I 
119TH CONGRESS 
1ST SESSION H. R. 3701 
To amend the Public Health Service Act to codify the Advisory Committee 
on Immunization Practices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 4, 2025 
Mr. PALLONE (for himself and Ms. SCHRIER) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to codify the Advi-
sory Committee on Immunization Practices, 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 ‘‘Family Vaccine Protec-
tion Act’’. 
SEC. 2. CODIFICATION OF ADVISORY COMMITTEE ON IM-
MUNIZATION PRACTICES. 
(a) IN GENERAL.—Title II of the Public Health Serv-
ice Act (42 U.S.C. 202 et seq.) is amended by inserting 
after section 222 (42 U.S.C. 2l7a) the following: 
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‘‘SEC. 222A. ADVISORY COMMITTEE ON IMMUNIZATION 
PRACTICES. 
‘‘(a) IN GENERAL.—The Advisory Committee on Im-
munization 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 avail-
able, peer-reviewed scientific evidence, provide advice 
and guidance, and make recommendations, to the 
Director regarding the use of vaccines and related 
agents licensed under section 351 for effective con-
trol of vaccine-preventable diseases in the civilian 
population of the United States. 
‘‘(2) PROCEDURE FOR PUBLICATION.— 
‘‘(A) IN GENERAL.—The Director shall re-
view any recommendations received under para-
graph (1). The Director shall adopt any such 
recommendation unless the Director determines 
such recommendation is not supported by a pre-
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ponderance 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 Direc-
tor, upon such adoption; and 
‘‘(ii) the Director shall— 
‘‘(I) publish such recommenda-
tion on the public website of the De-
partment of Health and Human Serv-
ices; 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 expla-
nation on why the Director found that the 
recommendation does not support the find-
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ings of a preponderance of the best avail-
able, peer-reviewed scientific evidence; and 
‘‘(ii) not later than 48 hours after 
such determination, submit a notification 
to the Committee on Energy and Com-
merce of the House of Representatives and 
the Committee on Health, Education, 
Labor, and Pensions of the Senate con-
taining the information described in clause 
(i). 
‘‘(3) CONSIDERATION
OF
NEW
VACCINES.— 
Upon the licensure of any vaccine or any new indica-
tion 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 rec-
ommendation 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, 
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Labor, and Pensions of the Senate an update 
on the status of the Advisory Committee’s con-
sideration of the use of the vaccine. 
‘‘(4) CONSIDERATION
FOR
BREAKTHROUGH 
THERAPIES AND FOR POTENTIAL USE DURING PUB-
LIC 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 sec-
tion 351 of this Act; or 
‘‘(B) are intended to address a public 
health emergency as determined by the Sec-
retary under section 319. 
‘‘(5) LIMITATION.—If the Secretary or the Di-
rector takes an action regarding the use of vaccines 
and related agents licensed under section 351 for ef-
fective 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 
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Advisory Committee, the Secretary or the Director 
(as applicable) shall— 
‘‘(A) publish the basis for the action, in-
cluding an explanation on why the Secretary or 
the Director (as applicable) found that the ac-
tion supports the findings of a preponderance of 
the best available, peer-reviewed scientific evi-
dence; 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 Com-
mittee shall do the following: 
‘‘(i) Provide advice and guidance, and 
make recommendations, to the Director as 
specified in subsection (c)(1). 
‘‘(ii) 
Make 
immunization 
rec-
ommendations for purposes of the require-
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ment under section 2713 for group health 
plans and health insurance issuers offering 
group or individual health insurance cov-
erage to provide coverage for immuniza-
tions 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 es-
tablished by the Advisory Committee for the 
purpose of the purchase, delivery, and adminis-
tration of pediatric vaccines in the Vaccines for 
Children Program under section 1928 of the 
Social Security Act. 
‘‘(2) ADVICE
AND
GUIDANCE
CONTENT.—Ad-
vice and guidance provided under paragraph (1)— 
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‘‘(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 prod-
ucts for prevention of infectious diseases; 
and 
‘‘(iii) special situations or populations 
that may warrant modification of the rou-
tine 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 
cir-
cumstances in which a vaccine or related 
agent is recommended; 
‘‘(ii) 
contraindications 
and 
pre-
cautions for use of the vaccine and related 
agents; and 
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‘‘(iii) information on recognized ad-
verse events associated with the use of 
such vaccine. 
‘‘(3) EMERGENCY USE AUTHORIZATION.—Guid-
ance for use of vaccines and related agents author-
ized for emergency use under section 564 of the 
Federal Food, Drug, and Cosmetic Act may be de-
veloped 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 RECOMMENDA-
TION.—The Advisory Committee, when making new 
recommendations under subsection (c)(1), or revi-
sions or withdrawals of such recommendations under 
paragraph (5), shall review evidence in the following 
categories: 
‘‘(A) Identification of the specific interven-
tion, including dosage and schedule. 
‘‘(B) The strength of the design of the 
study used to provide the evidence considered. 
‘‘(C) Randomized controlled trials or over-
whelming evidence from observational studies. 
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‘‘(D) Comparison and outcome of the tar-
get population for the vaccine, including stand-
ard of care, existing vaccines, and other preven-
tion options. 
‘‘(E) Prevention outcome or scientifically 
verified adverse effects associated with vaccina-
tion. 
‘‘(5) REVISION
OR
WITHDRAWAL
OF
REC-
OMMENDATION.—The Advisory Committee may re-
vise or withdraw any recommendation regarding a 
particular vaccine under this subsection if and when 
new information on disease epidemiology, vaccine ef-
fectiveness 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 rec-
ommendations made by the Advisory Committee. 
‘‘(2) AGENCY SUPPORT.—For purposes of sup-
porting the Advisory Committee in carrying out this 
section— 
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‘‘(A) the Office of the Director, National 
Center for Immunization and Respiratory Dis-
eases of the Centers for Disease Control and 
Prevention shall provide management and sup-
port services; and 
‘‘(B) the Advisory Committee may enter 
into an agreement with the National Academies 
of Sciences, Engineering, and Medicine to pro-
vide external support. 
‘‘(3) DESIGNATED FEDERAL OFFICER.— 
‘‘(A) SELECTION.—The Director shall se-
lect 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 Advi-
sory 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 di-
rectives; and 
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‘‘(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 in-
terest, 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 as-
signed 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 than three times per calendar 
year; and 
‘‘(B) upon the licensure of any vaccine, or 
any new indication for a vaccine, under section 
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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 ex-
cept as determined otherwise by the Director, or 
other official, to whom the authority has been dele-
gated, 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 ap-
pointed from among individuals recommended by the 
Comptroller General of the United States. Such 
members shall serve as Special Government Employ-
ees. 
‘‘(2) REQUIRED EXPERTISE.—The Comptroller 
General of the United States may only recommend 
as a member of the Advisory Committee an indi-
vidual 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. 
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‘‘(B) Expertise relating to epidemiology 
and vaccine-preventable disease burden. 
‘‘(C) Expert experience to rigorously evalu-
ate the best available scientific evidence with 
immunization 
recommendations 
and 
public 
health. 
‘‘(D) Expertise in immunology as evi-
denced by publications on the topic of immu-
nology 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, par-
ticularly 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 perspec-
tives or the social and community aspects of im-
munization programs, or both. 
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‘‘(3) EX-OFFICIO MEMBERS.—In addition to the 
individuals appointed under paragraph (1), the 
membership of the Advisory Committee shall also 
consist of the following 6 non-voting ex-officio mem-
bers (or their designees): 
‘‘(A) The Administrator of the Health Re-
sources 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 Insti-
tutes 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 mem-
bers 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 
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any meeting of the Advisory Committee, the Des-
ignated 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
REPRESENTA-
TIVES.—Meetings of the Advisory Committee may 
also be attended by non-voting liaison representa-
tives 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 mem-
bers of the Advisory Committee for overlapping 
terms of 4 years, except that any member ap-
pointed 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 Com-
mittee for a period not to exceed 180 days after 
the expiration of that member’s term if a suc-
cessor has not taken office. 
‘‘(B) CHAIRPERSON.—The term of the 
Chairperson of the Advisory Committee shall be 
7 years. 
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‘‘(h) SUBCOMMITTEES.— 
‘‘(1) IN
GENERAL.—The Advisory Committee 
may, subject to approval by the Secretary (or the 
Secretary’s designee), establish subcommittees com-
posed, in part, of members of the Advisory Com-
mittee and other subject matter experts. 
‘‘(2) REPORTING.—The subcommittees shall re-
port back to the parent committee and may not pro-
vide advice or work products directly to the Depart-
ment of Health and Human Services. 
‘‘(3) DEPARTMENT COMMITTEE MANAGEMENT 
OFFICER.—The Secretary shall— 
‘‘(A) notify the Department Committee 
Management Officer upon establishment of each 
subcommittee; and 
‘‘(B) provide to such Officer information 
on the name, membership, function, and esti-
mated frequency of meetings of such sub-
committee. 
‘‘(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 Com-
mittee Records, or other approved agency records disposi-
tion schedule. Such records shall be available for public 
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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 Associa-
tion; 
‘‘(E) the American College of Nurse Mid-
wives; 
‘‘(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; 
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‘‘(Y) the National Foundation for Infec-
tious 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 Asso-
ciation; 
‘‘(EE) the Society for Healthcare Epidemi-
ology of America; and 
‘‘(FF) such other non-voting liaison as the 
Secretary determines necessary to effectively 
carry out the functions of the Advisory Com-
mittee. 
‘‘(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 appro-
priated to carry out this section, including operating costs, 
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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), noth-
ing 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 enact-
ment 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 Pub-
lic 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 PRO-
GRAM. 
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 para-
graph (1), including any additions to the list of inju-
ries, disabilities, illnesses, conditions, and deaths for 
which compensation may be provided, shall be sup-
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ported 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).’’. 
Æ 
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