Letter to The Honorable Xavier Becerra, Secretary, U.S. Department of Health and Human Services (February 22, 2023)

Summary

Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, receives this February 22, 2023 letter from the Committee on Small Business. The Committee says it is investigating how the Department implements the Regulatory Flexibility Act, the Small Business Regulatory Enforcement Fairness Act, and Executive Order 13272, and that Republicans on the Committee wrote last Congress but the Secretary failed to respond. It asks for responses by March 10, 2023, including small entity compliance guides produced or in use at the agency within the last calendar year.

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“Letter to The Honorable Xavier Becerra, Secretary, U.S. Department of Health and Human Services (February 22, 2023).” Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/2023-02-22-housesbc-majority-to-hhs-02-22-2023-letter-to-hhs-re-rfa-4a93b3b36d/, SHA-256 fb3843df2ba6a49081de52763bcab227fd3bf21068ed78be55e24c4ee512d3df.

Full text

February 22, 2023

The Honorable Xavier Becerra
Secretary
U.S. Department of Health and Human Services
200 Independence Ave. S.W.
Washington, D.C. 20201

Dear Secretary Becerra:

The Committee on Small Business is investigating the Department of Health and Human
Services’ (HHS) implementation of the Regulatory Flexibility Act (RFA), the Small Business
Regulatory Enforcement Fairness Act (SBREFA), and Executive Order 13272 (EO13272).1
Republicans on this Committee wrote to you last Congress and you failed to respond. We write
today to request additional documents and information.

As mentioned in our last letter, the RFA, SBREFA, and EO13272 were designed to
provide small businesses notice of proposed agency rules that affected their business and provide
them the opportunity to participate in the process.2 Despite this stated goal, it seems that some
agencies are failing to properly implement these measures to the detriment of small businesses
across the country.

As you are well aware, agencies across the federal government are provided discretion
when determining a regulation’s impact on the small businesses. Agencies are required to
produce an Initial Regulatory Flexibility Analysis (IRFA) in proposed rules only after the agency
determines the proposed rule is expected to have a “significant impact” on a “substantial number
of small entities.”3 If not, the agency simply certifies the rule will not have a significant
economic impact on a substantial number of small entities and provides a “factual basis for such
certification.”4 That certification is published in the Federal Register and reported to the Chief
Counsel for Advocacy at SBA at the time the proposed or final rule is published for public
comment.5

1
5 U.S.C.§§ 601-12; Pub. L. No. 104-121 (Mar. 29, 1996); Proper Consideration of Small Entities in Agency
Rulemaking, 67 Fed. Reg. 53,461 (Aug. 16, 2002).
2
5 U.S.C.§§ 601-12.
3
5 U.S.C. § 603(a).
4
5 U.S.C. § 603(b).
5
Id.
The Honorable Xavier Becerra
February 22, 2023
Page 2 of 4

If the agency determines that the proposed rule will have a significant impact on a
substantial number of small entities, section 212 of SBREFA requires agencies to publish one or
more small entity compliance guides for each rule, or group of rules.6 Additionally, in the final
rule, the agency needs to publish a Final Regulatory Flexibility Analysis (FRFA) that includes
but is not limited to “a description of and an estimate of the number of small entities to which the
rule will apply or an explanation of why no such estimate is available.”7

Small businesses across America deserve to know how the HHS is working to consider
small businesses in their rulemaking process. We therefore request the following documents and
information, as soon as possible but no later than March 10, 2023:

1. Identify any central HHS position or office, if one exists, responsible for ensuring that
HHS complies with the RFA, SBREFA, and EO13272.

2. Identify any HHS positions or offices responsible for reducing the regulatory burden on
small businesses.

3. Provide all small entity compliance guides produced or in use at the agency within the
last calendar year.

4. Provide the agency’s definition of “significant impact” and “substantial number of small
entities” from 2010 until present, including any and all changes over that time and the
justifications for those changes.

5. Provide the name, docket number, and citation of all rules, proposed and final, that that
the agency certified as having no significant impact on a substantial number of small
entities from 2020 to present.

6. All documents and communications relating to the agency’s determination of whether
there was a “significant impact” on a “substantial number of small entities” for all
proposed and final rules from 2020 until present.

7. All documents and communications detailing any and all factors the agency considers
when determining whether the proposed rule will have a “significant impact” on a
“substantial number of small entities” and the weight of each factor given in the
determination.

8. All documents and communications relating to consideration of alternate rule proposals
when the agency has determined a proposed or final rule has a substantial impact on a
substantial number of small entities from 2020 until present.

6
Small Business Regulatory Enforcement Fairness Act, Pub. L. 104-121, § 212 (as amended by the Small Business
and Work Opportunity Act of 2007, Pub. L. 110-28 § 8302).
7
5 U.S.C. § 604(a)(4).
The Honorable Xavier Becerra
February 22, 2023
Page 3 of 4

9. All documents and communications relating to instances where input from mandated
SBREFA panels compelled the agency to amend a proposed rule, with supporting
documents, from 2020 to present.

10. All documents and communications relating to the standards the agency uses to
determine its “factual basis” to support a determination that a proposed rule would not
have a significant impact on a substantial number of small businesses.

To schedule the delivery of responsive documents or ask any related follow-up questions,
please contact Committee on Small Business Majority Staff at (202) 225-5821. The Committee
on Small Business has broad authority to investigate “problems of all types of small business”
under House Rule X. Thank you in advance for your cooperation with this inquiry.

Sincerely,

_________________________ _________________________
Roger Williams Blaine Luetkemeyer
Chairman Vice Chairman
Committee on Small Business Committee on Small Business

_________________________ _________________________
Beth Van Duyne Pete Stauber
Chairman Member of Congress
Subcommittee on Oversight, Committee on Small Business
Investigations, and Regulations

_________________________ _________________________
Dan Meuser Jake Ellzey
Member of Congress Member of Congress
Committee on Small Business Committee on Small Business

_________________________ _________________________
Marc Molinaro Aaron Bean
Member of Congress Member of Congress
Committee on Small Business Committee on Small Business
The Honorable Xavier Becerra
February 22, 2023
Page 4 of 4

_________________________
Nick LaLota
Member of Congress
Committee on Small Business

cc: The Honorable Nydia M. Velasquez, Ranking Member
Committee on Small Business

The Honorable Dean Phillips, Vice Ranking Member
Committee on Small Business

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