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ACIP
ACIP Charter
Advisory Committee on Immunization
Practices
Purpose
The
Secretary, the 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,
as amended, 42 U.S.C. 243 and 42 U.S.C. 247b,
to assist states and their political subdivisions
in the prevention and control of communicable
diseases; to advise the states on matters
relating to the preservation and improvement
of the public’s health; and to make
grants to states and, in consultation with
the state health authorities, to agencies
and political subdivisions of states to assist
in meeting the costs of communicable disease
control programs.
Authority
42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended. The committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App. 2), which sets forth standards for the formation and use of advisory committees.
The Advisory Committee on Immunization Practices has been given a statutory role under Section 13631 of the Omnibus Budget Reconciliation Act of 1993, Public Law 103-66 (42 U.S.C. 1396s(c)(2)(B)(i) and (e), subsections 1928(c)(2)(B)(i) and 1928(e) of the Social Security Act).
Function
The Advisory Committee on Immunization Practices shall provide advice and guidance to the Secretary, HHS, the Assistant Secretary for Health, and the Director, CDC, regarding the most appropriate application of antigens and related agents for effective control of vaccine-preventable diseases in the civilian population. The committee shall specifically provide advice for the control of diseases for which a vaccine is licensed in the U.S. The guidance will cover the appropriate use of the vaccine and may include recommendations for administration of immune globulin(s) and/or antimicrobial therapy shown to be effective in controlling the same disease. Guidance for the use of unlicensed vaccines may be developed if circumstances warrant.
For each recommended vaccine, the committee shall advise on population groups and/or circumstances in which an antigen or related agent is recommended. The committee shall develop guidance on the appropriate route, dose and frequency of administration of the vaccine, associated immune globulin, or antimicrobial agent. The committee shall also provide recommendations on contraindications and precautions for use of the vaccine and related agents and provide information on recognized adverse events. Committee deliberations on the appropriate use of vaccines to control disease in the U.S. should include consideration of population based studies such as efficacy, cost:benefit and risk:benefit analyses. The committee may alter or withdraw their recommendation(s) regarding a particular vaccine as new information becomes available or the risk of disease changes.
The committee may also provide recommendations which address the general use of vaccines and immune globulins as a class of biologic agents. These general recommendations may address the principles which govern administration technique, dosage and periodicity, the application of recognized contraindications and precautions, reporting adverse events, the correct storage, handling, and recording of vaccines and immune globulins, and special situations or populations that may warrant modification of the routine recommendations.
In accordance with Section 1928 of the Social Security Act, the committee shall also establish and periodically review and, as appropriate, revise a list of vaccines for administration to children eligible to receive vaccines through the Vaccines for Children Program, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the pediatric vaccines. The Secretary shall use, for the purpose of the purchase, delivery, and administration of pediatric vaccines in the Vaccines for Children Program, the list established by the committee.
Structure
The committee shall consist of 15 members, including the Chair. Members and the Chair shall be selected by the Secretary, HHS, from authorities who are knowledgeable in the fields of immunization practices and public health, have expertise in the use of vaccines and other immunobiologic agents in clinical practice or preventive medicine, have expertise with clinical or laboratory vaccine research, or have expertise in assessment of vaccine efficacy and safety. The committee shall include a person or persons knowledgeable about consumer perspectives and/or social and community aspects of immunization programs.
The committee shall also consist of eight non-voting ex-officio members: the Director, Division of Vaccine Injury Compensation, Bureau of Health Professions, Health Resources and Services Administration; the Deputy Director for Scientific Activities, Office of the Assistant Secretary of Defense for Health Affairs, Department of Defense; the Under Secretary for Health, Department of Veterans Affairs; the Director, Center for Biologics Evaluation and Research, Food and Drug Administration; the Director, Center for Medicaid and State Operations, Centers for Medicare and Medicaid Services; the Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health; the Director, Indian Health Service; and the Director, National Vaccine Program Office, HHS; or their designees.
The committee shall not take a vote unless at least eight ACIP members are present. If fewer than eight ACIP members are eligible to vote due to absence or a financial or other conflict of interest, the Executive Secretary, or designee, shall have the authority to temporarily designate the ex-officio members as voting members.
There also shall be non-voting liaison representatives from the American Academy of Family Physicians; the American Academy of Pediatrics; the America’s Health Insurance Plans; the American College Health Association; the American College of Obstetricians and Gynecologists; the American College of Physicians; the American Medical Association; the American Pharmacists Association; the Association of Teachers of Preventive Medicine; the Biotechnology Industry Organization; the Canadian National Advisory Committee on Immunization; the Healthcare Infection Control Practices Advisory Committee, CDC; the Infectious Diseases Society of America; the London Department of Health; the National Association of County and City Health Officials; the National Coalition for Adult Immunization; the National Foundation for Infectious Diseases; the National Immunization Council and Child Health Program, Mexico; the National Medical Association; the National Vaccine Advisory Committee, HHS; the Pharmaceutical Research Manufacturers of America; the Society for Adolescent Medicine; and such other non-voting liaison representatives as the Secretary deems necessary to effectively carry out the functions of the committee.
Members 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. Terms of more than two years are contingent upon renewal of the committee by appropriate action prior to its termination. A member may serve 180 days after expiration of that member’s term if a successor has not taken office.
The Chair shall be appointed for a 3-year term or for the remainder of his/her existing term. The Chair shall be chosen from among persons who have had at least one year experience as a voting member or at least two years close association with the committee in another position (i.e., liaison) and who have demonstrated ability both to lead the work of similar bodies and to work effectively in partnership with federal agencies.
Subcommittees may be established from time to time. 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.
Management and support services shall be provided by the Office of the Director, Epidemiology and Surveillance Division, National Immunization Program, CDC.
Meetings
Meetings shall be held approximately three times annually at the call of the Chair with the advance approval of a government official, who shall also approve the agenda. A government official shall be present at all meetings.
Meetings shall be open to the public except as determined otherwise by the Secretary, HHS or other official to whom the authority has been delegated; notice of all meetings shall be given to the public.
Meetings shall be conducted, and records of the proceedings kept, as required by applicable laws and Departmental regulations.
Compensation
Members who are not full-time Federal employees shall be paid at the rate of $250 per day, or at the rate of $31.25 per hour, as determined by the agency, not to exceed $250 per day; plus per diem and travel expenses in accordance with standard government travel regulations.
Annual Cost Estimate
Estimated annual cost of operating the committee, including compensation and travel expenses for members but excluding staff support, is $130,709. Estimate of annual person-years of staff support required is 2.2 at an estimated annual cost of $384,105.
Reports
In the event a portion of a meeting is closed to the public, a report shall be prepared which shall contain, as a minimum, a list of members and their business addresses, the committee activities, and recommendations made during the fiscal year. A copy of the report shall be provided to the Department Committee Management Office.
Termination
Date
Unless renewed by appropriate action prior to its expiration, the Advisory Committee on Immunization Practices will terminate on April 1, 2008.
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