[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3323 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3323
To amend the Public Health Service Act to codify the Advisory Committee
on Immunization Practices, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 3, 2025
Mr. Hickenlooper (for himself, Mr. Markey, Ms. Blunt Rochester, Mr.
Blumenthal, Ms. Alsobrooks, Mr. Kim, Mr. Schiff, Mr. Heinrich, and Mr.
Van Hollen) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to codify the Advisory Committee
on Immunization Practices, 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 ``Family Vaccine Protection Act''.
SEC. 2. CODIFICATION OF ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES.
(a) In General.--Title II of the Public Health Service Act (42
U.S.C. 202 et seq.) is amended by inserting after section 222 (42
U.S.C. 217a) the following:
``SEC. 222A. ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES.
``(a) In General.--The Advisory Committee on Immunization Practices
established pursuant to section 222 (referred to in this section as the
`Advisory Committee') shall carry out the duties specified in this
section.
``(b) Application of Chapter 10 of Title 5, United States Code.--
The provisions of chapter 10 of title 5, United States Code (other than
section 1013), shall apply with respect to the Advisory Committee.
``(c) Advice, Guidance, and Recommendations From Advisory
Committee.--
``(1) In general.--The Advisory Committee shall, based on a
preponderance of the best available, peer-reviewed scientific
evidence, provide advice and guidance, and make
recommendations, to the Director of the Centers for Disease
Control and Prevention (referred to in this section as the
`Director') regarding the use of vaccines and related agents
licensed under section 351 for effective control of vaccine-
preventable diseases in the civilian population of the United
States.
``(2) Procedure for publication.--
``(A) In general.--The Director shall review any
recommendations received under paragraph (1). The
Director shall adopt any such recommendation unless the
Director determines such recommendation is not
supported by a preponderance of the best available,
peer-reviewed scientific evidence and publishes the
results of that review.
``(B) Adopted.--If the Director adopts such a
recommendation--
``(i) such recommendation shall be
considered as an official recommendation of the
Secretary, acting through the Director, upon
such adoption; and
``(ii) the Director shall--
``(I) publish such recommendation
on the public website of the Department
of Health and Human Services; and
``(II) inform the Secretary and the
Assistant Secretary for Health, in
writing, of such recommendation.
``(C) Not adopted.--If the Director does not adopt
such a recommendation, the Director shall--
``(i) publish the basis for not adopting
such recommendation, including an explanation
on why the Director found that the
recommendation does not support the findings of
a preponderance of the best available, peer-
reviewed scientific evidence; and
``(ii) not later than 48 hours after such
determination, submit a notification to the
Committee on Energy and Commerce of the House
of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate
containing the information described in clause
(i).
``(3) Consideration of new vaccines.--Upon the licensure of
any vaccine or any new indication for a vaccine under section
351, the Advisory Committee shall--
``(A) consider the use of the vaccine not later
than its next regularly scheduled meeting;
``(B) not later than 90 days after receiving a
notification in writing from the holder of the license
of the vaccine or new indication for a vaccine under
section 351, make a recommendation with respect to the
use of such vaccine under paragraph (1); and
``(C) submit to the Committee on Energy and
Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of
the Senate an update on the status of the Advisory
Committee's consideration of the use of the vaccine.
``(4) Consideration for breakthrough therapies and for
potential use during public health emergency.--The Advisory
Committee shall make recommendations under paragraph (1) with
respect to the use of vaccines that--
``(A) are designated as a breakthrough therapy
under section 506 of the Federal Food, Drug, and
Cosmetic Act and licensed under section 351 of this
Act; or
``(B) are intended to address a public health
emergency as determined by the Secretary under section
319.
``(5) Limitation.--If the Secretary or the Director takes
an action regarding the use of vaccines and related agents
licensed under section 351 for effective control of vaccine-
preventable diseases in the civilian population of the United
States (including an action with respect to coverage under
section 2713 or the listing of vaccines for purposes of the
program under section 1928 of the Social Security Act) that is
contrary to a recommendation of the Advisory Committee, the
Secretary or the Director (as applicable) shall--
``(A) publish the basis for the action, including
an explanation on why the Secretary or the Director (as
applicable) found that the action supports the findings
of a preponderance of the best available, peer-reviewed
scientific evidence; and
``(B) not later than 48 hours after taking such
action, the Secretary or the Director (as applicable)
shall submit a notification to the Committee on Energy
and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of
the Senate containing the information described in
subparagraph (A).
``(d) Duties.--
``(1) In general.--
``(A) In general.--The Advisory Committee shall do
the following:
``(i) Provide advice and guidance, and make
recommendations, to the Director as specified
in subsection (c)(1).
``(ii) Make immunization recommendations
for purposes of the requirement under section
2713 for group health plans and health
insurance issuers offering group or individual
health insurance coverage to provide coverage
for immunizations that have in effect a
recommendation from the Advisory Committee.
``(iii) In accordance with section 1928 of
the Social Security Act and this section,
establish and periodically review and, as
appropriate, revise the list of vaccines for
administration to children and adolescents
eligible to receive vaccines through the
Vaccines for Children Program, along with
schedules regarding the appropriate dose and
dosing interval, and contraindications to
administration of the pediatric vaccines.
``(B) Use of list.--The Secretary, and as
delegated, the Director, shall use the list established
by the Advisory Committee for the purpose of the
purchase, delivery, and administration of pediatric
vaccines in the Vaccines for Children Program under
section 1928 of the Social Security Act.
``(2) Advice and guidance content.--Advice and guidance
provided under paragraph (1)--
``(A) shall address--
``(i) the general use of vaccines and
immune globulin preparations as a class of
biologic agents;
``(ii) the use of specific antibody
products for prevention of infectious diseases;
and
``(iii) special situations or populations
that may warrant modification of the routine
recommendations for vaccine use;
``(B) may include recommendations for the
administration of immune globulin preparations or
antimicrobial therapy shown to be effective in
controlling a vaccine-preventable disease for which a
vaccine is available; and
``(C) with respect to each vaccine described in
such paragraph, shall include--
``(i) population groups or circumstances in
which a vaccine or related agent is
recommended;
``(ii) contraindications and precautions
for use of the vaccine and related agents; and
``(iii) information on recognized adverse
events associated with the use of such vaccine.
``(3) Emergency use authorization.--Guidance for use of
vaccines and related agents authorized for emergency use under
section 564 of the Federal Food, Drug, and Cosmetic Act may be
developed by the Advisory Committee if circumstances warrant,
including in the case of a public health emergency, as
determined by the Secretary under section 319.
``(4) Considerations for recommendation development or
withdrawal of recommendation.--The Advisory Committee, when
making new recommendations under subsection (c)(1), or
revisions or withdrawals of such recommendations under
paragraph (5), shall review evidence in the following
categories:
``(A) Identification of the specific intervention,
including dosage and schedule.
``(B) The strength of the design of the study used
to provide the evidence considered.
``(C) Randomized controlled trials or overwhelming
evidence from observational studies.
``(D) Comparison and outcome of the target
population for the vaccine, including standard of care,
existing vaccines, and other prevention options.
``(E) Prevention outcome or scientifically verified
adverse effects associated with vaccination.
``(5) Revision or withdrawal of recommendation.--The
Advisory Committee may revise or withdraw any recommendation
regarding a particular vaccine under this subsection if and
when new information on disease epidemiology, vaccine
effectiveness or safety, or other data become available, and as
supported by a preponderance of the best available, peer-
reviewed scientific evidence.
``(e) Administration.--
``(1) Reporting structure.--The Advisory Committee shall
report to the Director. The Director shall inform the
Secretary, the Assistant Secretary for Health, and the
Administrator of the Centers for Medicare & Medicaid Services
of immunization recommendations made by the Advisory Committee.
``(2) Agency support.--For purposes of supporting the
Advisory Committee in carrying out this section--
``(A) the Office of the Director of the National
Center for Immunization and Respiratory Diseases of the
Centers for Disease Control and Prevention shall
provide management and support services; and
``(B) the Advisory Committee may enter into an
agreement with the National Academies of Sciences,
Engineering, and Medicine to provide external support.
``(3) Designated federal officer.--
``(A) Selection.--The Director shall select a full-
time or permanent part-time Federal employee to serve
as the Designated Federal Officer.
``(B) Duties.--The Designated Federal Officer
selected under subparagraph (A) shall--
``(i) attend each meeting of the Advisory
Committee (and any subcommittee thereof) or
select a designee to attend such a meeting;
``(ii) ensure that all procedures of the
Advisory Committee for such a meeting are
within applicable statutory, regulatory, and
HHS General Administration Manual directives;
and
``(iii) approve and prepare all policies
and agendas for each such meeting, call any
such meeting, adjourn any meeting when the
Designated Federal Officer deems adjournment to
be in the public interest, and chair meetings
when directed to do so by the official to whom
the Advisory Committee reports.
``(C) Assignment.--In the event that the Designated
Federal Officer cannot fulfill the assigned duties of
the Advisory Committee, one or more full-time or
permanent part-time Federal employees shall be assigned
as the Designated Federal Officer and carry out such
duties on a temporary basis.
``(f) Meetings.--
``(1) Frequency.--Pursuant to the call of the Designated
Federal Officer, in consultation with the Chair of the Advisory
Committee, meetings shall be held--
``(A) not less frequently than 3 times per calendar
year; and
``(B) upon the licensure of any vaccine, or any new
indication for a vaccine, under section 351(a), not
later than 90 days after the date of the first
marketing of such vaccine.
``(2) Open to the public.--Meetings of the Advisory
Committee shall be open to the public except as determined
otherwise by the Director, or other official, to whom the
authority has been delegated, in accordance with sections
552b(c) and 1009 of title 5, United States Code. Notice of all
such meetings shall be given to the public.
``(g) Membership.--
``(1) In general.--The Secretary shall appoint at least 15
and not more than 19 individuals to serve as members (including
the chairperson) of the Advisory Committee. Such individuals
shall be appointed from among individuals recommended by the
Comptroller General of the United States. Such members shall
serve as Special Government Employees.
``(2) Required expertise.--The Comptroller General of the
United States may recommend as a member of the Advisory
Committee only an individual who has expertise or experience
with respect to one or more of the following:
``(A) A prevalence of peer-reviewed and best
available scientific research.
``(B) Expertise relating to epidemiology and
vaccine-preventable disease burden.
``(C) Expert experience to rigorously evaluate the
best available scientific evidence with immunization
recommendations and public health.
``(D) Expertise in immunology as evidenced by
publications on the topic of immunology in peer-
reviewed journals.
``(E) Expertise in the use of vaccines and other
immunobiologic agents in clinical practice or
preventive medicine.
``(F) Expertise in infectious diseases,
particularly human immune responses to vaccines,
assessment of vaccine efficacy or effectiveness, or
vaccine safety, as evidenced by publications on the
topic in peer-reviewed journals.
``(G) Expertise with clinical or laboratory vaccine
research.
``(H) Expertise in assessment of vaccine efficacy
and safety.
``(I) Knowledge about consumer perspectives or the
social and community aspects of immunization programs,
or both.
``(3) Ex-officio members.--In addition to the individuals
appointed under paragraph (1), the membership of the Advisory
Committee shall include the following 6 non-voting ex-officio
members (or their designees):
``(A) The Administrator of the Health Resources and
Services Administration.
``(B) The Commissioner of Food and Drugs.
``(C) The Administrator of the Centers for Medicare
& Medicaid Services.
``(D) The Director of the National Institutes of
Health.
``(E) The Director of the Indian Health Service.
``(F) The Director of the National Vaccine Program
Office.
``(4) Quor