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Purdue Pharma, which makes the OxyContin painkiller that helped buy zithromax online ireland trigger an opioid crisis that led to hundreds of thousands of deaths, has pleaded guilty to three felony criminal charges as part of an $8.3 billion settlement that also resolves civil charges against the company.As part of the deal, Purdue admitted to lying to the Drug Enforcement Administration about a drug diversion program and reporting misleading information to the agency in order to boost manufacturing quotas. Purdue also admitted to violating anti-kickback laws by paying doctors – through speaker programs – to write more prescriptions and using electronic health records to influence prescribing.The settlement includes a $2 billion criminal forfeiture as well as $3.54 billion in criminal penalties, although not all of the money may be collected because the drug maker filed for bankruptcy protection and buy zithromax online ireland other creditors are in line for payouts. Purdue, meanwhile, also agreed to pay $2.8 billion in damages to settle civil claims buy zithromax online ireland. The agreement, by the way, covers infractions from 2007 to 2018.advertisement UPCOMING EVENT 2020 STAT Summit Agenda In addition, the drug maker would be transformed into a public benefit company and run on behalf of the numerous communities around the U.S.

That have been pursuing Purdue for compensation buy zithromax online ireland. The Sackler family, which pushed the idea, would not be involved in the new company, which would provide for free or at cost millions of doses of opioid addiction treatments and overdose reversal medicines.However, more than two dozen state attorneys general, who argue the business should be sold to private owners buy zithromax online ireland and have vowed to object to the maneuver in bankruptcy court.advertisement The agreement is the most notable attempt so far by the federal government to hold a drug maker accountable for the opioid crisis, which has claimed an estimated 470,000 lives in the U.S. Over the past two decades buy zithromax online ireland. Purdue, in fact, has been a poster child for the ongoing turmoil caused by overprescribing and misleading marketing that led to countless addictions, deaths and fractured families.Over the past couple of years, federal authorities have pursued several other companies, including McKesson (MCK), the big wholesaler, and Insys Therapeutics, which sold prescription fentanyl, as well as doctors who overprescribed or ran so-called pill mills.“We have targeted opioids at every level of the supply chain,” Jeffrey Rosen, a deputy attorney general, said at a press conference to announce the settlement.

€œThis global buy zithromax online ireland resolution builds on the department’s other recent opoioid successes. All of these are examples of the department’s unwavering commitment to turn the tide of the buy zithromax online ireland opioid crisis ravaging the country.”Notably, the announcement did not include criminal charges against any Purdue executives or Sackler family members. Earlier this year, Insys Therapeutics founder John Kapoor was sentenced to more than five years in prison for his role in a scheme in which doctors were paid kickbacks to prescribe the highly-addictive Subsys painkiller.But federal authorities indicated that such a move has not been ruled out buy zithromax online ireland and that a criminal investigation is ongoing.“I want to make clear, this settlement does not provide a pass to anybody on the criminal side,” said Rachael Honig, first assistant U.S. Attorney in New Jersey, who ran the criminal investigation, during the media briefing.

She did not offer more specific details, though.In a statement, the Sackler family insisted that family members “who served on Purdue’s board buy zithromax online ireland of directors acted ethically and lawfully, and the upcoming release of company documents will prove that fact in detail. This history of Purdue will also demonstrate that all financial distributions were proper… Regarding the plea agreement between the government buy zithromax online ireland and Purdue, no member of the Sackler family was involved in that conduct or served in a management role at Purdue during that time period.”Numerous lawmakers and advocacy groups have been urging the Justice Department to pursue charges against individuals. One state attorney general buy zithromax online ireland argued that the settlement falls short, because criminal charges were not yet filed and argued the deal was announced prematurely to give President Trump a boost in his re-election bid.“DOJ failed. Justice in this case requires exposing the truth and holding the perpetrators accountable, not rushing a settlement to beat an election.

I am not done with Purdue and the Sacklers, and I will never sell out the families who have been calling for justice for so long.” Massachusetts Attorney General Maura Healey said in a statement.“I’m pleased to see the DOJ take criminal and civil action against Purdue but there’s not much here to celebrate,” said Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University and is executive director of Physicians for Responsible Opioid Prescribing, an education and advocacy group.“The history of the opioid crisis buy zithromax online ireland has proven that fines, settlements and even criminal charges against corporations are not an adequate deterrence. They are buy zithromax online ireland seen as the cost of doing business. If we want to prevent executives, in their pursuit of profit, from taking actions that can lead to a massive loss of life, then individual executives must be held criminally and financially accountable.”.

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65, Does not have rocephin and zithromax Medicare)(OR http://www.grundschule-muehlenberg.de/buy-cheap-levitra-online/ has Medicare and has dependent child <. 18 or <. 19 in school) 138% FPL*** Children <.

5 and pregnant women have HIGHER LIMITS than shown ESSENTIAL PLAN* For MAGI-eligible people over rocephin and zithromax MAGI income limit up to 200% FPL No long term care. See info here 1 2 1 2 3 1 2 Income $884 (up from $875 in 2020) $1300 (up from $1,284 in 2020) $1,482 $2,004 $2,526 $2,146 $2,903 Resources $15,900 (up from $15,750 in 2020) $23,400 (up from $23,100 in 2020) NO LIMIT** NO LIMIT 2020 levels are in GIS 19 MA/12 – 2020 Medicaid Levels and Other Updates and attachments here * MAGI and ESSENTIAL plan levels are based on Federal Poverty Levels, which are not released until later in 2021. 2020 levels are used until then.

NEED rocephin and zithromax TO KNOW PAST MEDICAID INCOME AND RESOURCE LEVELS?. WHAT IS THE HOUSEHOLD SIZE?. See rules here.

HOW TO READ THE HRA Medicaid Levels chart - Boxes 1 and 2 are NON-MAGI Income and Resource levels -- Age 65+, Blind or Disabled and other adults who need to use "spend-down" because they rocephin and zithromax are over the MAGI income levels. Box 10 on page 3 are the MAGI income levels -- The Affordable Care Act changed the rules for Medicaid income eligibility for many BUT NOT ALL New Yorkers. People in the "MAGI" category - those NOT on Medicare -- have expanded eligibility up to 138% of the Federal Poverty Line, so may now qualify for Medicaid even if they were not eligible before, or may now be eligible for Medicaid without a "spend-down." They have NO resource limit.

Box 3 on page 1 is Spousal Impoverishment levels for Managed Long Term Care & rocephin and zithromax. Nursing Homes and Box 8 has the Transfer Penalty rates for nursing home eligibility Box 4 has Medicaid Buy-In for Working People with Disabilities Under Age 65 (still 2017 levels til April 2018) Box 6 are Medicare Savings Program levels (will be updated in April 2018) MAGI INCOME LEVEL of 138% FPL applies to most adults who are not disabled and who do not have Medicare, AND can also apply to adults with Medicare if they have a dependent child/relative under age 18 or under 19 if in school. 42 C.F.R.

§ 435.4 rocephin and zithromax. Certain populations have an even higher income limit - 224% FPL for pregnant women and babies <. Age 1, 154% FPL for children age 1 - 19.

CAUTION rocephin and zithromax. What is counted as income may not be what you think. For the NON-MAGI Disabled/Aged 65+/Blind, income will still be determined by the same rules as before, explained in this outline and these charts on income disregards.

However, for the rocephin and zithromax MAGI population - which is virtually everyone under age 65 who is not on Medicare - their income will now be determined under new rules, based on federal income tax concepts - called "Modifed Adjusted Gross Income" (MAGI). There are good changes and bad changes. GOOD.

Veteran's benefits, Workers compensation, and gifts from family or others rocephin and zithromax no longer count as income. BAD. There is no more "spousal" or parental refusal for this population (but there still is for the Disabled/Aged/Blind.) and some other rules.

For all of the rules rocephin and zithromax see. ALSO SEE 2018 Manual on Lump Sums and Impact on Public Benefits - with resource rules HOW TO DETERMINE SIZE OF HOUSEHOLD TO IDENTIFY WHICH INCOME LIMIT APPLIES The income limits increase with the "household size." In other words, the income limit for a family of 5 may be higher than the income limit for a single person. HOWEVER, Medicaid rules about how to calculate the household size are not intuitive or even logical.

There are different rules depending on the "category" rocephin and zithromax of the person seeking Medicaid. Here are the 2 basic categories and the rules for calculating their household size. People who are Disabled, Aged 65+ or Blind - "DAB" or "SSI-Related" Category -- NON-MAGI - See this chart for their household size.

These same rocephin and zithromax rules apply to the Medicare Savings Program, with some exceptions explained in this article. Everyone else -- MAGI - All children and adults under age 65, including people with disabilities who are not yet on Medicare -- this is the new "MAGI" population. Their household size will be determined using federal income tax rules, which are very complicated.

New rule is explained in State's directive rocephin and zithromax 13 ADM-03 - Medicaid Eligibility Changes under the Affordable Care Act (ACA) of 2010 (PDF) pp. 8-10 of the PDF, This PowerPoint by NYLAG on MAGI Budgeting attempts to explain the new MAGI budgeting, including how to determine the Household Size. See slides 28-49.

Also seeLegal Aid Society rocephin and zithromax and Empire Justice Center materials OLD RULE used until end of 2013 -- Count the person(s) applying for Medicaid who live together, plus any of their legally responsible relatives who do not receive SNA, ADC, or SSI and reside with an applicant/recipient. Spouses or legally responsible for one another, and parents are legally responsible for their children under age 21 (though if the child is disabled, use the rule in the 1st "DAB" category. Under this rule, a child may be excluded from the household if that child's income causes other family members to lose Medicaid eligibility.

See 18 NYCRR 360-4.2, MRG p rocephin and zithromax. 573, NYS GIS 2000 MA-007 CAUTION. Different people in the same household may be in different "categories" and hence have different household sizes AND Medicaid income and resource limits.

If a man is rocephin and zithromax age 67 and has Medicare and his wife is age 62 and not disabled or blind, the husband's household size for Medicaid is determined under Category 1/ Non-MAGI above and his wife's is under Category 2/MAGI. The following programs were available prior to 2014, but are now discontinued because they are folded into MAGI Medicaid. Prenatal Care Assistance Program (PCAP) was Medicaid for pregnant women and children under age 19, with higher income limits for pregnant woman and infants under one year (200% FPL for pregnant women receiving perinatal coverage only not full Medicaid) than for children ages 1-18 (133% FPL).

Medicaid for adults between rocephin and zithromax ages 21-65 who are not disabled and without children under 21 in the household. It was sometimes known as "S/CC" category for Singles and Childless Couples. This category had lower income limits than DAB/ADC-related, but had no asset limits.

It did not allow "spend down" rocephin and zithromax of excess income. This category has now been subsumed under the new MAGI adult group whose limit is now raised to 138% FPL. Family Health Plus - this was an expansion of Medicaid to families with income up to 150% FPL and for childless adults up to 100% FPL.

This has now been folded into the new MAGI adult group rocephin and zithromax whose limit is 138% FPL. For applicants between 138%-150% FPL, they will be eligible for a new program where Medicaid will subsidize their purchase of Qualified Health Plans on the Exchange. PAST INCOME &.

RESOURCE LEVELS rocephin and zithromax -- Past Medicaid income and resource levels in NYS are shown on these oldNYC HRA charts for 2001 through 2019, in chronological order. These include Medicaid levels for MAGI and non-MAGI populations, Child Health Plus, MBI-WPD, Medicare Savings Programs and other public health programs in NYS. This article was authored by the Evelyn Frank Legal Resources Program of New York Legal Assistance Group.A huge barrier to people returning to the community from nursing homes is the high cost of housing.

One way New York State is trying to address that barrier is rocephin and zithromax with the Special Housing Disregard that allows certain members of Managed Long Term Care or FIDA plans to keep more of their income to pay for rent or other shelter costs, rather than having to "spend down" their "excess income" or spend-down on the cost of Medicaid home care. The special income standard for housing expenses helps pay for housing expenses to help certain nursing home or adult home residents to safely transition back to the community with MLTC. Originally it was just for former nursing home residents but in 2014 it was expanded to include people who lived in adult homes.

GIS 14/MA-017 Since you are allowed to keep more of rocephin and zithromax your income, you may no longer need to use a pooled trust. KNOW YOUR RIGHTS - FACT SHEET on THREE ways to Reduce Spend-down, including this Special Income Standard. September 2018 NEWS -- Those already enrolled in MLTC plans before they are admitted to a nursing home or adult home may obtain this budgeting upon discharge, if they meet the other criteria below.

"How nursing home administrators, adult home operators and MLTC rocephin and zithromax plans should identify individuals who are eligible for the special income standard" and explains their duties to identify eligible individuals, and the MLTC plan must notify the local DSS that the individual may qualify. "Nursing home administrators, nursing home discharge planning staff, adult home operators and MLTC health plans are encouraged to identify individuals who may qualify for the special income standard, if they can be safely discharged back to the community from a nursing home and enroll in, or remain enrolled in, an MLTC plan. Once an individual has been accepted into an MLTC plan, the MLTC plan must notify the individual's local district of social services that the transition has occurred and that the individual may qualify for the special income standard.

The special income standard will be effective upon enrollment into the MLTC plan, rocephin and zithromax or, for nursing home residents already enrolled in an MLTC plan, the month of discharge to the community. Questions regarding the special income standard may be directed to DOH at 518-474-8887. Who is eligible for this special income standard?.

must be age 18+, must have been in a nursing home or an adult home for 30 days or more, must have had Medicaid pay toward the nursing home care, and must enroll in or REMAIN ENROLLED IN a Managed Long Term Care (MLTC) plan or FIDA plan upon leaving the nursing rocephin and zithromax home or adult home must have a housing expense if married, spouse may not receive a "spousal impoverishment" allowance once the individual is enrolled in MLTC. How much is the allowance?. The rates vary by region and change yearly.

Region Counties Deduction (2021) Central Broome, Cayuga, Chenango, Cortland, Herkimer, Jefferson, rocephin and zithromax Lewis, Madison, Oneida, Onondaga, Oswego, St. Lawrence, Tioga, Tompkins $450 Long Island Nassau, Suffolk $1,393 NYC Bronx, Kings, Manhattan, Queens, Richmond $1,535 (up from 1,451 in 2020) Northeastern Albany, Clinton, Columbia, Delaware, Essex, Franklin, Fulton, Greene, Hamilton, Montgomery, Otsego, Rensselaer, Saratoga, Schenectady, Schoharie, Warren, Washington $524 North Metropolitan Dutchess, Orange, Putnam, Rockland, Sullivan, Ulster, Westchester $1,075 Rochester Chemung, Livingston, Monroe, Ontario, Schuyler, Seneca, Steuben, Wayne, Yates $469 Western Allegany, Cattaraugus, Chautauqua, Erie, Genesee, Niagara, Orleans, Wyoming $413 Past rates published as follows, available on DOH website 2021 rates published in Attachment I to GIS 20 MA/13 -- 2021 Medicaid Levels and Other Updates 2020 rates published in Attachment I to GIS 19 MA/12 – 2020 Medicaid Levels and Other Updates 2019 rates published in Attachment 1 to GIS 18/MA015 - 2019 Medicaid Levels and Other Updates 2018 rates published in GIS 17 MA/020 - 2018 Medicaid Levels and Other Updates. The guidance on how the standardized amount of the disregard is calculated is found in NYS DOH 12- ADM-05.

2017 rate -- GIS 16 MA/018 - 2016 Medicaid Only Income and Resource Levels and Spousal Impoverishment Standards Attachment 12016 rate -- GIS 15-MA/0212015 rate -- Were not posted by DOH but were updated in WMS. 2015 Central $382 Long Island $1,147 NYC $1,001 Northeastern $440 N. Metropolitan $791 Rochester $388 Western $336 2014 rate -- GIS-14-MA/017 HOW DOES IT WORK?.

Here is a sample budget for a single person in NYC with Social Security income of $2,386/month paying a Medigap premium of $261/mo. Gross monthly income $2,575.50 DEDUCT Health insurance premiums (Medicare Part B) - 135.50 (Medigap) - 261.00 DEDUCT Unearned income disregard - 20 DEDUCT Shelter deduction (NYC—2019) - 1,300 DEDUCT Income limit for single (2019) - 859 Excess income or Spend-down $0 WITH NO SPEND-DOWN, May NOT NEED POOLED TRUST!. HOW TO OBTAIN THE HOUSING DISREGARD.

When you are ready to leave the nursing home or adult home, or soon after you leave, you or your MLTC plan must request that your local Medicaid program change your Medicaid budget to give you the Housing Disregard. See September 2018 NYS DOH Medicaid Update that requires MLTC plan to help you ask for it. The procedures in NYC are explained in this Troubleshooting guide.

In NYC, submit the application with the MAP-751W (check off "Budgeting Changes" and "Special Housing Standard"). (The MAP-751W is also posted in languages other than English in this link. (Updated 3-15-2021.)) NYC Medicaid program prefers that your MLTC plan file the request, using Form MAP-3057E - Special income housing Expenses NH-MLTC.pdf and Form MAP-3047B - MLTC/NHED Cover Sheet Form MAP-259f (revised 7-31-18)(page 7 of PDF)(DIscharge Notice) - NH must file with HRA upon discharge, certifying resident was informed of availability of this disregard.

GOVERNMENT DIRECTIVES (beginning with oldest). NYS DOH 12- ADM-05 - Special Income Standard for Housing Expenses for Individuals Discharged from a Nursing Facility who Enroll into the Managed Long Term Care (MLTC) Program Attachment II - OHIP-0057 - Notice of Intent to Change Medicaid Coverage, (Recipient Discharged from a Skilled Nursing Facility and Enrolled in a Managed Long Term Care Plan) Attachment III - Attachment III – OHIP-0058 - Notice of Intent to Change Medicaid Coverage, (Recipient Disenrolled from a Managed Long Term Care Plan, No Special Income Standard) MLTC Policy 13.02. MLTC Housing Disregard NYC HRA Medicaid Alert Special Income Standard for housing expenses NH-MLTC 2-9-2013.pdf 2018-07-28 HRA MICSA ALERT Special Income Standard for Housing Expenses for Individuals Discharged from a Nursing Facility and who Enroll into the MLTC Program - update on previous policy.

References Form MAP-259f (revised 7-31-18)(page 7 of PDF)(Discharge Notice) - NH must file with HRA upon discharge, certifying resident was informed of availability of this disregard. GIS 18 MA/012 - Special Income Standard for Housing Expenses for Certain Managed Long-Term Care Enrollees Who are Discharged from a Nursing Home issued Sept. 28, 2018 - this finally implements the most recent Special Terms &.

See info buy zithromax online ireland here 1 2 1 2 3 1 2 Income $884 (up from $875 in 2020) $1300 (up from $1,284 in 2020) $1,482 $2,004 $2,526 $2,146 $2,903 Resources $15,900 (up from $15,750 in 2020) $23,400 (up from $23,100 in 2020) NO LIMIT** NO LIMIT 2020 levels are in GIS 19 MA/12 – 2020 Medicaid Levels and Other Updates and attachments here * MAGI and ESSENTIAL plan levels are based on Buy cheap levitra online Federal Poverty Levels, which are not released until later in 2021. 2020 levels are used until then. NEED TO KNOW PAST MEDICAID INCOME AND RESOURCE LEVELS?. WHAT IS THE buy zithromax online ireland HOUSEHOLD SIZE?. See rules here.

HOW TO READ THE HRA Medicaid Levels chart - Boxes 1 and 2 are NON-MAGI Income and Resource levels -- Age 65+, Blind or Disabled and other adults who need to use "spend-down" because they are over the MAGI income levels. Box 10 on page 3 are the MAGI income levels -- The Affordable buy zithromax online ireland Care Act changed the rules for Medicaid income eligibility for many BUT NOT ALL New Yorkers. People in the "MAGI" category - those NOT on Medicare -- have expanded eligibility up to 138% of the Federal Poverty Line, so may now qualify for Medicaid even if they were not eligible before, or may now be eligible for Medicaid without a "spend-down." They have NO resource limit. Box 3 on page 1 is Spousal Impoverishment levels for Managed Long Term Care &. Nursing Homes and Box 8 has the Transfer Penalty rates for nursing home eligibility Box 4 has Medicaid Buy-In for Working People with Disabilities Under Age 65 (still 2017 levels til April 2018) Box 6 are Medicare Savings Program levels (will be updated in April 2018) MAGI INCOME LEVEL of 138% FPL applies to most adults who are not disabled and who do not have Medicare, AND can also apply to adults with Medicare if they have a dependent child/relative under buy zithromax online ireland age 18 or under 19 if in school.

42 C.F.R. § 435.4. Certain populations have an even higher income limit - 224% FPL buy zithromax online ireland for pregnant women and babies <. Age 1, 154% FPL for children age 1 - 19. CAUTION.

What is counted as income may not be buy zithromax online ireland what you think. For the NON-MAGI Disabled/Aged 65+/Blind, income will still be determined by the same rules as before, explained in this outline and these charts on income disregards. However, for the MAGI population - which is virtually everyone under age 65 who is not on Medicare - their income will now be determined under new rules, based on federal income tax concepts - called "Modifed Adjusted Gross Income" (MAGI). There are buy zithromax online ireland good changes and bad changes. GOOD.

Veteran's benefits, Workers compensation, and gifts from family or others no longer count as income. BAD buy zithromax online ireland. There is no more "spousal" or parental refusal for this population (but there still is for the Disabled/Aged/Blind.) and some other rules. For all of the rules see. ALSO SEE 2018 Manual on Lump Sums and Impact on Public Benefits - with resource rules HOW TO DETERMINE SIZE OF HOUSEHOLD TO IDENTIFY WHICH INCOME LIMIT APPLIES The income limits increase buy zithromax online ireland with the "household size." In other words, the income limit for a family of 5 may be higher than the income limit for a single person.

HOWEVER, Medicaid rules about how to calculate the household size are not intuitive or even logical. There are different rules depending on the "category" of the person seeking Medicaid. Here buy zithromax online ireland are the 2 basic categories and the rules for calculating their household size. People who are Disabled, Aged 65+ or Blind - "DAB" or "SSI-Related" Category -- NON-MAGI - See this chart for their household size. These same rules apply to the Medicare Savings Program, with some exceptions explained in this article.

Everyone buy zithromax online ireland else -- MAGI - All children and adults under age 65, including people with disabilities who are not yet on Medicare -- this is the new "MAGI" population. Their household size will be determined using federal income tax rules, which are very complicated. New rule is explained in State's directive 13 ADM-03 - Medicaid Eligibility Changes under the Affordable Care Act (ACA) of 2010 (PDF) pp. 8-10 of the PDF, buy zithromax online ireland This PowerPoint by NYLAG on MAGI Budgeting attempts to explain the new MAGI budgeting, including how to determine the Household Size. See slides 28-49.

Also seeLegal Aid Society and Empire Justice Center materials OLD RULE used until end of 2013 -- Count the person(s) applying for Medicaid who live together, plus any of their legally responsible relatives who do not receive SNA, ADC, or SSI and reside with an applicant/recipient. Spouses or legally responsible for one another, and parents are legally responsible for their children under age 21 (though if the child is disabled, use buy zithromax online ireland the rule in the 1st "DAB" category. Under this rule, a child may be excluded from the household if that child's income causes other family members to lose Medicaid eligibility. See 18 NYCRR 360-4.2, MRG p. 573, NYS GIS 2000 MA-007 CAUTION buy zithromax online ireland.

Different people in the same household may be in different "categories" and hence have different household sizes AND Medicaid income and resource limits. If a man is age 67 and has Medicare and his wife is age 62 and not disabled or blind, the husband's household size for Medicaid is determined under Category 1/ Non-MAGI above and his wife's is under Category 2/MAGI. The following programs were buy zithromax online ireland available prior to 2014, but are now discontinued because they are folded into MAGI Medicaid. Prenatal Care Assistance Program (PCAP) was Medicaid for pregnant women and children under age 19, with higher income limits for pregnant woman and infants under one year (200% FPL for pregnant women receiving perinatal coverage only not full Medicaid) than for children ages 1-18 (133% FPL). Medicaid for adults between ages 21-65 who are not disabled and without children under 21 in the household.

It was buy zithromax online ireland sometimes known as "S/CC" category for Singles and Childless Couples. This category had lower income limits than DAB/ADC-related, but had no asset limits. It did not allow "spend down" of excess income. This category has now been subsumed buy zithromax online ireland under the new MAGI adult group whose limit is now raised to 138% FPL. Family Health Plus - this was an expansion of Medicaid to families with income up to 150% FPL and for childless adults up to 100% FPL.

This has now been folded into the new MAGI adult group whose limit is 138% FPL. For applicants between 138%-150% FPL, they will be eligible for a new program where Medicaid will subsidize their purchase buy zithromax online ireland of Qualified Health Plans on the Exchange. PAST INCOME &. RESOURCE LEVELS -- Past Medicaid income and resource levels in NYS are shown on these oldNYC HRA charts for 2001 through 2019, in chronological order. These include Medicaid levels for MAGI and non-MAGI populations, Child Health Plus, MBI-WPD, Medicare Savings buy zithromax online ireland Programs and other public health programs in NYS.

This article was authored by the Evelyn Frank Legal Resources Program of New York Legal Assistance Group.A huge barrier to people returning to the community from nursing homes is the high cost of housing. One way New York State is trying to address that barrier is with the Special Housing Disregard that allows certain members of Managed Long Term Care or FIDA plans to keep more of their income to pay for rent or other shelter costs, rather than having to "spend down" their "excess income" or spend-down on the cost of Medicaid home care. The special income standard for housing expenses helps pay for housing expenses to help certain nursing home or adult home residents to safely transition back to the community with MLTC buy zithromax online ireland. Originally it was just for former nursing home residents but in 2014 it was expanded to include people who lived in adult homes. GIS 14/MA-017 Since you are allowed to keep more of your income, you may no longer need to use a pooled trust.

KNOW YOUR buy zithromax online ireland RIGHTS - FACT SHEET on THREE ways to Reduce Spend-down, including this Special Income Standard. September 2018 NEWS -- Those already enrolled in MLTC plans before they are admitted to a nursing home or adult home may obtain this budgeting upon discharge, if they meet the other criteria below. "How nursing home administrators, adult home operators and MLTC plans should identify individuals who are eligible for the special income standard" and explains their duties to identify eligible individuals, and the MLTC plan must notify the local DSS that the individual may qualify. "Nursing home administrators, nursing home discharge planning staff, adult home operators and MLTC health plans are encouraged to identify individuals who may qualify for the special income standard, if buy zithromax online ireland they can be safely discharged back to the community from a nursing home and enroll in, or remain enrolled in, an MLTC plan. Once an individual has been accepted into an MLTC plan, the MLTC plan must notify the individual's local district of social services that the transition has occurred and that the individual may qualify for the special income standard.

The special income standard will be effective upon enrollment into the MLTC plan, or, for nursing home residents already enrolled in an MLTC plan, the month of discharge to the community. Questions regarding the special income standard may be directed buy zithromax online ireland to DOH at 518-474-8887. Who is eligible for this special income standard?. must be age 18+, must have been in a nursing home or an adult home for 30 days or more, must have had Medicaid pay toward the nursing home care, and must enroll in or REMAIN ENROLLED IN a Managed Long Term Care (MLTC) plan or FIDA plan upon leaving the nursing home or adult home must have a housing expense if married, spouse may not receive a "spousal impoverishment" allowance once the individual is enrolled in MLTC. How much buy zithromax online ireland is the allowance?.

The rates vary by region and change yearly. Region Counties Deduction (2021) Central Broome, Cayuga, Chenango, Cortland, Herkimer, Jefferson, Lewis, Madison, Oneida, Onondaga, Oswego, St. Lawrence, Tioga, Tompkins $450 Long Island Nassau, Suffolk $1,393 NYC Bronx, Kings, Manhattan, Queens, Richmond buy zithromax online ireland $1,535 (up from 1,451 in 2020) Northeastern Albany, Clinton, Columbia, Delaware, Essex, Franklin, Fulton, Greene, Hamilton, Montgomery, Otsego, Rensselaer, Saratoga, Schenectady, Schoharie, Warren, Washington $524 North Metropolitan Dutchess, Orange, Putnam, Rockland, Sullivan, Ulster, Westchester $1,075 Rochester Chemung, Livingston, Monroe, Ontario, Schuyler, Seneca, Steuben, Wayne, Yates $469 Western Allegany, Cattaraugus, Chautauqua, Erie, Genesee, Niagara, Orleans, Wyoming $413 Past rates published as follows, available on DOH website 2021 rates published in Attachment I to GIS 20 MA/13 -- 2021 Medicaid Levels and Other Updates 2020 rates published in Attachment I to GIS 19 MA/12 – 2020 Medicaid Levels and Other Updates 2019 rates published in Attachment 1 to GIS 18/MA015 - 2019 Medicaid Levels and Other Updates 2018 rates published in GIS 17 MA/020 - 2018 Medicaid Levels and Other Updates. The guidance on how the standardized amount of the disregard is calculated is found in NYS DOH 12- ADM-05. 2017 rate -- GIS 16 MA/018 - 2016 Medicaid Only Income and Resource Levels and Spousal Impoverishment Standards Attachment 12016 rate -- GIS 15-MA/0212015 rate -- Were not posted by DOH but were updated in WMS.

2015 Central $382 Long Island $1,147 NYC $1,001 Northeastern $440 N. Metropolitan $791 Rochester $388 Western $336 2014 rate -- GIS-14-MA/017 HOW DOES IT WORK?. Here is a sample budget for a single person in NYC with Social Security income of $2,386/month paying a Medigap premium of $261/mo. Gross monthly income $2,575.50 DEDUCT Health insurance premiums (Medicare Part B) - 135.50 (Medigap) - 261.00 DEDUCT Unearned income disregard - 20 DEDUCT Shelter deduction (NYC—2019) - 1,300 DEDUCT Income limit for single (2019) - 859 Excess income or Spend-down $0 WITH NO SPEND-DOWN, May NOT NEED POOLED TRUST!. HOW TO OBTAIN THE HOUSING DISREGARD.

When you are ready to leave the nursing home or adult home, or soon after you leave, you or your MLTC plan must request that your local Medicaid program change your Medicaid budget to give you the Housing Disregard. See September 2018 NYS DOH Medicaid Update that requires MLTC plan to help you ask for it. The procedures in NYC are explained in this Troubleshooting guide. In NYC, submit the application with the MAP-751W (check off "Budgeting Changes" and "Special Housing Standard"). (The MAP-751W is also posted in languages other than English in this link.

(Updated 3-15-2021.)) NYC Medicaid program prefers that your MLTC plan file the request, using Form MAP-3057E - Special income housing Expenses NH-MLTC.pdf and Form MAP-3047B - MLTC/NHED Cover Sheet Form MAP-259f (revised 7-31-18)(page 7 of PDF)(DIscharge Notice) - NH must file with HRA upon discharge, certifying resident was informed of availability of this disregard. GOVERNMENT DIRECTIVES (beginning with oldest). NYS DOH 12- ADM-05 - Special Income Standard for Housing Expenses for Individuals Discharged from a Nursing Facility who Enroll into the Managed Long Term Care (MLTC) Program Attachment II - OHIP-0057 - Notice of Intent to Change Medicaid Coverage, (Recipient Discharged from a Skilled Nursing Facility and Enrolled in a Managed Long Term Care Plan) Attachment III - Attachment III – OHIP-0058 - Notice of Intent to Change Medicaid Coverage, (Recipient Disenrolled from a Managed Long Term Care Plan, No Special Income Standard) MLTC Policy 13.02. MLTC Housing Disregard NYC HRA Medicaid Alert Special Income Standard for housing expenses NH-MLTC 2-9-2013.pdf 2018-07-28 HRA MICSA ALERT Special Income Standard for Housing Expenses for Individuals Discharged from a Nursing Facility and who Enroll into the MLTC Program - update on previous policy. References Form MAP-259f (revised 7-31-18)(page 7 of PDF)(Discharge Notice) - NH must file with HRA upon discharge, certifying resident was informed of availability of this disregard.

GIS 18 MA/012 - Special Income Standard for Housing Expenses for Certain Managed Long-Term Care Enrollees Who are Discharged from a Nursing Home issued Sept. 28, 2018 - this finally implements the most recent Special Terms &. Conditions of the CMS 1115 Waiver that governs the MLTC program, dated Jan. 19, 2017. The section on this income standard is at pages 26-27.

In these revised ST&C, this special income standard applies to people who were in a NH or adult home paid by Medicaid and "who enroll into or remain enrolled in the MLTC program in order to receive community based long term services and supports" and to those in a NH who were required to enroll into MLTC because of "...the mandatory Nursing Facility transition, and subsequently able to be discharged to the community from the nursing facility, with the services of MLTC program in place." September 2018 DOH Medicaid Update - explains this benefit to medical providers (nursing homes, MLTC plans, home care agencies, adult home operators, and requires them to identify potential individuals who could benefit and help them apply - described here..

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There is a famous example of the fear, pain and joy concept told by Howard Schubiner, M.D., a leading pain researcher, of a construction worker who stepped on a nail that went through the sole of his boot and came do you need a prescription for zithromax out the top of the boot. Upon seeing the nail emerge through the top of his boot, the man began to scream in pain. He was taken to the emergency room, where he was do you need a prescription for zithromax given strong pain medication before they were able to get the boot off his foot. When they got the boot off his foot they discovered that the nail had gone between his toes and left no mark on his foot at all. So why do you need a prescription for zithromax did he experience pain?.

Because his brain was expecting it based on what he saw. That is the power of the do you need a prescription for zithromax brain – to create the sensation to protect the body from perceived danger. This is anexample of the power of the brain to create pain based on fear and expectation.It neuro-circuits in the brain causing the pain responding to danger signals. Becausethe sensation of pain is one of the brain’s responses to danger signals, anyexperience that increases the potential of danger signals can increase thepossibility of pain signals. Fear is one ofthose things that can increase the danger do you need a prescription for zithromax signal.

For example, if a person hashad an injury in their foot that resulted in pain while weight bearing, thenthey may, very understandably, fear bearing weight in the future. That fearwill then turn on the danger signal in the brain and increase the likelihood ofpain being experienced do you need a prescription for zithromax. It can become a vicious cycle. This type of painis do you need a prescription for zithromax real pain, because all pain is real pain. Anyone who says “it’s all in yourhead” is being insensitive and judgmental.

The truth is, all pain starts in ourhead, as a response to the danger alarm that says something is wrong. Thisdanger alarm might be do you need a prescription for zithromax triggered from a structural injury to the body, or thefear of expecting pain, or the fear of social rejection, or the emotional painof a traumatic memory, or anything that the alarm system perceives as adanger. This type of response is an unconscious response in the brain, not a choice that people make. One way to check to see if pain is related to the do you need a prescription for zithromax neuro-circuits is to use the imagination. If someone imagines doing the thing that has caused pain in the past and experiences pain or fear while imagining the movement or the situation, it is a good sign that it is learned neuro-circuits in the brain causing the pain.

This is good news do you need a prescription for zithromax because the brain can be rewired. Once people know that their brain may be creating the sensation of pain, it can free them to change it. There are anumber of ways a person can rewire the brain. One good way do you need a prescription for zithromax is to reduce thefear related to anticipating pain. Self-talk and affirmations can be used toreduce fear.

Once a person knows that all or some of their pain isneuro-circuit pain, and that it is not structural do you need a prescription for zithromax damage, they can say tothemselves “I am strong and healthy. There is nothing wrong with this part ofmy body. I am do you need a prescription for zithromax okay. I am safe. There is no danger.” This can help turn off thedanger signal.

In comparison, when a person says, “There is something wrongwith me do you need a prescription for zithromax. I am damaged,” the alarm system is turned on, which will perpetuatethe pain. It may sound simple,but for many people this is the beginning do you need a prescription for zithromax of changing the brain, rewiringneuro-circuits to stop the fear of pain, stop the tripping of the danger alarm,and break the cycle. But just like learning any new skill, which all involvedmaking neuro-circuit connections, it can take time and rehearsal. This rewiring canbecome even more powerful when combined with other tools to rewire the brain.Another tool is the use of deep breaths, which lets do you need a prescription for zithromax the danger alarm know thatthings are okay.

Another tool is the use of laughter and humor. Participatingin mindfulness, playfulness and joy can also rewire the brain to turn off thefear signals. Participating in any of these activities, or even imagining thesethings, during the previously feared movement or situation can do you need a prescription for zithromax help rewire thebrain. For more information on this, Dr. Schubiner has created a series of easy-to-understand animated video beginning with “What do you need a prescription for zithromax is pain.” For those who need more intense treatment for mental health conditions, MidMichigan Health provides an intensive outpatient program called Psychiatric Partial Hospitalization Program at MidMichigan Medical Center – Gratiot.

Those interested in more information about the PHP program may call (989) 466-3253. Those interested do you need a prescription for zithromax in more information on MidMichigan’s comprehensive behavioral health programs may visit www.midmichigan.org/mentalhealth.Each year, more than a million families in the United States experience a miscarriage, stillbirth or death of an infant. Yet because these events can be emotionally difficult to discuss, there is little public awareness, so families may not always get the support they need. October is Pregnancy and Infant Loss do you need a prescription for zithromax Awareness Month, a time to show support for these families, highlight available resources and build understanding of how family, friends and the community can help. If you visit a MidMichiganHealth facility during the month of October, you may notice staff wearing pinkand blue ribbons to show their support.

We will also participate in theInternational Wave of Light, a worldwide remembrance event on October 15, 7 to 8p.m. During this time, candles will do you need a prescription for zithromax be lit at the entrances of MidMichigan’sMedical Centers in Alma, Alpena, Midland and West Branch (the sites of our fourMaternity Centers) to honor babies gone too soon and their families. Patients,staff and community members are welcome to attend. Resources for Grieving Parents Your do you need a prescription for zithromax primarycare doctor or OB/Gyn can be a good first contact to help you understand thephysical and emotional impact of a loss and to identify other resources. MidMichigan Home Care offers grief support for individuals and families who have lost a loved one, including education, support groups, short-term counseling and referrals to community professionals for longer-term follow-up.

For more information, do you need a prescription for zithromax visit www.midmichigan.org/grief or call (800) 862-5002. There are manylocal and national nonprofits that specialize in helping families throughinfant and pregnancy loss. Their services range from resources and materialsthat discuss what families can expect during the grieving process, to in-personand online support groups to financial assistance with funeral and otherexpenses. Some organizations focus on do you need a prescription for zithromax certain bereaved family members, such asparents or siblings, or on specific causes of perinatal death. Consider callingUnited Way’s 2-1-1 hotline to identify local agencies in your area that mayprovide targeted grief services.

What to Say When Someone Loses a Child People tend totreat pregnancy or infant loss as a taboo subject, so do you need a prescription for zithromax loved ones are oftenuncomfortable or unfamiliar with what to say or do. Some well-meaning peoplemay even say things that are more hurtful than helpful. Experts recommend keepingyour condolences simple, following the family’s cues, do you need a prescription for zithromax and asking about theirpreferences if you are unsure. Tips. Acknowledgetheir loss in short, simple phrases, such as, “I’m sorry for your loss.” Or “Iimagine this must be painful for you.” Offer to listen if they want to talk.It’s also okay to simply admit that you don’t know what to say.Askwhether it is okay to talk about the baby and to use the baby’s name.Peopleoften treat miscarriage as “no big deal,” but the value of a life is notproportional to the time spent on earth.

When a do you need a prescription for zithromax family loses a child, they losethe entire future they had dreamed for themselves and that child. A lifetime ofmilestones and memories. In some cases, they do you need a prescription for zithromax may not have another opportunityto become parents, which can compound their grief. Avoidstatements that downplay their emotions, tell them how to feel, attempt to finda “silver lining” in their grief, or are based on religion, such as:Perhapsit was for the best.Godmust have wanted your special angel to be with him.You’reyoung. You can still do you need a prescription for zithromax have another child.Atleast now you know you can get pregnant.Atleast you didn’t really know him/her.Atleast you weren’t that far along.Rememberthe father, siblings and other family members.

The focus tends to be on mothers,but the whole family may need your support. Be aware that men may feel the needto “be strong” which can impede their grieving process.Offerto help with specific tasks. People who are grieving may not be able toidentify their needs or ask for help do you need a prescription for zithromax. You can offer to help with caring forother children, preparing meals, doing housework, funeral preparations, notifyingextended family or friends, or creating a special memento or ritual to rememberthe baby. Remember that help and support may be especially needed after do you need a prescription for zithromax otherhelpers have moved on.Acknowledgethem as parents.

This isoften overlooked if they don’t have living children, yet they are parents andshould be supported and addressed as parents.Rememberthem in years to come. Call, send a card, or offer to spend time with them onmilestone days. Grief does not end with the delivery or memorial service. You can findmore helpful tips at these and other websites:.

There is a famous example of the fear, pain and joy concept told by Howard Schubiner, buy zithromax online ireland M.D., a leading pain researcher, of a construction worker who stepped on a nail http://pacificanaturopathic.com/2012/08/vaccinationviewpoint/ that went through the sole of his boot and came out the top of the boot. Upon seeing the nail emerge through the top of his boot, the man began to scream in pain. He was taken to the emergency room, where he was given strong pain medication before they were able buy zithromax online ireland to get the boot off his foot.

When they got the boot off his foot they discovered that the nail had gone between his toes and left no mark on his foot at all. So why did he experience buy zithromax online ireland pain?. Because his brain was expecting it based on what he saw.

That is the power of the brain – to create the sensation to buy zithromax online ireland protect the body from perceived danger. This is anexample of the power of the brain to create pain based on fear and expectation.It neuro-circuits in the brain causing the pain responding to danger signals. Becausethe sensation of pain is one of the brain’s responses to danger signals, anyexperience that increases the potential of danger signals can increase thepossibility of pain signals.

Fear is one ofthose things buy zithromax online ireland that can increase the danger signal. For example, if a person hashad an injury in their foot that resulted in pain while weight bearing, thenthey may, very understandably, fear bearing weight in the future. That fearwill then turn on buy zithromax online ireland the danger signal in the brain and increase the likelihood ofpain being experienced.

It can become a vicious cycle. This type of painis buy zithromax online ireland real pain, because all pain is real pain. Anyone who says “it’s all in yourhead” is being insensitive and judgmental.

The truth is, all pain starts in ourhead, as a response to the danger alarm that says something is wrong. Thisdanger alarm might be triggered from a structural injury to the body, or thefear of expecting pain, or the fear of social rejection, buy zithromax online ireland or the emotional painof a traumatic memory, or anything that the alarm system perceives as adanger. This type of response is an unconscious response in the brain, not a choice that people make.

One way to check to buy zithromax online ireland see if pain is related to the neuro-circuits is to use the imagination. If someone imagines doing the thing that has caused pain in the past and experiences pain or fear while imagining the movement or the situation, it is a good sign that it is learned neuro-circuits in the brain causing the pain. This is good news because buy zithromax online ireland the brain can be rewired.

Once people know that their brain may be creating the sensation of pain, it can free them to change it. There are anumber of ways a person can rewire the brain. One good buy zithromax online ireland way is to reduce thefear related to anticipating pain.

Self-talk and affirmations can be used toreduce fear. Once a person knows that all or some of their pain isneuro-circuit pain, and that it is not buy zithromax online ireland structural damage, they can say tothemselves “I am strong and healthy. There is nothing wrong with this part ofmy body.

I am okay buy zithromax online ireland. I am safe. There is no danger.” This can help turn off thedanger signal.

In comparison, buy zithromax online ireland when a person says, “There is something wrongwith me. I am damaged,” the alarm system is turned on, which will perpetuatethe pain. It may sound buy zithromax online ireland simple,but for many people this is the beginning of changing the brain, rewiringneuro-circuits to stop the fear of pain, stop the tripping of the danger alarm,and break the cycle.

But just like learning any new skill, which all involvedmaking neuro-circuit connections, it can take time and rehearsal. This rewiring canbecome even more powerful when combined with other tools to rewire the brain.Another tool is the use buy zithromax online ireland of deep breaths, which lets the danger alarm know thatthings are okay. Another tool is the use of laughter and humor.

Participatingin mindfulness, playfulness and joy can also rewire the brain to turn off thefear signals. Participating in any of these activities, or even imagining thesethings, during the previously feared movement buy zithromax online ireland or situation can help rewire thebrain. For more information on this, Dr.

Schubiner has created a buy zithromax online ireland series of easy-to-understand animated video beginning with “What is pain.” For those who need more intense treatment for mental health conditions, MidMichigan Health provides an intensive outpatient program called Psychiatric Partial Hospitalization Program at MidMichigan Medical Center – Gratiot. Those interested in more information about the PHP program may call (989) 466-3253. Those interested in more information on MidMichigan’s comprehensive behavioral health programs may visit www.midmichigan.org/mentalhealth.Each year, more than a million families in the buy zithromax online ireland United States experience a miscarriage, stillbirth or death of an infant.

Yet because these events can be emotionally difficult to discuss, there is little public awareness, so families may not always get the support they need. October is Pregnancy and Infant Loss Awareness Month, a time to show buy zithromax online ireland support for these families, highlight available resources and build understanding of how family, friends and the community can help. If you visit a MidMichiganHealth facility during the month of October, you may notice staff wearing pinkand blue ribbons to show their support.

We will also participate in theInternational Wave of Light, a worldwide remembrance event on October 15, 7 to 8p.m. During this time, candles will be lit at the entrances of MidMichigan’sMedical Centers in Alma, buy zithromax online ireland Alpena, Midland and West Branch (the sites of our fourMaternity Centers) to honor babies gone too soon and their families. Patients,staff and community members are welcome to attend.

Resources for Grieving Parents Your primarycare doctor or OB/Gyn can be a good first contact to help you understand thephysical and emotional impact of a loss and buy zithromax online ireland to identify other resources. MidMichigan Home Care offers grief support for individuals and families who have lost a loved one, including education, support groups, short-term counseling and referrals to community professionals for longer-term follow-up. For more information, visit buy zithromax online ireland www.midmichigan.org/grief or call (800) 862-5002.

There are manylocal and national nonprofits that specialize in helping families throughinfant and pregnancy loss. Their services range from resources and materialsthat discuss what families can expect during the grieving process, to in-personand online support groups to financial assistance with funeral and otherexpenses. Some organizations buy zithromax online ireland focus on certain bereaved family members, such asparents or siblings, or on specific causes of perinatal death.

Consider callingUnited Way’s 2-1-1 hotline to identify local agencies in your area that mayprovide targeted grief services. What to Say When Someone Loses a Child People tend totreat pregnancy or infant loss as a taboo subject, so buy zithromax online ireland loved ones are oftenuncomfortable or unfamiliar with what to say or do. Some well-meaning peoplemay even say things that are more hurtful than helpful.

Experts recommend keepingyour condolences simple, following buy zithromax online ireland the family’s cues, and asking about theirpreferences if you are unsure. Tips. Acknowledgetheir loss in short, simple phrases, such as, “I’m sorry for your loss.” Or “Iimagine this must be painful for you.” Offer to listen if they want to talk.It’s also okay to simply admit that you don’t know what to say.Askwhether it is okay to talk about the baby and to use the baby’s name.Peopleoften treat miscarriage as “no big deal,” but the value of a life is notproportional to the time spent on earth.

When a family loses a child, they losethe entire future they buy zithromax online ireland had dreamed for themselves and that child. A lifetime ofmilestones and memories. In some cases, they may buy zithromax online ireland not have another opportunityto become parents, which can compound their grief.

Avoidstatements that downplay their emotions, tell them how to feel, attempt to finda “silver lining” in their grief, or are based on religion, such as:Perhapsit was for the best.Godmust have wanted your special angel to be with him.You’reyoung. You can still have another child.Atleast now you know you buy zithromax online ireland can get pregnant.Atleast you didn’t really know him/her.Atleast you weren’t that far along.Rememberthe father, siblings and other family members. The focus tends to be on mothers,but the whole family may need your support.

Be aware that men may feel the needto “be strong” which can impede their grieving process.Offerto help with specific tasks. People who are grieving may not be able toidentify their needs or ask for help. You can offer to help with caring forother children, preparing meals, doing housework, funeral preparations, notifyingextended family or friends, or creating a special memento or ritual to rememberthe baby.

Remember that help and support may be especially needed after otherhelpers have moved on.Acknowledgethem as parents. This isoften overlooked if they don’t have living children, yet they are parents andshould be supported and addressed as parents.Rememberthem in years to come. Call, send a card, or offer to spend time with them onmilestone days.

Grief does not end with the delivery or memorial service. You can findmore helpful tips at these and other websites:.

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A free pilot program to help new and expectant fathers navigate the physical, mental and emotional challenges of becoming a dad will be rolled out in four regions in NSW from today.Health Minister Brad Hazzard said the ‘Focus on New Fathers’ program will be trialled with men in Northern NSW, Northern and Western Sydney and the Murrumbidgee area zithromax heart problems. €œAsk any father and they will tell you, becoming a parent is an equally joyous and terrifying experience because your entire routine is turned on its head,” Mr Hazzard said. €œIt is zithromax heart problems a considerable adjustment which can put tremendous stress on you and on your relationship, so it’s important to know you are not alone and help is at hand – literally.

€œThis pilot will see texts sent to dads, offering valuable health advice and links into pathways to ensure support options are available, particularly in these uncertain buy antibiotics times.” Research has shown men are often reluctant to engage with the health system to get support, despite around one in 10 dads experiencing depression and anxiety in the postnatal period. The pilot, which is being delivered by the University of Newcastle in partnership with NSW Health, will run over the next year with results helping to improve the program. Men living in the trial site areas will be eligible for the program if they are over the age of 18, their partner is at least 16 weeks pregnant or their baby is up to 24 weeks of age zithromax heart problems.

They must have a mobile phone capable of receiving and sending text messages. Associate Professor Elisabeth Murphy, Senior Clinical Advisor, Child and Family Health, said self-care for new fathers is extremely important as the mental and physical wellbeing of both parents has a direct effect on their children. €œReceiving help with zithromax heart problems health issues early on ensures dads are in the best possible position to care for their new baby and partner,” Associate Professor Murphy said.

€œWe also understand expecting and new parents may experience more worries about their health and wellbeing in relation to buy antibiotics. We encourage expectant and new parents, particularly at this time, to reach out for support to their healthcare provider or GP.” ​​​​​​Regional and rural patients now have access to 24-hour critical care under a $21.7 million telestroke service being rolled out across NSW.Patients at Port Macquarie and Coffs Harbour hospitals are the first to benefit from the NSW Telestroke Service, based at Sydney’s Prince of Wales Hospital. Health Minister Brad Hazzard said the revolutionary service zithromax heart problems will expand to up to 23 sites over the next three years.

€œThe NSW Telestroke Service will remove geographical barriers and improve outcomes for thousands of regional and rural stroke patients every year, giving them a much greater chance of surviving and leading a normal life,” Mr Hazzard said. €œPeople in regional and rural areas have a far greater risk of hospitalisation from stroke and this vital service will provide them with immediate, life-saving diagnosis and treatment from the state’s leading clinicians.” In 2018-19, 13,651 people zithromax heart problems were hospitalised for a stroke in NSW. Of those, 32 per cent were from regional, rural or remote areas.

A successful pilot project in the Hunter New England, Central Coast and Mid North Coast local health districts since 2017 has already helped 1200 patients. The Stroke Foundation’s Chief Executive zithromax heart problems Officer Sharon McGowan welcomed the launch of the statewide service, jointly funded by the State and Federal governments. €œWhen a stroke strikes, it kills up to 1.9 million brain cells per minute.

This service will have an enormous impact by providing time-critical, best-practice treatment that saves lives and reduces lifelong disability,” Ms McGowan said. Prince of zithromax heart problems Wales Hospital’s Director of Clinical Neuroscience Professor Ken Butcher said. €œThe service links expert stroke clinicians with local emergency physicians to quickly determine the best possible treatment plan for a patient.” ​Date published.

August 26, 2020On this page Backgroundbuy antibiotics is an infectious disease caused by the antibiotics antibiotics. The World Health Organization declared a global zithromax in March 2020, and the Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices zithromax heart problems for Use in Relation to buy antibiotics on March 18, 2020. The Interim Order (IO) allows us to quickly address large-scale public health emergencies.This IO allows for faster authorization of Class I-IV medical devices for buy antibiotics.This document presents the criteria for safety and effectiveness that apply to test swabs used for buy antibiotics sampling.

It also provides guidance on zithromax heart problems how to meet these criteria in an application under the IO pathway. Diagnostic testing is a key element in both. identifying cases of preventing the spread of the antibiotics A test swab may be used to collect a sample for either Polymerase Chain Reaction (PCR) laboratory testing or point-of-care testing.

Point-of-care testing can be done directly in a hospital or zithromax heart problems doctor’s office. Once the sample has been taken, the swab is either placed in a preserving liquid and sent to a laboratory for testing, or placed directly in a testing device (point-of-care).Swabs may be packaged in a variety of zithromax transport media (VTM). Specifications for individual VTMs are beyond the scope of this document.

Swabs play zithromax heart problems a role in the accuracy of buy antibiotics diagnostic testing. For example, false negatives can occur in PCR tests if. the swab material inhibits the test reaction or the swab design doesn’t provide enough surface area to obtain a sufficient sample Test swabs that are not safe and effective may cause or lead to harm.

For example zithromax heart problems. A swab that breaks during sample collection can cause physical injury a non-sterile swab that produces an incorrect test result can lead to harmHealth Canada has published a guidance document to support the preparation of applications submitted under the IO. It should be zithromax heart problems read in conjunction with this document.

We are processing applications as quickly as possible. To avoid delays, please ensure you have completed your application properly.Medical Devices Regulations (MDR) classification In the Canadian regulatory framework, Class I devices present the lowest potential risk and Class IV the highest. Swabs are classified according to their labelling zithromax heart problems and intended use.

For example, if a swab is labelled for nasopharyngeal (NP) or oropharyngeal (OP) use only, it will be classified as a Class I medical device according to Classification Rule 2(2) of the MDR. If a swab is not exclusively for use in oral or nasal cavities, or its use is not explicitly stated, it will be classified as a Class II device by Rule 2(1). These swabs zithromax heart problems belong to a higher risk class because their use in other body orifices for the collection of tissue samples (for example, to test for chlamydia or ureaplasma) is associated with greater risk.

Rule 2 Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II. A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.Regulatory pathways for buy antibiotics devicesManufacturers of Class I swabs may seek authorization to import and sell their products under either. A Medical Device Establishment Licence (MDEL) MDEL is an establishment oversight framework that is not product-specific and not designed zithromax heart problems to assess safety and effectiveness an IO authorization information on safety and effectiveness are required as part of the application Health Canada is encouraging a sub-group of swab manufacturers to use the IO authorization pathway for Class I swabs, especially if they are.

New to the manufacturing of swabs and manufacturing in Canada (such as a company that has re-tooled to manufacture), or using a new manufacturing process or design for swabs (such as 3D printing or honeycomb design)IO applications for swabs should include the following information.Device description The device description should include. A picture and/or engineering drawing identification of all materials used in the production of the swab the intended zithromax heart problems use(s) (for example, NP swabs)Quality manufacturingManufacturers must either. demonstrate compliance with Quality Manufacturing Systems (for example, ISO 13485 certificate) applicable to the swab, or provide a clear description of the planned quality manufacturing systems that are consistent with similar existing manufacturing systemsDesign verificationProvide swab design verification (bench testing) data in a summary report.

It should show that the essential minimum design characteristics are met. These data should be based on test samples representative of finished swabs that have undergone sterilization prior to bench testing.Dimensions Swabs should have minimum length specifications and minimum and zithromax heart problems maximum head diameter specifications in order to be safe and effective. Minimum length specification for example, adult NP swabs require ≥14 cm to reach the posterior nasopharynx minimum and maximum head diameter specification for example, adult NP swabs require 1–4 mm to pass into the mid-inferior portion of the inferior turbinate and maneuver well FlexibilitySwab flexibility is assessed through.

Durability for example, tolerate 20 rough repeated insertions into a 4 mm inner diameter clear plastic tube curved back on itself with a curve radius of 3 cm bendability for example, bend tip and neck 90º without breaking ability to maintain initial form for example, restore to initial form following 45º bending Manufacturers may describe the test performed, the number of samples, and a summary of the results.Strength/Breakpoint (failure) To limit the potential for patient harm, the minimum breakpoint distance should be approximately 8 to 9 cm from the nasopharynx. However, no zithromax heart problems breaks or fractures should occur following reasonable manipulation. Applicants should submit a rationale for the design of the breakpoint distance from the swab tip.

It should demonstrate that the breakpoint length can be accommodated by commercially available swab/media tubes.Surface propertiesThe swab surface should be free of. processing aids (such as disinfectants) foreign materials degreasers mold release agents For injection molded swabs, no burrs, flashing, zithromax heart problems or sharp edges should be present. Design validationProvide swab validation (performance) data in a summary report that demonstrates that the swab.

can acquire samples comparable to zithromax heart problems a commercially available swab control, and will not inhibit the PCR reactionThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.Comparable sample acquisition to a control, and PCR compatibilityThe manufacturer should demonstrate test swab cycle threshold (Ct) recovery values (RT-PCR) that are statistically comparable to those obtained from a commercially available swab control using antibiotics (or a scientifically justified surrogate).Pass/Fail criteria. Values ≥ 2Cts indicate significantly less efficient ribonucleic acid collection and/or elution.Clinical feasibility/suitability simulationManufacturers should submit either. A clinical test report or previous clinical data Clinical test reportThe clinical test report should describe the use of the proposed finished swab (sterilized) in a sufficient number of individuals by trained healthcare professionals in a minimum of 30 patients that have tested positive for antibiotics, or a scientifically justified surrogate zithromax.

Include comparisons of the proposed swab against a flocked swab zithromax heart problems commercially available in Canada with respect to. flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Clinical testing considerations A scientifically justified surrogate zithromax may be used if buy antibiotics-positive patients are not available. Positive % agreement should not be determined using high Ct samples.

One-half (1/2) to zithromax heart problems two-thirds (2/3) of buy antibiotics-positive samples should have a high viral loads (Cts <. 30). Report agreement between control and test swabs in terms of quantitative (Ct) and qualitative (+/- test) values with appropriate descriptive statistics.

Include patient symptomatology for samples zithromax heart problems. For example, days from symptom onset, known vs. Suspected buy antibiotics zithromax heart problems status.

Use of different VTM/universal transport media (V/UTM) across buy antibiotics-positive samples may contribute to Ct variability. Ensure consistency by using the same media/tubes for each specimen within a clinical evaluation. Validate the chosen V/UTM media/tubes to show they will not interfere zithromax heart problems with the PCR test results.

For example, allowing 7 days of swab positive specimen incubation with the chosen media/vial is considered a worst-case transportation scenario to evaluate maximal leaching/interaction potential). Use a single PCR test platform throughout each clinical evaluation. The platform zithromax heart problems should have been previously authorized by HC or another jurisdiction.

Location (for example, left vs right nostril) and order of sampling (for example, control vs. Test swab) can affect specimen quality and results variability. Location and swab sampling order should be randomized.For additional information on collecting, handling, and testing buy antibiotics specimens, please refer to the Centers for Disease Control and Prevention (CDC) Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for zithromax heart problems buy antibiotics.Previous clinical dataPreviously obtained clinical data may be submitted in lieu of clinical testing.

Those data should demonstrate the safe and effective use of a swab of identical design and materials in human subjects. The proposed swab should be compared against a flocked swab commercially available in Canada with respect to. flexibility fit ability to navigate to the zithromax heart problems nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement) using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Sterility Provide sterilization validation data in a summary report.

It should demonstrate that the chosen sterilization method will achieve a minimum Sterility Assurance Level (SAL) of 10-6 for the proposed swab, using an appropriate biological indicator (BI) organism (see below). If the swab will be sterilized using an ethylene oxide (EtO) method, you should demonstrate zithromax heart problems that EtO and ethylene chlorohydrin (ECH) residuals meet the tolerable contact limits (TCL) specified in ISO 10993-7. Commonly used swab materials, compatible sterilization methods, and appropriate biological indicators are described below.

Sterilization Method Swab Materials EtO(for example, ISO 11135) Gamma Irradiation(ISO 11137) Polystyrene handle, polyester bicomponent fiber tipFootnote * X(for example, Puritan 25-3316-H/U) Not applicable Polystyrene handle, nylon flocked fiber tipFootnote * X(for example, Copan 503CS01) X(for example, BD 220252) Footnote * The CDC provides guidance on the types of swabs that should be used for optimal specimen collection for PCR testing. They include swabs that are made of zithromax heart problems polyester (for example, Dacron), rayon, or nylon-flocked. Cotton-tipped or calcium alginate swabs are not acceptable because residues present in those materials inhibit the PCR reaction.

Return to footnote * referrer Appropriate BIIf ionizing radiation will be used to sterilize the swab. Bacillus pumilus spores are recommended for doses of 25 kGy Bacillus cereus zithromax heart problems or Bacillus sphaericus spores are recommended for doses of >. 25 kGy (World Health Organization, The International Pharmacopoeia, 9th Ed., 2019) Sterilization Process Spore (Indicator Organism) Steam Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) Dry Heat Bacillus atrophaeus (formerly Bacillus subtilis var.

Niger) Ethlylene Oxide Bacillus atrophaeus (formerly Bacillus subtilis var. Niger) Hydrogen Peroxide Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) zithromax heart problems Source. US Food and Drug Administration, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," October 2007.

[Online].Packaging validation Provide packaging validation data zithromax heart problems in a summary report. It should demonstrate that the swab packaging system will maintain a sterile environment across the labelled shelf life (for example, ASTM F1980). without leakage (for example, ASTM D3078-02) with adequate seal strength (for example, ASTM F88/EN 868-5)Test packaging samples should be representative of finished swab packages that have undergone sterilization prior to testing.Biocompatibility Provide biocompatibility data in a summary report.

It should demonstrate compliance with biocompatibility tests recommended for devices in limited zithromax heart problems contact (≤24 hrs) with mucosal membranes, as per ISO 10993-1. These include. cytotoxicity sensitization irritation/intracutaneous reactivityThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.LabellingSwabs should be individually packaged and labelled.

The application must include the zithromax heart problems swab label, which must include. The name and model number of the device the term ‘sterile’, along with the sterilization method (EtO = ethylene oxide. R = gamma irradiation), if the swab is intended to be sold in a sterile condition the name and address of the manufacturer manufacturing and expiry datesIf swabs are not sterile but must be sterilized at the user facility, then the sterilization parameters and method should be clearly described in accompanying instructions for use documentation.Post-market requirementsAs stated in Section 12 of the IO, within 10 days of becoming aware of an incident in Canada, all IO authorization holders must.

report the incident specify the nature of the incident specify the circumstances surrounding the incidentOn this page About face shields Personal protective zithromax heart problems equipment (PPE) can help prevent potential exposure to infectious disease. They are considered medical devices in Canada and therefore must follow the requirements outlined in the Medical Devices Regulations. Medical devices are classified into 4 groups (Class I, II, III and IV) based on their zithromax heart problems risk to health and safety.

Class I devices, such as gauze bandages, pose the lowest potential risk, while Class IV devices, such as pacemakers, pose the greatest potential risk. In Canada, face shields are Class I medical devices. A face zithromax heart problems shield has a transparent window or visor that shields the face and associated mucous membranes (eyes, nose and mouth).

It protects the wearer against exposure from splashes and sprays of body fluids. Face shields are made of shatterproof plastic, fit over the face and are held in place by head straps or caps. They may be made of polycarbonate, propionate, acetate, polyvinyl chloride, or polyethylene terephthalate zithromax heart problems.

They are usually worn with other PPE, such as a medical mask, respirator or eyewear. Health Canada strongly advises against the use of plastic bags as an alternative to face shields. Standards and zithromax heart problems requirements for face shields Organizations that are manufacturing face shields are advised to consult some or all of the following standards throughout the design and testing stages.

ANSI/ISEA Z.87.1 (2015), American National Standard for Occupational and Educational Personal Eye and Face Protection Devices CSA Z94.3 (2020), Eye and Face Protectors CSA Z94.3.1 (2016), Guideline for Selection, Use, and Care of Eye and Face Protectors BS EN 166 (2002), Personal Eye Protection. Specifications. Minimum specifications must be incorporated into the design and verification stages to ensure safe and effective face shields.

Provide adequate coverage (CSA Z94.3 Sections 0.2.1/10.2.2/10.3/10.4). The size of the face shield is important because it must protect the face and front part of the head. This includes the eyes, forehead, cheeks, nose, mouth, and chin.

Protection may also need to extend to the front of the neck in situations with flying particles and sprays of hazardous liquids. Fit snugly to afford a good seal to the forehead area and to prevent slippage of the device Footnote 1. Be made of optically clear, distortion-free, lightweight materials (CSA Z94.3.1-16 and Footnote 1).

Be free of visible defects or flaws that would impede vision (ANSI Z87.1 Section 9.4). Be comfortable and easy to assemble, use and remove by health care professionals. Provide adequate space between the wearer’s face and the inner surface of the visor to allow for the use of ancillary equipment (for example, medical mask, respirator, eyewear) Footnote 1.

The characteristics and performance requirements of face shields must not be altered when attaching shields to other protective equipment, such as hats or caps. Display anti-fog characteristics on inside and outside of shield (CSA Z94.3.1-16). For face shields that are not fog resistant, anti-fog spray must be provided.

Provide user-contacting materials that have adequate material biocompatibility (skin sensitivity and cytotoxic testing) (ISO 10993-5, 10). Other items to take note of include. Face shields used for protection in hospital settings do not have to be impact- or flame- resistant.

If the device is specifically designed to withstand impact from sharp or fast projectiles, it must comply with set-out standards (ANSI Z87.1, sections 9.2 and 9.3, CSA Z94.3, section 10.1). For reuse, manufacturers must provide validated cleaning instructions. Sterilization procedures must not compromise the shield in any way, such as deformation or cracking.

Regulatory authorization Most PPE, including face shields, are Class I medical devices if they are manufactured, sold or represented for use for reducing the risk of or preventing the user from . This includes buy antibiotics. Face shields may be authorized for sale or import into Canada through the following regulatory pathways.

Pathway 1. Interim order authorization to import and sell medical devices related to buy antibiotics. Pathway 2.

Expedited review and issuance of Medical Device Establishment Licences (MDEL) related to buy antibiotics. MDEL holders that import and sell face shields should take measures to ensure they are safe and effective. Pathway 3.

Exceptional importation and sale of certain non-compliant medical devices related to buy antibiotics. Note that a sale generally requires the transfer of ownership of a device from one party to another and does not necessitate any transfer of money. Applicants should carefully review the pathways and select the most appropriate authorization route for their product.

For more information, see Personal protective equipment (buy antibiotics). How to get authorization. If you intend to manufacture 3D print face shields in response to the buy antibiotics crisis, see.

3D printing and other manufacturing of personal protective equipment in response to buy antibiotics Feedback If you have any questions or comments about this notice, contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca R. J. Roberge, "Face shields for control.

A review," Journal of Occupational and Environmental Hygiene, pp. 235-242, 2016. Related links FootnotesFootnote 1 R.

J. Roberge, "Face shields for control. A review," Journal of Occupational and Environmental Hygiene, pp.

235-242, 2016.Return to footnote 1 referrer.

A free great post to read pilot program to help new and expectant fathers navigate the physical, mental and emotional challenges of becoming a dad will be buy zithromax online ireland rolled out in four regions in NSW from today.Health Minister Brad Hazzard said the ‘Focus on New Fathers’ program will be trialled with men in Northern NSW, Northern and Western Sydney and the Murrumbidgee area. €œAsk any father and they will tell you, becoming a parent is an equally joyous and terrifying experience because your entire routine is turned on its head,” Mr Hazzard said. €œIt is a considerable adjustment which can put tremendous stress on you and on your relationship, so it’s important to buy zithromax online ireland know you are not alone and help is at hand – literally. €œThis pilot will see texts sent to dads, offering valuable health advice and links into pathways to ensure support options are available, particularly in these uncertain buy antibiotics times.” Research has shown men are often reluctant to engage with the health system to get support, despite around one in 10 dads experiencing depression and anxiety in the postnatal period.

The pilot, which is being delivered by the University of Newcastle in partnership with NSW Health, will run over the next year with results helping to improve the program. Men living in the trial site areas will be eligible for the program if they are over the age of 18, their partner is buy zithromax online ireland at least 16 weeks pregnant or their baby is up to 24 weeks of age. They must have a mobile phone capable of receiving and sending text messages. Associate Professor Elisabeth Murphy, Senior Clinical Advisor, Child and Family Health, said self-care for new fathers is extremely important as the mental and physical wellbeing of both parents has a direct effect on their children.

€œReceiving help with health issues early on ensures dads are in the best possible position to care for their new baby and partner,” Associate Professor buy zithromax online ireland Murphy said. €œWe also understand expecting and new parents may experience more worries about their health and wellbeing in relation to buy antibiotics. We encourage expectant and new parents, particularly at this time, to reach out for support to their healthcare provider or GP.” ​​​​​​Regional and rural patients now have access to 24-hour critical care under a $21.7 million telestroke service being rolled out across NSW.Patients at Port Macquarie and Coffs Harbour hospitals are the first to benefit from the NSW Telestroke Service, based at Sydney’s Prince of Wales Hospital. Health Minister Brad Hazzard said the revolutionary service buy zithromax online ireland will expand to up to 23 sites over the next three years.

€œThe NSW Telestroke Service will remove geographical barriers and improve outcomes for thousands of regional and rural stroke patients every year, giving them a much greater chance of surviving and leading a normal life,” Mr Hazzard said. €œPeople in regional buy zithromax online ireland and rural areas have a far greater risk of hospitalisation from stroke and this vital service will provide them with immediate, life-saving diagnosis and treatment from the state’s leading clinicians.” In 2018-19, 13,651 people were hospitalised for a stroke in NSW. Of those, 32 per cent were from regional, rural or remote areas. A successful pilot project in the Hunter New England, Central Coast and Mid North Coast local health districts since 2017 has already helped 1200 patients.

The Stroke Foundation’s Chief Executive Officer Sharon McGowan buy zithromax online ireland welcomed the launch of the statewide service, jointly funded by the State and Federal governments. €œWhen a stroke strikes, it kills up to 1.9 million brain cells per minute. This service will have an enormous impact by providing time-critical, best-practice treatment that saves lives and reduces lifelong disability,” Ms McGowan said. Prince of Wales Hospital’s Director of Clinical Neuroscience Professor Ken Butcher buy zithromax online ireland said.

€œThe service links expert stroke clinicians with local emergency physicians to quickly determine the best possible treatment plan for a patient.” ​Date published. August 26, 2020On this page Backgroundbuy antibiotics is an infectious disease caused by the antibiotics antibiotics. The World Health Organization declared a global zithromax in March 2020, and the buy zithromax online ireland Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to buy antibiotics on March 18, 2020. The Interim Order (IO) allows us to quickly address large-scale public health emergencies.This IO allows for faster authorization of Class I-IV medical devices for buy antibiotics.This document presents the criteria for safety and effectiveness that apply to test swabs used for buy antibiotics sampling.

It also provides guidance on how to buy zithromax online ireland meet these criteria in an application under the IO pathway. Diagnostic testing is a key element in both. identifying cases of preventing the spread of the antibiotics A test swab may be used to collect a sample for either Polymerase Chain Reaction (PCR) laboratory testing or point-of-care testing. Point-of-care testing can be done directly in a hospital or doctor’s buy zithromax online ireland office.

Once the sample has been taken, the swab is either placed in a preserving liquid and sent to a laboratory for testing, or placed directly in a testing device (point-of-care).Swabs may be packaged in a variety of zithromax transport media (VTM). Specifications for individual VTMs are beyond the scope of this document. Swabs play a role in the buy zithromax online ireland accuracy of buy antibiotics diagnostic testing. For example, false negatives can occur in PCR tests if.

the swab material inhibits the test reaction or the swab design doesn’t provide enough surface area to obtain a sufficient sample Test swabs that are not safe and effective may cause or lead to harm. For example buy zithromax online ireland. A swab that breaks during sample collection can cause physical injury a non-sterile swab that produces an incorrect test result can lead to harmHealth Canada has published a guidance document to support the preparation of applications submitted under the IO. It should be read in buy zithromax online ireland conjunction with this document.

We are processing applications as quickly as possible. To avoid delays, please ensure you have completed your application properly.Medical Devices Regulations (MDR) classification In the Canadian regulatory framework, Class I devices present the lowest potential risk and Class IV the highest. Swabs are buy zithromax online ireland classified according to their labelling and intended use. For example, if a swab is labelled for nasopharyngeal (NP) or oropharyngeal (OP) use only, it will be classified as a Class I medical device according to Classification Rule 2(2) of the MDR.

If a swab is not exclusively for use in oral or nasal cavities, or its use is not explicitly stated, it will be classified as a Class II device by Rule 2(1). These swabs belong to a higher risk class because their buy zithromax online ireland use in other body orifices for the collection of tissue samples (for example, to test for chlamydia or ureaplasma) is associated with greater risk. Rule 2 Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II. A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.Regulatory pathways for buy antibiotics devicesManufacturers of Class I swabs may seek authorization to import and sell their products under either.

A Medical Device buy zithromax online ireland Establishment Licence (MDEL) MDEL is an establishment oversight framework that is not product-specific and not designed to assess safety and effectiveness an IO authorization information on safety and effectiveness are required as part of the application Health Canada is encouraging a sub-group of swab manufacturers to use the IO authorization pathway for Class I swabs, especially if they are. New to the manufacturing of swabs and manufacturing in Canada (such as a company that has re-tooled to manufacture), or using a new manufacturing process or design for swabs (such as 3D printing or honeycomb design)IO applications for swabs should include the following information.Device description The device description should include. A picture and/or engineering drawing identification of all materials used in the production of the swab the intended use(s) (for example, buy zithromax online ireland NP swabs)Quality manufacturingManufacturers must either. demonstrate compliance with Quality Manufacturing Systems (for example, ISO 13485 certificate) applicable to the swab, or provide a clear description of the planned quality manufacturing systems that are consistent with similar existing manufacturing systemsDesign verificationProvide swab design verification (bench testing) data in a summary report.

It should show that the essential minimum design characteristics are met. These data should be based on test samples representative of finished swabs that have undergone sterilization prior to bench testing.Dimensions Swabs should have buy zithromax online ireland minimum length specifications and minimum and maximum head diameter specifications in order to be safe and effective. Minimum length specification for example, adult NP swabs require ≥14 cm to reach the posterior nasopharynx minimum and maximum head diameter specification for example, adult NP swabs require 1–4 mm to pass into the mid-inferior portion of the inferior turbinate and maneuver well FlexibilitySwab flexibility is assessed through. Durability for example, tolerate 20 rough repeated insertions into a 4 mm inner diameter clear plastic tube curved back on itself with a curve radius of 3 cm bendability for example, bend tip and neck 90º without breaking ability to maintain initial form for example, restore to initial form following 45º bending Manufacturers may describe the test performed, the number of samples, and a summary of the results.Strength/Breakpoint (failure) To limit the potential for patient harm, the minimum breakpoint distance should be approximately 8 to 9 cm from the nasopharynx.

However, no buy zithromax online ireland breaks or fractures should occur following reasonable manipulation. Applicants should submit a rationale for the design of the breakpoint distance from the swab tip. It should demonstrate that the breakpoint length can be accommodated by commercially available swab/media tubes.Surface propertiesThe swab surface should be free of. processing aids (such as buy zithromax online ireland disinfectants) foreign materials degreasers mold release agents For injection molded swabs, no burrs, flashing, or sharp edges should be present.

Design validationProvide swab validation (performance) data in a summary report that demonstrates that the swab. can acquire samples comparable to a commercially available swab control, and will not inhibit the PCR reactionThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.Comparable sample acquisition to a control, and PCR compatibilityThe manufacturer should demonstrate test swab cycle threshold (Ct) recovery values (RT-PCR) that are statistically comparable to those obtained from a commercially available swab control using antibiotics (or a scientifically buy zithromax online ireland justified surrogate).Pass/Fail criteria. Values ≥ 2Cts indicate significantly less efficient ribonucleic acid collection and/or elution.Clinical feasibility/suitability simulationManufacturers should submit either. A clinical test report or previous clinical data Clinical test reportThe clinical test report should describe the use of the proposed finished swab (sterilized) in a sufficient number of individuals by trained healthcare professionals in a minimum of 30 patients that have tested positive for antibiotics, or a scientifically justified surrogate zithromax.

Include comparisons of the buy zithromax online ireland proposed swab against a flocked swab commercially available in Canada with respect to. flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Clinical testing considerations A scientifically justified surrogate zithromax may be used if buy antibiotics-positive patients are not available. Positive % agreement should not be determined using high Ct samples. One-half (1/2) buy zithromax online ireland to two-thirds (2/3) of buy antibiotics-positive samples should have a high viral loads (Cts <.

30). Report agreement between control and test swabs in terms of quantitative (Ct) and qualitative (+/- test) values with appropriate descriptive statistics. Include patient buy zithromax online ireland symptomatology for samples. For example, days from symptom onset, known vs.

Suspected buy antibiotics buy zithromax online ireland status. Use of different VTM/universal transport media (V/UTM) across buy antibiotics-positive samples may contribute to Ct variability. Ensure consistency by using the same media/tubes for each specimen within a clinical evaluation. Validate the chosen V/UTM media/tubes to show they will not interfere buy zithromax online ireland with the PCR test results.

For example, allowing 7 days of swab positive specimen incubation with the chosen media/vial is considered a worst-case transportation scenario to evaluate maximal leaching/interaction potential). Use a single PCR test platform throughout each clinical evaluation. The platform should have been previously authorized by HC or another buy zithromax online ireland jurisdiction. Location (for example, left vs right nostril) and order of sampling (for example, control vs.

Test swab) can affect specimen quality and results variability. Location and swab sampling order should be randomized.For additional information on collecting, handling, and testing buy antibiotics specimens, please refer to the Centers buy zithromax online ireland for Disease Control and Prevention (CDC) Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for buy antibiotics.Previous clinical dataPreviously obtained clinical data may be submitted in lieu of clinical testing. Those data should demonstrate the safe and effective use of a swab of identical design and materials in human subjects. The proposed swab should be compared against a flocked swab commercially available in Canada with respect to.

flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene https://www.gastern.at/event/knoedelessen-7/ test results agreement for example, ≥ 90% positive % agreement) using a composite control (positive % agreement calculation that includes all positive buy zithromax online ireland findings from control and test swabs) Sterility Provide sterilization validation data in a summary report. It should demonstrate that the chosen sterilization method will achieve a minimum Sterility Assurance Level (SAL) of 10-6 for the proposed swab, using an appropriate biological indicator (BI) organism (see below). If the swab will be sterilized using an ethylene oxide (EtO) method, you should buy zithromax online ireland demonstrate that EtO and ethylene chlorohydrin (ECH) residuals meet the tolerable contact limits (TCL) specified in ISO 10993-7. Commonly used swab materials, compatible sterilization methods, and appropriate biological indicators are described below.

Sterilization Method Swab Materials EtO(for example, ISO 11135) Gamma Irradiation(ISO 11137) Polystyrene handle, polyester bicomponent fiber tipFootnote * X(for example, Puritan 25-3316-H/U) Not applicable Polystyrene handle, nylon flocked fiber tipFootnote * X(for example, Copan 503CS01) X(for example, BD 220252) Footnote * The CDC provides guidance on the types of swabs that should be used for optimal specimen collection for PCR testing. They include swabs that are made of polyester (for example, Dacron), buy zithromax online ireland rayon, or nylon-flocked. Cotton-tipped or calcium alginate swabs are not acceptable because residues present in those materials inhibit the PCR reaction. Return to footnote * referrer Appropriate BIIf ionizing radiation will be used to sterilize the swab.

Bacillus pumilus spores buy zithromax online ireland are recommended for doses of 25 kGy Bacillus cereus or Bacillus sphaericus spores are recommended for doses of >. 25 kGy (World Health Organization, The International Pharmacopoeia, 9th Ed., 2019) Sterilization Process Spore (Indicator Organism) Steam Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) Dry Heat Bacillus atrophaeus (formerly Bacillus subtilis var. Niger) Ethlylene Oxide Bacillus atrophaeus (formerly Bacillus subtilis var. Niger) Hydrogen Peroxide Geobacillus buy zithromax online ireland stearothermophilus(formerly Bacillus stearothermophilus) Source.

US Food and Drug Administration, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," October 2007. [Online].Packaging validation buy zithromax online ireland Provide packaging validation data in a summary report. It should demonstrate that the swab packaging system will maintain a sterile environment across the labelled shelf life (for example, ASTM F1980). without leakage (for example, ASTM D3078-02) with adequate seal strength (for example, ASTM F88/EN 868-5)Test packaging samples should be representative of finished swab packages that have undergone sterilization prior to testing.Biocompatibility Provide biocompatibility data in a summary report.

It should buy zithromax online ireland demonstrate compliance with biocompatibility tests recommended for devices in limited contact (≤24 hrs) with mucosal membranes, as per ISO 10993-1. These include. cytotoxicity sensitization irritation/intracutaneous reactivityThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.LabellingSwabs should be individually packaged and labelled. The application must include the swab label, which must include buy zithromax online ireland.

The name and model number of the device the term ‘sterile’, along with the sterilization method (EtO = ethylene oxide. R = gamma irradiation), if the swab is intended to be sold in a sterile condition the name and address of the manufacturer manufacturing and expiry datesIf swabs are not sterile but must be sterilized at the user facility, then the sterilization parameters and method should be clearly described in accompanying instructions for use documentation.Post-market requirementsAs stated in Section 12 of the IO, within 10 days of becoming aware of an incident in Canada, all IO authorization holders must. report the incident specify the nature of buy zithromax online ireland the incident specify the circumstances surrounding the incidentOn this page About face shields Personal protective equipment (PPE) can help prevent potential exposure to infectious disease. They are considered medical devices in Canada and therefore must follow the requirements outlined in the Medical Devices Regulations.

Medical devices are classified into 4 groups (Class I, II, III and buy zithromax online ireland IV) based on their risk to health and safety. Class I devices, such as gauze bandages, pose the lowest potential risk, while Class IV devices, such as pacemakers, pose the greatest potential risk. In Canada, face shields are Class I medical devices. A face shield has a transparent window or visor that shields the face and associated mucous membranes (eyes, buy zithromax online ireland nose and mouth).

It protects the wearer against exposure from splashes and sprays of body fluids. Face shields are made of shatterproof plastic, fit over the face and are held in place by head straps or caps. They may be made of polycarbonate, propionate, acetate, polyvinyl buy zithromax online ireland chloride, or polyethylene terephthalate. They are usually worn with other PPE, such as a medical mask, respirator or eyewear.

Health Canada strongly advises against the use of plastic bags as an alternative to face shields. Standards and requirements for face shields Organizations that are manufacturing face shields are advised to consult some or all of the following standards throughout the design and testing buy zithromax online ireland stages. ANSI/ISEA Z.87.1 (2015), American National Standard for Occupational and Educational Personal Eye and Face Protection Devices CSA Z94.3 (2020), Eye and Face Protectors CSA Z94.3.1 (2016), Guideline for Selection, Use, and Care of Eye and Face Protectors BS EN 166 (2002), Personal Eye Protection. Specifications.

Minimum specifications must be incorporated into the design and verification stages to ensure safe and effective face shields. Provide adequate coverage (CSA Z94.3 Sections 0.2.1/10.2.2/10.3/10.4). The size of the face shield is important because it must protect the face and front part of the head. This includes the eyes, forehead, cheeks, nose, mouth, and chin.

Protection may also need to extend to the front of the neck in situations with flying particles and sprays of hazardous liquids. Fit snugly to afford a good seal to the forehead area and to prevent slippage of the device Footnote 1. Be made of optically clear, distortion-free, lightweight materials (CSA Z94.3.1-16 and Footnote 1). Be free of visible defects or flaws that would impede vision (ANSI Z87.1 Section 9.4).

Be comfortable and easy to assemble, use and remove by health care professionals. Provide adequate space between the wearer’s face and the inner surface of the visor to allow for the use of ancillary equipment (for example, medical mask, respirator, eyewear) Footnote 1. The characteristics and performance requirements of face shields must not be altered when attaching shields to other protective equipment, such as hats or caps. Display anti-fog characteristics on inside and outside of shield (CSA Z94.3.1-16).

For face shields that are not fog resistant, anti-fog spray must be provided. Provide user-contacting materials that have adequate material biocompatibility (skin sensitivity and cytotoxic testing) (ISO 10993-5, 10). Other items to take note of include. Face shields used for protection in hospital settings do not have to be impact- or flame- resistant.

If the device is specifically designed to withstand impact from sharp or fast projectiles, it must comply with set-out standards (ANSI Z87.1, sections 9.2 and 9.3, CSA Z94.3, section 10.1). For reuse, manufacturers must provide validated cleaning instructions. Sterilization procedures must not compromise the shield in any way, such as deformation or cracking. Regulatory authorization Most PPE, including face shields, are Class I medical devices if they are manufactured, sold or represented for use for reducing the risk of or preventing the user from .

This includes buy antibiotics. Face shields may be authorized for sale or import into Canada through the following regulatory pathways. Pathway 1. Interim order authorization to import and sell medical devices related to buy antibiotics.

Pathway 2. Expedited review and issuance of Medical Device Establishment Licences (MDEL) related to buy antibiotics. MDEL holders that import and sell face shields should take measures to ensure they are safe and effective. Pathway 3.

Exceptional importation and sale of certain non-compliant medical devices related to buy antibiotics. Note that a sale generally requires the transfer of ownership of a device from one party to another and does not necessitate any transfer of money. Applicants should carefully review the pathways and select the most appropriate authorization route for their product. For more information, see Personal protective equipment (buy antibiotics).

How to get authorization. If you intend to manufacture 3D print face shields in response to the buy antibiotics crisis, see. 3D printing and other manufacturing of personal protective equipment in response to buy antibiotics Feedback If you have any questions or comments about this notice, contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca R. J.

Roberge, "Face shields for control. A review," Journal of Occupational and Environmental Hygiene, pp. 235-242, 2016. Related links FootnotesFootnote 1 R.

J. Roberge, "Face shields for control. A review," Journal of Occupational and Environmental Hygiene, pp. 235-242, 2016.Return to footnote 1 referrer.

Zithromax and tamiflu

Objectives, Participants, and Oversight We conducted a randomized, placebo-controlled, observer-blinded, phase 3 trial as zithromax and tamiflu part of a phase 1–2–3 trial assessing BNT162b2 safety, immunogenicity, and efficacy in healthy persons 12 years of age or older. This report presents findings from 12-to-15-year-old participants enrolled in the United States, including descriptive comparisons of safety between participants in that age cohort and those who were 16 to zithromax and tamiflu 25 years of age and an evaluation of the noninferiority of immunogenicity in the 12-to-15-year-old cohort to that in the 16-to-25-year-old cohort. Data were collected through the cutoff date of March 13, 2021. Eligible participants were healthy or had stable preexisting disease (including hepatitis B, zithromax and tamiflu hepatitis C, or human immunodeficiency zithromax ).

Persons with a previous clinical or virologic buy antibiotics diagnosis or antibiotics , previous antibiotics vaccination, zithromax and tamiflu diagnosis of an immunocompromising or immunodeficiency disorder, or treatment with immunosuppressive therapy (including cytotoxic agents and systemic glucocorticoids) were excluded. The ethical conduct of the trial is summarized in the Supplementary Appendix, available with the full text of this article at NEJM.org. Additional details of the trial zithromax and tamiflu are provided in the protocol, available at NEJM.org. Pfizer was responsible for the trial design and conduct, data collection, data analysis, data interpretation, and writing of the zithromax and tamiflu manuscript that was submitted.

Both Pfizer and BioNTech manufactured the treatment and placebo. BioNTech was the regulatory sponsor of the trial and contributed to data interpretation and writing of the zithromax and tamiflu manuscript. All data were available to the authors, who vouch zithromax and tamiflu for their accuracy and completeness and for the adherence of the trial to the protocol. Procedures Randomization was conducted with the use of an interactive Web-based response system.

Participants were assigned in a 1:1 ratio to receive two intramuscular injections of 30 μg of BNT162b2 or placebo (saline) zithromax and tamiflu 21 days apart. For evaluation of immediate treatment-associated reactions, participants were observed in the clinic for 30 minutes after vaccination. Safety Safety objectives included the assessment of local or systemic reactogenicity events, which were recorded by the zithromax and tamiflu participants in an electronic diary (e-diary) for 7 days after each dose. Unsolicited adverse zithromax and tamiflu events (i.e., those reported by the participant without e-diary prompting) and serious adverse events were also recorded from receipt of the first dose through 1 month and 6 months after dose 2, respectively.

Immunogenicity Immunogenicity assessments (antibiotics serum neutralization assay and receptor-binding domain [RBD]–binding or S1-binding IgG direct Luminex immunoassays) were performed before vaccination and 1 month after dose 2, as described previously.3 The immunogenicity objective was to show noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants. Noninferiority was assessed among participants who had no evidence of previous antibiotics with the use of the two-sided 95% confidence interval for the geometric mean ratio of antibiotics 50% neutralizing titers in 12-to-15-year-old participants as compared zithromax and tamiflu with 16-to-25-year-old participants 1 month after dose 2. BNT162b2 immunogenicity was evaluated in participants with and those without zithromax and tamiflu serologic or virologic evidence of previous antibiotics . Corresponding end points were the geometric mean antibiotics neutralizing titers at baseline (i.e., immediately before receipt of the first injection) and 1 month after dose 2 and geometric mean fold rises (GMFRs) in titers from baseline to 1 month after dose 2.

Efficacy The efficacy of BNT162b2 against confirmed buy antibiotics with an onset 7 or more days after dose 2 was summarized in participants who did not have evidence of previous antibiotics , as well as in all vaccinated participants zithromax and tamiflu. Surveillance for zithromax and tamiflu potential buy antibiotics cases was undertaken throughout the trial. If acute respiratory illness developed in a participant, the participant was tested for antibiotics. Methods for identifying antibiotics s and buy antibiotics diagnoses are summarized in the zithromax and tamiflu Supplementary Appendix.

Statistical Analysis The safety population included all zithromax and tamiflu participants who received at least one dose of BNT162b2 or placebo. The reactogenicity subset included all 12-to-15-year-old participants and a subset of 16-to-25-year-old participants (those who received an e-diary to record reactogenicity events). Safety end points are presented descriptively as counts, percentages, and associated Clopper–Pearson two-sided 95% confidence intervals, with adverse events and serious adverse events described according to terms in zithromax and tamiflu the Medical Dictionary for Regulatory Activities, version 23.1, for each group. Immunogenicity was assessed in a random subset of participants in each age cohort with the use of a simple random-sample selection procedure.

For immunogenicity zithromax and tamiflu assessments, all participants in both age cohorts were from U.S. Sites. The dose 2 immunogenicity population that could be evaluated included participants who underwent randomization and received two BNT162b2 doses in accordance with the protocol, received dose 2 within the prespecified window (19 to 42 days after dose 1), had at least one valid and determinate immunogenicity result from a blood sample obtained within 28 to 42 days after dose 2, and had no major protocol deviations. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was assessed on the basis of the geometric mean ratio of antibiotics 50% neutralizing titers.

A sample of 225 BNT162b2 recipients who could be evaluated (or 280 BNT162b2 recipients overall) in each age cohort was estimated to provide 90.8% power for declaring noninferiority (defined as a lower limit of the 95% confidence interval for the geometric mean ratio of >0.67). A testing laboratory supply limitation of the qualified viral lot used for assay validation and clinical testing resulted in the trial having fewer participants than anticipated for the immunogenicity analyses. Calculations of the geometric mean ratios, geometric mean titers, and GMFRs are described in the Supplementary Appendix. Although the formal evaluation of efficacy was to be based on the overall results obtained across all age cohorts, the statistical analysis plan specified that descriptive efficacy summaries would be provided for each age cohort (the stratification factor).

The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown. The efficacy population that could be evaluated included all eligible 12-to-15-year-old participants who underwent randomization and received two doses of BNT162b2 or placebo, received dose 2 within the prespecified window (19 to 42 days after dose 1), and had no major protocol deviations. The all-available efficacy population included all participants who received one or two doses. treatment efficacy was defined as 100×(1−IRR), where IRR is the ratio of the rate of a first confirmed buy antibiotics illness in the BNT162b2 group to the corresponding rate in the placebo group.

Two-sided Clopper–Pearson 95% confidence intervals were calculated (not adjusted for multiple comparisons). Because the number of participants who reported symptoms but were missing a valid polymerase-chain-reaction test result was small, data for these participants were not imputed in the analysis.The clinical picture of moderate-to-severe thrombocytopenia and thrombotic complications at unusual sites beginning approximately 1 to 2 weeks after vaccination against antibiotics with ChAdOx1 nCov-19 suggests a disorder that clinically resembles severe heparin-induced thrombocytopenia, a well-known prothrombotic disorder caused by platelet-activating antibodies that recognize multimolecular complexes between cationic PF4 and anionic heparin.6 However, unlike the usual situation in heparin-induced thrombocytopenia, these vaccinated patients did not receive any heparin to explain the subsequent occurrence of thrombosis and thrombocytopenia. In recent years, it has been recognized that triggers other than heparin can cause a prothrombotic disorder that strongly resembles heparin-induced thrombocytopenia on both clinical and serologic grounds, including certain polyanionic drugs (e.g., pentosan polysulfate,7 antiangiogenic agent PI-88,8 and hypersulfated chondroitin sulfate8). Such a prothrombotic syndrome has also been observed in the absence of preceding exposure to any polyanionic medication, such as after both viral and bacterial s9,10 and knee-replacement surgery.11,12 These various clinical scenarios with apparent nonpharmacologic triggers have been classified under the term autoimmune heparin-induced thrombocytopenia.13 Unlike patients with classic heparin-induced thrombocytopenia, patients with autoimmune heparin-induced thrombocytopenia have unusually severe thrombocytopenia, an increased frequency of disseminated intravascular coagulation, and atypical thrombotic events.

Serum from these patients strongly activate platelets in the presence of heparin (0.1 to 1.0 IU per milliliter) but also in the absence of heparin (heparin-independent platelet activation). When these unusual antibodies are observed in patients who have thrombocytopenia without preceding heparin exposure, the term “spontaneous” heparin-induced thrombocytopenia syndrome13,14 has been used. Sometimes, patients in whom heparin-induced thrombocytopenia develops after exposure to heparin present with atypical clinical features, such as an onset of thrombocytopenia beginning several days after stopping heparin (delayed-onset heparin-induced thrombocytopenia15,16) or thrombocytopenia that persists for several weeks despite the discontinuation of heparin (persisting or refractory heparin-induced thrombocytopenia17,18). Serum from these patients also shows the phenomenon of heparin-independent platelet-activating properties.

These clinical features that resemble those of autoimmune heparin-induced thrombocytopenia were observed in the patients with treatment-induced immune thrombotic thrombocytopenia. The serum usually showed strong reactivity on the PF4–heparin ELISA. Moreover, serum showed variable degrees of platelet activation in the presence of buffer that was in most cases greatly enhanced in the presence of PF4 (Figure 1A and 1B). More strikingly, most serum showed inhibition, rather than increased activation, in the presence of low-dose low-molecular-weight heparin (0.2 U per milliliter of anti–factor Xa).

In addition, antibodies from two patients, which were affinity purified on either immobilized PF4 or immobilized PF4–heparin, strongly activated platelets but only in the presence of PF4. Enhancement of platelet activation by PF4 is also a feature of heparin-induced thrombocytopenia19,20 and has been used to enhance detection of platelet-activating antibodies in diagnostic testing for this adverse drug reaction.21 Whether these antibodies are autoantibodies against PF4 induced by the strong inflammatory stimulus of vaccination or antibodies induced by the treatment that cross-react with PF4 and platelets requires further study. Although we found enhanced reactivity of patient serum with platelets in the presence of ChAdOx1 nCov-19, this is likely to be an in vitro artifact. It is well known that adenozithromax binds to platelets22 and causes platelet activation.22,23 Furthermore, the amount of adenozithromax in a 500-microliter treatment injection administered 1 or 2 weeks earlier would seem unlikely to contribute to subsequent platelet activation observed in these patients.

However, interactions between the treatment and platelets or between the treatment and PF4 could play a role in pathogenesis. One possible trigger of these PF4-reactive antibodies could be free DNA in the treatment. We have previously shown that DNA and RNA form multimolecular complexes with PF4, which bind antibodies from patients with heparin-induced thrombocytopenia and also induce antibodies against PF4–heparin in a murine model.24 Unfortunately, other buy antibiotics treatments were not available to us for testing. Our findings have several important clinical implications.

First, clinicians should be aware that in some patients, venous or arterial thrombosis can develop at unusual sites such as the brain or abdomen, which becomes clinically apparent approximately 5 to 20 days after vaccination. If such a reaction is accompanied by thrombocytopenia, it can represent an adverse effect of the preceding buy antibiotics vaccination. To date, this reaction has been reported only with the ChAdOx1 nCov-19 treatment, which has been used in approximately 25% of treatment recipients in Germany and in 30% of those in Austria. Second, ELISA to detect PF4–heparin antibodies in patients with heparin-induced thrombocytopenia is widely available and can be used to investigate patients for potential postvaccination thrombocytopenia or thrombosis associated with antibodies against PF4.25 A strongly positive ELISA result that is obtained in a patient who has not been recently exposed to heparin would be a striking abnormality.

Third, we have shown that these antibodies recognize PF4 and that the addition of PF4 greatly enhances their detectability in a platelet-activation assay. Since vaccination of millions of persons will be complicated by a background of thrombotic events unrelated to vaccination, a PF4-dependent ELISA or a PF4-enhanced platelet-activation assay may be used to confirm the diagnosis of treatment-induced immune thrombotic thrombocytopenia through this novel mechanism of postvaccination formation of platelet-activating antibodies against PF4. Although treatment decisions such as administering intravenous immune globulin and starting anticoagulation do not need to await laboratory diagnosis, detection of these unusual platelet-activating antibodies will be highly relevant for case identification and future risk–benefit assessment of this and other treatments. Figure 2.

Figure 2. Potential Diagnostic and Therapeutic Strategies for Management of Suspected treatment-Induced Immune Thrombotic Thrombocytopenia. Shown is a decision tree for the evaluation and treatment of patients who have symptoms of thrombocytopenia or thrombosis within 20 days after receiving the ChAdOx1 nCov-19 treatment and who have had no heparin exposure. The diagnostic and therapeutic strategies in such patients differ from those in patients with autoimmune heparin-induced thrombocytopenia (HIT).13 DIC denotes disseminated intravascular coagulation, INR international normalized ratio, PF4 platelet factor 4, and PTT partial thromboplastin time.Figure 2 shows a potential diagnostic and therapeutic strategy for managing this novel prothrombotic thrombocytopenic disorder.

One consideration is to administer high-dose intravenous immune globulin to inhibit Fcγ receptor–mediated platelet activation. This recommendation parallels emerging experience in the treatment of severe autoimmune heparin-induced thrombocytopenia in which high-dose intravenous immune globulin has resulted in rapid increases in platelet count and de-escalation of hypercoagulability.12,26 We found that the addition of immune globulin in doses that are readily achieved clinically was effective in inhibiting platelet activation by patients’ antibodies. Clinician reluctance to start anticoagulation may be tempered by administering high-dose intravenous immune globulin to raise the platelet count, especially when a patient presents with severe thrombocytopenia and thrombosis, such as cerebral venous thrombosis. Given the parallels with autoimmune heparin-induced thrombocytopenia, anticoagulant options should include nonheparin anticoagulants used for the management of heparin-induced thrombocytopenia,27 unless a functional test has excluded heparin-dependent enhancement of platelet activation.

Finally, we suggest naming this novel entity treatment-induced immune thrombotic thrombocytopenia (VITT) to avoid confusion with heparin-induced thrombocytopenia.To the Editor. Rare thromboembolic events have been observed during the vaccination rollout, which have prompted cautionary pauses in vaccinations by some regulatory authorities, including the South Africa Health Products Regulatory Authority.1,2 Here, we report interim safety data from the first 288,368 participants who were vaccinated with Ad26.COV2.S in the Sisonke study — an open label, single-group, phase 3b implementation study to monitor the effectiveness of the single-dose Ad26.COV2.S treatment among 500,000 health care workers in South Africa (ClinicalTrials.gov number, NCT04838795). Enrollment in the study began on February 17, 2021, and as of April 12, 2021, a total of 288,368 health care workers had received the Ad26.COV2.S treatment, among whom 5898 (2%) reported adverse events. The majority (81%) of adverse events reported were expected mild-to-moderate reactogenicity events.

Fifty health care workers had adverse events that met the criteria of being serious or of special interest3,4. A full list of these events is provided in Table 1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org. Among these 50 workers, 12 (24%) had antibiotics disease 2019 (buy antibiotics), which occurred within 28 days after vaccination. 12 (24%) had allergic reactions, of which one met the criteria for anaphylaxis.

And 6 (12%) had neurologic conditions, including a 40-year-old man who received a diagnosis of Guillain–Barré syndrome and a 53-year-old woman with Bell’s palsy. Five arterial, venous thrombotic, or embolic events were reported in 5 health care workers with known risk factors for thromboembolism (1.7 events per 100,000 participants). One case of pulmonary embolus occurred 23 days after vaccination in a 63-year-old woman who was overweight and had hypertension, diabetes mellitus, and a history of venous thrombosis. This event was fatal.

A second case occurred in a 64-year-old woman who received a diagnosis of cor pulmonale 17 days after vaccination. This case had features consistent with chronic and recurrent pulmonary emboli. Two cerebrovascular accidents (infarcts on imaging) were reported — one case involved a 45-year-old woman who had underlying rheumatic heart disease and a history of human immunodeficiency zithromax , cerebrovascular accident, and aortic valve replacement, in whom left-sided weakness developed the day after vaccination, and the other case involved a 38-year-old woman who had given birth to twins 9 months before vaccination and presented with features of transient ischemic attack 8 days after vaccination. A 65-year-old woman with chronic diabetes mellitus had deterioration and blurring of vision 8 days after vaccination and received a diagnosis of retinal vein occlusion and macular hemorrhage.

To date, no case of treatment-induced immune thrombotic thrombocytopenia has been documented. In South Africa, since the start of the zithromax, buy antibiotics has been reported in 1.58 million persons, including more than 55,000 health care workers. The rate of adverse events with vaccination is low, and thromboembolic events have occurred mainly in persons with risk factors for thromboembolism. Simbarashe Takuva, M.B., Ch.B.Azwidhwi Takalani, M.B., Ch.B.Fred Hutchinson Cancer Research Center, Seattle, WA [email protected]Nigel Garrett, M.B., B.S., Ph.D.Centre for the AIDS Programme of Research in South Africa, Durban, South AfricaAmeena Goga, M.B., Ch.B., Ph.D.South African Medical Research Council, Cape Town, South AfricaJonny Peter, M.B., Ch.B., Ph.D.Vernon Louw, M.B., Ch.B., Ph.D.Jessica Opie, M.B., Ch.B.University of Cape Town, Cape Town, South AfricaBarry Jacobson, M.B., Ch.B., Ph.D.University of the Witwatersrand, Johannesburg, South AfricaIan Sanne, M.B., Ch.B.Right to Care, Johannesburg, South AfricaLinda Gail-Bekker, M.B., Ch.B., Ph.D.University of Cape Town, Cape Town, South AfricaGlenda Gray, M.B., Ch.B., D.Sc.South African Medical Research Council, Cape Town, South Africa Supported by Janssen treatments and Prevention and the South African Medical Research Council.

Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. This letter was published on June 2, 2021, at NEJM.org.4 References.

Objectives, Participants, and Oversight We buy zithromax online ireland conducted a http://omalandro.com/?page_id=17 randomized, placebo-controlled, observer-blinded, phase 3 trial as part of a phase 1–2–3 trial assessing BNT162b2 safety, immunogenicity, and efficacy in healthy persons 12 years of age or older. This report presents findings from 12-to-15-year-old participants enrolled in the United States, including descriptive comparisons of safety between participants in that age cohort and those who were 16 to 25 years of age and an evaluation of the noninferiority of immunogenicity in the 12-to-15-year-old cohort to that in the 16-to-25-year-old cohort buy zithromax online ireland. Data were collected through the cutoff date of March 13, 2021. Eligible participants were healthy or had stable preexisting disease (including hepatitis buy zithromax online ireland B, hepatitis C, or human immunodeficiency zithromax ). Persons with a previous clinical or virologic buy zithromax online ireland buy antibiotics diagnosis or antibiotics , previous antibiotics vaccination, diagnosis of an immunocompromising or immunodeficiency disorder, or treatment with immunosuppressive therapy (including cytotoxic agents and systemic glucocorticoids) were excluded.

The ethical conduct of the trial is summarized in the Supplementary Appendix, available with the full text of this article at NEJM.org. Additional details of the trial are provided in the protocol, buy zithromax online ireland available at NEJM.org. Pfizer was buy zithromax online ireland responsible for the trial design and conduct, data collection, data analysis, data interpretation, and writing of the manuscript that was submitted. Both Pfizer and BioNTech manufactured the treatment and placebo. BioNTech was buy zithromax online ireland the regulatory sponsor of the trial and contributed to data interpretation and writing of the manuscript.

All data were available to the authors, who vouch for their accuracy and completeness and for the adherence of the trial buy zithromax online ireland to the protocol. Procedures Randomization was conducted with the use of an interactive Web-based response system. Participants were assigned in a 1:1 ratio to receive two buy zithromax online ireland intramuscular injections of 30 μg of BNT162b2 or placebo (saline) 21 days apart. For evaluation of immediate treatment-associated reactions, participants were observed in the clinic for 30 minutes after vaccination. Safety Safety objectives included the assessment of local or systemic buy zithromax online ireland reactogenicity events, which were recorded by the participants in an electronic diary (e-diary) for 7 days after each dose.

Unsolicited adverse events (i.e., those reported by the participant without e-diary prompting) and serious adverse events were also recorded from receipt of the first dose through 1 month and 6 months after dose buy zithromax online ireland 2, respectively. Immunogenicity Immunogenicity assessments (antibiotics serum neutralization assay and receptor-binding domain [RBD]–binding or S1-binding IgG direct Luminex immunoassays) were performed before vaccination and 1 month after dose 2, as described previously.3 The immunogenicity objective was to show noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants. Noninferiority was assessed among participants who had no evidence of previous antibiotics with the use buy zithromax online ireland of the two-sided 95% confidence interval for the geometric mean ratio of antibiotics 50% neutralizing titers in 12-to-15-year-old participants as compared with 16-to-25-year-old participants 1 month after dose 2. BNT162b2 immunogenicity was evaluated in participants with and those without serologic or buy zithromax online ireland virologic evidence of previous antibiotics . Corresponding end points were the geometric mean antibiotics neutralizing titers at baseline (i.e., immediately before receipt of the first injection) and 1 month after dose 2 and geometric mean fold rises (GMFRs) in titers from baseline to 1 month after dose 2.

Efficacy The efficacy of BNT162b2 against confirmed buy antibiotics with an buy zithromax online ireland onset 7 or more days after dose 2 was summarized in participants who did not have evidence of previous antibiotics , as well as in all vaccinated participants. Surveillance for potential buy antibiotics cases was buy zithromax online ireland undertaken throughout the trial. If acute respiratory illness developed in a participant, the participant was tested for antibiotics. Methods for buy zithromax online ireland identifying antibiotics s and buy antibiotics diagnoses are summarized in the Supplementary Appendix. Statistical Analysis The safety buy zithromax online ireland population included all participants who received at least one dose of BNT162b2 or placebo.

The reactogenicity subset included all 12-to-15-year-old participants and a subset of 16-to-25-year-old participants (those who received an e-diary to record reactogenicity events). Safety end points are presented descriptively as counts, percentages, and associated Clopper–Pearson two-sided 95% confidence intervals, with adverse events and serious adverse events described buy zithromax online ireland according to terms in the Medical Dictionary for Regulatory Activities, version 23.1, for each group. Immunogenicity was assessed in a random subset of participants in each age cohort with the use of a simple random-sample selection procedure. For immunogenicity buy zithromax online ireland assessments, all participants in both age cohorts were from U.S. Sites.

The dose 2 immunogenicity population that could be evaluated included participants who underwent randomization and received two BNT162b2 doses in accordance with the protocol, received dose 2 within the prespecified window (19 to 42 days after dose 1), had at least one valid and determinate immunogenicity result from a blood sample obtained within 28 to 42 days after dose 2, and had no major protocol deviations. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was assessed on the basis of the geometric mean ratio of antibiotics 50% neutralizing titers. A sample of 225 BNT162b2 recipients who could be evaluated (or 280 BNT162b2 recipients overall) in each age cohort was estimated to provide 90.8% power for declaring noninferiority (defined as a lower limit of the 95% confidence interval for the geometric mean ratio of >0.67). A testing laboratory supply limitation of the qualified viral lot used for assay validation and clinical testing resulted in the trial having fewer participants than anticipated for the immunogenicity analyses. Calculations of the geometric mean ratios, geometric mean titers, and GMFRs are described in the Supplementary Appendix.

Although the formal evaluation of efficacy was to be based on the overall results obtained across all age cohorts, the statistical analysis plan specified that descriptive efficacy summaries would be provided for each age cohort (the stratification factor). The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown. The efficacy population that could be evaluated included all eligible 12-to-15-year-old participants who underwent randomization and received two doses of BNT162b2 or placebo, received dose 2 within the prespecified window (19 to 42 days after dose 1), and had no major protocol deviations. The all-available efficacy population included all participants who received one or two doses. treatment efficacy was defined as 100×(1−IRR), where IRR is the ratio of the rate of a first confirmed buy antibiotics illness in the BNT162b2 group to the corresponding rate in the placebo group.

Two-sided Clopper–Pearson 95% confidence intervals were calculated (not adjusted for multiple comparisons). Because the number of participants who reported symptoms but were missing a valid polymerase-chain-reaction test result was small, data for these participants were not imputed in the analysis.The clinical picture of moderate-to-severe thrombocytopenia and thrombotic complications at unusual sites beginning approximately 1 to 2 weeks after vaccination against antibiotics with ChAdOx1 nCov-19 suggests a disorder that clinically resembles severe heparin-induced thrombocytopenia, a well-known prothrombotic disorder caused by platelet-activating antibodies that recognize multimolecular complexes between cationic PF4 and anionic heparin.6 However, unlike the usual situation in heparin-induced thrombocytopenia, these vaccinated patients did not receive any heparin to explain the subsequent occurrence of thrombosis and thrombocytopenia. In recent years, it has been recognized that triggers other than heparin can cause a prothrombotic disorder that strongly resembles heparin-induced thrombocytopenia on both clinical and serologic grounds, including certain polyanionic drugs (e.g., pentosan polysulfate,7 antiangiogenic agent PI-88,8 and hypersulfated chondroitin sulfate8). Such a prothrombotic syndrome has also been observed in the absence of preceding exposure to any polyanionic medication, such as after both viral and bacterial s9,10 and knee-replacement surgery.11,12 These various clinical scenarios with apparent nonpharmacologic triggers have been classified under the term autoimmune heparin-induced thrombocytopenia.13 Unlike patients with classic heparin-induced thrombocytopenia, patients with autoimmune heparin-induced thrombocytopenia have unusually severe thrombocytopenia, an increased frequency of disseminated intravascular coagulation, and atypical thrombotic events. Serum from these patients strongly activate platelets in the presence of heparin (0.1 to 1.0 IU per milliliter) but also in the absence of heparin (heparin-independent platelet activation).

When these unusual antibodies are observed in patients who have thrombocytopenia without preceding heparin exposure, the term “spontaneous” heparin-induced thrombocytopenia syndrome13,14 has been used. Sometimes, patients in whom heparin-induced thrombocytopenia develops after exposure to heparin present with atypical clinical features, such as an onset of thrombocytopenia beginning several days after stopping heparin (delayed-onset heparin-induced thrombocytopenia15,16) or thrombocytopenia that persists for several weeks despite the discontinuation of heparin (persisting or refractory heparin-induced thrombocytopenia17,18). Serum from these patients also shows the phenomenon of heparin-independent platelet-activating properties. These clinical features that resemble those of autoimmune heparin-induced thrombocytopenia were observed in the patients with treatment-induced immune thrombotic thrombocytopenia. The serum usually showed strong reactivity on the PF4–heparin ELISA.

Moreover, serum showed variable degrees of platelet activation in the presence of buffer that was in most cases greatly enhanced in the presence of PF4 (Figure 1A and 1B). More strikingly, most serum showed inhibition, rather than increased activation, in the presence of low-dose low-molecular-weight heparin (0.2 U per milliliter of anti–factor Xa). In addition, antibodies from two patients, which were affinity purified on either immobilized PF4 or immobilized PF4–heparin, strongly activated platelets but only in the presence of PF4. Enhancement of platelet activation by PF4 is also a feature of heparin-induced thrombocytopenia19,20 and has been used to enhance detection of platelet-activating antibodies in diagnostic testing for this adverse drug reaction.21 Whether these antibodies are autoantibodies against PF4 induced by the strong inflammatory stimulus of vaccination or antibodies induced by the treatment that cross-react with PF4 and platelets requires further study. Although we found enhanced reactivity of patient serum with platelets in the presence of ChAdOx1 nCov-19, this is likely to be an in vitro artifact.

It is well known that adenozithromax binds to platelets22 and causes platelet activation.22,23 Furthermore, the amount of adenozithromax in a 500-microliter treatment injection administered 1 or 2 weeks earlier would seem unlikely to contribute to subsequent platelet activation observed in these patients. However, interactions between the treatment and platelets or between the treatment and PF4 could play a role in pathogenesis. One possible trigger of these PF4-reactive antibodies could be free DNA in the treatment. We have previously shown that DNA and RNA form multimolecular complexes with PF4, which bind antibodies from patients with heparin-induced thrombocytopenia and also induce antibodies against PF4–heparin in a murine model.24 Unfortunately, other buy antibiotics treatments were not available to us for testing. Our findings have several important clinical implications.

First, clinicians should be aware that in some patients, venous or arterial thrombosis can develop at unusual sites such as the brain or abdomen, which becomes clinically apparent approximately 5 to 20 days after vaccination. If such a reaction is accompanied by thrombocytopenia, it can represent an adverse effect of the preceding buy antibiotics vaccination. To date, this reaction has been reported only with the ChAdOx1 nCov-19 treatment, which has been used in approximately 25% of treatment recipients in Germany and in 30% of those in Austria. Second, ELISA to detect PF4–heparin antibodies in patients with heparin-induced thrombocytopenia is widely available and can be used to investigate patients for potential postvaccination thrombocytopenia or thrombosis associated with antibodies against PF4.25 A strongly positive ELISA result that is obtained in a patient who has not been recently exposed to heparin would be a striking abnormality. Third, we have shown that these antibodies recognize PF4 and that the addition of PF4 greatly enhances their detectability in a platelet-activation assay.

Since vaccination of millions of persons will be complicated by a background of thrombotic events unrelated to vaccination, a PF4-dependent ELISA or a PF4-enhanced platelet-activation assay may be used to confirm the diagnosis of treatment-induced immune thrombotic thrombocytopenia through this novel mechanism of postvaccination formation of platelet-activating antibodies against PF4. Although treatment decisions such as administering intravenous immune globulin and starting anticoagulation do not need to await laboratory diagnosis, detection of these unusual platelet-activating antibodies will be highly relevant for case identification and future risk–benefit assessment of this and other treatments. Figure 2. Figure 2. Potential Diagnostic and Therapeutic Strategies for Management of Suspected treatment-Induced Immune Thrombotic Thrombocytopenia.

Shown is a decision tree for the evaluation and treatment of patients who have symptoms of thrombocytopenia or thrombosis within 20 days after receiving the ChAdOx1 nCov-19 treatment and who have had no heparin exposure. The diagnostic and therapeutic strategies in such patients differ from those in patients with autoimmune heparin-induced thrombocytopenia (HIT).13 DIC denotes disseminated intravascular coagulation, INR international normalized ratio, PF4 platelet factor 4, and PTT partial thromboplastin time.Figure 2 shows a potential diagnostic and therapeutic strategy for managing this novel prothrombotic thrombocytopenic disorder. One consideration is to administer high-dose intravenous immune globulin to inhibit Fcγ receptor–mediated platelet activation. This recommendation parallels emerging experience in the treatment of severe autoimmune heparin-induced thrombocytopenia in which high-dose intravenous immune globulin has resulted in rapid increases in platelet count and de-escalation of hypercoagulability.12,26 We found that the addition of immune globulin in doses that are readily achieved clinically was effective in inhibiting platelet activation by patients’ antibodies. Clinician reluctance to start anticoagulation may be tempered by administering high-dose intravenous immune globulin to raise the platelet count, especially when a patient presents with severe thrombocytopenia and thrombosis, such as cerebral venous thrombosis.

Given the parallels with autoimmune heparin-induced thrombocytopenia, anticoagulant options should include nonheparin anticoagulants used for the management of heparin-induced thrombocytopenia,27 unless a functional test has excluded heparin-dependent enhancement of platelet activation. Finally, we suggest naming this novel entity treatment-induced immune thrombotic thrombocytopenia (VITT) to avoid confusion with heparin-induced thrombocytopenia.To the Editor. Rare thromboembolic events have been observed during the vaccination rollout, which have prompted cautionary pauses in vaccinations by some regulatory authorities, including the South Africa Health Products Regulatory Authority.1,2 Here, we report interim safety data from the first 288,368 participants who were vaccinated with Ad26.COV2.S in the Sisonke study — an open label, single-group, phase 3b implementation study to monitor the effectiveness of the single-dose Ad26.COV2.S treatment among 500,000 health care workers in South Africa (ClinicalTrials.gov number, NCT04838795). Enrollment in the study began on February 17, 2021, and as of April 12, 2021, a total of 288,368 health care workers had received the Ad26.COV2.S treatment, among whom 5898 (2%) reported adverse events. The majority (81%) of adverse events reported were expected mild-to-moderate reactogenicity events.

Fifty health care workers had adverse events that met the criteria of being serious or of special interest3,4. A full list of these events is provided in Table 1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org. Among these 50 workers, 12 (24%) had antibiotics disease 2019 (buy antibiotics), which occurred within 28 days after vaccination. 12 (24%) had allergic reactions, of which one met the criteria for anaphylaxis. And 6 (12%) had neurologic conditions, including a 40-year-old man who received a diagnosis of Guillain–Barré syndrome and a 53-year-old woman with Bell’s palsy.

Five arterial, venous thrombotic, or embolic events were reported in 5 health care workers with known risk factors for thromboembolism (1.7 events per 100,000 participants). One case of pulmonary embolus occurred 23 days after vaccination in a 63-year-old woman who was overweight and had hypertension, diabetes mellitus, and a history of venous thrombosis. This event was fatal. A second case occurred in a 64-year-old woman who received a diagnosis of cor pulmonale 17 days after vaccination. This case had features consistent with chronic and recurrent pulmonary emboli.

Two cerebrovascular accidents (infarcts on imaging) were reported — one case involved a 45-year-old woman who had underlying rheumatic heart disease and a history of human immunodeficiency zithromax , cerebrovascular accident, and aortic valve replacement, in whom left-sided weakness developed the day after vaccination, and the other case involved a 38-year-old woman who had given birth to twins 9 months before vaccination and presented with features of transient ischemic attack 8 days after vaccination. A 65-year-old woman with chronic diabetes mellitus had deterioration and blurring of vision 8 days after vaccination and received a diagnosis of retinal vein occlusion and macular hemorrhage. To date, no case of treatment-induced immune thrombotic thrombocytopenia has been documented. In South Africa, since the start of the zithromax, buy antibiotics has been reported in 1.58 million persons, including more than 55,000 health care workers. The rate of adverse events with vaccination is low, and thromboembolic events have occurred mainly in persons with risk factors for thromboembolism.

Simbarashe Takuva, M.B., Ch.B.Azwidhwi Takalani, M.B., Ch.B.Fred Hutchinson Cancer Research Center, Seattle, WA [email protected]Nigel Garrett, M.B., B.S., Ph.D.Centre for the AIDS Programme of Research in South Africa, Durban, South AfricaAmeena Goga, M.B., Ch.B., Ph.D.South African Medical Research Council, Cape Town, South AfricaJonny Peter, M.B., Ch.B., Ph.D.Vernon Louw, M.B., Ch.B., Ph.D.Jessica Opie, M.B., Ch.B.University of Cape Town, Cape Town, South AfricaBarry Jacobson, M.B., Ch.B., Ph.D.University of the Witwatersrand, Johannesburg, South AfricaIan Sanne, M.B., Ch.B.Right to Care, Johannesburg, South AfricaLinda Gail-Bekker, M.B., Ch.B., Ph.D.University of Cape Town, Cape Town, South AfricaGlenda Gray, M.B., Ch.B., D.Sc.South African Medical Research Council, Cape Town, South Africa Supported by Janssen treatments and Prevention and the South African Medical Research Council. Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. This letter was published on June 2, 2021, at NEJM.org.4 References.

Does zithromax work for sinus

By the time Paul Krogue, the https://actio-rae.de/online-doctor-lasix jail’s medical director, realized there was does zithromax work for sinus a problem, nearly 50 inmates were infected in the jail, where some had been sleeping on mats on an overcrowded floor. After several weeks, Mr. Krogue got a call that s were spreading to a side of the jail that had been zithromax-free.He hung up the phone and put his head in his hands.“I just kind of lost it, like, ‘My God, I don’t know how much longer I can do this,’” Mr. Krogue, a does zithromax work for sinus nurse practitioner, recalled.

€œI was just scared that I’m not going to be able to see it through, that I’m going to get sick — you just feel so exhausted and it’s just a lot.”The Mountain West, which for months avoided the worst of the zithromax, has rapidly devolved into one of the most alarming hot spots in a country that recorded its eight millionth confirmed case on Thursday, a day when more than 65,000 cases were announced nationwide, the most in a single day since July.Seventeen states, including many in the Mountain West, have added more cases in the past week than any other week of the zithromax. And the spread through sparsely populated areas of rural America has created problems in small towns that lack critical resources — including doctors — even in ordinary times.Wyoming, which did not have 1,000 total cases until June, recently added more than 1,000 in a single week. Reports of new s have recently reached record levels in does zithromax work for sinus Alaska, Colorado and Idaho. And Montana, where more than half of the state’s cases have been announced since August, is averaging more than 500 cases per day.In Cascade County, more than 300 inmates and staff members have been infected in a facility meant to hold 365 people, the county’s first major outbreak in a region where the zithromax is suddenly surging.The county seat, Great Falls, is seeing its worst case numbers yet.

The local hospital and its 27-bed buy antibiotics unit is at capacity. The county health department is racing to hire new does zithromax work for sinus contact tracers. And Mr. Krogue, who also teaches nursing at Montana State University’s Great Falls campus, has seen attendance in his classes dwindle as students fall ill or quarantine.“I was just scared that I’m not going to be able to see it through, that I’m going to get sick,” said Paul Krogue, the jail’s medical director.Credit...Tailyr Irvine for The New York TimesOne place where the s have spread has been local jails, which are confined, often crowded spaces.

Jails are staples of local communities and tend to have people coming and going more quickly than does zithromax work for sinus prisons. Jails can hold everyone from people awaiting criminal trials for months to those picked up for a suspended driver’s license for a few hours. With so many people filtering in and out, jails pose extra risks for the zithromax’s spread — not only inside facilities but in potentially feeding outbreaks in the rest of the community.Nationally, jails and prisons have seen disproportionate rates of and death, with a mortality rate twice as high as in the general population and an rate more than four times as high, according to recent data. #styln-briefing-block does zithromax work for sinus { font-family.

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The antibiotics Outbreak 15h ago Senate Republicans push narrow stimulus bills as Pelosi and Mnuchin resume talks. 17h ago A frozen yogurt shop in Colorado offered maskless customers a 10 percent discount. Uproar ensued. 19h ago An at Pope Francis’ residence adds to concerns for his safety.

See more updates More live coverage. Markets A New York Times database has tracked clusters of at least 50 antibiotics cases in a dozen rural jails in Montana, Idaho, Utah and New Mexico during the zithromax. Among them. The Purgatory Correctional Center in Hurricane, Utah, with 166 s.

The jail in Twin Falls, Idaho, with 279. And, in New Mexico, the Cibola County Correctional Center, which has reported 357 cases.In Cascade County, s at the jail make up about a quarter of all known zithromax cases in the county. Health authorities say that the jail’s outbreak, which began in mid-August, was not believed to be the main cause of the community’s recent surge, but that it had led to some cases. In the past two months, Mr.

Krogue said, the jail released 29 people who were considered actively infected.s at the jail make up about a quarter of Cascade County’s known zithromax cases.Credit...Tailyr Irvine for The New York TimesGreat Falls, home to about 58,000 residents, is in the less mountainous part of Montana, with the Missouri River flowing through and a large oil refinery on its banks. The Cascade County Detention Center sits along a highway at the edge of town. Drive five miles in any direction and you are surrounded by wide-open plains.Montana requires that masks be worn inside businesses and indoor public spaces, and many people in Great Falls wear them when walking around downtown’s Central Avenue, where shops and cafes are still recovering from shutting down in the spring. Others go without masks, citing the open space and lack of crowds.Bob Kelly, the mayor, said people had not been overly worried about how the jail outbreak might affect the rest of town when it started.“I think that by the very definition of a jail, hopefully, the disease will be incarcerated, as well as the patients,” he said.

€œIs there concern?. Sure, there’s concern. But is there overreaction?. No.”The mayor of Great Falls said that residents had considered the jail’s outbreak a distant concern at first.Credit...Tailyr Irvine for The New York TimesSome residents’ nonchalance about the risks of the zithromax, said Mr.

Krogue, the jail’s medical director, can be traced to a spring and early summer when almost no one in Cascade County knew anyone who had been sickened.“We benefited from that early on,” he said. €œBut in some ways, I think it did us a disservice, too, because it also created a certain level of complacency.”That has quickly shifted now, he said, as cases have spiked.The number of active cases known to county officials on any given day has risen sharply to about 600, according to Trisha Gardner, Cascade County’s health officer. The county has seen 1,261 cases and six deaths during the zithromax, a Times database shows. Some of the cases have been tied to the jail outbreak, she said, and others have been connected to bars and restaurants.

Even figuring out what has led to some cases has been complex, she said, as residents have been reluctant to cooperate with contact tracers.“Our hospitals are at capacity, our public health system is at capacity,” she said. €œIt’s not sustainable at this rate.”When the outbreak at the jail began, social distancing was impossible, the authorities said. Three inmates shared cells designed for two. At night, men slept on thin blue pads in every available space.

On the floor in the day room, in shower stalls, in stairwells, in hallways outside of cells.Inmates did not receive masks until August, and jail officials said many have refused to wear them.In interviews with more than a dozen inmates and their family members, inmates described the jail during the outbreak as chaotic and unsanitary. They said their pleas for help often went unanswered by nurses and guards.Newly arriving inmates were not always quarantined from one another before their test results were known because of a lack of space, inmates and jail officials said.Owen Hawley, 30, said every inmate in his living area of 38 men had tested positive for the zithromax. He said he had been unable to eat for three days, had intensive body aches and suffered from a headache so powerful it felt as if it was “behind my eyes.”“After the fourth day of like, not eating and stuff, I just shut off, you know?. € he said.A jail area set aside for quarantining new inmates.Credit...Tailyr Irvine for The New York TimesAt one point, Mr.

Hawley said, he and other prisoners protested the way the zithromax was being handled by refusing to leave their living areas and by blocking new inmates from entering. Everyone was ultimately tested, Mr. Hawley said, and each prisoner was given a disposable mask.Sierra Jasmine Wells, 25, another inmate, said women in her dormitory had grown ill, one after the next.“Everyone around me was getting sick and it was tough on me,” she said. €œBy then, I had already accepted the fact that I was going to get sick.”When she became infected, she said, she was given cough syrup and Tylenol.“I kind of was just left alone to deal with it,” she said.Jesse Slaughter, the county sheriff who oversees the jail, said that the jail’s medical staff was doing everything it could, and that he had been seeking health care assistance from other counties.

Officials defended their handling of the outbreak, noting that all inmates received standard medications including Tylenol twice a day and were taken to area hospitals when they needed added care. Seven inmates, as well as some staff members, were hospitalized. No one from the jail has died from the zithromax, officials said.Sheriff Jesse Slaughter, who oversees the jail, said he had been seeking health care assistance from other counties.Credit...Tailyr Irvine for The New York TimesMr. Krogue said that since the start of the outbreak he had been working up to 16 hours each day and sleeping in his basement, away from his wife and children.

He remains healthy but says he fears bringing the zithromax home. The zithromax has slowed some in the jail, and officials have moved some inmates to other facilities, but other prisons and jails in the state are now seeing outbreaks.“You can start to see what some of these other places experienced much earlier on, and we just didn’t have that experience, but it’s certainly happening now,” Mr. Krogue said. €œIt’s just real in a way that it wasn’t.”Lucy Tompkins reported from Great Falls, Maura Turcotte from Chicago and Libby Seline from Lincoln, Neb.

Reporting was contributed by Izzy Colón from Columbia, Mo., Brendon Derr from Phoenix, Rebecca Griesbach from Tuscaloosa, Ala., Danya Issawi and Timothy Williams from New York, Ann Hinga Klein from Des Moines, K.B. Mensah from Silver Spring, Md., and Mitch Smith from Chicago.Start Preamble Federal Transit Administration (FTA), DOT. Notice of funding opportunity. The antibiotics Disease 2019 (buy antibiotics) public health emergency Start Printed Page 63654has had a significant impact on transit operations.

During a series of FTA listening sessions held over the last three months, transit agencies asked FTA to support research to identify solutions to address the operational challenges that they are facing as a result of buy antibiotics. In response, FTA makes available through this Notice of Funding Opportunity (NOFO) funding to support research demonstration grants to public transit agencies to develop, deploy, and demonstrate innovative solutions that improve the operational efficiency of transit agencies, as well as enhance the mobility of transit users affected by the buy antibiotics public health emergency. Demonstration grants under this NOFO are authorized under FTA's Public Transportation Innovation Program (49 U.S.C. 5312).

Eligible projects will demonstrate innovative solutions to improve the operational efficiencies of transit systems and enhance mobility for their communities in four major areas. (1) Vehicle, facility, equipment and infrastructure cleaning and dis. (2) exposure mitigation measures. (3) innovative mobility such as contactless payments.

And (4) measures that strengthen public confidence in transit services. The total funding available for awards under this NOFO is $10,000,000. FTA may supplement this amount if additional funding becomes available. Applicants must submit completed proposals for funding opportunity FTA-2020-015-TRI through the GRANTS.GOV “APPLY” function by 11:59 p.m.

Eastern Time on November 2, 2020. Prospective applicants should register as soon as possible on the GRANTS.GOV website to ensure they can complete the application process before the submission deadline. Application instructions are available on FTA's website at http://transit.dot.gov/​howtoapply and in the “FIND” module of GRANTS.GOV. FTA will not accept mail and fax submissions.

Start Further Info Please send any questions on this notice to Jamel El-Hamri email. Jamel.El-Hamri@dot.gov phone. 2020-366-8985. A Telecommunication Device for the Deaf (TDD) is available for individuals who are deaf or hard of hearing at 1-800-877-8339.

End Further Info End Preamble Start Supplemental Information Table of Contents A. Program Description B. Federal Award Information C. Eligibility Information D.

Application and Submission Information E. Application Review Information F. Federal Award Administration Information G. Federal Awarding Agency Contact Information A.

Program Description The Public Transportation buy antibiotics Research Demonstration Grant Program is funded through the Public Transportation Innovation Program (49 U.S.C. 5312), with the goal to develop, deploy, and demonstrate innovative solutions that improve the operational efficiency of transit agencies, as well as enhance the mobility of transit users affected by the buy antibiotics public health emergency. Eligible projects will propose to develop and deploy innovative solutions in four major areas. (1) Vehicle, facility, equipment and infrastructure cleaning and dis.

(2) exposure mitigation measures. (3) innovative mobility such as contactless payments. And (4) measures that strengthen public confidence in transit. As required by 49 U.S.C.

5312(e)(4), projects funded under this NOFO must participate in an evaluation by an independent outside entity that will conduct a comprehensive evaluation of the success or failure of the projects funded under this subsection and any plan for broad-based implementation of the innovation promoted by successful projects. B. Federal Award Information FTA makes available $10,000,000 in fiscal year (FY) 2020 funds under the Public Transportation Innovation Program (49 U.S.C. 5312) to finance the Public Transportation buy antibiotics Research Demonstration Grant Program.

FTA may supplement the total funds available if additional funding becomes available at the time project selections are made. FTA will grant pre-award authority starting on the date of the project award announcement for selected projects and should be completed within 24 months from the date of award. Funds are available only for eligible expenses incurred after the announcement of project selections. C.

Eligibility Information (1) Eligible Applicants Eligible applicants include State and local governmental authorities, direct recipients of Urbanized Area (49 U.S.C. 5307) and Rural Area (49 U.S.C. 5311) formula funds, and Indian tribes. Eligible applicants are limited to FTA grantees or subrecipients who would be the primary beneficiaries of the innovative products and services that are developed—typically public transit agencies.

Except for projects proposed by Indian tribes, proposals for projects in rural (non-urbanized) areas must be submitted as part of a consolidated State proposal. States and other eligible applicants also may submit consolidated proposals for projects in urbanized areas. The submission of the Statewide application will not preclude the submission and consideration of any application from other eligible recipients in an urbanized area in a State. Proposals may contain projects to be implemented by the recipient or its subrecipients.

Eligible subrecipients include public agencies, private nonprofit organizations, and private providers engaged in public transportation. Eligible applicants may submit consolidated proposals for projects. (2) Cost Sharing or Matching The maximum Federal share of project costs is 100 percent. FTA may give additional consideration to applicants that propose a local share and may view these applicants as more competitive.

The applicant must document the source(s) of the local match, if any, in the grant application. For any applicants proposing match, eligible local match sources include the following. Cash from non-Government sources other than revenues from providing public transportation services. Revenues derived from the sale of advertising and concessions.

Revenues generated from value capture financing mechanisms. Funds from an undistributed cash surplus. Replacement or depreciation cash fund or reserve. New capital.

Or in-kind contributions. (3) Eligible Projects Eligible projects will propose innovative solutions to improve operational efficiencies of transit agencies and enhance the mobility of transit users, through projects that demonstrate innovative solutions for. Vehicle, facility, equipment and infrastructure cleaning and dis. Exposure mitigation measures such a real-time notification of rail and bus passenger loads.

New multi-modal payment innovative mobility systems such as contactless payments. And measures that strengthen public confidence in transit. Each applicant may only submit one proposal.Start Printed Page 63655 D. Application and Submission Information (1) Address and Form of Application Submission Applications must be submitted through GRANTS.GOV.

Applicants can find general information for submitting applications through GRANTS.GOV at www.fta.dot.gov/​howtoapply, along with specific instructions for the forms and attachments required for submission. Mail and fax submissions will not be accepted. (2) Content and Form of Application Submission a. Proposal Submission A complete proposal submission consists of at least two forms.

1. The SF-424 Mandatory Form (downloadable from GRANTS.GOV) and 2. The supplemental form for the FY 2020 buy antibiotics Demonstration Program (downloadable from GRANTS.GOV), which is available on FTA's website at (placeholder for FTA buy antibiotics Demonstration Program). The application must include responses to all sections of the SF-424 mandatory form and the supplemental form unless a section is indicated as optional.

FTA will use the information on the supplemental form to determine applicant and project eligibility for the program and to evaluate the proposal against the selection criteria described in part E of this notice. FTA will accept only one supplemental form per SF-424 submission. FTA encourages applicants to consider submitting a single supplemental form that includes multiple activities to be evaluated as a consolidated proposal. Applicants may attach additional supporting information to the SF-424 submission, including but not limited to letters of support, project budgets, or excerpts from relevant planning documents.

Supporting documentation must be described and referenced by file name in the appropriate response section of the supplemental form, or it may not be reviewed. Information such as applicant name, Federal amount requested, local match amount, description of areas served, etc., may be requested in varying degrees of detail on both the SF-424 form and supplemental form. Applicants must fill in all fields unless stated otherwise on the forms. If applicants copy information into the supplemental form from another source, they should verify that the supplemental form has fully captured pasted text and that it has not truncated the text due to character limits built into the form.

Applicants should use both the “Check Package for Errors” and the “Validate Form” validation buttons on both forms to check all required fields. Applicants should also ensure that the Federal and local amounts specified are consistent. Addressing the deteriorating conditions and disproportionately high fatality rates on our rural transportation infrastructure is of critical interest to the Department, as rural transportation networks face unique challenges in safety, infrastructure condition, and passenger and freight usage. Consistent with the R.O.U.T.E.S.

Initiative, the Department encourages applicants to consider how the project will address the challenges faced by rural areas. B. Application Content The SF-424 Mandatory Form and the supplemental form will prompt applicants for the required information, including. I.

Applicant Name ii. Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number iii. Key contact information (contact name, address, email address, and phone number) iv. Congressional district(s) where project will take place v.

Project Information (title, executive summary, and type) vi. A detailed description of the need for the project vii. A detailed description of how the project will support the Program objectives viii. Evidence that the applicant can provide the local cost shares ix.

A description of the technical, legal, and financial capacity of the applicant x. A detailed project budget xi. Details on the local matching funds xii. A detailed project timeline xiii.

Whether the project impacts an Opportunity Zone (3) Unique Entity Identifier and System for Award Management (SAM) Each applicant is required to. (1) Be registered in SAM before submitting an application. (2) provide a valid unique entity identifier in its application. And (3) continue to maintain an active SAM registration with current information at all times during which the applicant has an active Federal award or an application or plan under consideration by FTA.

These requirements do not apply if the applicant. (1) Is excepted from the requirements under 2 CFR 25.110(b) or (c). Or (2) has an exception approved by FTA under 2 CFR 25.110(d). FTA may not make an award until the applicant has complied with all applicable unique entity identifier and SAM requirements.

If an applicant has not fully complied with the requirements by the time FTA is ready to make an award, FTA may determine that the applicant is not qualified to receive an award and use that determination as a basis for making a Federal award to another applicant. All applicants must provide a unique entity identifier provided by SAM. Registration in SAM may take as little as 3-5 business days, but there can be unexpected steps or delays. For example, the applicant may need to obtain an Employer Identification Number.

FTA recommends allowing ample time, up to several weeks, to complete all steps. For additional information on obtaining a unique entity identifier, please visit www.sam.gov. (4) Submission Dates and Times Project proposals must be submitted electronically through GRANTS.GOV by 11:59 p.m. Eastern on November 2, 2020.

Mail and fax submissions will not be accepted. FTA urges applicants to submit applications at least 72 hours prior to the due date to allow time to correct any problems that may have caused either GRANTS.GOV or FTA systems to reject the submission. Proposals submitted after the deadline will only be considered under extraordinary circumstances not within the applicant's control. Deadlines will not be extended due to scheduled website maintenance.

GRANTS.GOV scheduled maintenance and outage times are announced on the GRANTS.GOV website. Within 48 hours after submitting an electronic application, the applicant should receive two email messages from GRANTS.GOV. (1) Confirmation of successful transmission to GRANTS.GOV. And (2) confirmation of successful validation by GRANTS.GOV.

If the applicant does not receive confirmation of successful validation or receives a notice of failed validation or incomplete materials, the applicant must address the reason for the failed validation, as described in the email notice, and resubmit before the submission deadline. If making a resubmission for any reason, applicants must include all original attachments regardless of which attachments were updated and check the box on the supplemental form indicating this is a resubmission. Applicants are encouraged to begin the process of registration on the GRANTS.GOV site well in advance of the submission deadline. Registration is Start Printed Page 63656a multi-step process, which may take several weeks to complete before an application can be submitted.

Registered applicants may still be required to update their registration before submitting an application. Registration in SAM is renewed annually and persons making submissions on behalf of the Authorized Organization Representative (AOR) must be authorized in GRANTS.GOV by the AOR to make submissions. (5) Funding Restrictions Funds may be used for post-award expenditures only. Funds under this NOFO cannot be used to reimburse projects for otherwise eligible expenses incurred prior to the date of project award announcements.

(6) Other Submission Requirements FTA encourages applicants to identify scaled funding options in case insufficient funding is available to fund a project at the full requested amount. If an applicant indicates that a project is scalable, the applicant must provide an appropriate minimum funding amount that will fund an eligible project that achieves the objectives of the program and meets all relevant program requirements. The applicant must provide a clear explanation of how a reduced award would affect the project budget and scope. FTA may award a lesser amount whether or not the applicant provides a scalable option.

E. Application Review Information (1) Project Evaluation Criteria Addressing the deteriorating conditions and disproportionately high fatality rates on our rural transportation infrastructure is of critical interest to the Department, as rural transportation networks face unique challenges in safety, infrastructure condition, and passenger and freight usage. Consistent with the R.O.U.T.E.S. Initiative, the Department will consider how the project will address the challenges faced by rural areas.

In addition, the Department will review and consider applications for funding pursuant to this Notice in accordance with the President's September 2, 2020 memorandum, entitled Memorandum on Reviewing Funding to State and Local Government Recipients of Federal Funds that Are Permitting Anarchy, Violence, and Destruction in American Cities, consistent with guidance from the Office of Management and Budget and the Attorney General and with all applicable laws. FTA will evaluate proposals submitted according to the following criteria. (a) Project Innovation and Impact. (b) Project Approach.

(c) National Applicability. (d) Commercialization and/or Knowledge Transfer. And (e) Technical, Legal and Financial Capacity. FTA encourages each applicant to demonstrate how a project supports all criteria with the most relevant information the applicant can provide, regardless of whether such information has been specifically requested or identified in this notice.

A. Project Innovation and Impact i. Effectiveness of the project in achieving and demonstrating the specific objectives of this program. Ii.

Demonstration of benefits in addressing the needs of the transit agency and industry and impacts to infrastructure, equipment, transit workforce, and riders. Iii. Degree of improvement over current and existing technologies, designs, and/or practices applicable to the transit industry. B.

Project Approach i. Quality of the project approach such as existing partnerships, collaboration strategies and level of commitment of the project partners. Ii. Proposal is realistic in its approach to fulfill the milestones/deliverables, schedule and goals.

C. National Applicability i. Degree to which the project could be replicated by other transit agencies regionally or nationally. Ii.

Ability to evaluate technologies, designs and/or practices in a wide variety of conditions and locales. Iii. Degree to which the technology, designs and/or practices can be replicated by other transportation modes. D.

Commercialization and/or Knowledge Transfer i. Demonstrates a realistic plan for moving the results of the project into the transit marketplace (patents, conferences, articles in trade magazines, webinar, site visits, etc.). Ii. How the project team plans to work with the industry on improving best practices, guidance and/or standards, if applicable.

Iii. Demonstrate a clear understanding and robust approach to data collection, access and management. E. Technical, Legal and Financial Capacity Capacity of the applicant and any partners to successfully execute the project effort.

There should be no outstanding legal, technical, or financial issues with the applicant that would make this a high-risk project. (2) Review and Selection Process An FTA technical evaluation committee will evaluate proposals based on the published project evaluation criteria. Members of the technical evaluation committee will rate the applications and may seek clarification about any statement in an application. The FTA Administrator will determine the final selection and amount of funding for each project after consideration of the findings of the technical evaluation committee.

Geographic diversity, diversity of the project type, the amount of local match to be provided, and the applicant's receipt and management of other Federal transit funds may be considered in FTA's award decisions. Prior fare payment innovation efforts may receive priority consideration. The FTA Administrator will consider the following key DOT objectives. A.

Utilizing alternative funding sources and innovative financing models to attract non-Federal sources of investment. B. Whether the project is located in or supports public transportation service in a qualified opportunity zone designated pursuant to 26.U.S.C. 1400Z-1.

And c. The extent to which the project addresses challenges specific to the provision of rural public transportation. (3) FAPIIS Review Prior to making a grant award, FTA is required to review and consider any information about the applicant that is in the Federal Awardee Performance and Integrity Information System (FAPIIS) accessible through SAM. An applicant may review and comment on information about itself that a Federal awarding agency previously entered.

FTA will consider any comments by the applicant, in addition to the other information in FAPIIS, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR 200.205 Federal Awarding Agency Review of Risk Posed by Applicants. F. Federal Award Administration Information (1) Federal Award Notices FTA will announce the final project selections on the FTA website. Project recipients should contact their FTA Regional Office for additional information regarding allocations for Start Printed Page 63657projects.

At the time project selections are announced, FTA will extend pre-award authority for the selected projects. There is no blanket pre-award authority for these projects before announcement. There is no minimum or maximum grant award amount, but FTA intends to fund as many meritorious projects as possible. FTA only will consider proposals from eligible recipients for eligible activities.

Due to funding limitations, projects selected for funding may receive less than the amount originally requested. In those cases, applicants must be able to demonstrate that the proposed projects are still viable and can be completed with the amount awarded. (2) Administrative and National Policy Requirements a. Pre-Award Authority FTA will issue specific guidance to recipients regarding pre-award authority at the time of selection.

FTA does not provide pre-award authority for competitive funds until projects are selected, and there are Federal requirements that must be met before costs are incurred. For more information about FTA's policy on pre-award authority, see the FY 2020 Apportionments Notice published on June 3, 2020, at https://www.govinfo.gov/​content/​pkg/​FR-2020-06-03/​pdf/​2020-11946.pdf. b. Grant Requirements Selected applicants will submit a grant application through FTA's electronic grant management system and adhere to the customary FTA grant requirements for research project (insert Circular name).

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} } Latest Updates. The antibiotics Outbreak 15h ago Senate Republicans push narrow stimulus bills as Pelosi and Mnuchin resume talks. 17h ago A frozen yogurt shop in Colorado offered maskless customers a 10 percent discount. Uproar ensued.

19h ago An at Pope Francis’ residence adds to concerns for his safety. See more updates More live coverage. Markets A New York Times database has tracked clusters of at least 50 antibiotics cases in a dozen rural jails in Montana, Idaho, Utah and New Mexico during the zithromax. Among them.

The Purgatory Correctional Center in Hurricane, Utah, with 166 s. The jail in Twin Falls, Idaho, with 279. And, in New Mexico, the Cibola County Correctional Center, which has reported 357 cases.In Cascade County, s at the jail make up about a quarter of all known zithromax cases in the county. Health authorities say that the jail’s outbreak, which began in mid-August, was not believed to be the main cause of the community’s recent surge, but that it had led to some cases.

In the past two months, Mr. Krogue said, the jail released 29 people who were considered actively infected.s at the jail make up about a quarter of Cascade County’s known zithromax cases.Credit...Tailyr Irvine for The New York TimesGreat Falls, home to about 58,000 residents, is in the less mountainous part of Montana, with the Missouri River flowing through and a large oil refinery on its banks. The Cascade County Detention Center sits along a highway at the edge of town. Drive five miles in any direction and you are surrounded by wide-open plains.Montana requires that masks be worn inside businesses and indoor public spaces, and many people in Great Falls wear them when walking around downtown’s Central Avenue, where shops and cafes are still recovering from shutting down in the spring.

Others go without masks, citing the open space and lack of crowds.Bob Kelly, the mayor, said people had not been overly worried about how the jail outbreak might affect the rest of town when it started.“I think that by the very definition of a jail, hopefully, the disease will be incarcerated, as well as the patients,” he said. €œIs there concern?. Sure, there’s concern. But is there overreaction?.

No.”The mayor of Great Falls said that residents had considered the jail’s outbreak a distant concern at first.Credit...Tailyr Irvine for The New York TimesSome residents’ nonchalance about the risks of the zithromax, said Mr. Krogue, the jail’s medical director, can be traced to a spring and early summer when almost no one in Cascade County knew anyone who had been sickened.“We benefited from that early on,” he said. €œBut in some ways, I think it did us a disservice, too, because it also created a certain level of complacency.”That has quickly shifted now, he said, as cases have spiked.The number of active cases known to county officials on any given day has risen sharply to about 600, according to Trisha Gardner, Cascade County’s health officer. The county has seen 1,261 cases and six deaths during the zithromax, a Times database shows.

Some of the cases have been tied to the jail outbreak, she said, and others have been connected to bars and restaurants. Even figuring out what has led to some cases has been complex, she said, as residents have been reluctant to cooperate with contact tracers.“Our hospitals are at capacity, our public health system is at capacity,” she said. €œIt’s not sustainable at this rate.”When the outbreak at the jail began, social distancing was impossible, the authorities said. Three inmates shared cells designed for two.

At night, men slept on thin blue pads in every available space. On the floor in the day room, in shower stalls, in stairwells, in hallways outside of cells.Inmates did not receive masks until August, and jail officials said many have refused to wear them.In interviews with more than a dozen inmates and their family members, inmates described the jail during the outbreak as chaotic and unsanitary. They said their pleas for help often went unanswered by nurses and guards.Newly arriving inmates were not always quarantined from one another before their test results were known because of a lack of space, inmates and jail officials said.Owen Hawley, 30, said every inmate in his living area of 38 men had tested positive for the zithromax. He said he had been unable to eat for three days, had intensive body aches and suffered from a headache so powerful it felt as if it was “behind my eyes.”“After the fourth day of like, not eating and stuff, I just shut off, you know?.

€ he said.A jail area set aside for quarantining new inmates.Credit...Tailyr Irvine for The New York TimesAt one point, Mr. Hawley said, he and other prisoners protested the way the zithromax was being handled by refusing to leave their living areas and by blocking new inmates from entering. Everyone was ultimately tested, Mr. Hawley said, and each prisoner was given a disposable mask.Sierra Jasmine Wells, 25, another inmate, said women in her dormitory had grown ill, one after the next.“Everyone around me was getting sick and it was tough on me,” she said.

€œBy then, I had already accepted the fact that I was going to get sick.”When she became infected, she said, she was given cough syrup and Tylenol.“I kind of was just left alone to deal with it,” she said.Jesse Slaughter, the county sheriff who oversees the jail, said that the jail’s medical staff was doing everything it could, and that he had been seeking health care assistance from other counties. Officials defended their handling of the outbreak, noting that all inmates received standard medications including Tylenol twice a day and were taken to area hospitals when they needed added care. Seven inmates, as well as some staff members, were hospitalized. No one from the jail has died from the zithromax, officials said.Sheriff Jesse Slaughter, who oversees the jail, said he had been seeking health care assistance from other counties.Credit...Tailyr Irvine for The New York TimesMr.

Krogue said that since the start of the outbreak he had been working up to 16 hours each day and sleeping in his basement, away from his wife and children. He remains healthy but says he fears bringing the zithromax home. The zithromax has slowed some in the jail, and officials have moved some inmates to other facilities, but other prisons and jails in the state are now seeing outbreaks.“You can start to see what some of these other places experienced much earlier on, and we just didn’t have that experience, but it’s certainly happening now,” Mr. Krogue said.

€œIt’s just real in a way that it wasn’t.”Lucy Tompkins reported from Great Falls, Maura Turcotte from Chicago and Libby Seline from Lincoln, Neb. Reporting was contributed by Izzy Colón from Columbia, Mo., Brendon Derr from Phoenix, Rebecca Griesbach from Tuscaloosa, Ala., Danya Issawi and Timothy Williams from New York, Ann Hinga Klein from Des Moines, K.B. Mensah from Silver Spring, Md., and Mitch Smith from Chicago.Start Preamble Federal Transit Administration (FTA), DOT. Notice of funding opportunity.

The antibiotics Disease 2019 (buy antibiotics) public health emergency Start Printed Page 63654has had a significant impact on transit operations. During a series of FTA listening sessions held over the last three months, transit agencies asked FTA to support research to identify solutions to address the operational challenges that they are facing as a result of buy antibiotics. In response, FTA makes available through this Notice of Funding Opportunity (NOFO) funding to support research demonstration grants to public transit agencies to develop, deploy, and demonstrate innovative solutions that improve the operational efficiency of transit agencies, as well as enhance the mobility of transit users affected by the buy antibiotics public health emergency. Demonstration grants under this NOFO are authorized under FTA's Public Transportation Innovation Program (49 U.S.C.

5312). Eligible projects will demonstrate innovative solutions to improve the operational efficiencies of transit systems and enhance mobility for their communities in four major areas. (1) Vehicle, facility, equipment and infrastructure cleaning and dis. (2) exposure mitigation measures.

(3) innovative mobility such as contactless payments. And (4) measures that strengthen public confidence in transit services. The total funding available for awards under this NOFO is $10,000,000. FTA may supplement this amount if additional funding becomes available.

Applicants must submit completed proposals for funding opportunity FTA-2020-015-TRI through the GRANTS.GOV “APPLY” function by 11:59 p.m. Eastern Time on November 2, 2020. Prospective applicants should register as soon as possible on the GRANTS.GOV website to ensure they can complete the application process before the submission deadline. Application instructions are available on FTA's website at http://transit.dot.gov/​howtoapply and in the “FIND” module of GRANTS.GOV.

FTA will not accept mail and fax submissions. Start Further Info Please send any questions on this notice to Jamel El-Hamri email. Jamel.El-Hamri@dot.gov phone. 2020-366-8985.

A Telecommunication Device for the Deaf (TDD) is available for individuals who are deaf or hard of hearing at 1-800-877-8339. End Further Info End Preamble Start Supplemental Information Table of Contents A. Program Description B. Federal Award Information C.

Eligibility Information D. Application and Submission Information E. Application Review Information F. Federal Award Administration Information G.

Federal Awarding Agency Contact Information A. Program Description The Public Transportation buy antibiotics Research Demonstration Grant Program is funded through the Public Transportation Innovation Program (49 U.S.C. 5312), with the goal to develop, deploy, and demonstrate innovative solutions that improve the operational efficiency of transit agencies, as well as enhance the mobility of transit users affected by the buy antibiotics public health emergency. Eligible projects will propose to develop and deploy innovative solutions in four major areas.

(1) Vehicle, facility, equipment and infrastructure cleaning and dis. (2) exposure mitigation measures. (3) innovative mobility such as contactless payments. And (4) measures that strengthen public confidence in transit.

As required by 49 U.S.C. 5312(e)(4), projects funded under this NOFO must participate in an evaluation by an independent outside entity that will conduct a comprehensive evaluation of the success or failure of the projects funded under this subsection and any plan for broad-based implementation of the innovation promoted by successful projects. B. Federal Award Information FTA makes available $10,000,000 in fiscal year (FY) 2020 funds under the Public Transportation Innovation Program (49 U.S.C.

5312) to finance the Public Transportation buy antibiotics Research Demonstration Grant Program. FTA may supplement the total funds available if additional funding becomes available at the time project selections are made. FTA will grant pre-award authority starting on the date of the project award announcement for selected projects and should be completed within 24 months from the date of award. Funds are available only for eligible expenses incurred after the announcement of project selections.

C. Eligibility Information (1) Eligible Applicants Eligible applicants include State and local governmental authorities, direct recipients of Urbanized Area (49 U.S.C. 5307) and Rural Area (49 U.S.C. 5311) formula funds, and Indian tribes.

Eligible applicants are limited to FTA grantees or subrecipients who would be the primary beneficiaries of the innovative products and services that are developed—typically public transit agencies. Except for projects proposed by Indian tribes, proposals for projects in rural (non-urbanized) areas must be submitted as part of a consolidated State proposal. States and other eligible applicants also may submit consolidated proposals for projects in urbanized areas. The submission of the Statewide application will not preclude the submission and consideration of any application from other eligible recipients in an urbanized area in a State.

Proposals may contain projects to be implemented by the recipient or its subrecipients. Eligible subrecipients include public agencies, private nonprofit organizations, and private providers engaged in public transportation. Eligible applicants may submit consolidated proposals for projects. (2) Cost Sharing or Matching The maximum Federal share of project costs is 100 percent.

FTA may give additional consideration to applicants that propose a local share and may view these applicants as more competitive. The applicant must document the source(s) of the local match, if any, in the grant application. For any applicants proposing match, eligible local match sources include the following. Cash from non-Government sources other than revenues from providing public transportation services.

Revenues derived from the sale of advertising and concessions. Revenues generated from value capture financing mechanisms. Funds from an undistributed cash surplus. Replacement or depreciation cash fund or reserve.

New capital. Or in-kind contributions. (3) Eligible Projects Eligible projects will propose innovative solutions to improve operational efficiencies of transit agencies and enhance the mobility of transit users, through projects that demonstrate innovative solutions for. Vehicle, facility, equipment and infrastructure cleaning and dis.

Exposure mitigation measures such a real-time notification of rail and bus passenger loads. New multi-modal payment innovative mobility systems such as contactless payments. And measures that strengthen public confidence in transit. Each applicant may only submit one proposal.Start Printed Page 63655 D.

Application and Submission Information (1) Address and Form of Application Submission Applications must be submitted through GRANTS.GOV. Applicants can find general information for submitting applications through GRANTS.GOV at www.fta.dot.gov/​howtoapply, along with specific instructions for the forms and attachments required for submission. Mail and fax submissions will not be accepted. (2) Content and Form of Application Submission a.

Proposal Submission A complete proposal submission consists of at least two forms. 1. The SF-424 Mandatory Form (downloadable from GRANTS.GOV) and 2. The supplemental form for the FY 2020 buy antibiotics Demonstration Program (downloadable from GRANTS.GOV), which is available on FTA's website at (placeholder for FTA buy antibiotics Demonstration Program).

The application must include responses to all sections of the SF-424 mandatory form and the supplemental form unless a section is indicated as optional. FTA will use the information on the supplemental form to determine applicant and project eligibility for the program and to evaluate the proposal against the selection criteria described in part E of this notice. FTA will accept only one supplemental form per SF-424 submission. FTA encourages applicants to consider submitting a single supplemental form that includes multiple activities to be evaluated as a consolidated proposal.

Applicants may attach additional supporting information to the SF-424 submission, including but not limited to letters of support, project budgets, or excerpts from relevant planning documents. Supporting documentation must be described and referenced by file name in the appropriate response section of the supplemental form, or it may not be reviewed. Information such as applicant name, Federal amount requested, local match amount, description of areas served, etc., may be requested in varying degrees of detail on both the SF-424 form and supplemental form. Applicants must fill in all fields unless stated otherwise on the forms.

If applicants copy information into the supplemental form from another source, they should verify that the supplemental form has fully captured pasted text and that it has not truncated the text due to character limits built into the form. Applicants should use both the “Check Package for Errors” and the “Validate Form” validation buttons on both forms to check all required fields. Applicants should also ensure that the Federal and local amounts specified are consistent. Addressing the deteriorating conditions and disproportionately high fatality rates on our rural transportation infrastructure is of critical interest to the Department, as rural transportation networks face unique challenges in safety, infrastructure condition, and passenger and freight usage.

Consistent with the R.O.U.T.E.S. Initiative, the Department encourages applicants to consider how the project will address the challenges faced by rural areas. B. Application Content The SF-424 Mandatory Form and the supplemental form will prompt applicants for the required information, including.

I. Applicant Name ii. Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number iii. Key contact information (contact name, address, email address, and phone number) iv.

Congressional district(s) where project will take place v. Project Information (title, executive summary, and type) vi. A detailed description of the need for the project vii. A detailed description of how the project will support the Program objectives viii.

Evidence that the applicant can provide the local cost shares ix. A description of the technical, legal, and financial capacity of the applicant x. A detailed project budget xi. Details on the local matching funds xii.

A detailed project timeline xiii. Whether the project impacts an Opportunity Zone (3) Unique Entity Identifier and System for Award Management (SAM) Each applicant is required to. (1) Be registered in SAM before submitting an application. (2) provide a valid unique entity identifier in its application.

And (3) continue to maintain an active SAM registration with current information at all times during which the applicant has an active Federal award or an application or plan under consideration by FTA. These requirements do not apply if the applicant. (1) Is excepted from the requirements under 2 CFR 25.110(b) or (c). Or (2) has an exception approved by FTA under 2 CFR 25.110(d).

FTA may not make an award until the applicant has complied with all applicable unique entity identifier and SAM requirements. If an applicant has not fully complied with the requirements by the time FTA is ready to make an award, FTA may determine that the applicant is not qualified to receive an award and use that determination as a basis for making a Federal award to another applicant. All applicants must provide a unique entity identifier provided by SAM. Registration in SAM may take as little as 3-5 business days, but there can be unexpected steps or delays.

For example, the applicant may need to obtain an Employer Identification Number. FTA recommends allowing ample time, up to several weeks, to complete all steps. For additional information on obtaining a unique entity identifier, please visit www.sam.gov. (4) Submission Dates and Times Project proposals must be submitted electronically through GRANTS.GOV by 11:59 p.m.

Eastern on November 2, 2020. Mail and fax submissions will not be accepted. FTA urges applicants to submit applications at least 72 hours prior to the due date to allow time to correct any problems that may have caused either GRANTS.GOV or FTA systems to reject the submission. Proposals submitted after the deadline will only be considered under extraordinary circumstances not within the applicant's control.

Deadlines will not be extended due to scheduled website maintenance. GRANTS.GOV scheduled maintenance and outage times are announced on the GRANTS.GOV website. Within 48 hours after submitting an electronic application, the applicant should receive two email messages from GRANTS.GOV. (1) Confirmation of successful transmission to GRANTS.GOV.

And (2) confirmation of successful validation by GRANTS.GOV. If the applicant does not receive confirmation of successful validation or receives a notice of failed validation or incomplete materials, the applicant must address the reason for the failed validation, as described in the email notice, and resubmit before the submission deadline. If making a resubmission for any reason, applicants must include all original attachments regardless of which attachments were updated and check the box on the supplemental form indicating this is a resubmission. Applicants are encouraged to begin the process of registration on the GRANTS.GOV site well in advance of the submission deadline.

Registration is Start Printed Page 63656a multi-step process, which may take several weeks to complete before an application can be submitted. Registered applicants may still be required to update their registration before submitting an application. Registration in SAM is renewed annually and persons making submissions on behalf of the Authorized Organization Representative (AOR) must be authorized in GRANTS.GOV by the AOR to make submissions. (5) Funding Restrictions Funds may be used for post-award expenditures only.

Funds under this NOFO cannot be used to reimburse projects for otherwise eligible expenses incurred prior to the date of project award announcements. (6) Other Submission Requirements FTA encourages applicants to identify scaled funding options in case insufficient funding is available to fund a project at the full requested amount. If an applicant indicates that a project is scalable, the applicant must provide an appropriate minimum funding amount that will fund an eligible project that achieves the objectives of the program and meets all relevant program requirements. The applicant must provide a clear explanation of how a reduced award would affect the project budget and scope.

FTA may award a lesser amount whether or not the applicant provides a scalable option. E. Application Review Information (1) Project Evaluation Criteria Addressing the deteriorating conditions and disproportionately high fatality rates on our rural transportation infrastructure is of critical interest to the Department, as rural transportation networks face unique challenges in safety, infrastructure condition, and passenger and freight usage. Consistent with the R.O.U.T.E.S.

Initiative, the Department will consider how the project will address the challenges faced by rural areas. In addition, the Department will review and consider applications for funding pursuant to this Notice in accordance with the President's September 2, 2020 memorandum, entitled Memorandum on Reviewing Funding to State and Local Government Recipients of Federal Funds that Are Permitting Anarchy, Violence, and Destruction in American Cities, consistent with guidance from the Office of Management and Budget and the Attorney General and with all applicable laws. FTA will evaluate proposals submitted according to the following criteria. (a) Project Innovation and Impact.

(b) Project Approach. (c) National Applicability. (d) Commercialization and/or Knowledge Transfer. And (e) Technical, Legal and Financial Capacity.

FTA encourages each applicant to demonstrate how a project supports all criteria with the most relevant information the applicant can provide, regardless of whether such information has been specifically requested or identified in this notice. A. Project Innovation and Impact i. Effectiveness of the project in achieving and demonstrating the specific objectives of this program.

Ii. Demonstration of benefits in addressing the needs of the transit agency and industry and impacts to infrastructure, equipment, transit workforce, and riders. Iii. Degree of improvement over current and existing technologies, designs, and/or practices applicable to the transit industry.

B. Project Approach i. Quality of the project approach such as existing partnerships, collaboration strategies and level of commitment of the project partners. Ii.

Proposal is realistic in its approach to fulfill the milestones/deliverables, schedule and goals. C. National Applicability i. Degree to which the project could be replicated by other transit agencies regionally or nationally.

Ii. Ability to evaluate technologies, designs and/or practices in a wide variety of conditions and locales. Iii. Degree to which the technology, designs and/or practices can be replicated by other transportation modes.

D. Commercialization and/or Knowledge Transfer i. Demonstrates a realistic plan for moving the results of the project into the transit marketplace (patents, conferences, articles in trade magazines, webinar, site visits, etc.). Ii.

How the project team plans to work with the industry on improving best practices, guidance and/or standards, if applicable. Iii. Demonstrate a clear understanding and robust approach to data collection, access and management. E.

Technical, Legal and Financial Capacity Capacity of the applicant and any partners to successfully execute the project effort. There should be no outstanding legal, technical, or financial issues with the applicant that would make this a high-risk project. (2) Review and Selection Process An FTA technical evaluation committee will evaluate proposals based on the published project evaluation criteria. Members of the technical evaluation committee will rate the applications and may seek clarification about any statement in an application.

The FTA Administrator will determine the final selection and amount of funding for each project after consideration of the findings of the technical evaluation committee. Geographic diversity, diversity of the project type, the amount of local match to be provided, and the applicant's receipt and management of other Federal transit funds may be considered in FTA's award decisions. Prior fare payment innovation efforts may receive priority consideration. The FTA Administrator will consider the following key DOT objectives.

A. Utilizing alternative funding sources and innovative financing models to attract non-Federal sources of investment. B. Whether the project is located in or supports public transportation service in a qualified opportunity zone designated pursuant to 26.U.S.C.

1400Z-1. And c. The extent to which the project addresses challenges specific to the provision of rural public transportation. (3) FAPIIS Review Prior to making a grant award, FTA is required to review and consider any information about the applicant that is in the Federal Awardee Performance and Integrity Information System (FAPIIS) accessible through SAM.

An applicant may review and comment on information about itself that a Federal awarding agency previously entered. FTA will consider any comments by the applicant, in addition to the other information in FAPIIS, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR 200.205 Federal Awarding Agency Review of Risk Posed by Applicants. F. Federal Award Administration Information (1) Federal Award Notices FTA will announce the final project selections on the FTA website.

Project recipients should contact their FTA Regional Office for additional information regarding allocations for Start Printed Page 63657projects. At the time project selections are announced, FTA will extend pre-award authority for the selected projects. There is no blanket pre-award authority for these projects before announcement. There is no minimum or maximum grant award amount, but FTA intends to fund as many meritorious projects as possible.

FTA only will consider proposals from eligible recipients for eligible activities. Due to funding limitations, projects selected for funding may receive less than the amount originally requested. In those cases, applicants must be able to demonstrate that the proposed projects are still viable and can be completed with the amount awarded. (2) Administrative and National Policy Requirements a.

Pre-Award Authority FTA will issue specific guidance to recipients regarding pre-award authority at the time of selection. FTA does not provide pre-award authority for competitive funds until projects are selected, and there are Federal requirements that must be met before costs are incurred. For more information about FTA's policy on pre-award authority, see the FY 2020 Apportionments Notice published on June 3, 2020, at https://www.govinfo.gov/​content/​pkg/​FR-2020-06-03/​pdf/​2020-11946.pdf. b.

Grant Requirements Selected applicants will submit a grant application through FTA's electronic grant management system and adhere to the customary FTA grant requirements for research project (insert Circular name). All competitive grants, regardless of award amount, will be subject to the Congressional notification and release process. FTA emphasizes that third-party procurement applies to all funding awards, as described in FTA Circular 4220.1F, “Third Party Contracting Guidance.” However, FTA may approve applications that include a specifically identified partnering organization(s) (2 CFR 200.302(f)). When included, the application, budget, and budget narrative should provide a clear understanding of how the selection of these organizations is critical for the project and give sufficient detail about the costs involved.

C. Planning FTA encourages applicants to engage the appropriate State Departments of Transportation, Regional Transportation Planning Organizations, or Metropolitan Planning Organizations in areas to be served by the project funds available under this program. D. Standard Assurances The applicant assures that it will comply with all applicable Federal statutes, regulations, executive orders, FTA circulars, and other Federal administrative requirements in carrying out any project supported by the FTA grant.

The applicant acknowledges that it is under a continuing obligation to comply with the terms and conditions of the grant agreement issued for its project with FTA. The applicant understands that Federal laws, regulations, policies, and administrative practices might be modified from time to time and may affect the implementation of the project. The applicant agrees that the most recent Federal requirements will apply to the project unless FTA issues a written determination otherwise. The applicant must submit the Certifications and Assurances before receiving a grant if it does not have current certifications on file.

E. Free Speech and Religious Liberty In connection with any program or activity conducted with or benefiting from funds awarded under this notice, recipients of funds must comply with all applicable requirements of Federal law, including, without limitation, the Constitution of the United States. Statutory, regulatory, and public policy requirements, including without limitation, those protecting free speech, religious liberty, public welfare, the environment, and prohibiting discrimination. The conditions of performance, non-discrimination requirements, and other assurances made applicable to the award of funds in accordance with regulations of the Department of Transportation.

And applicable Federal financial assistance and contracting principles promulgated by the Office of Management and Budget. In complying with these requirements, recipients must ensure that no concession agreements are denied or other contracting decisions made on the basis of speech or other activities protected by the First Amendment. If the Department determines that a recipient has failed to comply with applicable Federal requirements, the Department may terminate the award of funds and disallow previously incurred costs, requiring the recipient to reimburse any expended award funds. (3) Reporting The post-award reporting requirements include submission of the Federal Financial Report (FFR) and Milestone Progress Report in TrAMS.

An evaluation of the grant will occur at various points in the demonstration process and at the end of the project. In addition, FTA is responsible for producing an Annual Report to Congress that compiles evaluation of selected projects, including an evaluation of the performance measures identified by the applicants. All applicants must develop an evaluation plan to measure the success or failure of their projects and describe any plans for broad-based implementation of successful projects. FTA may request data and reports to support the evaluation and Annual Report.

A. Independent Evaluation To achieve a comprehensive understanding of the impacts and implications of each proposed buy antibiotics Research Demonstration Program, projects funded under this announcement will require the recipient to conduct a third party independent evaluation of their project. Recipients will be required to contract with a third party independent evaluator to assist in developing an evaluation plan, and collecting, storing and managing data required to fulfill the evaluation requirement. No more than 10 percent of the Federal share of the project may be used to hire the third-party independent evaluator and the inclusion of a third-party independent evaluation should be described in the grant application.

If the project duration is more than two years, an interim evaluation report would need to be submitted to FTA, otherwise the evaluation report should be included as part of the final project report. B. buy antibiotics Research Demonstration Grant Program Evaluation Projects funded under this announcement will be required to establish a set of performance metrics set by the third-party independent evaluator and shared with FTA. G.

Federal Awarding Agency Contacts Information For questions about applying, please contact Jamel El-Hamri email. Jamel.El-Hamri@dot.gov phone. 202-366-8985. A TDD is available at 1-800-877-8339 (TDDFIRS).

To ensure that applicants receive accurate information about eligibility or the program, applicants are encouraged to contact FTA directly with questions, rather than through intermediaries or third parties.Start Printed Page 63658 FTA staff also may conduct briefings on the competitive grants selection and award process upon request. Start Signature K. Jane Williams, Deputy Administrator. End Signature End Supplemental Information [FR Doc.