H.R. 4529 — what changed

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:

“317W. CDC guidance documents

“(a) Good guidance practices

changed “(1) In general—The Secretary Secretary, acting through the Director of the Centers for Disease Control and Prevention (in this section referred to as the “Secretary”) “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.documents of the Centers for Disease Control and Prevention.

“(2) Contents—The regulation required by paragraph (1) shall—

changed “(A) incorporate each requirement of subsections (b) through (k); (j); and

changed “(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.

changed “(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 Training—The Secretary shall ensure that employees and contractors of the Centers do not deviate from such guidance documents without appropriate justification and supervisory concurrence.shall—

changed “(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 of the Centers in accordance with the regulation under subsection (a)(1); and

removed “(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).

added “(d) Public participation in process

changed “(e) Public “(1) In general—Subject to paragraph (2), the Secretary shall ensure that public participation in processrequired 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—

removed “(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.

added “(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—

removed “(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.

added “(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.

changed “(3) Consideration—In finalizing, implementing, and revising a “(e) Uniform nomenclature—In developing guidance document, documents of the Centers for Disease Control and Prevention, the Secretary shall take into account public comments received during public participation on the guidance document.ensure uniform nomenclature for such documents and uniform internal procedures for approval of such documents.

changed “(f) Uniform nomenclature—In developing Indication of nonbinding nature—The Secretary shall ensure that guidance documents of the Centers for Disease Control and Prevention, the Secretary shall ensure uniform nomenclature for Prevention and revisions of such documents are properly dated and uniform internal procedures for approval indicate the nonbinding nature of such the documents.

changed “(g) Indication of nonbinding nature—The Periodic review—The Secretary shall ensure that periodically review all guidance documents of the Centers for Disease Control and Prevention and revisions of and, where appropriate, revise such documents are properly dated and indicate the nonbinding nature of the documents.

changed “(h) Periodic review—The List of documents—The Secretary shall maintain electronically, and update and publish periodically review in the Federal Register, a list of all guidance documents of the Centers for Disease Control and Prevention and, where appropriate, revise such documents.Prevention.

changed “(i) List of documents—The Public availability—The Secretary shall maintain electronically and update and publish periodically in make available to the Federal Register a public the list of under subsection (h) and all guidance documents of the Centers for Disease Control and Prevention.Prevention, including by posting on the public website of the Centers.

changed “(j) Public availability—The Appeals mechanism—The Secretary shall make available ensure that an effective appeals mechanism is in place to the public the list under subsection (i) and all address complaints that guidance documents of the Centers for Disease Control and Prevention, including by posting on the public website of the Centers.Prevention are not being developed, issued, disseminated, or used in accordance with this section.”

removed “(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.”