[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4529 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 4529

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

_______________________________________________________________________

                                 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.
            ``(2) Contents.--The regulation required by paragraph (1) 
        shall--
                    ``(A) incorporate each requirement of subsections 
                (b) through (k); and
                    ``(B) require guidance documents 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) Effect on CDC Employees and Contractors.--Although guidance 
documents of the Centers for Disease Control and Prevention shall not 
be binding on the Secretary or the Director of the Centers, the 
Secretary shall ensure that employees and contractors of the Centers do 
not deviate from such guidance documents without appropriate 
justification and supervisory concurrence.
    ``(d) 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 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).
    ``(e) 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, 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) 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, the Secretary shall take into 
        account public comments received during public participation on 
        the guidance document.
    ``(f) 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.
    ``(g) 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.
    ``(h) Periodic Review.--The Secretary shall periodically review all 
guidance documents of the Centers for Disease Control and Prevention 
and, where appropriate, revise such documents.
    ``(i) 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.
    ``(j) Public Availability.--The Secretary shall make available to 
the public the list under subsection (i) and all guidance documents of 
the Centers for Disease Control and Prevention, including by posting on 
the public website of the Centers.
    ``(k) 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.''.
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