Connect with us

Published

on

[ad_1]

The U.S. Department of Health and Human Services (HHS) is overriding the Food and Drug Administration (FDA), which made a surprise announcement on Tuesday that any distillery that switched to producing hand sanitizer this year during the pandemic will owe thousands of dollars in fees and could be charged twice if they do not cease production immediately.

HHS Chief of Staff Brian Harrison announced Thursday: “Small businesses who stepped up to fight COVID-19 should be applauded by their government, not taxed for doing so. I’m pleased to announce we have directed FDA to cease enforcement of these arbitrary, surprise user fees. Happy New Year, distilleries, and cheers to you for helping keep us safe!”

The early and uncertain days of the pandemic created a high demand for hand sanitizer. Many craft-brewing distilleries, which found their regular operations at a standstill due to COVID shutdowns, pivoted to making sanitizer to stay financially afloat and help with the sudden shortage. More than 800 distilleries shifted from spirits to sanitizer, offering it for sale and even donating it to their communities.

How were the distilleries rewarded for their swift, resourceful, and admirable actions? The FDA slapped them with a notice that they owed an unexpected fee to the government of more than $14,000. Any facility described as an “over-the-counter drug monograph” facility would be subject to a $14,060 Monograph Drug Facility Fee.

The CARES Act, passed into law earlier this year as an initial round of COVID-19 spending defined all distilleries producing hand sanitizer as such facilities. Under the now-voided rule, distilleries would have been forced to shut down production of hand sanitizer and notify the federal government of their change in status in order to avoid having to pay the same fee in 2022.

For the blindsided distilleries, the unexpected fee would have been devastating in an already financially difficult year.

HHS officials said they first became aware of the fee this week via the press and held an emergency meeting late Wednesday night. In a statement, the HHS said the FDA’s March guidance document – the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) – gave flexibility for establishments capable of producing hand sanitizer to rapidly enter the market.

Advertisement

“In the guidance,” wrote the HHS, “the FDA stated it ‘does not intend to take action against firms that’ produce hand sanitizer products – which are classified as over-the-counter drugs – during the COVID-19 Public Health Emergency, provided the firm’s activities are consistent with the guidance.”

“Importantly, the guidance contains no discussion regarding user fees or any indication such fees would be due by these entities, many of which would be entering the drug manufacturing business for the first time,” wrote the HHS, highlighting how unfair the bureaucratic money grab was. “Nevertheless, on December 29, the FDA posted an over-the-counter drugs user fee notice that imposes a significant financial burden on these small businesses.”

The HHS declared the FDA notice void, citing that “Only the HHS Secretary has the authority to issue legislative rules, and he would never have authorized such an action during a time in which the Department is maximizing its regulatory flexibility to empower Americans to confront and defeat COVID-19.”

Evita Duffy is an intern at The Federalist and a junior at the University of Chicago, where she studies American History. She loves the Midwest, lumberjack sports, writing, & her family. Follow her on Twitter at @evitaduffy_1



[ad_2]

Advertisement
Comments

COVID-!9

Biden administration to allow 25,000 asylum-seekers to cross US-Mexico border while cases are pending

Published

on

By

Around 25,000 asylum-seekers who were ordered under former President Donald Trump to wait in Mexico while U.S. immigration courts processed their requests will now be allowed to cross the border starting next week, the Biden administration announced Friday. 

The Department of Homeland Security said the change in plans for those currently placed in Migrant Protection Protocols (MPP) — often referred to as “Remain in Mexico” — will go into effect on Feb. 19. The Trump administration introduced the policy in January 2019 and said it was critical to reversing a surge of asylum-seekers that peaked that year. 

“As President Biden has made clear, the U.S. government is committed to rebuilding a safe, orderly, and humane immigration system,” Secretary of Homeland Security Alejandro Mayorkas said in a statement. “This latest action is another step in our commitment to reform immigration policies that do not align with our nation’s values.”

The Biden administration estimates that around 25,000 individuals enrolled in the protocols still have active cases. 

“Individuals should not take any action at this time and should remain where they are to await further instructions,” Homeland Security said Friday. “We will soon announce a virtual registration process that will be accessible from any location.” 

“Individuals outside of the United States who were not returned to Mexico under MPP or who do not have active immigration court cases will not be considered for participation in this program and should await further instructions,” the department added. 

Homeland Security also warned migrants Friday that the announcement “should not be interpreted as an opening for people to migrate irregularly to the United States. 

“Eligible individuals will only be allowed to enter through designated ports of entry at designated times,” it added.  

Those who are processed under these new changes will be tested for COVID-19 before entering the U.S., Homeland Security said, yet it is unclear what the protocol will be for those whose results come back positive. Fox News has reached out to The White House for further comment. 

Advertisement

On Biden’s first day in office, Homeland Security had suspended the MPP policy for new arrivals. Since then, some asylum-seekers picked up at the border have been released in the U.S. with notices to appear in court. 

Hearings for people enrolled in “Remain in Mexico” have also been suspended since June due to the coronavirus pandemic. 

Advocates have argued that communication problems, including lack of working addresses in Mexico, caused some to miss hearings and lose their cases as a result. 

Raul Ortiz, deputy chief of the Border Patrol, told the Associated Press Tuesday that more than 3,000 people had been stopped crossing the border illegally in each of the previous 10 days, compared to a daily average of 2,426 in January. 

Advocates have argued that communication problems, including lack of working addresses in Mexico, caused some to miss hearings and lose their cases as a result. 

Raul Ortiz, deputy chief of the Border Patrol, told the Associated Press Tuesday that more than 3,000 people had been stopped crossing the border illegally in each of the previous 10 days, compared to a daily average of 2,426 in January. 

Continue Reading

Banned Video

Censored Dr. Goes Off On Lying Fauci, CDC and NIH

Published

on

By

Dr. Simone Gold lays out the facts on HCH, lying politicians , government officials and big tech dictators who created a pandemic for total control.

Advertisement

Continue Reading

COVID-!9

Frustrated father address in Loudoun County, VA

Published

on

By

HERE’S THE VIDEO — Early candidate for ‘Father of the year’… Dude Goes Off On Loudoun County School Board!

Advertisement

Continue Reading
Advertisement
Uncategorized1 day ago

School Board members caught mocking parents over lockdown — They thought their Zoom call was private…

Politics2 days ago

Convicted fundraiser who tried to work his way into Biden’s inner circle sentenced to prison

Politics2 days ago

Cruz responds to pictures of him on Mexico flight, with Texas struggling from deadly winter storm

Fox news2 days ago

‘A lot of people don’t know the severity of what’s going on’

Politics3 days ago

South Carolina House passes bill that would prohibit most abortions if a fetal heartbeat is detected

Politics3 days ago

Son of prominent conservative leader Bozell arrested in connection with Capitol siege

News3 days ago

Seven shot in Philadelphia near SEPTA station, according to police

Politics3 days ago

Trump calls Limbaugh ‘legend,’ in first TV interview since Senate trial

News4 days ago

CNN’s Stelter,’ ‘Saturday Night Live’ this weekend didn’t mention Cuomo’s nursing home COVID story

Politics4 days ago

Rep. Bennie Thompson targets Trump, Giuliani, Proud Boys and Oath Keepers in Capitol riot lawsuit

Donald Trump4 days ago

Trump unleashes scathing statement blasting Sen. Mitch McConnell

Politics4 days ago

Judicial Watch sues U.S. Capitol Police in pursuit of emails and videos pertaining to Jan. 6 riots

Bannon4 days ago

Bannon — ‘Trump may run for Congress in 2022 and lead impeachment against Biden’…

Donald Trump1 week ago

Trump acquitted in impeachment trial; 7 GOP Senators vote with Democrats to convict

Candace Owens1 week ago

Candace Owens post photo of her son with a message to all young feminist.

Facebook

Facebook

Trending

Copyright © 2021 By TSD