[Federal Register Volume 70, Number 69 (Tuesday, April 12, 2005)]
[Notices]
[Pages 19092-19093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7264]


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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 to the Vaccine Injury Table

AGENCY: Health Resources and Services Administration, 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

[[Page 19093]]

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 vaccine-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