a 300 degree oven for 1 hour, until puffed and golden brown.

domain: food


text:
In fallout from an onfield scuffle in Los Angeles Tuesday, standout rookie Dereck Rodríguez sustained a grade 1 right hamstring strain.
We’re approaching Major League Baseball’s second annual Players Weekend, the two games in 162 when players don’t risk fines for showing personality.
The Giants have released the nicknames their players have selected, which range from clever, to apropos, to simply boooriiinng.
What appeared to be the weakest pitching matchup of the series instead delivered the highest quality hurling of all.
Jed Lowrie launched career homer No. 100 Tuesday, leading Oakland to within one game of the AL West division lead.
The Athletics have been patiently waiting for All-Star Jed Lowrie to awaken from his second-half slumber.
This could be a week the A's look back on at the end of the season and either lament or exult.
The Giants retired No. 25 Saturday in honor of Barry Bonds before a sold out AT&T Park crowd
Dereck Rodríguez looks more and more like a veteran ace every time he gets on the mound.
San Francisco found a glimmer of positivity in recently promoted Casey Kelly, who pitched five scoreless innings, recording three strikeouts.
A baker's dozen was enough to hold Pittsburgh off and snap a three-game losing streak with a 13-10 victory.
The Giants promoted right-handed pitcher Casey Kelly Friday, optioning Derek Law to Triple-A and transferring Johnny Cueto to the 60-day DL.
Andrew Suárez had one rough, three-run inning Thursday night, but it was enough to hogtie a Giants squad for whom even a three-run deficit has seemed insurmountable.
The Giants placed Double-A catcher Aramis Garcia on the taxi-squad as Nick Hundley goes through the concussion protocol
The last time he faced the Dodgers, Mike Fiers twirled a no-hitter striking out 10. Making his A's debut Wednesday, he danced with the same fate.
The A's (67-47) proved Tuesday that they are susceptible to struggle in games that feature small-ball.
When Oakland can get the ball to the back end of its bullpen, it is as tough to beat as anyone.
Tuesday was a series of escapes for Madison Bumgarner as he fought his way out of multiple dangerous situations.
An extremely uncharacteristic ninth inning from Will Smith served up a two-out game-winning homer to Marwin Gonzalez.
In what was an oddly low-scoring series through the first two games, the A’s proved they can win with less just as effectively as they can with more.
As contenders continue to fold around them, the Athletics continue to climb up the American League playoff ladder.
The baseball gods have victimized yet another key Giant, as the team announced Saturday that they will continue to monitor Buster Posey for concussion symptoms.
Brett Anderson flirted with perfection for longer than he ever had in his previous 136 big league starts Friday night at the Oakland Coliseum.
The Giants announced Thursday that injury has wrought even more devastation on their roster after an MRI showed that Pablo Sandoval had sustained a season-ending torn right hamstring.
The Giants announced Wednesday that Johnny Cueto will undergo Tommy John surgery to repair the ulnar collateral ligament in his right arm.
The Sean Manaea-Jonathan Lucroy battery has produced some memorable moments. Tuesday, the duo led the Athletics to a 8-3 victory over the Blue Jays.
With approximately two-dozen big league players moved at Tuesday's non-waiver trade deadline, the A's were left on the outside looking in
After celebrating the 100th win in Edwin Jackson's career Monday night, Tuesday brought more merry-making.
For the third straight game Monday, Nick Martini found his name atop the lineup card when he arrived at the Oakland Coliseum.
Johnny Cueto and Pablo Sandoval joined the ranks of the benched Monday, as the Giants transferred both players to the 10-day disabled list.
The Athletics have just enough time and motivation to make a deadline move and bolster their playoff hopes.
The Giants rediscovered the win column with a sweep-avoiding 8-5 victory over Milwaukee Sunday at AT&T Park.
The Giants have tried to ease Johnny Cueto back into the rotation after he barely dodged season-ending Tommy John surgery in May.
The Giants have struggled to score runs for much of the 2018 season, but July has been an especially dry month.
The Giants managed the impact of yet another blow to their starting nine Thursday.
Brandon Belt left Wednesday’s game against the Mariners in the top of the seventh inning with a hyperextended right knee.


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domain: hobby


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Being overweight does not just affect your self-esteem or your social life. It also has a big impact on your health. Fat affects your heart, lungs, muscles and bones. An unhealthy lifestyle has a huge impact on your life too. Many of the common problems associated with being overweight are life threatening and could result in an early death. Here are just three of the many reasons why being overweight is unhealthy for you:
Being overweight can lead to one of the most common conditions seen around the modern world, Type 2 diabetes. Type 2 diabetes is based upon the deposits of fat in your body. As the body has more fat cells, it prevents other cells from taking the glucose which leads to a higher amount of glucose in the bloodstream instead. All it takes is to reduce your body weight between five and seven percent, along with 30 minutes of exercise five days a week, and your risk of developing Type 2 diabetes drops by 58 percent.
2) Heart Disease
Fat has a huge impact on your heart and increases your risk of a heart attack. Being overweight also affects the cholesterol and sodium levels in the body, which is the leading cause of heart attacks in the developed world. There is also an increase in blood pressure in those who are overweight, which means that your heart is working too hard. There are more heart disease related deaths due to this, such as angina or sudden heart attacks; those that cause death with no early symptoms. Just losing up to ten percent of your body weight will help to lower the risks of heart disease and heart attacks.
Stroke is still one of the top five causes of death, and is due to a problem with the flow of blood to the brain. There are many reasons linked to the causes of a stroke and being overweight is one of them, specifically due to a person’s overall body mass. This is because the arteries get narrowed and blood clots stop the blood from being able to flow to the brain. Stroke is also linked to high cholesterol and a lack of exercise, which is seen in many overweight people. While those who are not overweight are still at a risk of stroke, it makes those who are overweight at more of a risk. By having an extra 20 percent in body fat you are 50 percent more likely to suffer a stroke.
By losing your excess weight, you are not only going to look and feel better; you’ll dramatically reduce your risk of developing these frightening conditions too.
OPPLE Launches Twinkle Star An Innovative Light for Children OPPLE, a global integrated lighting solutions company and one of World’s Leading LED Lighting brand today launched a unique and innovatively designed light, Twinkle Star. This is OPPLE’s newest addition to their range of Home Luminaries.
- Shoppers Stop Partners with ToneTag for Sound-Based Contactless Payments
- Life is beautiful... If you just live it one more day!
- Zyxel Introduces Aurora Camera - Capture the Moment, Bring to Light
- A Fashionable End to the Max Design Awards 2016-17
- Aircel Launches Data Packs with Lowest Tariffs and Longest Validity in Bihar
- Nourish You Ushers in the Superfood Culture in India
- Kerala famous dish Appam and Stew which are mouth watering
- Now ShopX Allows Every Kirana Store to be a Travel Agent
- Aircel Launches First of its Kind Unlimited Combo Packs
- Day 5 of AIFW17 Showcases GenNext in Fashion at Pearl Portfolio
- Forever 21 Debuts in West Bengal with First Store Launch in Siliguri
- Chat with New TripAdvisor Facebook Messenger Bot to Get Great Travel Recommendations
- Get Married, Plan a Holiday and More with a Bajaj Finserv Personal Loan
- Mahiraa Jaan Pasha, the First Muslim Woman to Launch "Bhagavad Gita on Wheelchairs"
- ShopX Sells iPhone 5s in Tier 2 and Tier 3 Towns

domain: health


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Though the payout is less, playing these frequently will allow you to win more. Online casino games like craps have many different betting possibilities, so you will always want to look at which bets have the highest chances of winning with the highest payouts. Your best option is to place the best that give the house the lowest edge. Better is to click here or visit our official website to know more about AGEN Taruhan.
All card games like poker and blackjack are strategy based and you will have a better chance of winning these with the right tactics and skill. Bluffing seems to be one of the most effective and useful tactic when playing card games, even online casino poker games. Though your competitor may not see your face, your actions still speak as loud. Bluffing should be done within your budget limits, try not to bluff and bid more than you can afford to pay.
Slot machines, much like table games, are random and left to chance. However, there are techniques that have proven to increase your chances of winning, because slot machines have a puzzle or mathematical element involved. A great tactic to use for online casino slots is to place the maximum bet allowed by your budget. Online casino gamblers swear by this, and it has shown effective since that is the only way you can win the highest payout.
Another great technique for playing online casino games like slots is to play the high payout slots that cost from $1 and up. Although penny slots are nice, you will not get the maximum return for your money. All online casino games deal with chance and tactics , with some more than others. But it is best to look at the odds you have of winning to determine whether they are worth it or if the tactics will even make a difference. Keep in mind that online casino gambling is very addictive and it is important to make wise decisions when playing online casino games. If needed interested individuals can click here http://kingbola99.co/ or visit our official website in order to know about AGEN Judi Online.

domain: entertainment


text:
National Health and Nutrition Examination Survey III, 1988-1994 (ICPSR 2231)
Version Date: Mar 2, 1998 View help for published
Principal Investigator(s): View help for Principal Investigator(s)
United States Department of Health and Human Services. Centers for Disease Control and Prevention. National Center for Health Statistics
Summary View help for Summary
The third National Health and Nutrition Examination Survey (NHANES III), conducted in 1988-1994, was designed to obtain nationally representative information on the health and nutritional status of the population of the United States through interviews and direct physical examinations. NHANES III contains data for a sample of 33,994 persons aged 2 months and older who participated in the survey. A home examination option was employed for the first time in order to obtain examination data for very young children and for elderly persons who were unable to visit the mobile examination center (MEC). The home examination included only a subset of the components used in the full MEC examination, since it would have been difficult to collect some types of data in a home setting. The dataset contains information on high blood pressure and cholesterol, obesity, passive smoking, lung disease, osteoporosis, HIV, hepatitis, helicobacter pylori, immunization status, diabetes, allergies, growth and development, blood lead, anemia, food sufficiency, and dietary intake, including fats, antioxidants, and nutritional blood measures. Dietary Recall information is found in three data files (Parts 4, 7, and 8) and four table files (Parts 3, 5, 6, and 9). The Adult and Youth Household files (Parts 1 and 11) comprise the total number of respondents when combined. All of the data files may be linked by using the survey participant identification number (SEQN).
Citation View help for Citation
Subject Terms View help for Subject Terms
Geographic Coverage View help for Geographic Coverage
Restrictions View help for Restrictions
In preparing the data file(s) for this collection, the National Center for Health Statistics (NCHS) has removed direct identifiers and characteristics that might lead to identification of data subjects. As an additional precaution NCHS requires, under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m), that data collected by NCHS not be used for any purpose other than statistical analysis and reporting. NCHS further requires that analysts not use the data to learn the identity of any persons or establishments and that the director of NCHS be notified if any identities are inadvertently discovered. ICPSR member institutions and other users ordering data from ICPSR are expected to adhere to these restrictions.
Distributor(s) View help for Distributor(s)
Time Period(s) View help for Time Period(s)
Date of Collection View help for Date of Collection
Data Collection Notes View help for Data Collection Notes
Per agreement with National Center for Health Statistics (NCHS), ICPSR distributes the data file(s) and text of the technical documentation for this collection as prepared by NCHS.
- Errata for this dataset can be found on the NHANES III Web site and in a README file accompanying this release.
Sample View help for Sample
The survey used a complex, stratified, multistage, probability design.
Universe View help for Universe
The civilian noninstitutionalized population 2 months of age and over in the 50 states and the District of Columbia.
Data Source View help for Data Source
household interviews, laboratory reports, and clinical examinations
Data Type(s) View help for Data Type(s)
Original Release Date View help for Original Release Date
Version History View help for Version History
- United States Department of Health and Human Services. Centers for Disease Control and Prevention. National Center for Health Statistics. National Health and Nutrition Examination Survey III, 1988-1994. ICPSR02231-v1. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 1998. http://doi.org/10.3886/ICPSR02231.v1
The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.

domain: medical


text:
provides tools to manage their classrooms, communicate with parents and
share lesson plans and other resources. The site isn’t officially
active yet, but managing director
“We’ve been sitting here scratching our heads for the last couple of days,” Shrader told the
The lawsuit was filed in U.S. district court in
Shrader said Teachbook filed a trademark application
about a year ago, and Facebook voiced its opposition during the last
half of 2009. There were “ongoing discussions” over use of the name and
Shrader believed “we were working constructively with (Facebook),” but
is now expecting to file a response to the
According to the filing posted on Wired.com,
Facebook said the “book” part of its name is “highly distinctive in the
context of online communities and networking websites.”
“If others could freely use ‘generic plus BOOK’
marks for online networking services targeted to that particular
generic category of individuals, the suffix BOOK could become a generic
term for ‘online community/networking services’ or ‘social networking
services,’ ” Facebook argued in the lawsuit. “That would dilute the
distinctiveness of the Facebook Marks.”
Shrader compared Facebook’s tactics to “bombing a
mosquito” and said the term “book” is a natural fit for his website,
since it relates to teachers and education.
Facebook was not immediately available for comment.
(c) 2010, Chicago Tribune.
Distributed by McClatchy-Tribune Information Services.


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VANESSA SEWARD 'DUBLIN' BAG
- Dimensions (W*H*D): 19" x 19" x 3.5"
- Handle drop: 3.5"
- Color: Navy, red, pink and natural
STYLE NOTE: This summer season brings us a round, graphic basket from Vanessa Seward. Each piece is unique and hand-painted by the artist Jason Glasser in his Parisian apartment. This collaboration that has resulted in a fashion piece of true simplicity and elegance, just right for town, just right for the beach.


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Users of travel review website TripAdvisor voted Anna Maria Island and Siesta Key as two of their five favorite “underrated” U.S. beach towns.
More than 1,800 people participated in the poll.
Anna Maria Island is a “laid-back, less-developed island” with an “Old Florida feel,” the Huffington Post wrote.
Siesta Key is known for its quartz sand and is said to be “a dream to walk on,” according to the news site.
Poll respondents said the beach is the biggest draw when choosing a vacation spot, and 36 percent of them travel more than 500 to reach their destination.
Sanibel Island, Bandon, Ore. and Cannon Beach, Ore. also made the list.


Ajit stresses on crime control
RASHTRIYA LOK Dal president Chaudhury Ajit Singh, on Saturday, said there was no improvement in the law and order situation in the state. He blamed activities of mafiosi-turned-politicians for the deterioration in the situation.india Updated: Dec 17, 2006 01:24 IST
RASHTRIYA LOK Dal president Chaudhury Ajit Singh, on Saturday, said there was no improvement in the law and order situation in the state. He blamed activities of mafiosi-turned-politicians for the deterioration in the situation.
Talking to newsmen, the RLD chief laid stress on controlling rising crime and said the state government had given a wrong message by providing police security to small-time politicians and weapon licences to history-sheeters.
Expressing concern over the prevailing situation in Lucknow University, Singh said union election should be held only on the basis of Lyngdoh committee recommendations. He said there was an urgent need to check money and muscle power in the election. Singh said LU Vice-Chancellor RP Singh should ensure that students did not suffer on the academic front.
Regarding electoral alliance, Singh said he would take a decision would be taken before the Assembly election likely to be held by April-May. He had earlier announced of a poll pact by November.
The RLD chief also opposed the state government’s decision to enhance support price by Rs 10 per quintal to sugarcane farmers. Demanding a minimum price of Rs 150 per quintal for present crushing season, he said the increase was inadequate.
Singh informed last year, the government had announced that Rs 115 to Rs 120 per quintal would be given to the farmers. He said in view of the inordinate delay in declaring the support price, the farmers were forced to remain content with Rs 60 to Rs 100 per quintal in the last two months.
He said the government should ensure farmers received the balance payment with 14 per cent interest. He did not rule out the possibility of sugar mills exploiting farmers because of sugarcane categorisation.
First Published: Dec 17, 2006 01:24 IST


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These top-rated competitive, multiplayer games will be the people you ought to be playing. The gameplay grows a bit repetitive as the tale advances, however, if you intend to sneakily destroy a significant load of enemies, Gears of War 4 is a worthy pickup. Whilst http://bandarbet77.org the game is playable, the designers recently teased a fresh Paranoia” mode just around the corner. We fork out a lot of the time researching the greatest on line casinos that provide you a high quality selection of slots to play for real money.
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The Monster Hunter franchise, developed and posted by Capcom, is a series of fantasy-themed action role-playing video games that began aided by the game Monster Hunter for PlayStation 2. Once the name recommends, the player takes the part of a hunter in a dream environment and completes quests by hunting out particular forms of monsters to destroy or capture.
Developer Cryptic Studios combined the simpleness and combat-focused gameplay of Diablo with a more old-fashioned fantasy establishing generate Neverwinter, based upon lore from Dungeons & Dragons universe. The overall game continues to develop and grow although the players are away and even though in the open world setting, a person can free-roam without any artificial obstacles.
A scale ranges from “E” (means everyone else) inferring games that are ideal for both young ones and adults, to “M” (stands for Mature) recommending games that are limited to age above 17. Some explicit activity may be ranked “AO” (is short for Adult just), determining games that have content ideal for only adults older than 18. Additionally, online flash games must also carry an ESRB observe that warns that any “online interactions aren’t ranked by the ESRB”.


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He is no longer affectionate with you, physically or verbally. He no longer makes sweet or romantic gestures toward you. He doesn't say "I love you" anymore. He still says "I love you," but something about it feels hollow or forced, like he's just going through the motions.
Often, when the breakup is final, you no longer feel the need to keep in contact. You may no longer see your ex as the one person with whom you can bare your heart and soul. You may see them in the office or at a coffee shop and be able to feel no resentment or sadness or affection.
They are denial, anger, bargaining, depression and acceptance, according to Mental-Health-Matters.
Every relationship is different, and the reasons to break up are various. So, there cannot be a fixed timeframe for you to stop loving someone. However, according to a 2007 study, most people move on from a relationship within 3 months (1).
Fear. The threat of physical violence, further emotional abuse, harming your children by depriving them of a nuclear family, and concern about how friends and family will perceive them are commonly-cited reasons why people may choose to stay in an unhappy marriage.
Yes, a man can walk away from a woman whom he loves. There is more to every relationship than just love. If a man feels insecure, undervalued, disrespected, or unhappy with the relationship, then he might choose to walk out even when he loves his partner.
Simply stated, if the relationship is causing more hardship than anything else, what's the point? "When you fight more often than not, it's time to consider leaving. And if even at its best the relationship was never really good, you'll likely be happier if you leave the relationship," Leeds tells mbg.
While it may feel impossible and certainly takes time to stop loving someone, it's absolutely possible to do just that. In fact, you may find that in no longer loving this person you open yourself up to the possibility of loving others — and even yourself.
Physical attraction, sexual compatibility, empathy, and emotional connection are key to making a man fall in love with a woman.
1 He had unrealistic expectations. 2 He noticed signs of incompatibility. 3 He got bored after the “honeymoon phase.” 4 He's scarred by a past relationship.
Sometimes men run away when they fall in love, looking to rekindle the spark of singleness. Why men leave the women they love could be any number of reasons. Toxic relationships, being used, feeling emotionally spent, or meeting someone new could also contribute to what makes a man leave his wife.
If you're not sharing what's really on your mind, it might be a sign that you no longer want a deep connection. Similarly, if you've found that the usual fun banter between you is gone, or it's difficult to have engaging conversations, your bond could be getting weaker.
Communication issues and unrealistic expectations are two of the main reasons people find themselves falling out of love. But there are things that can be done to stop the fall. Relationships are hard work; they should be viewed as investments, particularly if there is a marriage.
Falling out of love can be a very scary feeling. It might feel like having noticeably less interest in your partner and feeling less excited about spending time with them, even though you still care about them.
Love may disappear slowly over time or suddenly after a traumatic event. Partners may confuse infatuation for love, so they assume the romance is done as soon as things begin to cool. The truth is, people fall out of love for any number of reasons.
Unfortunately, many people can fall out of love and start to move on long before the actual break-up happens. Secondly, it the necessity of significance doesn't happen over night. It's a process that needs time.
These include beauty, your dressing sense, scent, behavior, attitude, etc. Also, what makes a woman great to a man differs from man to man. However, you are special if he finds it challenging to find your qualities in other women. If you make your man feel loved, valued, and respected, it will make you special.
Both men and women consistently cite emotional stability and maturity as one of the most attractive traits in a potential spouse. While men often fall victim to the stereotype of prioritizing physical attraction, when it comes to a potential wife, they want a woman who is grounded and secure in herself.
It is possible to rekindle feelings of love with someone who has been distant. Even though you can't force anyone's feelings for you, you can take steps to improve yourself and the relationship. Focus on who you are and being your best self. Spend time together and be thoughtful and kind.
According to experts, it's totally possible to fall back in love with someone you used to date, and the reason why makes sense. "Once you love someone, unless your respect for them is destroyed, you can always love them again," Susan Trombetti, matchmaker and CEO of Exclusive Matchmaking, tells Elite Daily.

domain: psychology


Gartner IT Infrastructure & Operations Management Summitby Gartner
Published on: 03/02/2012
The Gartner IT Infrastructure & Operations Management Summit covers your top I&O issues and technologies, including cloud computing, virtualization, achieving operational excellence with limited resources, aligning I&O to business goals and more. Improve your technology, people and processes to deliver faster and more agile IT services at lower cost. Download the Summit brochure for more information about this must-attend event.
Cloud provider liability limits are quite the paradox. On the one hand, most large providers are saying to customers, "We accept no liability for business lost due to a breach in service." On the other, CIOs are loath to accept the financial risk of... More...
Aug 17, 2010
With the major standards bodies working out identity management and security and portability in the cloud, the industry has turned its attention to another matter: cloud computing law and order -- in particular, the lack of jurisprudence as... More...
Aug 12, 2010
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Countering Missiles with Missiles: U.S. Military Posture After the INF Treaty
Thirty-one years ago, the Senate approved the Intermediate-range Nuclear Forces (INF) Treaty, banning American and Soviet land-based missiles with ranges from 500 to 5,500 kilometers. Passed by a 93-5 vote, the INF Treaty promoted restraint after decades of Cold War competition. Although it survived the Soviet Union’s end, the agreement started showing signs of age by the mid-2000s. Meant to govern land-based nuclear delivery systems, its provisions also prevented the United States from pursuing conventional precision strike systems for land attack or maritime strike. With both Russia and the United States leaving the treaty, it is effectively a dead letter. Many have discussed why this is the case, but the time is ripe to look closely at what the U.S. armed services can and should do next now that America is unshackled by the treaty’s restrictions.
I experienced the treaty’s shortcomings firsthand while serving as a deputy assistant secretary of defense under Secretaries Donald Rumsfeld and Robert Gates. Since China was not party to the agreement, it was not required to follow the treaty’s rules. As a result, it was unconstrained in pursuing not only theater nuclear capabilities but also land-based conventional precision strike systems. Today, China possesses up to 2,650 land-based missiles of types that would be banned if it was party to the INF. These weapons, most of which are non-nuclear, pose a threat to U.S. and allied air bases in the Western Pacific as well as U.S. and allied naval forces, principally U.S. aircraft carriers. Meanwhile, Russia has developed systems that violate the agreement, including the Novator 9M729 ground-launched cruise missile.
As Eric Sayers and Scott Cuomo have previously argued, the treaty’s terms are increasingly out of step with today’s security environment. The treaty’s prohibition on land-based missiles of all kinds has put the United States and its allies at a disadvantage relative to China by allowing Beijing to field relatively cheap land-based missiles to hold U.S. and allied forces at risk while compelling the United States and its allies to expend considerable resources to defend themselves against those missiles. This has contributed to what those of us who served on the congressionally mandated National Defense Strategy Commission characterized as an eroding military balance in the Western Pacific.
It is time to turn the tables. As my colleagues and I have argued in a recent report for the Center of Strategic and Budgetary Assessments, the United States should field new ground units armed with intermediate-range land-based missiles on U.S. and allied territory along the Western Pacific archipelagos. Deploying these missiles will help prevent the nightmares that keep Pentagon officials up at night. Such weapons, capable of denying China the use of littoral waters, would be a powerful deterrent to Chinese aggression. In the event of war, these units should be able to disrupt and delay a Chinese attack long enough for air and naval forces to arrive and stymie the assault. By demonstrating the ability to halt aggression, these forces would deter Chinese leaders from attempting it in the first place.
Whereas previous studies have discussed the advantages of a land-based missile strategy in general terms, we lay out a road map to implement it. Specifically, we argue that the Department of Defense should weave together the disparate efforts of the Army and Marine Corps to craft a joint operational concept for land-based sea denial. In parallel, the Army and Marine Corps should conduct a robust program of experimentation with units dedicated to the joint mission. Wherever possible, they should do so with America’s close allies, such as Japan and Australia. The U.S. armed services also should accelerate greatly the fielding of mobile, land-based, and long-range missile capabilities so they have the weapons they need in quantities that would be operationally meaningful in a future conflict. In addition, because netting together and logistically supporting dispersed forces is challenging, the military services need to build a resilient, multi-domain C4ISR (command, control, communications, computer, intelligence, surveillance, and reconnaissance) architecture, develop and field counter-C4ISR capabilities, and develop sustainment concepts to support dispersed ground and air forces. The Navy can play a vital role in this approach as well by bolstering its stock of long-range anti-ship munitions. Similarly, the Air Force can support sea denial by integrating all its bomber aircraft, including the B-2, and in the future the B-21, with payloads for offensive maritime missions.
A missile strategy will require the military services to embrace new roles (or re-embrace old roles) such as Army, Marine Corps, and Air Force units striking enemy ships at sea. Change does not come easy to military organizations. To spur innovation, American political leaders should fund a robust experimentation and demonstration program so military leaders can assess what works before putting troops in harm’s way. Recent activities hint at what is possible. For example, last week U.S. and Australian forces demonstrated the ability to rapidly deploy, fire, and redeploy long-range high-mobility artillery rocket systems (HIMARS) rockets as part of the Talisman Sabre exercise and is remaining in Australia.
Congress can also play an important role in fostering innovation by promoting the development of new doctrine and organizations; supporting cooperation with America’s close allies; and providing funds for the procurement of larger stockpiles of missiles, a resilient C4ISR architecture, and more robust sustainment for dispersed forces. By raising the profile of these activities, Congress can help overcome some of the most persistent bureaucratic impediments to action that are among the most persistent.
Chinese and Russian land-based missiles undercut American strengths. Trucks can relocate some of these missiles so they evade aircraft and satellite detection. The missiles cost relatively little, making them easy to procure in large numbers. A salvo of missiles costing millions of dollars could disable an aircraft carrier costing billions of dollars. That lopsided ratio explains why a large U.S. defense budget provides less security than Americans might hope.
It is time to move forward with a land-based missile strategy because it is technically and budgetarily feasible. The required technologies already exist, so it’s unlikely that new programs would have to be started. The Pentagon could field ground-launch variants of existing missiles, including the proven Tomahawk and the cutting-edge Long-Range Anti-Ship Missile (LRASM). We found that implementing a missile strategy in the Western Pacific would cost $8 billion to $13 billion through 2024. That price tag is big but affordable, especially if the Department of Defense trims in other areas.
Whereas the main barriers to creating land-based missile forces are bureaucratic, the most prominent obstacles to implementing a missile strategy are political. First, there is a danger that China and Russia will seek to conflate the deployment of land-based intermediate-range missiles with the deployment of nuclear weapons. Indeed, it is in their interest to muddy these waters. Because land-based conventional missile forces are likely to be powerful deterrents, we should expect Beijing and Moscow to employ their formidable political warfare capabilities to forestall their deployment. Although U.S. allies such as Japan are procuring land-based maritime strike missiles of their own , parts of allied publics might fret hosting U.S. forces will drag their countries into a superpower arms race. American leaders should assuage these fears by emphasizing the missiles’ deterrent role as well as their defensive role in halting aggression. The presence of low-cost missiles would increase superpower stability by reducing the incentive to strike first in a crisis. Moreover, there are powerful incentives for the United States to work closely with its allies to implement such a strategy. Japan, for example, has long fielded land-based anti-ship missiles , and there is much the U.S. armed forces can learn from working closely with Japanese counterparts. Similarly, Congress should maintain a clear distinction between the need to deploy intermediate-range conventional strike systems and the possibility of developing land-based theater nuclear systems. Discussion and debate over the latter should not impede action on the former.
Third, states beyond America’s close allies face political and economic circumstances that could constrain their ability to support a missile strategy. Regional partners can support such a concept in other ways, such as by procuring and deploying capable but inexpensive unmanned air systems like the MQ-9 Reaper for intelligence, surveillance, and reconnaissance support.
In 1988, the INF Treaty reflected relaxing Cold War tensions. Today, however, amidst the return of great power competition, the United States is fighting with one arm tied behind its back. Washington should capitalize on the INF Treaty’s end to field conventionally armed, land-based maritime strike- and land-attack missiles that saddle America’s great power competitors with the same dilemmas they have imposed on the United States for years.
Thomas G. Mahnken is President and Chief Executive Officer of the Center for Strategic and Budgetary Assessments (CSBA) and a Senior Research Professor at the Philip Merrill Center for Strategic Studies at Johns Hopkins SAIS. He is the author, with Travis Sharp, Billy Fabian, and Peter Kouretsos, of Tightening the Chain: Implementing a Strategy of Maritime Pressure in the Western Pacific. From 2006 to 2009, he served as deputy assistant secretary of defense for policy planning.
Image: U.S. Marine Corps photo by Lance Cpl. Kaleb Martin


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Technologically speaking, we are constantly evolving, ever changing, and we’re always moving forward at an ever quickening rate. We have mobile devices, wearables, interactive TV and more. We always hear about the future of technology and where we’re headed. The tech we are using now will be old news within the next year, it seems. But if yo even speak of a headline that uses the word “banner,” you probably think about the old days of the internet were we had banner ads and the like. We also hear about the dying of older, more out-dated things.
Who even notices display advertising anymore? Display advertising was how we made the banner ad more noticeable, more appealing to web-goers. At this point, display advertising is a think of the past. But don’t scoff at it though, as the technology behind it, the power behind display, has become the engine that powers the most interesting aspects of advertising today.
As we’ve progressed in display advertising, we now encompass any ad that can be targeted to an individual. It all boils down to the data itself, and whether the individual can be targeted in this channel. You don’t have to worry about inventing any “personas” that are based on assumptions or standalone behavioral data.
In a Marketing Land post, written up by James Green, discusses the technology behind display advertising, and how it remains a key underpinning of what advertisers are seeking today. The column talks about how fractured media will make for new ad types, how video is increasingly appealing to consumers, unified, customized ads, and how media departments are being consolidated.
Check out James’ post by following the link provided below.
Marketing Land: Why Learnings From The ‘90s Banner Ad Still Apply Today


text:
Melody Beswick thought she was bringing herself and her thirteen month old son home to his father. It was her last ditch effort to make a better life for her and her boy. One in which Noah had a father to look up to and guide him. While she knew Grinder wasn’t perfect, she believed in him, and love always found a way, right?
Melody never thought her dreams for herself and her son could twist into such nightmares, and that it was so true, the old adage, that the road to hell is paved with good intentions. She’s about to find out that another adage is true, that sometimes it’s better the devil you know, when instead of finding Grinder, it’s his cold and critical brother Archer at the end of her long drive that she must contend with.
With no other options, and no place else to go, Melody is about to make a deal with this devil that she can’t refuse. Who knew it could, quite possibly, be the best decision she’s ever made?
“Archer! Man, let her go,” one called; the other right over the top of him saying, “What the fuck are you doing, man?”
“Archer, please!” I hauled my body away from him, dug my sneakers into the gravel but he was hurting me, dragging me inexorably away from the building. I was sliding and I either let him tow me or I was going to go down and he’d drag me across the sharp unforgiving stones anyways. He was a man on a mission and that mission was to get rid of me at all costs and as soon as possible.
“I don’t know what the fuck you were thinkin’ comin’ around here, Melody, but you damn sure ain’t welcome. Now, get back in your car and take your ass back to Arizona! I mean it, too, right the fuck now,” he was saying as I shouted and pleaded over his husky smoker’s voice, which he’d always had. A lot of the girls finding it sexy until they actually slept with him. I don’t ever remember any of the club girls doing it twice.
“Archer, I have to talk to Grinder, please let me go! Let me talk to him, you have to let me talk to him!”
He rounded on me and slammed me up against the side of my car and screamed, “Grinder’s dead, you bitch! Whatever the fuck you told him to chase him out here, it was the last move he ever made! It fuckin’ killed him, so I don’t have to do shit!”
I cried out as my back made an impact with the back door and his words made an impact with my heart. I looked up at him, shocked, eyes wide and the tears gathering just as the high, thin wail of my son broke the clear day as he started to cry. The noise and the car rocking from mine and Archer’s scuffle waking him.
Archer looked past me through the window glass at Noah’s small face, and his eyes widened in shock. I stared up at Archer, and I stammered out, “I told him I was pregnant. That’s why he left us.” All I could think was, oh my God, he must be lying, he must be lying, no Grinder can’t be dead, he can’t be dead… Oh my God, what was I going to do? It’d taken everything I had, all of my money, just to get us out here.
She pushed me back and I was so fixed on the boy in the car seat I just sort of stepped back, poleaxed, while she opened the back door and brought him out where I could see him better. Jesus Christ, he looked just like Grind when he was a kid. I mean, this kid had Melody’s bright blond hair, but the boy’s eyes? They were the same hazel as my brother’s and all I could do was stand there for a second and stare.
Fuck you, Grind. I thought at my dead brother, fuck you, if what she says is true. Which I knew it was. The proof was right in fuckin’ front of me, staring at me with my dead brother’s eyes.
“Archer, you fuckin’ cool, man?” I turned and looked at Reaver, who was standing there with Data and Disney flanking him to either side, all three of them lookin’ skeptical but Reaver’s eyes especially cold.
“Mel, put the baby back in his seat,” I ordered, staring Reaver down. He arched an eyebrow at me and I gave him a nod.
“Just put him in the fuckin’ cage, now!” I barked at her, and she jumped, the boy started up, screaming loud and she cuddled him close, making soothing noises and I cursed myself silently for scaring him.
I snatched her keys hanging out of her hip pocket and as soon as she shut the door, hauled her over to the passenger side of her own cage, dragging open the door and sitting her ass in the seat.
When I’d first seen her, the first thing I’d noticed was that she’d cut her hair, and that she’d filled out some in all the right ways, but now I knew why for the second. She’d had a fuckin’ baby, my brother’s baby. I shut her into the cage and went around to the driver’s seat.
“Where you takin’ her, Archer?” Reaver demanded, winter in his voice.
“My place,” I uttered. “It’ll have to fuckin’ do for now.” I got into the cage’s driver’s seat and turned it over, the guys walked back to the club and I pulled out in a spray of gravel. I could see ‘em watching in the rearview mirror but I didn’t care.
Text Copyright © 2016 A.J. Downey
This is a work of fiction. Names, characters, businesses, places, events and incidents are either the products of the author’s imagination or used in a fictitious manner. Any resemblance to actual persons, living or dead, or actual events is purely coincidental.
All Rights Reserved

domain: literature