December 7, 2020

APMA submitted comments to the US Department of Health and Human Services (HHS) on December 4 to express significant concerns with its proposed regulatory review plan.

In the proposed rule, HHS proposed that, subject to certain exceptions, all regulations issued by the secretary or his delegates or sub-delegates in Titles 21 (Food and Drugs), 42 (Public Health), and 45 (Public Welfare) of the Code of Federal Regulations (CFR), shall expire at the end of:

1. two calendar years after the year that this proposed rule first becomes effective;
   
   
2. 10 calendar years after the year of the regulation’s promulgation; or
   
   
3. 10 calendar years after the last year in which HHS assessed and, if required, reviewed the regulation, whichever is latest.

APMA agrees with and supports HHS’ underlying goals of this proposed rule: to ensure regulations are effectuating the intended impact and not becoming outdated or creating unnecessary inefficiencies or burdens. The rule as drafted, however, raises the following warning flags:

• substantial agency administrative and cost burden
• significant regulatory uncertainty
• absence of transparency

Read these and all comment letters in full at www.apma.org/commentletters. If you have questions, email the APMA Health Policy and Practice department.

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