[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4529 Reported in House (RH)]
<DOC>
Union Calendar No. 627
118th CONGRESS
2d Session
H. R. 4529
[Report No. 118-756]
To amend the Public Health Service Act regarding guidance documents of
the Centers for Disease Control and Prevention, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 11, 2023
Mrs. Rodgers of Washington introduced the following bill; which was
referred to the Committee on Energy and Commerce
November 19, 2024
Additional sponsor: Mr. Crenshaw
November 19, 2024
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on July
11, 2023]
_______________________________________________________________________
A BILL
To amend the Public Health Service Act regarding guidance documents of
the Centers for Disease Control and Prevention, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Public Health Guidance Transparency
and Accountability Act of 2023''.
SEC. 2. CDC GUIDANCE DOCUMENTS.
The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by
inserting after section 317V of such Act (42 U.S.C. 247b-24) the
following:
``SEC. 317W. CDC GUIDANCE DOCUMENTS.
``(a) Good Guidance Practices.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention (in
this section referred to as the `Secretary'), shall, by
regulation, develop, establish, and maintain good guidance
practices setting forth the policies and procedures of the
Centers for the development, issuance, dissemination, and use
of guidance documents of the Centers for Disease Control and
Prevention.
``(2) Contents.--The regulation required by paragraph (1)
shall--
``(A) incorporate each requirement of subsections
(b) through (j); and
``(B) require guidance documents of the Centers for
Disease Control and Prevention to be developed with
public participation.
``(3) Initial regulation.--The Secretary shall--
``(A) not later than 30 days after the date of
enactment of the Public Health Guidance Transparency
and Accountability Act of 2023, initiate the rulemaking
process for the initial regulation under paragraph (1);
and
``(B) not later than 2 years after the date of
enactment of the Public Health Guidance Transparency
and Accountability Act of 2023, finalize such
regulation.
``(b) No Creation, Conferring, Restricting, or Revoking of Rights,
Responsibilities, or Liabilities.--Guidance documents of the Centers
for Disease Control and Prevention may present views on matters under
the jurisdiction of the Centers, but shall not--
``(1) create, confer, restrict, or revoke any rights,
responsibilities, or liabilities for or on any person;
``(2) be treated (including in any civil or criminal
proceeding) as having the force and effect of law; or
``(3) include any provision that--
``(A) is binding on the public or a State, local,
Tribal, or Territorial government; or
``(B) requires an individual to take or refrain
from an action.
``(c) Training.--The Secretary shall--
``(1) provide training to employees of the Centers for
Disease Control and Prevention in how to develop, issue,
disseminate, and use guidance documents of the Centers in
accordance with the regulation under subsection (a)(1); and
``(2) monitor the development, issuance, dissemination, and
use of such documents to ensure compliance with the regulation
under subsection (a)(1).
``(d) Public Participation in Process.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall ensure that public participation required by subsection
(a)(2)(B) occurs prior to finalization and implementation of
any guidance document of the Centers for Disease Control and
Prevention, including any guidance document that sets forth--
``(A) initial interpretations of a statute, a
regulation, or an emerging public health situation;
``(B) changes or updates in interpretation or
policy that are of more than a minor nature;
``(C) complex scientific issues; or
``(D) highly controversial issues.
``(2) Exceptions.--The Secretary may provide for public
participation required by subsection (a)(2)(B) with respect to
a guidance document of the Centers for Disease Control and
Prevention to occur after the guidance document has been
finalized and after implementation of the guidance document has
begun if--
``(A) the Secretary determines that commencing
public participation sooner is not feasible or
appropriate; or
``(B) the guidance document sets forth only
existing practices or minor changes in policy.
``(3) Consideration.--In finalizing, implementing, and
revising a guidance document of the Centers for Disease Control
and Prevention, the Secretary shall take into account public
comments received during public participation on the guidance
document.
``(e) Uniform Nomenclature.-- In developing guidance documents of
the Centers for Disease Control and Prevention, the Secretary shall
ensure uniform nomenclature for such documents and uniform internal
procedures for approval of such documents.
``(f) Indication of Nonbinding Nature.--The Secretary shall ensure
that guidance documents of the Centers for Disease Control and
Prevention and revisions of such documents are properly dated and
indicate the nonbinding nature of the documents.
``(g) Periodic Review.--The Secretary shall periodically review all
guidance documents of the Centers for Disease Control and Prevention
and, where appropriate, revise such documents.
``(h) List of Documents.--The Secretary shall maintain
electronically, and update and publish periodically in the Federal
Register, a list of all guidance documents of the Centers for Disease
Control and Prevention.
``(i) Public Availability.--The Secretary shall make available to
the public the list under subsection (h) and all guidance documents of
the Centers for Disease Control and Prevention, including by posting on
the public website of the Centers.
``(j) Appeals Mechanism.--The Secretary shall ensure that an
effective appeals mechanism is in place to address complaints that
guidance documents of the Centers for Disease Control and Prevention
are not being developed, issued, disseminated, or used in accordance
with this section.''.
Union Calendar No. 627
118th CONGRESS
2d Session
H. R. 4529
[Report No. 118-756]
_______________________________________________________________________
A BILL
To amend the Public Health Service Act regarding guidance documents of
the Centers for Disease Control and Prevention, and for other purposes.
_______________________________________________________________________
November 19, 2024
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed