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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 implementation, UNM is seeking medical and non-medical volunteers to help staff the site.  “We all have been i...

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 review and approval. 85 Fed. Reg. 81466. The draft guide provides additional clarity on what is meant by...

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 the statement, HHS has “directed FDA to cease enforcement of these arbitrary, surprise user fees....

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 Staff.  According to the statement, HHS has “directed FDA to cease enforcement of these arbitrar...

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 set at $14,060,[i] and the annual facility fee for CMOs was set at $9,373.[ii] According to the notice...