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###### Department of Health and Human Services

###### Health Resources and Services Administration

# AGENCY:

Health Resources and Services Administration (HRSA), HHS.

# ACTION:

Notice.

# 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                               ( print 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]

BILLING CODE 4165-15-P