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January 22, 2021
In commitment to community health, The University of New Mexico is permitting employees to use compensated work hours to staff a COVID vaccine clinic at The Pit. The newly created UNM Health COVID-19 Vaccination Clinic at The Pit is enabling UNM Hospital officials to administer vaccinations with guidance and support from the New Mexico Department of Health (DOH). Vaccines will be administered under the phases outlined by the DOH. To maintain an orderly, efficient and coordinated implementatio...
January 22, 2021
TSCA/FIFRA/TRI EPA Seeks Comments On Draft Compliance Guide Addressing Surface Coatings Under PFAS SNUR: On December 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft compliance guide that outlines which imported articles are covered by EPA’s July 2020 final significant new use rule (SNUR) that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA revi...
January 6, 2021
Tuesday, January 5, 2021 Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff. According to...
January 6, 2021
To embed, copy and paste the code into your website or blog: Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of...
January 6, 2021
To embed, copy and paste the code into your website or blog: Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for OTC monograph drug product contract manufacturing organizations (“CMOs”). The annual facility fee for OTC monograph drug manufacturers – the so-called Monograph Drug Facility (“MDF”) fee – was se...
January 1, 2021
The U.S. Department of Health and Human Services (HHS) is overriding the Food and Drug Administration (FDA), which made a surprise announcement 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 governmen...