National Vaccine Injury Compensation Program: Addition of Trivalent Influenza Vaccines to the Vaccine Injury Table, 19092-19093 [05-7264]
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Federal Register / Vol. 70, No. 69 / Tuesday, April 12, 2005 / Notices
submit one copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. The guidance and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Additional copies of this guidance are
available at https://www.fda.gov/oc/
combination or https://www.fda.gov/
ohrms/dockets/default.htm. You may
also request additional copies of the
guidance by e-mailing
combination@fda.gov.
Dated: April 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7265 Filed 4–11–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: Addition of Trivalent
Influenza Vaccines to the Vaccine
Injury Table
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: Through this notice, the
Secretary announces that trivalent
influenza 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 trivalent influenza 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 trivalent influenza
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 April
12, 2005. As described below, trivalent
influenza vaccines will be covered
under the VICP on July 1, 2005.
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,
VerDate jul<14>2003
19:53 Apr 11, 2005
Jkt 205001
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 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
trivalent influenza vaccines to the VICP
as covered vaccines as well as to the
Table have been satisfied. In its May 28,
2004, issue of the Morbidity and
Mortality Weekly Report, the CDC
published its recommendation that
influenza vaccines be routinely
administered to children between 6 and
23 months of age because children in
this age group are at an increased risk
for complications from influenza. In
addition, on October 22, 2004, the
excise tax for trivalent influenza
vaccines was enacted by Public Law
108–357, the ‘‘American Jobs Creation
Act of 2004 (the Act).’’ Section 890 of
this Act adds all trivalent vaccines
against influenza to section 4132(a)(1) of
the Internal Revenue Code of 1986,
which defines all taxable vaccines.
By way of background, two types of
influenza vaccines are routinely given to
millions of individuals in the United
States each year. One is an inactivated
(killed) virus vaccine administered
using a syringe, while the other is a live,
attenuated product administered in a
nasal spray. Both vaccine types are
trivalent, meaning that they each
contain three vaccine virus strains
which are thought most likely to cause
disease outbreaks during the influenza
season. While trivalent vaccines are
commonly used for yearly influenza
vaccine campaigns, a monovalent
product may sometimes be used if it
appears that one strain has the potential
to cause widespread disease. Such was
the case in 1976–1977 when Swine flu
influenza virus was thought to have
potential to cause a worldwide
pandemic. Bivalent influenza vaccines
have also been used in the past,
although infrequently. This notice only
covers trivalent influenza vaccines.
Under the regulations governing the
VICP, Category XIV of the Table
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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’s
recommendation has been accepted.
This Notice serves to satisfy the
regulation’s publication requirement.
Through this notice, trivalent influenza
vaccines are included as covered
vaccines under Category XIV of the
Table. Because the excise tax enacted
with respect to influenza vaccines
extends only to trivalent vaccines, any
non-trivalent influenza vaccines (should
they be administered to the public in
the future) will not be covered under the
VICP or the Table. To the Secretary’s
knowledge, the only influenza vaccines
that have been administered in the
United States in the past 8 years are
trivalent influenza vaccines.
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 890 of the
American Jobs Creation Act of 2004, the
effective date for the excise tax enacted
for trivalent vaccines against influenza
applies on and after the later of: ‘‘(A) the
first day of the first month which begins
more than 4 weeks after the date of the
enactment of [the Act]; or (B) the date
on which the Secretary of Health and
Human Services lists any vaccines
against influenza for purposes of
compensation for any vaccine-related
injury or death through the Vaccine
Injury Compensation Trust Fund.’’ 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.
Under this authorizing statutory
language, the Secretary may choose to
use December 1, 2004, or a later date as
effective date of coverage, imposing the
excise tax for trivalent influenza
vaccines on this effective date. On
November 10, the Advisory Commission
on Childhood Vaccines voted to
recommend July 1, 2005, as the effective
date for the imposition of excise tax on
trivalent influenza vaccines. Imposition
of a new excise tax in the middle of this
2004–2005 influenza season may cause
confusion and possibly impede the
prompt sale and/or distribution or
redistribution of influenza vaccines. To
E:\FR\FM\12APN1.SGM
12APN1
Federal Register / Vol. 70, No. 69 / Tuesday, April 12, 2005 / Notices
avoid any confusion and possible effects
on the prompt sale and/or distribution
of such vaccine, the Secretary has
determined that the effective date for
the enactment of the excise tax for
trivalent influenza vaccines should be
July 1, 2005. Thus, trivalent influenza
vaccines are included as covered
vaccines under Category XIV of the
Table as of July 1, 2005. Petitioners may
file petitions related to trivalent
influenza vaccines as of July 1, 2005.
Petitions filed concerning vaccinerelated injuries or deaths associated
with trivalent influenza 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)). 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 trivalent influenza
vaccines until July 1, 2007, as long as
the vaccine-related injury or death
occurred on or after July 1, 1997 (8 years
prior to the effective date of the addition
that included trivalent influenza
vaccines as covered vaccines).
The Secretary plans to amend the
Table through the rulemaking process
by including trivalent influenza
vaccines as a separate category of
vaccines in the Table. July 1, 2005, will
remain the applicable effective date
when the Secretary makes a
corresponding amendment to add
trivalent influenza vaccines as a
separate category on the Table through
rulemaking.
Dated: April 5, 2005.
Elizabeth M. Duke,
Administrator.
[FR Doc. 05–7264 Filed 4–11–05; 8:45 am]
BILLING CODE 4165–15–P
VerDate jul<14>2003
16:48 Apr 11, 2005
Jkt 205001
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–4978–N–03]
Notice of Proposed Information
Collection for Public Comment; Indian
Housing Operating Cost Study
Office of the Assistant
Secretary for Public and Indian
Housing, HUD.
ACTION: Notice.
AGENCY:
SUMMARY: The proposed information
collection requirement described below
will be submitted to the Office of
Management and Budget (OMB) for
review, as required by the Paperwork
Reduction Act. The Department is
soliciting public comments on the
subject proposal.
DATES: Comments Due Date: June 13,
2005.
Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name/or OMB Control
number and should be sent to: Aneita
Waites, Reports Liaison Officer, Public
and Indian Housing, Department of
Housing and Urban Development, 451
7th Street, SW., Room 4114,
Washington, DC 20410–5000.
FOR FURTHER INFORMATION CONTACT:
Aneita Waites, (202) 708–0713,
extension 4114, for copies of proposed
forms and/or other available documents.
(This is not a toll-free number).
SUPPLEMENTARY INFORMATION: The
Department will submit the proposed
information collection to OMB for
review, as required by the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35, as amended). This Notice is
soliciting comments from members of
the public and affected agencies
concerning the proposed collection of
information to: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (2) evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (3) enhance the quality,
utility, and clarity of the information to
be collected; and (4) minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated collection techniques or
other forms of information technology;
e.g., permitting electronic submission of
responses.
This Notice also lists the following
information:
ADDRESSES:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
19093
Title of Proposal: Indian Housing
Operating Cost Study, 1937 Act Housing
Operating Costs Survey.
OMB Control Number: 2577–XXXX
[to be assigned].
Description of the need for the
information and proposed use: The
Indian Housing Block Grant (IHBG)
formula uses Allowable Expense Level
(AEL) data in determining the operating
subsidy portion of the IHBG grant for
Tribes that continue to operate housing
units developed under 1937 Act
programs. During recent Formula
Negotiated Rulemaking Committee
sessions several Committee members
indicated that AEL did not adequately
recognize the real cost of operating
housing in Indian Country and that the
AEL values needed to be replaced with
a more current, accurate measure of the
costs to operate housing in tribal areas.
HUD committed to working with the
Tribes to address this concern. There is
no database with information about
current operating costs of 1937 Act
housing programs in Indian Country.
The information gathered in this form
will be used to establish a current,
accurate cost database, and will support
continued discussions on the role of
AEL in the IHBG formula.
Agency form number, if applicable:
Not applicable.
Members of affected public: Tribal
Governments.
Estimation of the total number of
hours needed to prepare the information
collection including number of
respondents: 269 tribally designated
housing entities (TDHEs) manage the
1937 Act housing for Tribes. Estimated
response time is 2 hours. Estimated total
responses based on 75% return rate is
202. Estimated total reporting burden is
404 hours.
Status of the proposed information
collection: New collection.
Authority: Section 3506 of the Paperwork
Reduction Act of 1995, 44 U.S.C. Chapter 35,
as amended.
Dated: April 1, 2005.
Michael Liu,
Assistant Secretary for Public and Indian
Housing.
[FR Doc. E5–1656 Filed 4–11–05; 8:45 am]
BILLING CODE 4210–27–P
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[Federal Register Volume 70, Number 69 (Tuesday, April 12, 2005)]
[Notices]
[Pages 19092-19093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7264]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Vaccine Injury Compensation Program: Addition of
Trivalent Influenza Vaccines to the Vaccine Injury Table
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Through this notice, the Secretary announces that trivalent
influenza 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 trivalent influenza
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 trivalent influenza 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 April 12, 2005. As described below,
trivalent influenza vaccines will be covered under the VICP on July 1,
2005.
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 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 trivalent influenza vaccines to
the VICP as covered vaccines as well as to the Table have been
satisfied. In its May 28, 2004, issue of the Morbidity and Mortality
Weekly Report, the CDC published its recommendation that influenza
vaccines be routinely administered to children between 6 and 23 months
of age because children in this age group are at an increased risk for
complications from influenza. In addition, on October 22, 2004, the
excise tax for trivalent influenza vaccines was enacted by Public Law
108-357, the ``American Jobs Creation Act of 2004 (the Act).'' Section
890 of this Act adds all trivalent vaccines against influenza to
section 4132(a)(1) of the Internal Revenue Code of 1986, which defines
all taxable vaccines.
By way of background, two types of influenza vaccines are routinely
given to millions of individuals in the United States each year. One is
an inactivated (killed) virus vaccine administered using a syringe,
while the other is a live, attenuated product administered in a nasal
spray. Both vaccine types are trivalent, meaning that they each contain
three vaccine virus strains which are thought most likely to cause
disease outbreaks during the influenza season. While trivalent vaccines
are commonly used for yearly influenza vaccine campaigns, a monovalent
product may sometimes be used if it appears that one strain has the
potential to cause widespread disease. Such was the case in 1976-1977
when Swine flu influenza virus was thought to have potential to cause a
worldwide pandemic. Bivalent influenza vaccines have also been used in
the past, although infrequently. This notice only covers trivalent
influenza 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's recommendation has
been accepted. This Notice serves to satisfy the regulation's
publication requirement. Through this notice, trivalent influenza
vaccines are included as covered vaccines under Category XIV of the
Table. Because the excise tax enacted with respect to influenza
vaccines extends only to trivalent vaccines, any non-trivalent
influenza vaccines (should they be administered to the public in the
future) will not be covered under the VICP or the Table. To the
Secretary's knowledge, the only influenza vaccines that have been
administered in the United States in the past 8 years are trivalent
influenza vaccines.
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 890 of the American Jobs
Creation Act of 2004, the effective date for the excise tax enacted for
trivalent vaccines against influenza applies on and after the later of:
``(A) the first day of the first month which begins more than 4 weeks
after the date of the enactment of [the Act]; or (B) the date on which
the Secretary of Health and Human Services lists any vaccines against
influenza for purposes of compensation for any vaccine-related injury
or death through the Vaccine Injury Compensation Trust Fund.'' 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.
Under this authorizing statutory language, the Secretary may choose
to use December 1, 2004, or a later date as effective date of coverage,
imposing the excise tax for trivalent influenza vaccines on this
effective date. On November 10, the Advisory Commission on Childhood
Vaccines voted to recommend July 1, 2005, as the effective date for the
imposition of excise tax on trivalent influenza vaccines. Imposition of
a new excise tax in the middle of this 2004-2005 influenza season may
cause confusion and possibly impede the prompt sale and/or distribution
or redistribution of influenza vaccines. To
[[Page 19093]]
avoid any confusion and possible effects on the prompt sale and/or
distribution of such vaccine, the Secretary has determined that the
effective date for the enactment of the excise tax for trivalent
influenza vaccines should be July 1, 2005. Thus, trivalent influenza
vaccines are included as covered vaccines under Category XIV of the
Table as of July 1, 2005. Petitioners may file petitions related to
trivalent influenza vaccines as of July 1, 2005.
Petitions filed concerning vaccine-related injuries or deaths
associated with trivalent influenza 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)). 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 trivalent influenza vaccines until July 1, 2007,
as long as the vaccine-related injury or death occurred on or after
July 1, 1997 (8 years prior to the effective date of the addition that
included trivalent influenza vaccines as covered vaccines).
The Secretary plans to amend the Table through the rulemaking
process by including trivalent influenza vaccines as a separate
category of vaccines in the Table. July 1, 2005, will remain the
applicable effective date when the Secretary makes a corresponding
amendment to add trivalent influenza vaccines as a separate category on
the Table through rulemaking.
Dated: April 5, 2005.
Elizabeth M. Duke,
Administrator.
[FR Doc. 05-7264 Filed 4-11-05; 8:45 am]
BILLING CODE 4165-15-P
