[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Rules and Regulations]
[Pages 75893-75894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Subtitle A


Public Access to Materials Underlying Impact Analyses; Statement 
of Policy

    The Department believes that its decision-making ought to be as 
transparent as appropriate to better enable the citizenry to comment on 
its proposed rules and demonstration projects. This document furthers 
that objective and the objectives of the Richardson Waiver (see 36 FR 
2532 (Feb. 5, 1971)) by requiring that all assumptions, working papers, 
models, and other information used as part of any impact analysis 
(e.g., economic, actuarial) associated with a rule (including 
ratemakings) or demonstration project (hereinafter, ``analyses'') are 
posted on the Department's website at the time the results of the 
analysis are publicly disclosed, subject to the limitations set forth 
below. This document also applies to rules issued or demonstration 
projects approved by this Department jointly with one or more other 
Departments, but only after consultation with such other Departments 
and only with respect to the analyses performed by this Department.
    The Department's regulations and demonstration projects involving 
federal healthcare programs, the Affordable Care Act, the Food, Drug, 
and Cosmetic Act, or the Public Health Service Act are amongst the most 
economically significant actions undertaken by any Federal agency. The 
Office of the Assistant Secretary for Planning and Evaluation, the 
Office of Economics and Analysis within the Office of Policy, 
Legislation, and International Affairs at the Food and Drug 
Administration, the Office of the Actuary at the Centers for Medicare & 
Medicaid Services, and other applicable agencies and offices all 
undertake impact analyses that assess or seek to predict the wide range 
of economic and other impacts and burdens associated with each rule or 
demonstration project.
    The Office of Management and Budget (``OMB'') Circular A-4 requires 
agencies to make their impact analyses reproducible by third-party 
evaluators. Disclosing the information underlying such analyses, to the 
extent permitted by law and consistent with robust privacy protections, 
will promote an informed public comment process that in turn advances 
both the quality and accountability of the Department's important 
programs. Implementing this policy will allow the public to review and 
evaluate the methodologies and assumptions that underlie the impact 
analysis. This transparency should enable a more accurate calculation 
of anticipated effects because the public will be better positioned to 
analyze and provide formal comment upon the models and data to identify 
and correct faulty assumptions or other errors.
    Effective for any rulemaking or demonstration project proposed 
after November 30, 2020, all agencies and offices of the Department 
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. For 
purposes of this Notice, a rulemaking or demonstration project is 
deemed to have started with the publication in the Federal Register of 
a notice of proposed rulemaking or proposed demonstration projection, 
advanced notice of proposed rulemaking or final rule (whether interim 
or otherwise) or demonstration project, whichever occurs first.
    The disclosure must occur no later than 3 days after the date when 
the results of such analyses are publicly released and are to be posted 
in-full on the Department's website notwithstanding Exemption 5 of the 
Freedom of Information Act (5 U.S.C. 552(b)(5)), except as noted below. 
This Notice does not contemplate the release of information that would 
otherwise be exempt from disclosure under the Freedom of Information 
Act, other than Exemption 5 as noted in the preceding sentence, or the 
Privacy Act of 1974.
    The disclosure requirements in this Notice do not apply to analyses 
undertaken for settlement or litigation purposes or to communications 
with the Executive Office of the President, OMB, or other departments 
or agencies that are not part of a published analysis for a rulemaking 
or demonstration project, or to information that is deemed to fall 
within the attorney-client privilege, or to privileges that inure to 
officials outside this Department. Whether an exception contained in 
this paragraph applies shall be determined by the Office of the General 
Counsel in consultation with the relevant division within the 
Department.
    Nothing in this policy shall be construed to impair or otherwise 
affect the functions of the Director of OMB

[[Page 75894]]

relating to budgetary or administrative proposals. The effect of 
regulations on estimates of budget baseline spending will continue to 
be developed separately using the budget's economic and technical 
assumptions according to OMB Circular A-11.

Alex M. Azar II,
Secretary.
[FR Doc. 2020-25957 Filed 11-24-20; 8:45 am]
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