I 
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 Pre-
vention, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Public Health Guid-
ance 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: 
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‘‘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, es-
tablish, and maintain good guidance practices set-
ting 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 sub-
sections (b) through (k); and 
‘‘(B) require guidance documents to be de-
veloped 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 
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Transparency and Accountability Act of 2023, 
finalize such regulation. 
‘‘(b) NO CREATION, CONFERRING, RESTRICTING, OR 
REVOKING OF RIGHTS, RESPONSIBILITIES, OR LIABIL-
ITIES.—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 crimi-
nal 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 re-
frain from an action. 
‘‘(c) EFFECT ON CDC EMPLOYEES AND CONTRAC-
TORS.—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 ap-
propriate justification and supervisory concurrence. 
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‘‘(d) TRAINING.—The Secretary shall— 
‘‘(1) provide training to employees of the Cen-
ters for Disease Control and Prevention in how to 
develop, issue, disseminate, and use guidance docu-
ments in accordance with the regulation under sub-
section (a)(1); and 
‘‘(2) monitor the development, issuance, dis-
semination, 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 fi-
nalization and implementation of any guidance docu-
ment, including any guidance document that sets 
forth— 
‘‘(A) initial interpretations of a statute, a 
regulation, or an emerging public health situa-
tion; 
‘‘(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. 
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‘‘(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 guid-
ance document has begun if— 
‘‘(A) the Secretary determines that com-
mencing public participation sooner is not fea-
sible or appropriate; or 
‘‘(B) the guidance document sets forth 
only existing practices or minor changes in pol-
icy. 
‘‘(3) CONSIDERATION.—In finalizing, imple-
menting, and revising a guidance document, the Sec-
retary shall take into account public comments re-
ceived 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 no-
menclature for such documents and uniform internal pro-
cedures 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 
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of such documents are properly dated and indicate the 
nonbinding nature of the documents. 
‘‘(h) PERIODIC REVIEW.—The Secretary shall peri-
odically 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 periodi-
cally in the Federal Register a list of all guidance docu-
ments 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 en-
sure that an effective appeals mechanism is in place to 
address complaints that guidance documents of the Cen-
ters for Disease Control and Prevention are not being de-
veloped, issued, disseminated, or used in accordance with 
this section.’’. 
Æ 
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