119-hr3701

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3701 Introduced in House

    (IH) ]

<DOC>

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 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. 2l7a) 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 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, 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 than three 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 only recommend as a member of the Advisory 
 Committee 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 also consist of 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 also 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 Department Committee Management 
 Officer 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) .''.
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