[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67369-67370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


National Vaccine Injury Compensation Program: Addition to the 
Vaccine Injury Table to Include All Vaccines Against Seasonal Influenza

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: Through this notice, the Secretary of the U.S. Department of 
Health and Human Services (the Secretary) announces that all FDA-
approved vaccines against seasonal influenza are covered 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. Prior to this publication, 
trivalent influenza vaccines were included under Category XIV on the 
Vaccine Injury Table (Table) and will continue to be listed in that 
category. This notice serves to include all vaccines against seasonal 
influenza (not already covered under Category XIV) as covered vaccines 
under Category XVII of the Table (new vaccines covered under the VICP). 
This notice ensures that petitioners may file petitions relating to all 
vaccines against seasonal influenza (not already covered under the 
VICP) 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 November 12, 2013. As described 
below, all vaccines against seasonal influenza (except trivalent 
influenza vaccines, which are already covered under the VICP) will be 
covered under the VICP on November 12, 2013.

FOR FURTHER INFORMATION CONTACT: Vito Caserta, M.D., M.P.H., Acting 
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) 443-5287.

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)).
    By way of background, trivalent influenza vaccines (meaning they 
each contain three vaccine virus strains which are thought most likely 
to cause disease outbreaks during the influenza season) are routinely 
given to millions of individuals in the United States each year. 
Trivalent influenza vaccines include an inactivated (killed) virus 
vaccine administered using a syringe as well as a live, attenuated 
product administered in a nasal spray. All trivalent vaccines have been 
covered under the VICP since July 1, 2005. On April 12, 2005, the 
Health Resources and Services Administration (HRSA) published a notice 
in the Federal Register announcing that such vaccines were covered 
under the category for new vaccines on the Table. See 70 FR 19092. 
Subsequently, the Secretary engaged in rulemaking to add trivalent 
influenza vaccines as a separate category on the Table (category XIV on 
the Table). See 76 FR 36367.
    Since that time, quadrivalent influenza vaccines (meaning that they 
contain four vaccine virus strains which are thought most likely to 
cause disease outbreaks during the influenza season) have been approved 
by the Food and Drug Administration (FDA), and such vaccines are 
expected to be administered as an alternative to trivalent influenza 
vaccines during the upcoming and future flu seasons. On June 25, 2013, 
Public Law 113-15 was enacted, extending the applicable excise tax on 
trivalent influenza vaccines to also include any other vaccines against 
seasonal influenza. See Public Law 113-15 (amending 26 U.S.C. Sec.  
4132(a)(1)(N)).
    The amendment included in Public Law 113-15 ensures that all FDA-
approved seasonal influenza vaccines, including quadrivalent influenza 
vaccines, and other new seasonal influenza vaccines are covered under 
the VICP. Under the regulations governing the VICP, Category XVII of 
the Table specifies that ``[a]ny new vaccine recommended by 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 XVII). As explained in HRSA's notice of coverage with 
respect to the coverage of trivalent influenza vaccines, the CDC 
recommended in its May 28, 2004, issue of the Morbidity and Mortality 
Weekly Report (MMWR) 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. That 
recommendation extends to seasonal influenza vaccines beyond trivalent 
vaccines. The latest CDC update of its annual influenza vaccination 
recommendation was published in the MMWR on September 20, 2013. MMWR 
2013;62, No. 7. This report updated the 2012 recommendations by the CDC 
and its Advisory Committee on Immunization Practices regarding the use 
of influenza vaccines for the prevention and control of seasonal 
influenza. Routine annual influenza vaccination is recommended for all 
persons aged 6 months and older. For the 2013-14 influenza season, it 
is expected that trivalent live attenuated influenza vaccine (LAIV3) 
will be replaced by a quadrivalent LAIV formulation (LAIV4). 
Inactivated influenza vaccines (IIVs) will be available in both 
trivalent (IIV3) and quadrivalent (IIV4) formulations. No preferential 
recommendation was made for one influenza vaccine product over another 
for persons for whom more than one product is otherwise appropriate.
    This notice serves to satisfy the regulation's publication 
requirement. Through this notice, all vaccines against seasonal 
influenza (beyond trivalent influenza vaccines, which are already 
covered under Category XIV on the Table) are included as covered 
vaccines under Category XVII of the Table (new 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 Public Law 113-15, the excise tax 
for vaccines against seasonal influenza (beyond trivalent influenza 
vaccines) ``shall apply to sales and uses on or 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 this Act [i.e., Pub. L. 113-

[[Page 67370]]

15]; or (B) the date on which the Secretary of Health and Human 
Services lists any vaccines against seasonal influenza (other than any 
vaccine against seasonal influenza listed by the Secretary prior to the 
date of the enactment of this Act) for purposes of compensation for any 
vaccine-related injury or death through the Vaccine Injury Compensation 
Trust Fund.'' Public Law 113-15, Sec.  1. The law 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. Id.
    Under this statutory language, the effective date of the excise tax 
for seasonal influenza vaccines other than trivalent influenza vaccines 
is the later of August 1, 2013 (which is the first day of the first 
month beginning more than 4 weeks after the effective date of Public 
Law 113-15, which was June 25, 2013), or the date on which the 
Secretary publishes a notice of coverage under the VICP for seasonal 
influenza vaccines not previously covered under the VICP. This 
publication is the notice referred to in the latter requirement. 
Because this publication is made after August 1, 2013, the effective 
date of coverage for all vaccines against seasonal influenza (beyond 
trivalent influenza vaccines, which are already covered by the VICP) is 
the effective date of this publication, November 12, 2013.
    Petitions filed concerning vaccine-related injuries or deaths 
associated with all vaccines against seasonal 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 
category of vaccines under Category XVII 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 seasonal influenza vaccines (with the exception of 
trivalent influenza vaccines that are already covered under the VICP) 
until November 12, 2015, as long as the vaccine-related injury or death 
occurred on or before November 12, 2021 (8 years prior to the effective 
date of the addition of non-trivalent seasonal influenza vaccines as 
covered vaccines).
    The Table will be amended through subsequent rulemaking to include 
all vaccines against seasonal influenza in place of only trivalent 
influenza vaccines under Category XIV of the Table. Once that is done, 
the Table's coverage provisions (codified at 42 CFR 100.3(c)) will 
explain that trivalent influenza vaccines are included on the Table as 
of July 1, 2005, and that other seasonal influenza vaccines are 
included on the Table as of November 12, 2013.

    Dated: November 5, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-26992 Filed 11-8-13; 8:45 am]
BILLING CODE 4165-15-P