[Federal Register Volume 69, Number 230 (Wednesday, December 1, 2004)]
[Notices]
[Pages 69945-69946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26273]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


National Vaccine Injury Compensation Program: Inclusion of 
Hepatitis A Vaccines in the Vaccine in the Injury Table

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Notice.

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SUMMARY: Through this notice, the Secretary of Health and Human 
Services announces that Hepatitis A 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 
Hepatitis A 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 Hepatitis A

[[Page 69946]]

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 December 1, 2004. As described 
below, Hepatitis A vaccines will be covered under the VICP on December 
1, 2004.

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 in the Table as covered vaccines 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 Hepatitis A vaccines to the VICP 
as covered vaccines as well as to the Table have been satisfied. First, 
the CDC published its recommendation that Hepatitis A vaccines be 
routinely administered to certain children in the October 1, 1999, 
issue of the Morbidity and Mortality Weekly Report (MMWR). 
Specifically, the CDC recommended that all children in States, 
counties, and communities with rates of Hepatitis A that are twice the 
1987-1997 national average or greater (i.e., greater than or equal to 
20 cases per 100,000 population) receive the Hepatitis A vaccine.
    Second, on October 22, 2004, the excise tax for Hepatitis A 
vaccines was enacted by Public Law 108-357, the ``American Jobs 
Creation Act of 2004.'' Section 889 of this Act adds all vaccines 
against Hepatitis A to section 4132(a)(1) of the Internal Revenue Code 
of 1986, which defines all taxable vaccines. Unlike the CDC's 
recommendation, the American Jobs Creation Act of 2004 does not 
distinguish between Hepatitis A vaccines administered in areas in which 
rates of Hepatitis A are at least twice the national average and 
Hepatitis A vaccines administered in other areas of the country. For 
this reason, all Hepatitis A vaccines manufactured or produced in the 
United States, or entered into the United States for consumption, use, 
or warehousing, will be subject to this excise tax (26 U.S.C. 
4132(a)(1)).
    Under the regulations governing the VICP, Item XIV of the Table 
specifies that ``[a]ny new vaccine recommended by the Centers for 
Disease Control and Prevention 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 was accepted. This notice 
serves to satisfy the regulation's publication requirement. Through 
this notice, Hepatitis A vaccines are included as covered vaccines 
under Category XIV of the Table. As explained above, because the 
American Jobs Creation Act of 2004 enacted an excise tax for Hepatitis 
A vaccines administered throughout the United States, all Hepatitis A 
vaccines will be covered under the VICP and under the Table.
    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. The American Jobs Creation Act of 2004 
provides that the addition of Hepatitis A vaccines to the list of 
taxable vaccines applies to sales and uses on or after the first day of 
the first month which begins more than 4 weeks after the date of the 
enactment of the Act. 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. Because the American Jobs Creation Act of 2004 was 
enacted on October 22, 2004, the effective date of the excise tax 
adding Hepatitis A vaccines as taxable vaccines is December 1, 2004. 
Thus, Hepatitis A vaccines are included as covered vaccines under 
Category XIV of the Table as of December 1, 2004. Petitioners may file 
petitions related to Hepatitis A vaccines as of December 1, 2004.
    Petitions filed concerning vaccine-related injuries or deaths 
associated with Hepatitis A vaccines must, of course, be filed within 
the applicable statute of limitations. The statutes of 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, a person who may be 
eligible to file a petition 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 satisfy the limitations periods 
described in section 2116(a) of the PHS Act may still file petitions 
concerning vaccine-related injuries or deaths associated with Hepatitis 
A vaccines until December 1, 2006, as long as the vaccine-related 
injury or death occurred on or after December 1, 1996 (8 years prior to 
the effective date of the addition that included Hepatitis A as a 
covered vaccine).
    The Secretary plans to amend the Table through the rulemaking 
process by including Hepatitis A vaccines as a separate category of 
vaccines in the Table. December 1, 2004, will remain the applicable 
effective date when the Secretary makes a corresponding amendment to 
add Hepatitis A vaccines as a separate category on the Table through 
rulemaking.

    Dated: November 22, 2004.
Elizabeth M. Duke,
Administrator, HRSA.
[FR Doc. 04-26273 Filed 11-30-04; 8:45 am]
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