PRIA, Government Policy, Made Personal

Summary

Creates an Advisory Commission on Childhood Vaccines made up of nine appointed members and four nonvoting government members. The nine appointees must include three health professionals who are not federal employees (at least two must be pediatricians), three people from the public (at least two must be legal representatives of children who suffered vaccine-related injury or death), and three attorneys (at least one who represents injured people and one who represents vaccine makers). The Director of NIH, the Assistant Secretary for Health, the Director of CDC, and the Commissioner of FDA (or their designees) are nonvoting ex officio members. Appointed members serve 3-year terms, with the first group staggered so three serve 1 year, three serve 2 years, and three serve 3 years as set by the Secretary. The commission must meet first within 60 days after all members are named, then at least four times a year and whenever the chair calls a meeting. Five voting members make a quorum, and decisions are by majority of voting members present. Federal employees on the commission get no extra pay; nonfederal members may be paid up to the daily equivalent of GS‑18 and may receive travel and per diem under section 5703 of title 5. The Secretary must give the commission staff, information, and consultants it needs. The commission must advise the Secretary on running the Program; recommend changes to the Vaccine Injury Table on its own or after a petition; advise on the need for childhood vaccines that cause fewer or no serious adverse reactions under section 300aa–27; review federal, state, and local efforts to collect vaccine injury information (including reporting under section 300aa–25(b)) and advise on how to get and use reliable data; and recommend vaccine-injury research to the Director of the National Vaccine Program.

Title 42, §300aa–19

The Public Health and Welfare, Source: USLM XML via OLRC

(a)There is established the Advisory Commission on Childhood Vaccines. The Commission shall be composed of:

(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.

(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 Food and Drugs (or the designees of such officials), each of whom shall be a nonvoting ex officio member.

(b)Appointed members of the Commission shall be appointed for a term of office of 3 years, except that of the members first appointed, 3 shall be appointed for a term of 1 year, 3 shall be appointed for a term of 2 years, and 3 shall be appointed for a term of 3 years, as determined by the Secretary.

(c)The Commission shall first meet within 60 days after all members of the Commission are appointed, and thereafter shall meet not less often than four times per year and at the call of the chair. A quorum for purposes of a meeting is 5. A decision at a meeting is to be made by a ballot of a majority of the voting members of the Commission present at the meeting.

(d)Members of the Commission who are officers or employees of the Federal Government shall serve as members of the Commission without compensation in addition to that received in their regular public employment. Members of the Commission who are not officers or employees of the Federal Government shall be compensated at a rate not to exceed the daily equivalent of the rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are engaged in the performance of their duties as members of the Commission. All members, while so serving away from their homes or regular places of business, may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as such expenses are authorized by section 5703 of title 5 for employees serving intermittently.

(e)The Secretary shall provide the Commission with such professional and clerical staff, such information, and the services of such consultants as may be necessary to assist the Commission in carrying out effectively its functions under this section.

(f)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 300aa–27 of this title 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 300aa–25(b) of this title, 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, and

(5)recommend to the Director of the National Vaccine Program research related to vaccine injuries which should be conducted to carry out this part.

Notes & Related Subsidiaries

Editorial Notes

Codification In subsec. (a), “October 1, 1988” substituted for “the

Effective Date

of this subpart” on authority of section 323 of Pub. L. 99–660, as amended, set out as an

Effective Date

note under section 300aa–1 of this title.

Amendments

1992—Subsec. (a)(2). Pub. L. 102–531 substituted “Centers for Disease Control and Prevention” for “Centers for Disease Control”. 1991—Subsec. (c). Pub. L. 102–168 inserted “present at the meeting” before period at end. 1987—Subsec. (a). Pub. L. 100–203 substituted “

Effective Date

of this subpart” for “

Effective Date

of this part” in last sentence.

Statutory Notes and Related Subsidiaries

Termination of Advisory CommissionsAdvisory commissions established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a commission established by the President or an officer of the Federal Government, such commission is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a commission established by the Congress, its duration is otherwise provided by law. See section 1001(2) and 1013 of Title 5, Government Organization and Employees. Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975. References in Other Laws to GS–16, 17, or 18 Pay RatesReferences in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

§300aa–19 Advisory Commission on Childhood Vaccines

Summary

Title 42, §300aa–19

Notes & Related Subsidiaries

Editorial Notes

Effective Date

Effective Date

Amendments

Effective Date

Effective Date

Statutory Notes and Related Subsidiaries

Citations & Metadata