This guidance, originally published in 2003, contains the following introduction:
“Executive Order 13272 (the Order), issued by the President on August 13, 2002, requires that the Department of Health and Human Services (HHS) thoroughly review draft rules to assess and take appropriate account of their potential impact on small business, small governmental jurisdictions, and small organizations, as mandated by the Regulatory Flexibility Act of 1980 (the Act), as amended and as codified at 5 U.S.C. § 601 et seq.
Section 3(a) of the Order directs agencies to issue a written statement of procedures and policies to ensure proper consideration of small entities in the rulemaking process. After review of this statement of policies and procedures by the Small Business Administration’s Office of Advocacy, the statement is to be made readily available to the public through the Internet or other easily accessible means. The following guidance, expressed in question and answer format and reflecting the Office of Advocacy’s review, constitutes the Department’s compliance with this mandate. HHS components assessing the impact of regulatory proposals will conduct these analyses within the conceptual framework set out below.”
HHS has developed and published Guidelines for Regulatory Impact Analysis (2016) that provide additional analytic guidance to HHS agencies conducting regulatory analysis, including considerations related to initial and final regulatory flexibility analyses required under the Regulatory Flexibility Act. The Guidelines also direct analysts to additional guidance developed and maintained by the Small Business Administration’s Office of Advocacy.