Pursuant to the Regulatory Flexibility Act 5 USC 601 et.seq., HHS must prepare a regulatory flexibility analysis if the Secretary certifies that a proposed rule would have a significant economic impact on a substantial number of small entities.
This analysis addresses six issues: (1) reasons for promulgating the rule; (2) the proposed rule’s objectives and legal basis; (3) the number and types of small entities affected by the proposed rule; (4) the specific activities and costs associated with compliance; (5) options that HHS considered to minimize the rule’s economic burdens or increase its benefits for small entities; and (6) the relevant Federal rules that could duplicate, overlap, or conflict with the proposed rule. The following sections provide details on each of these issues.
Reasons for Promulgating the Rule
This proposed rule is being promulgated primarily because we have been statutorily mandated to do so under section 264 of Public Law 104-191. Additional information on the reasons for promulgating the rule can be found in earlier preamble discussions (section I.).
Objectives and Legal Basis
This information can be found in earlier preamble discussions (section I.).
Relevant Federal Provisions
This information can be found in earlier preamble discussions (section I.B.)