National Vaccine Injury Compensation Program: Addition of Meningococcal and Human Papillomavirus (HPV) Vaccines to the Vaccine Injury Table, 19937-19938 [E7-7591]
Download as PDF
<![CDATA[
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices
regulatory/industry project to improve,
through harmonization, the efficiency of
the process for developing and
registering new medicinal products in
Europe, Japan and the United States
without compromising the regulatory
obligations of safety and effectiveness.
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for medical product
development among regulatory
agencies. ICH was organized to provide
an opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. ICH is concerned with
harmonization among three regions: The
European Union, Japan, and the United
States. The six ICH sponsors are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labor and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and Health Canada, the
European Free Trade Area and the
World Health Organization. The ICH
process has achieved significant
harmonization of the technical
requirements for the approval of
pharmaceuticals for human use in the
three ICH regions.
The current ICH process and structure
can be found at the following Web site:
https://www.ich.org.
Interested persons may present data,
information, or views orally or in
writing, on issues pending at the public
meeting. Oral presentations from the
public will be scheduled between
approximately 4:30 p.m. and 5 p.m.
Time allotted for oral presentations may
be limited to 10 minutes. Those desiring
to make oral presentations should notify
the contact person by April 27, 2007,
and submit a brief statement of the
VerDate Aug<31>2005
18:52 Apr 19, 2007
Jkt 211001
general nature of the evidence or
arguments they which to present, the
names and addresses, phone number,
fax, and e-mail of proposed participants,
and an indication of the approximate
time requested to make their
presentation.
The agenda for the public meeting
will be made available via the internet
at https://www.fda.gov/cder/meeting/
ICH_20060508.htm.
Dated: April 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–1952 Filed 4–16–07; 3:25 pm]
BILLING CODE 4160–01–S
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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
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 nofault 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.
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
19937
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20APN1.SGM
20APN1
sroberts on PROD1PC70 with NOTICES
19938
Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices
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 vaccinerelated 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
VerDate Aug<31>2005
18:52 Apr 19, 2007
Jkt 211001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Heart, Lung, and Blood
Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Advisory Council.
Date: June 5, 2007.
Open: 8:30 a.m. to 12 p.m.
Agenda: To discuss program policies and
issues.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Closed: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Contact Person: Stephen Mockrin, PhD.,
Director, Division of Extramural Research
Activities, National Institutes of Health, 6701
Rockledge Drive, Room 7100, Bethesda, MD
20892, (301) 435–0260,
mockrins@nhlbi.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/index.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 72, Number 76 (Friday, April 20, 2007)]
[Notices]
[Pages 19937-19938]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-7591]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
