What are the General Requirements for an Initial RFA?
The Act, at §603, requires (1)identification of the small entities that will be affected by our regulations; (2) analysis of the burden the regulations will impose on small entities; and (3) assessment of whether the burden of the regulations will have a significant economic impact on a substantial number of small entities. If, as an alternative, HHS concludes that a rule WILL NOT HAVE a significant economic impact on a substantial number of small entities, a statement certifying to this effect may be included in the preamble. Such a certification must, under § 605(b) of the Act, be accompanied by a statement of its factual basis. (Further guidance regarding this certification is provided on page 9 below). If, on the other hand, we conclude that a rule MAY HAVE a significant adverse impact on a substantial number of small entities, then the agency must describe significant alternatives to the proposed rule which minimize any significant economic impact on small entities. What is Specif
