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[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) Quorum.--Two-thirds of the voting members of the
Advisory Committee shall constitute a quorum for purposes of
meetings of the Advisory Committee.
``(5) Voting if less than quorum present.--If fewer than a
quorum of members of the Advisory Committee are eligible to
vote due to absence or a financial or other conflict of
interest at any meeting of the Advisory Committee, the
Designated Federal Officer, or their designee, shall have the
authority to temporarily designate the ex-officio members under
paragraph (3) as voting members.
``(6) Non-voting liaison representatives.--Meetings of the
Advisory Committee may be attended by non-voting liaison
representatives who shall be deemed representatives from a
stakeholder organization.
``(7) Terms.--
``(A) In general.--Except as specified in
subparagraph (B), individuals appointed under paragraph
(1) shall be invited to serve as members of the
Advisory Committee for overlapping terms of 4 years,
except that any member appointed to fill a vacancy for
an unexpired term shall be appointed for the remainder
of that term. A member of the Advisory Committee may
continue to serve on the Advisory Committee for a
period not to exceed 180 days after the expiration of
that member's term if a successor has not taken office.
``(B) Chairperson.--The term of the Chairperson of
the Advisory Committee shall be 7 years.
``(h) Subcommittees.--
``(1) In general.--The Advisory Committee may, subject to
approval by the Secretary (or the Secretary's designee),
establish subcommittees composed, in part, of members of the
Advisory Committee and other subject matter experts.
``(2) Reporting.--The subcommittees shall report back to
the parent committee and may not provide advice or work
products directly to the Department of Health and Human
Services.
``(3) Department committee management officer.--The
Secretary shall--
``(A) notify the Committee Management Officer of
the Department of Health and Human Services upon
establishment of each subcommittee; and
``(B) provide to such Officer information on the
name, membership, function, and estimated frequency of
meetings of such subcommittee.
``(i) Recordkeeping.--The records of the Advisory Committee,
established subcommittees, or other subgroups of the committee, shall
be managed in accordance with General Records Schedule 6.2, Federal
Advisory Committee Records, or other approved agency records
disposition schedule. Such records shall be available for public
inspection and copying, subject to section 552 of title 5, United
States Code.
``(j) Definitions.--In this section:
``(1) Stakeholder organization.--The term `stakeholder
organization' means--
``(A) the American Academy of Family Physicians;
``(B) the American Academy of Pediatrics;
``(C) the American Academy of Physician Associates;
``(D) the American College Health Association;
``(E) the American College of Nurse Midwives;
``(F) the American College of Obstetricians and
Gynecologists;
``(G) the American College of Physicians;
``(H) the American Geriatrics Society;
``(I) the America's Health Insurance Plans;
``(J) the American Immunization Registry
Association;
``(K) the American Medical Association;
``(L) the American Nurses Association;
``(M) the American Osteopathic Association;
``(N) the American Pharmacists Association;
``(O) the Association of Immunization Managers;
``(P) the Association for Prevention Teaching and
Research;
``(Q) the Association of State and Territorial
Health Officials;
``(R) the Biotechnology Innovation Organization;
``(S) the Council of State and Territorial
Epidemiologists;
``(T) the Canadian National Advisory Committee on
Immunization;
``(U) the Infectious Diseases Society of America;
``(V) the International Society of Travel Medicine;
``(W) the National Association of County and City
Health Officials;
``(X) the National Association of Pediatric Nurse
Practitioners;
``(Y) the National Foundation for Infectious
Diseases;
``(Z) the National Medical Association;
``(AA) the Pediatric Infectious Diseases Society;
``(BB) the Pharmaceutical Research and
Manufacturers of America;
``(CC) the Society for Adolescent Health and
Medicine;
``(DD) the American Public Health Association;
``(EE) the Society for Healthcare Epidemiology of
America; and
``(FF) such other non-voting liaison as the
Secretary determines necessary to effectively carry out
the functions of the Advisory Committee.
``(2) Vaccine.--The term `vaccine' means any substance (and
any related agent) that is licensed under section 351 for the
prevention of 1 or more diseases. Such term includes related
agents that are administered prophylactically for active or
passive antigen-specific immunity.
``(k) Funding.--There are authorized to be appropriated to carry
out this section, including operating costs, compensation and travel
expenses for members, and staff support of the Advisory Committee,
$2,800,000 for each of fiscal years 2026 through 2029.''.
(b) Rule of Construction.--Except as expressly provided in the
amendment made by subsection (a), nothing in such amendment shall be
construed as limiting the authority of the Advisory Committee on
Immunization Practices, or the duties of such Advisory Committee, that
were in effect as of the day before the date of the enactment of this
Act, including with respect to subsections (c)(2)(B)(i) and (e) of
section 1928 of the Social Security Act (42 U.S.C. 1396s) and section
2713(a)(2) of the Public Health Service Act (42 U.S.C. 300gg-13(a)(2))
(as such sections were in effect on the day before the date of the
enactment of this Act).
SEC. 3. NATIONAL VACCINE INJURY COMPENSATION PROGRAM.
Subsection (c) of section 2114 of the Public Health Service Act (42
U.S.C. 300aa-14) is amended by adding at the end the following:
``(5) Any removal of a vaccine from the Vaccine Injury
Table, or any other modification under paragraph (1), including
any additions to the list of injuries, disabilities, illnesses,
conditions, and deaths for which compensation may be provided,
shall be supported by the preponderance of the best available
scientific evidence regarding the safety or efficacy of the
vaccine. Nothing in the preceding sentence shall be construed
to limit the authority of the Secretary to amend the Vaccine
Injury Table to include new vaccines pursuant to subsection
(e).''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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