[Federal Register: April 20, 2007 (Volume 72, Number 76)]
[Notices]
[Page 19937-19938]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap07-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Vaccine Injury Compensation Program: Addition of
Meningococcal and Human Papillomavirus (HPV) 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
meningococcal (conjugate and polysaccharide) and human papillomavirus
(HPV) 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 meningococcal and HPV
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 meningococcal and HPV vaccines with the VICP even before
such vaccines are added as separate and distinct categories to the
Table through rulemaking.
DATES: This notice is effective on April 20, 2007. As described below,
meningococcal and HPV vaccines are covered under the VICP as of
February 1, 2007.
FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Division
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) 443-6593.
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) 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 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 meningococcal (conjugate and
polysaccharide) and HPV vaccines to the VICP as covered vaccines as
well as to the Table have been satisfied. In its May 27, 2005, issue of
the Morbidity and Mortality Weekly Report (MMWR), the CDC published its
recommendation that meningococcal conjugate vaccines be routinely
administered to young adolescents at the pre-adolescent visit (11-12
years olds). Additionally, for those individuals who have not
previously received the meningococcal conjugate vaccine, the CDC has
recommended vaccination before high school entry to further reduce the
incidence of meningococcal disease in adolescents and young adults. The
CDC also recommends routine vaccination for college freshmen who live
in dormitories because they are at higher risk for meningococcal
disease when compared with same aged cohorts. The use of meningococcal
conjugate vaccine is preferred among persons aged 11-55 years. If
meningococcal conjugate vaccine is unavailable, meningococcal
polysaccharide vaccine is an acceptable alternative for persons aged
11-55 years. Meningococcal polysaccharide vaccine is also recommended
for children aged 2-10 years and persons aged 55 years and older who
are at increased risk for meningococcal disease.
In its March 23, 2007, issue of the MMWR, the CDC published its
recommendation that the HPV vaccine be routinely administered to
females aged 11-12 years. The HPV vaccine can be administered to
females as young as 9 years. Vaccination is recommended for females
aged 13-26 years who have not previously received the vaccine or who
have not completed the full series.
On December 20, 2006, the excise tax legislation for meningococcal
and HPV vaccines was enacted by Pub. L. 109-432, the ``Tax Relief and
Health Care Act of 2006 (the Act).'' Section 408 of this Act adds all
meningococcal and
[[Page 19938]]
HPV vaccines to section 4132(a)(1) of the Internal Revenue Code of
1986, as amended, which defines all taxable 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 issued its
recommendation. This notice serves to satisfy the regulation's
publication requirement. Through this notice, meningococcal and HPV
vaccines are included as covered vaccines under Category XIV of 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. Under section 408 of the Tax Relief and
Health Care Act of 2006, the effective date for the excise taxes
enacted for meningococcal vaccines against meningococcal disease and
the HPV vaccine against HPV disease and infection applies to sale 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 this Act.'' It further
provides that if the vaccines were sold on or before 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 effective date for
coverage of the meningococcal and HPV vaccines under the VICP is
February 1, 2007. Thus, meningococcal and HPV vaccines are included as
covered vaccines under Category XIV of the Table as of February 1,
2007. Petitioners may file petitions related to meningococcal and HPV
vaccines as of February 1, 2007.
Petitions filed concerning vaccine-related injuries or deaths
associated with meningococcal and HPV 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)). Persons who may be eligible must file
petitions within: three (3) years from the first symptom or
manifestation of onset of an injury or of the significant aggravation
of the injury; or two (2) years from the date of a vaccine-related
death and four (4) years after the start of the first symptom of the
vaccine-related injury from which the death occurred.
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 meningococcal and HPV vaccines until February 2, 2009,
as long as the vaccine-related injury or death occurred on or after
February 1, 1999 (8 years prior to the effective date of the addition
that included meningococcal vaccines and HPV as covered vaccines).
Although two years from the date of February 1, 2007, would be February
1, 2009, under the current Rules of the United States Court of Federal
Claims, the deadline under section 2116(b) of the PHS Act would be
February 2, 2009, because February 1, 2009, falls on a Sunday.
The Secretary plans to amend the Table through the rulemaking
process by including meningococcal and HPV vaccines as separate
categories of vaccines in the Table. February 1, 2007, will remain the
applicable effective date when the Secretary makes a corresponding
amendment to add meningococcal and HPV vaccines as separate categories
on the Table through rulemaking.
Dated: April 16, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7-7591 Filed 4-19-07; 8:45 am]
BILLING CODE 4165-15-P