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Latest Heart News MONDAY, cheap lasix online Nov. 30, 2020 (American Heart Association News)People with heart failure who eat a diet high in foods that cause inflammation are twice as likely to end up in the hospital or die as those who eat foods known to reduce inflammation, new research shows."If people with heart failure can reduce the amount of pro-inflammatory foods that they eat, it might help with their survival," said lead researcher JungHee Kang, a nursing research assistant and PhD student at the cheap lasix online University of Kentucky in Lexington.Diet has been shown to play a role in regulating inflammation, which is associated with many chronic illnesses, including heart disease. Diets high in foods such as red meat, refined grains and high-fat dairy products have been shown to increase inflammation, while foods such as olive oil, whole grains, and fruits and vegetables have been shown to lower it.Kang looked at data from a previous study in which her team asked 213 heart failure patients to keep diaries of what they ate for four days.

They then categorized cheap lasix online the diets using an index that scores foods based on whether they increase or decrease inflammation. After following participants for a year, they found those whose diets had higher inflammatory scores were more than twice as likely to die or be hospitalized compared to those whose diets had lower inflammatory scores.The results were presented at the American Heart Association's virtual Scientific Sessions earlier this month. The research is considered preliminary until published in a peer-reviewed journal."It's well known that diet plays a critically important role in cheap lasix online the development of heart disease and stroke," said Dr.

Amit Khera, professor of medicine and director of the preventive cardiology program at the University of Texas Southwestern Medical Center in Dallas. "This is a cheap lasix online reminder that diet is important. The only surprise to me was the magnitude cheap lasix online of the effect."Khera said the study also was important because it looked specifically at heart failure outcomes, whereas previous diet studies focused more on heart attacks and strokes.

According to AHA statistics, an estimated 6.2 million U.S. Adults have heart failure, which occurs when the heart doesn't pump enough blood and oxygen to cheap lasix online support the other organs in the body.Many diets that are considered heart-healthy "have more in common than they do differences," said Khera, an author of AHA and American College of Cardiology guidelines for preventing cardiovascular disease.For example, the Mediterranean diet, which describes an eating pattern common in countries bordering the Mediterranean Sea, includes olive oil as a primary fat source, a lot of fruits, vegetables, grains, beans, nuts and seeds and low amounts of dairy products, eggs, fish and poultry. The DASH (Dietary Approaches to Stop Hypertension) diet, meanwhile, was designed to help lower blood pressure.

It also includes a lot of vegetables, fruits and whole cheap lasix online grains and limits foods high in saturated fats. But the DASH diet allows more protein from low-fat dairy, meat and poultry.The guidelines recommend plant-based and Mediterranean eating patterns, while limiting processed meats, refined carbohydrates, cholesterol, sodium and sweetened drinks."There's a lot of overlap," Khera said. "It's like cheap lasix online a Venn diagram.

The sweet spot is in the middle."What's needed now, Kang said, is research to confirm cheap lasix online whether anti-inflammatory diets can be used to reduce heart failure mortality.American Heart Association News covers heart and brain health. Not all views expressed in this story reflect the official position of the American Heart Association. Copyright is owned or held by the American Heart cheap lasix online Association, Inc., and all rights are reserved.

If you have questions or comments about this story, please email [email protected] QUESTION In the U.S., 1 in every 4 deaths is caused by heart disease. See AnswerLatest Heart News By cheap lasix online Cara Murez HealthDay ReporterMONDAY, Nov. 30, 2020 (HealthDay News)Here's a good reason for women to take a heart attack more seriously than they might.

A new study shows that women are more likely to develop heart failure or die within five years of their first severe heart attack than cheap lasix online men are.Though the gender gap was narrower for a less severe type of heart attack, that wasn't true with a more severe type, according to Canadian researchers who discovered women have a 20% greater risk of developing heart failure or dying within five years.Why?. The study found a few clues. Women were generally older at the time of cheap lasix online their heart attacks and had more risk factors that could have increased their heart failure risk, but they also were seen less frequently by a cardiovascular specialist, were not as likely to have been prescribed heart medications, and had slightly lower rates of certain surgical procedures.Women tend to be about 10 years older than men when they first have heart attacks and there may be some barriers that can be resolved by improving elder care, said study co-author Dr.

Justin Ezekowitz cheap lasix online. He's a cardiologist and co-director of the Canadian VIGOUR Centre at the University of Alberta, in Edmonton."I think still there is a gap that needs to be better understood. I think we do need to understand whether or not there are also different risks that women may have," Ezekowitz said cheap lasix online.

"And we tried to identify a few of those, but we didn't come up with one single factor. I think it's a constellation of factors that makes it more difficult to understand."For the study, the researchers analyzed data on more than 45,000 patients who were hospitalized for their first heart attack between cheap lasix online 2002 and 2016 in Alberta, Canada. Nearly 31% of those patients were women.The investigators focused on two types of heart attacks.

The severe, cheap lasix online life-threatening ST-elevation myocardial infarction (STEMI). And the cheap lasix online less severe NSTEMI, which is more common. The study followed the patients for an average of six years.Women were more likely to develop heart failure in the hospital or after discharge for both types of heart attack when no adjustments were made for variables, but the gap was considerably narrower for the NSTEMI patients after those adjustments, according to the study authors.Women were an average age of 72, compared to 61 for men at the time of their first heart attacks.

They also tended to have more complicated medical histories at the cheap lasix online time of their heart attacks, including high blood pressure, diabetes, atrial fibrillation and chronic obstructive pulmonary disease (COPD). These are risk factors that contribute to heart failure.Nearly 73% of women were seen by a cardiovascular specialist, compared to 84% of men. Women were also less likely to receive heart medicines like beta blockers or cholesterol-lowering statins, and slightly less likely to receive certain procedures to restore blood flow, cheap lasix online such as surgical angioplasty.The study was published online Nov.

30 in the journal Circulation.Among the potential solutions to close the gap could be more accommodations for patients' preferences when delivering care, Ezekowitz said."For the longest time we've offered cardiac rehabilitation in fixed buildings. It may be more difficult for somebody who's older to attend cardiac rehabilitation cheap lasix online than somebody who's younger because of mobility or they can't get transportation," Ezekowitz explained. "We can start to offer that in a much more bespoke model as in 'this person has these types of issues, therefore we need to offer this different type of model for them.' I think that will help more people access care and get high-quality care."If a woman is older at the cheap lasix online time of her heart attack, there may be some intrinsic biases by providers that certain therapies don't work as well in older people, and so some of that care may be held back, he added."We've got to recognize some of the gaps can be filled in by providing elder-friendly care, care that's appropriate for different ages but also making people more aware that many of our therapies work equally well in young and old people," Ezekowitz said.

"We need to be very careful not to limit their therapy based on age alone." SLIDESHOW Heart Disease. Causes of cheap lasix online a Heart Attack See Slideshow Critically important is increasing efforts to prevent these types of heart attacks in the first place, said Dr. Gregg Fonarow, a cardiologist at the University of California, Los Angeles.

This includes reducing cholesterol, controlling blood pressure, increasing exercise, stopping smoking and eating a healthy diet.Even after a heart attack occurs, there are therapies that can lower the risk of cheap lasix online developing heart failure or mortality after that heart attack that are cardioprotective, Fonarow added. These include ACE inhibitor and beta blocker drugs, as well as high-intensity statins."These therapies tend to be underutilized in women relative to men," Fonarow said. "So, there's more work that needs to be done to provide higher quality and equitable care to women in a way that will decrease their cheap lasix online risk of complications and recurrent events, heart failure and premature cardiovascular death after an acute coronary event."More informationThe U.S.

Centers for Disease Control and Prevention offers more information on heart failure.SOURCES cheap lasix online. Justin Ezekowitz, MD, cardiologist, Mazankowski Alberta Heart Institute, co-director, Canadian VIGOUR Centre, professor, department of medicine, division of cardiology, University of Alberta, Edmonton, Alberta, Canada. Gregg Fonarow, MD, chief, division of cardiology, University of California, Los Angeles cheap lasix online.

Circulation, Nov. 30, 2020, cheap lasix online onlineCopyright © 2020 HealthDay. All rights reserved.

From Healthy Heart Resources Featured Centers Health Solutions From Our SponsorsLatest Cancer News cheap lasix online MONDAY, Nov. 30, 2020 (HealthDay News)Nearly 15% of talc-based cosmetic products analyzed in a recent study contained asbestos.Environmental Working Group (EWG)an American advocacy nonprofit that commissioned the tests and did the analysis -- said methods used by the cosmetics industry to screen talc supplies are inadequate. The voluntary testing method developed by industry is not sensitive enough to screen for asbestos when compared to electron microscopy, the group said."Many well-known brands use talc in body and facial powders that can be inhaled," said Nneka Leiba, an EWG vice president.She noted that EWG's online cheap lasix online database has identified more than 2,000 personal care products that contain talc, including more than 1,000 loose or pressed powders that could pose an inhalation risk."It's troubling to think how many Americans have been using talc-based cosmetics products potentially contaminated with asbestos," Leiba said in an EWG news release.The analysis was published Nov.

25 in the journal Environmental Health Insights.The Scientific Analytical Institute conducted cheap lasix online the tests, using electron microscopy to analyze samples. The U.S. Food and cheap lasix online Drug Administration does not require testing talc supplies."It is critical that the FDA develop a rigorous screening method for talc used in personal care products," said Sean Fitzgerald, head of the Greensboro, N.C.-based institute.

"The lab repeatedly finds asbestos in products made with talc, including cosmetics marketed to children. It's outrageous that a precise method for testing personal care products for the presence of asbestos exists, but the cosmetics industry isn't required to use it."Fitzgerald's lab tested 21 samples of powder cosmetics, including eye shadow, foundation, blush, face and body powders.Talc is often used in cosmetics as a filler or to cheap lasix online improve texture or absorb moisture. Talc and asbestos can be formed in the same rocks that are mined for both cosmetics use and industrial use.

The federal government does not require that cosmetics be tested cheap lasix online for asbestos, instead encouraging companies to select talc mines carefully to avoid asbestos contamination, according to the study.In May, Johnson &. Johnson announced it would end the sale of cheap lasix online its talc-based baby powder in the United States and Canada. Thousands of people have filed lawsuits against the company, claiming the product caused cancer, the study said."Inhaling even the tiniest amount of asbestos in talc can cause mesothelioma and other deadly diseases, many years after exposure," Tasha Stoiber, a senior scientist at EWG, said in the release.

"How much talc is inhaled -- and how much is contaminated with asbestos -- is hard to know, but it only takes one asbestos fiber, lodged in the lungs, to cause mesothelioma decades later."EWG reports that exposure to asbestos is linked to asbestosis, mesothelioma, and lung and ovarian cancer.Based on cheap lasix online federal data, the EWG Action Fund estimates that up to 15,000 Americans die each year from asbestos-triggered disease.In March 2019, Congresswoman Debbie Dingell (D-Mich.), introduced legislation that would require warning labels on cosmetics that could contain asbestos and are marketed to children.EWG called for Congress to pass legislation mandating rigorous testing of talc-based personal care products.More informationThe U.S. Environmental Protection Agency has more information on asbestos.SOURCE. Environmental Working Group, news cheap lasix online release, Nov.

25, 2020Cara MurezCopyright © 2020 HealthDay. All rights reserved. SLIDESHOW Skin Cancer Symptoms, Types, Images See Slideshow.

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Although only a tenth as massive http://www.danielpeixe.com/my-little-tribute-to-pixar-cars/ as Earth, Mars looks to have once been habitable like our own world, leading scientists to wonder where can i get lasix whether such similarity cuts to the cores of both planets. In its innards, is Mars still a shrunken mirror of Earth, or is the interplanetary resemblance only crust-deep?. Tantalizing hints have been gleaned from gravitational data provided by past missions.

But now the interior of Mars has been revealed as never before, thanks to unprecedented measurements from NASA’s InSight lander where can i get lasix. Shortly after reaching the Martian surface in late 2018, InSight has been monitoring seismic waves rippling through the planet and using the echoing reflections of these “marsquakes” to map the subsurface. Only Earth and its moon have previously been subjected to such deep scrutiny.

The results show a world both like and unlike where can i get lasix our own and offer a thrilling second data point in a vast universe of rocky orbs. €œInSight is kind of like the first telescope looking into the interior of the planet,” says Michael Meyer, lead scientist of NASA’s Mars Exploration Program at the agency’s headquarters. InSight (Interior Exploration Using Seismic Investigations, Geodesy and Heat Transport) is not your typical Mars mission.

Whereas others, such as the recently landed Perseverance, were sent to scientifically rich destinations that may have once supported life, InSight’s landing zone in Elysium Planitia was decidedly mundane, described by some as a “parking lot.” Flat and smooth—nearly featureless where can i get lasix save for scattered rocks and impact craters—the site was the perfect place for the stationary lander to study the Martian interior. The Seismic Experiment for Interior Structure (SEIS) instrument, provided by France’s space agency and place gently on the surface by InSight’s robotic arm in December 2018, was encased in a domed shield, allowing it to detect waves moving through Mars without interference from wind or dust storms. Storms.

SEIS “can see motions on the order of atomic-sized vibrations,” says Andrew Lazarewicz of the Massachusetts Institute of Technology, where can i get lasix who took part in a 1976 attempt to detect seismic waves with a seismometer on NASA’s Viking 2 lander. In a series of papers published today in the journal Science, researchers describe how they used this instrument to trace seismic waves caused by dozens of detected marsquakes through the Martian interior. These events were possibly caused by meteorites hitting the planet’s surface or even by the stirrings of magma (some were localized to nearby Cerberus Fossae, a geologic formation displaying signs of recent volcanic activity).

At less than magnitude 4 on the where can i get lasix moment magnitude scale, all of these quakes were so small that they would be barely noticeable on Earth. But SEIS registered them clearly, allowing researchers to track their reverberations through the interior of Mars, all the way down to its core, revealing what was going on inside. Simon Stähler of the Institute of Geophysics at the Swiss Federal Institute of Technology Zurich and his colleagues measured the waves’ reflections off the core to calculate its size and bulk composition.

They found that it is likely 1,830 kilometers in radius, several where can i get lasix hundred kilometers larger than predicted. And the strength of the reflected waves suggested they were bouncing off a core mostly composed of molten iron and nickel. The size of the core was a “surprise,” Stähler says.

€œPeople were assuming it must be on the order of 1,500 or 1,600 kilometers,” based on the fact that, kilogram for kilogram, Mars is a bit less dense than Earth, and the core would be expected to be mostly iron and nickel, which is where can i get lasix heavier than rock. Instead the results show that the ratio of Mars’s core radius to its planetary radius is similar to that of Earth—which counterintuitively means the relatively low-density Martian core must be enriched with other elements, such as sulfur and oxygen, that are comparatively less abundant in our planet’s core. Why Mars’s core would have a different composition than ours is unclear.

€œIf you assume where can i get lasix that Mars was made from the same building blocks as Earth, then it is not so easy to explain,” Stähler says. Moving outward, Amir Khan of the Institute of Geophysics and his colleagues used the seismic waves to probe Mars’s mantle, the region between the planet’s core and surface crust. Although Earth has an insulating liquid lower mantle layer that sits above its core, there is no such feature on our neighboring world.

€œThat lower mantle does not where can i get lasix exist on Mars,” Khan says. Instead, above the core, the lower mantle of Mars resembles the upper mantle of Earth, which then gives way to a higher layer, colder and more brittle, called the lithosphere. Mars’s lithosphere, the study shows, is about 500 kilometers in thickness, compared with Earth’s approximately 250-kilometer-thick lithosphere.

Such a thick lithosphere, Khan says, could where can i get lasix be why Mars lacks plate tectonics today. This unearthly configuration of subsurface layers could also explain how the Red Planet lost its heat because, unlike Earth, it lacks an insulating liquid mantle layer above its core. At the surface, Brigitte Knapmeyer-Endrun of the University of Cologne in Germany and her colleagues measured the thickness of the Martian crust.

They found two possibilities where can i get lasix for the crust under InSight. One interpretation of the data suggests a two-layer crust like that of Earth with a thickness of 20 kilometers. The other hints at the presence of three layers totaling 39 kilometers in thickness.

For the planet as a whole, the researchers estimate a crustal thickness of up to 72 kilometers, several where can i get lasix dozens of kilometers thinner than predicted. If accurate, that estimate could be an important window into the fundamental differences between how Earth and Mars first formed. €œMost of the crust is really old and is from really early on the planet, whereas on Earth, we have a lot of recycling going on due to plate tectonics,” Knapmeyer-Endrun says.

The results as a whole reveal where can i get lasix intriguing differences between Earth and Mars. €œWhat they’ve done with this single instrument is remarkable,” Lazarewicz says. Despite being rocky worlds that arose in relatively close proximity to the sun, these two planets may not have formed in the same way.

They could have, say, coalesced from different mixes of materials where can i get lasix that circulated in the disk of gas and dust that surrounded the young sun. Additionally, if InSight manages to seismically probe Mars’s inner core during its mission, that could help settle the long-standing mystery of how the planet lost its protective magnetic field, an event that is thought to have occurred perhaps four billion years ago and that may have allowed solar winds to sweep away much of the world’s atmosphere. It was not until 1889 that we made our first measurements of seismic waves passing through Earth’s mantle, getting a glimpse at our own world’s interior.

Now, more than a century later, we have our first comparative measurements for another planet in the universe, although these may be but a teaser of what is where can i get lasix yet to come as scientists delve deeper into InSight’s data. €œNow that we know how large the core is, and we know more about the crust and mantle, we can reinterpret the events we’ve detected so far in light of the interior model we have now,” Stähler says.The Intergovernmental Panel on Climate Change grabbed the world’s attention in 2018 when it released a sobering report that warned—in no uncertain terms—world leaders needed to take drastic and immediate steps to blunt the most catastrophic impacts of global warming. Policymakers responded with a range of emotion, from denial to outrage.

But the message was where can i get lasix clear. €œIt’s like a deafening, piercing smoke alarm going off in the kitchen,” Erik Solheim, executive director of the United Nations Environment Programme, told The Washington Post at the time. Next month, the Intergovernmental Panel on Climate Change—or IPCC for short—plans to release another report.

And again, scientists, where can i get lasix lawmakers and activists are bracing themselves for the news. The report will come three months before world leaders gather in Glasgow, Scotland, to try and figure out a plan to avert the worst effects of climate change. And it’s all but certain the IPCC’s findings will inform that debate.

So, what is the IPCC and what does it where can i get lasix do?. One thing it isn’t is a fly-by-night operation. The U.N.

Group has been around for more than three decades assessing where can i get lasix the science behind climate change, projecting what’s to come and offering ways to respond. All with the eyes of the world upon it. €œNo other science has been scrutinized as heavily as climate science has in the past 30 years, and that’s thanks to these intergovernmental reports,” said Corinne Le Quéré, research professor of climate change science at the University of East Anglia.

One consistent where can i get lasix message among them all. An ever-stronger statement about the human influence on global temperature rise as a consequence of growing greenhouse gases, said Emily Shuckburgh, director of the Cambridge Carbon Neutral Futures Initiative. On Aug.

9, the IPCC will release where can i get lasix the first of four reports under its latest assessment cycle. Here are five things to know about the IPCC, its upcoming report and the politics that surround the effort. 1.

What it is The IPCC consists of government representatives who commission regular environmental where can i get lasix reports from academics from around the world. Those experts have produced their assessments on a seven-year cycle since 1988, with special reports in the interim years. The IPCC is currently in its sixth assessment cycle.

The assessments are divided between three working groups, each with a where can i get lasix different focus and published on different intervals. Working Group I is a synthesis of the existing physical science. It answers questions about how much global warming is occurring and where.

How warming impacts oceans, sea-level rise and weather where can i get lasix pattern changes. And it lays out projections of what we might see in the future. This is the report that will be published in August.

Working Group II, slated for February, focuses on how vulnerable humans and nature are to global where can i get lasix warming, the costs of climate impacts or adaptation options. Working Group III, to come in March, will look at options for keeping to global temperature targets and scenarios on renewable energy or carbon capture and storage. 2.

How it where can i get lasix works At the end of the cycle there is a final synthesis report. This cycle also will include a task force report on national greenhouse gas inventories. On Aug.

9, the IPCC will release its summary for policymakers following a series of where can i get lasix meetings where it will be discussed, revised and then signed off on. There are more than 230 authors from 65 countries. Men have historically comprised the majority of these contributors, though that pattern has started to change.

Women now make up where can i get lasix about 30% of the group. A gender panel and task force is working to bring more women into the process. The latest assessment will include new advances in science and a better understanding of the human impact on global warming.

It will also have an interactive atlas—a novel addition—and five emissions scenarios that will explore where can i get lasix the impact of rising emissions. 3. What to look for A certainty statement.

Each assessment has included a level of confidence that human activities are responsible for projected warming where can i get lasix. The last one in 2013 put that confidence at extremely likely. Shifting baselines.

This assessment where can i get lasix will be fed by a new generation of computer models. A report last year, for example, suggested that historical temperature rise has been slightly bigger than previously thought, said Richard Black, a senior associate at the Energy and Climate Intelligence Unit. €œWhat will that turn into about the carbon budget left?.

€ he where can i get lasix asked. Other gases. Given advances in the science around the different greenhouse gases, Working Group I could separate the way they treat carbon dioxide and other long-lived greenhouse gases from methane and other short-lived ones.

Timing. What impact might the report have on upcoming meetings, such as the U.N. General Assembly, the Group of 20 and the climate talks in Glasgow, Scotland?.

Is the window for achieving the 1.5 degree Celsius temperature limit of the Paris Agreement closing?. How quickly?. How feasible is it to meet the temperature targets?.

Wording http://closelyknitphotography.com/the-pinkle-toes-experience-2/. The power of the IPCC is that it’s comprehensive, said Le Quéré. It’s the only report that looks at measurements from the land to the ocean to the stratosphere.

It looks at modeling and human experience. That makes the strength of the language and the coherence between the observations all the more important. She said she expects all the new information to come together in a powerful way.

4. What makes this assessment different The last major report from Working Group I was published in 2013. What has happened since then is seven years of a warming climate.

In that time, nations also signed onto the Paris Agreement, which includes very clear objectives around warming limits of 1.5 C. It also brings out an important set of challenges about assessing the climate science. Global warming has unfolded at approximately the rate that was projected in the 1990s, Le Quéré said.

€œBut what we see now is that the warming itself, the extreme events, we can see with our own eyes.” There is also a lot more granular information about the regional distribution of these events and the role of attribution in climate change. In many instances, attribution science has been able to demonstrate scientifically that climate change has increased the probability of extreme weather events, and a lot of that knowledge owes to new observations and modeling. Working Group I provides a variety of climate projections given an emissions scenario.

In the past, it has focused on the most likely climate projections. But his time around, said Le Quéré, governments have asked the IPCC to look at low-probability events that could potentially be very damaging. That means a lot more explicit information about the risks of extreme climate events, and a lot more regional information as requested by individual governments, she added.

5. Points of contention As Black points out, all the governments accept these reports, so they can’t say they didn’t know what the science was saying. The question is.

Will they translate that science into action?. Another weedy topic is the carbon budget. While it brings together so much of the science, it also involves all the uncertainty that goes with projection, said Le Quéré.

There also could be issues around procedure because it’s the first time there’s been an attempt to adopt a summary for policymakers on Zoom, said Black. If countries are looking for an excuse to disrupt the whole thing, that’s a good one, he added. It would be better if all the reports—including Working Group II on impacts and vulnerability and Working Group III on mitigation—were released ahead of climate change talks in November, Shuckburgh said.

But what next month’s report does put forth, she added, will make the risk that climate change poses abundantly clear. It will then be up to leaders to respond. Reprinted from E&E News with permission from POLITICO, LLC.

Copyright 2021. E&E News provides essential news for energy and environment professionals.MISSOULA, Mont.—Missoula’s new downtown library was teeming with people who might typically spend a Saturday afternoon hiking, biking or otherwise making the most of Montana’s abundant outdoor recreation. One look at the soupy haze blanketing the city and it was clear why.

€œWe’re definitely trying to stay out of the smoke,” Charlie Booher said as his kids picked out books from the stacks. Smoke from the wildfires burning through bone-dry forests and grasslands in the West has damaged air quality this week from California to the Eastern Seaboard. The polluting smoke has been thickest in the Northwest, including Montana, where over the past week Missoula, Helena, Great Falls and other cities ranked among the 10 places with the worst air quality, according to AirNow.

The smoke and unrelenting heat pummeling the state have driven people to seek refuge at libraries, movie theaters, museums and other indoor venues. In areas with low hypertension medications vaccination rates where people have largely abandoned masks and physical distancing, health officials are concerned the result will be hypertension medications outbreaks. Adding to that worry is the rise of the highly transmissible delta variant of the hypertension, and research suggests that hypertension medications cases and deaths increase during periods of intense wildfire smoke.

Missoula County has the highest vaccination rate in Montana, at 60%, but Whitney Kors was still mindful of the risks as she took her family to the library to get out of the smoke. €œMy daughter and I are still masked because she’s not vaccinated,” Kors said. She said that until her daughter, who’s under 12 years old, becomes eligible for her shot, her family will continue to distance from others when they’re out.

However, health officials worry that not everyone seeking out smoke-free activities indoors this summer will take the same precautions if they are unvaccinated. To the north in Flathead County, Joe Russell, the county health officer, said he’s tracking a roughly 50% increase in hypertension medications cases over the past two weeks, mostly from unvaccinated people catching the lasix at events. €œThese are activities that are happening specific to events or settings, and they are indoors,” he explained.

Russell said his team is more closely investigating new clusters to see if people went inside to escape heat and smoke. About 6 of 10 county residents who are eligible for hypertension medications treatments have not gotten them, and Russell is worried these large clusters could get worse if more people gather indoors. The dangers of the lasix appear to have waned in people’s minds as they gather in indoor public spaces, many of which dropped masking and physical distancing requirements earlier this year.

In Yellowstone County and Billings, Montana’s largest city, the lasix is still being felt in hospitals that have been treating younger, sicker patients than they saw earlier in the lasix. hypertension medications deaths also spiked there in early July. Yellowstone County Health Officer John Felton hoped the summer would provide time to boost the county’s 50% vaccination rate before cold weather sends people indoors and increases the risk of unvaccinated people transmitting hypertension medications.

€œBut this year has been so hot, so dry and with so much smoke, we are concerned we’re going to have increases happening a little earlier,” he said. Across Montana, about 48% of the eligible population is fully vaccinated, but Magdalena Scott with the state Department of Public Health and Human Services said county rates range from about 23% to 60%. She said that means case numbers, hospitalizations and deaths are likely to vary more widely than they did last summer, when treatments weren’t yet available.

€œWe are concerned that it’s going to be a long smoke season for sure,” Scott said. There are also worries that wildfire smoke could drive up hypertension medications transmission not just by driving people indoors, but also by making them more susceptible to the hypertension. Fine particulate matter in wildfire smoke, known as PM 2.5, is so small it bypasses the body’s natural defenses, building up in the bloodstream, inflaming the lungs and wearing down the immune system, according to the Centers for Disease Control and Prevention.

PM 2.5 from urban air pollution and wildfire smoke is increasingly associated with susceptibility to respiratory s in general, but researchers have been racing to study the same possible association with the hypertension, a respiratory lasix, since last summer. Daniel Kiser is a researcher at the Desert Research Institute in Reno, Nevada. He worked on a recently published paper about an increase in hypertension medications cases in Reno during the wildfire season.

€œWhat we found was that there was about an 18% increase in the rate of positive tests during the period that was most affected by wildfire smoke,” Kiser said. Other studies also have shown a correlation between increases in particulate levels and hypertension medications deaths. Sultan Ayoub Meo with King Saud University in Saudi Arabia led a team of researchers that studied 10 California counties where levels of fine particulate matter increased on average by 220 times at the height of the state’s wildfire season last year.

€œWe found that the hypertension medications cases and deaths increased by 57% and 148%” at the same time, Meo said. Meo said his team now is studying rates among partially and fully vaccinated people during wildfire smoke events. University of Montana researcher Erin Landguth is also expanding her past study showing intense wildfire seasons in Montana have been followed by bad flu seasons months later in the fall and winter.

€œComparing bad fire seasons to non-bad fire seasons, one would expect to see three to five times worse flu seasons,” Landguth said. Landguth is compiling particulate-matter readings across the western U.S. To examine whether the same association holds across a larger area for not only the flu, but hypertension medications and other respiratory diseases, too.

While evidence showing hypertension medications cases and deaths have increased during wildfire events continues to emerge, more study is needed. However, Landguth said, we know enough to be concerned and to advise people to protect themselves. Back in Missoula, county Air Quality Specialist Sarah Coefield said the best thing people can do is get vaccinated, especially if they plan to seek out public spaces to escape heat and smoke.

They can also create a clean-air space at home. With about 2.5 million acres already burned this year in the U.S., and drought worsening across the West, Coefield said, “There’s nothing in the forecast to suggest it’s going to end anytime soon—and it’s not going to get any easier as it goes on.” KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.The White House has rehired a climate scientist who was forced out by the Trump administration, and is proposing to dramatically increase the budget of the Centers for Disease Control and Prevention.

€œScience is back” has become a Biden slogan. But listening to scientists is only the first step—and only a partial step, given the deep distrust many Americans have for experts. We must improve how ordinary citizens help shape science policy.

This is one of the findings of a recent report from the Hastings Center that examines the role of citizens in shaping policy in health and science. That role should not be limited to electing candidates and then, a few years later, expressing approval or disapproval of their job performance. Too many issues are in play at once for the voting–governing connection to be meaningful for many of them, and most people do not choose candidates on the basis of a clear understanding of policies, anyway It is unlikely, for example, that elections will provide guidance about the governance of new technologies such as gene editing, assisted reproduction or artificial intelligence.

That doesn’t mean that citizens’ views can’t help shape those policies through mechanisms such as public comment periods on proposed federal rules and public referenda at the state level. But those who influence rulemaking rarely represent the larger public, and neither comment periods nor referenda are deliberative processes in which people become informed about an issue and discuss it with people who might have different views. What we need are opportunities for Americans to talk and listen to each other face to face, as equals, ideally in person but virtually if need be, about the values and the facts that should guide policy.

Americans are not as divided as elected officials, and where they disagree, deliberation can reduce the distance between them. We also can learn to talk and listen with greater mutual respect. The nation was built on this principle of equality, and Americans of all political perspectives must live it.

There have been many small-scale efforts along these lines, mostly undertaken by academics or small nonprofits in what’s known as the civic renewal movement. Typically, these bring people from a community together to discuss local issues, which can help shift the focus from national politics and disagreements about issues that may be abstract and distant toward immediate, concrete problems and shared interests. For example, instead of discussing climate change in general, which is hard to disconnect from the national political divide, participants can focus on the effect of river flooding on farmers.

This kind of local entry point can even lead to a deeper understanding of the broader national issue. But deliberation is possible, and could be productive, at a national level as well. One example is America in One Room, in which 523 Americans spent a weekend together discussing a range of policy issues in order to become less polarized and more confident about U.S.

Democracy. Such an event is a logistical challenge, but similar events can be held online, which also reduces costs and allows more people to participate. Public deliberation could also be tailored to the many issues that tend to elude the voting/governing feedback loop.

Gene editing is a prime example. Reports from the National Academies of Sciences, Engineering, and Medicine and other bodies around the world have argued that policy on genetic editing technologies should be guided by public deliberation. Public deliberation could also shape the distribution of scarce resources in a disaster like the hypertension medications lasix, or the use of public health measures such as treatment certificates.

And the groundswell of support among the public for more attention to climate change suggests that public deliberation could help galvanize the political will to overcome the policy-making logjam in the federal government. In the end, good science depends on democracy, and democracy depends on a deeper, richer engagement between citizens and governance structures. In a healthy democracy, institutions both private and governmental help create citizens who learn, talk and listen better—who are better able to be engaged and effective—and in turn, active, engaged citizens strengthen the institutions of a good democracy.

We don’t just need good government. We need a good society that builds good citizens, who in turn build a better society. This is an opinion and analysis article.

What lurks cheap lasix online straight from the source within the Red Planet?. Although only a tenth as massive as Earth, Mars looks to have once been habitable like our own world, leading scientists to wonder whether such similarity cuts to the cores of both planets. In its innards, is Mars still a shrunken mirror of Earth, or is the interplanetary resemblance only crust-deep?.

Tantalizing hints have been gleaned from gravitational data provided by past cheap lasix online missions. But now the interior of Mars has been revealed as never before, thanks to unprecedented measurements from NASA’s InSight lander. Shortly after reaching the Martian surface in late 2018, InSight has been monitoring seismic waves rippling through the planet and using the echoing reflections of these “marsquakes” to map the subsurface.

Only Earth and its cheap lasix online moon have previously been subjected to such deep scrutiny. The results show a world both like and unlike our own and offer a thrilling second data point in a vast universe of rocky orbs. €œInSight is kind of like the first telescope looking into the interior of the planet,” says Michael Meyer, lead scientist of NASA’s Mars Exploration Program at the agency’s headquarters.

InSight (Interior Exploration Using Seismic Investigations, Geodesy and Heat Transport) is not your typical Mars mission cheap lasix online. Whereas others, such as the recently landed Perseverance, were sent to scientifically rich destinations that may have once supported life, InSight’s landing zone in Elysium Planitia was decidedly mundane, described by some as a “parking lot.” Flat and smooth—nearly featureless save for scattered rocks and impact craters—the site was the perfect place for the stationary lander to study the Martian interior. The Seismic Experiment for Interior Structure (SEIS) instrument, provided by France’s space agency and place gently on the surface by InSight’s robotic arm in December 2018, was encased in a domed shield, allowing it to detect waves moving through Mars without interference from wind or dust storms.

Storms. SEIS “can see motions on the order of atomic-sized vibrations,” says Andrew Lazarewicz of the Massachusetts Institute of Technology, who took part in a 1976 attempt to detect seismic waves with a seismometer on NASA’s Viking 2 lander. In a series of papers published today in the journal Science, researchers describe how they used this instrument to trace seismic waves caused by dozens of detected marsquakes through the Martian interior.

These events were possibly caused by meteorites hitting the planet’s surface or even by the stirrings of magma (some were localized to nearby Cerberus Fossae, a geologic formation displaying signs of recent volcanic activity). At less than magnitude 4 on the moment magnitude scale, all of these quakes were so small that they would be barely noticeable on Earth. But SEIS registered them clearly, allowing researchers to track their reverberations through the interior of Mars, all the way down to its core, revealing what was going on inside.

Simon Stähler of the Institute of Geophysics at the Swiss Federal Institute of Technology Zurich and his colleagues measured the waves’ reflections off the core to calculate its size and bulk composition. They found that it is likely 1,830 kilometers in radius, several hundred kilometers larger than predicted. And the strength of the reflected waves suggested they were bouncing off a core mostly composed of molten iron and nickel.

The size of the core was a “surprise,” Stähler says. €œPeople were assuming it must be on the order of 1,500 or 1,600 kilometers,” based on the fact that, kilogram for kilogram, Mars is a bit less dense than Earth, and the core would be expected to be mostly iron and nickel, which is heavier than rock. Instead the results show that the ratio of Mars’s core radius to its planetary radius is similar to that of Earth—which counterintuitively means the relatively low-density Martian core must be enriched with other elements, such as sulfur and oxygen, that are comparatively less abundant in our planet’s core.

Why Mars’s core would have a different composition than ours is unclear. €œIf you assume that Mars was made from the same building blocks as Earth, then it is not so easy to explain,” Stähler says. Moving outward, Amir Khan of the Institute of Geophysics and his colleagues used the seismic waves to probe Mars’s mantle, the region between the planet’s core and surface crust.

Although Earth has an insulating liquid lower mantle layer that sits above its core, there is no such feature on our neighboring world. €œThat lower mantle does not exist on Mars,” Khan says. Instead, above the core, the lower mantle of Mars resembles the upper mantle of Earth, which then gives way to a higher layer, colder and more brittle, called the lithosphere.

Mars’s lithosphere, the study shows, is about 500 kilometers in thickness, compared with Earth’s approximately 250-kilometer-thick lithosphere. Such a thick lithosphere, Khan says, could be why Mars lacks plate tectonics today. This unearthly configuration of subsurface layers could also explain how the Red Planet lost its heat because, unlike Earth, it lacks an insulating liquid mantle layer above its core.

At the surface, Brigitte Knapmeyer-Endrun of the University of Cologne in Germany and her colleagues measured the thickness of the Martian crust. They found two possibilities for the crust under InSight. One interpretation of the data suggests a two-layer crust like that of Earth with a thickness of 20 kilometers.

The other hints at the presence of three layers totaling 39 kilometers in thickness. For the planet as a whole, the researchers estimate a crustal thickness of up to 72 kilometers, several dozens of kilometers thinner than predicted. If accurate, that estimate could be an important window into the fundamental differences between how Earth and Mars first formed.

€œMost of the crust is really old and is from really early on the planet, whereas on Earth, we have a lot of recycling going on due to plate tectonics,” Knapmeyer-Endrun says. The results as a whole reveal intriguing differences between Earth and Mars. €œWhat they’ve done with this single instrument is remarkable,” Lazarewicz says.

Despite being rocky worlds that arose in relatively close proximity to the sun, these two planets may not have formed in the same way. They could have, say, coalesced from different mixes of materials that circulated in the disk of gas and dust that surrounded the young sun. Additionally, if InSight manages to seismically probe Mars’s inner core during its mission, that could help settle the long-standing mystery of how the planet lost its protective magnetic field, an event that is thought to have occurred perhaps four billion years ago and that may have allowed solar winds to sweep away much of the world’s atmosphere.

It was not until 1889 that we made our first measurements of seismic waves passing through Earth’s mantle, getting a glimpse at our own world’s interior. Now, more than a century later, we have our first comparative measurements for another planet in the universe, although these may be but a teaser of what is yet to come as scientists delve deeper into InSight’s data. €œNow that we know how large the core is, and we know more about the crust and mantle, we can reinterpret the events we’ve detected so far in light of the interior model we have now,” Stähler says.The Intergovernmental Panel on Climate Change grabbed the world’s attention in 2018 when it released a sobering report that warned—in no uncertain terms—world leaders needed to take drastic and immediate steps to blunt the most catastrophic impacts of global warming.

Policymakers responded with a range of emotion, from denial to outrage. But the message was clear. €œIt’s like a deafening, piercing smoke alarm going off in the kitchen,” Erik Solheim, executive director of the United Nations Environment Programme, told The Washington Post at the time.

Next month, the Intergovernmental Panel on Climate Change—or IPCC for short—plans to release another report. And again, scientists, lawmakers and activists are bracing themselves for the news. The report will come three months before world leaders gather in Glasgow, Scotland, to try and figure out a plan to avert the worst effects of climate change.

And it’s all but certain the IPCC’s findings will inform that debate. So, what is the IPCC and what does it do?. One thing it isn’t is a fly-by-night operation.

The U.N. Group has been around for more than three decades assessing the science behind climate change, projecting what’s to come and offering ways to respond. All with the eyes of the world upon it.

€œNo other science has been scrutinized as heavily as climate science has in the past 30 years, and that’s thanks to these intergovernmental reports,” said Corinne Le Quéré, research professor of climate change science at the University of East Anglia. One consistent message among them all. An ever-stronger statement about the human influence on global temperature rise as a consequence of growing greenhouse gases, said Emily Shuckburgh, director of the Cambridge Carbon Neutral Futures Initiative.

On Aug. 9, the IPCC will release the first of four reports under its latest assessment cycle. Here are five things to know about the IPCC, its upcoming report and the politics that surround the effort.

1. What it is The IPCC consists of government representatives who commission regular environmental reports from academics from around the world. Those experts have produced their assessments on a seven-year cycle since 1988, with special reports in the interim years.

The IPCC is currently in its sixth assessment cycle. The assessments are divided between three working groups, each with a different focus and published on different intervals. Working Group I is a synthesis of the existing physical science.

It answers questions about how much global warming is occurring and where. How warming impacts oceans, sea-level rise and weather pattern changes. And it lays out projections of what we might see in the future.

This is the report that will be published in August. Working Group II, slated for February, focuses on how vulnerable humans and nature are to global warming, the costs of climate impacts or adaptation options. Working Group III, to come in March, will look at options for keeping to global temperature targets and scenarios on renewable energy or carbon capture and storage.

2. How it works At the end of the cycle there is a final synthesis report. This cycle also will include a task force report on national greenhouse gas inventories.

On Aug. 9, the IPCC will release its summary for policymakers following a series of meetings where it will be discussed, revised and then signed off on. There are more than 230 authors from 65 countries.

Men have historically comprised the majority of these contributors, though that pattern has started to change. Women now make up about 30% of the group. A gender panel and task force is working to bring more women into the process.

The latest assessment will include new advances in science and a better understanding of the human impact on global warming. It will also have an interactive atlas—a novel addition—and five emissions scenarios that will explore the impact of rising emissions. 3.

What to look for A certainty statement. Each assessment has included a level of confidence that human activities are responsible for projected warming. The last one in 2013 put that confidence at extremely likely.

Shifting baselines. This assessment will be fed by a new generation of computer models. A report last year, for example, suggested that historical temperature rise has been slightly bigger than previously thought, said Richard Black, a senior associate at the Energy and Climate Intelligence Unit.

€œWhat will that turn into about the carbon budget left?. € he asked. Other gases.

Given advances in the science around the different greenhouse gases, Working Group I could separate the way they treat carbon dioxide and other long-lived greenhouse gases from methane and other short-lived ones. Timing. What impact might the report have on upcoming meetings, such as the U.N.

General Assembly, the Group of 20 and the climate talks in Glasgow, Scotland?. Is the window for achieving the 1.5 degree Celsius temperature limit of the Paris Agreement closing?. How quickly?.

How feasible is it to meet the temperature targets?. Wording. The power of the IPCC is that it’s comprehensive, said Le Quéré.

It’s the only report that looks at measurements from the land to the ocean to the stratosphere. It looks at modeling and human experience. That makes the strength of the language and the coherence between the observations all the more important.

She said she expects all the new information to come together in a powerful way. 4. What makes this assessment different The last major report from Working Group I was published in 2013.

What has happened since then is seven years of a warming climate. In that time, nations also signed onto the Paris Agreement, which includes very clear objectives around warming limits of 1.5 C. It also brings out an important set of challenges about assessing the climate science.

Global warming has unfolded at approximately the rate that was projected in the 1990s, Le Quéré said. €œBut what we see now is that the warming itself, the extreme events, we can see with our own eyes.” There is also a lot more granular information about the regional distribution of these events and the role of attribution in climate change. In many instances, attribution science has been able to demonstrate scientifically that climate change has increased the probability of extreme weather events, and a lot of that knowledge owes to new observations and modeling.

Working Group I provides a variety of climate projections given an emissions scenario. In the past, it has focused on the most likely climate projections. But his time around, said Le Quéré, governments have asked the IPCC to look at low-probability events that could potentially be very damaging.

That means a lot more explicit information about the risks of extreme climate events, and a lot more regional information as requested by individual governments, she added. 5. Points of contention As Black points out, all the governments accept these reports, so they can’t say they didn’t know what the science was saying.

The question is. Will they translate that science into action?. Another weedy topic is the carbon budget.

While it brings together so much of the science, it also involves all the uncertainty that goes with projection, said Le Quéré. There also could be issues around procedure because it’s the first time there’s been an attempt to adopt a summary for policymakers on Zoom, said Black. If countries are looking for an excuse to disrupt the whole thing, that’s a good one, he added.

It would be better if all the reports—including Working Group II on impacts and vulnerability and Working Group III on mitigation—were released ahead of climate change talks in November, Shuckburgh said. But what next month’s report does put forth, she added, will make the risk that climate change poses abundantly clear. It will then be up to leaders to respond.

Reprinted from E&E News with permission from POLITICO, LLC. Copyright 2021. E&E News provides essential news for energy and environment professionals.MISSOULA, Mont.—Missoula’s new downtown library was teeming with people who might typically spend a Saturday afternoon hiking, biking or otherwise making the most of Montana’s abundant outdoor recreation.

One look at the soupy haze blanketing the city and it was clear why. €œWe’re definitely trying to stay out of the smoke,” Charlie Booher said as his kids picked out books from the stacks. Smoke from the wildfires burning through bone-dry forests and grasslands in the West has damaged air quality this week from California to the Eastern Seaboard.

The polluting smoke has been thickest in the Northwest, including Montana, where over the past week Missoula, Helena, Great Falls and other cities ranked among the 10 places with the worst air quality, according to AirNow. The smoke and unrelenting heat pummeling the state have driven people to seek refuge at libraries, movie theaters, museums and other indoor venues. In areas with low hypertension medications vaccination rates where people have largely abandoned masks and physical distancing, health officials are concerned the result will be hypertension medications outbreaks.

Adding to that worry is the rise of the highly transmissible delta variant of the hypertension, and research suggests that hypertension medications cases and deaths increase during periods of intense wildfire smoke. Missoula County has the highest vaccination rate in Montana, at 60%, but Whitney Kors was still mindful of the risks as she took her family to the library to get out of the smoke. €œMy daughter and I are still masked because she’s not vaccinated,” Kors said.

She said that until her daughter, who’s under 12 years old, becomes eligible for her shot, her family will continue to distance from others when they’re out. However, health officials worry that not everyone seeking out smoke-free activities indoors this summer will take the same precautions if they are unvaccinated. To the north in Flathead County, Joe Russell, the county health officer, said he’s tracking a roughly 50% increase in hypertension medications cases over the past two weeks, mostly from unvaccinated people catching the lasix at events.

€œThese are activities that are happening specific to events or settings, and they are indoors,” he explained. Russell said his team is more closely investigating new clusters to see if people went inside to escape heat and smoke. About 6 of 10 county residents who are eligible for hypertension medications treatments have not gotten them, and Russell is worried these large clusters could get worse if more people gather indoors.

The dangers of the lasix appear to have waned in people’s minds as they gather in indoor public spaces, many of which dropped masking and physical distancing requirements earlier this year. In Yellowstone County and Billings, Montana’s largest city, the lasix is still being felt in hospitals that have been treating younger, sicker patients than they saw earlier in the lasix. hypertension medications deaths also spiked there in early July.

Yellowstone County Health Officer John Felton hoped the summer would provide time to boost the county’s 50% vaccination rate before cold weather sends people indoors and increases the risk of unvaccinated people transmitting hypertension medications. €œBut this year has been so hot, so dry and with so much smoke, we are concerned we’re going to have increases happening a little earlier,” he said. Across Montana, about 48% of the eligible population is fully vaccinated, but Magdalena Scott with the state Department of Public Health and Human Services said county rates range from about 23% to 60%.

She said that means case numbers, hospitalizations and deaths are likely to vary more widely than they did last summer, when treatments weren’t yet available. €œWe are concerned that it’s going to be a long smoke season for sure,” Scott said. There are also worries that wildfire smoke could drive up hypertension medications transmission not just by driving people indoors, but also by making them more susceptible to the hypertension.

Fine particulate matter in wildfire smoke, known as PM 2.5, is so small it bypasses the body’s natural defenses, building up in the bloodstream, inflaming the lungs and wearing down the immune system, according to the Centers for Disease Control and Prevention. PM 2.5 from urban air pollution and wildfire smoke is increasingly associated with susceptibility to respiratory s in general, but researchers have been racing to study the same possible association with the hypertension, a respiratory lasix, since last summer. Daniel Kiser is a researcher at the Desert Research Institute in Reno, Nevada.

He worked on a recently published paper about an increase in hypertension medications cases in Reno during the wildfire season. €œWhat we found was that there was about an 18% increase in the rate of positive tests during the period that was most affected by wildfire smoke,” Kiser said. Other studies also have shown a correlation between increases in particulate levels and hypertension medications deaths.

Sultan Ayoub Meo with King Saud University in Saudi Arabia led a team of researchers that studied 10 California counties where levels of fine particulate matter increased on average by 220 times at the height of the state’s wildfire season last year. €œWe found that the hypertension medications cases and deaths increased by 57% and 148%” at the same time, Meo said. Meo said his team now is studying rates among partially and fully vaccinated people during wildfire smoke events.

University of Montana researcher Erin Landguth is also expanding her past study showing intense wildfire seasons in Montana have been followed by bad flu seasons months later in the fall and winter. €œComparing bad fire seasons to non-bad fire seasons, one would expect to see three to five times worse flu seasons,” Landguth said. Landguth is compiling particulate-matter readings across the western U.S.

To examine whether the same association holds across a larger area for not only the flu, but hypertension medications and other respiratory diseases, too. While evidence showing hypertension medications cases and deaths have increased during wildfire events continues to emerge, more study is needed. However, Landguth said, we know enough to be concerned and to advise people to protect themselves.

Back in Missoula, county Air Quality Specialist Sarah Coefield said the best thing people can do is get vaccinated, especially if they plan to seek out public spaces to escape heat and smoke. They can also create a clean-air space at home. With about 2.5 million acres already burned this year in the U.S., and drought worsening across the West, Coefield said, “There’s nothing in the forecast to suggest it’s going to end anytime soon—and it’s not going to get any easier as it goes on.” KHN (Kaiser Health News) is a nonprofit news service covering health issues.

It is an editorially independent program of KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.The White House has rehired a climate scientist who was forced out by the Trump administration, and is proposing to dramatically increase the budget of the Centers for Disease Control and Prevention. €œScience is back” has become a Biden slogan. But listening to scientists is only the first step—and only a partial step, given the deep distrust many Americans have for experts.

We must improve how ordinary citizens help shape science policy. This is one of the findings of a recent report from the Hastings Center that examines the role of citizens in shaping policy in health and science. That role should not be limited to electing candidates and then, a few years later, expressing approval or disapproval of their job performance.

Too many issues are in play at once for the voting–governing connection to be meaningful for many of them, and most people do not choose candidates on the basis of a clear understanding of policies, anyway It is unlikely, for example, that elections will provide guidance about the governance of new technologies such as gene editing, assisted reproduction or artificial intelligence. That doesn’t mean that citizens’ views can’t help shape those policies through mechanisms such as public comment periods on proposed federal rules and public referenda at the state level. But those who influence rulemaking rarely represent the larger public, and neither comment periods nor referenda are deliberative processes in which people become informed about an issue and discuss it with people who might have different views.

What we need are opportunities for Americans to talk and listen to each other face to face, as equals, ideally in person but virtually if need be, about the values and the facts that should guide policy. Americans are not as divided as elected officials, and where they disagree, deliberation can reduce the distance between them. We also can learn to talk and listen with greater mutual respect.

The nation was built on this principle of equality, and Americans of all political perspectives must live it. There have been many small-scale efforts along these lines, mostly undertaken by academics or small nonprofits in what’s known as the civic renewal movement. Typically, these bring people from a community together to discuss local issues, which can help shift the focus from national politics and disagreements about issues that may be abstract and distant toward immediate, concrete problems and shared interests.

For example, instead of discussing climate change in general, which is hard to disconnect from the national political divide, participants can focus on the effect of river flooding on farmers. This kind of local entry point can even lead to a deeper understanding of the broader national issue. But deliberation is possible, and could be productive, at a national level as well.

One example is America in One Room, in which 523 Americans spent a weekend together discussing a range of policy issues in order to become less polarized and more confident about U.S. Democracy. Such an event is a logistical challenge, but similar events can be held online, which also reduces costs and allows more people to participate.

Public deliberation could also be tailored to the many issues that tend to elude the voting/governing feedback loop. Gene editing is a prime example. Reports from the National Academies of Sciences, Engineering, and Medicine and other bodies around the world have argued that policy on genetic editing technologies should be guided by public deliberation.

Public deliberation could also shape the distribution of scarce resources in a disaster like the hypertension medications lasix, or the use of public health measures such as treatment certificates. And the groundswell of support among the public for more attention to climate change suggests that public deliberation could help galvanize the political will to overcome the policy-making logjam in the federal government. In the end, good science depends on democracy, and democracy depends on a deeper, richer engagement between citizens and governance structures.

In a healthy democracy, institutions both private and governmental help create citizens who learn, talk and listen better—who are better able to be engaged and effective—and in turn, active, engaged citizens strengthen the institutions of a good democracy. We don’t just need good government. We need a good society that builds good citizens, who in turn build a better society.

How should I use Lasix?

Take Lasix by mouth with a glass of water. You may take Lasix with or without food. If it upsets your stomach, take it with food or milk. Do not take your medicine more often than directed. Remember that you will need to pass more urine after taking Lasix. Do not take your medicine at a time of day that will cause you problems. Do not take at bedtime.

Talk to your pediatrician regarding the use of Lasix in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of Lasix contact a poison control center or emergency room at once.

NOTE: Lasix is only for you. Do not share Lasix with others.

Potassium supplement for dogs on lasix

Location. University of Birmingham, Edgbaston, Birmingham UK Full Time - Fixed term contract up to June 2023Closing date – 27th June 2021PrecisionTox is a multidisciplinary research project to advance the field of Precision Environmental Health. This new post is created to recruit an early career researcher to contribute original scientific discoveries from a large multi-omics dataset, and to conduct new laboratory experiments using model species Daphnia that will reveal toxicity pathways that are shared with other model species by evolutionary descent by using machine learning approaches and to disseminate these findings through top-tiered publications in peer reviewed scientific journals.Summary of RoleStudy the multi-omics and chemistry data produced by earlier experiments, which include RNA-Seq, metabolomics and analytical chemistry.Initiate and conduct laboratory experiments and original research using model species Daphnia exposed to 250 chemicals to profile toxicological, genome-wide transcriptomes and metabolomes for the discovery of molecular toxicity pathways and other measurable outcomes.Grow the international reputation of the research group and contribute to the University of Birmingham Centre for Precision Toxicology.Plan, design and co-ordinate research activities by supervising laboratory technicians and by supervising students.Contribute to the development of Precision Environmental Health research strategies.Publish results of own research.Give undergraduate lectures.Contribute to the Department/School through management/leadership.Develop and make substantial contributions to knowledge transfer, enterprise, business engagement, public engagement activities, widening participation, schools outreach or similar activities at Department/School level or further within the UniversityMain Duties/ResponsibilitiesTo plan and carry out research, using appropriate methodology and techniques. This may include, where appropriate to the discipline:Pursue laboratory experiments using Daphnia as described in the PrecisionTox grant agreement under Work Package 2Pursue personal research including developing research ideas and winning support, including financial supportPlan, publish and/or execute high quality researchProject manage research activities, and/or supervise other research staffPresent findings in high quality publications and conference proceedingsDevelop novel methodologies and techniques appropriate to the type of research being pursuedSupervise Masters and PhD studentsProvide expert advice to colleagues and students within disciplineDevelop and make substantial contributions to knowledge transfer, enterprise, business engagement, and public engagement activities of manifest benefit to the research group and the CollegePerson SpecificationPhD or near completion in environmental or toxicological genomics.High level of experience in conducting experimental studies using model species Daphnia.High level of experience in the computational analysis of transcriptomics, metabolomics and/or molecular mechanistic toxicity data.Familiarity with mathematical modelling approaches and ability to conduct modelling in the context of computational toxicology.Familiarity with approaches and methods for assessing the safety of chemicals to human and environmental health, and familiarity with Adverse Outcome Pathways (AOPs).Familiarity with regulations governing the safety of chemicals to human health.High level analytical capability.Hands-on skills in bioinformatics, data science or data analytics.Experience in computer programming (e.g.

R-language).Excellent ability to communicate complex information clearly.Valuing excellence, sustaining investmentWe value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible workingPhD opportunitiesThe Centre for Cardiovascular Health and The Centre for Mental Health Practice, Policy and Law Research, School of Health and Social Care (SHSC) at Edinburgh Napier University (ENU)We have 4 fully funded opportunities. 2 in cardiovascular health, 2 in mental health. The studies that we will accept applications for are. Cardiovascular Health1.

What impact does medication AdhereR based visualisations have on improving health-related outcomes for people living with cardiovascular disease and polypharmacy?. . A mixed-methods study within the PARADIGMS project. Adherence to medication is a key indicator of healthcare systems performance, and an essential behaviour for patients to benefit from appropriately prescribed medication.

With population aging and the increasing prevalence of people living longer with cardiovascular disease, the use of multiple medications (polypharmacy) has increased. The Scottish Government are sponsoring the development of a real time adherence monitoring tool namely the PARADIGMS project. This studentship will focus on the service user’s perspective of this real time adherence monitoring tool. In this fully funded PhD studentship the aim is to coproduce and evaluate a service user facing platform designed to optimise medicines adherence behaviour in people with cardiovascular disease and polypharmacy.

Contact Dr. Ruth Paterson r.paterson@napier.ac.uk for information about this opportunity OR 2. Improving care transitions for critically ill patients Critical illness survivors experience chronically impaired health-related quality of life, report significant unmet needs post-hospital discharge, accrue excessive healthcare costs in the first-year post-hospital discharge and have high rates of emergency readmissions to hospital. This PhD proposal complements current work on improving care transitions and discharge planning for critically ill patients with cardiovascular disease in their journey from ICU to community.

Our aim is to identify and evaluate strategies to improve patient transition from hospital discharge to the community. The student will develop skills in conducting systematic reviews, in mixed research methods including implementation science and behaviour change theories. Contact Dr. Claire Kydonaki c.kydonaki@napier.ac.uk for information about this opportunity.

OR 3. Text messaging to promote physical activityPhysical activity is beneficial for both physical and mental health The widespread availability of mobile technology provides an opportunity to support self-management during and beyond the hypertension medications lasix. Text messaging has become a popular and simple way to communicate in a low cost and unobtrusive way. Randomised controlled trials (RCTs) have demonstrated the effectiveness of text messaging to promote smoking cessation, weight loss, and physical activity.

An RCT of a lifestyle-focused text messaging support programmeshowed that, compared with control, the intervention group achieved higher physical activity levels. The programme was also found to be cost-effective,engaging, useful and easy to understand by patients.The proposed PHD studentship will compliment an existing PhD exploring the use of an app and online support system for Physical Activity Referral Schemes in Scotland. Contact Dr. Coral Hanson c.hanson@napier.ac.uk for information about this opportunity.

Mental Health1. Benevolent and traumatic experiences in PTSD and CPTSD Research in the area of psychological trauma has predominantly focused on the impact of negative life events on PTSD and CPTSD. There is very little information on a) what are those positive experiences that might counterbalance the impact of negative life experiences in childhood and b) whether their importance is tempered by the developmental periods they occur. This PhD programme of work involves analysis of existing large datasets to explore the role of negative and positive childhood experiences on PTSD and CPTSD.

This information is essential for the development of preventative and intervention strategies for CPTSD. Contact Professor Thanos Karatzias t.karatzias@napier.ac.uk for information about this opportunity. OR2. Understanding factors associated with the ‘Mental Health Pathway’ This PhD proposal will use a range of approaches, including evidence synthesis, quantitative and qualitative research to understand why citizens contact Police Scotland with mental health concerns, to better understand the citizen journey through the Mental Health Pathway, including what promotes repeat calling amongst the population who phone with non-emergency calls and are referred to NHS24 dedicated mental health call centre.

This PhD is fully funded and will appeal to a wide range of candidates experienced in mental health, criminology, forensic psychology or criminal justice backgrounds. It will be based at Scottish Centre for Law Enforcement and Public Health, Edinburgh Napier University and in partnership with Police Scotland. Contact Dr. Nadine Dougall n.dougall@napier.ac.uk for information about this opportunity.

OR3. Alternatives to psychiatric compulsion. Legal, ethical and practice frameworks Recent WHO and international human rights developments emphasise the ethical requirement to seek alternatives to compulsory treatment for persons with mental illness, where possible. Whilst some jurisdictions, for example Scotland, require patient participation and least restrictive treatment, there is little robust evidence of what alternatives to compulsion are effective, acceptable and safe.

There is also growing debate over which framework(s) (e.g, human rights) are most appropriate for determining when compulsion is ethically justified. This inter-disciplinary (law, clinical psychology) PhD will make a major contribution to ongoing reforms of mental health law and clinical practice, nationally and internationally. Contact Professor Jill Stavert j.stavert@napier.ac.uk for information about this opportunity. For all topicsAcademic qualifications A first degree (at least a 2.1)IELTS score must be at least 6.5 (with not less than 6.0 in each of the four components).

Other, equivalent qualifications will be accepted. Full details of the University’s policy are available online.Essential attributes. Experience of fundamental statisticsCompetent in MS office suiteGood written and oral communication skillsStrong motivation, with evidence of independent research skills relevant to the projectGood time managementDesirable attributes. Previous experience with publication and preparing reportsEnglish language requirement IELTS score must be at least 6.5 (with not less than 6.0 in each of the four components).

Other, equivalent qualifications will be accepted. Full details of the University’s policy are available online.To apply. go to www.napier.ac.uk/research-and-innovation/research-degrees/application-process and apply following the link Health and Social Care Full-Time.Applications should be submitted by. 31st July 2021Interview date.

18th August 2021 at ENU Sighthill CampusScholarship start date. Friday 1st October 2021.

Location can you get lasix over the counter cheap lasix online. University of Birmingham, Edgbaston, Birmingham UK Full Time - Fixed term contract up to cheap lasix online June 2023Closing date – 27th June 2021PrecisionTox is a multidisciplinary research project to advance the field of Precision Environmental Health. This new post is created to recruit an early career researcher to contribute original scientific discoveries from a large multi-omics dataset, and to conduct new laboratory experiments using model species Daphnia that will reveal toxicity pathways that are shared with other model species by evolutionary descent by using machine learning approaches and to disseminate these findings through top-tiered publications in peer reviewed scientific journals.Summary of RoleStudy the multi-omics and chemistry data produced by earlier experiments, which include RNA-Seq, metabolomics and analytical chemistry.Initiate and conduct laboratory experiments and original research using model species Daphnia exposed to 250 chemicals to profile toxicological, genome-wide transcriptomes and metabolomes for the discovery of molecular toxicity pathways and other measurable outcomes.Grow the international reputation of the research group and contribute to the University of Birmingham Centre for Precision Toxicology.Plan, design and co-ordinate research activities by supervising laboratory technicians and by supervising students.Contribute to the development of Precision Environmental Health research strategies.Publish results of own research.Give undergraduate lectures.Contribute to the Department/School through management/leadership.Develop and make substantial contributions to knowledge transfer, enterprise, business engagement, public engagement activities, widening participation, schools outreach or similar activities at Department/School level or further within the UniversityMain Duties/ResponsibilitiesTo plan and carry out research, using appropriate methodology and techniques.

This may include, where appropriate to the discipline:Pursue laboratory experiments using Daphnia as described in the PrecisionTox grant agreement under Work Package 2Pursue personal research including developing research ideas and winning support, including financial supportPlan, publish and/or execute high quality researchProject manage research activities, and/or supervise other research staffPresent findings in high quality publications and conference proceedingsDevelop novel methodologies cheap lasix online and techniques appropriate to the type of research being pursuedSupervise Masters and PhD studentsProvide expert advice to colleagues and students within disciplineDevelop and make substantial contributions to knowledge transfer, enterprise, business engagement, and public engagement activities of manifest benefit to the research group and the CollegePerson SpecificationPhD or near completion in environmental or toxicological genomics.High level of experience in conducting experimental studies using model species Daphnia.High level of experience in the computational analysis of transcriptomics, metabolomics and/or molecular mechanistic toxicity data.Familiarity with mathematical modelling approaches and ability to conduct modelling in the context of computational toxicology.Familiarity with approaches and methods for assessing the safety of chemicals to human and environmental health, and familiarity with Adverse Outcome Pathways (AOPs).Familiarity with regulations governing the safety of chemicals to human health.High level analytical capability.Hands-on skills in bioinformatics, data science or data analytics.Experience in computer programming (e.g. R-language).Excellent ability to communicate complex information clearly.Valuing excellence, sustaining investmentWe value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible workingPhD opportunitiesThe Centre for Cardiovascular Health and The Centre for Mental Health Practice, Policy and Law Research, School of Health and Social Care (SHSC) at Edinburgh Napier University (ENU)We have 4 fully funded opportunities. 2 in cardiovascular health, 2 in mental cheap lasix online health.

The studies that we will accept applications for are. Cardiovascular Health1 cheap lasix online. What impact does medication AdhereR based visualisations have on improving health-related outcomes for people living with cardiovascular disease and polypharmacy?.

. A mixed-methods study within the PARADIGMS project. Adherence to medication is a key indicator of healthcare systems performance, and an essential behaviour for patients to benefit from appropriately prescribed medication.

With population aging and the increasing prevalence of people living longer with cardiovascular disease, the use of multiple medications (polypharmacy) has increased. The Scottish Government are sponsoring the development of a real time adherence monitoring tool namely the PARADIGMS project. This studentship will focus on the service user’s perspective of this real time adherence monitoring tool.

In this fully funded PhD studentship the aim is to coproduce and evaluate a service user facing platform designed to optimise medicines adherence behaviour in people with cardiovascular disease and polypharmacy. Contact Dr. Ruth Paterson r.paterson@napier.ac.uk for information about this opportunity OR 2.

Improving care transitions for critically ill patients Critical illness survivors experience chronically impaired health-related quality of life, report significant unmet needs post-hospital discharge, accrue excessive healthcare costs in the first-year post-hospital discharge and have high rates of emergency readmissions to hospital. This PhD proposal complements current work on improving care transitions and discharge planning for critically ill patients with cardiovascular disease in their journey from ICU to community. Our aim is to identify and evaluate strategies to improve patient transition from hospital discharge to the community.

The student will develop skills in conducting systematic reviews, in mixed research methods including implementation science and behaviour change theories. Contact Dr. Claire Kydonaki c.kydonaki@napier.ac.uk for information about this opportunity.

OR 3. Text messaging to promote physical activityPhysical activity is beneficial for both physical and mental health The widespread availability of mobile technology provides an opportunity to support self-management during and beyond the hypertension medications lasix. Text messaging has become a popular and simple way to communicate in a low cost and unobtrusive way.

Randomised controlled trials (RCTs) have demonstrated the effectiveness of text messaging to promote smoking cessation, weight loss, and physical activity. An RCT of a lifestyle-focused text messaging support programmeshowed that, compared with control, the intervention group achieved higher physical activity levels. The programme was also found to be cost-effective,engaging, useful and easy to understand by patients.The proposed PHD studentship will compliment an existing PhD exploring the use of an app and online support system for Physical Activity Referral Schemes in Scotland.

Contact Dr. Coral Hanson c.hanson@napier.ac.uk for http://blog.hiddenblessings.com/about/ information about this opportunity. Mental Health1.

Benevolent and traumatic experiences in PTSD and CPTSD Research in the area of psychological trauma has predominantly focused on the impact of negative life events on PTSD and CPTSD. There is very little information on a) what are those positive experiences that might counterbalance the impact of negative life experiences in childhood and b) whether their importance is tempered by the developmental periods they occur. This PhD programme of work involves analysis of existing large datasets to explore the role of negative and positive childhood experiences on PTSD and CPTSD.

This information is essential for the development of preventative and intervention strategies for CPTSD. Contact Professor Thanos Karatzias t.karatzias@napier.ac.uk for information about this opportunity. OR2.

Understanding factors associated with the ‘Mental Health Pathway’ This PhD proposal will use a range of approaches, including evidence synthesis, quantitative and qualitative research to understand why citizens contact Police Scotland with mental health concerns, to better understand the citizen journey through the Mental Health Pathway, including what promotes repeat calling amongst the population who phone with non-emergency calls and are referred to NHS24 dedicated mental health call centre. This PhD is fully funded and will appeal to a wide range of candidates experienced in mental health, criminology, forensic psychology or criminal justice backgrounds. It will be based at Scottish Centre for Law Enforcement and Public Health, Edinburgh Napier University and in partnership with Police Scotland.

Contact Dr. Nadine Dougall n.dougall@napier.ac.uk for information about this opportunity. OR3.

Alternatives to psychiatric compulsion. Legal, ethical and practice frameworks Recent WHO and international human rights developments emphasise the ethical requirement to seek alternatives to compulsory treatment for persons with mental illness, where possible. Whilst some jurisdictions, for example Scotland, require patient participation and least restrictive treatment, there is little robust evidence of what alternatives to compulsion are effective, acceptable and safe.

There is also growing debate over which framework(s) (e.g, human rights) are most appropriate for determining when compulsion is ethically justified. This inter-disciplinary (law, clinical psychology) PhD will make a major contribution to ongoing reforms of mental health law and clinical practice, nationally and internationally. Contact Professor Jill Stavert j.stavert@napier.ac.uk for information about this opportunity.

For all topicsAcademic qualifications A first degree (at least a 2.1)IELTS score must be at least 6.5 (with not less than 6.0 in each of the four components). Other, equivalent qualifications will be accepted. Full details of the University’s policy are available online.Essential attributes.

Experience of fundamental statisticsCompetent in MS office suiteGood written and oral communication skillsStrong motivation, with evidence of independent research skills relevant to the projectGood time managementDesirable attributes. Previous experience with publication and preparing reportsEnglish language requirement IELTS score must be at least 6.5 (with not less than 6.0 in each of the four components). Other, equivalent qualifications will be accepted.

Full details of the University’s policy are available online.To apply. go to www.napier.ac.uk/research-and-innovation/research-degrees/application-process and apply following the link Health and Social Care Full-Time.Applications should be submitted by. 31st July 2021Interview date.

18th August 2021 at ENU Sighthill CampusScholarship start date. Friday 1st October 2021.

Lasix 40mg daily

Start Preamble Food lasix 40mg daily and check out here Drug Administration, HHS. Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic lasix 40mg daily Act” (“revised draft guidance”).

This revised draft guidance, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, it addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially lasix 40mg daily copies of a commercially available drug product.

This draft guidance revises the draft guidance issued in 2016 entitled, “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act” (“draft guidance”). FDA is revising the draft guidance to address stakeholder feedback and provide further clarification on policies regarding hospital and health system compounding. This revised draft guidance is not final nor is lasix 40mg daily it in effect at this time.

Submit either electronic or written comments on the revised draft guidance by December 6, 2021 to ensure that the Agency considers your comment on this revised draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the revised draft guidance by December 6, 2021. You may lasix 40mg daily submit comments on any guidance at any time as follows.

Electronic Submissions Submit electronic comments in the following way. Start Printed Page 55848 • Federal eRulemaking Portal. Https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process.

Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows.

• Mail/Hand Delivery/Courier (for written/paper submissions). Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions. All submissions received must include the Docket No. FDA-2016-D-0271 for “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.

And 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total.

One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff.

If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at. Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket. For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this revised draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the revised draft guidance may be sent.

See the SUPPLEMENTARY INFORMATION section for information on electronic access to the revised draft guidance. Start Further Info With regard to the revised draft guidance. Tracy Rupp, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.

51, Silver Spring, MD 20993, 301-796-3100. With regard to the proposed collection of information. Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information I. Background FDA is announcing the availability of a revised draft guidance for industry entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Pharmacies located within a hospital, or standalone pharmacies that are part of a health system, frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders seek to compound under section 503A of the FD&C Act (21 U.S.C.

353a) and others have registered with FDA as outsourcing facilities and are subject to section 503B of the FD&C Act (21 U.S.C. 353b). Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act.

Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice (CGMP) requirements). Section 502(f)(1) (21 U.S.C.

352(f)(1)) (concerning the labeling of drugs with adequate directions for use). And Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications).

This revised draft guidance proposes policies for FDA's application of certain provisions of section 503A of the FD&C Act to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, the revised draft guidance addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product.

This revised draft guidance does not apply to human drug products compounded by outsourcing facilities under section 503B of the FD&C Act, compounded drug products that are not distributed for use within a hospital or health system, or drug products compounded for use in animals. In the Federal Register of April 18, 2016 (81 FR 22610), FDA announced the availability of a draft guidance for industry entitled, “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act” Start Printed Page 55849 (“draft guidance”). The draft guidance proposed new policies for the application of section 503A of the FD&C Act to drug products compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.

In particular, the draft guidance described certain circumstances under which FDA generally would not intend to take action if a hospital or health system pharmacy distributed compounded drug products without first receiving a patient-specific prescription or order. The comment period on the initial draft guidance ended on July 18, 2016. FDA received approximately 76 comments on the draft guidance.

FDA is issuing a revised draft guidance with certain changes made in response to received comments or on its own initiative. For example, the prescription requirement enforcement policy described in the revised draft guidance does not consider whether the drug products are distributed only to healthcare facilities that are located within a 1-mile radius of the compounding pharmacy (“1-mile radius policy”). Instead, the Agency is proposing a two-part, risk-based compliance policy.

In addition, the revised draft guidance proposes new policies for hospital and health system pharmacies regarding the provision in section 503A of the FD&C Act which states that to qualify for the exemptions under section 503A of the FD&C Act, among other conditions, a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. FDA is issuing this revised draft guidance to address stakeholders' feedback, reflect additional Agency consideration of the proposed policies, and enable the public to further review and comment before finalization. This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115).

The revised draft guidance, when finalized, will represent the current thinking of FDA on “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II.

Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. €œCollection of information” is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval.

To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. We are consolidating the information collection in the revised draft guidance with the information collections and approvals under OMB control number 0910-0800. With respect to the following collection of information, FDA invites comments on these topics.

(1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility. (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used. (3) ways to enhance the quality, utility, and clarity of the information to be collected.

And (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Human Drug Compounding Under Sections 503A and 503B the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910-0800—Revision This notice solicits comments on certain information collections found in the revised draft guidance entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“revised draft guidance”). This guidance, when finalized, will support implementation of the copies provisions of the 1997 Food and Drug Administration Modernization Act (FDAMA) (Pub.

L. 105-115) discussed in section 503A of the FD&C Act, which were maintained by the 2013 Drug Quality and Security Act (DQSA) (Title I of Pub. L.

113-54). For efficiency of Agency operations, we are revising OMB control number 0910-0800 to include information collections relating to the copies policies for hospital and health system pharmacies that are not outsourcing facilities, as proposed in the revised draft guidance document. As proposed in section III.B of the revised draft guidance, among other conditions, we generally would not intend to take action against a hospital or health system pharmacy that is not an outsourcing facility for compounding a drug product regularly or in inordinate amounts that is essentially a copy of a commercially available drug product, if the compounded drug product is administered only to patients within the hospital or health system and the pharmacy obtains from the prescriber a statement that.

(1) Specifies a change between the compounded drug product and the commercially available drug product. (2) indicates that the compounded drug product will be administered only to patients for whom the change produces a significant difference from the commercially available drug product. And (3) describes the intended patient population for the compounded drug product.

In addition, the revised draft guidance specifies that the statement would be maintained in the hospital or health system pharmacy to address routine orders for patients for whom the change produces a significant difference, and a statement would be on file for each prescriber that covers each drug product that is compounded. As provided in section III.B of the revised draft guidance, except for the policy proposed above regarding the documentation of a prescriber's determination of significant difference, we propose to apply the policies described in the guidance, “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“503A copies guidance”) to drug products compounded by hospital and health system pharmacies that are not outsourcing facilities. As described in section III.B.2 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, if a compounder intends to rely on a prescriber determination of significant difference to establish that a compounded drug is not essentially a copy of a commercially available drug product, the compounder should ensure that the determination is documented on the prescription.

If a prescription Start Printed Page 55850 does not make clear that the prescriber made the determination required by section 503A(b)(2) of the FD&C Act, or a compounded drug is substituted for the commercially available drug product, the compounder can contact the prescriber and if the prescriber confirms it, make a notation on the prescription that the compounded drug product contains a change that makes a significant difference for the patient. The notations should be as specific as those described in the 503A copies guidance, and the date of the conversation with the prescriber should be included on the prescription. With respect to the determination of significant difference described above, we estimate that, annually, a total of approximately 3,075 hospital or health system pharmacies (table 1) will obtain a prescriber determination of significant difference.

This estimate represents approximately half of the hospitals in the United States, including those that are in health systems. Of these, we estimate that approximately half (1,538) will have hospital or health system pharmacies that will follow the policy in the revised draft guidance, obtaining a statement of significant difference for the intended patient population, and approximately half (1,537) will have hospital or health system pharmacies that will follow the policy with respect to prescriber determination of significant difference in the 503A copies guidance, documenting the notation on the individual patient prescription. This estimate assumes that most pharmacies in smaller hospitals and health systems will follow the policy in the 503A copies guidance because a prescriber determination of significant difference will not be routinely needed and can be most efficiently managed on a patient-by-patient basis.

On the other hand, this estimate assumes that most pharmacies in larger hospitals and health systems will follow the policy in the revised draft guidance because the need for a prescriber determination of significant difference is more routinely necessary and, therefore, most efficiently managed with a statement of significant difference that is maintained in the hospital or health system pharmacy to address routine orders for patients for whom the change produces a significant difference. We estimate that, annually, approximately 1,538 hospital or health system pharmacies following the policy in the revised draft guidance will obtain approximately 30 statements of significant difference for compounded drug products, for a total of approximately 46,140 statements (table 1, row 1). We estimate that the consultation between the hospital or health system pharmacy and the prescriber to obtain the statement of significant difference will require approximately 5 minutes per statement (table 1, row 1).

We estimate that, annually, approximately 1,537 hospital or health pharmacies following the policy in the 503A copies guidance will consult a prescriber to determine whether the prescriber has made a determination that the compounded drug product has a change that produces a significant difference for a patient as compared to the comparable commercially available drug and that the compounders will document this determination on approximately 76,850 prescription orders for compounded drug products (table 1, row 2). We estimate that the consultation between the compounder and the prescriber and adding a notation to each prescription that does not already document this determination will take approximately 3 minutes per prescription order (table 1, row 2). The average burden per consultation and notation for pharmacies following the significant difference policy in the 503A copies guidance, compared to pharmacies following the significant difference policy in the revised draft guidance, is estimated to be less (3 minutes) because the significant difference determination described in the 503A copies policy is specific to one patient, whereas the statement of significant difference in the revised draft guidance describes the intended patient population.

In addition, as described in section III.B.3 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, if the drug product was compounded because the approved drug product was not commercially available because it was on the FDA drug shortage list, the prescription or a notation on the prescription should note that it was on the drug shortage list and note the date the list was checked. We estimate that a total of approximately 4,613 hospital or health system pharmacies will document this information on approximately 922,600 prescription orders for compounded drug products (table 1, row 3). We estimate that checking FDA's drug shortage list and documenting this information will require approximately 2 minutes per prescription order (table 1, row 3).

With respect to maintaining records of the statement of significant difference proposed in section III.B of the revised draft guidance, we estimate that a total of approximately 1,538 hospital or health system pharmacies will maintain approximately 46,140 statements of significant difference (table 2, row 1). We estimate that maintaining the records will require approximately 2 minutes per record (table 2, row 1). With respect to maintaining records of the significant difference determination, as provided in section III.B.5 of the 503A copies guidance, we estimate that a total of approximately 1,537 hospital or health system pharmacies will maintain approximately 76,850 records (table 2, row 2).

We estimate that maintaining records will require approximately 2 minutes per record (table 2, row 2). Also with respect to maintenance of records, as described in section III.B.5 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, compounders under section 503A should maintain records of (1) the frequency in which they have compounded drug products that are essentially copies of commercially available drug products and (2) the number of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products. We estimate that a total of approximately 3,075 hospital or health system pharmacies will maintain approximately 61,500 records of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products http://www.massage-energiecenter.at/?page_id=47 (table 2, row 3).

We estimate that maintaining the records will require approximately 2 minutes per record (table 2, row 3). We estimate the burden of this collection of information as follows. Start Printed Page 55851 Table 1—Estimated Annual Third-Party Disclosure Burden 1ActivityNumber of respondentsNumber of disclosures per respondentTotal annual disclosuresAverage burden per disclosureTotal hoursConsultation between the hospital or health system pharmacy and the prescriber to document the statement of significant difference (revised draft guidance)1,5383046,140.08 (5 minutes)3,691Consultation between the hospital or health system pharmacy and prescriber and the notation on the prescription documenting the prescriber's determination of significant difference (503A copies guidance)1,5375076,850.05 (3 minutes)3,843Hospital or health system pharmacy checking FDA's drug shortage list and documenting on the prescription that the drug is in shortage (503A copies guidance)4,613200922,600.03 (2 minutes)27,678Total35,2121  There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden 1ActivityNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hoursRecords of the statement of significant difference (revised draft guidance)1,5383046,140.03 (2 minutes)1,384Records of documentation of significant difference (503A copies guidance)1,5375076,850.03 (2 minutes)2,306Records of frequency and number of prescriptions filled for compounded drug products that are essentially a copy (503A copies guidance)3,0752061,500.03 (2 minutes)1,845Total5,5351  There are no capital costs or operating and maintenance costs associated with this collection of information. IV. Electronic Access Persons with access to the internet may obtain an electronic version of the revised draft guidance at either https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or https://www.regulations.gov.

Start Signature Dated. October 4, 2021. Lauren K.

Roth, Associate Commissioner for Policy. End Signature End Supplemental Information [FR Doc. 2021-21970 Filed 10-6-21.

8:45 am]BILLING CODE 4164-01-PStart Preamble Centers for Medicare &. Medicaid Services, Health and Human Services (HHS). Notice.

The Centers for Medicare &. Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action.

Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments must be received by October 19, 2021. When commenting, please reference the document identifier or OMB control number.

To be assured consideration, comments and recommendations must be submitted in any one of the following ways. 1. Electronically.

You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2.

By regular mail. You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention.

Document Identifier/OMB Control Number. __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following.

1. Access CMS' website address at website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N.

Parham at (410) 786-4669. End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

CMS-10280 Home Health Change of Care Notice CMS-1557 Survey Report Form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations CMS-3070G-I ICF/IID Survey Report Form and Supporting Regulations Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

Information Collection 1. Type of Information Collection Request. Extension of a currently approved collection.

Title of the Information Collection. Home Health Change of Care Notice. Use.

The purpose of the Home Health Change of Care Notice (HHCCN) is to notify original Medicare beneficiaries receiving home health care benefits of plan of care changes. Home health agencies (HHAs) are required to provide written notice to Original Medicare beneficiaries under various circumstances involving the reduction or termination of items and/or services consistent with Home Health Agencies Conditions of Participation (COPs). The home health COP requirements are set forth in § 1891[42 U.S.C.

1395bbb] of the Social Security Act (the Act). The implementing regulations under 42 CFR 484.10(c) specify that Medicare patients receiving HHA services have rights. The patient has the right to be informed, in advance about the care to be furnished, and of any changes in the care to be furnished.

The HHA must advise the patient in advance of the disciplines that will furnish care, and the frequency of visits proposed to be furnished. The HHA must advise the patient in advance of any change in the plan of care before the change is made.” Notification is required for covered and non-covered services listed in the plan of care (POC). The beneficiary will use the information provided to decide whether or not to pursue alternative options to continue receiving the care noted on the HHCCN.

Form Number. CMS-10280 (OMB control number. 0938-1196).

Private Sector (Business or other for-profits, Not-for-Profit Institutions). Number of Respondents. 11,157.

Total Annual Responses. 12,385,108. Total Annual Hours.

824,848. (For policy questions regarding this collection contact Jennifer McCormick at 410-786-2852.) 2. Type of Information Collection Request.

Extension of a currently approved collection. Title of Information Collection. Survey Report Form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations.

Use. The form is used to report surveyor findings during a CLIA survey. For each type of survey conducted (i.e., initial certification, recertification, validation, complaint, addition/deletion of specialty/subspecialty, transfusion fatality investigation, or revisit inspections) the Survey Report Form incorporates the requirements specified in the CLIA regulations.

Form Number. CMS-1557 (OMB control number. 0938-0544).

Private sector (Business or other for-profit and Not-for-profit institutions, State, Local or Tribal Governments and Federal Government). Number of Respondents. 15,975.

Total Start Printed Page 46855Annual Responses. 7,988. Total Annual Hours.

3,994. (For policy questions regarding this collection contact Kathleen Todd at 410-786-3385). 3.

Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection.

ICF/IID Survey Report Form and Supporting Regulations. Use. The information collected with forms 3070G, CMS-3070H and CMS-3070I is used by the surveyors from the State Survey Agencies (SAs) to determine the level of compliance with the ICF/IID Conditions of Participation (CoPs) necessary to participate in the Medicare/Medicaid program and to report any non-compliance with the ICF/IID CoPs to the Federal government.

These forms summarize the survey team characteristics, facility characteristics, client population, and the special needs of clients. These forms are used in conjunction with the CMS regulation text and additional surveyor aids such as the CMS interpretive guidelines and probes. The CMS-3070G-I forms serves as coding worksheets, designed to facilitate data entry and retrieval into the Automated Survey Processing Environment Suite (ASPEN) in the State and at the CMS regional offices.

Form Number. CMS-3070G-I (OMB control number. 0938-0062).

Frequency. Reporting—Yearly. Affected Public.

Business or other for-profits and Not-for-profit institutions. Number of Respondents. 5,758.

Total Annual Responses. 5,758. Total Annual Hours.

17,274. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) Start Signature Dated. August 17, 2021.

William N. Parham, III Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. End Signature End Supplemental Information [FR Doc.

2021-17908 Filed 8-19-21. 8:45 am]BILLING CODE 4120-01-P.

Start Preamble Food and http://www.em-tilleuls-ostwald.ac-strasbourg.fr/lecole/contact/ Drug cheap lasix online Administration, HHS. Notice of availability. The Food and Drug cheap lasix online Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“revised draft guidance”).

This revised draft guidance, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, it addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it cheap lasix online addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product.

This draft guidance revises the draft guidance issued in 2016 entitled, “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act” (“draft guidance”). FDA is revising the draft guidance to address stakeholder feedback and provide further clarification on policies regarding hospital and health system compounding. This revised draft guidance is not final cheap lasix online nor is it in effect at this time.

Submit either electronic or written comments on the revised draft guidance by December 6, 2021 to ensure that the Agency considers your comment on this revised draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the revised draft guidance by December 6, 2021. You may submit comments on any cheap lasix online guidance at any time as follows.

Electronic Submissions Submit electronic comments in the following way. Start Printed Page 55848 • Federal eRulemaking Portal. Https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process.

Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows.

• Mail/Hand Delivery/Courier (for written/paper submissions). Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions. All submissions received must include the Docket No. FDA-2016-D-0271 for “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.

And 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total.

One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff.

If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at. Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket. For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this revised draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the revised draft guidance may be sent.

See the SUPPLEMENTARY INFORMATION section for information on electronic access to the revised draft guidance. Start Further Info With regard to the revised draft guidance. Tracy Rupp, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.

51, Silver Spring, MD 20993, 301-796-3100. With regard to the proposed collection of information. Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information I. Background FDA is announcing the availability of a revised draft guidance for industry entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Pharmacies located within a hospital, or standalone pharmacies that are part of a health system, frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders seek to compound under section 503A of the FD&C Act (21 U.S.C.

353a) and others have registered with FDA as outsourcing facilities and are subject to section 503B of the FD&C Act (21 U.S.C. 353b). Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act.

Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice (CGMP) requirements). Section 502(f)(1) (21 U.S.C.

352(f)(1)) (concerning the labeling of drugs with adequate directions for use). And Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications).

This revised draft guidance proposes policies for FDA's application of certain provisions of section 503A of the FD&C Act to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, the revised draft guidance addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product.

This revised draft guidance does not apply to human drug products compounded by outsourcing facilities under section 503B of the FD&C Act, compounded drug products that are not distributed for use within a hospital or health system, or drug products compounded for use in animals. In the Federal Register of April 18, 2016 (81 FR 22610), FDA announced the availability of a draft guidance for industry entitled, “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act” Start Printed Page 55849 (“draft guidance”). The draft guidance proposed new policies for the application of section 503A of the FD&C Act to drug products compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.

In particular, the draft guidance described certain circumstances under which FDA generally would not intend to take action if a hospital or health system pharmacy distributed compounded drug products without first receiving a patient-specific prescription or order. The comment period on the initial draft guidance ended on July 18, 2016. FDA received approximately 76 comments on the draft guidance.

FDA is issuing a revised draft guidance with certain changes made in response to received comments or on its own initiative. For example, the prescription requirement enforcement policy described in the revised draft guidance does not consider whether the drug products are distributed only to healthcare facilities that are located within a 1-mile radius of the compounding pharmacy (“1-mile radius policy”). Instead, the Agency is proposing a two-part, risk-based compliance policy.

In addition, the revised draft guidance proposes new policies for hospital and health system pharmacies regarding the provision in section 503A of the FD&C Act which states that to qualify for the exemptions under section 503A of the FD&C Act, among other conditions, a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. FDA is issuing this revised draft guidance to address stakeholders' feedback, reflect additional Agency consideration of the proposed policies, and enable the public to further review and comment before finalization. This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115).

The revised draft guidance, when finalized, will represent the current thinking of FDA on “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II.

Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. €œCollection of information” is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval.

To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. We are consolidating the information collection in the revised draft guidance with the information collections and approvals under OMB control number 0910-0800. With respect to the following collection of information, FDA invites comments on these topics.

(1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility. (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used. (3) ways to enhance the quality, utility, and clarity of the information to be collected.

And (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Human Drug Compounding Under Sections 503A and 503B the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910-0800—Revision This notice solicits comments on certain information collections found in the revised draft guidance entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“revised draft guidance”). This guidance, when finalized, will support implementation of the copies provisions of the 1997 Food and Drug Administration Modernization Act (FDAMA) (Pub.

L. 105-115) discussed in section 503A of the FD&C Act, which were maintained by the 2013 Drug Quality and Security Act (DQSA) (Title I of Pub. L.

113-54). For efficiency of Agency operations, we are revising OMB control number 0910-0800 to include information collections relating to the copies policies for hospital and health system pharmacies that are not outsourcing facilities, as proposed in the revised draft guidance document. As proposed in section III.B of the revised draft guidance, among other conditions, we generally would not intend to take action against a hospital or health system pharmacy that is not an outsourcing facility for compounding a drug product regularly or in inordinate amounts that is essentially a copy of a commercially available drug product, if the compounded drug product is administered only to patients within the hospital or health system and the pharmacy obtains from the prescriber a statement that.

(1) Specifies a change between the compounded drug product and the commercially available drug product. (2) indicates that the compounded drug product will be administered only to patients for whom the change produces a significant difference from the commercially available drug product. And (3) describes the intended patient population for the compounded drug product.

In addition, the revised draft guidance specifies that the statement would be maintained in the hospital or health system pharmacy to address routine orders for patients for whom the change produces a significant difference, and a statement would be on file for each prescriber that covers each drug product that is compounded. As provided in section III.B of the revised draft guidance, except for the policy proposed above regarding the documentation of a prescriber's determination of significant difference, we propose to apply the policies described in the guidance, “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“503A copies guidance”) to drug products compounded by hospital and health system pharmacies that are not outsourcing facilities. As described in section III.B.2 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, if a compounder intends to rely on a prescriber determination of significant difference to establish that a compounded drug is not essentially a copy of a commercially available drug product, the compounder should ensure that the determination is documented on the prescription.

If a prescription Start Printed Page 55850 does not make clear that the prescriber made the determination required by section 503A(b)(2) of the FD&C Act, or a compounded drug is substituted for the commercially available drug product, the compounder can contact the prescriber and if the prescriber confirms it, make a notation on the prescription that the compounded drug product contains a change that makes a significant difference for the patient. The notations should be as specific as those described in the 503A copies guidance, and the date of the conversation with the prescriber should be included on the prescription. With respect to the determination of significant difference described above, we estimate that, annually, a total of approximately 3,075 hospital or health system pharmacies (table 1) will obtain a prescriber determination of significant difference.

This estimate represents approximately half of the hospitals in the United States, including those that are in health systems. Of these, we estimate that approximately half (1,538) will have hospital or health system pharmacies that will follow the policy in the revised draft guidance, obtaining a statement of significant difference for the intended patient population, and approximately half (1,537) will have hospital or health system pharmacies that will follow the policy with respect to prescriber determination of significant difference in the 503A copies guidance, documenting the notation on the individual patient prescription. This estimate assumes that most pharmacies in smaller hospitals and health systems will follow the policy in the 503A copies guidance because a prescriber determination of significant difference will not be routinely needed and can be most efficiently managed on a patient-by-patient basis.

On the other hand, this estimate assumes that most pharmacies in larger hospitals and health systems will follow the policy in the revised draft guidance because the need for a prescriber determination of significant difference is more routinely necessary and, therefore, most efficiently managed with a statement of significant difference that is maintained in the hospital or health system pharmacy to address routine orders for patients for whom the change produces a significant difference. We estimate that, annually, approximately 1,538 hospital or health system pharmacies following the policy in the revised draft guidance will obtain approximately 30 statements of significant difference for compounded drug products, for a total of approximately 46,140 statements (table 1, row 1). We estimate that the consultation between the hospital or health system pharmacy and the prescriber to obtain the statement of significant difference will require approximately 5 minutes per statement (table 1, row 1).

We estimate that, annually, approximately 1,537 hospital or health pharmacies following the policy in the 503A copies guidance will consult a prescriber to determine whether the prescriber has made a determination that the compounded drug product has a change that produces a significant difference for a patient as compared to the comparable commercially available drug and that the compounders will document this determination on approximately 76,850 prescription orders for compounded drug products (table 1, row 2). We estimate that the consultation between the compounder and the prescriber and adding a notation to each prescription that does not already document this determination will take approximately 3 minutes per prescription order (table 1, row 2). The average burden per consultation and notation for pharmacies following the significant difference policy in the 503A copies guidance, compared to pharmacies following the significant difference policy in the revised draft guidance, is estimated to be less (3 minutes) because the significant difference determination described in the 503A copies policy is specific to one patient, whereas the statement of significant difference in the revised draft guidance describes the intended patient population.

In addition, as described in section III.B.3 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, if the drug product was compounded because the approved drug product was not commercially available because it was on the FDA drug shortage list, the prescription or a notation on the prescription should note that it was on the drug shortage list and note the date the list was checked. We estimate that a total of approximately 4,613 hospital or health system pharmacies will document this information on approximately 922,600 prescription orders for compounded drug products (table 1, row 3). We estimate that checking FDA's drug shortage list and documenting this information will require approximately 2 minutes per prescription order (table 1, row 3).

With respect to maintaining records of the statement of significant difference proposed in section III.B of the revised draft guidance, we estimate that a total of approximately 1,538 hospital or health system pharmacies will maintain approximately 46,140 statements of significant difference (table 2, row 1). We estimate that maintaining the records will require approximately 2 minutes per record (table 2, row 1). With respect to maintaining records of the significant difference determination, as provided in section III.B.5 of the 503A copies guidance, we estimate that a total of approximately 1,537 hospital or health system pharmacies will maintain approximately 76,850 records (table 2, row 2).

We estimate that maintaining records will require approximately 2 minutes per record (table 2, row 2). Also with respect to maintenance of records, as described in section III.B.5 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, compounders under section 503A should maintain records of (1) the frequency in which they have compounded drug products that are essentially copies of commercially available drug products and (2) the number of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products. We estimate that a total of approximately 3,075 hospital or health system pharmacies will maintain approximately 61,500 records of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products (table 2, best online lasix row 3).

We estimate that maintaining the records will require approximately 2 minutes per record (table 2, row 3). We estimate the burden of this collection of information as follows. Start Printed Page 55851 Table 1—Estimated Annual Third-Party Disclosure Burden 1ActivityNumber of respondentsNumber of disclosures per respondentTotal annual disclosuresAverage burden per disclosureTotal hoursConsultation between the hospital or health system pharmacy and the prescriber to document the statement of significant difference (revised draft guidance)1,5383046,140.08 (5 minutes)3,691Consultation between the hospital or health system pharmacy and prescriber and the notation on the prescription documenting the prescriber's determination of significant difference (503A copies guidance)1,5375076,850.05 (3 minutes)3,843Hospital or health system pharmacy checking FDA's drug shortage list and documenting on the prescription that the drug is in shortage (503A copies guidance)4,613200922,600.03 (2 minutes)27,678Total35,2121  There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden 1ActivityNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hoursRecords of the statement of significant difference (revised draft guidance)1,5383046,140.03 (2 minutes)1,384Records of documentation of significant difference (503A copies guidance)1,5375076,850.03 (2 minutes)2,306Records of frequency and number of prescriptions filled for compounded drug products that are essentially a copy (503A copies guidance)3,0752061,500.03 (2 minutes)1,845Total5,5351  There are no capital costs or operating and maintenance costs associated with this collection of information. IV. Electronic Access Persons with access to the internet may obtain an electronic version of the revised draft guidance at either https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or https://www.regulations.gov.

Start Signature Dated. October 4, 2021. Lauren K.

Roth, Associate Commissioner for Policy. End Signature End Supplemental Information [FR Doc. 2021-21970 Filed 10-6-21.

8:45 am]BILLING CODE 4164-01-PStart Preamble Centers for Medicare &. Medicaid Services, Health and Human Services (HHS). Notice.

The Centers for Medicare &. Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action.

Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments must be received by October 19, 2021. When commenting, please reference the document identifier or OMB control number.

To be assured consideration, comments and recommendations must be submitted in any one of the following ways. 1. Electronically.

You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2.

By regular mail. You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention.

Document Identifier/OMB Control Number. __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following.

1. Access CMS' website address at website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N.

Parham at (410) 786-4669. End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

CMS-10280 Home Health Change of Care Notice CMS-1557 Survey Report Form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations CMS-3070G-I ICF/IID Survey Report Form and Supporting Regulations Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

Information Collection 1. Type of Information Collection Request. Extension of a currently approved collection.

Title of the Information Collection. Home Health Change of Care Notice. Use.

The purpose of the Home Health Change of Care Notice (HHCCN) is to notify original Medicare beneficiaries receiving home health care benefits of plan of care changes. Home health agencies (HHAs) are required to provide written notice to Original Medicare beneficiaries under various circumstances involving the reduction or termination of items and/or services consistent with Home Health Agencies Conditions of Participation (COPs). The home health COP requirements are set forth in § 1891[42 U.S.C.

1395bbb] of the Social Security Act (the Act). The implementing regulations under 42 CFR 484.10(c) specify that Medicare patients receiving HHA services have rights. The patient has the right to be informed, in advance about the care to be furnished, and of any changes in the care to be furnished.

The HHA must advise the patient in advance of the disciplines that will furnish care, and the frequency of visits proposed to be furnished. The HHA must advise the patient in advance of any change in the plan of care before the change is made.” Notification is required for covered and non-covered services listed in the plan of care (POC). The beneficiary will use the information provided to decide whether or not to pursue alternative options to continue receiving the care noted on the HHCCN.

Form Number. CMS-10280 (OMB control number. 0938-1196).

Private Sector (Business or other for-profits, Not-for-Profit Institutions). Number of Respondents. 11,157.

Total Annual Responses. 12,385,108. Total Annual Hours.

824,848. (For policy questions regarding this collection contact Jennifer McCormick at 410-786-2852.) 2. Type of Information Collection Request.

Extension of a currently approved collection. Title of Information Collection. Survey Report Form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations.

Use. The form is used to report surveyor findings during a CLIA survey. For each type of survey conducted (i.e., initial certification, recertification, validation, complaint, addition/deletion of specialty/subspecialty, transfusion fatality investigation, or revisit inspections) the Survey Report Form incorporates the requirements specified in the CLIA regulations.

Form Number. CMS-1557 (OMB control number. 0938-0544).

Private sector (Business or other for-profit and Not-for-profit institutions, State, Local or Tribal Governments and Federal Government). Number of Respondents. 15,975.

Total Start Printed Page 46855Annual Responses. 7,988. Total Annual Hours.

3,994. (For policy questions regarding this collection contact Kathleen Todd at 410-786-3385). 3.

Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection.

ICF/IID Survey Report Form and Supporting Regulations. Use. The information collected with forms 3070G, CMS-3070H and CMS-3070I is used by the surveyors from the State Survey Agencies (SAs) to determine the level of compliance with the ICF/IID Conditions of Participation (CoPs) necessary to participate in the Medicare/Medicaid program and to report any non-compliance with the ICF/IID CoPs to the Federal government.

These forms summarize the survey team characteristics, facility characteristics, client population, and the special needs of clients. These forms are used in conjunction with the CMS regulation text and additional surveyor aids such as the CMS interpretive guidelines and probes. The CMS-3070G-I forms serves as coding worksheets, designed to facilitate data entry and retrieval into the Automated Survey Processing Environment Suite (ASPEN) in the State and at the CMS regional offices.

Form Number. CMS-3070G-I (OMB control number. 0938-0062).

Frequency. Reporting—Yearly. Affected Public.

Business or other for-profits and Not-for-profit institutions. Number of Respondents. 5,758.

Total Annual Responses. 5,758. Total Annual Hours.

17,274. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) Start Signature Dated. August 17, 2021.

William N. Parham, III Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. End Signature End Supplemental Information [FR Doc.

2021-17908 Filed 8-19-21. 8:45 am]BILLING CODE 4120-01-P.

Lasix ampul

Former Theranos CEO Elizabeth Holmes arrives for a hearing at a federal court in lasix ampul San Jose, California, July 17, 2019.Stephen Lam | ReutersSAN JOSE, where can i buy lasix over the counter CALIF. -- Former Safeway CEO Steve Burd on Wednesday testified in the Elizabeth Holmes criminal fraud trial, saying repeated delays with Theranos' blood-testing machine raised red flags about his company's failed multi-million dollar partnership with the healthcare startup."Deadlines were continuing to be missed and we often weren't given an explanation for that," Burd told the lasix ampul jury. "I kept asking 'Give me some details here.' So that was the frustrating part.

We always tried to help them any way we could."Burd's testimony came on the same day that a juror in the trail disclosed that she would have a difficult time sending Holmes to prison, prompting the judge to excuse her from the case.Safeway lasix ampul spent over $300 million to build out clinics in hundreds of its grocery stores in anticipation of the blood-testing technology. The idea of the partnership being that "while you're shopping and before you lasix ampul leave you're gonna get the results of that blood test," Burd said.Burd served as CEO of Safeway for two decades. He testified that he was initially charmed by Holmes and her vision to create cheaper and faster blood testing technology for his customers."I was very impressed," Burd said.

"There are lasix ampul very few people I had met in the business that I would actually say are charismatic. She was charismatic, she was very smart and she was doing one of the hardest lasix ampul things you can do in a business, and that's to create an enterprise from scratch."The former Theranos CEO is fighting 12 counts of wire fraud and conspiracy to commit wire fraud. Federal prosecutors allege Holmes and her top executive, Ramesh "Sunny" Balwani, engaged in a multi-million dollar scheme to defraud investors and patients.

Holmes and Balwani have pleaded not guilty.Burd testified that he viewed the partnership with Theranos lasix ampul as an opportunity for Safeway to expand into the healthcare world. However, repeated delays with the miniLabs, Theranos' blood-testing machine, raised red flags.Burd testified that lasix ampul Holmes demonstrated the device at a board meeting. They ran a prostate-antigen test on a board member.

Burd recalled that "blood was drawn, it went into the machine and we never got a result."Burd also testified that Holmes never disclosed to him that she was in a romantic relationship with Balwani."It just raises the question of what else is hidden," Burd said.'It's really hard for me,' says jurorBurd's testimony came on the lasix ampul heels of the judge excusing juror No. 4. The juror said she was Buddhist and expressed significant concern and anxiety about http://metallicwebsites.net/uncategorized/hello-world/ the lasix ampul topic of punishment."It's really hard for me," the juror told the judge.

"I'm thinking what lasix ampul happened if she has to be there for a long, long time. It's my fault, and I feel guilty for that." The juror said she believes in love, compassion and forgiveness."Your responsibility as a juror is to only decide the facts of the case, you are not to determine any punishment at all," U.S. District Court Judge Edward Davila lasix ampul said.

"That's for lasix ampul the court to decide. That's not your decision."NBC News Legal Analyst Danny Cevallos said having a juror excused because they demonstrate overwhelming sympathy for a defendant is "incredibly rare.""Maybe we should have seen this coming," Cevallos said. "After all, Elizabeth Holmes successfully charmed some of the highest-profile, most-respected lasix ampul individuals, including Henry Kissinger, George Shultz and James Mattis.

What's particularly amazing is that she's had this effect on the jurors, without saying a word, by just sitting there at lasix ampul the defense table."This was the second juror to be excused from Holmes' trial.In September, Davila excused a 19-year-old woman for financial hardships. There are now three alternate jurors left from the original five.Cevallos warned that losing too many alternate jurors runs the risk of a mistrial."That would have been a wonderful juror for the defense to keep," Cevallos said. "I'm sure lasix ampul they are lamenting the loss of a juror who has grown an emotional attachment to Elizabeth Holmes."Her replacement, alternate juror No.

2, expressed lasix ampul similar uneasiness after being seated on the main bench. The juror said she had concerns about how her role deciding a verdict would affect Holmes' future."She's so young," the juror said while looking at Holmes. "I don't know if I'm 100% ready to participate in something like this, being English is not my first language, so I don't know."Davila reminded the juror she would not be responsible for possible punishment lasix ampul in the case and a diverse jury is important.

Federal prosecutors and defense attorneys for Holmes agreed she can stay on the jury..

Former Theranos CEO Elizabeth Holmes arrives for a hearing at a federal court in San Jose, California, July 17, 2019.Stephen Lam | ReutersSAN http://metallicwebsites.net/uncategorized/hello-world/ JOSE, cheap lasix online CALIF. -- Former cheap lasix online Safeway CEO Steve Burd on Wednesday testified in the Elizabeth Holmes criminal fraud trial, saying repeated delays with Theranos' blood-testing machine raised red flags about his company's failed multi-million dollar partnership with the healthcare startup."Deadlines were continuing to be missed and we often weren't given an explanation for that," Burd told the jury. "I kept asking 'Give me some details here.' So that was the frustrating part.

We always tried cheap lasix online to help them any way we could."Burd's testimony came on the same day that a juror in the trail disclosed that she would have a difficult time sending Holmes to prison, prompting the judge to excuse her from the case.Safeway spent over $300 million to build out clinics in hundreds of its grocery stores in anticipation of the blood-testing technology. The idea of the partnership being that "while you're shopping and before you leave you're gonna get cheap lasix online the results of that blood test," Burd said.Burd served as CEO of Safeway for two decades. He testified that he was initially charmed by Holmes and her vision to create cheaper and faster blood testing technology for his customers."I was very impressed," Burd said.

"There are very few people I had met in the business that I would actually say are cheap lasix online charismatic. She was charismatic, she was very smart and she was doing one of the hardest things you can do in a business, and that's to create cheap lasix online an enterprise from scratch."The former Theranos CEO is fighting 12 counts of wire fraud and conspiracy to commit wire fraud. Federal prosecutors allege Holmes and her top executive, Ramesh "Sunny" Balwani, engaged in a multi-million dollar scheme to defraud investors and patients.

Holmes and Balwani have pleaded not guilty.Burd testified that he viewed cheap lasix online the partnership with Theranos as an opportunity for Safeway to expand into the healthcare world. However, repeated delays with the miniLabs, Theranos' blood-testing machine, raised red flags.Burd testified that Holmes demonstrated the device at cheap lasix online a board meeting. They ran a prostate-antigen test on a board member.

Burd recalled that "blood was cheap lasix online drawn, it went into the machine and we never got a result."Burd also testified that Holmes never disclosed to him that she was in a romantic relationship with Balwani."It just raises the question of what else is hidden," Burd said.'It's really hard for me,' says jurorBurd's testimony came on the heels of the judge excusing juror No. 4. The juror said she was Buddhist and expressed significant concern and anxiety about the topic of punishment."It's really hard for cheap lasix online me," the juror told the judge.

"I'm thinking what happened if she has to be there for a cheap lasix online long, long time. It's my fault, and I feel guilty for that." The juror said she believes in love, compassion and forgiveness."Your responsibility as a juror is to only decide the facts of the case, you are not to determine any punishment at all," U.S. District Court Judge cheap lasix online Edward Davila said.

"That's for the cheap lasix online court to decide. That's not your decision."NBC News Legal Analyst Danny Cevallos said having a juror excused because they demonstrate overwhelming sympathy for a defendant is "incredibly rare.""Maybe we should have seen this coming," Cevallos said. "After all, cheap lasix online Elizabeth Holmes successfully charmed some of the highest-profile, most-respected individuals, including Henry Kissinger, George Shultz and James Mattis.

What's particularly amazing is that she's had this effect on the jurors, without saying a word, by just sitting there at the defense table."This was the second juror to be excused from Holmes' trial.In September, Davila excused cheap lasix online a 19-year-old woman for financial hardships. There are now three alternate jurors left from the original five.Cevallos warned that losing too many alternate jurors runs the risk of a mistrial."That would have been a wonderful juror for the defense to keep," Cevallos said. "I'm sure they are lamenting the loss of a juror who has grown an emotional attachment to Elizabeth Holmes."Her replacement, alternate juror cheap lasix online No.

2, expressed similar uneasiness after being seated on the main bench cheap lasix online. The juror said she had concerns about how her role deciding a verdict would affect Holmes' future."She's so young," the juror said while looking at Holmes. "I don't know if I'm 100% cheap lasix online ready to participate in something like this, being English is not my first language, so I don't know."Davila reminded the juror she would not be responsible for possible punishment in the case and a diverse jury is important.

Federal prosecutors and defense attorneys for Holmes agreed she can stay on the jury..