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Wrap-Up of Federal and State Chemical Regulatory Developments, January 2021 | Bergeson & Campbell, P.C.

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 a “surface coating,” identifies which entities are regulated, describes the activities that are required or prohibited, and summarizes the notification requirements of the final SNUR. More information on the draft compliance guide is available in our December 14, 2020, memorandum, “EPA Publishes Draft Compliance Guide Addressing Surface Coatings under PFAS SNUR.” Comments on the d ....

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Distilleries Making Hand Sanitizers Will Not Face Drug Facility Fees

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.” FDA announced the fee rates on December 29, 2020. 85 Fed. Reg. 85646. According to the notice, MDFs are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities and updated their registration with FDA to that effect, prior to December 31, 2019 an impossibility for distilleries that began making hand sanitizer in 2020 in response to the COVID-19 pande ....

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Drug Facility Fees Will Not Apply to Distilleries Producing Hand Sanitizer | Bergeson & Campbell, P.C.

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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.” FDA announced the fee rates on December 29, 2020. 85 Fed. Reg. 85646. According to the notice, MDFs are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities and updated their registration with FDA to that effect, prior to December 31, 2019 an impossibility for distilleries that began making hand sanitizer in 2020 in response t ....

United States , Brian Harrison , Bergeson Campbell , Human Services , Department Of Health , Drug Administration , Office Of Public Affairs , Spirits Council , Monograph Drug Facilities , Monograph Drug , Public Affairs , Distilled Spirits Council , Temporary Policy , Public Health Emergency , General Counsel , ஒன்றுபட்டது மாநிலங்களில் , பிரையன் ஹாரிசன் , பெர்கெசோங் கேம்ப்பெல் , மனிதன் சேவைகள் , துறை ஆஃப் ஆரோக்கியம் , அலுவலகம் ஆஃப் பொது வாழ்க்கைத்தொழில்கள் , ஆவிகள் சபை , பொது வாழ்க்கைத்தொழில்கள் , காய்ச்சி வடிகட்டிய ஆவிகள் சபை , தற்காலிகமானது பாலிஸீ , பொது ஆரோக்கியம் அவசரம் ,