Ozone-Depleting Final Rule Escapes Freeze

In a Federal Register Notice published today, FDA announced that the direct final rule on “Use of Ozone Depleting Substances” published on October 26, 2016 is “excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ‘Regulatory Freeze Pending Review,’ this action confirms the effective date of February 23, 2017, for the direct final rule.”

Remember that there was a moratorium delaying finalization of certain regulations pending a critical review.  The “memorandum of January 20, 2017 (82 FR 8346), from the Assistant to the President and Chief of Staff, entitled ‘Regulatory Freeze Pending Review,’” directed the heads of Executive Departments and Agencies to temporarily postpone for 60 days, from the date of the memorandum, the effective dates of all regulations that had been published in the Federal Register, but had not yet taken effect, for the purpose of “reviewing questions of fact, law, and policy they raise.”  The memorandum also stated that the Director of OMB may exclude certain regulations if they “affect critical health, safety, financial, or national security matters, or for some other reason.”

“On October 26, 2016, the Food and Drug Administration (FDA or Agency) issued a direct final rule amending the regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons, to remove the designations for sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered dose atropine sulfate aerosol human drugs administered by oral inhalation as “essential uses” under the Clean Air Act.”  FDA took this action because these two drugs no longer utilized ODS in their alternative formulations and thus the essential use designation was no longer warranted.  The Rule was thus deemed effective February 23, 2017.

Nice to see that some FR notices are being issued by FDA again and that, perhaps, business is getting back to some sense of normalcy. The full notice can be viewed here.