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News & Events
FDA User Fees 2012: How Innovation Helps Patients and Jobs (JS)
Statement of
Jeffrey Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
Department of Health and Human Services
Before the
Subcommittee on Health
Committee on Energy and Commerce
U.S. House of Representatives
April 18, 2012
Mr. Chairman and Members of the Subcommittee, I am Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I am pleased to be here today to discuss reauthorization of the Medical Device User Fee Act, or MDUFA.
Background on MDUFA
The enactment in 2002 of the Medical Device User Fee and Modernization Act (MDUFMA I) was prompted by growing concerns about the medical device review program's capacity and performance. MDUFMA I and MDUFA II (enacted in 2007) authorized user fees for the review of medical device premarket applications, reports, supplements, and premarket notification submissions. These additional resources enabled FDA to make its reviews more timely, predictable, and transparent to applicants. MDUFA fees and mandated appropriations for the medical device program helped FDA expand available expertise, modernize its information management systems, provide new review options, and provide more guidance to prospective applicants.
MDUFA authorizes FDA to collect user fees for certain medical device applications, the registration of certain medical device establishments, and certain other purposes. Small businesses may qualify for a waiver or a reduced fee on certain submissions to FDA.
Of the total $292,707,540 obligated in support of the process for the review of medical device submissions in FY 2010, MDUFA fees funded about 20 percent. The remainder of the funding was through appropriations. Fees currently charged for device review under MDUFA include $220,050 for a Premarket Approval (PMA) application for high-risk medical devices (a business with gross receipts under $100 million qualifies for the "small business" PMA fee of about $55,000, and for firms with gross receipts under $30 million, the firm's first PMA fee is also waived). For lower-risk devices cleared under the 510(k) review program, manufacturers pay $4,049 per 510(k) application review ($2,024 for small businesses).[1] As a point of comparison, PDUFA fees—nearly $568 million in FY 2010—currently account for about two-thirds of the drug review program's budget, and the current fee for FY 2012 associated with review of a New Drug Application (NDA) requiring clinical data is $1,841,500.[2]
The medical device user fee program has produced benefits for public health. A better-resourced premarket device review program has enhanced FDA's abilities to help bring more safe and effective medical devices to the market, while keeping pace with the increasing complexity of technology and changes in clinical practice. Since MDUFA II was reauthorized in 2007, FDA has approved 106 original PMAs and cleared more than 13,000 devices under the 510(k) program.
For example, approvals have included devices intended to address unmet needs in the pediatric population, such as the first heart pump designed to support the hearts of infants to adolescents until they receive a heart transplant, and the first percutaneous heart valve (approved for both children and adults).
The device program also has approved important new laboratory tests, including an emergency-use diagnostic test in response to H1N1 outbreak in humans, and the first quick test for malaria. Device reviews have significantly contributed to the very important trend toward personalized medicine through clearance of a test system that can assist in assessing the risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer.
Other important devices that have become available to patients over the course of MDUFA II include, for example, the Implantable Miniature Telescope (IMT), used for monocular implantation to improve vision in elderly patients with stable severe to profound vision impairment associated with end-stage age-related macular degeneration (AMD)[3]; the Infrascanner™ infrared brain hematoma detector, a non-invasive hand-held device that uses near-infrared spectroscopy to evaluate suspected brain hematomas at the site of injury within the "golden hour" (the period following head trauma when pre-hospital analysis is needed to rapidly assess a patient's neurological condition)[4]; and the NeuRx DPS™ RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.[5]
However, neither the FDA nor industry believe that the user fee program has reached the level of performance, or produced the extent of benefits, that it has the potential to achieve.
MDUFA II Performance
FDA has been meeting or exceeding goals agreed to by FDA and industry under MDUFA II for approximately 95 percent of the submissions we review each year. For example, FDA completes at least 90 percent of 510(k) reviews within 90 days or less. In the few areas where FDA is not yet meeting its MDUFA goals, the Agency's performance has generally been improving—despite growing device complexity and an increased workload. FDA's performance over the course of MDUFA II has not been limited to achieving quantitative goals for the timely review of premarket submissions like PMAs and 510(k)s; we have also accomplished a number of "qualitative" goals set by MDUFA II in 2007, including issuing more than 50 new and updated guidances for industry. Guidance documents are important resources for industry because they describe the Agency's interpretation of, or policy on, regulatory issues, and as such, are critical to support industry efforts to comply with the law and develop new products that may benefit the public health.[6] The availability of guidance documents also facilitates regulatory predictability and consistency.
It is important to note that MDUFA metrics reflect FDA time only; they do not reflect the time taken by device sponsors to respond to requests for additional information. Overall time to decision—the time that FDA has the application, plus the time the manufacturer spends answering any questions FDA may have—has increased steadily since 2001. As the graphs below illustrate, while the time FDA spends reviewing an application has improved (for both low- and high-risk devices), average total days for the review of 510(k)s has been increasing since 2005, and has been increasing for PMA applications since 2004.
FDA bears some responsibility for the increase in total time to decision, and we have been instituting management, policy, and process changes to address this issue. As a result, we are starting to see indicators of improved review performance. For example, the Agency has currently completed review of 85 percent of the 510(k) submissions received in FY 2011. The graph below, illustrating average time to decision during the last five years at this same point (85 percent of 510(k)s reviewed), shows that progress was made, starting last year, in stabilizing 510(k) review times.
In addition, in FY 2011, CDRH for the first time began reducing what previously was an increasing backlog of unresolved 510(k) submissions, as indicated in the chart below—and that trend is clearly continuing as we approach the mid-point of FY 2012:
Likewise, there had been a continuous annual increase, since FY 2002, in the percentage of 510(k) submissions requiring an Additional Information (AI) letter[7] after the first review cycle, which had contributed to the increasing total time from submission to decision. As indicated in the chart below, however, in FY 2011, the percentage of 510(k)s requiring an AI letter declined for the first time since 2002.
Smart Regulation's Role in Facilitating Medical Device Innovation
FDA recognizes that, if the United States is to maintain its leadership role in this area, we must continue to streamline and modernize our processes and procedures to make device approval not just scientifically rigorous, but clear, consistent, and predictable, without compromising safety. We are committed to continued improvements in the device approval process to address legitimate concerns raised by industry and other stakeholders.
A little over two years ago, CDRH recognized that, given the growing complexities of medical product development, we needed to re-evaluate and modernize our regulatory review processes in order to ensure that patients had timely access to safe and effective medical devices. At that time, CDRH began to undertake a new systematic approach to device regulation, moving away from the traditional misperception that safety and effectiveness and innovation are incompatible. Rather than focus on more regulation or less regulation, we began to focus on "smart regulation."
Our goal has been to ensure that safety and effectiveness and innovation are complementary, mutually supporting aspects of our mission to promote the public health. As part of our process to improve CDRH's internal systems, we first reached out to stakeholders to hear their concerns and listen to their recommendations about our premarket programs. This is what we heard: industry felt that inadequate predictability, consistency, and transparency were stifling innovation and driving jobs overseas; and consumer groups, third-party payers, and some health care professionals believed that one of our premarket pathways—the 510(k) program—did not provide adequate protection for American patients and did not generate sufficient information for practitioners and patients to make well-informed treatment and diagnostic decisions. In turn, CDRH employees expressed concerns that the 510(k) program had not adapted to the increasing complexity of devices, and that poor-quality 510(k) submissions, poor-quality clinical studies conducted in support of PMA applications, and an ever-growing workload were straining already overburdened premarket programs.
We also began two assessments of our premarket programs to identify issues, their root causes, and the appropriate solutions. One assessment focuses on the 510(k) program. The other looks at how we use science in regulatory decision-making, touching on aspects of several of our premarket review pathways, such as our clinical trials program. In addition, we contracted with the Institute of Medicine (IOM) to conduct an independent evaluation of our 510(k) program.
In August 2010, following extensive public input, we released two reports that identified issues regarding our premarket programs and proposed potential actions for us to take to address the underlying root causes. The number one problem we found was insufficient predictability in our premarket programs, which can create inefficiencies, increase costs for industry and FDA, and delay bringing safe and effective products to market. We identified several root causes of these issues. They include very high reviewer and manager turnover at CDRH (almost double that of FDA's drug and biologics centers); insufficient training for staff and industry; extremely high ratios of employees to front-line supervisors; insufficient oversight by managers; CDRH's rapidly growing workload, caused by the increasing complexity of devices and the number of overall submissions we review; unnecessary and/or inconsistent data requirements imposed on device sponsors; insufficient guidance for industry and FDA staff; and poor-quality submissions from industry.
While it is true that providing more user fee resources alone won't solve the problems with our premarket programs, insufficient funding is at the root of, or a contributing factor to, several of these problems. Adequate and stable funding is one key component to our and industry's success in bringing safe and effective devices to market quickly and efficiently.
After considering extensive and varied public input on our recommendations, in January 2011, FDA announced a Plan of Action that included 25 specific actions that we would take in 2011 to improve the predictability, consistency, and transparency of our premarket programs. We continued to engage in dialogue about issues of importance to CDRH and to members of the public, including the medical device industry, health care professionals, patients, and consumers,[8] and followed up the Plan of Action with eight additional steps we would take. As of April 2012, 29 actions are already completed or are well underway.[9]
In February 2011, we announced our Innovation Initiative, which included several proposals to help maintain the position of the United States as the world's leader in medical device innovation, including the creation of a new approach for important, new technologies called the Innovation Pathway. On April 9, 2012, CDRH launched its second version of the Innovation Pathway, called "Innovation Pathway 2.0." Innovation Pathway 2.0 offers new and modified tools and methods to deepen collaboration between FDA and innovators early in the process, prior to premarket submission, with the goal of making the regulatory process more efficient and timely. The Pathway also serves as a living laboratory to test new tools and methods for breakthrough devices that we may also apply to other technologies to enhance all of our device premarket programs. Under the Pathway, CDRH selected three companies with promising breakthrough treatments for end-stage renal disease (ESRD), which is an area of growing public health concern that could benefit from innovative technology. We plan to accept up to five more companies during the year with promising, breakthrough treatments for ESRD to participate in the Innovation Pathway and to test out new tools for reducing the time and cost of device development and assessment.
We have announced additional efforts to improve our premarket programs, including actions to improve our program for clinical trials and the Investigational Device Exemption (IDE) program. The actions we are taking can be grouped into three main areas of emphasis. Overall, our actions seek to:
- Create a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks;
- Ensure more predictable and consistent recommendations, decision-making, and application of the least-burdensome principle; and
- Implement more efficient processes and use of resources.
Specific steps that we are taking include:
- Issuing guidance clarifying the criteria used to make benefit-risk determinations a part of device premarket decisions. This will provide greater predictability and consistency and apply a more patient-centric approach by considering patients' tolerance for risk in appropriate cases (draft guidance issued August 15, 2011, and final guidance issued on March 27, 2012);
- Creating standard operating procedures for when a reviewer can request additional information regarding a premarket submission and identifying at what management level the decision must be made. These steps are intended to provide greater predictability, consistency, and the appropriate application of the least-burdensome principle by reducing the number of inappropriate information requests (Standard Operating Procedures issued November 10, 2011);
- Developing a range of updated and new guidances to clarify CDRH requirements for predictable, timely, and consistent product review, including device-specific guidance in several areas such as mobile applications (draft guidance released July 19, 2011) and artificial pancreas systems (draft guidance released December 1, 2011);
- Revamping the guidance development process through a new tracking system, streamlined processes, and, to the greatest extent possible within available resources, core staff to oversee the timely drafting and clearance of documents (December 2011);
- Improving communications between FDA and industry through enhancements to interactive review (some enhancements are already in place);
- Streamlining the clinical trial (IDE) processes by providing industry with guidance to clarify the criteria for approving clinical trials, and the criteria for when a first-in-human study can be conducted earlier during device development. These actions aim to create incentives to bring new technologies to the United States first (guidances issued November 10, 2011) (IDEs are required before device testing in humans that involves significant risks may begin, and they ensure that the rights of human subjects are protected while gathering data on the safety and efficacy of medical products);
- Implementing internal business process improvements to ensure that decisions are made by the appropriate level of management, that decisions are made consistently and efficiently, and that we appropriately apply the least-burdensome principle. For example, CDRH created the internal Center Science Council to actively monitor the quality and performance of the Center's scientific programs and ensure consistency and predictability in CDRH scientific decision-making (Center Science Council established March 31, 2011);
- Creating a network of experts to help the Center resolve complex scientific issues, which will ultimately result in more timely reviews. This network will be especially helpful as FDA confronts new technologies (Standard Operating Procedures issued September 30, 2011);
- Instituting a mandatory Reviewer Certification Program for new reviewers (program launched September 2011);
- Beginning a pilot Experiential Learning Program to provide review staff with real-world training experiences as they participate in visits to manufacturers, research and health care facilities, and academia (to begin in May 2012);
- Providing industry with specific guidance on how to ensure the quality and performance of clinical trials while applying the least-burdensome principle, so that industry conducts studies that are more likely to support the approval of their products (guidance released August 15, 2011); and
- Streamlining the de novo review process, the pathway by which novel, lower-risk devices without a predicate can come to market (draft guidance released October 3, 2011).
Our efforts to improve the premarket review programs at CDRH are ongoing. We recently released our Strategic Priorities for 2012,[10] in which we commit to completing or continuing the work we already started in four priority areas: (1) Fully Implement a Total Product Life Cycle Approach,[11] (2) Enhance Communication and Transparency, (3) Strengthen Our Workforce and Workplace, and (4) Proactively Facilitate Innovation to Address Unmet Public Health Needs. Our plan for 2012 includes time frames associated with each strategy and specific actions we will take to meet those goals or make significant progress toward achieving those goals, including, for example:
- By April 30, 2012, begin the Triage of Premarket Submissions Pilot to increase submission review efficiency and better manage the premarket review workload;
- By September 30, 2012, make recommendations on how to adequately recognize good employee performance and address poor performance;
- By September 30, 2012, create processes and tools that will improve the pipeline for innovative medical devices and transform the way CDRH works with medical device innovators, such as the new Entrepreneurs-in-Residence program;
- By September 30, 2012, develop methods and procedures for the systematic analysis and use of medical device recall information;
- By October 31, 2012, develop a comprehensive strategy to assess real-world device performance;
- By December 31, 2012, conduct an evaluation of CDRH staffing, infrastructure, policies, and practices pertaining to medical device software;
- By December 31, 2012, review remaining Class III pre-amendment medical devices;
- By December 31, 2012, fully implement the Experiential Learning Program to enhance premarket reviewer knowledge of how medical devices are designed, manufactured, and utilized by providing real-world learning opportunities; and
- By December 31, 2012, launch the CDRH Leadership Enhancement and Development (LEAD) program to provide CDRH managers and supervisors information and tools to ensure effective leadership.
We believe the actions that we've taken and plan to take in the future will have a positive impact on the device review process by providing greater predictability of data requirements through guidance, reducing unnecessary data requests through training and policy and process changes, implementing policies to appropriately balance benefit-risk determinations, using external experts more extensively (consistent with conflict-of-interest guidelines), creating incentives to conduct clinical studies first in the United States, speeding up IDE approval decisions, and instituting efficiencies in the premarket review process.
For example, I'm pleased to report that, consistent with our many improvements to the 510(k) program, the recent increase in the "not substantially equivalent" (NSE) rate[12] appears to be turning around. For manufacturers and FDA, NSE determinations often represent an inefficient use of time and resources. NSE determinations require significant Agency resources and time, yet fail to result in the marketing of a new product. As shown in the chart below, from a peak of 8 percent in FY 2010, the NSE rate has decreased to 4 percent by the end of the first five months of FY 2012. Just as important, we also may be seeing a reversal in the trend of declining rate in Substantially Equivalent (SE) decisions that clear a 510(k) submission for marketing. After several years of declining percentages, reaching a low of 73 percent in 2010, SE rates increased by 6 percentage points by the end of the first five months of FY 2012, as shown in the chart below.
To best serve patients, both the medical device industry and FDA must have the flexibility to be innovative and entrepreneurial. CDRH must continue making critical improvements to our device program. At the same time, the medical device industry and CDRH must continue to work together to ensure that the Center receives high-quality submissions that contain the information we need to make well-informed and timely decisions. Finally, CDRH must have adequate and stable resources to get the job done right and quickly. Timely reauthorization of MDUFA, as well as the Congressional appropriations process, is critical to achieving these goals.
Moving Forward: Reauthorization of MDUFA
When MDUFA was reauthorized in 2007, Congress directed FDA to take additional steps to ensure that public stakeholders would have adequate opportunity to provide input to any program enhancements. In addition to FDA receiving input from stakeholders during an initial public meeting[13] in September 2010, as directed by Congress, we met with stakeholders, including representatives of patient and consumer groups, between January 2011 and February 2012, and made the minutes of those meetings available to the public.[14]
During that 13-month period, we also held discussions with representatives of the medical device industry, as required under the MDUFA II statute, in an effort to develop a package of proposed recommendations for MDUFA reauthorization. Minutes of those consultation meetings were also made available to the public.[15]
We were pleased to announce that on February 1, FDA and representatives from the medical device industry reached an agreement on the proposed recommendations for MDUFA III. That agreement, which would authorize FDA to collect $595 million in user fees over five years (plus increases based on inflation), strikes a careful balance between what industry agreed to pay and what FDA can accomplish with the amount of funding proposed. We believe that it will result in greater predictability, consistency, and transparency through a number of improvements to the review process. On March 15, 2012, FDA made public the package of proposed recommendations,[16] requested written public comment on those proposed recommendations, and announced that we would be holding a public meeting at which interested stakeholders could present their views. That public meeting took place on March 28, 2012.
The proposed recommendations for MDUFA III address many of the priorities and concerns identified by public stakeholders and the device industry and many of the important challenges identified by FDA. Some of the notable improvements to the MDUFA program in the MDUFA III proposed recommendations include:
Review Process, Infrastructure, and Capacity Enhancements:
- Facilitating earlier and more transparent and predictable interactions between FDA and the applicant, both during the early product development or "pre-submission" stage as well as during the review process, by implementing a structured process for managing pre-submissions and continuing to incorporate an interactive review process;
- Providing more detailed and objective "submission acceptance criteria" for determining when a premarket submission is complete and when a premarket submission is incomplete and should not be accepted for review;
- Improving the process of developing, reviewing, tracking, issuing, and updating guidance documents;
- Recommending reauthorization of the third-party review program and working with interested parties to strengthen and improve the current program as resources permit;
- Fully implementing guidance on factors to consider when making benefit-risk determinations, meeting with patient groups to better understand the patient perspective on disease severity and unmet medical need, and increasing FDA's utilization of Patient Representatives to provide patients' views early in the medical product development process;
- Identifying additional low-risk medical devices to exempt from premarket notification requirements;
- Working with industry to develop a transitional In Vitro Diagnostics (IVD) approach for the regulation of emerging diagnostics;
- Enhancing scientific and regulatory review capacity by hiring additional staff and reducing the ratio of review staff to front line supervisors—FDA is seeking to obtain streamlined hiring authority in order to accomplish this;
More Rigorous Review Performance Goals and Shared Outcome Goals:
- Adopting streamlined FDA review goals to provide better overall performance and greater predictability, including a commitment to meet with an applicant if FDA's review of their submission extends beyond the goal date;
- Eliminating the "two-tier" goal structure of MDUFA II and adopting a more simplified structure, incorporating a single, high-percentage goal for each performance metric;
- Instituting more rigorous performance review goals:
- increasing the percentage of 510(k) reviews that are completed in 90 review days from the current 90 percent to 95 percent by FY 2015;
- increasing the percentage of PMA reviews that are completed within 180 review days, from the current 60 percent to 90 percent by FY 2016, for PMAs not requiring external advisory panel review—for PMAs that do undergo panel review, FDA will complete 90 percent of the reviews within 320 review days by FY 2017;
- Instituting a Substantive Interaction goal for several submission types to track the Agency's communication with applicants at specified points during the review process;
- A joint commitment between FDA and industry to accomplish shared outcome goals to reduce the total average calendar time to a decision for PMAs and 510(k)s so that safe and effective devices reach patients and health care professionals more quickly;
Enhanced Metrics for Improvements to the Premarket Review Process:
- Conducting a comprehensive independent assessment of the premarket review process to identify potential enhancements to efficiency and effectiveness, and incorporating those findings and recommendations into management of the review program;
- More detailed quarterly and annual reporting of MDUFA III review program performance.
Additional details regarding the proposed recommendations for reauthorization of MDUFA, including the draft MDUFA III Commitment Letter and Legislative Language, are available on FDA's website at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm292860.htm.
The public comment period for review of the proposed recommendations for MDUFA III began on March 15, 2012, and closed on April 16, 2012. FDA is in the process of considering the public's views and comments, and will revise the proposed recommendations as necessary and transmit a final package of recommendations to Congress, along with a summary of the views and comments that were received and any changes that were made to the proposed recommendations in response to the public's views and comments. As we continue to work with all interested stakeholders and Congress toward reauthorization of MDUFA in order to provide adequate and stable funding for the program, we will also be moving forward with our ongoing CDRH program improvements, focusing on smart regulation that will facilitate device innovation. As these new policies and processes continue to be implemented, we expect to see notable improvements in the consistency, transparency, and predictability of our premarket review programs.
Smart Regulation's Role in Assuring Patient Safety
As we continue to look for ways to improve our ability to facilitate innovation and to speed safe and effective products to patients, we must not lose sight of the benefits of smart regulation to the medical device industry, to patients, and to society. Smart regulation of medical devices results in better, safer, more effective treatments as well as worldwide confidence in, and adoption of, the devices that industry produces.
We at FDA see daily the kinds of problems that occur with medical devices that are poorly designed or manufactured, difficult to use, and/or insufficiently tested. We appreciate the concern that some devices come on the market in the European Union (EU) before they do in the United States. While we want devices to be available to American patients as soon as possible, consistent with U.S. law, they need to be both safe and effective. The U.S. system has served patients well by preventing devices from entering the U.S. market that were later shown to be unsafe or ineffective.[17]
There are significant differences between the EU and the U.S. medical device review systems. In the EU, manufacturers must demonstrate safety and performance, while in the United States, the standard for approval is safety and effectiveness.[18] In the EU, more than 70 private, non-governmental entities called "Notified Bodies" review and approve devices by giving them a "CE mark." These decisions are kept confidential and are not released to the public or to EU regulatory bodies. In fact, the EU does not have one centralized regulatory body. Instead, each country can designate an entity as a Notified Body, yet the decision of one Notified Body applies to all EU countries.
Because of these factors, it is impossible to track medical device approvals, adverse events, or recalls in the EU, since there are few to no publicly accessible, centralized systems for collecting and monitoring information about medical device approvals or safety problems. The use of Notified Bodies has been criticized as encouraging "forum shopping" by sponsors to identify those Notified Bodies with the most lax operating standards, and the varying levels of expertise among Notified Bodies has been critiqued.
Some have suggested that the United States adopt the medical device regulatory system of the EU. Yet, outside the United States, pressure is growing toward greater premarket scrutiny of medical devices. A June 2011 report from the Belgian Health Care Knowledge Centre (a governmental agency that produces studies to advise policymakers when deciding on health care and health insurance)[19] concluded that "[f]or innovative high-risk devices the future EU Device Directive should move away from requiring clinical safety and 'performance' data only to also require pre-market data that demonstrate 'clinical efficacy,'" and "[t]he device industry should be made aware of the growing importance of generating clinical evidence and the specific expertise this requires."[20]
In May 2011, the European Society of Cardiology (ESC) issued a "case for reform" of the European medical device regulatory system: that body's recommendations included creating a unified regulatory system, imposing stronger clinical data requirements, and requiring more accountability for notified bodies.[21] The ESC cited examples of several different cardiovascular technologies that were implanted in patients in the EU that were later proven to be unsafe and/or ineffective through clinical trials required under the U.S. system and were subsequently removed from the European market.
Also in May 2011, a series of feature articles was published in the British Medical Journal, criticizing the opacity of the European medical device regulatory system, and raising concerns about the regulation of high-risk devices and how well they are tested before coming on to the European market.[22] Several of the featured articles cited the FDA system's transparency as helping physicians to make informed decisions about which devices to use and providing patients with access to information about the devices that will be used on them.
Most recently, France's Directorate General for Health and its consumer safety body AFSSAPS[23] issued a report[24] urging stronger national and European regulation and monitoring of medical devices. In an accompanying statement, France's Minister of Health, Xavier Bertrand, said that EU rules on regulating and monitoring medical devices "must be radically overhauled."[25]
FDA continues exploring ways to get medical products to patients with serious and life-threatening diseases or conditions faster, but lowering U.S. approval standards isn't in the best interest of American patients, our health care system, or U.S. companies whose success relies on the American public's confidence in their products. We are pleased that a U.S. medical device industry trade association, AdvaMed, has stated that it supports maintaining our current rigorous standards of safety and effectiveness for marketing medical devices: "The medical technology industry has long recognized that a strong and well-functioning FDA is vital to maintaining America's preeminence in medical technology innovation, and we support the current regulatory framework in the U.S."[26]
Moving Forward
The user fee agreement we have reached with industry strikes a careful balance between what industry agreed to pay and what FDA can accomplish with the amount of funding proposed. The device user fee resource increases contemplated under MDUFA III are designed to help CDRH meet specific goals. Additional mandates that are beyond the scope of the agreement risk diverting resources from product review, challenging FDA's ability to achieve the new, agreed-upon performance goals.
While we recognize that there are some areas in which legislation may complement the user fee agreement, we note that the success of the user fee agreement rests on enabling CDRH to focus on meeting the ambitious new MDUFA program goals and enhancing timely patient access to safe and effective devices. This is an objective that we share with industry, health care practitioners, patients, and consumers.
Over the course of MDUFA II, and especially during the last two years, CDRH has been working, with extensive input from industry and other stakeholders, to take concrete actions toward creating a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks; ensuring predictable and consistent recommendations, decision-making, and application of the least-burdensome principle; and implementing efficient processes and use of resources. These actions—geared toward a system of smart regulation—have already started to have a measurable, positive impact on our premarket programs, and we fully expect that positive trend to continue as we proceed to implement the improvements we have committed to make.
While we work with industry, other stakeholders, and Congress in the statutory process toward the reauthorization of medical device user fees, in order to ensure adequate and stable funding of the program, we are also continuing to move forward with CDRH program improvements. MDUFA II is scheduled to expire on September 30, 2012, and FDA is ready to work with you to ensure timely reauthorization of this critical program. If we are to sustain and build on our record of accomplishment, it is critical that the MDUFA reauthorization occurs seamlessly, without any gap between the expiration of current law and the enactment of MDUFA III. At the same time, we must remain mindful that, unlike the PDUFA program in which fees fund more than 60 percent of drug review costs, user fees under MDUFA III (as described in the recently announced agreement) will fund about a third of the total cost of the medical device premarket review process, making it important to keep these resources focused on the performance goals identified in the MDUFA agreement.
Mr. Chairman and Members of the Subcommittee, I share your goal of smart, streamlined regulatory programs. Thank you for your commitment to the mission of FDA, and to the continued success of our medical device program, which helps to ensure that patients and practitioners have access to safe and effective innovative medical technologies on a daily basis. I am happy to answer questions you may have.
[1] See U.S. FDA, "Medical Device User Fee Rates for Fiscal Year 2012," 76 Federal Register 45,826-45,831 (Aug. 1, 2011), available at http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/html/2011-19335.htm.
[2] See U.S. FDA, "Prescription Drug User Fee Rates for Fiscal Year 2012," 76 Federal Register 45,831-45,838 (Aug. 1, 2011), available at http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19332.pdf.
[3] See FDA News Release, "FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD Patients" (July 6, 2010), available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm218066.htm.
[4] See Office of Naval Research, "Naval Technology Could be a Lifesaver" (Dec. 21, 2011), available at http://www.onr.navy.mil/Media-Center/Press-Releases/2011/Infrascanner-brain-TBI-FDA-approval.aspx.
[5] See FDA News Release, "FDA Approves Diaphragm-Pacing Device" (June 18, 2008), available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm116914.htm.
[6] Guidance documents include documents that relate to: (1) the design, production, labeling, promotion, manufacturing, and testing of regulated products; (2) the processing, content, and evaluation or approval of submissions; and (3) FDA's inspection and enforcement policies. See generally, "Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency" (issued Dec. 2011), available at http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM285124.pdf.
[7] If, after reviewing an application, FDA determines that it cannot approve or clear the application in its current form, FDA sends a letter informing the sponsor of this decision. For 510(k) applications, this is called an "Additional Information" (AI) letter.
[8] Numerous public meetings and workshops, including three "town hall" discussions with the Center Director and senior CDRH management, were held in 2011; similar CDRH outreach to stakeholders is ongoing. For more details, see http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm111051.htm.
[9] More information about FDA's progress in implementing the CDRH "Plan of Action for 510(k) and Science" is available on FDA's website at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRH
[10] CDRH, "2012 Strategic Priorities," available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRH
[11] A Total Product Life Cycle (TPLC) approach involves making well-supported regulatory decisions that take into consideration all of the relevant information available to CDRH at any stage of a product's life cycle to assure the safety, effectiveness, and quality of medical devices and the safety of non-device radiation-emitting products. The Center's TPLC database integrates premarket and post-market data about medical devices. For more information, see CDRH's website at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRH
[12] Among the reasons that 510(k) submissions result in NSE determinations are: lack of a suitable predicate device; intended use of the new device is not the same as the intended use of the predicate; technological characteristics are different from those of the predicate and raise new questions of safety and effectiveness; and/or performance data failed to demonstrate that the device is as safe and effective as the predicate. The vast majority of NSE decisions are due to the absence of adequate performance data, sometimes despite repeated FDA requests.
[13] A transcript of the September 2010 public meeting, and related meeting materials, are available on FDA's website at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm.
[14] The minutes of the stakeholder discussions on MDUFA III reauthorization are available on FDA's website at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFee
[15] The minutes of the industry discussions on MDUFA III reauthorization are available on FDA's website at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFee
[16] The proposed package of recommendations for MDUFA III is available on FDA's website at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm292860.htm.
[17] See, e.g., D. Cohen and M. Billingsley, "Europeans Are Left to Their Own Devices," British Medical Journal, 342:d2748 (2011), available at http://www.bmj.com/content/342/bmj.d2748.
[18] See "Recast of the Medical Devices Directives: Public Consultation," available at http://ec.europa.eu/consumers/sectors/medical-devices/files/recast_docs_2008/public_consultation_en.pdf; European Commission, "Guidelines on Medical Devices: Clinical Evaluation: A Guide for Manufacturers and Notified Bodies" (Dec. 2009), at p. 4, available athttp://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf.
[19] Additional information about the Belgian Health Care Knowledge Centre, and its mission and activities, is available at https://kce.fgov.be/content/about-the-kce.
[20] Belgian Health Care Knowledge Centre, "The Pre-market Clinical Evaluation of Innovative High-risk Medical Devices," KCE Reports 158 (2011) at p. vii, available at http://www.kce.fgov.be/index_en.aspx?SGREF=202677.
[21] See "Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform," Alan G. Fraser, et al., European Heart Journal, May 2011.
[22] "The Truth About Medical Devices," British Medical Journal, vol. 342, at pp. 1115-1130 (May 21, 2011), available at http://www.bmj.com/content/342/7807/Feature.full.pdf(Deborah Cohen, "Out of Joint: The Story of the ASR," British Medical Journal 2011; 342:d2905; Deborah Cohen and Matthew Billingsley, "Medical Devices: European Patients Are Left to Their Own Devices," British Medical Journal 2011; 342:d2748); see also Fiona Godlee, "Editorial: The Trouble With Medical Devices," British Medical Journal 2011; 342:d3123, available at http://www.bmj.com/content/342/bmj.d3123.full; Carl Heneghan, et al., "Medical-Device Recalls in the UK and the Device-Regulation Process: Retrospective Review of Safety Notices and Alerts," BMJOpen (May 2011), available at http://bmjopen.bmj.com/content/early/2011/05/12/bmjopen-2011-000155.full.pdf.
[23] Agence française de sécurité sanitaire des produits de santé, France's Agency for the Safety of Health Products.
[24] See AFSSAPS, "Poly Implant Prothèse: remise d'un rapport de la DGS et de l'Afssaps aux ministres chargés de la santé – Communiqué," available at http://www.afssaps.fr/index.php/Infos-de-securite/Communiques-Points-presse/Poly-Implant-Prothese-remise-d-un-rapport-de-la-DGS-et-de-l-Afssaps-aux-ministres-charges-de-la-sante-Communique.
[25] See "France Calls for Europe-wide Control on Prosthetics following PIP Breast Implant Scare," The Telegraph (Feb. 1, 2012), available at http://www.telegraph.co.uk/health/women_shealth/9054282/France-calls-for-Europe-wide-control-on-prosthetics-following-PIP-breast-implant-scare.html.
[26] Advanced Medical Technology Association (AdvaMed), "AdvaMed Statement on the House Energy and Commerce Subcommittee Hearing on FDA Device Regulation" (July 20, 2011).


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Top Ten Things in Yor House That Can Kill the Mood!!
What's the one thing in your place that totally kills the mood if you're about to GET IT ON? According to a new survey, here are the ten biggest turn-offs.
1. Bad smells. Which could include feet, passing gas, or just neglecting to take the trash out.
2. A dirty kitchen. Even if you're not getting BUSY in the kitchen.
3. A picture of your ex. Which is weird, because it's something most people don't just have lying around their HOUSE. But I guess Facebook also factors in.
4. A dirty bedroom.
5. Having a weird collection. Like Steve Carell in "The 40-Year-Old Virgin", who had old action figures all over his apartment. Or if you're a woman, having a bunch of stuffed animals.
6. Empty beer bottles, or anything that suggests you were partying and didn't bother to clean up.
7. Too much sports memorabilia.
8. Dust. Which is something only WOMEN care about. (Has a guy ever turned down sex because of DUST?)
9. Anything that reminds you of your kids, or THEIR kids. Like toys lying around.
10. Anything that takes up space and makes it feel claustrophobic.

subset: commoncrawl


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TRENTON-It's been an up-and-down season for the Trenton High baseball team.
The ability to win the close ones has haunted coach Scott Guthrie.
"We've lost six games by one run,"said Guthrie, whose team's overall record was 13-11 heading into Tuesday's Class 2A District 5 Tournament opener against Bronson. "We had a terrible March at the plate."
While the inconsistency has been frustrating for coach Guthrie, things are definitely better than his first year at the helm when the Tigers finished 3-15.
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Aberdeen Business School - Scotland - European MBA
Robert Gordon University is known worldwide for its expertise in Energy and the University has a wide range of degrees in Energy, Engineering, Business and Health. The University has been in existence as an educational institution since 1750.Robert Gordon University is located in Aberdeen, Scotland and is part of the UK public education system, and was formally designated a University in 1992.
- Academic underpinning and Ethical Practice
- Career and Personal Development
- Behavioural and Skill Development
- Industry Engagement
Programme information:Accreditation: The course is accredited in all modes by the Association of MBAs (AMBA); the CMI (the Chartered Management Institute) and the Energy Institute.
Rankings:Aberdeen Business School (ABS) is ranked in the global top 50 for its MBA programmes in the highly acclaimed 'Beyond Grey Pinstripes' survey, published by The Aspen Institutes Centre for Business Education, 2011. RGU was rated as Scotland's highest placed school, at 50, and was one of only five UK universities to be ranked in the top 100 MBA programmes.
Type of programme: FT/PT/Online/distance learning
Programme format:
MBA key modules:
- Business Creativity and Innovation
- Organisational Development and People Management
- Technology Commercialisation Project
- Leadership, Communication & Change
- New Media Marketing
- Strategic Management
- Oil and Gas Management
- Oil and Gas Economics
- Strategic Operations Management: Oil and Gas
- Project Management
- Energy Policy and the Environment
- Oil and Gas Law
Course Strength: MBA Oil and Gas Management– the only upstream course of its kind in the UK and the project at the end of the course.
MBA – Ideas, selection of ideas and communication. Creative ideas leading to new products are the lifeblood of a company. Choosing the best ideas and making money are of paramount importance – the MBA at Aberdeen Business School will help you to do this.
Application deadlines: June for September start
Starting dates: September (FT and online/distance learning)
January (online/distance learning)
% of salary increase after graduation: 20%
Student Body:Ratio of Applicants to Places: 10:1
Male to Female Ratio: 70 (male) 30 (female)
Age range: 26 – 50
Average age: 33
Degree background: science; technology; engineering; business
International Students:
Europe: 40%
North America: 5%
Central/South America: 5%
Middle East: 10%
Oceania and Asia: 20%
Africa: 20%
Admission Requirements:University degree: hold a first degree, at honours level in a top class banding
TOEFL: TOEFL 570 (paper) or TOEFL 230 (computer) or IELTS 6.5
References: two
Minimum length of work experience: at least three years full-time work experience at a professional level. For the Oil and Gas MBA a degree in science or technology or engineering is required.
Costs:Costs: MBA (Full Time)
Application fees: 0
Tuition fees: £16500
Scholarships: Available and awarded on merit – 10% – 40% of tuition fee
Costs: MBA (Part-Time & Online)
Application fees: 0
Tuition fees: £12500
Scholarships: Available and awarded on merit – 10% – 40% of tuition fee
Costs: MBA Oil and Gas Management
Application fees: 0
Tuition fees: £19500
Scholarships: Available and awarded on merit – 10% – 40% of tuition fee
Costs: MBA Oil and Gas Management (Part-Time & Online)
Application fees: 0
Tuition fees: £16500
Scholarships: Available and awarded on merit – 10% – 40% of tuition fee
Costs: MBA Information Management (Online)
Application fees: 0
Tuition fees: £12500
Scholarships: Available and awarded on merit – 10% – 40% of tuition fee
All graduates, honorary graduates and honorary fellows of the Robert Gordon University and its predecessor institutions are automatically members of the Alumni Association. We have a worldwide network of over 70,000 Robert Gordon University alumni.
The Alumni Office is here to:
- help you keep in touch with the University and each other
- support you in your future development
- provide you with exclusive benefits and services
- invite you to a range of informative, educational and social events
- provide you with exciting opportunities to support the University
To find out more about our activities why not explore the website, or contact firstname.lastname@example.com or 01224 262032 for more details.
Garthdee Road,
Scotland, UK
Telephone: 0044 (0) 1224 263800
Fax: 0044 (0) 1224 263838
Dean: Rita Marcella
MBA program director: Allan Scott
MBA course leader: Linda Jenkins


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Season 13, Episode 3 - Patient Zero - Updated. The greatest mysteries have a shadowy figure at the center—someone who sets things in motion and holds the key to how the story unfolds—Patient Zero. This hour, Radiolab hunts for Patient Zeroes of all kinds and considers the course of an ongoing outbreak. http://goo.gl/JSAr1t #FullPodcastAvailable #Podcasts
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REPORT: Justin Timberlake to part ways with fashion label William Rast
It looks like Justin Timberlake doesn't need much as long as he's got his "suit and tie."
According to New York Magazine, the singer is on the outs with his clothing line called William Rast, which he started with his close friend Trace Ayala back in 2005. The label had a successful New York Fashion Week debut, but has since been seen a serious dip in sales and is being sold at less glamorous retailers like JC Penney.
JT's reps aren't exactly denying that the star may be parting ways with his label, vaguely telling the magazine that Justin is "eternally" connected to the brand as it's named after his grandfather.
But the star has upped his game with his most recent comeback. His re-invention was actually spearheaded by American designer of the stars Tom Ford, whose clothing and accessories were featured prominently in the "Suit & Tie" video.


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POMONA - The Public Library's service hours will soon change, an adjustment brought about partly at the request of patrons.
As of Dec. 18, the library will be open from 2 to 7 p.m. Monday through Wednesday and from noon to 5 p.m. Saturday.
Library personnel said they noticed a drop in patrons on Tuesdays, when the library is open from the mornings to the early afternoon.
Patrons, particularly students, have requested more service hours later in the day, said Susan Paul, the city's human resources and risk management director.
"The public wanted really consistent hours," Paul said.
Library hours changed this summer after the implementation of personnel and service cuts.
Plans had called for temporarily closing the library at 625 S. Garey Ave. for a year as part of a cost-cutting effort. City officials gave the library a reprieve and it will continue operating until the end of June but with limited hours and staff reductions.
During a series of meetings in October, residents expressed a desire for consistent hours for when the library is open, Paul said. The meetings aimed to gather feedback as part of an effort to create a plan for the library's future.
The new schedule will "make it much easier for people to keep track" of hours," Councilwoman Paula Lantz said.
"It really came as a recommendation of library staff and patrons of library. I think it makes sense."
Councilwoman Cristina Carrizosa said she attended two of the meetings and heard residents speak about the variation in service hours. Patrons complained the schedule made it difficult to know when they could visit the library, Carrizosa said.
"Now we will have consistency until June," she said.
Personnel will continue to monitor activity at the library and make further schedule adjustments if necessary, Paul said.
Efforts are underway to inform the public about the library schedule change, Paul said.
Reach Monica via email or call her at 909-483-9336.


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How to Protect Your Skin This Winter
Seasons change and so should your skin care.
-Dr.Neal Schultz, DermTV.com
The temperatures are quickly falling. The humidity in the air changes as does each season. Now's the time to re-evaluate your skin care routine.
Make sure you are getting the most out of your products, and that they are doing is what's best for your skin. Keep in mind that your skin will have different needs in the coming months.
Follow these simple tips to recharge your skincare routine and stay in tune with each season's demands:
Start by evaluating the products you are currently using in your daily basic regimen. They should include cleanser, toner, moisturizer and sunscreen.
Read Treat Insomnia the Natural Way
Seasonal changes often demand a change in the consistency of the products you are using. When it's warm and humid out, you want to use lighter products such as serums, moisturizers and sunscreens that are delivered via lightweight formula. In the winter when it is dry and cold, your skin will crave thicker, heavier and more intense moisturizing products. You may want to use a gentler cleanser and toner now.
Your skin itself is the best indicator—In the winter if it feels dry, tight or even itchy, or if your cheeks are flakey, these are the definitive signs that you need to adjust your skin care routine.
Whether you should exfoliate, is exfoliating really good for you and more up next


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Enjoy the relaxed atmosphere of Huntsville Caravan Park, set on the banks of the Mary River in Maryborough. Located just five minutes from the town centre, golf course, bowling greens, RSL Club, and opposite a shopping centre and 500 metres to boat ramp.
Huntsville Caravan Park boasts clean amenity blocks and laundry, with washing machines, troughs, dryer, ironing board and separate babies bathroom.
Air conditioned ensuite cabins include reverse cycle air conditioning, cooking facilities, microwave, television, double bed with linen supplied to double bed. Sleeps three.
Standard Cabins (no ensuite) include a double bed, two single beds, cooking facilities, television and fan. You supply your own linen, blankets (sleeping bags), towels and pillows.
Air Conditioned Standard Cabins (No Ensuite) include a double bed, bunks, air conditioning, cooking facilities and television with linen supplied to double bed.
Ensuite Powered Sites have ensuite, water, sullage and power provided. Some have a concrete annexe pad.
Powered Sites have water, sullage and power provided. Most have a concrete annexe pad.
Shady tent site with use of clean amenities blocks and laundry with washing machines, troughs, dryer, ironing board and separate babies bathroom.
Note: Information on listed products and services are provided by the operator and were correct at the time of publishing. Rates are indicative based on the minimum and maximum available prices of products and services. Please visit the operator's website for further information. All prices quoted are in Australian dollars (AUD).


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SANTA ANA - Four men were sentenced to varying prison terms for their guilty pleas Tuesday to stealing more than $400,000 by taking automated teller machines with stolen trucks and forklifts.
Richard Dwayne Bockman, 45, of Yucca Valley, Ricky Joe Coffey, 46, of Orange, Curtis Edward Weber, 40, of Anaheim, and Charles Edward Roberts, 43, of Riverside, all accepted plea bargains from Orange County Superior Court Judge Robert Fitzgerald, Deputy District Attorney John Christl said.
Bockman was sentenced to 10 years in prison, Weber and Coffey seven years and Roberts three years, but because he has credit for that amount of time served in custody he will be released from custody, Christl said. Roberts played a lesser role in the thefts and pleaded guilty to conspiracy charges, Christl added.
Christl advocated stricter punishments for the defendants, and offered "substantially higher" prison sentences for the men in his plea bargain offer.
Christl said he pushed for longer prison sentences because "there was approximately $420,000 in loss and the events involved a great deal of sophistication and planning."
"They ripped ATMs out of their foundations or stole them from stores with stolen trucks to transport them," Christl said. "They broke into them and stole substantial amounts of money, and then they committed arson by burning the ATMs and vehicles they used to steal."
The defendants also had criminal records, Christl said.
The guilty pleas amount to two strikes for each defendant, Christl said.
Between May 30, 2009, and May 1, 2010, the conspirators used stolen pick- up trucks, a box truck and a forklift to steal ATMs in Aliso Viejo, Anaheim, Fullerton, Long Beach and Yorba Linda.
The thieves would drive a stolen truck early mornings to businesses that had ATMs that were free-standing or anchored into the ground with concrete, and use a pallet jack or forklift to pry them from the store to put them in a truck.
The four men burned a stolen moving truck with an ATM in it in a Home Depot parking lot on May 1, 2010.


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Lisa Madigan
Associated Press
News about Lisa Madigan, including commentary and archival articles published in The New York Times.
Illinois: Attorney General Seeks Release of a Police Video
Attorney General Lisa Madigan asked the Chicago police on Wednesday to release a video that is said to show an officer shooting a black teenager 16 times last year....
November 19, 2015, Thursday
MORE ON LISA MADIGAN AND: Police Brutality, Misconduct and Shootings , Blacks , Chicago (Ill) , McDonald, Laquan (d 2014) , Madigan, Lisa
It's Illinois v. Illinois in Supreme Court Duel for Justices' Attention
The state's attorney general has contested a filing by Gov. Bruce Rauner in a case about unions, saying the governor has no authority to represent the state in court....
October 27, 2015, Tuesday
MORE ON LISA MADIGAN AND: Illinois , Organized Labor , Supreme Court (US) , Madigan, Lisa , Rauner, Bruce , Attorneys General , Governors (US) , Government Employees
Illinois: Official Refuses Order to Halt Union Fees
The state comptroller, Leslie Munger, said Friday she would not follow an executive order by Gov. Bruce Rauner to hold up so-called fair-share union dues from nonunion workers....
February 14, 2015, Saturday
MORE ON LISA MADIGAN AND: Illinois , Rauner, Bruce , Organized Labor , Prices (Fares, Fees and Rates) , Madigan, Lisa
Obama Had Security Fears on JPMorgan Data Breach
Officials say no one could answer what the president wanted to know most: What was the motive of the attack?...
October 8, 2014, Wednesday
MORE ON LISA MADIGAN AND: Security and Warning Systems , JPMorgan Chase & Company , Identity Theft , Banking and Financial Institutions , Cyberwarfare , Cyberattacks and Hackers , Federal Bureau of Investigation , National Security Agency , Industrial Espionage , Surveillance of Citizens by Government , Jepsen, George C , Madigan, Lisa , Obama, Barack
Companies That Offer Help With Student Loans Are Often Predatory, Officials Say
The debt settlement industry, already accused of questionable tactics related to mortgages, is finding a gold mine of new clients among those with college loans....
July 13, 2014, Sunday
MORE ON LISA MADIGAN AND: Banking and Financial Institutions , Mortgages , Credit and Debt , Personal Finances , Colleges and Universities , Illinois , Student Loans , Consumer Protection , Madigan, Lisa , First American Tax Defense LLC , Consumer Financial Protection Bureau , Education Department (US) , Federal Trade Commission , Broadsword Student Advantage LLC
Durbin Lends Support to Pro-Clinton Group
Senator Richard J. Durbin will co-host a June 5 Chicago fund-raiser for Ready for Hillary, an outside group designed to build enthusiasm for Mrs. Clinton's 2016 candidacy, should she decide to run....
May 20, 2014, Tuesday
MORE ON LISA MADIGAN AND: Madigan, Lisa , Durbin, Richard J , Emanuel, Rahm , Clinton, Hillary Rodham , Chicago (Ill) , Illinois , Ready for Hillary PAC , Presidential Election of 2016
Costly Loans Are Drawing Attention From States
States are increasing efforts to shield vulnerable Americans from short-term loans with interest rates that can exceed 300 percent....
March 18, 2014, Tuesday
MORE ON LISA MADIGAN AND: Illinois , Consumer Protection , Credit and Debt , Madigan, Lisa , States (US) , Consumer Financial Protection Bureau
A Run of Luck in Illinois for Its Embattled Governor
Gov. Pat Quinn, a Democrat facing a tough re-election next year, has seen his Democratic opponents, including William M. Daley, halt their bids....
September 18, 2013, Wednesday
MORE ON LISA MADIGAN AND: Raoul, Kwame , Dillard, Kirk , Brady, Bill , Madigan, Lisa , Quinn, Patrick J , Rutherford, Dan , Rauner, Bruce , Illinois , Elections, Governors , Daley, William M
Deceptive Practices in Foreclosures
A lawsuit filed by the state of Illinois describes the latest abuses against homeowners....
September 14, 2013, Saturday
MORE ON LISA MADIGAN AND: Illinois , Foreclosures , Madigan, Lisa , Banking and Financial Institutions , Editorials , Suits and Litigation (Civil) , Safeguard Properties , Real Estate and Housing (Residential)
Illinois Attorney General Will Not Run for Governor
Lisa Madigan, the attorney general of Illinois and the daughter of the longtime speaker of the state House, will not run for governor next year, ending months of speculation that she would....
July 15, 2013, Monday
MORE ON LISA MADIGAN AND: Madigan, Lisa , Illinois , Elections, Attorneys General , Elections, Governors
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The Walt Disney Company, based in Burbank, California, is the third largest media and entertainment corporation in the world. Founded on October 16, 1923 by brothers Walt and Roy Disney as a small animation studio, it has become one of the biggest Hollywood studios and owner of 11 theme parks and several television networks, including the American Broadcasting Company (ABC).
Walt Disney Pictures is a main motion-picture producing studio of The Walt Disney Company and a subsidiary of the Walt Disney Studio Entertainment sector of the organization. In keeping with Disney's family-friendly image, it released only G- and PG-rated films until 2003's Pirates of the Caribbean: The Curse of the Black Pearl, which was rated PG-13.
This article uses material from the Wikipedia article "The Walt Disney Company" and is licensed under the GNU Free Documentation License.


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* -43 => +56
* make sure you're using your MONITOR INTERFACE (wlan0 or mon0, depends on your card/driver)
* No wireless clients on the AP => no handshakes
I wonder if I'm doing something bad, trying to find out a WPA key
- my card supports mode monitoring
- its name is wlan0
Some friend told me the PWR value should be positive (and not negative)
1- main screen
2- cowpatty
3- aircrack
I clearly see that the "handshake" could not be made. May I know why?
- The time I tried to do this? 0:02am
- No one connected to AP?
- something else?
Thanks a lot in advance and hope anyone can guide me to correct these mistakes...
* -43 => +56
* make sure you're using your MONITOR INTERFACE (wlan0 or mon0, depends on your card/driver)
* No wireless clients on the AP => no handshakes
Last edited by Lucifer; 04-20-2010 at 10:14 PM.
thanks Lucifer
sad to read that, but good to know.
I'll have to get another computer and make it connect to the AP and download p0rn while I try again
make sure you preface all this with
airmong-ng start wlan0
and then use mon0 as your interface
I've now managed to do the first things correctly.
I connected a palm tx to the AP (this will be the other client)
I run my lap with BT, and then begun working with mon0
All goes fine, I get 300 data packets in some mins. My only problem is that when I exec the aireplay --deauth... command (after trying some times until it matches channel 11), it sends 10 lines to the AP, one of these lines have a positive number (ACK), but the handshake never happens...
Does any1 know what's wrong?
Thanks again


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Osterburken Germany Businesses For Sale
Searched the DealStream database for Osterburken Germany Businesses For Sale and found no matches. Expanded the search to nearby areas and found the following matches.
Three Star Hotels in Wiesbaden #458539 posted Nov 28, 2016
- Wiesbaden, Hesse, Germany
The four-storey hotel built in 1992. Total area - 1820 sq.m. The hotel has 54 rooms + 1 + Suite is a conference area. 21 seats in the underground parking. Land area of 938 sq.m. Wiesbaden - a town in Germany, the capital of the federal state of Hesse. Wiesbaden - the second largest city in Hesse...
Hotel Three Stars in the Center of Baden-Baden #458504 posted Nov 25, 2016
- Baden-Baden, Baden-Württemberg, Germany
Five floors. Total area - 6342 sq.m. The hotel has 52 rooms. 22 double rooms (9 rooms have balconies), 4 rooms Junior Suite, Suite with a terrace and a royal suite with two bedrooms. Central heating. On the ground floor there is a reception desk, Internet terminal, an office, a private toilet (130 m²)....
The Hotel, Four Stars, in a Suburb of Frankfurt #458257 posted Nov 21, 2016
- Frankfurt am Main, Hesse, Germany
The five-storey hotel was built in 1998 and renovated in 2015. Total area - 2500 sq.m. (Without underground car park). Land area - 1900 sq.m. The hotel has 72 rooms and 2 conference rooms. Very good condition, used in the decoration of high quality materials, marble and precious woods. Modern lobby....
The Luxurious Five-Star Hotel in Frankfurt am Main #458243 posted Nov 20, 2016
- Frankfurt am Main, Hesse, Germany
The hotel was built in 1813. Repaired. 7 floors. In the hotel's 159 rooms (135 rooms of different categories, 23 Deluxe rooms and one presidential Suite). 10 meeting rooms, 2 restaurants. Spa-area: the Spacious Spa-centre (1 500 sq. m.) with a thermal spring, thermal pool, fitness centre, 12 treatments...
Did you know that social networking is a great way to buy a business? Sign up now and we'll show you how.


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AT&T Connects Communities With New Mobile App
Dallas, Texas, June 26, 2013
AT&T* now offers an easier way for small-to-mid size governments to connect with citizens virtually anywhere or anytime using a mobile device. AT&T Community Central is a cloud-based mobile application that enables government entities to more effectively and dynamically communicate with citizens.
Community members can use a smartphone or tablet not only to access helpful information such as maps and directories, but also to immediately report city-related problems. The application also allows local governments to quickly respond to instant feedback from citizens on general issues.
Several key features of AT&T Community Central include:
- Customizable user interface to better meet the needs of cities and counties.
- The ability to use a smartphone camera to report city-related issues. Citizens can upload and send pictures of problems such as potholes, landscaping, and traffic signs that need repair.
- Alert notifications that remind community members of upcoming events as well as updates on city hazards such as a water main break or broken traffic light.
- A mobile view of the local transportation network to access the latest information on travel schedules and routes.
- An in-hand ability to find information on city parks and recreational centers related to hours, upcoming events, maps, and directions.
- A directory listing of all departments that detail contact information, address information, and supporting hours along with the ability to call or email personnel within the app.
"Mobile technology is redefining the way government agencies connect with their community, and we're helping to make this process more efficient," said Mike Troiano, Vice President, Advanced Mobility Solutions, AT&T Business Solutions. "AT&T Community Central helps local government simplify communication through a device found in the pockets and purses of on-the-go citizens."
AT&T Community Central aims to stand out amongst similar mobile applications by offering government agencies an easy-to-manage software platform and access to customer service, all while providing the ability to connect with citizens where they live, work, and play.
AT&T has extensive experience in helping organizations to integrate and customize their mobile applications. In addition, AT&T Mobility Solutions Services specializes in guiding organizations through the entire process of going mobile – from consulting and design to solution configuration and full lifecycle management of the end-to-end solution.
For more information on AT&T Community Central, visit www.att.com/stateandlocal.


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Safety Management Information System (SSA Accident, Injury and Illness Reporting System), Social Security Administration, Deputy Commissioner for Finance, Assessment and Management, Office of Facilities Management
Effective Date: January 11, 2006
System name:
Safety Management Information System (SSA Accident, Injury and Illness Reporting System), Social Security Administration, Deputy Commissioner for Finance, Assessment and Management, Office of Facilities Management.
Security classification:
System Location:
Social Security Administration
Office of Facilities Management
Room 2-J-9
Categories of individuals covered by the system:
Social Security Administration (SSA) employees, who are involved in an accident which arises out of and in the course of their employment whether occurring on SSA premises or not and results in:
(a) A fatality;
(b) Lost workdays beyond the day in which the accident occurred;
(c) Nonfatal injuries which result in transfer to another job, termination of employment, medical treatment other than first aid, loss of consciousness or restriction of work or motion;
(d) A possible tort claim;
(e) A claim for compensation;
(f) Property damage in excess of $50;
(g) Interruption or interference with the orderly progress of work of other employees;
(h) Radiation overexposure;
(i) Biological exposure resulting in lost time or of accidental release of biologicals where the public may be over-exposed. It also covers visiting scientists, contractor personnel;
(j) Hospitalized patients, out-patients, employees of other Federal agencies, State or local governments or members of the public who suffer injury, illness or property damage on or in SSA premises or as a result of SSA activities.
Categories of Records in the system:
This system consists of a variety of information and supporting documentation resulting from the reporting and investigation of accidents which have resulted in injury, illness, property damage or the interruption or interference with the orderly progress of work.
The records contain information about individuals involved in, or experiencing, accidents including, but not limited to, the severity of the injury, whether consciousness was lost, the type of injury, culmination of any injury, days lost from work, if any, the nature of the injury, illness or disease, the body part affected, causal factors, weather factors, agency of accident, whether unsafe mechanical, physical, or personal acts or factors were involved, the accident's area of origin and if fire was involved, the type and form of materials involved.
Property damage (both public and private) is noted through the property sequence number, who owned the property involved, property damage and actual or estimated monetary loss, the SSA installation number, if appropriate, and the year of manufacture or construction if appropriate.
Identifiers relating to a particular accident include the organization, case number assigned, date and time of occurrence, State or territory, site, type and classification of accident, estimated amount of tort claims, if appropriate, name of individual(s) involved, the Social Security number (SSN), sex, age, grade series and level, Computer Sciences Corporation (CSC) series, address, other departments notified of accident, duty status, activity at time of accident and time on duty before accident. Management's evaluation and corrective action taken or proposed is also noted.
Authority for maintenance of the system:
Section 19 of the Occupational Safety and Health Act of 1970 (Pub. L. 91-596, 29 U.S.C. 651, et seq.); 5 U.S.C. 7902; 29 CFR part 1960; Executive Order (E.O.) No. 12196 (45 FR 12769 4/26/80).
The purpose of the system is to comply with the reporting and statistical analyses requirements of section 19 of the Occupational Safety and Health Act (OSHA) of 1970 (Pub. L. 91-596) as amended (29 U.S.C. 668); 5 U.S.C. 7902; 29 CFR Part 1960; E.O. 12196 and such other purposes as are described below. The Safety Management Information System is a SSA-wide system utilized by all organizational components of the Agency. Thus, in addition to the routine uses subsequently noted in this system notice, there may be other ad hoc disclosures within the Agency on an official business ``need-to-know'' basis. Some of the purposes are the following:
Establish a written record of the causes of accidents;
Provide information to initiate and support corrective or preventive action;
Provide statistical information relating to accidents resulting in occupational injuries; illnesses, and/or property damage;
Provide management with information with which to evaluate the effectiveness of safety management programs;
Provide the means for complying with the reporting requirements of section 19 of the Occupational Safety and Health Act of 1970 and such other reporting requirements as may be required by legislative or regulative requirements;
Provide such other summary descriptive statistics and analytical studies as necessary in support of the function for which the records are collected and maintained including general requests for statistical information without personal identification of individuals;
Information in these records is used by or may be disclosed to:
The Office of Facilities Management (OFM), Office of the Deputy Commissioner for Finance, Assessment and Management (DCFAM), in the review of accident experience data to determine the adequacy of corrective actions, the effect of codes, standards and guides, the consolidation, summarization and dissemination of accident experience data throughout SSA and other government departments and agencies as needed or required;
The supervisor, administrative officer or other official initiating an accident report, including each succeeding reviewing official in the chain of command through which the report passes, to insure that corrective action, as needed and appropriate, is taken; and
Appropriately appointed Safety Directors, Officers, or others with safety responsibilities within the Agency in the verifying, assembling, analyzing, summarizing and disseminating data concerning the accident in their areas of responsibility and in the initiation of appropriate corrective action.
Routine uses of records maintained in the system, including categories of users and the purposes of such uses:
Disclosure may be made for routine uses as indicated below:
1. To a Federal, State, local agency or private sources to obtain information relevant to the investigation of an accident and/or corrective action.
2. To a congressional office in response to an inquiry from that office made at the request of the subject of the record.
3. To the Department of Justice (DOJ), a court or other tribunal, or another party before such tribunal, when:
(a) The Social Security Administration (SSA), or any component thereof; or
(b) Any SSA employee in his/her official capacity; or
(c) Any SSA employee in his/her individual capacity where DOJ (or SSA where it is authorized to do so) has agreed to represent the employee; or
(d) The United States or any agency thereof where SSA determines that the litigation is likely to affect the operations of SSA or any of its components, is a party to the litigation or has an interest in such litigation, and SSA determines that the use of such records by DOJ, a court or other tribunal, or another party before tribunal, is relevant and necessary to the litigation, provided, however, that in each case, SSA determines that such disclosure is compatible with the purpose for which the records were collected.
4. To Federal, State, or local law enforcement agencies if a record maintained by this agency to carry out its functions indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature.
5. To student volunteers, individuals working under a personal services contract, and other workers who technically do not have the status of Federal employees, when they are performing work for the Social Security Administration (SSA), as authorized by law, and they need access to personally identifiable information in SSA records in order to perform their assigned Agency functions.
6. To the General Services Administration and the National Archives Records Administration (NARA) under 44 U.S.C. 2904 and 2906, as amended by the NARA Act of 1984, information which is not restricted from disclosure by Federal law for the use of those agencies in conducting records management studies.
7. We may disclose information to appropriate Federal, State, and local agencies, entities, and persons when (1) we suspect or confirm that the security or confidentiality of information in this system of records has been compromised; (2) we determine that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs of SSA that rely upon the compromised information; and (3) we determine that disclosing the information to such agencies, entities, and persons is necessary to assist in our efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm. SSA will use this routine use to respond only to those incidents involving an unintentional release of its records.
Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:
Records are maintained in automated format (e.g., on magnetic tapes, discs, computer storage,) and in paper form (e.g., punch cards, lists, forms, in file folders, binders and index cards).
Records are retrieved by name, SSN, case number or cross reference.
Access to, and use of, those records is limited to those persons whose official duties require such access. Personnel screening is employed to prevent unauthorized disclosure. Access http://www.socialsecurity.gov/foia/bluebook/app_g.htm for additional information relating to SSA data security measures.
Retention and disposal:
All accident reports, records, logs, and other information relating to an accident are retained by Headquarters and components for at least five years following the end of the calendar year in which the accident occurred. Specific occupational safety and health standards (such as the standards, covering the handling of carcinogenic chemicals) may be required to be kept for up to twenty years. Records may be retained indefinitely.
System manager(s) and address(es):
Safety Manager
Office of Facilities Management
Social Security Administration
Notification procedures:
An individual can determine if this system contains a record about him/her by writing to the system manager(s) at the above address and providing his/her name, SSN or other information that may be in the system of records that will identify him/her. An individual requesting notification of records in person should provide the same information, as well as provide an identity document, preferably with a photograph, such as a driver's license or some other means of identification. If an individual does not have any identification documents sufficient to establish his/her identity, the individual must certify in writing that he/she is the person claimed to be and that he/she understands that the knowing and willful request for, or acquisition of, a record pertaining to another individual under false pretenses is a criminal offense.
If notification is requested by telephone, an individual must verify his/her identity by providing identifying information that parallels information in the record to which notification is being requested. If it is determined that the identifying information provided by telephone is insufficient, the individual will be required to submit a request in writing or in person. If an individual is requesting information by telephone on behalf of another individual, the subject individual must be connected with SSA and the requesting individual in the same phone call. SSA will establish the subject individual's identity (his/her name, SSN, address, date of birth and place of birth, along with one other piece of information, such as mother's maiden name) and ask for his/her consent in providing information to the requesting individual.
If a request for notification is submitted by mail, an individual must include a notarized statement to SSA to verify his/her identity or must certify in the request that he/she is the person claimed to be and that he/she understands that the knowing and willful request for, or acquisition of, a record pertaining to another individual under false pretenses is a criminal offense. These procedures are in accordance with SSA Regulations (20 CFR 401.40(c)).
Record access procedures:
Same as Notification procedures. Requester should also reasonably identify the record, specify the record contents being sought, and state time and brief description of the accident in which they were involved. These procedures are in accordance with SSA Regulations (20 CFR 401.40(c)).
Contesting record procedures:
Same as Notification procedures. Requester should also reasonably identify the record, specify the information they are contesting and the corrective action sought, and the reasons for the correction, with supporting justification showing how the record is incomplete, untimely, inaccurate or irrelevant. These procedures are in accordance with SSA Regulations (20 CFR 401.65(a)).
Record source categories:
The information in this system is obtained from the following sources:
(1) The individual to whom the record pertains;
(2) witnesses to the accident;
(3) investigation officials (Federal, State, local);
(4) medical personnel seeing the individual as a result of the accident;
(5) supervisory personnel;
(6) reviewing officials;
(7) personnel offices;
(8) investigative material furnished by Federal, State, or local agencies; and
(9) on site observations.
Systems exempted from certain provisions of the Privacy Act:


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Seasonal Gardening: Seasonal Plants and New Garden Tools
We offer a collection of seasonal gardening accessories including new garden tools and seasonal plants. From elevated garden beds to raised beds, from self watering vertical planter and vertical pole planter, the choice is wide and varied. The secret to a well-maintained garden is the availability of the right supplies. Our collection of garden supplies like watering cans, twine, garden tools, garden supports, baskets, gloves and more can help you set up a beautiful garden at home. You can also use our interesting range of gardening gifts like beehive starter kit, cheese making kit, preserved lemon crate and more to introduce your loved ones to the joys of gardening and homemade treats.


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The best solvent for cleaning oil-based paint
Mineral spirits or paint thinner… which is better? For cleaning brushes, paint thinner is best since it's half the cost of mineral spirits and basically works the same. Other than the price, the differences between the two solvents are subtle:
- Both are petroleum products.
- Both can be used to thin oil-based paints and varnishes and to clean paintbrushes.
- Paint thinner is mineral spirits, but in a less refined form. It contains other types of solvents, which makes it a lot smellier and more volatile.
- Mineral spirits is not as stinky. Because it's more refined, it's slightly more effective in smaller quantities than paint thinner.
No matter which solvent you choose, use it in a well-ventilated space and observe proper safety precautions.


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Results 1 to 7 of 7
Thread: New to site
- Join Date
- Mar 2014
- Location
- Quad Cities,IL
- Posts
- 8
New to site
Hello guys and gals, I'm new to the site. Been shooting bow since I was about 13 been hunting for about 7 years now. Been thinking about getting into my first 3D tournaments but not quite sure what to expect. Any tips, tricks, or know how's to get me started in competition shooting would be greatly appreciated. Don't claim to be a bow guru, just know I can shoot.
- Join Date
- Mar 2014
- Location
- Hardin MO
- Posts
- 9
Not sure I have earned a place to say welcome as this is also my first post, but to attempt an answer at your question. What to expect? You can expect to meet a ton of great people who like to have a good time. There will be some who are pretty serious about the sport, but overall, just regular Joes out doing what they love, shooting bows.
Tips and Tricks. The best tip you can get is the age old practice, practice, practice. However, what you really will need to concentrate on is judging yardage. In the "old days" (15-20 years ago) if you could judge yardage within 3-4 yards you'd fair pretty well at a shoot. Now days, with ASA targets and such, if you are looking to climb the ranks you have to be pretty much spot on with your judgement.
- Join Date
- Mar 2014
- Location
- Quad Cities,IL
- Posts
- 8
In my book shear knowledge will give you the right to speak. I love to shoot also have a 12 year old who wants to shoot everyday. I usually take things pretty serious when it comes to competition but never a poor sport. My goal is to break into the sport of comp shooting and see how I do. I guess I'm one of those guys who like to think I'm pretty good at what I do and always strive to get better. Thanks for the input.
Are you going with people you know? Alone?
If you are going alone, it is usually pretty easy to join a small group and meet new people. It is more fun shooting with others (for me anyway).
Have fun! Don't be too serious about it!
- Join Date
- Mar 2014
- Location
- Quad Cities,IL
- Posts
- 8
Yeah I will be going alone. I want sure how serious people may be.
- Join Date
- Apr 2014
- Posts
- 38
The best thing to be perfect in bow shooting is practice. You should have good command on the equipment you choose, just stick with it and practice. Hire an expert trainer and start with small targets, not large ones, get used to hitting3 inch circles at 20 yards. You should know some small game blunt tips and go squirrel hunting and use bright veins on your arrows.
Firearms Safety Training MA
Last edited by GunnerJacky; 04-24-2014 at 05:58 AM.
- Join Date
- Jan 2014
- Posts
- 24
Total Archery Challenge
For great practice come out to one of our Events. Our next one is at Seven Springs, PA
The Prime Total Archery Challenge is coming to Seven Springs, Pennsylvania on May 16-18th and we want you there! The Total Archery Challenge has partnered with Prime bows by G5 to bring Seven Springs, Pennsylvania the worlds greatest out door 3D Shoot and Expo. We work hard to provide a fun, family friendly environment where everyone can enjoy the great sport of archery. Its like we always say Life Its Better with a Bow!
The Total Archery Challenge, or TAC, is the foremost leader in fun non-competitive outdoor 3D shoots and expos in the United States. We work hard to provide our participants with real world archery shots in a safe and family friendly environment. Participants can expect:
100+ 3D archery targets
3 different courses with targets from 10 yds to 100 yds
Pop-up System with moving 3D targets
Novelty Shots with the chance to win multiple prizes
Vendors with the latest outdoor products
Free Education for novice and beginners
An Amazing Venue
Fun for the whole family
Great food and Fun!
This is the one archery event you do not want to miss. All participants that pre-register will get a free t-shirt, and a free entry to win a Prime or Quest bow (The One is not included). Please feel free to contact us any time we look forward to seeing you soon.
Register today for a chance to win a new Bow @
The Total Archery Challenge Staff
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Knit this ladies crew neck cardigan, a design from the Rowan archive that is now available to purchase online. Designed by Kim Hargreaves using one of our best loved yarns Original Denim (cotton), this cropped cardi has a contrasting stripe sequence and features pretty embroidered flowers.
This design is available to purchase for £3 as a single pattern from our online pattern store.Click here to view
Or alternatively you can purchase the full collection of 18 designs for only £9.Click here to view


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Barcus Berry Cello Transducer w/ Preamp
Barcus Berry Cello Transducer w/ Preamp
More Images
Excellent reliability and easy installation makes this model ideal for virtually all sound reinforcement and studio applications. May be quickly and easily installed or removed from any standard-type bridge on all types of instrument setups. It has wideband frequency response, essentially unlimited dynamic range, and excellent string balance. In addition, it offers a high degree of feedback rejection and outstanding signal isolation. Includes clip-on transducer, Barcus Berry 3000 Piezo Buffer Preamp with EQ, one set of rubber feet, attachable belt clip, Velcro strap, metal strap-mounting bracket, and installation instructions.
Barcus Berry
Transducer w/ Preamp
This item is no longer available for purchase.


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Kenny Leon
News about Kenny Leon, including commentary and archival articles published in The New York Times.
Review: 'Hairspray Live!' Had Power Voices but Still Lacked Power
The latest live musical from NBC sabotaged itself with distracting side business....
December 8, 2016, Thursday
MORE ON KENNY LEON AND: Television , Hairspray Live! (TV Program) , National Broadcasting Co , Baillio, Maddie , Hudson, Jennifer , Leon, Kenny , Chenoweth, Kristin , Fierstein, Harvey , Sykes, Ephraim (1985- )
Review: A Campus Caldron Too Hot to Touch in 'Smart People'
Characters in Lydia R. Diamond's drama grapple with race, class, prejudice, identity and sexuality....
February 12, 2016, Friday
MORE ON KENNY LEON AND: Theater , Diamond, Lydia R , Ali, Mahershala (1974- ) , Thompson, Tessa , Jackson, Joshua (1978- ) , Son, Anne (1978- ) , Second Stage Theater , Stick Fly (Play) , Leon, Kenny , Smart People (Play)
'Children of a Lesser God' to Return to Broadway
The producer Hal Luftig plans to bring Mark Medoff's play back to Broadway for the 2015-16 season, with Kenny Leon to direct....
September 29, 2014, Monday
MORE ON KENNY LEON AND: Leon, Kenny , Deafness , Theater
Popcast: Can Hip-Hop Thrive on Broadway?
Jon Caramanica and Charles Isherwood discuss "Holler if Ya Hear Me," the musical based on the work of Tupac Shakur, and what its failure means for hip-hop on Broadway....
July 18, 2014, Friday
MORE ON KENNY LEON AND: Leon, Kenny , Shakur, Tupac , Williams, Saul , Theater , Music
'Holler if Ya Hear Me' to Close on Sunday
The Broadway musical, inspired by the music and lyrics of Tupac Shakur, failed to draw theatergoers after six weeks of performances....
July 14, 2014, Monday
MORE ON KENNY LEON AND: Healy, Patrick , Shakur, Tupac , Leon, Kenny , Miranda, Lin-Manuel , Palace Theater , New York Times , Theater , Rap and Hip-Hop , Music
To Be Young, Besieged and Black
The rapper Tupac Shakur inspired "Holler if Ya Hear Me," a new Broadway musical with a vision of black life in urban America....
June 20, 2014, Friday
MORE ON KENNY LEON AND: Pinkins, Tonya , Cilento, Wayne , Music , Theater , Holler If Ya Hear Me (Play) , Shakur, Tupac , Kreidler, Todd , Williams, Saul , Leon, Kenny , Rap and Hip-Hop
A Tupac for Everyone
"Holler if Ya Hear Me," a new musical that weaves songs and poetry from the rapper Tupac Shakur, is set to open on Broadway....
June 8, 2014, Sunday
MORE ON KENNY LEON AND: Theater , Holler If Ya Hear Me (Play) , Williams, Saul , Music , Rap and Hip-Hop , Leon, Kenny , Poetry and Poets , Shakur, Tupac
Saul Williams to Star in Tupac Shakur Musical 'Holler If Ya Hear Me'
Tonya Pinkins and Christopher Jackson will also be in the cast of the show....
April 7, 2014, Monday
MORE ON KENNY LEON AND: Jelks, John Earl , Shakur, Tupac , Williams, Saul , Kreidler, Todd , Leon, Kenny , Palace Theater , Theater
No Rest for the Weary
Starring Denzel Washington, "A Raisin in the Sun" at the Ethel Barrymore Theater is a disarmingly relaxed revival, brimming with empathy for its flawed characters....
April 4, 2014, Friday
MORE ON KENNY LEON AND: Hansberry, Lorraine , Washington, Denzel , Theater , Leon, Kenny , Barrymore, Ethel, Theater , A Raisin in the Sun (Play)
Tupac Shakur Musical Sets Broadway Opening Date
The show, which is inspired by the late rapper but is not a biographical treatment of his life, is scheduled to open on June 19....
January 8, 2014, Wednesday
MORE ON KENNY LEON AND: Kreidler, Todd , Shakur, Tupac , Leon, Kenny , Shakur, Afeni , Palace Theater , Theater
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