Last Updated April 1, 2012
Authority, Objective, and Description
The Advisory Committee on Immunization Practices 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, as amended, 5 U.S.C. App., 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 (subsections 1928(c)(2)(B)(i) and 1928(e) of the Social Security Act, 42 U.S.C. 1396s(c)(2)(B)(i) and (e)).
Objective and Scope of Activities
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.
Description of Duties
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 selection of vaccines 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 preparations and/or antimicrobial therapy shown to be effective in controlling the same disease. Guidance for 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 a vaccine 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 also shall 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 also may provide recommendations that address the general use of vaccines and immune globulins as a class of biologic agents. These general recommendations may address the principles that govern administration technique, dose and dosing interval, 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 also shall establish and periodically review and, as appropriate, revise a 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. 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. Further, under provisions of the Affordable Care Act, at section 2713 of the Public Health Service Act, immunization recommendations of the committee that have been adopted by the Director of the Centers for Disease Control and Prevention must be covered by applicable health plans.
Agency, Support, Cost, and Federal Officer
Agency or Official to Whom the Committee Reports
The committee reports to the Secretary, HHS; the Assistant Secretary for Health; and the Director, CDC.
Management and support services shall be provided by the Office of the Director, National Center for Immunization and Respiratory Diseases, Office of Infectious Diseases, CDC.
Estimated Annual Operating Costs and Staff Years
Estimated annual cost for operating the committee, including compensation and travel expenses for members, but excluding staff support, is $241,121. Estimate of annual person-years of staff support required is 3.00, at an estimated annual cost of $649,015.
Designated Federal Officer
CDC will select a full-time or permanent part-time Federal employee to serve as the Designated Federal Officer (DFO) to attend each committee meeting and ensure that all procedures are within applicable statutory, regulatory, and HHS General Administration manual directives. The DFO will approve and prepare all meeting policies and agendas, call all of the committee and subcommittee meetings, adjourn any meeting when the DFO deems adjournment to be in the public interest, and chair meetings when directed to do so by the official to whom the board reports. The DFO or his/her designee shall be present at all meetings of the full committee and subcommittees.
Meetings, Duration, and Termination
Estimated Number and Frequency of Meetings
Meetings shall be held approximately three times per year at the call of the DFO, in consultation with the Chair.
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, in accordance with the Government in the Sunshine Act (5 U.S.C. Section 552b(c)) and Section 10(d) of the Federal Advisory Committee Act. Notice of all meetings shall be given to the public.
Unless renewed by appropriate action prior to expiration, the Advisory Committee on Immunization Practices will terminate two years from the date this charter is filed.
Membership, Subcommittees, and Recordkeeping
Membership and Designation
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. Members shall be deemed Special Government Employees.
The committee also shall consist of eight nonvoting 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.
If fewer than eight 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.
There also shall be non-voting liaison representatives from American Academy of Family Physicians; American Academy of Pediatrics; American Academy of Physician Assistants; American College Health Association; American College of Obstetricians and Gynecologists; American College of Physicians; American Geriatrics Society; America’s Health Insurance Plans; American Medical Association; American Nurses Association; American Osteopathic Association; American Pharmacists Association; Association of Immunization Managers; Association for Prevention Teaching and Research; Association of State and Territorial Health Officials; Biotechnology Industry Organization; Council of State and Territorial Epidemiologists; Canadian National Advisory Committee on Immunization; Department of Health, United Kingdom; Healthcare Infection Control Practices Advisory Committee; Infectious Diseases Society of America; National Association of County and City Health Officials; National Association for Pediatric Nurse Practitioners; National Foundation for Infectious Diseases; National Immunization Council and Child Health Program, Mexico; National Medical Association; National Vaccine Advisory Committee; Pharmaceutical Research Manufacturers of America; Society for Adolescent Health and Medicine; Society for Healthcare Epidemiology of America and such other non-voting liaison representatives as the Secretary deems necessary to effectively carry out the functions of the committee. Liaisons shall be deemed representatives.
The Chair shall be appointed for a 3-year term. The Chair shall be chosen from among persons who have had at least one year experience as a voting member and have demonstrated ability both to lead the work of similar bodies and to work effectively in partnership with federal agencies and partner organizations.
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 the renewal of the committee by appropriate action prior to its termination. A member may serve 180 days after the expiration of that member’s term if a successor has not taken office.
Subcommittees composed of members and nonmembers of the parent committee may be established with the approval of the Secretary, HHS, or his/her designee. 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.
The records of the committee, established subcommittees, or other subgroups of the committee, shall be managed in accordance with General Records Schedule 26, Item 2, or other approved agency records disposition schedule. These records shall be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.
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Advisory Committee on Immunization Practices (ACIP)
1600 Clifton Road, N.E., Mailstop A27
Atlanta, GA 30333
- Centers for Disease Control and Prevention
1600 Clifton Rd
Atlanta, GA 30333
TTY: (888) 232-6348