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News & Events
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments)
Statement of
Daniel E. Troy
Chief Counsel
U.S. Food and Drug Administration
the Senate Committee on the Judiciary
Mr. Chairman and Members of the Subcommittee, I am Daniel E. Troy, Chief Counsel for the United States Food and Drug Administration (FDA or the Agency). I am joined by Gary Buehler, R.Ph., Director, Office of Generic Drugs, Center for Drug Evaluation and Research.
I am pleased to be with you today to discuss FDA's implementation of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Amendments and recent Congressional action on amendments to Hatch-Waxman.
This testimony will discuss a number of issues that affect the timely introduction of generic drugs into the U.S. marketplace. It will focus in particular on whether certain "later-listed" patents or inappropriate patent submissions by the sponsors of innovator drug products have resulted in the delay of generic drug approvals. On June 18, 2003, FDA published its final rule intended to speed access to and increase the availability of generic drugs by limiting the use of 30-month stays by brand-name drug sponsors and by clarifying the types of patents that must and must not be submitted to FDA for listing in the Orange Book.
The Hatch-Waxman Amendments were intended to balance two important public policy goals. First, Congress wanted to ensure that brand-name (also known as innovator) drug manufacturers would have meaningful patent protection and a period of marketing exclusivity to enable them to recoup their investments in the development of valuable new drugs. Second, Congress sought to ensure that, once the statutory patent protection and marketing exclusivity for these new drugs has expired, consumers would benefit from the rapid availability of lower priced generic versions of innovator drugs.
Since its enactment in 1984, Hatch-Waxman has governed the generic drug approval process. In general, the law has been working well. Since 1984, over 10,000 generic drugs have entered the market, and generics now account for close to 50 percent of prescriptions filled. Attention has recently focused on two key provisions of the law that allow for 180 days of marketing exclusivity to certain generic drug applicants, and for the 30-month stay on generic approvals. Both of these provisions are discussed in detail below.
FDA's objective is to enhance the ability of innovators, generic firms and the Agency to achieve the goals embodied in Hatch-Waxman. While the new rule will improve FDA's implementation of the law, this is only one part of a set of FDA initiatives that will reduce drug costs by encouraging innovation and speeding up the drug development and approval process, while maintaining FDA's high standards for safety and effectiveness. Our reforms in the generic approval process will generally shave months off the time to availability of generic drugs across the board. Similarly, new pathways for approving inhaled and topical generic drugs will potentially affect many products. This broad improvement in the availability, of both new drugs and generic drugs, will have a positive impact on all patients, not just those affected by imperfections in the operation of Hatch-Waxman.
The Hatch-Waxman Amendments amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and created a statutory generic drug approval process with section 505(j). Section 505(j) established the abbreviated new drug application (ANDA) approval process, which permits generic versions of previously approved innovator drugs to be approved without submitting a full new drug application (NDA). An ANDA refers to the previously approved NDA (the "listed drug") and relies on the Agency's finding of safety and effectiveness for the listed drug product.
The timing of an ANDA approval depends in part on patent protections for the innovator drug. Innovator drug applicants must include, in an NDA, information about patents relating to the drug product that is the subject of the NDA. FDA is required to publish the patent information submitted once the drug is approved. The statute establishes a process that requires that ANDA applicants certify to the patents listed, provide notice to the NDA holder and patent owner, and, if patent infringement litigation is filed, it imposes a 30-month stay on the approval of an ANDA. The Hatch-Waxman Amendments also created a period of market exclusivity for certain generic applicants.
Only certain types of patent information can be submitted to FDA. FDA publishes patent information on approved drug products in the Agency's publication Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book." The Orange Book is available on FDA's website and is updated every few weeks. The book is also printed yearly by the Government Printing Office, updated monthly, and is available to the public. It lists all approved drug products with their therapeutic equivalence codes in addition to the products' patent and exclusivity information (if such information exists).
Concerns have been expressed over FDA's role in the listing of patents in the "Orange Book." Under the FD&C Act, pharmaceutical companies seeking to market innovator drugs must submit information on any patent that: 1) claims the pending or approved drug or a method of using the approved drug, and 2) for which a claim of patent infringement could reasonably be asserted against an unauthorized party. Patents that may be submitted are drug substance (active ingredient) patents, drug product (formulation and composition) patents, and method of use patents. Process (or manufacturing) patents may not be submitted to FDA. FDA's final rule published on June 18, 2003, clarified the types of patents that must be listed in the Orange Book.
When an NDA applicant submits a patent covering the formulation, composition, or method of using an approved drug, the applicant must also submit a signed declaration stating that the patent covers the formulation, composition, or use of the approved product. The current required text of the declaration is described in FDA's regulations. The final rule replaces the signed declaration with a declaration form that must be used for the submission of patent information.
The process of patent certification, notice to the NDA holder and patent owner, a 45-day waiting period, possible patent infringement litigation and the statutory 30-month stay may result in a considerable delay in the approval of ANDAs when an innovator company submits a new patent listing to FDA. Therefore, ANDA applicants often closely scrutinize these listings. FDA's regulations provide that, in the event of a dispute as to the accuracy or relevance of patent information submitted to and subsequently listed by FDA, an ANDA applicant must provide written notification of the grounds for dispute to the Agency. FDA will then ask the NDA holder to confirm the correctness of the patent information and listing. Unless the patent information is withdrawn or amended by the NDA holder, FDA does not change the patent information in the "Orange Book."
If a patent is listed in the "Orange Book," an applicant seeking approval for an ANDA must submit a certification to the patent. Even an applicant whose ANDA is pending when additional patents are submitted for listing by the sponsor must certify to the new patents, unless the additional patents are submitted by the patent holder more than 30-days after issuance by the U.S. Patent and Trademark Office. Until the final rule effective date, pending generic drug applications may be subject to multiple overlapping 30-month stays if new patents are listed for the innovator drug and those patents result in litigation.
FDA does not undertake an independent review of the patents submitted by the NDA sponsor. The statute requires FDA to publish patent information upon approval of the NDA. This strongly suggests – and FDA has long held – that the Agency's role in the patent-listing process is intended to be ministerial. Issues of patent claim and infringement are matters of patent law, and FDA lacks the authority, the resources, and the capability to assess whether a submitted patent claims an approved drug and whether a claim of patent infringement could reasonably be made against an unauthorized use of the patented drug. As such, FDA has implemented the statutory patent listing provisions by informing interested parties of what patent information is to be submitted, who must submit the information, and when and where to submit the information. Generic and innovator firms may resolve any disputes concerning patents in private litigation.
Over the past few years, new patents have occasionally been submitted to FDA for listing in the "Orange Book" shortly before patents already listed in the "Orange Book" were scheduled to expire. These new patents have been submitted to FDA within the required 30-days of issuance by the Patent and Trademark Office. If the NDA sponsor complies with the requirements of the statute and regulations in submitting a patent for listing in the "Orange Book," the Agency may not reject a patent merely on the basis that, but for the filing of the patent, ANDAs would be eligible for final approval.
It has been suggested that FDA should review drug patents to determine if they should be listed in the "Orange Book" as protection for innovator drug products -- that is, FDA should assess whether a submitted patent properly claims the approved drug product and could support a claim of patent infringement. The Agency believes that, even if it had the authority and expertise (which it does not), such a review would not speed the availability of generic drugs. Rather, it would instead add a layer of complexity and delay, leading to litigation between FDA and the generic or innovator, in addition to any litigation between the generic and innovator.
Moreover, FDA review of patents would be unlikely to speed approval and marketing of generic drugs in a meaningful way. Even if FDA were to decide not to list a patent, the innovator company could obtain an injunction against approval or marketing of the generic drug until the patent listing question is resolved. In such a case, FDA's review of the patents would have done nothing to speed approval of generic drugs. Patent reviews would lead to substantial litigation that will impose a new and substantial burden on FDA's Office of the Chief Counsel and Department of Justice litigation resources. Finally, the Agency does not have the resources or expertise to review patents.
Patent listings are important in the generic drug approval process because challenges to listed patents can lead to stays in approval. The FD&C Act requires that generic drug applicants include, in their ANDAs, a certification for each patent listed in the "Orange Book" for the innovator drug. Similar information is required for applicants filing 505(b)(2) applications under section 505(b)(2) of the FD&C Act. This certification must state one of the following:
(I) that the required patent information relating to such patent has not been filed;
(II) that such patent has expired;
(III) that the patent will expire on a particular date; or
(IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought.
A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.
A paragraph IV certification, however, begins a process in which the question of whether the listed patent is valid or will be infringed by the proposed generic product may be answered by the courts before the expiration of the patent. Under the current regulations, the ANDA applicant who files a paragraph IV certification to a listed patent must notify the patent owner and the NDA holder for the listed drug that it has filed an ANDA containing a patent challenge. Until the effective date of FDA's final rule, all patents submitted and listed in the Orange Book that are the subject of a paragraph IV certification require notice to the NDA holder and patent owner. The notice must include a detailed statement of the factual and legal basis for the ANDA applicant's opinion that the patent is not valid or will not be infringed.
The submission of an ANDA for a drug product claimed in a patent is an infringing act if the generic product is intended to be marketed before expiration of the patent. Accordingly, the ANDA applicant who submits an application containing a paragraph IV certification may be sued for patent infringement. If the NDA holder or patent owner files a patent infringement suit against the ANDA applicant within 45 days of the receipt of notice, FDA may not give final approval to the ANDA for at least 30 months from the date of that notice.
This 30-month stay will delay approval of the generic drug product unless the court reaches a decision earlier in the patent infringement case or otherwise orders a longer or shorter period for the stay. A court may modify the length of a stay, under the FD&C Act, "if either party in the action failed to reasonably cooperate in expediting the action." (21 U.S.C. 335(j)(5)(iii))
Under FDA's traditional interpretation of the Hatch-Waxman Amendments, multiple 30-month stays have been possible. Submission of newly issued patents after an ANDA application has been filed with FDA has required the appropriate certification and notice to the NDA holder and patent owner with the possibility of a 30-month stay if patent infringement litigation resulted. As a result, there have been a number of instances where there has been more than a single 30-month stay. These include paroxetine hydrochloride (Paxil) and gabapentin (Neurontin).
A recent review of FDA's records indicates that of the 442 active ANDAs that contained paragraph IV certifications, only 17 have had multiple 30-month stays, representing 3.8 percent of all applications with patent challenges. However, we note that a significant number of these products have high dollar value annual sales, and we are aware of some instances where multiple stays have resulted in the delay of a generic drug approval for a number of years.
The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the "first" generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit. The statute provides that the first applicant to file a substantially complete ANDA containing a paragraph IV certification to a listed patent will be eligible for a 180-day period of exclusivity beginning either from the date it begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable or not infringed, whichever is first. These two events -- first commercial marketing and a court decision favorable to the generic -- are often called "triggering" events, because under the statute they can trigger the beginning of the 180-day exclusivity period.
In some circumstances, an applicant who obtains 180-day exclusivity may be the sole marketer of a generic competitor to the innovator product for 180 days. But 180-day exclusivity can begin to run -- with a court decision -- even before an applicant has received approval for its ANDA. In that case, some, or all of the 180-day period, could expire without the ANDA applicant marketing its generic drug. Conversely, if there is no court decision and the first applicant does not begin commercial marketing of the generic drug, there may be prolonged or indefinite delays in the beginning of the first applicant's 180-day exclusivity period. Approval of an ANDA has no effect on exclusivity, except if the sponsor begins to market the approved generic drug. Until an eligible ANDA applicant's 180-day exclusivity period has expired, FDA cannot approve subsequently submitted ANDAs for the same drug. This is true even if the later ANDAs are otherwise ready for approval and the sponsors are willing to begin marketing immediately. Therefore, an ANDA applicant who is eligible for exclusivity can often delay all generic competition for the innovator product.
Only an ANDA containing a paragraph IV certification may be eligible for exclusivity. If an applicant changes from a paragraph IV certification to a paragraph III certification, for example, upon losing its patent infringement litigation, the ANDA will no longer be eligible for exclusivity. The 180-day exclusivity provision has been the subject of considerable litigation and administrative review in recent years, as the courts, industry, and FDA have sought to interpret it in a way that is consistent both with the statutory text and with the legislative goals underlying the Hatch-Waxman Amendments. A series of Federal court decisions beginning with the 1998 Mova1 case describe acceptable interpretations of the 180-day exclusivity provision, identify potential problems in implementing the statute, and establish certain principles to be used by the Agency in interpreting the statute. As described in a June 1998 guidance for industry, FDA currently is addressing on a case-by-case basis those 180-day exclusivity issues not addressed by existing regulations.
One of the most fundamental changes to the 180-day exclusivity program, resulting from the legal challenges to FDA's regulations, is the determination by the courts of the meaning of the phrase "court decision." The courts have determined that the "court decision" that can begin the running of the 180-day exclusivity period may be the decision of the district court, if it finds that the patent at issue is invalid, unenforceable, or will not be infringed by the generic drug product. FDA had previously interpreted the "court decision" that could begin the running of 180-day exclusivity (and the approval of the ANDA) as the final decision of a court from which no appeal can be or has been taken - generally a decision of the Federal Circuit. FDA's interpretation had meant that an ANDA applicant could wait until the appeals court had finally resolved the patent infringement or validity question before beginning the marketing of the generic drug.
FDA had taken this position so that the generic manufacturer would not have to run the risk of being subject to potential treble damages for marketing the drug, if the appeals court ruled in favor of the patent holder. The current interpretation means that if the 180-day exclusivity is triggered by a decision favorable to the ANDA applicant in the district court, the ANDA sponsor who begins to market during that exclusivity period now may run the risk of treble damages if the district court decision is reversed on appeal to the Federal Circuit. As a practical matter, it means that many generic applicants may choose not to market the generic and thus the 180-day exclusivity period could run during the pendency of an appeal.
In response to reports of brand-name and generic drug companies engaging in anti-competitive behavior, the FTC conducted a study to determine if the 180-day exclusivity and the 30-month stay provisions of the Hatch-Waxman Amendments have been used strategically to delay consumer access to generic drugs. In July 2002, FTC published the findings of their study and provided two primary recommendations.
FTC recommended that only one automatic 30-month stay per drug product per ANDA be permitted to resolve infringement disputes over patents listed in the "Orange Book" prior to the filing date of the generic applicant's ANDA. FDA agrees with FTC's conclusion that, recently, more ANDAs have been subject to 30-month stays, there have been more multiple 30-month stays than in years past, and more patents on average are now being litigated per generic drug application than in the past.
FTC's second recommendation was to pass legislation to require brand-name companies and first generic applicants to provide copies of certain agreements to FTC. This is a response to FTC's finding that brand-name companies and first generic applicants have on occasion entered into agreements to delay generic competition. FDA has no objection to this recommendation.
FDA agrees with many of the conclusions of the FTC study and has found the factual information provided in the report to be extremely valuable in our own deliberations regarding the generic drug approval process. One example of this is the compilation of information on the disposition of litigation surrounding patents filed after NDA approval. Finally, we note that FTC's report recognized that FDA does not have the capacity to review the appropriateness of patent listings.
On June 12, 2003, President Bush, HHS Secretary Thompson and FDA Commissioner
McClellan announced a new regulation to be effective on August 18, 2003, that will streamline the process for making safe, effective generic drugs available to consumers. This rule was first proposed on October 24, 2002, in response, in part, to the FTC recommendations and other changes the Agency identified as being useful in improving generic competition. The new rule will limit an innovator drug company to only one 30-month stay of a generic drug applicant's entry into the market for resolution of a patent challenge. The changes in the regulations will save consumers an estimated $35 billion over ten years by making generic alternatives to certain more costly brand-name drugs available more quickly, by avoiding time-consuming legal delays. The new regulations were published as a final rule in the Federal Register on June 18, 2003.
The rule provides a full opportunity for only one 30-month stay per ANDA or 505(b)(2) application; prohibits the submission of patents claiming packaging, intermediates, or metabolites; requires the submission of certain patents claiming a different polymorphic form of the active ingredient described in the NDA; adds a requirement that, for submission of polymorph patents, the NDA holder must have test data demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the NDA; makes changes to the patent information required to be submitted and provides declaration forms for submitting that information to FDA, both with the NDA and after NDA approval; and does not require claim-by-claim listing on the declaration form except for method-of-use patents claiming approved methods of use.
30-Month Stay Provisions
The final rule limits brand-name companies to only one 30-month stay. The rule accomplishes this by establishing when generic companies must provide notice of a paragraph IV patent challenge to a brand-name sponsor and the patent owner (which initiates the process that may result in a 30-month stay). Notice of a paragraph IV certification must be provided with an initial paragraph IV certification, and when a previous certification and notice did not result in a full opportunity for a single 30-month stay.
If an ANDA or 505(b)(2) application is amended to include a paragraph IV certification, notice must be provided to the NDA holder and patent owner only if the application did not already contain a paragraph IV certification or there was not a full opportunity for a 30-month stay. If an ANDA or 505(b)(2) applicant changes its paragraph IV certification before the 45-day period after notice to the NDA holder and patent owner has expired, and the NDA holder or patent owner has not initiated patent litigation, such paragraph IV certification and related notice are not considered to have satisfied the requirement of providing one notice of a paragraph IV certification and a full opportunity for a 30-month stay.
Generic drug applicants will still have to file paragraph IV certifications to FDA, and the ability of brand-name firms to obtain patents and to defend patent rights in court is undiminished. They will not, however, be able to forestall approval of a generic version of a drug by submitting later-issued patents. These later submissions will no longer result in multiple 30-month stays.
Requirements for Drug Patent Submissions
Under the final rule, drug manufacturers will not be allowed to submit patent information for listing in the Orange Book for drug packaging, drug metabolites, and intermediate forms of a drug. Permitted submissions include patent information on drug product (active ingredients), drug substance (formulation/composition), and approved uses of a drug.
In addition, patent submission declarations will be more detailed. There are mandatory forms that must be used to submit patent information to FDA. The forms include a series of questions with check-off boxes to be completed that provide details on the type of patent information submitted. The questions request information on whether the patent is one of the type permitted under the regulations, whether the patent is a product-by-process patent and the product claimed is novel, whether the method of use is an approved method of use and the relevant indication included in the approved labeling, and other relevant information.
The declarations must be filed with the NDA, amendment, or supplement, and for patent information submitted after NDA approval. The check-off questions are designed so that FDA does not have to do anything more than quickly review the form to determine whether the patent information is eligible for listing. A signed attestation is required on the declaration form that requires that the submitter attest to the familiarity with the regulations and the information submitted. A warning is included that a willfully and knowingly false statement in the attestation can lead to criminal charges. These changes will significantly reduce opportunities to submit inappropriate patents for listing in order to delay approval of generic drugs and prevent fair competition.
Concurrent with FDA's June 12, 2003, announcement on publication of its final rule, President Bush announced an initiative on Improving Access to Generic Drugs, which includes the following components:
- A proposed increase of $13 million in fiscal year 2004 in FDA resources devoted to improving access to generic drugs.
The proposed addition in the President's fiscal year 2004 budget of an additional $13 million in spending for FDA's generic drug programs would be the largest annual infusion of resources into the generic drug program ever, increasing the program's size by about one-third. FDA would be able to hire about 40 additional staff in generic drugs and expand the new chemistry review division in the Office of Generic Drugs. This expansion should help reduce the average review time by at least two months, increase the percentage of reviews that are completed within 180 days, approach the goal of reviewing 100 percent within 180 days and further reduce the time it takes FDA to review.
- New processes to reduce the time and cost of generic drug approvals.
Beginning in the next fiscal year, FDA will make significant changes in its processes for approving generic drugs. In particular, FDA will implement early communications with generic drug manufacturers to discuss their applications. FDA will increase the number of guidances available for generic manufacturers regarding what is required to prepare and submit quality, complete applications. FDA will also institute regular meetings with generic trade associations to discuss the process for improving the quality of applications and to impart information on changes in policies and procedures. Studies of FDA processes for new drugs indicate that early communications and more explicit guidances can often improve drug applications and allow deficiencies to be corrected while an application is under review, rather than having to wait for additional review cycles to fix problems. This can significantly reduce the time it takes to approve a drug.
- Enhanced public education and scientific study of generic drugs.
FDA will expand its educational programs and partnerships involving generic drugs to help health care practitioners and consumers get accurate information about the availability of generic drugs for health care needs. FDA will also undertake additional scientific studies of certain types of generic drugs where adequate bioavailability methods have not been adequately developed, to make it easier to approve these generic drugs. FDA will also enhance the monitoring of the safety of generic drugs currently on the market.
These steps to improve access to generic drugs are expected to reduce the average time for most generic drug approvals by three months or more. Because this approach to increase availability will apply to all generic drugs, it can have a substantial impact on health care costs. In particular, faster access and a lower-cost approval process for the hundreds of generic drugs expected to come on the market would be expected to save consumers many billions. Improved consumer education and generic drug science is also intended to lead to additional savings from greater confidence and use of generic drugs.
Although patent-related challenges have delayed approval of generic drugs in a number of high-profile cases, there are a number of other important barriers to generic competition. These barriers, which usually result from insufficient scientific knowledge and standards, are likely to become even more significant as scientific advances in drug development lead to new forms of therapy.
Currently, some classes of drug products entirely lack generic versions because scientific methods for evaluating their bioequivalence are not available. Examples include the nasal and inhaled corticosteroids used for allergy and asthma treatment. Prospective manufacturers of inhaled or topical generic drugs face uncertainty and high development costs, and thus few such products have been developed. Other widely used drugs, such as conjugated estrogens (available since the 1940s), lack generic competition due to scientific uncertainty about the composition of the active ingredient (s). Disputes over composition and bioequivalence standards also have caused delays in approval of many generic drugs while innovator challenges to the standards are evaluated. Scientific research to support the development of additional standards in these areas would enable FDA to approve drugs in additional classes, and also to address scientific challenges to pending generic drug approvals more expeditiously.
Innovations in drug therapy are leading to new methods of drug delivery, including via liposomes, implantable systems, transcutaneous or transmucosal products, and inhalation methods. At the same time, due to innovations in chemistry, drugs with very complex molecular structures are possible. If generic copies of such innovative therapies are eventually to be made available, standards must be developed to accommodate these products within the Hatch-Waxman framework. This includes work on issues of composition, formulation and bioequivalence. Scientific research in each of these areas is needed to support new standards.
A significant portion of the FY 2004 budget increase for the generic drug program noted above will allow for additional bioequivalence research on inhalers, topical generics, and other dosage forms, so that in the future, new classes of generics can be made possible. This is a long-term research activity that will take time and a lot of effort, but FDA is dedicated to opening up these new product areas.
Both the Senate and the House have added generic drug access provisions to their versions of the Medicare bill, which have passed both chambers and are currently in conference. We are pleased that both versions of this legislation include key ideas embodied in FDA's regulation to improve access to generic drugs, and do not include certain other problematic provisions contained in legislation (S. 812) that passed the Senate last year.
Summary of the Generic Drug Amendment to the Senate Medicare Bill (S. 1)
The Senate bill amends the existing statutory 30-month stay in the following ways:
- requires the ANDA2 applicant to provide notice to the patent owner and NDA holder within 20 days after the applicant is notified that FDA has filed its ANDA when the applicant has submitted a certification that can trigger a lawsuit and resulting 30-month stay;
- limits the patents eligible for the 30-month stay to those submitted to the Agency prior to submission of the ANDA, disallowing later-submitted patents from triggering additional 30-month stays;
- permits approval of an ANDA if, before any 30-month stay expires, a district court finds the patent invalid or not infringed, or if a district court judgment finding the patent infringed is overturned on appeal, upon judgment of the court of appeals.
The Senate bill also allows an ANDA applicant to file a declaratory judgment action against a patent owner or the NDA holder if no patent infringement suit is brought within 45 days after the applicant provides notice of the certification challenging the patent. The provision seeks to make the failure to file such a suit an actual controversy under the declaratory judgment statute. If a suit is filed, the applicant may assert a counterclaim for an order to require deletion of patent information that the NDA holder should not have submitted for listing in the Orange Book.
The Senate bill amends the existing statutory 180-day exclusivity provision as follows:
- applies exclusivity on a product basis, rather than patent-by-patent basis;
- allows all ANDA applicants that challenge patents on the first day that ANDAs challenging patents are submitted for a particular listed drug to qualify for exclusivity;
- triggers 180-day exclusivity only with commercial marketing;
- provides for forfeiture of an applicant's eligibility for exclusivity if it does not market the drug within a particular period of time or after courts resolve the status of the challenged patents, if the applicant withdraws its ANDA, if the patent challenges are withdrawn, if the applicant fails to obtain tentative approval within 30 months, if the applicant enters into an anticompetitive agreement, or if all qualifying patents expire.
The bill defines bioavailabilty and bioequivalence for non-systemic drugs (those not absorbed into the bloodstream).
Lastly, the Senate bill states that a court may refuse to award treble damages in a patent litigation action if the NDA holder fails to submit a patent to FDA for listing in the Orange Book that claims a drug or a method of using a drug.
Differences between Senate and House Generic Drug Legislation
The House version of the generic drug legislation is very similar to the Senate version described above. The bills differ in the following areas:
- Approval of a different listed drug - The House bill prohibits ANDA applicants from amending or supplementing an application to seek approval of a generic drug referencing a listed drug different from the listed drug identified in the original application. That prohibition does not apply to different strengths. The Senate bill lacks this language.
- Civil action for patent certainty - The Senate bill allows the ANDA applicant to bring a civil action for a declaratory judgment that the patent is invalid or will not be infringed if the patent owner or NDA holder does not bring suit within 45 days after notice is received. The House bill is slightly different.
- Access to confidential ANDA information - The House bill allows a declaratory judgment action to be brought if the 45 days expires and the notice was accompanied by a document providing a right of confidential access to the ANDA applicant's application for the purposes of determining whether a lawsuit should be brought. The provision sets forth the contents of the document, including restrictions on access to the application and the uses of information obtained through the process. The Senate bill does not contain the confidential access provision.
- Failure to bring patent infringement action - The Senate bill makes the failure to bring a patent infringement action within 45 days of notice an actual case or controversy sufficient to confer subject matter jurisdiction on the Federal courts. The House bill does not contain this provision.
- Treble damages - The Senate bill provides that in determining remedies for infringement of a patent that claims a drug or a method of using a drug, the court shall consider whether information on the patent was required to be submitted under section 505(b), and if such information was required to be submitted but was not, the court may refuse to award treble damages. The House bill lacks this provision.
- Filing of certain agreements with FTC - Both bills contain requirements that certain agreements between generic drug manufacturers and innovators regarding the marketing of a generic drug be filed with the FTC. The House bill requires that certain agreements between generic manufacturers also be filed with FTC, while the Senate bill does not.
Relationship Between the Legislation and the Final Rule
The legislation, included as part of the Medicare bills in the House and Senate, does not address all of the provisions in the final rule. If such legislation were to pass, based on our review, we believe that only the 30-month stay provision of the final rule would be impacted.
Greater access to generic drugs will reduce health care costs because the price of generic drugs is typically much lower than the brand-name drug. Reducing expensive lawsuits over drug patents and making the approval process more efficient will also help to lower national health care costs by reducing the cost of bringing safe and effective generic drugs to market. Thanks to the President's leadership, we are making real progress to build on his initiatives on speeding access to generic drugs by finalizing a generic drug rule that will save consumers $35 billion over 10 years by increasing access and availability to generic drugs.
FDA continues to implement the Hatch-Waxman Amendments exclusivity provisions in the best manner possible given the text and history of the legislation, and the numerous court challenges. In doing so, FDA has tried to maintain a balance between innovation in new drug development and expediting the approval of lower-cost generic drugs, as Congress sought to do in enacting this statute. We are confident that the President's initiative and the Agency's regulatory changes will go far towards achieving these goals, and improving health care outcomes as a result.
Thank you for the opportunity to discuss these important issues with you, and I will be happy to answer any questions you may have.
1Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060, 1065 (D.C. Cir. 1998).
2Also applies to applicants who submit applications under Section 505(b)(2).


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AMD has launched the FirePro S7000, a single-slot server graphics card for compute, virtual desktop infrastructure (VDI) and workstation graphics deployments in data centers.
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subset: commoncrawl


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This map shows the location of point sources of nutrient pollution and priority agricultural watersheds as identified by the Chesapeake Bay Program with input from the Natural Resources Conservation Service (NRCS). Point sources include both monitored and estimated data submitted from or approved by each jurisdiction. Priority agricultural watersheds include SPARROW catchments ranking in the top quartile for delivered loads of nitrogen or phosphorus from agricultural sources normalized by the total amount of agricultural areas within the catchment. The priority areas were further refined to emphasize high loading areas which also contained potential agriculture-related water quality impairments based on individual state 303d (impaired waters) lists.
Author: John Wolf
Date created: Mar 09 2009 / Download ( 1.4 MB )


text: With its emphasis on promoting good health, Tai Chi is one of the fastest growing martial arts styles. It is now common to see groups of people performing these exercises in city parks across the United States and Europe. An interest in the use of swords in Tai Chi is the most remarkable trend to develop out of the form's growing popularity. As with other Tai Chi Chuan exercise programs, the use of the sword is a form of meditation in motion based on an inner energy known as chi. In Classical T'ai Chi Sword, a martial arts master teaches the 50 basic positions of the Tai Chi sword. Easy-to-use diagrams, charts, and over 100 black and white photographs illustrate each position and the thirteen basic sword techniques. Practice exercises for both solo and partner forms teach inner harmony and self-defense.


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Giuseppi Fortunino Francesco Verdi (October 9 or 10, 1813 - January 27, 1901) was born in Italy in 1813. Verdi is considered one of the most influential composers of 19th century Italian opera. The Triumphal March is from his grand opera "Aida".
Triumphal March from "Aida" by Giuseppi Verdi for Easy Flute Solo with Piano Accompaniment
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text: The top General in Afghanistan who was scheduled to have confirmation hearings this week to be promoted, instead will probably lose his job and be forced to resign as it turns out he was sending as many as 30-40 e-mails daily back and forth to Jill Kelley. She is the other woman in the Petraeus affair and who Paula Broadwell saw as competition for the General's peen. It turns out that Jill already had another General even though they are both married. The FBI uncovered about 30,000 pages of communications between General John Allen and Jill Kelley. Those communications were during a two year period. So, 15,000 a year which is a little over 1,000 a month which is about 30 pages a day and that is being conservative. The FBI described the e-mails as intimate.


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Let's be honest.
Were it not for the heroics of Carey Price, your Montreal Canadiens would not be in the playoffs.
But as we say in this red-hot – and, this week, unseasonably cold – hockey city, what have you done for me lately?
Heading into Game 1 in Tampa Bay, the Canadiens goaltender was 4-14 in his previous 18 postseason starts.
Price's overall playoff record was 9-17. His save percentage: a very ordinary .905.
But .905 is better than .750.
Through 60 minutes against the Lightning, Price was beaten four times on 16 shots.
There were turnovers to create some Tampa Bay chances.
And Steven Stamkos scores against many NHL goaltenders.
But still …
The ghosts of playoffs past are never far from fans' memories in Montreal.
Through three periods, Carey Price in 2014 was not Jaroslav Halak in 2010. That role was played by Anders Lindback, as the Tampa Bay goaltender faced a barrage of 35 shots.
And when the Canadiens blew two third-period leads, fans had to asking some questions about their goaltender.
Price answered them in OT. He made nine saves, including a game-saver on Alex Killorn, the kid who stayed at Harvard after Louis Leblanc, his friend from from Montreal's West Island suburbs, left school to go off and ruin his career.
Killorn and Stamkos were the best players in blue jerseys on a night dominated by the guys in white.
In his postgame press conference, Michel Therrien cited "contributions from everyone", and the stat sheet bears out the coach's analysis:
• No fewer than 11 Canadiens skaters made the scoresheet.
• The Thomas Vanek-David Desharnais-MaxPacioretty combined for 17 shots on goal. Vanek had seven, plus two that were blocked. Desharnais, shooting more often than is his wont, had six.
• Josh Gorges played 28 minutes and, uncharacteristically, didn't block a shot. But his defensive alertness prevented a least two Lightning goals.
• Daniel Brière picked up an assist to run his playoff point total to 110 in 109 games. Brière added playmaking punch to a fourth line that spent long stretches in the Tampa Bay end, thanks to the speed and on-the-puck tenacity of Michäel Bournival (playing the first postseason game of what I hope will be a long Canadiens career) and Dale Weise, the trade acquisition whose OT goal had Marc Bergevin hugging everyone in the Canadiens suite at the St. Pete Forum.
• Lars Eller, back from a bout with the flu, had a goal and an assist, as did his linemate, Brian Gionta. Eller added four hits to match the line's LW, Rene Bourque.
• Tomas Plekanec scored the first-period goal that deflated the home crowd 19 seconds after Nikita Kucherov opened the scoring. Pleks won 16 of 29 faceoffs and played 2:04 of the four minutes the Canadiens were shorthanded.
Heading into Game 2 on Friday, Therrien enjoys the luxury of deploying three lines that excelled in Game 1 – and one that was OK. Playing with Pleks and the customarily energetic Brendan Gallagher, Brandon Prust struggled a bit in his first game since March 18. He'll be better as the series progresses.
If Tampa bay isn't better on Friday, the series could end quickly. One need look no further than last spring's Montreal-Ottawa series for evidence that losing the first game on home ice is not an ideal start.
With the exception of Victor Hedman and Radko Gudas, who had nine hits, Tampa Bay's D struggled against the Canadiens' speed and peristence. Mattthew Carle had three giveaways, Sami Salo two. Eric Brewer had difficulty with the Canadiens' speed and was beaten badly by Brière on Weise's winner..
Not that the Canadiens shone on the back end. Mike Weaver had a rough night, as did Alexei Emelin. P.K. Subban looked shakey early on but improved as the game progressed; he still hangs on to the puck too long. Andrei Markov played 33:41, high on both teams, but had no SoG and was minus-2.
I thought this game was won by the forwards, who worked hard to keep the puck in the Lightning zone for long stretches and fired 44 shots at Lindback.
Most of the offensive pressure, however, came at even strength. The Canadiens' power play continues to fire blanks: No goals since March 25 – nine games and counting.
But the PP's ineptitude was a minor blemish on a solid effort.
"We kept our composure," Therrien said. "We stuck to the game plan, and we were rewarded at the end."
If the Canadiens play this well in Game 2 – and if Price is as sharp as he was in OT – the Lightning could be travelling north in a big hole.
• 2,200-plus Comments on the game blog. I guess it's the playoffs, eh?
• The victory dance:


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In the News
Original journalism from the Center's OpenSecrets Blog
Leftover Loot: More Leave Congress With Lots of Campaign Cash
September 5, 2013 | Members of Congress spend much of their time chasing campaign cash and struggling to boost their war chests to fight off the next rival. And for a variety of reasons, an increasing number find themselves with flush bank accounts when their congressional careers are over, keeping them high on their former colleagues' call lists.
Money and Votes Aligned in Congress's Last Debate Over Bank Regulation
September 23, 2008 | The last time Congress seriously debated how to regulate the financial industry, the result was legislation that allowed the nation's largest banks to get even larger and take risks that had been prohibited since the Great Depression. A look back at that debate, which was over the 1999 Financial Services Modernization Act, reveals that campaign contributions may have influenced the votes of politicians who, a decade later, are now grappling with the implosion of the giant banks they helped to foster.
Update: Fannie Mae and Freddie Mac Invest in Lawmakers
September 11, 2008 | When the federal government announced two months ago that it would be seizing mortgage buyers Fannie Mae and Freddie Mac, CRP looked at how much money members of Congress had collected since 1989 from the companies. On Sunday the government proceeded with the takeover and we've returned to our data to bring you the updates, this time providing a list of all 354 lawmakers who have gotten money from Fannie Mae and Freddie Mac (in July we posted the top 25).
Feel free to distribute or cite this material, but please credit the Center for Responsive Politics. For permission to reprint for commercial uses, such as textbooks, contact the Center.


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Bookmark this site
SAN DIEGO, CA -- Fresh Healthy Vending is adding hot beverages to its vending machine menu. The company, which markets healthy vending franchises, is now offering a combination machine that vends gourmet hot beverages, along with "healthy" snacks and cold drinks.
Dubbed Fresh Healthy Vending Café, the new vender offers a selection of coffeehouse-quality drinks like organic coffee, cappuccino, espresso and chai vanilla tea for $1.25 to $2 a cup. Once a customer makes a selection, the machine grinds whole beans, brews espresso, froths the milk and disposes of the grounds, all within 40 seconds.
The San Diego-based franchisor said it sees a wide-open market for its new machine, which benefits from its compact 3x3-ft. footprint. The company envisions placement in colleges, B&I accounts and public venues, among other sites.
"The exclusive Fresh Healthy Vending Café machines are the first of what Fresh Healthy Vending expects to be a wave of new vending machines from the company over the coming years," said Dan Negroni, chief executive and president of Fresh Healthy Vending.
Founded in 2010, Fresh Healthy Vending reports that its flagship machine, a dual-temperature snack and drink combination, has been placed in more than 1,500 locations nationwide. It's stocked with better-for-you foods, including yogurt, fresh fruits and vegetables, smoothies and baked chips, and equipped with a telemeter.


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As an architect, the bigger you build, the more you have to worry about the moral and ethical consequences of your work. It is one thing to make a house for a single person, or even a small office building, and perhaps tear down a nice old structure or destroy a garden to do so. It is another to use up vast amount of resources in making large buildings, both because of the effect of that expenditure on our environment and its future, and because the kinds of clients who can command such resources have power. Evil dictators and rapacious corporations make the best clients. But at a cost.
Not only that, but, as the process of constructing new monuments in the Arab Peninsula makes clear, the very act of building can kill. As recently reported by The Guardian, hundreds of migrants workers have died in Qatar the last two years as result of the construction boom surrounding the 2022 FIFA World Cup. At the center of the controversy is Zaha Hadid, Hon. FAIA, who designed the Al-Wakrah stadium. Wouter Vanstiphout, a Dutch critic, tweeted: "Qatar Stadium, the Burma Railroad of Parametricism." Likewise, horrible living and working conditions on the sites of the cultural projects designed by Frank Gehry, FAIA, and Jean Nouvel, FAIA, in Abu Dhabi, have made it clear that this is not an isolated case.
Hadid has defended herself by pointing out that she, as an architect, has no control over the construction site. That is very true—and in fact, this case might make architects think twice about their continual clamor for more power over how their designs are realized. I might have wished that Hadid had shown a little bit more compassion and concern than her short statement evidences, but we cannot blame her directly for the deaths.
What the issue does bring up is the bigger question of for whom architects should work. Hadid has designed schools for troubled youth, cancer centers, and urban projects that bring a human scale to vast developments—yet she has also found herself working for developers who have fewer concerns for site or humanity. Hadid has worked for dictators in Azerbaijanweaetxdyvaydzcwq and Libya. Let's not single out Hadid, though; her firm is no different from every architecture office above a certain size. We only notice the issue, it seems, either when the designs catch our attention, or, as when Rem Koolhaas worked for China's state-controlled television network, CCTV, the project is particularly overt in its ideological nature.
Even separate from the nature of the client or the site, however, every large project brings its own dangers. One question I would love to see answered is whether more experimental or structurally daring work increases the risks. I know of no evidence of this, and so, for now, we cannot and should not blame parametricism for the deaths in Qatar. In this case, however, there is a particular sub-category of the ethical dilemma architects face: Should they work on projects they know or suspect might not be constructed in a way that ensures the health, well-being, and safety of those building it as the highest priority?
The Solomon R. Guggenheim Museum issued a response to criticism of alleged human rights abuses and worker exploitation at its Abu Dhabi satellite, stating that the museum is working with the client to ameliorate those conditions. Is that enough? Or should architects wash their hands of such conditions and watch what might be vastly inferior structures go up? The logical answer would be to engage in what old social Democrats used to call "constructive engagement"—that is, trying to change the politics of the place by working through the existing structures.
I do think it is clear that architects should avoid working on some structures in which their very architectural skills will be used for oppression and violence. For that reason I support the petition created by Architects/Designers/Planners for Social Responsibility calling on architects to refuse to design maximum-security prisons. Beyond that, the scene is murkier. One can only hope that architects such as Hadid will do the right thing even at the risk of the smooth execution of their visions.
Aaron Betsky is a regularly featured columnist whose stories appear on this website each week. His views and conclusions are not necessarily those of ARCHITECT magazine nor of the American Institute of Architects.


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Chefs' Secrets: Mr. & Ms. G's Cabbage
Ham hocks give the dish a deep, smoky flavor.
Updated 12:00 am, Wednesday, September 7, 2011
Dear Pat: Since Mr. & Ms. G's Home Cooking shared its banana pudding recipe, I was wondering if it would share its cabbage recipe. Its version is delicious! Thanks.
O. Carrigo
Dear O. Carrigo: At Mr. & Ms. G's Home Cooking, "it's just real plain country cooking," says Ms. G. (Addie Garner), "real simple." No one's complaining about that, especially when the results are so satisfying. Ms. G is the dessert expert, but Mr. G. is in charge of the savory side, and he's happy to share his easy, down-home method for preparing cabbage. It involves some long, slow cooking, but requires very little attention.
Garner cooks his cabbage with smoked ham hocks in true Southern soul-food style, although he allows you could substitute a smoked turkey leg. Ham hock, for the uninitiated, is the lower portion of a hog's hind leg. You'll likely find them cut into about 3-inch lengths. Most have been cured, smoked, or both, although you can sometimes find them fresh. The ham hocks are slowly simmered, so the meat becomes fork-tender, meanwhile flavoring the cooking water with their good smoky juices, essentially creating a ham broth.
When the cabbage is added and cooked in that same flavorful broth, it takes on that smoky goodness. Other hearty greens such as collard or mustard greens can be cooked in the same manner. The only other ingredient Mr. G uses is salt, added to taste, but be sure to serve this with a bottle of hot pepper sauce at the ready. A plate of corn bread wouldn't hurt either. Real simple — just like Ms. G. says.
Mr. & Ms. G's Home Cooking is at 2222 S. W. W. White Road between Rigsby and Southcross.
Food & Drink Channel
Pat Mozersky is a freelance writer for the Express-News. Contact her at firstname.lastname@example.com.


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"The Definitive Source for Everything Pierced"
Tribalectic Body Jewelry is unlike any other online body jewelry store. We have been servicing the body piercing community with high quality body jewelry and piercing accessories for over 10 years. At Tribalectic, we only sell quality body jewelry made by and for real people.
Most of the body jewelry we sell is made in the USA by small, custom jewelers. You can learn about each manufacturer by clicking their logo on the product ordering pages. Other online body jewelry sites offer price matching. We always offer the best prices on body jewelry and offer our repeat customers numerous discounts of 15% or more!
As always, you can find top-of-the-line body piercing information in our free body piercing community, a free service we've offered for over 17 years.
Our body jewelry always comes to you 100% sterilized and we still offer FREE SHIPPING on U.S. orders over $60.00.
See what our customers say about us!
Do you have a website or homepage? If so, you could be earning 10% on all sales referred to Tribalectic. To learn more about the Tribalectic Affiliate Program and to sign up just click here.


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CEM DT-318 Digital Gooseneck Flexible Thermometer Anemometer Vane Wind Air Velocity Meter
Regular Price: $ 99.95
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This 2-in-1 meter measures the air velocity and the air temperature simultaneously. It is designed to be used at home, office, factory or industrial buildings. Learn More
CEM IR-68 Non-contact Flexible Infrared Thermometer with Laser up to 1112 oF, 600 oC 8:1 D/S Ratio
Regular Price: $ 199.95
Special Price: $ 99.95
This new device has a 16 inch flexible gooseneck which can send the laser pointer and IR detector to the hard to reach space. It has a wide measuring range of -58 oF to 1112 oF (-50 oC to 600 oC). Learn More
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It's time to get off this ride. The Buffalo Sabres have had a roller coaster season so far. Recently, however, they have been on the downhill swing. Saturday night in Ottawa, the Sabres played a very sloppy game and it cost them a crucial two points as the Senators beat them 3-0.
Sabres shoot blanks against Sens
November 4, 2001 Submitted by
Via: Sabres Central


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The Australian Terrier is one of the smallest terriers but it is certainly mighty! The Aussie was developed in Australia but its ancestors hail from Britain. This cheeky, bold, and entertaining dog is great for families and apartment dwellers.
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Thread: PSE-NOVA bow as new
Threaded View
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- Jan 2012
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- 1
PSE-NOVA bow as new
An as new PSE-NOVA compound bow, used 20 times in target archery.
The Kit includes the bow, a toxonics sight, a foam insert carry case, counter-balance pole, bow stand, D-loop with release aid, a cavalier fall way arrow rest and seven arrows.
The bow specs are as follows:
60 pound draw weight
65% actual let off
26-31 inch draw length
The Bow is in perfect condition as are all the accessories.
Selling for $650 the lot.
Selling gold coast location
Email email@example.com
Last edited by ahar8514; 01-01-2012 at 06:26 PM.
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Channing Tatum Covers GQ "Men of the Year" December 2012
On the heels of being named People's "Sexiest Man Alive," Channing Tatum happily accepted the title of "Movie Star of the Year" by covering the December 2012 issue of GQ magazine.
The 32-year-old actor looked handsome as he suited up for the Sebastian Kim shot spread while talking about everything from receiving celebrity career advice to accepting his role in "The Vow."
A few highlights from Mr. Tatum's interview are as follows. For more, be sure to pay a visit to GQ!
On getting advice from his celebrity friends:
"Ahhh, I'm not gonna drop names, you know, very successful, smart actors. And they were like: 'Grind it. If you love it, grind it.' I did. And a lot of people who didn't grind it, it's not that they're not in a good place, but I'm in a better place."
On filming "White House Dawn:"
[I shoot everything] except for maybe a Javelin missile. But the president might get to shoot a missile, I'm not saying."
On taking up less action-packed movie roles:
"I did The Vow because I really love being in love."
Photo Credit: Sebastian Kim for GQ


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Espresso and Coffee Grinders
Every dynamite cup of espresso or coffee starts with a dynamite grind. Consistency, texture, size - it all matters. Whether you are new to the world of espresso or have been making the perfect cup of coffee for as long as you can remember, fresh coffee grounds are the first step.
Take your pick from our curated collection that includes everything from entry-level coffee grinders to precision-designed espresso grinders. With video tips and reviews of each grinder, you too can master the daily grind!
Learn More about Coffee Grinders
Breville Smart Grinder ProLock down your coffee dosing with the Breville Smart Grinder Pro! Breville's Dosing IQ technology lets you set grind time down to 0.2-second increments for easily repeatable coffee at the touch of a button. And, with 60 easy stepped adjustments for grind size—from espresso fine to French press—coarse, the Smart Grinder Pro is a perfect fit for any brew method. Learn More$199.97
Breville Dose Control Pro Burr GrinderA grinder so simple, you'll feel like a pro! With 60 separate grind settings and easy to read suggestions on the grind adjustment collar, it's simple to grind anywhere from espresso to French Press and back with the Breville Dose Control Pro Burr Grinder. Learn More$179.97


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Wittenberg Welcomes Alumnus For Unique Playwright Residency
March 5, 2010
Filed in Arts and Culture, Arts Scene, Campus Headlines, Headlines
Springfield, Ohio – Wittenberg University Department of Theatre and Dance recently welcomed John Cassel, class of 1998, "home" as he returned to campus to oversee the production of his play Janey Miller's World Tour: a fairy tale. He was on campus briefly in late February and will return again in mid-April to work with current theatre students and faculty and spend time at the university that prepared him for a successful career in New York.
Cassel's love for the stage and the spotlight was nurtured as he grew up in Overland Park, Kan. His family valued and emphasized the importance of the arts in his development, and it was exactly the backing that Cassel needed to ignite his passion and inspire him to pursue a career in theatre.
"When I was in grade school, we had season tickets to the local children's theatre (Theatre for Young America in Overland Park)," Cassel said. "I took acting classes there and was cast in some of their productions. It was there that I fell in love with the theatre."
Cassel brought his passion to Wittenberg, where he earned a Bachelor of Arts in Theatre and Dance. Asked to return to the school that molded him into a playwright and taught him how to follow his passion, Cassel didn't think twice about accepting the offer.
"It was an unexpected and true honor to be invited back. It meant a lot," he said. "Some of my best memories, and some of my best friends, come from Wittenberg's Theatre and Dance Department. To have a chance to collaborate with the whole gang – I couldn't have passed that up. And if I am able to give anything back by way of sharing my experiences with the current students, that's only a bonus."
Cassel has taken his career to the bright lights of New York, where he has spent every ounce of time and energy towards his passion of the fine arts. He has written more than 25 plays, including the Myth of the Moon and the Morning Star and Match, which have been produced in New York and around the country. He has also had readings of his works in Berlin, Germany, and Los Angeles, Calif.
Cassel has also written sketch comedy for Epiphany Theater Company's Seriously Sketch Series for several years, and he works as editorial director of PowerKids Press and Windmill books, which are two imprints of Rosen Publishing.
Janey Miller's World Tour: a fairy tale, directed by Professor of Theatre and Dance Steve Reynolds, is scheduled for 7:30 p.m. Thursday-Saturday, April 15-18, in Chakeres Memorial Theatre. Ticket information will be distributed in a future Wittenberg news release.
Written By: Trent Brunic '10
Photo By: Erin Pence
- Media Contact: Ryan Maurer


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Belkin Washable Mouse : Admit it, even your's is a bit grotty
Belkin are one step ahead. They've released a Washable Mouse! That's right, when you've accidentally split a bit of Coke on your mouse, simply disconnect and wash under the nearest tap.
It'll be a couple of weeks till they arrive in Australia.
Via Engadget.
Labels: Belkin, washable mouse, waterproof mouse


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Adianti Framework provides an architecture for developing PHP applications, reducing development costs, and helping developers write less code. It is a component-based and event-driven framework which uses commonly-known enterprise design patterns like MVC (Model View Controller), Front Controller, and ORM (Object-Relational Mapping) design patterns like Active Record and Repository. It provides two different widget toolkits, one for Web applications (HTML/CSS) and another for graphical applications (with a Graphical User Interface) which uses Gtk internally. The developer can write one set of code, and it can run in a Web environment and also as a graphical application.
Adianti Studio is a multi-platform environment for PHP development which includes a great range of resources a developer needs to be productive. It uses a tabbed interface which brings basic resources like syntax highlighting, auto-complete, an outline tree, bookmarks, code insight, change tracking, method traceability, workspace saving, brace matching, source code navigation, database navigation, a plugins gallery (managed by the user), a PDF document generator, a calendar, and more. In the professional version, it adds a form design tool called Adianti Designer which allows the user to draw its forms with a graphical interface using Adianti Framework components and containers like inputs, combos, radios, check buttons, imagens, frames, notebooks, datagrids, and more. The professional version also offers a source code generator which allows the user to generate form classes and datagrid classes from database structures using the Adianti Framework pattern of source code.
Weed-FS is a simple and highly scalable distributed file system. There are two objectives: to store billions of files, and to serve the files fast! Instead of supporting full POSIX file system semantics, it implements only a key-file mapping. Instead of managing all file metadata in a central master, it manages file volumes in the central master and lets volume servers manage files and the metadata. This relieves concurrency pressure from the central master and spreads file metadata into volume servers' memories, allowing faster file access with just one disk read operation. It is modelled on Facebook's Haystack design paper. Only 40 bytes of disk storage are required for each file's metadata, and disk reads are O(1).
CMDBuild (Configuration and Management Data Base) is a fully configurable Web application for managing asset lifecycles. It includes workflow, report, dashboard, attachment archiving, and georeference functions. It supports the management of hardware devices (client and server computers, peripheral devices, network and phone equipment), software (basic, environment, application), services, and documents (contracts, manuals). However it can be used as a standard asset management system (real estate, inventory, maintenance process, etc). It is also a framework suitable for applications that manage office business using workflows.
Networked Decision Making is fun Web-based group decision making software to complement meetings and voting. There are many situations in which groups need to make decisions. Existing methods are inefficient, synchronous, and often overly influenced by politics, egos, and hierarchy. Hence the need for a new method without these limitations. Networked Decision Making is developed on the web2py platform and is fully compatible with Google App Engine and most SQL platforms.
Nibble Forms 2 is a PHP form class which allows developers to quickly create HTML5 forms and validate submitted results. An evolution of the original Nibble Forms class, it follows some of the key principles of Nibble Forms: It's simple to instantiate, it uses simple form field calls, it's flexible, and it provides validation out of the box.
A company administration manager.
A Magento script for online bookings.


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1940s Caged Utility Pendant
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Recalling the fixtures that illuminated factory floors of the '40s, our pendant pairs Art Deco geometry with industrial utility. A convex cage, held by contrasting latches, ensures that the recessed bulb stays out of harm's way.
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- Medium: 18½" diam., 27½"H; 22.5 lbs.
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Title: Edna Tiny Tarbutton Collection
The collection contains items that document the career of national records setting and Hall of Fame coach, Willie Edna Tiny Tarbutton. She coached all of her 33 years at Baskin where she posted 654 wins, 263 losses and 2 ties. Her honors include four Halls of Fame: Louisiana High School Athletic Association Hall of Fame, Louisiana Sports Writer's Hall of Fame, national High School Hall of Fame and the Women's Basketball Hall of Fame.
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VIDEO: Parma woman one of three Turnpike crash victims
(Milan, OH) The State Highway Patrol says a woman from Parma is one of three people who died in a series of crashes involving at least 50 vehicles on the Ohio Turnpike.
20-year-old Hannah Matheny of Parma, a passenger in a Ford Focus, was killed in the first crash zone, which involved about 16 vehicles. Also killed in that same crash was 42-year-old Grzegorz A. Piwowarczyk of Palatine, Illinois, who was driving a commercial vehicle.
The second crash zone, involving approximately 20 vehicles, resulted in the death of 66-year-old Janice M. Robb of Schererville, Indiana. She was a passenger in a Chevy Venture.
The Patrol also says a trooper responding to one of the first accidents Wednesday was seriously injured when he was pinned between two vehicles. Tpr. Andrew Clouser, who is 29, is in the intensive care unit of St. Vincent Medical Center in Toledo, where he was taken from Firelands Hospital in Sandusky.
Pileups stretched across a two-mile section in the eastbound lanes midway between Toledo and Cleveland.
At least two lanes of the eastbound Turnpike were open by late Thursday morning.
The Patrol received a call about the first crash at 1:25 p.m. and dispatched a trooper to the scene. The trooper alerted dispatchers that he had been struck and pinned between two vehicles at 2:05 p.m. This crash started a chain reaction of crashes with two severe crash zones, one near the initial crash, near milepost 102 and one at the rear, near milepost 101. Approximately 50 vehicles were trapped between these two crash zones with minor or no damage to the vehicles.
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(Copyright 2014 Clear Channel and The Associated Press, all rights reserved.)


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Bob Dylan to headline Americanarama Festival summer tour
Listen to Bob Dylan on iHeartRadio
Bob Dylan is making his summer touring plans. The folk-rock legend is expected to hit the road as the headliner on the Americanarama Festival of Music. He has an image of the trek's poster up on his website, which says shows will also feature Wilco, My Morning Jacket, "and more!"
Dylan's post adds that the Richard Thompson Electric Trio and Ryan Bingham are slated to appear at select stops. Dates haven't been announced yet, but RollingStone.com says a rundown is expected to be unveiled on Monday. Ticket presales are set to start on Wednesday.
Dylan is currently on the road. He launched a spring trek behind his latest album, "Tempest," earlier this month with the folk-rock group Dawes as his opener. There are ten more dates left to the tour, which comes to a close in St. Augustine, Florida on May 5th. Dylan's next show will be in St. Louis, Missouri on Tuesday.
Photo Credit Getty Images


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Deviated Septums Run Rampant In Hollywood!
Not that I really care either way, but let's say that Zooey Deschanel did get some kind of nose job, she'll probably blame it on her deviated septum. It is the Hollywood way. Whenever a celeb gets a nose job, but doesn't want to admit to have working done for the sake of having work done, this seems to be the reason. Yes, this is a legitimate medical condition. It basically means that the bottom, middle cartilage part of your nose (proper name: septum) is off-center, causing your nostrils to be different sizes.
My septum is deviated. Actually, yours probably is too. Stats say that about 80 percent of the population have deviated septums. It's usually not serious. And if you have one, life will go on without you ever noticing it except maybe when you have a cold. In more extreme cases, it can inhibit breathing, cause frequent nosebleeds or chronic sinusitis. But mostly, it's serves as a thinly veiled excuse to get a rhinoplasty. Click through to see all of famous peeps who attributed their nose jobs to deviated septums.


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Wu-Tang Rapper Cuts Off His Own Privates in Suicide Attempt
According to TMZ, Andre Johnson - a Wu-Tang Clan-affiliated hip-hop artist - jumped off a balcony in an apparent suicide attempt after removing his own private parts.
Law enforcement believes that it was an apparent suicide attempt - they found him lying on a sidewalk in North Hollywood, critically injured.
Wu-Tang discovered Johnson's band Northstar back in 1998.


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That said, don't worry about any unfriendly opinions John, won't help – all the best, congrats on getting the gig, wicked stuff.
That said, don't worry about any unfriendly opinions John, won't help – all the best, congrats on getting the gig, wicked stuff.
'Go read a fucking book, you piece of shit.'
I'm not familiar with the fella I don't feel the need to make out I do in order to impress a few dweebs on the tinterweb.
My knowledge of UK MMA is limited but growing. I'm a Muay Thai fan primarily who has watched Pride, UFC for years, just getting into the UK side of things.
I thought he did a good job with an awful co presenter.
hey andrew, i wasn't having a dig at you there. only having a pop at go-time, sengoku, whoever that bird is and anyone who posts on the internet.
'Go read a fucking book, you piece of shit.'
but he commentates for CW, you're posting on the CW forum, c'mon Sengoku...you could at least refer to him by his name.
The only issue I had was that as a result of keep cutting back to them we missed the USA broadcast.
It was clearly shown onscreen midway through the broadcast that upcoming was the Luke Barnatt fight, but in the UK we had some more chat instead. great!
Its good that they are building it up, and explaining things for the casual fans, but at the end of the day people tune into a UFC show for fights.
Fortunately due to work I ended up watching it the following day off Sky+, I soon resulted in fastforwarding between fights.
I do think the format would work better if the questions and general chat were led more by Gooden though.
I didn't watch any of the bits with GAD in.
http://www.ChrisReesAcademy.com - http://thetattooedchimp.blogspot.co.uk/
At first I was annoyed at them cutting to the studio straight after a fight / during walk ins but I believe when BT went back to the studio the American footage was showing adverts. I've watched the FOX coverage of a fight night before and it's dreadful, advert after advert.


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Any error messages you get when running startx?
Also you might have to install the mobile device drivers at first.
i have backtrack 4 rc2 on a dvd, when i boot it up i put fixvesa since startx doesnt work, then i tried startx and it dtill doesnt work, how do i fix this?
do i need special drivers?
btw i have a gt 420M gpu and my wireless card is
intel r wifi link 1000 bgn
my laptop is a dellxps 15
Any error messages you get when running startx?
Also you might have to install the mobile device drivers at first.
Tiocfaidh ár lá
When startx was entered at root@bt:~#, I was graced with a black screen, or maybe my screen switching off.
I've burnt at least 4 or 5 copys of backtrack 4 rc2 on dvd using bt4r2.iso from 2 different sources, 'direct link' and 'torrent'.
I thought the problem was with my Macbook Superdrive or a bad iso.
I did a little searching for info and came across a few mentions of using:
I don't know exactly what either do, yet I used fix-vesa at root@bt:~# then startx and BT4R2 entered the GUI with no problem.
I could of got straight to the point or fix but this will help others looking for answers.
I'm a Linux noob, but it worked for me... Hope I've helped.
fixvesa didnt work, where can i get the right drivers?
Like I say; I'm a Linux Noob...
I'm using a White MacBook. (not sure of exact model/firmware etc...)
Results may differ depending on the hardware your using.
This is what I did/have noticed and has worked for me;
- Booted from bt4r2 on DVD
- Entered fix-vesa at the root@bt:~# promt.
(Not fixvesa. although I'm unsure as to exactly what both do, they are two seperate comands.)
- Entered startx at the root@bt:~# promt.
- The BT4R2 GUI started successfully.
- Used the Install script on the desktop to perform a Hard Drive Install.
- On first boot from the Hard Drive I had to;
Enter fix-vesa at the root@bt:~# promt.
Enter startx at the root@bt:~# promt.
- Every boot after that all I did was/am still doing is;
Enter startx at the root@bt:~# promt.
Like I say, things may differ depending on hardware...
The above method does work on the type of MacBook I'm using and may work across many other, if not all, hardware setups.
The reason I dare to imagine such a thing is due to me getting hints of the problem being related to xorg config. (or summat... ouch, I'm a noob) fix-vesa may rewrite said config file/s or pop them in the right place or something.
Anyway, hope it works for you and if not, hope you find your fix soon.


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The Real Secrets WOW
Every woman has a story to tell, and a secret to share...
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The Real Secrets WOW is a social network
Warning: sometimes ignorance is bliss; after gaining this knowledge, you may be hurt when it is obvious that someone is lying to you. The following deception detection techniques are often used by police, forensic psychologists, security experts and other investigators.
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Have you ever find ants on your bedroom? I am sure that really disturb you, you cannot sleep well on your bed. The bad thing is that you will be itchy when they bite your skin. Actually ants are only small animals, but it is really disturbi...[Read More]
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The Hastings College Computer Science program puts you in the driver's seat, giving you an opportunity to develop software, design databases and information systems, build operating systems, learn about machine learning, design and create games, and consult with businesses looking for support. With unlimited access to professors with doctorate degrees, you'll have great flexibility in your program while building an adaptable computer science skill set designed for the future.
Our faculty offer experience and flexibility. Their real world experience in software design allows them to give you great classroom opportunities and lead directed studies in areas that interest you but fall outside the Hastings College course catalog. Even more great opportunities come via Hasting's January term (J-term), when professors offer courses in their own areas of interest, including computer hardware, artificial intelligence, game theory and web based game design.
Collaborating with professors and classmates allows you to hone your skills while preparing for experiences outside of college. Most of our computer science students complete one or more internships, thanks to Hastings College's relationships with businesses and government organizations in the region and throughout the state. Internships and professional opportunities allow you to apply all your skills to problem solving in real-world situations. Each such learning experience builds upon the previous ones, culminating in a professional level senior project related to an area of special interest to you.
You'll find Hastings College Computer Science graduates all over the world. They design and write software, work as computer technicians, serve as business consultants, design web sites for businesses, continue to graduate school for an advanced degree and even own their own software companies.
Those holding Computer Science degrees are in demand – and often command high salaries. It's a great, wide open future. Start down that road by applying to Hastings College.


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Ask A Deputy - KIMBERLY GAMBLE
This is the 5th in an occasional series in which Inside 7 gets the inside scoop on our various divisions.
Kimberly Gamble joined District 7 on June 1 as its Deputy District Director of External Affairs, which includes Media Relations, Public Affairs, Graphics, Equal Employment Opportunity and Governmental and Legislative Affairs. Gamble has been involved in implementing task management and strategic planning efforts for the Department and in the private sector. Prior to her position in District 7, she worked at Caltrans Sacramento Headquarters as a statewide liaison for the Division of Right of Way and Land Surveys. Gamble holds a Bachelor of Science degree in business administration from California State University, Sacramento. She speaks Mandarin Chinese fluently.
Inside 7: Tell us about a little about yourself and how you learned to speak Mandarin.
KG: I'm an Air Force brat. My father is from Detroit; he met my mother while serving in Taiwan. My mother is from Tsingtao in the Province of Shandong, China. Mandarin was my first language, but I never learned to read or write it. As a child, I spoke Mandarin in order to obtain as much food and candy as possible from my parents and grandparents. I've grown into an international 'foodie.' I love regional foods, especially Taiwanese noodle houses and foods from Korea, Thailand, Vietnam and the Madras region of India. Occasionally, I enjoy a McDonald's burger. I've lived in several mid-western states, but my parents chose to settle in Sacramento following military duty. I was raised, literally, in my mother's Chinese restaurant, which was one of the first in Carmichael (a Sacramento suburb). My entire family has first names beginning with 'K.' My sister's name is Kim, so, I always go by Kimberly. Mom's English was limited and Dad was away when she had to choose my name. The hospital nurses helped Mom with some choices, and she didn't realize the similarities between the names Kim and Kimberly.
Inside 7: What were your first impressions of District 7?
KG: The sheer massiveness of it all was my first impression of District 7. The building, the quantity of people and the large amount of projects District 7 is responsible for delivering annually. Sacramento is the state's capital, but Los Angeles offers so much more as far as transportation needs and services are concerned. Each Caltrans district has unique challenges and characteristics, and I'm excited about getting to work in one of the largest Caltrans districts. I'm impressed with the culture and food choices in downtown LA. Also, my daughter and I love Tiny Dots! She attends daily and it's the main topic of our conversations.
Inside 7: With your background in marketing and strategic planning in both the public and private sectors, what kind of bold, significant changes could District 7 quickly implement to make an even better, stronger and more innovative department?
KG: I'm a big believer in archiving, succession planning, training, pro-activeness and forward-thinking. In External Affairs, we're going to work on a better system to track and archive documents, graphics and general information for easier retrieval and sharing. We'll refrain from being reactive and reinventing the wheel. The district is on the right track with its efforts to fill the lobby museum space with interesting transportation-related projects and concepts, and open our door to the public to see what we're doing. To strengthen our public education efforts, we could invite more tours, groups and delegations to District 7 to share good news of our innovative work. For example, our Maintenance folks are constantly developing and employing the use of modern technologies and are real leaders in their field. We're going to highlight our successes by applying for more transportation awards. Public Affairs and Graphics staff is on track to create a unique brand and logo for District 7 for our printed materials and website. In all marketing plans, the basics are messaging, packaging and branding. We're going to better package Caltrans messages to highlight the district's goal to "Deliver Sound Transportation Solutions." All of these changes, I believe, will make Caltrans even better and stronger.
Inside 7: What would you plan for your division if you had all the resources you could want at your disposal?
KG: Training! With unlimited resources, I would schedule more specific kinds of cross-functional training, job-shadowing and job-sharing. This is important for succession planning. I'd like staff to participate in field reviews of major projects. It's one thing to see a project's horizontal design on paper and another to actually see it. We'd get a better feel of the location, why the work is needed, and the conflicts and challenges that design, construction, right of way, and utility engineers may encounter. We'd take more road trips with the area project managers and resident engineers to see firsthand the roadway conditions and how neighborhoods, residents and businesses may be impacted and what we can do to minimize potential impacts.
Inside 7: Why does External Affairs matter and how does it contribute to Caltrans' mission and goals for safety, mobility, delivery, stewardship and service?
KG: External Affairs definitely is the ultimate resource for getting our good news to the general public, local agencies, elected officials and legislators. Accurate and timely information from Public Affairs and Media Relations staff helps to educate the public on the scope of our work, helps to gain public support for our transportation projects and garners public trust. Graphic Services staff helps tell the Caltrans story with photos, video, or well-designed materials, maps, and models. EEO supports the workforce with harassment preventive training, mediating personnel conflicts and promoting equality and diversity within Caltrans. This, in turn, enhances quality service throughout our workforce. The Legislative Affairs unit works with local and state elected officials to advance Caltrans' goals through the legislative process. It also supports our Disadvantaged Business Enterprise Program and provides customer service that helps to efficiently deliver quality products and services, enhancing our resources and assets.
Inside 7: What, if any, changes do you see coming down the pike for your division? Are you implementing any new goals or directions this year?
KG: On the first day I met with my staff collectively, I said that I'm open to hear only constructive criticism and suggestions. We'll accentuate the positive and carve out time to incorporate some thoughtful and strategic planning. We're going to brag about our successes and good stories that happen daily – but too often go unnoticed. For example, there are opportunities to submit nominations for the AASHTO Transportation Communication Awards and many other awards that highlight our good work. External Affairs has the multi-disciplinary talent to submit in several categories for public outreach, social media, websites, graphics, video, publications and special events. We are also available to assist other divisions in packaging their award submissions.
Inside 7: What are External Affairs' top priorities at this time?
KG: Transportation issues elicit public interest, involvement, feedback and critique. It's important to capture and hold the attention of our customers upon delivering Caltrans messages. Currently, a number of projects have incited passionate public participation and comments. It's important that we stay positive and keep our commitment to Californians to improve regional and statewide mobility and to find innovative ways to move goods and people. It's a priority that External Affairs provides excellent customer service internally and externally and delivers timely, transparent information and resources.
Inside 7: Besides a love of food, restaurants and noodles, what other hobbies or activities do you enjoy?
KG: Travel, of course, so that I can get my exotic foods straight from the source!


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Thursday, January 28 2010 - 9/11 A/V Galleries
Visibilty 9-11 - Two New Interviews from Host John Bursill
January 28, 2010
As part of a new series of interviews from Michael Wolsey s Visibility 9-11, Host John Bursill talks to 911Truth.org Executive Director, Janice Matthews and Richard Gage, AIA, founder of Architects & Engineers for 9/11 Truth. John
John Bursill is a licensed aircraft maintenance engineer, with over 20 years of experience working on large commercial jets in Sydney. Bursill has an extensive knowledge of the 9/11 attacks, and is one of the most prominent 9/11 truth activists and speakers in Australia today. John was the principal organiser of the The Hard Evidence Tour Down Under and has organised several other events, including the Sydney Truth Now Conference 2008 and Delusion 9/11. He has also toured across Australia with his talk Why 9/11 Truth?
Visibilty 9-11 Welcomes Richard Gage AIA - 1,000 Member Milestone
This interview was inspired by the recent news that Architects and Engineers for 9/11 Truth had reached the milestone of 1,000 qualified and licensed members. Gage, who is an experienced San Francisco Architect, member of the American Institute of Architects and the founder of Architects and Engineers for 9/11 Truth, describes some of the group s recent successes worldwide and talks about his recent tour of Australia, New Zealand and Japan.
We hear about the upcoming Press Conference planned next month to announce the 1,000 AE911truth.org members to the world, which includes approximately 40 Structural Engineers. Richard also mentions some celebrations that are planned for the AE911Truth members. Please see the site for more details www.AE911Truth.org
Visibility 9-11 Welcomes Janice Matthews, 911truth.org
In the first part of this wide ranging interview Janice talks about "The Hard Evidence Tour Down Under" in Australia and New Zealand in which she participated. She also touches on conversations she had with other speakers in Sydney about what s working for 9/11 Truth and what 911Truth.org means to them now and what role it should play in the future.
See www.TheHardEvidence.com for more on the tour, and also Janice s brief report at www.911truth.org.
Subscribe to Visibility 9-11 to receive notice of all future interviews, or check Visibility911.com to listen to the many previous excellent interviews, where you ll also find blogs from Michael Wolsey, Erik Larson and Scott Ford.
The views expressed in this article are the sole responsibility of the author, who is solely responsible for its content, and do not necessarily reflect those of 911Truth.org. 911Truth.org will not be responsible or liable for any inaccurate or incorrect statements contained in this article.