[Federal Register Volume 66, Number 99 (Tuesday, May 22, 2001)]
[Notices]
[Page 28166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


National Vaccine Injury Compensation Program: Addition of 
Pneumococcal Conjugate 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 pneumococcal 
conjugate vaccines are now 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 pneumococcal 
conjugate vaccines under Category XIII (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 
pneumococcal conjugate 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 May 22, 2001.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, Medical Director, 
Division of Vaccine Injury Compensation, BHPr, HRSA, Parklawn Building, 
Room 8A-46, 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 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 
Pub. L. 103-66, the regulations governing the VICP provide that such 
vaccines will be included 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)(4)).
    The two prerequisites for adding pneumococcal conjugate vaccines to 
the VICP as covered vaccines as well as to the Table have been 
satisfied. First, on December 17, 1999, the excise tax for pneumococcal 
conjugate vaccines was enacted by Pub. L. 106-170, the Ticket to Work 
and Work Incentives Improvement Act of 1999, with an effective date of 
December 18, 1999. Section 523 of this Act provides that all conjugate 
vaccines against streptococcus pneumoniae (pneumococcus) are added to 
section 4132(a)(1) of the Internal Revenue Code of 1986, which defines 
all taxable vaccines. Second, the CDC published its recommendation that 
pneumococcal conjugate vaccines be routinely administered to children 
up to 23 months of age in the October 6, 2000, issue of the Morbidity 
and Mortality Weekly Report.
    Under the regulations governing the VICP, Item XIII 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 XIII.) As explained above, CDC's recommendation has been 
made. This Notice serves to satisfy the regulation's publication 
requirement. Through this notice, pneumococcal conjugate vaccines are 
now included as covered vaccines under Category XIII of the Table. 
Because the CDC only recommended pneumococcal conjugate vaccines to the 
Secretary for routine administration to children, polysaccharide-type 
pneumococcal vaccines are not covered under the VICP or included on the 
Table.
    Under section 2114(e) of the PHS Act, as amended by section 
13632(a) of the Omnibus Budget Reconciliation Act of 1993, a revision 
to the Table adding 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 added to the Table. Thus, pneumococcal conjugate vaccines are 
included in the Table under Category XIII with an effective date of 
December 18, 1999. Petitioners may file petitions related to 
pneumococcal conjugate vaccines as of May 22, 2001.
    The Secretary plans to amend the Table through the rulemaking 
process by including pneumococcal conjugate vaccines as a separate 
category of vaccines in the Table. December 18, 1999, will remain the 
applicable effective date when the Secretary makes a corresponding 
amendment to add pneumococcal conjugate vaccines as a separate category 
on the Table through rulemaking.

    Dated: May 15, 2001.
Elizabeth James Duke,
Acting Administrator.
[FR Doc. 01-12808 Filed 5-21-01; 8:45 am]
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