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She lay behind a glass barrier, heavily sedated, kept alive by a machine that blew oxygen into her lungs through generic viagra for sale a tube taped to her mouth and lodged at the back of her throat. She had deteriorated rapidly since arriving a short time earlier. €œHer respiratory system is failing, and her cardiovascular system is failing,” generic viagra for sale said Dr. Luis Huerta, a critical care expert in the intensive care unit. The odds of survival generic viagra for sale for the patient, who could not be identified for privacy reasons, were poor, Huerta said.

The woman, in her 60s, was among 50 patients so ill with erectile dysfunction treatment that they required constant medical attention this week in ICUs at Los Angeles County+USC Medical Center, a 600-bed public hospital on L.A.’s Eastside. A large majority of them had diabetes, obesity or hypertension. An additional 100 erectile dysfunction treatment patients, less ill at least generic viagra for sale for the moment, were in other parts of the hospital, and the numbers were growing. In the five days that ended Wednesday, eight erectile dysfunction treatment patients at the hospital died — double the number from the preceding five days. Doctors huddle inside the intensive care generic viagra for sale unit at LAC+USC Medical Center.

(Heidi de Marco/California Healthline) A patient infected with the erectile dysfunction at LAC+USC Medical Center. (Heidi de Marco/California Healthline) As erectile dysfunction treatment patients have flooded into LAC+USC in recent weeks, they’ve put an immense strain on its ICU capacity and staff — especially since non-erectile dysfunction treatment patients, with gunshot wounds, drug overdoses, heart attacks and strokes, also need intensive care. No more generic viagra for sale ICU beds were available, said Dr. Brad Spellberg, the hospital’s chief medical officer. Similar scenes generic viagra for sale — packed wards, overworked medical staffers, harried administrators and grieving families — are playing out in hospitals across the state and the nation.

In California, only 4.1% of ICU beds were available as of Wednesday. In the 11-county Southern California region, just 0.5 % of ICU beds were open, and in the San Joaquin Valley, none were generic viagra for sale. Registered nurse Yvonne Yaory puts on her personal protective gear before entering a erectile dysfunction patient’s room. (Heidi de Marco/California Healthline) The county of Los Angeles, the nation’s largest, was perilously close to zero capacity. County health officials reported Wednesday that the number of daily new erectile dysfunction treatment cases, deaths and hospitalizations had generic viagra for sale all soared beyond their previous highs for the entire viagra.

LAC+USC has had a heavy erectile dysfunction treatment burden since the beginning of the viagra, largely because the low-income, predominantly Latino community it serves has been hit so hard. Latinos represent generic viagra for sale about 39% of California’s population but have accounted for nearly 57% of the state’s erectile dysfunction treatment cases and 48% of its erectile dysfunction treatment deaths, according to data updated this week. Many people who live near the hospital have essential jobs and “are not able to work from home. They are going out there and exposing themselves because they have to make a living,” Spellberg said. And, he said, “they don’t live in giant houses where they can isolate themselves in a room.” A patient infected with the erectile dysfunction at LAC+USC Medical generic viagra for sale Center.

(Heidi de Marco/California Healthline) The worst cases end up lying amid a tangle of tubes and bags, in ICU rooms designed to prevent air and viral particles from flowing out into the hall. The sickest among them, like the woman generic viagra for sale described above, need machines to breathe for them. They are fed through nose tubes, their bladders draining into catheter bags, while intravenous lines deliver fluids and medications to relieve pain, keep them sedated and raise their blood pressure to a level necessary for life. To take some pressure off the ICUs, the hospital this week opened a new “step-down” generic viagra for sale unit, for patients who are still very sick but can be managed with a slightly lower level of care. Spellberg said he hopes the unit will accommodate up to 10 patients.

Hospital staff members have also been scouring the insurance plans of patients to see if they can be transferred to other hospitals. €œBut at this point, it’s generic viagra for sale become almost impossible, because they’re all filling up,” Spellberg said. Two weeks ago, a smaller percentage of erectile dysfunction treatment patients in the ER were showing signs of severe disease, which meant fewer needed to be admitted to the hospital or the ICU than during the July surge. That was helping, as Spellberg put it, to keep the water below the generic viagra for sale top of the levee. But not anymore.

€œOver the last 10 days, it is my distinct impression that the severity has worsened again, and that’s why our ICU has filled up quickly,” Spellberg said Monday. The total number of erectile dysfunction treatment patients in the hospital, and the number in its ICUs, are now well above the peak of July — and both are nearly six times as high as in late October generic viagra for sale. €œThis is the worst it’s been,” Spellberg said. And it will only get worse over the coming weeks, he added, if people travel and gather with their extended families over Christmas and New Year’s as they did for generic viagra for sale Thanksgiving. €œThink New York in April.

Think Italy in March,” Spellberg said. €œThat’s how bad things could get.” They are already bad generic viagra for sale enough. Nurses and other medical staffers are exhausted from long months of extremely laborious patient care that is only getting more intense, said Lea Salinas, a nurse manager in one of the hospital’s ICU units. To avoid being short-staffed, she’s been asking her nurses to generic viagra for sale work overtime. Nurse manager Lea Salinas and registered nurse Jonathan Magdaleno go over a patient’s record.

(Heidi de Marco/California Healthline) Normally, ICU generic viagra for sale nurses are assigned to two patients each shift. But one really sick erectile dysfunction treatment patient can take up virtually the entire shift — even with help from other nurses. Jonathan Magdaleno, a registered nurse in the ICU, said he might have to spend 10 hours during a 12-hour shift at the bedside of an extremely ill patient. Even in the best case, he said, he typically has to enter generic viagra for sale a patient’s room every 30 minutes, because the bags delivering medications and fluids empty at different rates. Every time nurses or other care providers enter a patient’s room, they must put on cumbersome protective gear — then take it off when they leave.

One of the most delicate and difficult tasks is a maneuver known as “proning,” in which a patient in acute respiratory distress is flipped onto his or her stomach to improve lung generic viagra for sale function. Salinas said it can take a half-hour and require up to six nurses and a respiratory therapist, because tubes and wires have to be disconnected, then reconnected — not to mention the risks involved in moving an extremely fragile person. And they must do it twice, because every proned patient needs to be flipped back later in the day. Nurse Yvonne Yaory checks on a erectile dysfunction patient who generic viagra for sale is connected to a ventilator. (Heidi de Marco/California Healthline) Nurse Jonathan Magdaleno says it’s been stressful working in the erectile dysfunction treatment ICU at LAC+USC Medical Center.

€œI grew up in this generic viagra for sale community,” he says. €œYou see your parents, you see your grandparents in these patients.” (Heidi de Marco/California Healthline) For some nurses, working on the erectile dysfunction treatment ward at LAC+USC feels very personal. That’s the case for generic viagra for sale Magdaleno, a native Spanish speaker who was born in Mexico City. €œI grew up in this community,” he said. €œEven if you don’t want to, you see your parents, you see your grandparents, you see your mom in these patients, because they speak the language.” He planned to spend Christmas only with members of his own household and urged everyone else to do the same.

€œIf you lose any member of generic viagra for sale your family, then what’s the purpose of Christmas?. € he asked. €œIs it worth it going to generic viagra for sale the mall right now?. Is it worth even getting a gift for somebody who’s probably going to die?. € That the darkest hour of the viagra should come precisely at the moment when erectile dysfunction treatments are beginning to arrive is especially poignant, said Dr.

Paul Holtom, chief generic viagra for sale epidemiologist at LAC+USC. €œThe tragic irony of this is that the light is at the end of the tunnel,” he said. €œThe treatment is rolling out as we speak, and people just need to keep themselves alive generic viagra for sale until they can get the treatment.” Bernard J. Wolfson. bwolfson@kff.org, @bjwolfson Related Topics Contact generic viagra for sale Us Submit a Story TipTELLURIDE, Colo.

€” The day after Thanksgiving, Dr. Jana Eller and Dr. Shiraz Naqvi were seated beside an outdoor fire pit at the base of Telluride Ski Resort, taking a short break from skiing.The two generic viagra for sale physicians from Houston had driven more than 18 hours to get here for the holiday weekend, and they were staying (and preparing meals) in a rented home. They traveled with another couple and their kids, colleagues they’ve been “bubbling” with in Houston.“We got a erectile dysfunction treatment test prior to leaving and will get another when we return,” Naqvi said.The skiing itself doesn’t feel much different during the viagra, Eller said, but “the après ski scene is just gone.” Don't Miss A Story Subscribe to California Healthline’s free Weekly Edition newsletter. In March, at generic viagra for sale the beginning of the viagra, Colorado Gov.

Jared Polis issued an executive order requiring the state’s ski resorts to close in response to erectile dysfunction treatment, which had hit the state’s ski towns early and hard. Now, as the resorts enter their busy season, the state has taken pains to avoid blanket closures even though cases of erectile dysfunction treatment are reaching their highest levels yet.How to stay open amid the viagra is an issue resorts across the U.S. Are facing generic viagra for sale. Mandatory face coverings have become the norm, but other erectile dysfunction treatment mitigation efforts vary by site. Vermont resorts ask skiers to certify generic viagra for sale their compliance with rules governing interstate travel during the viagra when buying a lift ticket, and in Colorado’s Pitkin County (home to Aspen), visitors will be required to confirm they’ve had a negative erectile dysfunction treatment test result within 72 hours of travel or pledge to quarantine for 14 days after arrival or until they obtain a negative test result.Telluride is an internationally renowned destination trying to operate safely while protecting the 8,000 or so permanent residents in the area.

Located in a remote southwestern part of Colorado, its economy depends on tourism, and the resort posts as many as 6,500 visitors on its busiest days.On Nov. 25, with its erectile dysfunction treatment case numbers skyrocketing and its positivity rate hitting 4.6%, San Miguel County, which includes Telluride, closed its bars and restricted its restaurants to takeout and outdoor dining only. Signs posted throughout the resort remind visitors of the “five commitments of containment” — wear a mask, maintain 6 feet of physical distance, minimize group size, wash hands frequently and, when you feel sick, stay home and get tested.How bad would things have to get generic viagra for sale to close the resort?. That’s hard to gauge, said Grace Franklin, public health director for the county. People are going to do what they will regardless, she said.“If we shut down the ski resort, how many people will take to the backcountry and get injured or trigger avalanches where the impact is greater? generic viagra for sale.

It’s a ‘damned if you do, damned if you don’t’ situation,” Franklin said.Instead, Franklin said, the question becomes “How do we create safer, engineered events so people have an outlet, but we minimize as much risk as possible?. €People from the generic viagra for sale same household can stand in line together and ride Telluride’s lifts next to one another, but when riding a lift with someone from another household, guests are asked to leave a vacant seat between them. (Christie Aschwanden)Skiing itself poses relatively little risk, said Kate Langwig, an epidemiologist at Virginia Tech. €œYou’re outside with a lot of airflow, you’ve got something strapped to your feet so you’re not in super close contact with other people, and most of the time you’re riding the lift with people in your group.”Gathering in the lodge or bar is by far the biggest erectile dysfunction treatment risk associated with skiing, said Langwig, who grew up skiing in northern New York. €œIn my family, one of the things you do after a day of skiing is connect with friends and have a beer in the lodge,” and it’s this social aspect of skiing that’s too risky right now, she said.In an effort to discourage tourists and residents from congregating, local governments, medical facilities and the ski resort released a co-signed letter in November urging people to cancel any plans to gather with those outside their immediate generic viagra for sale household and celebrate the holidays solely with people from their own household.

Keeping the resort open will require everybody to do their part, said Lindsey Mills, erectile dysfunction treatment public information consultant for San Miguel County.“We are not telling anybody not to come, at least not yet,” said Todd Brown, Telluride’s mayor pro tem. But local officials are broadcasting a strong message to everyone in the area — “Chill out generic viagra for sale. Don’t have the big party with five families.”Officials aren’t worried only about erectile dysfunction transmission. They’re also concerned about overtaxing their medical facilities. San Miguel County has an urgent care center but no hospital, and its medical center experienced a 22% generic viagra for sale staffing shortage at the end of November, mostly because so many employees are in quarantine.

Hospitals in nearby Mesa County reached their ICU capacity last month, and other hospitals in the region are also pinched.“We can’t have a situation where people break their legs on the slopes and we can’t get them care,” said Franklin.To reduce contact in and around the lifts, Telluride workers have created “ghost lines” of empty space to ensure a 6-foot distance between groups while they’re waiting in lift lines. Face coverings generic viagra for sale are also required. (Christie Aschwanden)The resort has taken steps to facilitate physical distancing among visitors. Reservations aren’t required at Telluride, but lift tickets must be purchased in advance, and the resort can restrict ticket sales if necessary, generic viagra for sale said Jeff Proteau, vice president of operations and planning at the Telluride Ski Resort. Gondolas are operating with the windows open and each load is restricted to members of the same household.To reduce contact in and around the lifts, workers have created “ghost lines” of empty space to ensure a 6-foot distance between groups while they wait in lift lines.

People from the same household can stand in line together and ride the two- to four-person lifts next to one another, Proteau said, but when riding a lift with someone from another household, guests are asked to leave a vacant seat between them.Langwig was a children’s ski instructor for many years and worries about ski school. €œYou interact pretty generic viagra for sale closely with the kids,” she said, noting that runny noses are common. €œYou spend a lot of time getting kids bundled up and to and from the bathroom.” This could be especially challenging if indoor spaces are closed, she said. €œHot chocolate breaks are one of the ways you get kids through the day, and that’s not safe anymore.”In anticipation of visitors needing to take breaks to warm up, the resort has installed generic viagra for sale six temporary structures around the mountain with insulated ceilings and heated panels. When the sides are rolled up, they’re considered outdoor spaces, Proteau said, but they can be closed into confined spaces with limited occupancy as needed, especially on a blustery day.The risk for most employees on the mountain should be relatively minimal, Langwig said, at least at work.

€œLift attendants are outside wearing thick gloves and a mask most of the time. Compared to someone who works in a restaurant, their risk is pretty low.”Employees are generally assigned to work in small groups that can be quarantined, if necessary, without wiping out a whole department, generic viagra for sale Proteau said. There’s also contact tracing in place for resort employees.Arizona native Joey Rague moved to Telluride last year and works as a ski valet on the mountain. He said there’s a huge incentive among employees to keep the resort generic viagra for sale open. With affordable housing sparse in Telluride, “all of us are struggling seasonally to be able to pay rent.”So far, he said, most visitors have been respectful and conscientious of the rules.“It seems as though people understand that if we want to stay open, we have to come together,” he said.

Related Topics Mountain States Bureau Public Health States Colorado erectile dysfunction treatment.

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Credit https://pearsonlg.com/buy-zithromax-online-canada/ teva generic viagra cost. IStock Share Fast Facts New @HopkinsMedicine study finds African-American women with common form of hair loss at increased risk of uterine fibroids - Click to Tweet New study in @JAMADerm shows most common form of alopecia (hair loss) in African-American women associated with higher risks of uterine fibroids - Click to Tweet In a study of medical records gathered on hundreds of thousands of African-American women, Johns Hopkins researchers say they have evidence that women with a common form of hair loss have an increased chance of developing uterine leiomyomas, or fibroids.In a report on the research, published in the December 27 issue of JAMA Dermatology, the researchers call on physicians who treat women with central centrifugal cicatricial alopecia (CCCA) to make patients aware that they may be at increased risk for fibroids and should be screened for the condition, particularly if they have symptoms such as heavy bleeding and pain. CCCA predominantly affects black teva generic viagra cost women and is the most common form of permanent alopecia in this population. The excess scar tissue that forms as a result of this type of hair loss may also explain the higher risk for uterine fibroids, which are characterized by fibrous growths in the lining of the womb. Crystal Aguh, teva generic viagra cost M.D., assistant professor of dermatology at the Johns Hopkins University School of Medicine, says the scarring associated with CCCA is similar to the scarring associated with excess fibrous tissue elsewhere in the body, a situation that may explain why women with this type of hair loss are at a higher risk for fibroids.People of African descent, she notes, are more prone to develop other disorders of abnormal scarring, termed fibroproliferative disorders, such as keloids (a type of raised scar after trauma), scleroderma (an autoimmune disorder marked by thickening of the skin as well as internal organs), some types of lupus and clogged arteries.

During a four-year period from 2013-2017, the researchers analyzed patient data from the Johns Hopkins electronic medical record system (Epic) of 487,104 black women ages 18 and over. The prevalence teva generic viagra cost of those with fibroids was compared in patients with and without CCCA. Overall, the researchers found that 13.9 percent of women with CCCA also had a history of uterine fibroids compared to only 3.3 percent of black women without the condition. In absolute numbers, out of the 486,000 women who were reviewed, 16,212 had fibroids.Within that population, 447 had CCCA, of which 62 had fibroids. The findings translate to a fivefold increased risk of teva generic viagra cost uterine fibroids in women with CCCA, compared to age, sex and race matched controls.

Aguh cautions that their study does not suggest any cause and effect relationship, or prove a common cause for both conditions. €œThe cause of the link between the two conditions remains unclear,” she says teva generic viagra cost. However, the association was strong enough, she adds, to recommend that physicians and patients be made aware of it. Women with this type of scarring alopecia should be screened not only for fibroids, but also for other disorders associated teva generic viagra cost with excess fibrous tissue, Aguh says. An estimated 70 percent of white women and between 80 and 90 percent of African-American women will develop fibroids by age 50, according to the NIH, and while CCCA is likely underdiagnosed, some estimates report a prevalence of rates as high as 17 percent of black women having this condition.

The other teva generic viagra cost authors on this paper were Ginette A. Okoye, M.D. Of Johns Hopkins and Yemisi Dina of Meharry Medical College.Credit. The New England Journal of Medicine Share Fast Facts This study clears up how big an effect the teva generic viagra cost mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types. - Click to Tweet The number of mutations in a tumor’s DNA is a good predictor of whether it will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors.

- Click to Tweet The “mutational burden,” or the number of mutations present in a tumor’s DNA, is a good predictor of whether that cancer type will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors, teva generic viagra cost a new study led by Johns Hopkins Kimmel Cancer Center researchers shows. The finding, published in the Dec. 21 New teva generic viagra cost England Journal of Medicine, could be used to guide future clinical trials for these drugs. Checkpoint inhibitors are a relatively new class of drug that helps the immune system recognize cancer by interfering with mechanisms cancer cells use to hide from immune cells. As a result, the drugs cause the immune system to fight cancer in the same way that it would fight an .

These medicines have had remarkable success in treating some types of cancers that historically have had poor prognoses, such as advanced melanoma and teva generic viagra cost lung cancer. However, these therapies have had little effect on other deadly cancer types, such as pancreatic cancer and glioblastoma. The mutational burden of certain tumor types has previously been proposed as an explanation for why certain cancers respond better than others to immune checkpoint inhibitors says study leader Mark Yarchoan, M.D., chief teva generic viagra cost medical oncology fellow. Work by Dung Le, M.D., associate professor of oncology, and other researchers at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Cancer Institute for Cancer Immunotherapy showed that colon cancers that carry a high number of mutations are more likely to respond to checkpoint inhibitors than those that have fewer mutations. However, exactly how big an teva generic viagra cost effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types was unclear.

To investigate this question, Yarchoan and colleagues Alexander Hopkins, Ph.D., research fellow, and Elizabeth Jaffee, M.D., co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care and associate director of the Bloomberg~Kimmel Institute, combed the medical literature for the results of clinical trials using checkpoint inhibitors on various different types of cancer. They combined these findings with data on the mutational burden of thousands of tumor samples from patients teva generic viagra cost with different tumor types. Analyzing 27 different cancer types for which both pieces of information were available, the researchers found a strong correlation. The higher a cancer type’s mutational burden tends to be, the more likely it is to respond to checkpoint inhibitors. More than half of the differences in how well cancers responded teva generic viagra cost to immune checkpoint inhibitors could be explained by the mutational burden of that cancer.

€œThe idea that a tumor type with more mutations might be easier to treat than one with fewer sounds a little counterintuitive. It’s one of those things that doesn’t sound right when you hear it,” teva generic viagra cost says Hopkins. €œBut with immunotherapy, the more mutations you have, the more chances the immune system has to recognize the tumor.” Although this finding held true for the vast majority of cancer types they studied, there were some outliers in their analysis, says Yarchoan. For example, teva generic viagra cost Merkel cell cancer, a rare and highly aggressive skin cancer, tends to have a moderate number of mutations yet responds extremely well to checkpoint inhibitors. However, he explains, this cancer type is often caused by a viagra, which seems to encourage a strong immune response despite the cancer’s lower mutational burden.

In contrast, the most common type of colorectal cancer has moderate mutational burden, yet responds poorly to checkpoint inhibitors for reasons that are still unclear. Yarchoan notes that these findings could help guide clinical trials to test checkpoint inhibitors on cancer types for which these teva generic viagra cost drugs haven’t yet been tried. Future studies might also focus on finding ways to prompt cancers with low mutational burdens to behave like those with higher mutational burdens so that they will respond better to these therapies. He and his colleagues plan to extend this line of research by teva generic viagra cost investigating whether mutational burden might be a good predictor of whether cancers in individual patients might respond well to this class of immunotherapy drugs. €œThe end goal is precision medicine—moving beyond what’s true for big groups of patients to see whether we can use this information to help any given patient,” he says.

Yarchoan receives teva generic viagra cost funding from the Norman &. Ruth Rales Foundation and the Conquer Cancer Foundation. Through a licensing agreement with Aduro Biotech, Jaffee has the potential to receive royalties in the future..

Credit. IStock Share Fast Facts New @HopkinsMedicine study finds African-American women with common form of hair loss at increased risk of uterine fibroids - Click to Tweet New study in @JAMADerm shows most common form of alopecia (hair loss) in African-American women associated with higher risks of uterine fibroids - Click to Tweet In a study of medical records gathered on hundreds of thousands of African-American women, Johns Hopkins researchers say they have evidence that women with a common form of hair loss have an increased chance of developing uterine leiomyomas, or fibroids.In a report on the research, published in the December 27 issue of JAMA Dermatology, the researchers call on physicians who treat women with central centrifugal cicatricial alopecia (CCCA) to make patients aware that they may be at increased risk for fibroids and should be screened for the condition, particularly if they have symptoms such as heavy bleeding and pain. CCCA predominantly affects black women and is the most common form of permanent alopecia in this population. The excess scar tissue that forms as a result of this type of hair loss may also explain the higher risk for uterine fibroids, which are characterized by fibrous growths in the lining of the womb.

Crystal Aguh, M.D., assistant professor of dermatology at the Johns Hopkins University School of Medicine, says the scarring associated with CCCA is similar to the scarring associated with excess fibrous tissue elsewhere in the body, a situation that may explain why women with this type of hair loss are at a higher risk for fibroids.People of African descent, she notes, are more prone to develop other disorders of abnormal scarring, termed fibroproliferative disorders, such as keloids (a type of raised scar after trauma), scleroderma (an autoimmune disorder marked by thickening of the skin as well as internal organs), some types of lupus and clogged arteries. During a four-year period from 2013-2017, the researchers analyzed patient data from the Johns Hopkins electronic medical record system (Epic) of 487,104 black women ages 18 and over. The prevalence of those with fibroids was compared in patients with and without CCCA. Overall, the researchers found that 13.9 percent of women with CCCA also had a history of uterine fibroids compared to only 3.3 percent of black women without the condition.

In absolute numbers, out of the 486,000 women who were reviewed, 16,212 had fibroids.Within that population, 447 had CCCA, of which 62 had fibroids. The findings translate to a fivefold increased risk of uterine fibroids in women with CCCA, compared to age, sex and race matched controls. Aguh cautions that their study does not suggest any cause and effect relationship, or prove a common cause for both conditions. €œThe cause of the link between the two conditions remains unclear,” she says.

However, the association was strong enough, she adds, to recommend that physicians and patients be made aware of it. Women with this type of scarring alopecia should be screened not only for fibroids, but also for other disorders associated with excess fibrous tissue, Aguh says. An estimated 70 percent of white women and between 80 and 90 percent of African-American women will develop fibroids by age 50, according to the NIH, and while CCCA is likely underdiagnosed, some estimates report a prevalence of rates as high as 17 percent of black women having this condition. The other authors on this paper were Ginette A.

Okoye, M.D. Of Johns Hopkins and Yemisi Dina of Meharry Medical College.Credit. The New England Journal of Medicine Share Fast Facts This study clears up how big an effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types. - Click to Tweet The number of mutations in a tumor’s DNA is a good predictor of whether it will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors.

- Click to Tweet The “mutational burden,” or the number of mutations present in a tumor’s DNA, is a good predictor of whether that cancer type will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors, a new study led by Johns Hopkins Kimmel Cancer Center researchers shows. The finding, published in the Dec. 21 New England Journal of Medicine, could be used to guide future clinical trials for these drugs. Checkpoint inhibitors are a relatively new class of drug that helps the immune system recognize cancer by interfering with mechanisms cancer cells use to hide from immune cells.

As a result, the drugs cause the immune system to fight cancer in the same way that it would fight an . These medicines have had remarkable success in treating some types of cancers that historically have had poor prognoses, such as advanced melanoma and lung cancer. However, these therapies have had little effect on other deadly cancer types, such as pancreatic cancer and glioblastoma. The mutational burden of certain tumor types has previously been proposed as an explanation for why certain cancers respond better than others to immune checkpoint inhibitors says study leader Mark Yarchoan, M.D., chief medical oncology fellow.

Work by Dung Le, M.D., associate professor of oncology, and other researchers at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Cancer Institute for Cancer Immunotherapy showed that colon cancers that carry a high number of mutations are more likely to respond to checkpoint inhibitors than those that have fewer mutations. However, exactly how big an effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types was unclear. To investigate this question, Yarchoan and colleagues Alexander Hopkins, Ph.D., research fellow, and Elizabeth Jaffee, M.D., co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care and associate director of the Bloomberg~Kimmel Institute, combed the medical literature for the results of clinical trials using checkpoint inhibitors on various different types of cancer. They combined these findings with data on the mutational burden of thousands of tumor samples from patients with different tumor types.

Analyzing 27 different cancer types for which both pieces of information were available, the researchers found a strong correlation. The higher a cancer type’s mutational burden tends to be, the more likely it is to respond to checkpoint inhibitors. More than half of the differences in how well cancers responded to immune checkpoint inhibitors could be explained by the mutational burden of that cancer. €œThe idea that a tumor type with more mutations might be easier to treat than one with fewer sounds a little counterintuitive.

It’s one of those things that doesn’t sound right when you hear it,” says Hopkins. €œBut with immunotherapy, the more mutations you have, the more chances the immune system has to recognize the tumor.” Although this finding held true for the vast majority of cancer types they studied, there were some outliers in their analysis, says Yarchoan. For example, Merkel cell cancer, a rare and highly aggressive skin cancer, tends to have a moderate number of mutations yet responds extremely well to checkpoint inhibitors. However, he explains, this cancer type is often caused by a viagra, which seems to encourage a strong immune response despite the cancer’s lower mutational burden.

In contrast, the most common type of colorectal cancer has moderate mutational burden, yet responds poorly to checkpoint inhibitors for reasons that are still unclear. Yarchoan notes that these findings could help guide clinical trials to test checkpoint inhibitors on cancer types for which these drugs haven’t yet been tried. Future studies might also focus on finding ways to prompt cancers with low mutational burdens to behave like those with higher mutational burdens so that they will respond better to these therapies. He and his colleagues plan to extend this line of research by investigating whether mutational burden might be a good predictor of whether cancers in individual patients might respond well to this class of immunotherapy drugs.

€œThe end goal is precision medicine—moving beyond what’s true for big groups of patients to see whether we can use this information to help any given patient,” he says. Yarchoan receives funding from the Norman &. Ruth Rales Foundation and the Conquer Cancer Foundation. Through a licensing agreement with Aduro Biotech, Jaffee has the potential to receive royalties in the future..

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Read fast-track articles.Editorial BoardInformation for AuthorsSubscribe to this TitleInternational Journal of Tuberculosis and Lung DiseasePublic Health ActionIngenta Connect is not responsible for the content or availability of external websitesDownload Article. Download (PDF is there viagra for women 41.2 kb) No AbstractNo Reference information available - sign in for access. No Supplementary Data.No Article MediaNo MetricsDocument Type. EditorialAffiliations:1. Research is there viagra for women Institute of the McGill University Health Centre, Montréal, QC, Faculty of Medicine, McGill University, Montréal, QC, McGill International TB Centre, Montréal, QC, Canada 2.

Clinical Epidemiology &. Biostatistics Unit, Department of Medicine Makerere University College of Health Sciences and Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda 3. Faculty of Medicine, McGill University, is there viagra for women Montréal, QC, McGill International TB Centre, Montréal, QC, CanadaPublication date:01 August 2021More about this publication?. The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as erectile dysfunction treatment, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.

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Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for generic viagra for sale details. The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication.

Read fast-track articles.Editorial BoardInformation for AuthorsSubscribe to this TitleInternational Journal of Tuberculosis and Lung DiseasePublic Health ActionIngenta Connect is generic viagra for sale not responsible for the content or availability of external websitesDownload Article. Download (PDF 41.2 kb) No AbstractNo Reference information available - sign in for access. No Supplementary Data.No Article MediaNo MetricsDocument Type.

EditorialAffiliations:1. Research Institute of the McGill University Health Centre, Montréal, QC, Faculty of Medicine, McGill University, Montréal, QC, McGill International TB Centre, Montréal, QC, Canada 2. Clinical Epidemiology &.

Biostatistics Unit, Department of Medicine Makerere University College of Health Sciences and Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda 3.

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The Kids Helpline counselling centre in Western Sydney is on track to respond to an extra 18,000 contacts during it’s first year of operation, thanks to a $5.5 million investment from the NSW Government.Minister for Mental Health Bronnie Taylor said the Blacktown hub, which employs 30 professional counsellors dedicated to taking calls from children and young adults in NSW, has already responded to 14,528 contacts since its opening in April last year.“It’s been a really tough year, especially for children and young people, which is why we’re making sure that no matter where they live, support services are ready and available, 24 hours a day, seven days a week,” Mrs Taylor said.“We’re building a safer, stronger NSW and having a bricks and mortar presence in Western Sydney means that Kids Helpline now has a physical hub for creating better local connections with communities and services all across the state.”Between March and September 2020, Kids Helpline answered 35,403 calls and online chats from children and young people living in NSW, a increase of 33% on the same period last year.Mrs Taylor said the increased capacity is also helping ensure children and young people can connect with the same counsellor over a period of time.“Being able to speak to what happens if a woman takes viagra the same person on the end of the line week in, week out is so important for building that trusted relationship and making that help-seeking behaviour we want to encourage feel really normal,” https://eingrext.at/shop-neu/hausgemachte-vegane-zucchinicremesuppe/ Mrs Taylor said.yourtown CEO Tracy Adams said she looks forward to another year of supporting children and young people.“Kids Helpline is not only celebrating its first year of operation here, we are also celebrating a milestone of 30 years of dedicated service to children and young people,” Ms Adams said..

The Kids Helpline counselling centre in Western Sydney is on track to respond to an extra 18,000 contacts during it’s first year of operation, thanks to a $5.5 million investment from the NSW Government.Minister for Mental Health Bronnie Taylor said the Blacktown hub, which employs 30 professional counsellors dedicated to taking calls from children and young adults in NSW, has already responded to 14,528 contacts since its opening in April last year.“It’s been a really tough year, especially for children and young people, which is why we’re making sure that no matter where they live, support services are ready and available, 24 hours a day, seven days a week,” Mrs Taylor said.“We’re building a safer, stronger NSW and having a bricks and mortar presence in Western Sydney means that Kids Helpline now has a physical hub for creating better local connections with communities and services all across the state.”Between March and September 2020, Kids Helpline answered 35,403 calls and online chats from children and young people living in NSW, a increase of 33% on the same period last year.Mrs Taylor said the increased capacity is generic viagra for sale also helping ensure children and young people can connect with the same counsellor over a period of time.“Being able to speak to the same person on the end of the line week in, week out is so important for building that trusted relationship and making that help-seeking behaviour we want to encourage feel really normal,” Mrs Taylor said.yourtown CEO Tracy Adams said she looks forward to another year of supporting children and young people.“Kids Helpline is not only celebrating its first year of operation here, we are also celebrating a milestone of 30 years of dedicated service to children and young people,” Ms Adams said..

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€‹The families of four children who were tragically killed by a drunk and drugged driver are launching an annual forgiveness day with the support of the NSW Government.Siblings Antony, Angelina and Sienna Abdallah and their cousin Veronique Sakr were killed in February this year when an out-of-control ute mounted the footpath.The two families have taken the extraordinary step of forgiving the man behind the wheel as an important step in their grieving process.The families want i4give Day to be held every year on the anniversary of the deaths in memory of the children.In launching this day, a memorial service will be held on the eve of the anniversary, Sunday, 31 January 2021, which will be live streamed to the public.Daniel Abdallah said he wants i4give Day to become one can you get viagra over the counter when people can remember the four children but it may also help others who have suffered.“We still black market viagra feel pain and sorrow everyday, but forgiveness has helped to get rid of the anger and bitterness. It’s helped us get through each day and make sure we are there for our other children,” said Mr Abdallah.Both families say this is about honouring their four little saints in heaven.“Our four children are now our four saints and this day is for them. Forgiveness is the greatest gift black market viagra you can give yourself and others. The more you practise the better you become at it and it allows you live peacefully and to heal.” Leila Abdallah said.“Christmas Eve is a very hard time for us as it is also Angelina’s birthday. Even though it is tough, we’ll be celebrating Christmas for the rest of our kids.”Veronique’s mother Bridget Sakr, said “Christmas can be a difficult time for many families.

I hope people can reflect on what so tragically black market viagra happened to our beautiful children to mend bridges with estranged family members and move forward, to love each other in peace and harmony. Life is too precious.”People across the state will be encouraged to reflect on events and relationships in their own lives and look to the example set by the Abdallah and Sakr families.Minister for Mental Health Bronnie Taylor said that while grieving is a normal part of life, when a tragedy such as this occurs the impact on the family is profound.“The grief experienced can take many forms and there is no set timeline. For some people a psychologist or grief and trauma therapist may be of assistance and the need for this may occur months or years after the event,” Mrs Taylor said.“For some people where the loss has occurred through trauma, forgiveness may play a healing role as part of black market viagra the grieving process.“This day is about honouring Antony, Angelina, Sienna and Veronique. Their families have shown amazing strength through such a terrible tragedy.”A website i4give.com will also be launched where people will be directed to links dealing with grief and trauma counselling.​The NSW Government has announced 11 organisations will collectively receive more than $500,000 in grants for innovative ideas to help workplaces reduce the impact of mental health issues and to aid recovery. Minister for Customer Service Victor Dominello said the Recovery Boost program, administered by the State Insurance Regulatory Authority (SIRA), provides up to $50,000 in funding for projects that promote seeking assistance early, supporting an individual's recovery and reducing stigma around mental health.

"Workplaces play a pivotal role at the coal face black market viagra in promoting mental fitness and these grants will empower them to provide staff with help and support when needed," Mr Dominello said. "I congratulate the successful recipients who have proven their commitment to the mental health recovery journey." Minister for Mental Health Bronnie Taylor said the grants would support employers to create and maintain an environment that promotes and encourages good mental health. "Everyone in a workplace can contribute to a culture where people feel safe and supported to talk about mental health and these grants will help the recipients embed tailored support for individuals and teams," Mrs Taylor said. Media:William Sparling │Minister Dominello | 0408 576 636 Richard Shute | Minister Taylor | 0409 394 232 The black market viagra full list of grant recipients and their projects includes. MATES in Construction.

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€‹The families of four read children who were tragically killed by generic viagra for sale a drunk and drugged driver are launching an annual forgiveness day with the support of the NSW Government.Siblings Antony, Angelina and Sienna Abdallah and their cousin Veronique Sakr were killed in February this year when an out-of-control ute mounted the footpath.The two families have taken the extraordinary step of forgiving the man behind the wheel as an important step in their grieving process.The families want i4give Day to be held every year on the anniversary of the deaths in memory of the children.In launching this day, a memorial service will be held on the eve of the anniversary, Sunday, 31 January 2021, which will be live streamed to the public.Daniel Abdallah said he wants i4give Day to become one when people can remember the four children but it may also help others who have suffered.“We still feel pain and sorrow everyday, but forgiveness has helped to get rid of the anger and bitterness. It’s helped us get through each day and make sure we are there for our other children,” said Mr Abdallah.Both families say this is about honouring their four little saints in heaven.“Our four children are now our four saints and this day is for them. Forgiveness is the greatest gift you generic viagra for sale can give yourself and others.

The more you practise the better you become at it and it allows you live peacefully and to heal.” Leila Abdallah said.“Christmas Eve is a very hard time for us as it is also Angelina’s birthday. Even though it is tough, we’ll be celebrating Christmas for the rest of our kids.”Veronique’s mother Bridget Sakr, said “Christmas can be a difficult time for many families. I hope people can reflect on what so tragically happened to our beautiful generic viagra for sale children to mend bridges with estranged family members and move forward, to love each other in peace and harmony.

Life is too precious.”People across the state will be encouraged to reflect on events and relationships in their own lives and look to the example set by the Abdallah and Sakr families.Minister for Mental Health Bronnie Taylor said that while grieving is a normal part of life, when a tragedy such as this occurs the impact on the family is profound.“The grief experienced can take many forms and there is no set timeline. For some people a psychologist or grief and trauma therapist may generic viagra for sale be of assistance and the need for this may occur months or years after the event,” Mrs Taylor said.“For some people where the loss has occurred through trauma, forgiveness may play a healing role as part of the grieving process.“This day is about honouring Antony, Angelina, Sienna and Veronique. Their families have shown amazing strength through such a terrible tragedy.”A website i4give.com will also be launched where people will be directed to links dealing with grief and trauma counselling.​The NSW Government has announced 11 organisations will collectively receive more than $500,000 in grants for innovative ideas to help workplaces reduce the impact of mental health issues and to aid recovery.

Minister for Customer Service Victor Dominello said the Recovery Boost program, administered by the State Insurance Regulatory Authority (SIRA), provides up to $50,000 in funding for projects that promote seeking assistance early, supporting an individual's recovery and reducing stigma around mental health. "Workplaces play a pivotal role at the coal face in promoting mental fitness and these grants generic viagra for sale will empower them to provide staff with help and support when needed," Mr Dominello said. "I congratulate the successful recipients who have proven their commitment to the mental health recovery journey." Minister for Mental Health Bronnie Taylor said the grants would support employers to create and maintain an environment that promotes and encourages good mental health.

"Everyone in a workplace can contribute to a culture where people feel safe and supported to talk about mental health and these grants will help the recipients embed tailored support for individuals and teams," Mrs Taylor said. Media:William Sparling │Minister Dominello | 0408 576 636 Richard Shute | Minister Taylor | 0409 394 generic viagra for sale 232 The full list of grant recipients and their projects includes. MATES in how to get viagra at cvs Construction.

Stronger together in Regional generic viagra for sale NSW. Expanding the MATES in construction in regional communitiesThe NRMA:"We Carry You" Peer support program Australian Manufacturing Workers' Union (AMWU). Mates in Manufacturing – pilot and evaluation of a peer support mental health program tailored for the manufacturing industryRape &.

Domestic Violence generic viagra for sale Services Australia. Aboriginal and Torres Strait Islander Vicarious Trauma (VT) Management ProgramWestpac Helicopter Service. Mental Wellbeing in Emergency Services throughout the Employment Life Cycle Murrumbidgee Local Health District (MLHD), NSW Health:Building Health leaders of the future.

A mental generic viagra for sale health coaching pilot programSouths Cares. Souths Cares Mental Health Initiative Rumpus Skillshare Inc. LunchBreak.

A 4-week program to build mental health skills and habits Headline Productions. Mental Health literacy podcast University of Sydney. LISTEN TO ME.

A virtual platform that supports healthcare workers recovering from mental health Western Sydney Local Health District (WSLHD), NSW Health. Development of an Emergency Department staff wellbeing framework and Code Black virtual reality training program.

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Start Preamble can you get viagra without a prescription their website Food and 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, can you get viagra without a prescription 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 addresses the provision concerning compounded can you get viagra without a prescription 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 nor is it in effect at this can you get viagra without a prescription 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 guidance can you get viagra without a prescription 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 http://solarhairsalon.com/?p=1641 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, 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 how to get viagra over the counter and generic viagra for sale Drug Administration, HHS. Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a revised generic viagra for sale 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 addresses the provision concerning compounded drug products that are essentially copies of a commercially available generic viagra for sale 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 generic viagra for sale draft guidance is not final 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 guidance at any time as follows generic viagra for sale.

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 http://www.ec-bergbieten.ac-strasbourg.fr/devoirs/ prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products (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.