[Federal Register Volume 59, Number 88 (Monday, May 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11066]


[[Page Unknown]]

[Federal Register: May 9, 1994]


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FEDERAL TRADE COMMISSION
 

Health Resources and Services Administration Advisory Council; 
Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), announcement is made of the following 
National Advisory bodies scheduled to meet during the month of June 
1994.

    Name: Advisory Commission on Childhood Vaccines (ACCV).
    Date and Time: June 1, 1994; 9 a.m.-5 p.m. June 2, 1994; 9:00 
a.m.-3:00 p.m.
    Place: Parklawn Building, Conference Rooms G & H, 5600 Fishers 
Lane, Rockville, Maryland 20857.
    The meeting is open to the public.
    Purpose: The Commission:
    (1) Advises the Secretary on the implementation of the Program,
    (2) On its own initiative or as the result of the filing of a 
petition, recommends changes in the Vaccine Injury Table,
    (3) Advises the Secretary in implementing the Secretary's 
responsibilities under section 2127 regarding the need for childhood 
vaccination products that result in fewer or no significant adverse 
reactions,
    (4) Surveys 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 advises 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) Recommends to the Director of the National Vaccine Program 
research related to vaccine injuries which should be conducted to 
carry out the National Vaccine Injury Compensation Program.
    Agenda: The full Commission will meet commencing at 9 a.m. on 
Wednesday, June 1 until 5 p.m., and from 9 a.m. to 3 p.m. on 
Thursday, June 2. Agenda items will include, but not be limited to, 
a report on the March 15 meeting of the Ad-hoc Subcommittee of the 
National Vaccine Advisory Committee on the Institute of Medicine's 
review of ``Pertussis Immunization and Serious Acute Neurologic 
Illnesses in Children'' (The Miller Study), a report on the FDA's 
assessment of different vaccine lots, a report by the Department of 
Justice on the efforts to streamline the damages process, a report 
on the task force on safer vaccines, an update on the vaccine 
information materials, a report on the National Vaccine Plan, 
routine Program reports; reports from the National Vaccine Program, 
and reports from the ACCV Subcommittees. In addition, on June 1, 
following the meeting of the full Commission, there will be 
simultaneous meetings of two of the Commission's Working 
Subcommittees:

    Name: Financial Review Subcommittee of the Advisory Commission 
on Childhood Vaccines.
    Time: June 1, 1994, 4 p.m.-5 p.m.
    Place: Conference Room H, Parklawn Building, 5600 Fishers Lane, 
Rockville, Maryland 20857.
    Open for entire meeting.
    Purpose: This Subcommittee reviews quarterly, with the 
administrative staff, the financing of the Vaccine Injury 
Compensation Trust Fund, the output of funds resulting from each 
vaccine and each adverse event, and the relationship of each vaccine 
and each adverse event to the rate of depletion of the Trust Fund.
    If these studies justify any increase or any decrease of surtax 
for each vaccine, these recommendations can be made to the full 
Commission and, if accepted, can be forwarded to the Secretary.
    Agenda: The Subcommittee will meet and discuss the trust fund 
balance for the post-1988 claims and the status of spending on the 
pre-1988 claims.

    Name: Scientific Review Subcommittee of the Advisory Commission 
on Childhood Vaccines.
    Time: June 1, 1994, 4 p.m.-5 p.m.
    Place: Conference Room G, Parklawn Building, 5600 Fishers Lane, 
Rockville, Maryland 20857.
    Open for entire meeting.
    Purpose: This Subcommittee will review statistics from all 
sources (the Compensation System, Vaccine Adverse Events Reporting 
System (VAERS), the U.S. Court of Federal Claims, etc.) that can 
give any reason for any alterations (additions, subtractions, or 
revisions) in the Vaccine Injury Table. The Subcommittee will 
consider any applications for inclusion of additional vaccines and 
associated events to the table and make recommendations on these to 
the Commission. All recommendations by the Subcommittee will be 
considered by the full Commission and, if accepted, will be 
forwarded to the Secretary. This Subcommittee will also be the first 
line of study for all outside studies and literature reports with 
subjects affecting the Vaccine Injury Table.
    Agenda: The Subcommittee will meet and discuss recent update on 
the VAERS project.
    Additionally, on June 2, following the meeting of the full 
Commission, there will be a meeting of one of the Commission's 
Working Subcommittees:

    Name: Subcommittee on Process of the Advisory Commission on 
Childhood Vaccines.
    Time: June 2, 1 p.m.-3 p.m.
    Place: Conference Room G, Parklawn Building, 5600 Fishers Lane, 
Rockville, Maryland 20857.
    Open for entire meeting.
    Purpose: This Subcommittee is responsible for seeking, 
receiving, and analyzing systematic feedback (from interested 
parents' groups, petitioner's attorneys, etc.) on the implementation 
of the Vaccine Injury Compensation Program (VICP) and for making 
recommendations to the full Commission for appropriate changes in 
the system in order to improve the processes and procedures used by 
the various parties involved in the VICP.
    Agenda: To be determined.
    Public comment will be permitted at the respective Subcommittee 
meetings before they adjourn in the evening; before noon and at the 
end of the full Commission meeting on June 1; and before noon and 
before they adjourn on the second day on June 2. Oral presentations 
will be limited to 5 minutes per public speaker.
    Persons interested in providing an oral presentation should 
submit a written request, along with a copy of their presentation to 
Mr. Bryan Johnson, Division of Vaccine Injury Compensation, Bureau 
of Health Professions, Health Resources and Services Administration, 
room 8A-35, 5600 Fishers Lane, Rockville, MD 20852; Telephone (301) 
443-1533.
    Requests should contain the name, address, telephone number, and 
any business or professional affiliation of the person desiring to 
make an oral presentation. Groups having similar interests are 
requested to combine their comments and present them through a 
single representative. The allocation of time may be adjusted to 
accommodate the level of expressed interest. The Division of Vaccine 
Injury Compensation will notify each presenter by mail or telephone 
of their assigned presentation time. Persons who do not file an 
advance request for presentation, but desire to make an oral 
statement, may sign up in Conference Rooms G & H before 10 a.m. on 
June 1 and 2. These persons will be allocated time as time permits.
    Anyone requiring information regarding the Commission should 
contact Mr. Bryan Johnson, Division of Vaccine Injury Compensation, 
Bureau of Health Professions, room 8A-35, 5600 Fishers Lane, 
Rockville, Maryland 20852; Telephone (301) 443-1533.
    Agenda Items are subject to change as priorities dictate.

    Dated: May 3, 1994.
Jackie E. Baum,
Advisory Committee Management Officer, HRSA.
[FR Doc. 94-11066 Filed 5-6-94; 8:45 am]
BILLING CODE 4160-15-P