[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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