The ACCV advises and makes recommendations to the Secretary of Health and Human Services on issues relating to the operation of the National Vaccine Injury Compensation Program (VICP). There are nine voting members who provide oversight of the VICP and recommend ways to improve the VICP.
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42 U.S.C. 300aa-19, Section 2119 of the PHS Act. The Advisory Commission on Childhood Vaccines (hereinafter referred to as the “Commission”) is governed by the provisions of Public Law 92-463 (5 U.S.C. App. 2), which sets forth standards for the formation of advisory committees.
Objectives and Scope of Activities
The Secretary of Health and Human Services is mandated under Section 2119 of the Public Health Service (PHS) Act to appoint an advisory commission to give advice regarding the National Vaccine Injury Compensation Program (the Program), which provides compensation for certain vaccine-related injuries or deaths.
Description of Duties
The Commission shall: (1) advise the Secretary on the implementation of the Program; (2) on its own initiative or as the result of the filing of a petition, recommend changes in the Vaccine Injury Table; (3) advise the Secretary in implementing the Secretary's responsibilities under Section 2127 of the PHS Act regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions; (4) survey Federal, State, and local programs and activities relating to the gathering of information on injuries associated with the administration of childhood vaccines, including the adverse reaction reporting requirements of Section 2125(b), and advise the Secretary on means to obtain, compile, publish, and use credible data related to the frequency and severity of adverse reactions associated with childhood vaccines; (5) recommend to the Director of the National Vaccine Program research related to vaccine injuries which should be conducted to carry out the Program; and (6) consult regarding the development or revision of vaccine information materials as required by Section 2126 of the PHS Act.
Agency or Official to Whom the Committee Reports
The Commission on Childhood Vaccines shall advise and make recommendations to the Secretary on matters related to the Program responsibilities.
Management and support services shall be provided by the Division of Vaccine Injury Compensation, Healthcare Systems Bureau, Health Resources and Services Administration.
Estimated Annual Operating Costs and Staff Years
Estimated annual cost for operating the Commission, including compensation and travel expenses for members, but excluding staff support, is approximately $84,685. The estimate of annual person-years of staff support required is 1.5 at an estimated annual cost of $257,582.
Designated Federal Official
HRSA will select a full-time or permanent part-time Federal employee to serve as the Designated Federal Official (DFO) to attend each Commission 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 agendas, call all of the Commission or subcommittee meetings, adjourn any meeting when the DFO determines adjournment to be in the public interest, and chair meetings when directed to do so by the official to whom the Commission reports. The DFO or his/her designee shall be present at all meetings of the full Commission and subcommittees.
Estimated Number and Frequency of Meetings
The Commission shall meet no less than 4 times per year and at the call of the DFO. Meetings shall be open to the public except as determined otherwise by the Secretary or designee in accordance with the Government in the Sunshine Act 5 U.S.C. 552b(c) and the Federal Advisory Committee Act. 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.
Unless renewed by appropriate action prior to its expiration, this charter will expire two years from the date the charter is filed.
Membership and Designation
The Secretary shall select members of the Commission. The members of the Commission shall select a Chair and Vice Chair from among the members. Appointed members of the Commission shall be appointed for a term of office of 3 years. Members may serve after the expiration of their term until their successors have taken office.
The Commission shall be composed of the following:
(1) Nine members appointed by the Secretary as follows:
(A) three members who are health professionals, who are not employees of the United States, and who have expertise in the health care of children, the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines, of whom at least two shall be pediatricians;
(B) three members from the general public, of whom at least two shall be legal representatives of children who have suffered a vaccine-related injury or death; and
(C) three members who are attorneys, of whom at least one shall be an attorney whose specialty includes representation of persons who have suffered a vaccine-related injury or death and of whom one shall be an attorney whose specialty includes representation of vaccine manufacturers.
(2) The Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of the Food and Drug Administration (or the designees of such officials), each of whom shall be a nonvoting ex officio member.
The nine members appointed by the Secretary shall serve as Special Government Employees. The ex-officio members and the DFO shall be Regular Government Employees.
Subcommittees may be established with the approval of the Secretary or designee. Subcommittee members may be members of the parent Commission. The subcommittee shall make recommendations to be deliberated by the parent Commission. The Department’s Committee Management Officer will be notified upon the establishment of the each subcommittee and will be provided information on the subcommittee’s name, membership, function, and estimated frequency of meetings.
The records of the committee, formally and informally established subcommittees, or other subgroups of the committee, shall be handled 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.
July 21, 2012
July 17, 2012
Director, Office of Management
|This information reflects the current thinking of the United States Department of Health and Human Services on the topics addressed. This information is not legal advice and does not create or confer any rights for or on any person and does not operate to bind the Department or the public. The ultimate decision about the scope of the statutes authorizing the VICP is within the authority of the United States Court of Federal Claims, which is responsible for resolving claims for compensation under the VICP.|
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