ACIP Charter

For Everyone

Key points

The Advisory Committee on Immunization Practices (ACIP) comprises medical and public health experts who develop recommendations on the use of vaccines in the civilian population of the United States. It operates under a charter that includes ACIP's authority and objective. It lays out the procedures that ACIP follows.

Authority, Objective, and Description

Printer friendly version of ACIP Charter [6 pages]

Authority

ACIP was established under Section 222 of the Public Health Service Act (42 U.S.C. §2l7a), as amended. The Committee is governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463 (5 U.S.C. § 1001 et seq.), as amended.

ACIP has been given statutory roles under subsections 1928(c)(2)(B)(i) and 1928(e) of the Social Security Act (42 U.S.C. § 1396s(c)(2)(B)(i) and 1396s(e)) and subsection 2713(a)(2) of the Public Health Service Act (42 U.S.C. § 300gg-13(a)(2)).

Objective and Scope of Activities

The Secretary, Department of Health and Human Services (HHS), and by delegation the Director, Centers for Disease Control and Prevention (CDC), are authorized under Section 311 and Section 317 of the Public Health Service Act, [42 U.S.C. §243 and 42 U.S.C. §247b], as amended, to assist states and their political subdivisions in the prevention and control of communicable diseases and to support related public health activities.

The Advisory Committee on Immunization Practices (ACIP) provides advice and recommendations to the CDC Director on the use of vaccines and immunization program strategies to inform clinical practice and public health action. The Committee convenes scientific and medical experts to evaluate the best available evidence regarding vaccine safety, efficacy, effectiveness, and implementation.

ACIP shall provide advice and guidance regarding the use of vaccines and related immunobiologic agents for the control of vaccine-preventable diseases in the United States, including identifying areas where additional data or evaluation would inform future recommendations regarding such vaccines and immunizations. Recommendations made by ACIP are reviewed by the CDC Director and, if adopted, become official CDC and HHS recommendations and may be published in the Morbidity and Mortality Weekly Report (MMWR).

Description of Duties

The Committee shall provide advice and recommendations to the CDC Director regarding the use of vaccines and related immunobiologic agents for the prevention and control of vaccine-preventable diseases in the civilian population of the United States.

  1. Vaccine Use Recommendations
    Review available scientific evidence and provide recommendations on the use of vaccines licensed or authorized for use in the United States, including:
    • Indications for use in specific populations and settings;
    • Dosing schedules, intervals, and routes of administration;
    • Contraindications and precautions; and
    • Use of related immunobiologic agents, such as immune globulin preparations, where appropriate.
    The Committee may provide guidance on the use of unlicensed vaccines or investigational products only when specifically requested by the CDC Director and consistent with applicable federal laws and regulations.
    Upon the licensure or authorization of any vaccine or any new indication for a vaccine, the Committee shall, as appropriate, consider the use of the vaccine at its next regularly scheduled meeting. If the Committee does not make a recommendation at the Committee’s first regularly scheduled meeting, the Committee shall provide an update on the status of such review.
  2. Immunization Schedules
    Develop and recommend updates to CDC immunization schedules for children, adolescents, and adults, taking into account:
    • Epidemiology and burden of disease;
    • Vaccine safety, efficacy, and effectiveness;
    • Changes in disease patterns; and
    • Feasibility of implementation in clinical and public health settings.
  3. Evidence Review and Recommendation Framework
    Evaluate scientific and medical evidence relevant to immunization policy, including:
    • Clinical trial data and post-licensure studies;
    • Vaccine safety and effectiveness data;
    • Quality and strength of available evidence;
    • Economic analyses, where appropriate; and
    • Implementation considerations.
    In evaluating evidence and formulating recommendations, the Committee may consider the availability and effectiveness of other preventive measures, including non-vaccine interventions, where relevant to assessing the appropriate use of vaccines.
    The Committee may identify gaps or limitations in the available evidence that are relevant to its recommendations and may provide advice regarding priority areas where additional data, analysis, or evaluation would inform future immunization policy.
    In carrying out its review, the Committee may consider immunization recommendations, schedules, and practices from other countries and international public health bodies, as appropriate, for contextual and comparative purposes, while maintaining a primary focus on the public health needs of the United States.
    All such considerations shall be undertaken solely to inform recommendations regarding the appropriate use of vaccines and shall not extend the Committee’s role beyond its advisory function.
    Recommendations shall be based on a transparent, evidence-based deliberative process and may be updated or withdrawn as new information becomes available.
  4. Vaccine Safety and Related Considerations
    Review information on vaccine safety and known adverse events and provide advice on:
    • Contraindications and precautions;
    • Considerations for safe administration; and
    • Areas where additional data, evaluation, or analysis may be warranted to better understand vaccine safety and inform recommendations.
    In carrying out this function, the Committee may identify gaps or uncertainties in available safety evidence and may provide advice regarding areas where further evaluation would support informed decision-making.
    The Committee’s role is advisory and does not include regulatory oversight or management of
    federal safety surveillance systems.
  5. Public Health Strategies
    Provide advice on strategies to optimize the use of vaccines in the United States, including:
    • Approaches to improve vaccination coverage;
    • Considerations for populations at increased risk; and
    • Factors affecting access to immunization services.
    In providing such advice, the Committee may consider how vaccination integrates with other preventive measures to reduce disease burden and improve population health outcomes. Such consideration shall not include the development of independent recommendations regarding non-vaccine or immunization interventions.
  6. Special Populations and Circumstances
    Provide recommendations, as appropriate, for:
    • Populations with specific clinical considerations;
    • Use of vaccines during outbreaks or public health emergencies; and
    • Situations requiring modification of routine immunization recommendations.
  7. Vaccines for Children (VFC) Program Responsibilities
    In accordance with Section 1928 of the Social Security Act, establish and periodically review, and as appropriate revise:
    • The list of vaccines for administration to eligible children and adolescents;
    • Recommended dosing schedules and intervals; and
    • Contraindications to administration.
    In carrying out these responsibilities, the Committee shall consider available scientific evidence and may identify areas where additional data would inform future updates.
  8. Deliberative Process and Transparency
    ACIP shall employ a transparent, evidence-based decision-making process. The Committee shall review scientific data, receive input from subject matter experts, and consider public input as appropriate.
    Committee deliberations shall include consideration of disease epidemiology and burden, vaccine safety, efficacy, and effectiveness, quality of evidence, economic analyses, and implementation considerations. Such deliberations may include consideration of relevant international practices where informative.
    In the course of its deliberations, the Committee may identify limitations or gaps in the available evidence and may note areas where additional data or evaluation would support future recommendations.
    Recommendations are advisory to the CDC Director and become official policy only upon adoption.

Agency, Support, Cost, and Federal Officer

Agency or Federal Officer Receiving the Advisory Committee’s Advice/Recommendations

The Committee reports to the CDC Director. The CDC Director informs the HHS Secretary and the Assistant Secretary for Health, HHS, of Committee recommendations.

Support

Management and support services shall be provided by the CDC Office of the Chief of Staff and other CDC Components as instructed by the CDC Director.

Estimated Annual Operating Costs and Staff Years

Estimated annual costs for operating the Committee, including (i) Federal personnel (3) and other Federal internal costs are $1,080,340; (ii) compensation and travel expense payments for up to 19 members is $42,750; and (iii) reimbursable costs are $83,106.

Meetings, Duration, and Termination

Estimated Number and Frequency of Meetings

Meetings will be held at the discretion of the ACIP Designated Federal Officer in consultation with the Chair and will be open to the public except as determined otherwise by the CDC Director or other official, to whom the authority has been delegated, in accordance with the Government in the Sunshine Act (5 U.S.C. § 552b(c)) and Section 10(d) of the FACA (5 U.S.C. § 1009(d)).

Notice of all meetings shall be given to the public.

Duration

The duration of the ACIP is continuing, subject to the Termination section below.

Termination

Unless renewed by appropriate action, ACIP will terminate 2 years from the date this charter is filed.

Membership, Subcommittees, and Recordkeeping

Membership and Designation

The Committee consists of up to 19 voting members appointed by the Secretary of Health and Human Services, who are Special Government Employees, including the Chair and Vice Chair. Members shall collectively represent a balanced range of scientific, clinical, and public health expertise relevant to the Committee’s mission. The Committee shall include person(s) knowledgeable about consumer perspectives and/or social and community aspects of immunization programs.

The Committee also shall consist of non-voting ex officio members from the Health Resources and Services Administration, the U.S. Food and Drug Administration, Centers for Medicare and Medicaid Services, National Institutes of Health, Indian Health Service, and the National Vaccine Program at HHS, or their designees.

Ex officio members shall participate fully in Committee discussions relevant to the agency which they are representing. If fewer than a quorum of ACIP members are eligible to vote due to absence or a financial or other conflict of interest, the DFO, or designee, shall have the authority to temporarily designate the ex-officio members as voting members for the limited purpose of establishing a quorum and voting on matters before the Committee during that meeting, provided that they do not constitute a majority of voting members present and such participation is consistent with applicable law and Departmental policy.

There also shall be 33 non-voting liaison representatives from the American Academy of Family Physicians; American Academy of Pediatrics; American Academy of Physician Associates; American College Health Association; American College of Nurse Midwives; American College of Physicians; American Geriatrics Society; America’s Health Insurance Plans; American Immunization Registry Association; American Medical Association; American Nurses Association; American Osteopathic Association; American Pharmacists Association; Association of Immunization Managers; Association of American Physicians and Surgeons; Association for Prevention Teaching and Research; Association of State and Territorial Health Officials; Biotechnology Innovation Organization; Council of State and Territorial Epidemiologists; Canadian National Advisory Committee on Immunization; Infectious Diseases Society of America; Independent Medical Alliance; International Society of Travel Medicine; Medical Academy of Pediatrics and Special Needs; National Association of County and City Health Officials; National Association of Pediatric Nurse Practitioners; National Foundation for Infectious Diseases; National Medical Association; Pediatric Infectious Diseases Society; Pharmaceutical Research and Manufacturers of America; Physicians for Informed Consent; Society for Adolescent Health and Medicine; and Society for Healthcare Epidemiology of America. Liaisons shall be deemed representatives.

Members, including the Chair and Vice Chair, shall be selected by the HHS Secretary and shall be invited to serve for overlapping terms of up to four 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 may serve up to 180 days after the expiration of that member’s term if a successor has not taken office.

Subcommittees

Subcommittees composed of members of the parent committee and other subject matter experts may be established with the approval of the HHS Secretary. The subcommittees must report back to the parent committee and do not provide advice or work products directly to the agency. The Department Committee Management Officer will be notified upon establishment of each subcommittee and will be provided information on its name, membership, function, and estimated frequency of meetings.

Print
Content Source:
National Center for Immunization and Respiratory Diseases (NCIRD)