Reading through.... here's an excellent point, imo. Here's the part in the deeming doc that addresses the RFA (and exec orders): pg185
XII. Analysis of Impacts: Summary
FDA has examined the impacts of the proposed rule under Executive Order 12866,
Executive Order 13563, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4). Executive Orders 12866 and 13563 direct
agencies to assess all costs and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other advantages; distributive impacts;
and equity). The agency believes that this proposed rule would be an economically significant
regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would
minimize any significant impact of a rule on small entities. FDA has determined that this
proposed rule
would have a significant economic impact on a substantial number of small
entities.
And from Advocacy:
Under the RFA, an IRFA must contain: (1) a description of the reasons why the regulatory action is being taken; (2) the objectives and legal basis for the proposed regulation; (3) a description and estimated number of regulated small entities; (4) a description and estimate of compliance requirements, including any differential for different categories of small entities; (5) identification of duplication, overlap, and conflict with other rules and regulations; and (6) a description of significant alternatives to the rule.[10] Advocacy is concerned that because the proposed rule’s IRFA is deficient, the public has not been adequately informed about the possible impact of the proposal on small entities and whether there are less burdensome significant alternatives to the proposed rule that would meet the FDA’s objectives.
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There is no such assessment in the deeming doc - not ever close. They offer the impact doc...
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf
... as their justification but all alternatives in the impact doc are rendered moot by the deeming doc. Yeah, they did some assessments, but they mean nothing and they don't even justify that in the deeming doc. There's one comment and only on Exec Order 12866 that comes close:
"The agency believes that this proposed rule would be an economically significant
regulatory action as defined by Executive Order 12866."
... whatever that means - 'economically significant'?? Yeah - it would economically devastate many small businesses.
If I were a vendor, I'd look closely at joining/contacting Advocacy.
