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[Federal Register: April 12, 2005 (Volume 70,
Number 69)]
[Notices]
[Page 19092-19093]
printer-friendly
Addition of Trivalent Influenza Vaccines Federal
Register Notice
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Vaccine Injury Compensation Program:
Addition of Trivalent Influenza Vaccines in
the Injury Table
AGENCY: Health Resources and Services Administration
(HRSA), HHS.
ACTION: Notice.
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SUMMARY:
Through this notice, the Secretary announces
that trivalent influenza vaccines are covered
vaccines under the National Vaccine Injury Compensation
Program (VICP), which provides a system of no-fault
compensation for certain individuals who have
been injured by covered childhood vaccines.
This notice serves to include trivalent influenza
vaccines as covered vaccines under Category
XIV (new vaccines) of the Vaccine Injury Table
(Table), which lists the vaccines covered under
the VICP. This notice ensures that petitioners
may file petitions relating to trivalent influenza
vaccines with the VICP even before such vaccines
are added as a separate and distinct category
to the Table through rulemaking.
DATES: This Notice is effective
on April 12, 2005. As described below, trivalent
influenza vaccines will be covered under the
VICP on July 1, 2005.
FOR FURTHER INFORMATION CONTACT:
Geoffrey Evans, M.D., Medical Director, Division
of Vaccine Injury Compensation, Healthcare Systems
Bureau, Health Resources and Services Administration,
Parklawn Building, Room 11C–26, 5600 Fishers
Lane, Rockville, Maryland 20857; telephone number
(301) 443–4198.
SUPPLEMENTARY INFORMATION:
The statute authorizing the VICP provides for
the inclusion of additional vaccines in the
VICP when they are recommended by the Centers
for Disease Control and Prevention (CDC) to
the Secretary for routine administration to
children. See section 2114(e)(2) of the Public
Health Service (PHS) Act, 42 U.S.C. 300aa–14(e)(2).
Consistent with section 13632(a)(3) of Public
Law 103– 66, the regulations governing
the VICP provide that such vaccines will be
included as covered vaccines in the Table as
of the effective date of an excise tax to provide
funds for the payment of compensation with respect
to such vaccines (42 CFR 100.3(c)(5)).
The two prerequisites for adding trivalent influenza
vaccines to the VICP as covered vaccines as
well as to the Table have been satisfied. In
its May 28, 2004, issue of the Morbidity and
Mortality Weekly Report, the CDC published its
recommendation that influenza vaccines be routinely
administered to children between 6 and 23 months
of age because children in this age group are
at an increased risk for complications from
influenza. In addition, on October 22, 2004,
the excise tax for trivalent influenza vaccines
was enacted by Public Law 108–357, the
‘‘American Jobs Creation Act of
2004 (the Act).’’ Section 890 of
this Act adds all trivalent vaccines against
influenza to section 4132(a)(1) of the Internal
Revenue Code of 1986, which defines all taxable
vaccines.
By way of background, two types of influenza
vaccines are routinely given to millions of
individuals in the United States each year.
One is an inactivated (killed) virus vaccine
administered using a syringe, while the other
is a live, attenuated product administered in
a nasal spray. Both vaccine types are trivalent,
meaning that they each contain three vaccine
virus strains which are thought most likely
to cause disease outbreaks during the influenza
season. While trivalent vaccines are commonly
used for yearly influenza vaccine campaigns,
a monovalent product may sometimes be used if
it appears that one strain has the potential
to cause widespread disease. Such was the case
in 1976–1977 when Swine flu influenza
virus was thought to have potential to cause
a worldwide pandemic. Bivalent influenza vaccines
have also been used in the past, although infrequently.
This notice only covers trivalent influenza
vaccines.
Under the regulations governing the VICP, Category
XIV of the Table specifies that ‘‘[a]ny
new vaccine recommended by the [CDC] for routine
administration to children, after publication
by the Secretary of a notice of coverage’’
is a covered vaccine under the Table (42 CFR
100.3(a), Item XIV). As explained above, the
CDC’s recommendation has been accepted.
This Notice serves to satisfy the regulation’s
publication requirement. Through this notice,
trivalent influenza vaccines are included as
covered vaccines under Category XIV of the Table.
Because the excise tax enacted with respect
to influenza vaccines extends only to trivalent
vaccines, any non-trivalent influenza vaccines
(should they be administered to the public in
the future) will not be covered under the VICP
or the Table. To the Secretary’s knowledge,
the only influenza vaccines that have been administered
in the United States in the past 8 years are
trivalent influenza vaccines. Under section
2114(e) of the PHS Act, as amended by section
13632(a) of the Omnibus Budget Reconciliation
Act of 1993, coverage for a vaccine recommended
by the CDC for routine administration to children
shall take effect upon the effective date of
the tax enacted to provide funds for compensation
with respect to the vaccine included as a covered
vaccine in the Table. Under section 890 of the
American Jobs Creation Act of 2004, the effective
date for the excise tax enacted for trivalent
vaccines against influenza applies on and after
the later of: ‘‘(A) the first day
of the first month which begins more than 4
weeks after the date of the enactment of [the
Act]; or (B) the date on which the Secretary
of Health and Human Services lists any vaccines
against influenza for purposes of compensation
for any vaccine-related injury or death through
the Vaccine Injury Compensation Trust Fund.’’
It further provides that if the vaccines were
sold before or on the effective date of the
excise tax, but delivered after this date, the
delivery date of such vaccines shall be considered
the sale date.
Under this authorizing statutory language, the
Secretary may choose to use December 1, 2004,
or a later date as effective date of coverage,
imposing the excise tax for trivalent influenza
vaccines on this effective date. On November
10, the Advisory Commission on Childhood Vaccines
voted to recommend July 1, 2005, as the effective
date for the imposition of excise tax on trivalent
influenza vaccines. Imposition of a new excise
tax in the middle of this 2004–2005 influenza
season may cause confusion and possibly impede
the prompt sale and/or distribution or redistribution
of influenza vaccines. To avoid any confusion
and possible effects on the prompt sale and/or
distribution of such vaccine, the Secretary
has determined that the effective date for the
enactment of the excise tax for trivalent influenza
vaccines should be July 1, 2005. Thus, trivalent
influenza vaccines are included as covered vaccines
under Category XIV of the Table as of July 1,
2005. Petitioners may file petitions related
to trivalent influenza vaccines as of July 1,
2005.
Petitions
filed concerning vaccine-related injuries or
deaths associated with trivalent influenza vaccines
must be filed within the applicable statute
of limitations. The filing limitations applicable
to petitions filed with the VICP are set out
in section 2116(a) of the PHS Act (42 U.S.C.
300aa–16(a)). In addition, section 2116(b)
of the PHS Act lays out specific exceptions
to these statutes of limitations that apply
when the effect of a revision to the Table makes
a previously ineligible person eligible to receive
compensation or when an eligible person’s
likelihood of obtaining compensation significantly
increases. Under this provision, persons who
may be eligible to file petitions based on the
addition of a new vaccine under Category XIV
of the Table may file a petition for compensation
not later than 2 years after the effective date
of the revision if the injury or death occurred
not more than 8 years before the effective date
of the revision of the Table (42 U.S.C. 300aa–16(b)).
Thus, persons whose petitions may not be timely
under the limitations periods described in section
2116(a) of the PHS Act, may still file petitions
concerning accine-related injuries or deaths
associated with trivalent influenza vaccines
until July 1, 2007, as long as the vaccine-related
injury or death occurred on or after July 1,
1997 (8 years prior to the effective date of
the addition that included trivalent influenza
vaccines as covered vaccines). The Secretary
plans to amend the Table through the rulemaking
process by including trivalent influenza vaccines
as a separate category of vaccines in the Table.
July 1, 2005, will remain the applicable effective
date when the Secretary makes a corresponding
amendment to add trivalent influenza vaccines
as a separate category on the Table through
rulemaking.
Dated: April 5, 2005.
Elizabeth M. Duke, Administrator.
[FR Doc. 05–7264 Filed 4–11–05;
8:45 am]
BILLING CODE 4165–15–P
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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