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Islamic Circle Of North America Launches Billboard Campaign In DallasA billboard has gone up by the Dallas Zoo that reads "One Family - One Message." It's part of a campaign, in both English and Spanish, launched by the Islamic Circle of North America.
Dead Sea Scrolls At Fort Worth Baptist SeminaryThe Dead Sea Scrolls were discovered over 60 years ago and are keys to biblical times. Now, Southwestern Baptist Theological Seminary is getting ready to unveil a portion never seen by the public.
Champion Boxer Studying To Become RabbiYuri Foreman is proving that an athlete can fully commit to his or her faith while still achieving personal and competitive goals.
New Poll Tests Religious Knowledge


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TeleProfessional offers 3 satellite offices with the best in technology and the best in customer care. We have been in business since 1981 and our customer care retention is 85%! This means our customer care representatives are around to build rapport with your clients.
TeleProfessional is dedicated to answer every call in 3 rings or less.
Our mission statement:
To anticipate your customer's needs and relay them to you professionally, accurately and in a timely fashion.

subset: commoncrawl


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Drivetrain Warranty Coverage
What Does a Drivetrain Warranty Cover?
All internally lubricated parts inclusive of: pistons - crankshaft and main bearings - connecting rods and bearings - camshaft and bearings - timing gear - timing chain - rocker arms - shafts and bushings - valves - valve springs - guides and seats - push rods - lifters (if collapsed) and oil pump; externally: Distributor shaft - gear and bushing. Engine head(s) - engine block - gaskets and seals - oil pan - valve covers... if damaged as a result of failure from a covered internal engine part. All internal parts within the turbo/supercharger housing.
Get a » Powertrain Warranty Quote « or Call for details!
All internally lubricated parts contained within an automatic transmission inclusive of: clutches - bands - pumps - carrier assemblies - internal shafts - (main - intermediate - reaction) - thrust washers and bearings - governor - valve body - servo and accumulator assemblies - torque converter - throttle valve cable - case and pan if damaged as a result of failure of covered automatic transmission parts. Internally lubricated parts contained within a manual transmission inclusive of: main shaft - coupler shaft - all gears - synchro hub assemblies - bearings - shift rails and internal shift forks - input shaft synchro rings and retainers - case and pan if damaged as a result of failure of covered components. Internally lubricated parts within the trans-axle of a front wheel drive including ring and pinion gears - internal bearings - axle(s) and case if damaged by covered components.
DRIVE AXLEParts contained within the differential housing including ring gear and pinion gears ¤ bearings ¤ differential housing if damaged by failure of internally lubricated parts ¤ axle ¤ universal joints.
Parts contained within the transfer case: transfer case if damaged by failure of internally lubricated parts.
All necessary labor will be paid by Auto Service Protection Using the approved retail labor rate and time as defined by Mitchell's on demand/Alldata software... to repair or replace all parts covered under this auto warranty agreement.
OPTIONAL COVERAGEElectrical: Power window motors,starter motor, alternator, voltage regulator, blower motor, and front wiper motor.
Air Conditioning: Compressor motor, compressor clutch, condenser and coil.
24/7 Roadside Assistance Program
Towing ¤ Emergency tire ¤ battery ¤ gasoline & lockout service.
Request a Custom » Powertrain Warranty Quote «
Got a Question? Call or contact us now for a speedy reply!


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Brake Lines
At times cars have this innate ability to totally irritate you. Walter as you can see from the latest posts is on a mission to become an irritant, starting with the suspension air pump, crank sensor, windshield, then the wheel alignment, and a few days ago a brake line.
Lets step back for a moment.
There was an hydraulic fluid leak in front of the left rear wheel. At first blush it could be the shock absorber which has hydraulic fluid, that started to leak.
Not a big deal, but a constant minor leak.
Peaking under the car during the wheel alignment the left rear shock is very dry...oops does not seem to be the shock abosorber.
If its not the shock abosorber, the other possibility is a brake line. It almost does not make sense that a brake line would leak (seep)...or does it?
Until the "brake fluid low visit workshop" comes on in the dash at the most inopportune time. A case of "I don't need this s$%t this morning"
If you see some sort of hydraulic fluid leaking/seeping from the car, got to a workshop immediately and have the leak confirmed and repaired.
Been around Benzes for decades, we keep on driving Walter, even when it was not the shock we still drive Walter, even when the lights in the dash come on, we still drive Walter.
Hydraulic leak, low brake fluid, how much is left in the master cylinder?
Walter makes it on its own to the friendly mechanic. Yes...drove Walter in a very cautious fashion to minize brake applications.
The conversation goes as follows.
"A brake line is leaking in front of the left rear wheel" reply from the mechanic "You should not have driven the car...not safe"
"How could a brake line leak?" reply from the mechanic "SBC brakes generate very high line pressures the metal fatigues cracks, leaks". It all makes a ton of sense on a 12 year old car.
From the mechanic "You know that its a pain to bleed the lines with SBC brakes...you remember" the reply "Yes...and it consumes a ton of brake fluid too...I don't think its bad that too much air went in the system".
Fortunately we have other vehicles...and the patience to endure Walter's foibles.
Hopefully whoever engineered those weak brake lines from over a decade ago and saved a few pennies in the process got a promotion.
Again...if you see hydraulic fluid on the ground best not to drive the car, if a leaking brake line bursts especially with SBC brakes it can turn into a dangerous situation in a nano second.
Bottom Line:
Replaced the left and right brake line and bled the brakes. Absolutely not lingering on what could have happened if the brakes failed.


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Update: Ricky Beech has since been caught by police.
AN ARMED robber could be on the run in North Yorkshire after escaping from prison in Yarm.
Ricky Darren Beech, 29, absonded from Kirklevington Grange Prison in Yarm between 4.45pm and 7.50pm yesterday.
He was jailed in 2008 for an armed robbery at a petrol station in Hull in 2006, when he assaulted a shop assistant, and was serving an indeterminate sentence.
Beech is white, with dark hair and a beard, five foot nine inches tall, with brown eyes and two scars above his left eye. He has an England tattoo on the left hand side of his chest.
Cleveland Police say they are working with prison authorities and other police forces to trace him, and although they do not think he poses a risk to the public have advised anyone who sees him not to approach him but to call 999 immediately.


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This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/3.0/).
Zoonotic events of simian immunodeficiency virus (SIV) from non-human primates to humans have generated the acquired immunodeficiency syndrome (AIDS), one of the most devastating infectious disease of the last century with more than 30 million people dead and about 40.3 million people currently infected worldwide. Human immunodeficiency virus (HIV-1 and HIV-2), the two major viruses that cause AIDS in humans are retroviruses of the lentivirus genus. The genus includes arthritis-encephalitis virus (CAEV) and Maedi-Visna virus (MVV), and a heterogeneous group of viruses known as small ruminant lentiviruses (SRLVs), affecting goat and sheep. Lentivirus genome integrates into the host DNA, causing persistent infection associated with a remarkable diversity during viral replication. Direct evidence of mixed infections with these two closely related SRLVs was found in both sheep and goats. The evidence of a genetic continuum with caprine and ovine field isolates demonstrates the absence of an efficient species barrier preventing cross-species transmission. In dual-infected animals, persistent infections with both CAEV and MVV have been described, and viral chimeras have been detected. This not only complicates animal trade between countries but favors the risk that highly pathogenic variants may emerge as has already been observed in the past in Iceland and, more recently, in outbreaks with virulent strains in Spain. SRLVs affecting wildlife have already been identified, demonstrating the existence of emergent viruses adapted to new hosts. Viruses adapted to wildlife ruminants may acquire novel biopathological properties which may endanger not only the new host species but also domestic ruminants and humans. SRLVs infecting sheep and goats follow a genomic evolution similar to that observed in HIV or in other lentiviruses. Lentivirus genetic diversity and host factors leading to the establishment of naturally occurring virulent
Lentiviruses are causative agents of many emerging and re-emerging infectious diseases threatening both animals and humans [
Organization of HIV-1 and CAEV/MVV lentivirus genomes. Both genomes have a 5' LTR and 3' LTR at each of their extremities and the structural and enzyme
Small ruminant lentiviruses (SRLVs), comprising arthritis-encephalitis virus (CAEV) and Maedi-Visna virus (MVV) are a genetic continuum of lentiviral species that were initially isolated from goats and sheep, respectively [
The evidence of a genetic continuum of caprine and ovine field isolates from various geographical areas, that did not simply cluster according to the animal species from which they were isolated, demonstrates the emergence of new viral recombinants capable of overcoming species barrier and resulting in cross-species transmission/infection. Direct evidence of mixed infections under field conditions with these two closely related SRLVs was found, as suggested by detection of some subtypes in both sheep and goats [
Many emerging viruses partly escaping detection are already circulating in various hosts worldwide [
SRLVs affecting wildlife have already been identified, demonstrating the existence of emergent viruses adapted to new hosts [
Cross-species transmission of SRLVs in domestic and wild ruminants. CAEV and MVV cause natural infection, adaptation and induced pathogenesis in both domestic sheep and goats (left). Experimental and natural cross-species infections were recently documented in wild small ruminants (right).
Although controversial, it is debated that SRLVs infecting sheep and goats follow a genomic evolution similar to that observed in HIV or in other lentiviruses [
Example of phylogenetic analysis of CAEV sequences in goats and following spill over in goat/ibex hybrids and in wild ibex. Sequence analyses in
The main factors in the worldwide spread of retroviruses are the rapid evolution and genetic variability associated with virus replication in the host. Other contributing elements are viral latency, viral persistence within infected host, inability of immune system to mount sustained immune responses against shifting targets due to antigenic drift and the failure of correct diagnosis due to antigen diversity. All these factors are the main drawbacks to the development of effective and safe vaccines. Although SRLVs share conserved genome organization and similar pathogenic mechanisms [
SRLVs were reclassified into five principal sequence groups, A–E based on analysis of a genetic sequence comprising 1.8 Kb of the
Like others retroviruses, SRLVs are positive RNA viruses that copy their genomes into complementary DNA during their replication [
The extent of genetic diversity depends on a set of factors, but variation arises ultimately through two major mechanisms: Mutation and recombination. The
Recombination is a complementary mechanism of genetic variation which can assemble the beneficial genetic combinations more efficiently than mutation alone. Insertions and deletions in the lentivirus genome are also frequent occurrences due to high rates of virus replication [
On the other hand, dual infections (coinfections or superinfections) are an essential status for such recombination events [
In several countries, SRLVs strains have been analyzed and compared with current prototype strains of CAEV and MVV [
But outbreaks of disease with virulent strains kept re-emerging in susceptible populations in various parts of the globe. More recently, outbreaks with virulent strains associated with extensive neurological diseases were found in sheep of the central area of Spain [
Most transmissions of SRLVs among sheep or goats occur through the ingestion of virus infected colostrum [
Genetic diversity also poses a relevant problem for SRLVs, testing and diagnosis [
SRLVs have been detected by ELISA, PCR and
SRLV's mutagenic potential and diverse assortment of antigen epitopes have hampered vaccine development efforts [
SRLVs are widespread throughout the world causing serious economic implications for farmers and animal industry. SRLV infected animals produce less milk of poor quality, lose weight and are often prematurely culled [
There are millions of sheep and goats infected with SRLVs worldwide. The prevalence of SRLVs infections in North America and Europe ranges from 30%–80% compared to 0–10% in Africa and South America [
Besides the high prevalence of infection in many countries, another major obstacle to eradication of SRLV is the ability of SRLVs to jump the species barrier. The first direct evidence came from natural interspecies transmission of SRLV subtype A4 between different animal species living under natural conditions [
Recombination of different strains and subtypes contributes significantly to viral diversity and evolution both within individuals and populations [
Numerous emerging infectious diseases, including zoonoses, were shown to originate from wildlife [
Independent zoonotic transmission events from NHPs to humans have generated two major virus types HIV-1 and HIV-2. HIV-1 remains a major global health problem with an estimated 33.3 million people living with the disease and over 30 million that have since died [
Small ruminant lentiviruses (SRLVs) have a number of features in common with HIV-1 such as genome organization, long preclinical period following transmission of the virus, latency and persistence with a slow development of chronic degenerative disease, which may gradually lead to death [
Prevalence of SRLVs often reaches 100% among infected flocks [
Sheep, goats and cattle are major sources of high quality protein worldwide, and due to (I) rising incomes, (II) population growth, and (III) increased urbanization, there is a growing demand for meat and other animal products [
In most countries crude milk is used as the raw substrate for dairy products [
There is growing evidence of increased cross-species infection in mixed flocks worldwide resulting in the emergence of new variants adapted to new hosts and viral chimeras [
Although incipient, there is still a possibility of persistence of SRLVs infection in human cells [
Experimental infection of bovine calves with CAEV demonstrated that CAEV causes productive but not persistent infections in calves [
Recent detection of cross-species infection and adaptation of domestic ruminant lentiviruses in free wild ruminants have further cemented this argument [
Despite the proven efficiency of lactogenic transmission, the pastures are places where the transmission rate of infectious diseases between domestic and wildlife ruminants is the highest [
Different factors can promote the constantly increasing interactions between wildlife and domestic animals. In Brazil, various endangered native goat breeds were infected with SRLVs through the introduction of exotic breeds to improve efficiency of milk production in local dairy herds [
In many countries, large populations of wild ungulates are concentrated in small delimited areas because of high human density and distribution [
In order to successfully adapt to a new host, lentiviruses must evolve quickly to evade host defenses before they are transmitted to other individuals of the same species [
In domestic SRLV-free flocks, virus may re-emerge spontaneously. Serology tests in many cases also fail to detect antigenic variants by routine methods [
Wildlife and domestic animals are the major reservoirs for emerging and re-emerging pathogens, threatening both animals and humans [
Furthermore, the emergence of infectious diseases within new hosts species or naïve populations can greatly influence species survival and adaptation. In fact, the cross-species infection of simian lentiviruses from non-human primates to humans has resulted in one of the most devastating infectious diseases (HIV/AIDS) of the last century. This demonstrates how a new viral pathogen can pose serious threats to public health [
Cross-species transmission between domestic small ruminants and wild species may affect the pathogenic and tropism properties of SRLVs, jeopardizing health and environmental safety. A continuous surveillance of wild small ruminant populations may improve our knowledge of the relationship between genetic evolution and new biological properties of emergent viruses, which in turn could generate biomedical advances and improved strategies for lentiviruses control in humans, domestic and wildlife small ruminants.
Finally, the recent discovery that goats in Europe are readily infected with highly attenuated strains of CAEV that escape the detection tools and are not associated with disease development provides unique opportunity to use some of these strains as live-attenuated vaccines for goats to induce protection against the highly pathogenic strains. Since CAEV is not an infectious pathogenic virus in human, these highly naturally attenuated strains of CAEV could be used as a basis to derive live‑attenuated chimeric genomes as vaccines against the deadly HIV-1 in human.
J.C.M Cruz was supported by FUNCAP (DCR program). We thank the Departement of Santé Animale of INRA, France for the financial support of the program. Thanks to J. Gagnon for his English and suggestion input.
The authors declare no conflict of interest.


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Pickaway Treasurer named to State Association
Pickaway County is making a name for itself among the statewide associations representing county elected officials.
Last week, we told you of a Pickaway County Commissioner elected to their state association, and now we report that Pickaway Treasurer Ellery Elick is the secretary of the County Treasurer's Association of Ohio. Elick has been Pickaway County Treasurer for 10 years.
Elick says things are looking up for the county, with a strong sales tax income and improvement in the local economy.


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Office Space to Rent in Penicuik
We have a variety of serviced offices available to rent in Penicuik. Each office space is offered at the best rates and suited to your individual needs and requirements.
We have a variety of serviced offices available to rent in Penicuik. Each office space is offered at the best rates and suited to your individual needs and requirements.
The accommodation is offered at a fixed price to include rent, rates, power, water, reception and telephone infrastructure. In addition, broadband internet connection, furniture, variable office layout and 24 hour Service Centre support are included. The offices, which range from 150-500 sq ft (14-47 sq m), are available either individually or in suites on simplified leases (with a minimum lease length of one year). Occupiers will also have the ability to buy additional services on a 'pay as you go' basis from a menu of options. These optional services include the hire of meeting rooms, catering, secretarial support and switchboard services.
A modern business centre offering fully serviced offices of varying sizes and styles. Each office is equipped with telephone lines, internet access and furniture to suit each occupants specific requirements.
Offering various office sizes with bespoke features that suit your budget and meeting needs. Car parking, on site storage space, easy access and IT connectivity available. Enquire today!
This modern 2 storey building offers a variety of serviced offices on flexible terms, within a prime business location. Additional services include car parking, 24hr access, air conditioning, CCTV and on-demand meeting rooms as standard. This centre offers all-inclusive pricing, so you can move in with peace of mind that there will be no unexpected costs each month.
The property in South Gyle is located in a prestigious new building conveniently located just minutes away from the city bypass. The centre has been designed to provide high quality flexible office solutions for the needs of business occupiers large and small. It is provisioned with a comprehensive IT and telecoms infrastructure as well as extensive business support services including first-class meeting and conference facilities.
This business centre is situated in a bright, modern and recently fully refurbished building whose location is acknowledged as one of Scotland's premier out of town business districts. The three storey business centre, set in landscaped grounds with parking for both cars and bicycles, offers suites varying in size and available on flexible terms and configurations to suit small, medium or large businesses. Customers also have use of a variety of meeting rooms, showers and changing rooms plus a great social and breakout area with kitchen space to relax in.
Located in a prominent contemporary building, this modern business centre provides fully furnished and serviced office suites to suit all sizes of business. Located within the Exchange District this facility is adjacent to Edinburgh's International Conference Centre. This space is available on flexible terms with no upfront capital. Features include latest technology with super-fast Internet, fully transparent online billing, staffed reception, meeting rooms and business lounge.
This business centre is located in a prime position on The Exchange (a financial district) of Edinburgh. The centre provides fully serviced offices on flexible terms, with reception staff and support teams, kitchen areas, state-of-the-art technology, secure underground car parking and on-demand meeting rooms provided as standard. This centre offers all-inclusive pricing, so you can move in with peace of mind that there will be no unexpected costs each month.
The right choice for Flexible Office Solutions, this property is a unique newly-renovated, listed building providing flexible quality serviced office suites encompassing leading-edge technology to support the most demanding of modern business needs. Our impressive Reception and Conference Suites create the right corporate image for you whether your requirement is as a new business start up, satellite office, relocation, new market entry or temporary site. Flexible licenses offer immediate access to our quality suites with personalised telephone answering by our professional reception staff whilst our skilled admin team can provide a wide range of business support services.
This centre in Edinburgh comprises the upper floors of an end terraced townhouse over first, second and third floors. The upper floors share a common entrance at ground floor level front on to Walker Street. Internally the serviced offices provide a combination of large open plan rooms and smaller cellular space with WC and tea prep facilities located on the first and second floors.
Below you can see the nearest areas to Penicuik where you can find serviced offices:


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Shared Exclusivity for Paroxetine Hydrochloride Tablets
July 30, 2003
Apotex Corporation
Attention: Marcy Macdonald
U.S. Agent for Torpharm
616 Heathrow Drive
Lincolnshire, Illinois 60069
Sent by Facsimile and U.S. Mail
Dear Ms. Macdonald:
This is in reference to your abbreviated new drug application (ANDA) dated March 31, 1998, submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (the Act) for Paroxetine Hydrochloride Tablets 10 mg, 20 mg, 30 mg, and 40 mg. Specifically, this letter addresses the matter of 180-day exclusivity under section 505(j)(5)(B)(iv) of the Act for ANDAs referencing Paxil®, manufactured by GlaxoSmithKline (GSK).
As noted in the agency's publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book), multiple patents are listed for this drug product. The patent numbers and expiration dates of the patents listed in the Orange Book are as follows:
U.S. Patent No. 4,721,723 expiration (with pediatric exclusivity) June 29, 2007
U.S. Patent No. 5,789,449 " July 6, 2009
U.S. Patent No. 5,872,132 " November 19, 2015
U.S. Patent No. 5,900,423 " November 19, 2015
U.S. Patent No. 6,063,927 " October 23, 2019
U.S. Patent No. 6,080,759 " November 19, 2015
U.S. Patent No. 6,113,944 " June 14, 2015
U.S. Patent No. 6,121,291 " September 17, 2017
U.S. Patent No. 6,133,289 " November 19, 2015
U.S. Patent No. 6,172,233 " July 15, 2018
(Note: Patents will be referred to in this letter by the last three digits of the patent number.)
We have reviewed the submissions, including original applications and amendments, for the ANDAs referencing Paxil, and have determined that different applicants have been the first to submit paragraph IV certifications for these patents. Torpharm was the first to submit paragraph IV certifications for all four strengths as to the '723 patent, the '759 patent, the '289 patent, and the '233 patent, and as to the '291 patent for the 10 mg, 20 mg, and 30 mg strengths. Different ANDA applicants were the first to submit paragraph IV certifications as to the other listed patents and for other strengths.
As you may be aware, in a limited number of cases, FDA has addressed the situation in which different ANDA applicants were first to submit patent challenges as to different listed patents. FDA has adopted the "shared exclusivity" approach to address eligibility for 180-day exclusivity in these circumstances.
The facts related to the Paroxetine Hydrochloride ANDAs present many of the same issues as were addressed by FDA in its application of the shared exclusivity approach to approval of ANDAs for omeprazole delayed-release capsules in November 2001. As explained below, the same general principles apply to the Paroxetine ANDAs.
The statutory provision governing 180-day exclusivity reads:
If the application contains a certification described in subclause IV of paragraph (j)(2)(A)(vii) and is for a drug for which a previous application has been submitted under this subsection [containing] such a certification, the application shall be made effective not earlier than one hundred and eighty days after -
(I) the date the Secretary receives notice from the applicant under the previous application of first commercial marketing of the drug under the previous application, or
(II) the date of a decision of a court in action described in clause (ii) holding the patent which is the subject of the certification to be invalid or not infringed,
whichever is earlier.
Section 505(j)(5)(B)(iv).1
FDA's regulations at 21 CFR § 314.107(c)(1) & (2) address the beginning of 180-day exclusivity as follows:
If an abbreviated new drug application contains a certification that a relevant patent is invalid, unenforceable, or will not be infringed and the application is for a generic copy of the same listed drug for which one or more substantially complete abbreviated new drug applications were previously submitted containing a certification that the same patent was invalid, unenforceable, or would not be infringed, approval of the subsequent abbreviated new drug application will be made effective no sooner than 180 days from whichever of the following dates is earlier:
(i) The date the applicant submitting the first application first commences commercial marketing of its drug product; or
(ii) The date of a decision of the court holding the relevant patent invalid, unenforceable, or not infringed.
The "applicant submitting the first application" is the applicant that submits an application that is both substantially complete and contains a certification that the patent was invalid, unenforceable, or not infringed prior to the submission of any other application for the same listed drug that is both substantially complete and contains the same certification.
In an August 2, 1999, response to petitions from two generic drug firms addressing this issue with respect to approval of ANDAs for cisplatin, FDA stated that these regulations must be interpreted, at least in the situation with cisplatin, to make eligibility for 180-day exclusivity based on who submitted the first paragraph IV certification for each listed patent. (Docket No. 99P-1271/PSA1 and PSA2). Therefore, in cases where multiple patents are listed, multiple applicants may be eligible for periods of exclusivity for a single drug product. Based upon the statements in the petition response, and FDA's actions in approving ANDAs for cisplatin, the agency's approach had been to use a patent-based analysis in determining eligibility for exclusivity. In other words, the first applicant with a paragraph IV certification for each listed patent was separately eligible for 180-day exclusivity based on that patent. Note that, in the case of cisplatin, one of the patents upon which eligibility for exclusivity was based had expired by the time any of the ANDAs eligible for exclusivity could be approved, so the agency's interpretation did not result in a delay in approvals of ANDAs.
Exclusivity Stand-Off
The agency has recognized, however, that if eligibility for exclusivity is patent-based, without regard to the facts and circumstances of specific applications, the agency could be prevented from approving ANDAs referencing a particular drug product by multiple conflicting exclusivities, which is inconsistent with the purpose and operation of the statute. This issue is discussed in some detail in the preamble to the proposed rule addressing changes to the ANDA approval regulations. 64 Fed. Reg. 42873, 42875-6 (August 6, 1999); withdrawn 67 Fed. Reg. 66593 (Nov. 1, 2002).
The situation with omeprazole ANDAs referencing Prilosec illustrated how untenable the patent-based multiple exclusivity approach could be in certain situations, when there are multiple patents listed for the listed drug and different first applicants for these patents. Under the patent-by-patent approach described in the cisplatin petition response, different ANDA applicants would have been eligible for exclusivity with respect to different patents listed for the reference listed drug. Absent a regulatory solution, these different exclusivity periods would have blocked approval of omeprazole ANDAs indefinitely.
An exclusivity stand-off whereby each ANDA applicant's approval is delayed indefinitely would be so at odds with both the narrow purpose of the 180-day exclusivity provision and the broader purposes of 1984 Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Amendments) as to be absurd. Court decisions, including Mova Pharmaceutical Corp., v. Shalala, 140 F.3d 1060, 1074 (D.C.Cir. 1998), observe that the 180-day exclusivity period is intended as a reward to the ANDA applicant who challenges a listed patent. Such a challenge may make it possible for generic drugs to be approved before the expiration date of the challenged patent. The exclusivity stand-off would prevent the ANDA applicants who are eligible for the exclusivity from benefiting in any meaningful way from the exclusivity, and could substantially and indefinitely delay the availability of lower cost drugs for consumers. In that case, the eligible first ANDA applicants would be hamstrung by the very provision intended to provide them a benefit, and competition would be stifled by the very provision intended to encourage it. The only beneficiary of this interpretation would be the innovator who - despite the expiration of 30-month stays on ANDA approval - would see an indefinite extension of its monopoly market in a manner inconsistent with the intent of the Hatch-Waxman Amendments.
Regulatory Solution
To avoid results that cannot be reconciled with the purposes of the 180-day exclusivity provision in particular and the
Hatch-Waxman Amendments in general, the agency has sought an approach to 180-day exclusivity that both hews as closely as possible to statutory language and is consistent with the goals of the legislation. It seems clear that Congress did not anticipate, and therefore did not address, this factual situation in drafting the 180-day exclusivity provisions of the Act, and FDA certainly did not contemplate it in promulgating the regulations now in effect. As noted in the cisplatin petition response, these regulations were adopted when the agency interpreted the statute to require that an ANDA applicant be sued and win its patent litigation to qualify for exclusivity. The chances of two applicants, each of whom was first for a different patent, winning their patent litigation was extremely low.2
The text of the Act does not address the situation in which two ANDA applicants' eligibility for exclusivity will create a stand-off in approvals, and the legislative history is similarly unilluminating. Accordingly, the agency has the discretion to construe the statute reasonably to further the purposes of the statute. Alternatively, even if the statutory language could be interpreted to result in an exclusivity stand-off, such an interpretation would be inconsistent with the purpose of the statute, inconsistent with agency policy, and the agency should reject it for producing an absurd result.
Once the interpretation resulting in the exclusivity stand-off is rejected, the choice appears to be between rewarding all applicants who submitted a first paragraph IV ANDA by giving them all the shared chance to market during the exclusivity period, or rewarding the very first applicant to challenge any listed patent by giving that applicant the entire exclusivity period to itself.
Under the usual application of the 180-day exclusivity provision, the agency would approve the ANDA eligible for exclusivity whenever it was ready for approval, and the exclusivity would begin to run, independent of the approval, with the commercial marketing of that drug product or with a court decision on the patent, whichever was first. However, when two or more applicants have exclusivity as to different patents that effectively blocks one another, the approval of the eligible ANDAs (and thus the possibility of the commercial marketing trigger coming into play) cannot occur without some resolution of the stand-off. The agency reviewed two approaches to resolving the question of which ANDA(s) may be approved - and when - in cases where different applicants are first to submit paragraph IV certifications to different patents.
FDA determined that when approval of an ANDA eligible for exclusivity is blocked by another applicant's eligibility for exclusivity, the applicants that are eligible for the 180-day period of generic drug exclusivity may share the same exclusivity period. An approach that shares the exclusivity among all of the first ANDA applicants ("shared exclusivity") would reward the first applicants to submit a paragraph IV certification with respect to any listed patent, and is therefore consistent with the most natural reading of the statutory text, which refers to the paragraph IV certification for the patent. The general approach to shared exclusivity is as follows:
When different applicants have submitted first paragraph IV ANDAs for different listed patents, FDA will approve the ANDAs that are first for any listed patent as soon as they are otherwise eligible for approval. That is, if it is only another applicant's eligibility for 180-day exclusivity as to a different patent that would block approval for an applicant that is itself eligible for 180 days of exclusivity, FDA will approve the ANDA. Exclusivity for all the ANDAs eligible for exclusivity at that time will be shared, and it will be triggered by the earlier of either first commercial marketing of any first applicant or a court decision on any one of the patents that qualified any applicant for exclusivity.3 During that "shared" exclusivity period, FDA may approve any ANDA eligible for exclusivity, but no other ANDAs.
Obviously, this approach may deprive any one applicant of the chance to be the sole competitor to the NDA holder. But the exclusivity is already structured in such a way that eligibility for exclusivity does not guarantee 180 days as the sole marketed generic drug (i.e., the court decision trigger could start exclusivity before an ANDA is approved, or uncertainty over the patent could result in no marketing of an approved product until an affirmance in the Federal Circuit of a district court win). A shared exclusivity approach will limit the number of ANDAs approved during the exclusivity period to the number of "first" applicants. Moreover, it may give each first applicant some part of the benefit from removing the multiple patents as barriers to approval, when any one of those patents could have delayed approval of ANDAs. There is also a clear benefit to consumers if FDA were to approve more then one ANDA: with multiple ANDAs approved and eligible for exclusivity, it is more likely that the exclusivity period will be triggered more quickly and at least one of the generic drugs will reach the market during the exclusivity period. Past experience has shown that first generics who are the sole applicants eligible for exclusivity often find it in their interest not to begin the exclusivity period.
FDA rejected a "one first applicant" approach, which would give all the exclusivity to the very first ANDA applicant to submit a patent challenge to any patent listed for the innovator drug. FDA would approve only the ANDA of the applicant who submitted the first paragraph IV certification for any patent, regardless of the patent for which it was submitted. That applicant's exclusivity would then begin to run with first marketing or a court decision on the patent that is the subject of the first certification. During the exclusivity period the agency would approve no other ANDA for the listed drug. When the exclusivity expired, all subsequent applicants would be eligible for approval if they otherwise met the approval requirements.
The one first applicant approach would reward the first applicant to begin to clear the path to ANDA approvals by challenging a listed patent. However, the agency believes that this approach would be less consistent with the statutory language than the shared exclusivity option, because this approach would be based upon a challenge to only one listed patent (the one for which the earliest paragraph IV certification was submitted). As noted above, the statute appears to apply exclusivity specifically with respect to an ANDA containing a paragraph IV certification for a patent for which a previous paragraph IV certification has been received for the same patent. Also, although promptness in challenging patents listed early in the Orange Book is important, it is certainly not adequate to remove the barriers to approval posed by later listed patents. Finally, by vesting the power to begin the exclusivity and the marketing of the drug in the hands of only one applicant, this approach would hold the potential for delays in the approval of generic drugs because there may be no court decision on this particular patent and the sole first applicant might not begin commercial marketing of its drug product. As a result, the 180-day exclusivity period would not begin to run, and the availability of multiple generic drugs could be substantially delayed.
Thus, the agency has adopted the shared exclusivity approach as more consistent with the statutory language, and with the intent of both the 180-day exclusivity provision and the Hatch-Waxman Amendments. FDA has now applied this approach on several occasions.
Shared 180-Day Exclusivity and Paroxetine Hydrochloride Tablets
Shared exclusivity applies to Paroxetine Hydrochloride ANDAs because different applicants are eligible for 180-day exclusivity as to different listed patents.
The agency has determined that TorPharm's ANDA was the first substantially complete ANDA containing a paragraph IV certification for all four strengths as to the '723 patent, the '759 patent, the '289 patent, and the '233 patent, and as to the '291 patent for the 10 mg, 20 mg, and 30 mg strengths. Different ANDA applicants were first to submit paragraph IV certifications as to the other listed patents and strengths.
Therefore, FDA has determined that it will approve your ANDA, and the ANDAs of other applicants also eligible for 180-day exclusivity, as soon as they are otherwise eligible for approval (i.e., all patents with a paragraph III certification have expired, no 30-month stay, ANDA meets other 505(j) approval requirements, etc.). Approval of an ANDA will not trigger the beginning of exclusivity. Exclusivity will begin to run with 1) the first commercial marketing of the drug product by any sponsor eligible for 180-day exclusivity, or 2) a court decision on any of the patents as to which any applicant qualified for the 180-day exclusivity, whichever comes first. During the 180-day exclusivity period, only those applicants eligible for exclusivity may be approved. Once the 180 days of exclusivity expire, FDA may approve any other ANDAs for Paroxetine Hydrochloride that are otherwise eligible for approval.
Status of the TorPharm ANDA
FDA has determined that there is one remaining 30-month stay, relating to the '233 patent, applicable to TorPharm's ANDA. As you know, by letter of July 1, 2003, GSK requested that FDA remove the '927, '759, and '233 patents from the Orange Book. Thus, GSK has effectively abandoned its claim to that 30-month stay. There are no other barriers to approval of TorPharm's ANDA and that ANDA is being approved today by separate approval letter.
Pursuant to 21 C.F.R. § 314.94(a)(12)(viii)(B), FDA will not remove a patent from the Orange Book that has been the subject of relevant patent litigation until the agency has determined that no ANDA applicant is eligible for 180-day exclusivity as to that patent. TorPharm is eligible for 180-day exclusivity as to the '759 and '233 patents. Therefore, FDA will not remove those patents from the Orange Book until the 180-day exclusivity period has expired.
4 There has been no relevant litigation as to the '927 patent, and therefore the '927 patent is being withdrawn from the Orange Book, and will not serve as a basis for exclusivity. If TorPharm were to relinquish its eligibility
Please note that a letter containing substantially the same information is being sent to the other ANDA applicants eligible to share the 180-day exclusivity for Paroxetine Hydrochloride. If you have any questions regarding this letter, please contact Ms. Cecelia Parise, Regulatory Policy Advisor to the Director, Office of Generic Drugs, at 301-827-5845.
Gary Buehler
Office of Generic Drugs
Center for Drug Evaluation and Research
The referenced provision governing paragraph IV certifications at section
505(j)(2)(a)(vii)(IV) states that an ANDA must contain
a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug referred to in clause (i) or which claims a use for such listed drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b) or (c)... .
(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.
2 In the years from 1984 to 1998, only three ANDA applicants qualified for 180-day exclusivity. Since the Mova decision in 1999, over 70 ANDAs have received 180 days of exclusivity.
3 FDA has been asked to clarify which court decisions on which patents may begin the running of "shared" exclusivity. FDA intends that exclusivity could be triggered by a court decision on any of the patents that qualify an ANDA applicant for exclusivity as of the time of the application of the shared exclusivity: that is, at the time an applicant eligible for 180-day exclusivity is ready for final approval except for another applicant's eligibility for 180-day exclusivity as to another patent.
4 Although FDA reached a different outcome recently in deciding to immediately delist a method of use patent (the '479 patent) for gabapentin, that situation involved different circumstances. In the gabapentin case, the patent holder essentially admitted to FDA that it had violated FDA regulations in submitting the patent for listing that did not claim an approved use. Further, the court in Purepac Pharm. Co. v. Thompson, 238 F. Supp. 2d 191(D.D.C. 2002) found that the '479 patent had been improperly submitted and enjoined FDA from refusing to approve any ANDA solely on the ground that it contained a section viii statement to the '479 patent. For reasons explained in the gabapentin administrative decisions and litigation, those circumstances led FDA to immediately delist the patent. However, those circumstances are not present in this case.


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Monday, December 23, 2013
Creative Fatigue
I'm on record saying Writer's Block doesn't exist. There's really no writing problem that can't be solved by staring at a blinking cursor until you think of something.
But man do I get tired sometimes. This happened to me in the past month. I worked like crazy to get my guide to writing a novel finished and published and promoted just as I was starting a new job while still maintaining my commitment to make sure I'm getting enough time away from the computer and spending time with friends in person. It was a lot.
I got it done, I got it promoted, the job is going well, and then I had that thunk that sometimes happens when you work like crazy and wake up and realize you're creatively exhausted.
I had to let the blog slide for a while, I took a break from writing even though I'm itching to get going on a new project, and I had to trust that I would get my creative juices back when some time passed and that there would still be people visiting the blog when I returned to it.
But then I think back to 2008, which was by far the most productive year of my life. I was working twelve hours a day as a literary agent, I was blogging five days a week, and I wrote a novel on top of that, which ended up being the start of the Jacob Wonderbar series. I have never gotten so much done in a single year, and it laid the groundwork for a lot of the things I look back on with pride.
And yet I was also really unhappy. I was neglecting friendships, I wasn't feeling like myself, and I paid the price in many ways.
All of those tensions are so incredibly difficult to manage. Sometimes you have to push yourself to get things done. Sometimes you have to let things slide for the sake of your own happiness. Sometimes you have to stare at the blinking cursor until you think of something. Sometimes you have to know to step away.
I don't think I'll ever totally figure it out. All I know is I'm ready to get working again.
How do you figure out when to push forward and when to pull back?
Art: Eingeschlafen by Hubert von Herkomer
36 comments:
- Brian G said...
This article basically sums up the exact same thing I have been feeling this past month with my writing. You are right, creativity burn out is real, and stepping away from the computer is the right thing. Hope you have a great holiday and that your cup is refilled with those creative juices.
- December 23, 2013 at 12:10 PM
- Stephsco said...
I don't think you can box up the creative process to be the same for everyone. Some people write every day--I am not one of those people. Though when I am actively working on a draft, my goal is to write as many days a week as I can. When I'm editing, I may write/edit in spurts. It depends on your goals for yourself, and your life balance. Totally fine by me to turn inward for a time to complete or work on projects, but it's good to give that a break and actually talk to friends and family outside of facebook, twitter, email.
Creatives seem to come up against these hurdles often; we feel guilty for time spent away from: [name your guilt source: family, kids, church, social life]. Mothers seem to feel this acutely. I think we need to give ourselves permission to be creative, and also, to not.
- December 23, 2013 at 12:25 PM
- Fadzlishah Johanabas said...
Heyya Mr Bransford,
Bought your book on Smashwords, and I have to say, YOU DA MAN! I've bought a lot of books on the craft of writing, but I love how you use Star Wars and Jacob Wonderbar as your references. Others tend to use great American classics, which we people outside of US aren't all that familiar with.
I don't care if they're literary classics. They're still Great American Classics, and I'm not an American. Heh.
Anyway, I was discussing with my friend how both of us love the book and its relevance, but we got twitchy when we read about the non-existent writer's block.
Because it does exist.
Hear me out. I'm an emotional writer. Not to say that I throw temper tantrums, but I use my stories to evoke emotional response from readers. One of my strengths is emotion in writing. However, I was involved in a road traffic accident that claimed 1 life slightly over 2 years ago. I have PTSD and I've shut down all emotions, partly because I work in a hospital and deal with life and death on a regular basis. It's a coping mechanism.
Unfortunately, I cannot access that emotional well anymore, and how do I affect readers when I am not feeling it myself?
I can write for my day job. No problem. But the few stories I've written since the accident are somehow lesser. For someone who's all about emotions, this is not a good thing. So in a sense, writer's block does exist. It happens when you cannot write using your full capacity.
- December 23, 2013 at 12:29 PM
- crow productions said...
Your blog during those years was the foundation for me to understand what I was undertaking when I stared at the blinking cursor as I had finished a first draft. Thank you for all the helpful knowledge you shared. We rode the wave a change with you as the publishing industry was changing right before our eyes. After many query letters sent, and many lessons on "How To Write a Query Letter" I decided to ride the wave of self publishing. After many rewrites and a year of editing, my book is available on amazon.com.
My work now is getting people to read it.
- December 23, 2013 at 12:34 PM
- Fred said...
I don't have a problem letting go when I'm tired and writing feels like a chore. Forgiving myself for it is another subject.
- December 23, 2013 at 12:51 PM
- AD Starrling said...
I strongly believe all writers go through this phase if not once, then several times during their careers. We all yearn for that elusive balance where everything is perfect, where not only are we happy successful writers but also great life partners, parents, and friends, as well as being healthy and fit. But that's not life.
In the end, it comes down to priorities and what's important to us at that stage in our lives. If we want something bad, if we have a dream, we're going to have to make sacrifices to get there. But that doesn't me ignoring the warning signs. If you can see yourself heading for a burnout, then try to put the brakes on. Even if it's just a day or weekend break, ideally somewhere different (not home because that sure as hell doesn't work). Plan rewards along the way that will make the hard work worthwhile.
It's also about realising that before everything else (the writing job, the partner, the friends), we are human beings. So let's give ourselves a break. Look at the road we have travelled already and all that we have achieved. Learn from past mistakes. Then take a deep breath and look to the future.
- December 23, 2013 at 1:33 PM
- Cat Moleski said...
I definitely feel the ebb of creative juice between projects or drafts. I try to gently come back and check in to see if I'm ready to write again and if not, recognize that it is likely a temporary lull and that I need to focus on other things: walks, people, reading, painting. I have yet to face that blinking cursor though when a deadline is looming and I wonder if I'll be able to be as gentle with myself then. I hope so. Thanks for all your blogging, it has had an impact on my writing life.
- December 23, 2013 at 2:41 PM
- Norma Beishir said...
Been there--I went through a major creative burnout years ago. I thought--I still think--it came from trying to continue a career writing something I was never suited to in the first place.
- December 23, 2013 at 3:07 PM
- Ted Cross said...
I go through long phases of burnout and just put writing aside until I feel the urge return. Then I write as many chapters as I can before the burnout hits again. Not sure it's the best method, but it's all I have until I can retire from my career.
- December 23, 2013 at 4:16 PM
- Terin Tashi Miller said...
It is the standard conundrum of particularly writers (perhaps more than some other artists).
You need to be in the world to get material for your writing, at least somewhat and sometime, rather than just locked in a little room drawing entirely upon your own imagination.
At least I do.
And, you cannot write in a crowd, or in the middle of a conversation, or when you're supposed to be relating to others.
It's a juggling act, like most of life. Often, for me, interactions are far more out of my control than writing: I have little to no input on when they occur, or how, or where, or with whom.
On the other hand, that's also part of the rather randomness of life.
I take breaks from writing, and projects, when life dictates and demands that I do. Like now, essentially, during the holidays.
I go at it hard and with renewed determination when the obligations of life seem taken care of, and suddenly "free" time, as in not time from me someone or something else requires, presents itself. Or I declare: "I'm writing for the next two hours."
I find like with many emotions as well as thoughts, however, writing benefits from building up pressure. If you relieve the pressure constantly, it will not be as strong to drive the idea or project as if you (or I) let it build.
Or so goes my current theory.
I'm in the midst, really the beginning, of a project more than one person has suggested to "do it right," I'll need to concentrate on it for something like three years.
I look at this project--and much of writing--like a sporting competition. I'm at the beginning of training for it. I'm in the windsprint, situp, crunch and heavybag stage.
If you don't take time to build up your muscles, your stamina, your pacing, your reactions, you'll get gassed before the project is through. If, however, you've trained hard and are physically and mentally ready, it won't matter how many rounds you have to go with your characters. Or how many times you have to pick yourself up off the canvas.
See you on the other side, Mr. Former Agent Man. Happy 2014, and I am grateful and thankful for 2013's successes!
(And your blog).
- December 23, 2013 at 6:57 PM
- Kristi Helvig said...
I can so relate to this, and I'm not sure I'd believe anyone who said they had the whole work/life balance thing perfected. I push ahead when I have to (aka when my editor tells me she wants my sequel yesterday), but then I pull back again for a bit. I do much better working with ebbs and flows rather than forcing it, though I know this contradicts the "butt in chair" wisdom. I think there's no right answer, and everyone has to find what works best for them. Happy holidays!
- December 23, 2013 at 9:10 PM
- wendy said...
I think creative burn out ties in with our energy levels. Energy is everything and when low our mind doesn't function as well as it should...so of course everything seems much harder.
You've achieved so much over the last few years, and you've certainly worked for it, Nathan. You deserve a break to just contemplate and dream.
Have a wonderful Christmas and an even more successful New Year. Btw, if you get a chance, check out Saving Mr Banks - recently released movie.
- December 23, 2013 at 10:20 PM
- Anne R. Allen said...
I think your instinct to take a break is a good one, Nathan. I've read scientific articles that say not only does creative burnout or "writers block" exist, but that it can be dangerous. It's a warning that we need to switch brain gears. The part of the brain used for creativity is the same one activated by depression, so the two are linked. They say "burnout" can be the first sign of depression, so it's time to stimulate other parts of your brain. Dance, sing, go out with friends and tie one on, whatever. But stop with the staring at the cursor thing. That's probably why your most productive year was not a happy one. I have a hard time breaking away from writing myself, but I'm planning on working less and taking care of myself more in the coming year. Balance is good. Congrats on your book!!
- December 23, 2013 at 10:43 PM
- Mira said...
Interesting topic.
So, my opinion - I think there are times when it's good to push yourself, but the trick is knowing when those times are.
For me, there are a couple of important things here. First, re writing, I believe that quality is much more important that quantity. And quality comes when you are in touch with yourself, when you can access your inner world, and let the muse speak. That takes rest and being with yourself.
Stress, fear, pressure, these all block our access to our inner wisdom. Time with ourselves, and also time when we get out of ourselves, fun, connection, nature, contemplation, quiet, peace, all these things help us stay balanced inside, and give us access.
The other important thing is that (I believe) balance and rhythm are not discovered through the part of our mind that 'thinks' about things. It's a more organic process. It's something we learn, and feel our way through, rather than deciding it - if that makes sense.
Over time, what happens is you get to know your own rhythm and trust it.
For me, and this is just for me, the time to push myself is when I'm scared. When I have something to say, but I'm avoiding saying it - that's when it's time to push.
Although, regular routines of writing, if they are not too onerous, and held lightly, can be really valuable, too.
As for the blog, I find I'm very open when folks take breaks, but it helps if they tell me they are going away for awhile. Then I don't feel left hanging. But that may just be me, it may not matter to others.
- December 23, 2013 at 11:23 PM
- RC O'Leary said...
Nathan, I've always found comfort in St. Barton's ode, which can apply to many situations:
"I am hurt by I am not slain, I'll lie me down to bleed a while and then I'll rise and fight again."
You can modify it to "I am weary, but I am not done, I'll lie me down and rest a while, and then I'll rise and "write" again."
- December 23, 2013 at 11:44 PM
"How do you figure out when to push forward and when to pull back?"
You should really be looking for something in between those feelings. A pace you're comfortable with. If you feel the need to push forward or pull back something is off and needs to be fixed.
- December 24, 2013 at 12:53 AM
- Bruce Bonafede said...
"How do you figure out when to push forward and when to pull back?"
Many good comments here. For me it's simple. My nature is to push forward, always, constantly, until I can't anymore. And when I can't, I stop for awhile. And I don't worry about it. I've had to take a break from writing lots of times in my life, but I've never have a problem starting again. I trust Old Man River to just keep rolling along.
- December 24, 2013 at 1:51 AM
- Nicole L Rivera said...
If I know that whatever I write I'll have to toss the next day, then I pop in a movie or open a book or go for a walk and call it a day. :)
- December 24, 2013 at 8:32 AM
- Lori Schafer said...
I totally sympathize, Nathan. I'm like you; I don't suffer much from writer's block because I can always find something I feel like doing - if I don't want to do something original, I can edit, or if I'm not in the mood for fiction, I can write an essay, and so on. In the summer I can work from before breakfast until nearly bedtime and still not get burnt out. But there are certain times of year in which I am so busy with my day jobs that I can't do any writing at all. If I only have an hour free on any given day, I just don't have time to get in the mood to be creative. So if I have deadlines or particular projects I have to complete during those times, then it's a tremendous burden, because I'm trying to force myself to be "creative" on a schedule, which I don't think works very well. Although technically I'm not spending any more time working, it's much harder, and the results usually show that pretty plainly. So I take a break. I do not have time to write this month, I tell myself. Next month I can write again. And I will enjoy it more because I gave myself some time in which to miss it.
- December 24, 2013 at 11:05 AM
- Laurie Boris said...
When I grow grim about the mouth and want to knock people's hats off... Seriously, if I take the time to listen to my body, I can usually tell when I need to go out and play, or work on other things. Trusting that the empty well will refill is another part of it.
- December 24, 2013 at 11:10 AM
- Julie Musil said...
I've been feeling this way for the past few days. So much to get done. BUT…my kids are home from school. Work will get done, but I can't get these moments back with my kids. Balance is a tricky bugger.
Merry Christmas, Nathan!
- December 24, 2013 at 11:15 AM
- Avery Tingle said...
Well, this is just me, but I have a book in progress, I work a full time job, I'm in the middle of a divorce (and new relationship) and I'm dealing with legal issues surrounding my kids. I GOTS the creative exhaustion.
This may sound arrogant but to me, the work has to get done, no matter what else may be going on, so I deal with the exhaustion by completely walking away. Usually, the Muse in my head will be like "Wait, you're really stopping?! Okay, wait! I'll tell you everything!" But I put the work aside, maybe for a few hours or a few days, and I get back to the things I love. I read. Play video games. Watch football. Remember that I absolutely love what I do and get back to it, reminded that I am doing this so I never have to do anything else again. That's how I deal with it.
- December 24, 2013 at 11:40 AM
- JDuncan said...
Ditto, Nathan. I get the creativity doldrums or whatever you want to call them a couple times a year. Two to six weeks usually, where the interest to write stuff just isn't there. Then, for reasons I don't fully understand, the stories start popping in my head once more, the characters start doing things, and I get back to it. The worst is trying to write through those lows. Nothing is good, it's tedious, forced, and not enjoyable in the slightest. I've concluded that it's just the way my brain works. The ebb and flow of creative energies. The best one can do is just roll with it.
- December 24, 2013 at 11:44 AM
- abc said...
I haven't yet had this thing you speak of. Maybe I'm too busy not being busy. This is an opposite sort of problem. Sometimes unhappiness can creep in here too. Actually, I'm exaggerating, But I wish I was busier with creativity vs. stressing about the job or the kid or that I'm eating poorly and not exercising enough or that my dog's teeth really need a cleaning! You know, life. I want some more creativity loaded in.
Merry merry Christmas, Nathan! Whatever you do I know it will definitely be worth our attention. I have loved your blog and your books! And I hope that you can find that balance you want. I suspect that because you are so thoughtful and aware, you are already half way there.
- December 24, 2013 at 10:15 PM
- Robin Storey said...
I know exactly how you feel. After publishing two novels this year and doing all the necessary marketing,as well as holding down a part time job and trying to fit in family/friends time, I was exhausted. I was trying to start my next novel but it just wasn't happening, so I decided to take a complete break from writing until the beginning of 2014. It seems to have worked - I can feel my creative mojo gradually returning. It's the old 'can you have it all?' question? And I seriously think, no you can't. If you want high productivity, you have to make sacrifices, and sometimes they just aren't worth it.
- December 25, 2013 at 8:45 PM
- Nicole said...
Just like you - I try to find that balance, don't always get it right, learn and readjust. ;) You're right about it being exhausting sometimes!
- December 26, 2013 at 2:24 PM
- Carolynnwith2Ns said...
I can't step back and let go because I am on deadline. My column comes first, projects second and somewhere along the way I figure out how to have a life...which includes a full time job and family.
It's called plate spinning...I do it well...so far.
- December 27, 2013 at 9:51 PM
- Lisa Lane said...
I give myself a short break in between projects. I tend to write myself into the ground whenever I'm nearing the end of a book. All concern over health and personal well-being go out the window, and typically I'll complete the final 10,000 words in two or three days. I have no choice in the matter; the writer in me is compelled to do it.
When I've finally finished whatever I'd been killing myself to get done, the physical and mental fatigue can be quite profound. The well, so to speak, has run dry and needs time to refill. I've also expended so much time and energy that I end up physically ill. It's not uncommon for me to spend a week (or longer) in bed because the abuse I've put my body through has triggered a lupus flare.
When I'm too exhausted to write, I brainstorm. When I'm burned out and feeling out of ideas, I shift gears and work on something entirely different. When I'm too tired or burned out to do any of those things, I'll grab my Kindle and read someone else's writing. :-)
- December 28, 2013 at 4:16 AM
- Anuradha said...
Finished a novel, published it and promoted it and already on to the next one and everything else and facing 'creative fatigue'? It is going to happen when you work that hard.
But, if you are hard(ly) working, no problem, Trust me!
- December 28, 2013 at 11:03 AM
@ Fadzlishah Johanabas--I've been going through something similar. While it's (the emotional trauma)thrown up some blocks, it's made me come up with ways to go around and sometimes through them. I've taken on a different POV, experimented with different subject matter, genres and styles of writing. I've tried writing through different sorts of characters and spoken--sometimes more comfortably, sometimes less--through narrators. I don't know that any of it has led to great creative achievement...I'm simply relating it and perhaps suggesting it as a process.
Any way you look at it, it's part of life, part of what makes us who we are. And the way we deal with it (or don't, which is also a way of dealing with it and changes us accordingly) changes our writing: subject matter, voice, what we even care about and think is worthy of putting into words. It can pare down, expand or show you different ways of conveying your message.
I think, for me, that emotional disconnect has led me back to less telling and more showing. There can be great emotional impact in the fact that your character (maybe you) can't say...find the keys to his (recently deceased) father's car though they're right in front of him or that he can't look someone in the eye or pay attention to things he feels are important, though he once could...that he's exhausted and can't find the strength to get out of bed. Maybe these are things you've been going through, maybe not.
If they are, and they're part of your new reality, they'll find their way into your writing. Maybe directly, maybe indirectly, but I believe they'll come back to you. That the emotion you're missing in your writing will come back to you and it will likely be stronger and more resonant.
- December 28, 2013 at 9:50 PM
- Dan said...
I've also been one to say writer's block doesn't exist and I stand by that. But we do need short breaks. And there will be times we look at a blank page. It's all part of writing. For me, if I struggle writing in one format (novel), I'll work in another (blog, song, or journal).
- December 30, 2013 at 8:27 AM
- Magdalena Munro said...
Happy New Year Nathan. Be kind to yourself and simply go with the ebb and flow of your nature. I'm still reading your blog and did so back in 2008 and continue to do so today. :)
For me, writer's blockage typically stems from fear vs ability as the essence of me is always there. Fear of mediocrity, fear of failure, fear of self loathing..on and on.
Here's hoping that 2014 brings you meaning, authenticity, and joy.
- January 2, 2014 at 7:21 PM
- ammi roy said...
Keep working, great post! Just what I had to know.
jeux dora 2014
- January 4, 2014 at 5:22 AM
- David Gaughran said...
Sometimes you just need to unplug completely. Hope you managed that over Christmas!
- January 5, 2014 at 6:25 AM
- thewriteedge said...
Thanks again, Nathan, for sharing your thoughts in book form as well as the short email exchange we had. Here's my official review of the book, although I knew long before I read it that I would love it.
- January 6, 2014 at 12:55 PM
- Suzan Robertson said...
When I get tired of working on my mss, I may put it aside for a day or two and do something arts-related or get outside, like taking a walk, listening to new music, drawing, watching a movie, a play or ballet. Or I look through my ideas folder and work on something else for a while.
Sometimes I brainstorm with my writer friends, too.
- March 17, 2014 at 1:07 PM


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Whether you're painting en plein air, going to or from a class, or just looking to safely store unfinished paintings, this superb canvas carrying case from Jullian is sure to please! Made from strong yet lightweight bass wood, this sturdy case securely carries and protects wet paintings during transport. Adjustable interior dividers let you carry as many as 6, 3/4" canvases in a range of sizes up to 16x20". The lid swings smoothly on brass plated hinges and latches securely shut, while a leather handle and an adjustable linen shoulder strap make carrying a breeze. Just slide a wet canvas between the dividers and shut the lid to keep it safe between painting sessions. Enjoy the freedom of painting outdoors without worrying about damaging your wet paintings — keep them safe and secure in the Jullian Canvas Carrying Case!


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By Karl Ginter on September 29th, 2009
Categories: Company News, New Site Features
Although our old design brought in a load of development leads and was featured in many CSS design showcases throughout the web, it was still time for a change. Because we are currently in the development of many massive client projects, there aren't enough hours in the day, especially to try and get away from the client work and re-design our internal portfolio site.
It was at that point I decided to take on the project myself, from design right through to development. With the help of our talented programmer – Andrew Johnson for the behind the scenes work, my ideas and design were brought to life.
Here are just a few of the features of the new site:
Who Are You Guys? – Our previous site didn't feature much information about who we are and how we got here. Our About Us section now features a Company Overview, a full listing of our Team Members, a description and photos of Our Office, as well as a summary about the Priceline Partner Network and Client Testimonials.
Full Portfolio with Case Studies – Each of the project featured within our portfolio now have individual case studies. You can now read an overview about each project, as well as development details, and view screenshots of the actual live site.
Services Section – Our Services section has been revised to include a full breakdown of our web development process. Our other services are also highlighted with a full description of each.
I really hope that everyone enjoys the new site. Please feel free to comment with any feedback.


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Adventure tours in South Africa. Are you looking for some real african adventure. Tours, Wildlife Safaris, White water rafting, horse trails in the Drakensberg or game viewing on horseback. All this and more can be arranged while you base yourself at our delightful guesthouse in KwaZulu-Natal South Africa in the foothills of the Drakensberg.This thatch cottage is a charming and romantic retreat for any visitor with it's wooden interiors. The name of this cottage comes from a previous "resident" who lived beneath the floor boards before restoration. Here you will find that comfort & hospitality are part of the whole experience of The Antbear. A truly unique stay. A revisit will be a must as Antbear has a perfect recipe for relaxation. Here you have the option to have all your meals, bed and breakfast or to self-cater. And meals are part of the surprises at the Antbear has on offer.
Situated on a hill with breathtaking views of the mountains and surrounds this country guesthouse overlooks the Bushman's river, which rises in the high Drakensberg near Giants castle and meets the Tugela north east of the small town of Weenen. The area really has much to offer everyone.
Adventures and day trips can be planned to accommodate your needs and abilities. Action day adventures can include exploring a game reserve on Horseback, 4 x 4 Off road Routes, Hiking Trails, Mountain Bike Trails, microlight Flights and Safari drives. We do not actually take you on the tour ourselves rather we bring you in connection with experienced guides who offer these services.
Safari drives: Explore a game reserve on horse back and view giraffes and zebras from only a few paces in the Weenen and Spionkop game reserves. These especially scenic game parks without malaria offer the possibility for day trips, an especially interesting option with a guide. Trails through the parks are especially rewarding regarding game sightings.
4 x 4 Adventures: There are many back roads here which make for delightful 4x4ing
White water rafting: Tractor tubes make for a different experience floating down the Bushmans river. We guide you down the river and after you end at Moorpark nature reserve we reward your hard work with delightful picnic fare.
Township experience: We will take you to experience exactly how most of the people live in this country. This is not a tourist show like most of these tours but rather an attempt to let tourists experience the real thing.
Canoe safaris: An adventure paddle into the wilds of Wagondrift Dam. Experience the scenery, bird life and places of interest from a new point of view.
Hiking Trails: The surrounding areas of the Antbear offer easy to adventurous hiking trails. Overnight hiking can be arranged where you sleep in a mountain hut, tent or bushman cave in Drakensberg. Day hikes here are as numerous as the mountains that surround us. The Drakensberg is renown for some of the best hiking available anywhere in the world.
adventure tours South Africa
(c) Copyright 2001 Antbear Guesthouse


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Government may be trying to force FedEx into settlement, experts say
By adding money laundering to the charges against FedEx Corp., federal prosecutors are trying to force the package-shipping company to settle its drug- trafficking case, attorneys and analysts said.
"This looks like it's a matter of ratcheting up the pressure," said Larry Cote, an attorney at Quarles & Brady LLP in Washington and former associate counsel with the U.S. Drug Enforcement Administration. "It's like charging someone with murder and then adding an underlying weapons charge."
Allegations of conspiring to launder money were added on Aug. 15 to July conspiracy and drug-trafficking charges alleging that FedEx delivered drugs for online pharmacies, supplying pills to customers who were never examined by doctors, while knowing the actions violated federal and state drug laws. FedEx says it's innocent of all counts and will fight the case in court.
The new charges, along with the amount of money and time involved to rebut the accusations and on public relations efforts, might make a settlement without an admission of guilt the best course, said Kevin Sterling, a BB&T Capital Markets analyst in Richmond, Va.
"They're trying to throw the book at FedEx," Sterling said in an interview. "The government is pushing it and, unfortunately, probably the best course of action, the quietest course, is to settle. They're trying to make life as miserable as possible for FedEx."
FedEx slipped less than 1 percent to $150 at the close in New York. The shares have risen 4.3 percent this year, compared with a 7.2 percent gain for the Standard & Poor's 500 Index.
Lillian ArauzHaase, a spokeswoman for U.S. Attorney Melinda Haag in San Francisco, didn't immediately return a voicemail message seeking comment on the new charges.
FedEx "cannot estimate the amount or range of loss, if any," from a conviction, the company said in a July 17 regulatory filing. "However, it is reasonably possible that it could be material."
FedEx Chief Executive Officer and founder Fred Smith "can keep fighting it, but there's also a cost to that," Sterling said.
The added money-laundering charges "can turn up the heat a bit on the company," said Tim Crudo, head of the white collar defense and government enforcement practice at Coblentz Patch Duffy & Bass LLP and former assistant U.S. Attorney in San Francisco. Anything linking FedEx to the illegal drug distribution charges "gives a jury another hook" on which to convict, he said.
As part of a crackdown on prescription drug abuse, United Parcel Service Inc. agreed last year to forfeit $40 million in payments from illicit online pharmacies under a non-prosecution agreement with the U.S. Justice Department. Walgreen Co. and CVS Caremark Corp. have paid a total of more than $150 million in civil fines over claims they sold medications knowing they weren't for legitimate medical use.
FedEx on Tuesday reiterated its innocence on all charges in an emailed statement. The Memphis-based company has said "settlement is not an option" in the case.
"We will continue to defend against this attack on the integrity of FedEx," Patrick Fitzgerald, FedEx senior vice president for marketing and communications, said in the statement. The company has said privacy rights of customers who ship 10 million packages a day are essential for its business.
FedEx and its co-conspirators could face a fine of twice the gains from the illegal conduct, alleged to be at least $820 million. According to the Aug. 15 charges filed in federal court in San Francisco, FedEx, along with others, ran the illicit pharmacies "knowingly and intentionally" and schemed to launder more than $630,000 in shipping payments that were derived from drug sales.


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Inbal Ofir's Profile
A few years ago, a good friend of mine asked me to babysit her sewing machine. I gladly accepted, I just asked her to show me how to turn the thing on and how to put the threads in…
I had no clue about sewing, but a very keen sense of curiosity, which lead me to test every nut and bolt in the new toy... and buy L-O-T-S of fabrics.
By the time my friend asked for her machine back, I was already in love with the huge lump of metal and shortly afterwards, bought my first very own sewing machine!
My storage room was quickly emptied; all its contents were split among friends, sent back home to my parents or given to charity. Shelves were installed, lighting was amplified and a huge door became a worktable; threads, fabrics, buttons and especially pins were scattered all around - the studio was born!…
- Female
- Born on July 6
- Joined August 4, 2011
Favorite materials
- Inbal Ofir
- Tel Aviv, Israel


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Uses of Powerprep for GMAT
Powerprep for GMAT Preparation
PowerPrep GMAT (GMATPrep) software is one of the best software available to prepare for GMAT. The Graduate Management Admission Council (GMAC) designed the software as a diagnostic test for students to measure their aptitude or readiness to appear for this test. You can either download the free version or order the CD-ROM from the following weblink:http://www.mba.com/the-gmat/download-free-test-preparation-software.aspx
The questions in this software are designed using the pattern of questions in the actual exam. Because it simulates the actual test, you can understand the kind of questions to expect. It includes practice questions for each type of question. This is supplemented with detailed answers and explanations. It also includes two full-length computer adaptive practice tests, wherein answers are included but explanations are not provided with the answers. It also comprises of GMAT pacing practices and a comprehensive review of the Math section.
Making the best use of Powerprep for GMAT (GMATPrep)
The way you use this software depends entirely on you. You might want to go through all the tests on a day-to-day basis until there aren't any tests remaining. Doing so will exhaust the question bank and you will face the same question the next time you access the software. It is usually best to leave one test so that you can attempt it prior to the actual GMAT to check your readiness for the exam. Because it provides you with near accurate scores, you can judge whether you are prepared to face the actual test. If you feel that you have "run out of questions" in the software, you can re-install the software so that the questions do not appear as "used". The following websites provide information on installing and re-installing the software to gain maximum output:
- http://www.beatthegmat.com/gmat-prep-reinstall-t12545.html
- http://gmatclub.com/forum/gmat-prep-power-prep-official-free-gmat-tests-77548.html
The advantage of using this is that the question bank for the quantitative section is much larger than the question bank for the verbal ability section. As a result, if you take tests repeatedly, you will notice more new questions from the math section than the verbal ability section. However, the question bank for the tough set of questions is relatively small. It is best not to expect tough questions when attempting from the software because the test is not adaptive. It is only designed to give you a feel of the test interface and the actual test. Because of time constraints, the actual test does not have many tough questions. In order to download the software, you need to register yourself on the official website.
A Word about the Software
However, there is a caveat to this. Unlike the early years when it was launched, it is not a one-stop-shop for practicing test papers. It is important that you supplement this with other practice tests so that your preparation is complete. You must remember that the software is only an indicator of how you will fare in the exam. Therefore, it would be wise to use the score to prepare adequately for the test.


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This traditional-style keyboard addition to the Hammond XK-3 shows the versatility and power of the XK-3 platform. With no modifications to the XK-3 itself, adding this lower manual converts the XK-3 to a double-manual electronic keyboard with similar styling to a traditional B-3.
Our product catalog varies by country due to manufacturer restrictions. If you change the Ship-To country, some or all of the items in your cart may not ship to the new destination.


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The Lollipop Leggings are the perfect year-round staple with an extra touch of fun! The Lollipop Leggings PDF Sewing Pattern is designed as a layering item with a nice snug fit and the perfect rise to keep little bottoms covered.
Options Included:
-Button Tab
Lengths Included:
Double the fun with a matching pair for dolly! Designed to fit 18" Dolls.
PDF Sewing Pattern comes with a full tutorial and color photos in an easy to print PDF. Pattern pieces are computer generated and color coded for easy cutting.
3 mos.
6 mos.
12 mos.
18 mos.
18" Doll
An instant download link will be sent to your email as soon as payment is completed. Save the PDF to your computer and print off as many times as you like.
You may sell items made with this pattern. You may not resell, copy, or redistribute this pattern in any form.
Fabric courtesy of The Fabric Fairy
Showing reviews 1-20 of 26 | Next
Posted by Kim on 13th May 2017
I have 2 granddaughters. One is 5 and the other is a newborn. This pattern is great because I can use it for both of them. I have made at least 6 and they are so easy and fun to sew.
Posted by Claire on 25th Feb 2017
Love this pattern. Quick and easy!
Posted by Unknown on 4th Oct 2016
This pattern is great! Very easy, works up quickly, and perfect for someone new to sewing with knits. I made 10 pairs of leggings for my girls in one weekend!
Posted by Sarah on 27th Sep 2016
This pattern has a great fit! Very simple, and easy to make adjustments if needed. The instructions are easy to follow, and Amy is always ready to answer questions and help out.
Posted by Susannah Harper on 7th Apr 2016
this is such a great pattern, it's perfect for my leggy 4.5 yr old! I made them in under half an hour, including cutting out, with most stitching down with my overlocker. simple and quick!
My recipient wasn't home when i made them and i hadn't measured her legs in a while (long legs) so i cut them a little longer than the pattern but shouldn't have continued shaping them as it made the cuffs a little tight. they ended up being too long (a first for any pattern i've bought for her!) so i redid the hems shorter
Posted by Jessica on 3rd Jan 2016
I can't say enough great things about this pattern. They fit my daughter perfectly, they are super quick and easy to make and the possibilities are endless. These are the only type of pants my daughter wears because jeans are uncomfortable for her so I am making endless pairs of these! Not only are they great pants they look adorable to wear under dresses as well to play in the park or when the weather gets cooler. The skirt option is just too cute as well as the button tabs. If you have a little girl you must buy these!
Posted by Maud b d on 27th Sep 2015
Very easy to sew and fits well
Posted by Jacque on 26th Sep 2015
Simple design and easy to make. Good staple for any little girl's wardrobe.
Posted by Tristin Pitts on 23rd Sep 2015
This pattern is perfect!
Posted by Melinda on 28th May 2015
My daughter loves her lollopop leggings. I upcycled some of my older daughters T-shirts to make leggings.
Posted by Sandy Willis on 17th Apr 2015
What a fun pattern to work with! I have several Peek-a-boo patterns. Easy to follow, print, and sew with! Thank you!
Posted by Lynne on 17th Apr 2015
I decided to add ribbing as the waistband. My darter in law loved that because it ensured the baby's back was covered.
Posted by Cristen Dorman on 15th Jan 2015
I made my daughter a pair of 18 month leggings, the pattern has clear directions which is great for a newbie like me, I can't wait to make her the skirtie leggings next!
Posted by Cheryl on 26th Dec 2014
A super easy sew that looks so cute! Made four pairs for my niece and she LOVES them!
Posted by Meg on 14th Dec 2014
These leggings are adorable and work up FAST--about 30 minutes or less. Definitely saves me from buying a bunch! Thank you for the fabulous pattern, Amy!
Posted by Unknown on 6th Dec 2014
This pattern is easy to follow although for a beginner I did struggle with the instructions for the ruffles. I believe there are easier ways to do them than as described. I also found the sizing perhaps a little inconsistant. My daughter measured to fit a size 2 but traditionally she is in size 4 and she definitely needed a size 3-4 in this pattern! Otherwise easy sew for beginner.
Posted by Claire on 4th Dec 2014
I made my daughter some leggings and she loved them! They were such a quick and easy sew and I am a beginner!
Posted by Linda on 9th Oct 2014
I have purchased other patterns from Peek-a-boo patterns before. This one was just as awesome as all the others. I love the skirt option, to dress up any onesie or t-shirt.
Posted by Ellen Siegel on 7th Oct 2014
The lollipop leggings is one of the easiest patterns to make . I have made 8 pairs now and the fit is great.
Posted by Unknown on 26th Sep 2014
A great pattern! Fits my skinny mini toddler really well with some extra length (her pants always need more length). Sew up very quickly, you can make several pairs in an hour. Highly recommend this pattern!
Showing reviews 1-20 of 26 | Next


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Choose Between Two Options
$99 for one body-slimming package (a $289 total value)
- One 60-minute body-slimming treatment (a $200 value), which employs electrical currents to contract muscles, encouraging inch loss while toning
- One 30-minute hot ginger body wrap (a $50 value) to further promote inch loss
- One 30-minute infrared sauna session (a $39 value), which works to trigger the metabolism and promote detoxification

$289 for three of the above body-slimming packages (an $867 total value)

Body Lounge Spa
The staff at Body Lounge Spa cossets skin during rejuvenating facials and body wraps, and redefines nails while patrons recline in cushioned red pedicure thrones. Guests can sip a glass of wine at the beverage bar as they take in the earth-toned décor grounded in deep chocolate and caramel tones. Massage therapists then invite patrons to rooms illuminated with candles, where treatments such as the energizing Thai massage combat stress and render muscles loose enough to bound up an escalator that's going down.


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December 21, 2012
Read the full review here…
Make ideas stick with reusable dry erase sheets that cling to almost any flat surface. All our products are made from recyclable, statically charged polypropylene film that sticks with static. These products provide a fantastic alternative to flip charts and whiteboards. Read More >>
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Well everything is fine and all.
Had a medical procedure done today...
Won't go into detail.
Work is work....
4th of July is near, and I'm ready to blow shit up.
Anyway tired of being single. ( 5 years now)
I wish there where some people from Georgia on this site ( the state not the country) but a