National Vaccine Injury Compensation Program: Addition to the Vaccine Injury Table to Include All Vaccines Against Seasonal Influenza, 67369-67370 [2013-26992]
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Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices
Dated: November 4, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–27006 Filed 11–8–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: Addition to the Vaccine
Injury Table to Include All Vaccines
Against Seasonal Influenza
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
Through this notice, the
Secretary of the U.S. Department of
Health and Human Services (the
Secretary) announces that all FDAapproved vaccines against seasonal
influenza are covered 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.
Prior to this publication, trivalent
influenza vaccines were included under
Category XIV on the Vaccine Injury
Table (Table) and will continue to be
listed in that category. This notice
serves to include all vaccines against
seasonal influenza (not already covered
under Category XIV) as covered
vaccines under Category XVII of the
Table (new vaccines covered under the
VICP). This notice ensures that
petitioners may file petitions relating to
all vaccines against seasonal influenza
(not already covered under the VICP)
with the VICP even before such vaccines
are added as a separate and distinct
category to the Table through
rulemaking.
SUMMARY:
This notice is effective on
November 12, 2013. As described
below, all vaccines against seasonal
influenza (except trivalent influenza
vaccines, which are already covered
under the VICP) will be covered under
the VICP on November 12, 2013.
FOR FURTHER INFORMATION CONTACT: Vito
Caserta, M.D., M.P.H., Acting 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) 443–5287.
emcdonald on DSK67QTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
17:41 Nov 08, 2013
Jkt 232001
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)).
By way of background, trivalent
influenza vaccines (meaning they each
contain three vaccine virus strains
which are thought most likely to cause
disease outbreaks during the influenza
season) are routinely given to millions
of individuals in the United States each
year. Trivalent influenza vaccines
include an inactivated (killed) virus
vaccine administered using a syringe as
well as a live, attenuated product
administered in a nasal spray. All
trivalent vaccines have been covered
under the VICP since July 1, 2005. On
April 12, 2005, the Health Resources
and Services Administration (HRSA)
published a notice in the Federal
Register announcing that such vaccines
were covered under the category for
new vaccines on the Table. See 70 FR
19092. Subsequently, the Secretary
engaged in rulemaking to add trivalent
influenza vaccines as a separate
category on the Table (category XIV on
the Table). See 76 FR 36367.
Since that time, quadrivalent
influenza vaccines (meaning that they
contain four vaccine virus strains which
are thought most likely to cause disease
outbreaks during the influenza season)
have been approved by the Food and
Drug Administration (FDA), and such
vaccines are expected to be
administered as an alternative to
trivalent influenza vaccines during the
upcoming and future flu seasons. On
June 25, 2013, Public Law 113–15 was
enacted, extending the applicable excise
tax on trivalent influenza vaccines to
also include any other vaccines against
seasonal influenza. See Public Law 113–
15 (amending 26 U.S.C. § 4132(a)(1)(N)).
The amendment included in Public
Law 113–15 ensures that all FDAapproved seasonal influenza vaccines,
including quadrivalent influenza
vaccines, and other new seasonal
influenza vaccines are covered under
the VICP. Under the regulations
governing the VICP, Category XVII of
the Table specifies that ‘‘[a]ny new
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
Sfmt 4703
67369
vaccine recommended by 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 XVII).
As explained in HRSA’s notice of
coverage with respect to the coverage of
trivalent influenza vaccines, the CDC
recommended in its May 28, 2004, issue
of the Morbidity and Mortality Weekly
Report (MMWR) 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. That recommendation
extends to seasonal influenza vaccines
beyond trivalent vaccines. The latest
CDC update of its annual influenza
vaccination recommendation was
published in the MMWR on September
20, 2013. MMWR 2013;62, No. 7. This
report updated the 2012
recommendations by the CDC and its
Advisory Committee on Immunization
Practices regarding the use of influenza
vaccines for the prevention and control
of seasonal influenza. Routine annual
influenza vaccination is recommended
for all persons aged 6 months and older.
For the 2013–14 influenza season, it is
expected that trivalent live attenuated
influenza vaccine (LAIV3) will be
replaced by a quadrivalent LAIV
formulation (LAIV4). Inactivated
influenza vaccines (IIVs) will be
available in both trivalent (IIV3) and
quadrivalent (IIV4) formulations. No
preferential recommendation was made
for one influenza vaccine product over
another for persons for whom more than
one product is otherwise appropriate.
This notice serves to satisfy the
regulation’s publication requirement.
Through this notice, all vaccines against
seasonal influenza (beyond trivalent
influenza vaccines, which are already
covered under Category XIV on the
Table) are included as covered vaccines
under Category XVII of the Table (new
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 Public Law 113–15,
the excise tax for vaccines against
seasonal influenza (beyond trivalent
influenza vaccines) ‘‘shall apply to sales
and uses on or 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 this Act [i.e., Pub. L. 113–
E:\FR\FM\12NON1.SGM
12NON1
emcdonald on DSK67QTVN1PROD with NOTICES
67370
Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices
15]; or (B) the date on which the
Secretary of Health and Human Services
lists any vaccines against seasonal
influenza (other than any vaccine
against seasonal influenza listed by the
Secretary prior to the date of the
enactment of this Act) for purposes of
compensation for any vaccine-related
injury or death through the Vaccine
Injury Compensation Trust Fund.’’
Public Law 113–15, § 1. The law 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. Id.
Under this statutory language, the
effective date of the excise tax for
seasonal influenza vaccines other than
trivalent influenza vaccines is the later
of August 1, 2013 (which is the first day
of the first month beginning more than
4 weeks after the effective date of Public
Law 113–15, which was June 25, 2013),
or the date on which the Secretary
publishes a notice of coverage under the
VICP for seasonal influenza vaccines not
previously covered under the VICP.
This publication is the notice referred to
in the latter requirement. Because this
publication is made after August 1,
2013, the effective date of coverage for
all vaccines against seasonal influenza
(beyond trivalent influenza vaccines,
which are already covered by the VICP)
is the effective date of this publication,
November 12, 2013.
Petitions filed concerning vaccinerelated injuries or deaths associated
with all vaccines against seasonal
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 category of vaccines
under Category XVII 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
VerDate Mar<15>2010
17:41 Nov 08, 2013
Jkt 232001
associated with seasonal influenza
vaccines (with the exception of trivalent
influenza vaccines that are already
covered under the VICP) until
November 12, 2015, as long as the
vaccine-related injury or death occurred
on or before November 12, 2021 (8 years
prior to the effective date of the addition
of non-trivalent seasonal influenza
vaccines as covered vaccines).
The Table will be amended through
subsequent rulemaking to include all
vaccines against seasonal influenza in
place of only trivalent influenza
vaccines under Category XIV of the
Table. Once that is done, the Table’s
coverage provisions (codified at 42 CFR
100.3(c)) will explain that trivalent
influenza vaccines are included on the
Table as of July 1, 2005, and that other
seasonal influenza vaccines are
included on the Table as of November
12, 2013.
Dated: November 5, 2013.
Mary K. Wakefield,
Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, October 10, 2013, 09:00
a.m. to October 10, 2013, 03:00 p.m.,
National Institutes of Health, 6700 B
Rockledge Drive, 3137, Bethesda, MD,
20892 which was published in the
Federal Register on September 16, 2013,
78 FR 56904.
The meeting notice is amended to
change the date of the meeting from
October 10, 2013 to December 5, 2013.
The meeting is closed to the public.
Dated: November 5, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–26906 Filed 11–8–13; 8:45 am]
[FR Doc. 2013–26992 Filed 11–8–13; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Virology—A Study
Section, October 03, 2013, 08:30 a.m. to
October 04, 2013, 05:30 p.m., Embassy
Suites Baltimore—Downtown, 222 St.
Paul Place, Baltimore, MD which was
published in the Federal Register on
September 17, 2013, 78 FR 180 Pgs.
57169–57170.
The meeting will start on December
16, 2013 at 9:00 a.m. and end December
17, 2013 at 5:00 p.m. The meeting
location remains the same. The meeting
is closed to the public.
Dated: November 5, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–26894 Filed 11–8–13; 8:45 am]
PO 00000
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National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
National Institutes of Health
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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: Heart, Lung, and
Blood Initial Review Group; Heart, Lung, and
Blood Program Project Review Committee.
Date: December 6, 2013.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Jeffrey H Hurst, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, National Institutes of Health,
6701 Rockledge Drive, Room 7208, Bethesda,
E:\FR\FM\12NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67369-67370]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26992]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Vaccine Injury Compensation Program: Addition to the
Vaccine Injury Table to Include All Vaccines Against Seasonal Influenza
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Through this notice, the Secretary of the U.S. Department of
Health and Human Services (the Secretary) announces that all FDA-
approved vaccines against seasonal influenza are covered 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. Prior to this publication,
trivalent influenza vaccines were included under Category XIV on the
Vaccine Injury Table (Table) and will continue to be listed in that
category. This notice serves to include all vaccines against seasonal
influenza (not already covered under Category XIV) as covered vaccines
under Category XVII of the Table (new vaccines covered under the VICP).
This notice ensures that petitioners may file petitions relating to all
vaccines against seasonal influenza (not already covered under the
VICP) 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 November 12, 2013. As described
below, all vaccines against seasonal influenza (except trivalent
influenza vaccines, which are already covered under the VICP) will be
covered under the VICP on November 12, 2013.
FOR FURTHER INFORMATION CONTACT: Vito Caserta, M.D., M.P.H., Acting
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) 443-5287.
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)).
By way of background, trivalent influenza vaccines (meaning they
each contain three vaccine virus strains which are thought most likely
to cause disease outbreaks during the influenza season) are routinely
given to millions of individuals in the United States each year.
Trivalent influenza vaccines include an inactivated (killed) virus
vaccine administered using a syringe as well as a live, attenuated
product administered in a nasal spray. All trivalent vaccines have been
covered under the VICP since July 1, 2005. On April 12, 2005, the
Health Resources and Services Administration (HRSA) published a notice
in the Federal Register announcing that such vaccines were covered
under the category for new vaccines on the Table. See 70 FR 19092.
Subsequently, the Secretary engaged in rulemaking to add trivalent
influenza vaccines as a separate category on the Table (category XIV on
the Table). See 76 FR 36367.
Since that time, quadrivalent influenza vaccines (meaning that they
contain four vaccine virus strains which are thought most likely to
cause disease outbreaks during the influenza season) have been approved
by the Food and Drug Administration (FDA), and such vaccines are
expected to be administered as an alternative to trivalent influenza
vaccines during the upcoming and future flu seasons. On June 25, 2013,
Public Law 113-15 was enacted, extending the applicable excise tax on
trivalent influenza vaccines to also include any other vaccines against
seasonal influenza. See Public Law 113-15 (amending 26 U.S.C. Sec.
4132(a)(1)(N)).
The amendment included in Public Law 113-15 ensures that all FDA-
approved seasonal influenza vaccines, including quadrivalent influenza
vaccines, and other new seasonal influenza vaccines are covered under
the VICP. Under the regulations governing the VICP, Category XVII of
the Table specifies that ``[a]ny new vaccine recommended by 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 XVII). As explained in HRSA's notice of coverage with
respect to the coverage of trivalent influenza vaccines, the CDC
recommended in its May 28, 2004, issue of the Morbidity and Mortality
Weekly Report (MMWR) 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. That
recommendation extends to seasonal influenza vaccines beyond trivalent
vaccines. The latest CDC update of its annual influenza vaccination
recommendation was published in the MMWR on September 20, 2013. MMWR
2013;62, No. 7. This report updated the 2012 recommendations by the CDC
and its Advisory Committee on Immunization Practices regarding the use
of influenza vaccines for the prevention and control of seasonal
influenza. Routine annual influenza vaccination is recommended for all
persons aged 6 months and older. For the 2013-14 influenza season, it
is expected that trivalent live attenuated influenza vaccine (LAIV3)
will be replaced by a quadrivalent LAIV formulation (LAIV4).
Inactivated influenza vaccines (IIVs) will be available in both
trivalent (IIV3) and quadrivalent (IIV4) formulations. No preferential
recommendation was made for one influenza vaccine product over another
for persons for whom more than one product is otherwise appropriate.
This notice serves to satisfy the regulation's publication
requirement. Through this notice, all vaccines against seasonal
influenza (beyond trivalent influenza vaccines, which are already
covered under Category XIV on the Table) are included as covered
vaccines under Category XVII of the Table (new 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 Public Law 113-15, the excise tax
for vaccines against seasonal influenza (beyond trivalent influenza
vaccines) ``shall apply to sales and uses on or 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 this Act [i.e., Pub. L. 113-
[[Page 67370]]
15]; or (B) the date on which the Secretary of Health and Human
Services lists any vaccines against seasonal influenza (other than any
vaccine against seasonal influenza listed by the Secretary prior to the
date of the enactment of this Act) for purposes of compensation for any
vaccine-related injury or death through the Vaccine Injury Compensation
Trust Fund.'' Public Law 113-15, Sec. 1. The law 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. Id.
Under this statutory language, the effective date of the excise tax
for seasonal influenza vaccines other than trivalent influenza vaccines
is the later of August 1, 2013 (which is the first day of the first
month beginning more than 4 weeks after the effective date of Public
Law 113-15, which was June 25, 2013), or the date on which the
Secretary publishes a notice of coverage under the VICP for seasonal
influenza vaccines not previously covered under the VICP. This
publication is the notice referred to in the latter requirement.
Because this publication is made after August 1, 2013, the effective
date of coverage for all vaccines against seasonal influenza (beyond
trivalent influenza vaccines, which are already covered by the VICP) is
the effective date of this publication, November 12, 2013.
Petitions filed concerning vaccine-related injuries or deaths
associated with all vaccines against seasonal 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
category of vaccines under Category XVII 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 seasonal influenza vaccines (with the exception of
trivalent influenza vaccines that are already covered under the VICP)
until November 12, 2015, as long as the vaccine-related injury or death
occurred on or before November 12, 2021 (8 years prior to the effective
date of the addition of non-trivalent seasonal influenza vaccines as
covered vaccines).
The Table will be amended through subsequent rulemaking to include
all vaccines against seasonal influenza in place of only trivalent
influenza vaccines under Category XIV of the Table. Once that is done,
the Table's coverage provisions (codified at 42 CFR 100.3(c)) will
explain that trivalent influenza vaccines are included on the Table as
of July 1, 2005, and that other seasonal influenza vaccines are
included on the Table as of November 12, 2013.
Dated: November 5, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-26992 Filed 11-8-13; 8:45 am]
BILLING CODE 4165-15-P
