Following on the heels of the 4 November 2020 proposed rule that would require retrospective reviews of and establish expiration dates for nearly all of the Department’s existing regulations1 these two policies suggest a continued interest in regulatory reform by the Trump Administration.
Policy on Redundant, Overlapping, or Inconsistent Regulations
First, HHS Chief of Staff Brian Harrison issued a Policy Statement announcing that effective immediately, all agencies and offices of HHS that prepare regulations— including the U.S. Food and Drug Administration (FDA)—must ensure that any rule is not inconsistent with, and does not overlap with, any regulation that has already been issued through an agency within the department.2 In the event an agency proposing a new rule discovers that such rule is inconsistent or overlaps with another Department rule, the proposing agency shall not recommend issuance until it also recommends to the Secretary the steps to be taken to avoid duplicative or overlapping regulations. The policy does not provide any additional information on how an Agency may make a determination that a rule is redundant, overlapping, or inconsistent.
To that end, the HHS issued a companion Request for Information (RFI) seeking input from the public on how HHS may improve its regulations.3 According to the Federal Register notice, the HHS plans to use comments received from the public to “improve existing regulations, and eliminate unnecessary or duplicative regulations through future exercise of rulemaking authority.” The HHS is specifically seeking comment on the following four topics:
- Any HHS regulations that are redundant with other HHS regulations, and how HHS could best eliminate such redundancies.
- Any HHS regulations that are inconsistent with other HHS regulations, and how HHS could best resolve any inconsistencies.
- Any HHS regulations that overlap with federal regulation issued by another HHS office or agency in a manner that creates confusion or uncertainty, and how HHS could best address potential problems caused by such overlapping HHS regulations.
- Challenges faced by you, your company, or others when trying to comply with redundant, overlapping, or inconsistent HHS regulations and the impact or result of facing such challenges.
All comments must be received by 21 December 2020 and must be submitted electronically to DuplicativeRegulations@hhs.gov.
Public Access to Materials Underlying Impact Analyses
Second, HHS Secretary Alex M. Azar issued a policy statement announcing that for all rulemakings proposed after 30 November 2020 all HHS agencies which issue analyses, whether economic, actuarial or otherwise, as part of a proposed or final rulemaking or demonstration project must post for public viewing on the Department’s website all data and assumptions underlying any such analysis, including all working papers, all calculations, all references, and all other information necessary to allow a third-party to replicate the agency’s analytic work.4 Currently, agencies are required to issue analyses related to certain rulemakings, and to make those analyses reproducible by third-party evaluators; this policy expands on those existing obligations to require that agencies publicly disclose all information underlying those analyses, to the extent permitted by law and consistent with privacy protections.
HHS Chief of Staff Brian Harrison stated in a press release published on the HHS website: “We are providing needed transparency by requiring the Department to show its math so the American people can know and challenge the methods government uses to calculate effects of regulations it imposes on them.”5 The HHS also published a Frequently Asked Questions (FAQ) document related to the policy, where it offered additional details, including that (1) the analyses conducted by the technical experts will be released at the same time a proposal is released to the public, (2) each HHS division will determine the exact online location where the analyses will be posted, and (3) the policy will not “create burdens” on HHS agencies, as “it simply requires that analyses and underlying assumptions be made public after they are completed.”6 The HHS also noted that this policy does not require rulemaking because it is a directive concerning “agency management” expressly exempt by the Administrative Procedure Act (APA) from the normal rulemaking requirements.7
We will continue to monitor developments related to FDA rulemakings. If you have any questions, please do not hesitate to contact us.
References
1 See HL Memo, HHS Proposes to Sunset Regulations Issued by FDA, CMS, and Other Regulatory Agencies (18 November 2020), available at https://www.engage.hoganlovells.com/knowledgeservices/news/hhs-proposes-to-sunset-regulations-issued-by-fda-cms-and-other-regulatory-agencies.
2 Policy on Redundant, Overlapping, or Inconsistent Regulations, Department of Health and Human Services, FR Doc. 2020-26023, Filed 24 November 2020, available at https://www.hhs.gov/sites/default/files/public-access-to-materials-underlying-impact-analyses-faq.pdf.
3 Request for Information on Redundant, Overlapping, or Inconsistent Regulations, Department of Health and Human Services, FR Doc. 2020-26022, Filed 24 November 2020, available at https://public-inspection.federalregister.gov/2020-26022.pdf.
4 Statement of Policy, Public Access to Materials Underlying Impact Analyses, FR Doc. 2020-25957, filed 24 November 2020, available at https://public-inspection.federalregister.gov/2020-25957.pdf.
5 Statement from HHS Chief of Staff Brian Harrison on Efforts to Increase Transparency at HHS (24 November 2020) available at https://www.hhs.gov/about/news/2020/11/24/statement-hhs-chief-staff-brian-harrison-efforts-increase-transparency-hhs.html.
6 Frequently Asked Questions on Public Access to Materials Underlying Impact Analyses (24 November 2020) available at https://www.hhs.gov/sites/default/files/public-access-to-materials-underlying-impact-analyses-faq.pdf.
7 See Id. (citing 5. U.S.C. 553(a)(2)).
Authored by Elizabeth Fawell and Anneke Altieri.
