JD Supra: HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies

“Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 – with only a 30-day comment period – that would establish sunset (expiration) dates for virtually all of the Department’s regulations, including existing regulations currently administered by the Food and Drug Administration (FDA). This sweeping action has a very limited window for public comment, with written comments due on Friday, 4 December.”

“Specifically, the HHS’s proposed rule would establish sunset (expiration) dates for effectively all of the Department’s regulations. As such, it extends to regulations issued by the Centers for Medicare and Medicaid Services (CMS) and all FDA regulations (including foods, pharmaceuticals, medical devices, and tobacco products) with very limited exceptions. The proposal would require the FDA to conduct detailed reviews and assessments of all such regulations under the Regulatory Flexibility Act within a two year period to prevent their automatic expiration.”

“On 16 November 2020, the HHS published a notice of a public meeting for interested stakeholders to provide input on this proposed rule. The public meeting is to be held virtually this coming Monday, 23 November 2020, and requests for participation must be submitted by tomorrow, Thursday, 19 November 2020…”

“The proposed rule raises issues that fall into three categories…” Read the full article here.

Source: HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies – By Elizabeth Fawell, Martin Hahn, and Joseph Levitt, November 19, 2020. JD Supra.



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