National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 36367-36369 [2011-15617]
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Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 100
RIN 0906–AA74
National Vaccine Injury Compensation
Program: Revisions to the Vaccine
Injury Table
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Final rule.
AGENCY:
On September 13, 2010, the
Secretary of Health and Human Services
(the Secretary) published in the Federal
Register a Notice of Proposed
Rulemaking (NPRM) proposing changes
to the regulations governing the
National Vaccine Injury Compensation
Program (VICP). Specifically, the
Secretary proposed revisions to the
Vaccine Injury Table (Table) to create
distinct listings for hepatitis A, trivalent
influenza, meningococcal, and human
papillomavirus vaccines. The Secretary
is now making this amendment to the
Table by final rule; it is technical in
nature. The four categories of vaccines
described in this final rule are already
covered vaccines under the VICP
(starting in 2004) and are currently
listed in a placeholder category (box
XIII) in the Table. This final rule will
list these vaccines as separate categories
on the Table, with no associated injuries
noted at this time, in order to help the
public identify clearly that these
vaccines are covered by the VICP. The
changes implemented here are
authorized by section 2114(e) of the
Public Health Service Act (the Act).
DATES: This regulation is effective July
22, 2011.
FOR FURTHER INFORMATION CONTACT:
Geoffrey Evans, M.D., Director, Division
of Vaccine Injury Compensation,
Healthcare Systems Bureau, Health
Resources and Services Administration,
Room 11C–26, Parklawn Building, 5600
Fishers Lane, Rockville, Maryland
20857; telephone at (301) 443–6593.
SUPPLEMENTARY INFORMATION: On
September 13, 2010, the Secretary
published in the Federal Register (75
FR 55503, September 13, 2010) an
NPRM to revise and amend the Table by
moving these vaccines to separate and
distinct listings of the Table. The NPRM
was issued pursuant to Section 2114(e)
of the Act, which directs the Secretary
to add to the Table, by rulemaking,
coverage of additional vaccines which
are recommended by the Centers for
Disease Control and Prevention for
routine administration to children.
The Department held a 6-month
comment period, which ended on
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SUMMARY:
VerDate Mar<15>2010
18:22 Jun 21, 2011
Jkt 223001
March 14, 2011, in connection with this
NPRM. The Secretary received one nonsubstantive comment that was not
responsive to the NPRM. A public
hearing was held on March 4, 2011, as
announced in the Federal Register (76
FR 8965, February 16, 2011), but no
individual or organization appeared to
testify.
Because the Secretary has not
received any substantive comments,
either written or oral, from any
interested individual or organization on
the proposals made in the NPRM, and
because the Secretary continues to
believe the advisability of effectuating
such proposals, this final rule
implements the proposals made in the
NPRM. The rationale for all revisions
were explained fully in the Preamble to
the NPRM. For the reasons set forth in
the NPRM, the Secretary amends the
Table in this final rule.
Economic and Regulatory Impact
Executive Order 12866, as amended
by Executive Orders 13258 and 13422,
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when rulemaking is
necessary, to select regulatory
approaches that provide the greatest net
benefits (including potential economic,
environmental, public health, safety,
distributive and equity effects). In
addition, under the Regulatory
Flexibility Act, if a rule has a significant
economic effect on a substantial number
of small entities, the Secretary must
specifically consider the economic
effect of a rule on small entities and
analyze regulatory options that could
lessen the impact of the rule. Executive
Order 12866, as amended by Executive
Orders 13258 and 13422, requires that
all regulations reflect consideration of
alternatives, of costs, of benefits, of
incentives, of equity, and of available
information. Regulations must meet
certain standards, such as avoiding an
unnecessary burden. Regulations which
are ‘‘significant’’ because of cost,
adverse effects on the economy,
inconsistency with other agency actions,
effects on the budget, or novel legal or
policy issues, require special analysis.
The Secretary has determined that no
resources are required to implement the
requirements in this final rule.
Therefore, in accordance with the
Regulatory Flexibility Act of 1980
(RFA), and the Small Business
Regulatory Enforcement Fairness Act of
1996, which amended the RFA, the
Secretary certifies that this final rule
will not have a significant impact on a
substantial number of small entities.
The Secretary has also determined
that this final rule does not meet the
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36367
criteria for a major rule as defined by
Executive Order 12866, as amended by
Executive Orders 13258 and 13422, and
would have no major effect on the
economy or Federal expenditures. The
Secretary has determined that this final
rule is not a ‘‘major rule’’ within the
meaning of the statute providing for
Congressional Review of Agency
Rulemaking, 5 U.S.C. 801.
Similarly, it will not have effects on
State, local, and Tribal governments and
on the private sector such as to require
consultation under the Unfunded
Mandates Reform Act of 1995.
The Secretary has reviewed this final
rule in accordance with Executive Order
13132 regarding federalism, and has
determined that it does not have
‘‘federalism implications.’’ This final
rule would not ‘‘have substantial direct
effects on the States, or on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’
This final rule would not adversely
affect the following family elements:
Family safety, family stability, marital
commitment; parental rights in the
education, nurture and supervision of
their children; family functioning,
disposable income or poverty; or the
behavior and personal responsibility of
youth, as determined under section
654(c) of the Treasury and General
Government Appropriations Act of
1999.
Impact of the New Rule
This final rule is technical in nature.
Because the vaccines being added to the
Table as separate categories are already
included on the Table under Category
XIII, this Table will have no effect on
current or potential petitioners other
than to help clarify which vaccines are
covered by the VICP. This final rule
would not prevent otherwise eligible
individuals with claims of injuries or
deaths allegedly resulting from the
hepatitis A, trivalent influenza,
meningococcal and human
papillomavirus vaccines from filing
claims with the VICP and would not
otherwise affect such petitioners.
Paperwork Reduction Act
This final rule does not have any
information collection requirements.
E:\FR\FM\22JNR1.SGM
22JNR1
36368
Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations
Dated: May 2, 2011.
Mary Wakefield,
Administrator, Health Resources and Services
Administration.
Approved: June 16, 2011.
Kathleen Sebelius,
Secretary.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, and
Immunization.
Accordingly, 42 CFR part 100 is
amended as set forth below:
1. The authority citation for 42 CFR
part 100 continues to read as follows:
Authority: Secs. 312 and 313 of Pub. L.
99–660, 100 Stat. 3779–3782 (42 U.S.C.
300aa–1 note); sec. 2114(c) and (e) of the PHS
Act (42 U.S.C. 300aa–14(c) and (e)); sec.
2115(a)(3)(B) of the PHS Act (42 U.S.C.
300aa–15(a)(3)(B)); sec. 904(b) of Pub. L. 105–
34, 111 Stat. 873; sec. 1503 of Pub. L. 105–
277, 112 Stat. 2681–741; and sec. 523(a) of
Pub. L. 106–170, 113 Stat. 1927–1928.
2. Amend § 100.3 by revising the
Vaccine Injury Table following
paragraph (a), revising paragraph (c)(1),
redesignating paragraph (c)(5) as
paragraph (c)(8) and revising newly
designated paragraph (c)(8), and adding
new paragraphs (c)(5), (c)(6), and (c)(7),
to read as follows:
§ 100.3
PART 100—VACCINE INJURY
COMPENSATION
■
■
Vaccine injury table
(a) * * *
VACCINE INJURY TABLE
Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration
Vaccine
Illness, disability, injury or condition covered
I. Vaccines containing tetanus toxoid
(e.g., DTaP, DTP, DT, Td, or TT).
A. Anaphylaxis or anaphylactic shock .........................................
4 hours.
B. Brachial Neuritis ......................................................................
C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which
illness, disability, injury, or condition arose within the time period prescribed.
A. Anaphylaxis or anaphylactic shock .........................................
2–28 days.
Not applicable.
B. Encephalopathy (or encephalitis) ............................................
C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which
illness, disability, injury, or condition arose within the time period prescribed.
A. Anaphylaxis or anaphylactic shock .........................................
72 hours.
Not applicable.
B. Encephalopathy (or encephalitis) ............................................
5–15 days (not less than 5 days and
not more than 15 days).
Not applicable.
II. Vaccines containing whole cell pertussis bacteria, extracted or partial
cell pertussis bacteria, or specific
pertussis antigen(s) (e.g., DTP,
DTaP, P, DTP–Hib).
III. Measles, mumps, and rubella vaccine or any of its components (e.g.,
MMR, MR, M, R).
IV. Vaccines containing rubella virus
(e.g., MMR, MR, R).
V. Vaccines containing measles virus
(e.g., MMR, MR, M).
B. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which
illness, disability, injury, or condition arose within the time period prescribed.
A. Thrombocytopenic purpura .....................................................
4 hours.
7–42 days.
Not applicable.
7–30 days.
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18:22 Jun 21, 2011
B. Vaccine-Strain Measles Viral Infection in an immunodeficient
recipient.
C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which
illness, disability, injury, or condition arose within the time period prescribed.
A. Paralytic Polio .........................................................................
6 months.
—in a non-immunodeficient recipient ...................................
—in an immunodeficient recipient ........................................
—in a vaccine associated community case .........................
B. Vaccine-Strain Polio Viral Infection.
—in a non-immunodeficient recipient ...................................
—in an immunodeficient recipient ........................................
—in a vaccine associated community case .........................
C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which
illness, disability, injury, or condition arose within the time period prescribed.
VI. Vaccines containing polio live virus
(OPV).
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C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which
illness, disability, injury, or condition arose within the time period prescribed.
A. Chronic arthritis .......................................................................
4 hours.
30 days.
6 months.
Not applicable.
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Not applicable.
30 days.
6 months.
Not applicable.
Not applicable.
22JNR1
Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations
36369
VACCINE INJURY TABLE—Continued
Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration
Vaccine
Illness, disability, injury or condition covered
VII. Vaccines containing polio inactivated virus (e.g., IPV).
A. Anaphylaxis or anaphylactic shock .........................................
4 hours
Not applicable.
VIII. Hepatitis B. vaccines ....................
B. Any acute complication or sequela (including death of an illness, disability, injury, or condition referred to above which
illness, disability, injury, or condition arose within the time period prescribed..
A. Anaphylaxis or anaphylactic shock .........................................
B. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which
illness, disability, injury, or condition arose within the time period prescribed.
No Condition Specified ................................................................
4 hours.
Not applicable.
No
No
No
No
No
No
No
Not
Not
Not
Not
Not
Not
Not
IX. Hemophilus influenzae type b polysaccharide conjugate vaccines.
X. Varicella vaccine .............................
XI. Rotavirus vaccine ...........................
XII. Pneumococcal conjugate vaccines
XIII. Hepatitis A vaccines .....................
XIV. Trivalent influenza vaccines ........
XV. Meningococcal vaccines ...............
XVI. Human papillomavirus (HPV)
vaccines.
XVII. Any new vaccine recommended
by the Centers for Disease Control
and Prevention for routine administration to children, after publication
by the Secretary of a notice of coverage.
*
*
*
*
(c) * * * (1) Except as provided in
paragraph (c)(2), (3), (4), (5), (6), or (7)
of this section, the revised Table of
Injuries set forth in paragraph (a) of this
section and the Qualifications and Aids
to Interpretation set forth in paragraph
(b) of this section apply to petitions for
compensation under the Program filed
with the United States Court of Federal
Claims on or after March 24, 1997.
Petitions for compensation filed before
such date shall be governed by section
2114(a) and (b) of the Public Health
Service Act as in effect on January 1,
1995, or by § 100.3 as in effect on March
10, 1995 (see 60 FR 7678, et seq.,
February 8, 1995), as applicable.
*
*
*
*
*
(5) Hepatitis A vaccines (Item XIII of
the Table) are included on the Table as
of December 1, 2004.
(6) Trivalent influenza vaccines (Item
XIV of the Table) are included on the
Table as of July 1, 2005.
(7) Meningococcal vaccines and
human papillomavirus vaccines (Items
XV and XVI of the Table) are included
on the Table as of February 1, 2007.
(8) Other new vaccines (Item XVII of
the Table) will be included in the Table
as of the effective date of a tax enacted
to provide funds for compensation paid
with respect to such vaccines. An
amendment to this section will be
published in the Federal Register to
VerDate Mar<15>2010
18:22 Jun 21, 2011
Specified
Specified
Specified
Specified
Specified
Specified
Specified
................................................................
................................................................
................................................................
................................................................
................................................................
................................................................
................................................................
No Condition Specified ................................................................
*
jlentini on DSK4TPTVN1PROD with RULES
Condition
Condition
Condition
Condition
Condition
Condition
Condition
Jkt 223001
announce the effective date of such a
tax.
*
*
*
*
*
[FR Doc. 2011–15617 Filed 6–21–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2011–0002; Internal
Agency Docket No. FEMA–8185]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities, where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP), that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
SUMMARY:
PO 00000
Frm 00089
Fmt 4700
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Not applicable.
applicable.
applicable.
applicable.
applicable.
applicable.
applicable.
applicable.
Not applicable.
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date.
DATES: Effective Dates: The effective
date of each community’s scheduled
suspension is the third date (‘‘Susp.’’)
listed in the third column of the
following tables.
FOR FURTHER INFORMATION CONTACT: If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact David Stearrett,
Mitigation Directorate, Federal
Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,
(202) 646–2953.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
flood insurance which is generally not
otherwise available. In return,
communities agree to adopt and
administer local floodplain management
aimed at protecting lives and new
construction from future flooding.
Section 1315 of the National Flood
Insurance Act of 1968, as amended,
42 U.S.C. 4022, prohibits flood
insurance coverage as authorized under
the NFIP, 42 U.S.C. 4001 et seq.; unless
an appropriate public body adopts
adequate floodplain management
E:\FR\FM\22JNR1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36367-36369]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15617]
[[Page 36367]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 100
RIN 0906-AA74
National Vaccine Injury Compensation Program: Revisions to the
Vaccine Injury Table
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On September 13, 2010, the Secretary of Health and Human
Services (the Secretary) published in the Federal Register a Notice of
Proposed Rulemaking (NPRM) proposing changes to the regulations
governing the National Vaccine Injury Compensation Program (VICP).
Specifically, the Secretary proposed revisions to the Vaccine Injury
Table (Table) to create distinct listings for hepatitis A, trivalent
influenza, meningococcal, and human papillomavirus vaccines. The
Secretary is now making this amendment to the Table by final rule; it
is technical in nature. The four categories of vaccines described in
this final rule are already covered vaccines under the VICP (starting
in 2004) and are currently listed in a placeholder category (box XIII)
in the Table. This final rule will list these vaccines as separate
categories on the Table, with no associated injuries noted at this
time, in order to help the public identify clearly that these vaccines
are covered by the VICP. The changes implemented here are authorized by
section 2114(e) of the Public Health Service Act (the Act).
DATES: This regulation is effective July 22, 2011.
FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Director,
Division of Vaccine Injury Compensation, Healthcare Systems Bureau,
Health Resources and Services Administration, Room 11C-26, Parklawn
Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone at
(301) 443-6593.
SUPPLEMENTARY INFORMATION: On September 13, 2010, the Secretary
published in the Federal Register (75 FR 55503, September 13, 2010) an
NPRM to revise and amend the Table by moving these vaccines to separate
and distinct listings of the Table. The NPRM was issued pursuant to
Section 2114(e) of the Act, which directs the Secretary to add to the
Table, by rulemaking, coverage of additional vaccines which are
recommended by the Centers for Disease Control and Prevention for
routine administration to children.
The Department held a 6-month comment period, which ended on March
14, 2011, in connection with this NPRM. The Secretary received one non-
substantive comment that was not responsive to the NPRM. A public
hearing was held on March 4, 2011, as announced in the Federal Register
(76 FR 8965, February 16, 2011), but no individual or organization
appeared to testify.
Because the Secretary has not received any substantive comments,
either written or oral, from any interested individual or organization
on the proposals made in the NPRM, and because the Secretary continues
to believe the advisability of effectuating such proposals, this final
rule implements the proposals made in the NPRM. The rationale for all
revisions were explained fully in the Preamble to the NPRM. For the
reasons set forth in the NPRM, the Secretary amends the Table in this
final rule.
Economic and Regulatory Impact
Executive Order 12866, as amended by Executive Orders 13258 and
13422, directs agencies to assess all costs and benefits of available
regulatory alternatives and, when rulemaking is necessary, to select
regulatory approaches that provide the greatest net benefits (including
potential economic, environmental, public health, safety, distributive
and equity effects). In addition, under the Regulatory Flexibility Act,
if a rule has a significant economic effect on a substantial number of
small entities, the Secretary must specifically consider the economic
effect of a rule on small entities and analyze regulatory options that
could lessen the impact of the rule. Executive Order 12866, as amended
by Executive Orders 13258 and 13422, requires that all regulations
reflect consideration of alternatives, of costs, of benefits, of
incentives, of equity, and of available information. Regulations must
meet certain standards, such as avoiding an unnecessary burden.
Regulations which are ``significant'' because of cost, adverse effects
on the economy, inconsistency with other agency actions, effects on the
budget, or novel legal or policy issues, require special analysis.
The Secretary has determined that no resources are required to
implement the requirements in this final rule. Therefore, in accordance
with the Regulatory Flexibility Act of 1980 (RFA), and the Small
Business Regulatory Enforcement Fairness Act of 1996, which amended the
RFA, the Secretary certifies that this final rule will not have a
significant impact on a substantial number of small entities.
The Secretary has also determined that this final rule does not
meet the criteria for a major rule as defined by Executive Order 12866,
as amended by Executive Orders 13258 and 13422, and would have no major
effect on the economy or Federal expenditures. The Secretary has
determined that this final rule is not a ``major rule'' within the
meaning of the statute providing for Congressional Review of Agency
Rulemaking, 5 U.S.C. 801.
Similarly, it will not have effects on State, local, and Tribal
governments and on the private sector such as to require consultation
under the Unfunded Mandates Reform Act of 1995.
The Secretary has reviewed this final rule in accordance with
Executive Order 13132 regarding federalism, and has determined that it
does not have ``federalism implications.'' This final rule would not
``have substantial direct effects on the States, or on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.''
This final rule would not adversely affect the following family
elements: Family safety, family stability, marital commitment; parental
rights in the education, nurture and supervision of their children;
family functioning, disposable income or poverty; or the behavior and
personal responsibility of youth, as determined under section 654(c) of
the Treasury and General Government Appropriations Act of 1999.
Impact of the New Rule
This final rule is technical in nature. Because the vaccines being
added to the Table as separate categories are already included on the
Table under Category XIII, this Table will have no effect on current or
potential petitioners other than to help clarify which vaccines are
covered by the VICP. This final rule would not prevent otherwise
eligible individuals with claims of injuries or deaths allegedly
resulting from the hepatitis A, trivalent influenza, meningococcal and
human papillomavirus vaccines from filing claims with the VICP and
would not otherwise affect such petitioners.
Paperwork Reduction Act
This final rule does not have any information collection
requirements.
[[Page 36368]]
Dated: May 2, 2011.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
Approved: June 16, 2011.
Kathleen Sebelius,
Secretary.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, and Immunization.
Accordingly, 42 CFR part 100 is amended as set forth below:
PART 100--VACCINE INJURY COMPENSATION
0
1. The authority citation for 42 CFR part 100 continues to read as
follows:
Authority: Secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-
3782 (42 U.S.C. 300aa-1 note); sec. 2114(c) and (e) of the PHS Act
(42 U.S.C. 300aa-14(c) and (e)); sec. 2115(a)(3)(B) of the PHS Act
(42 U.S.C. 300aa-15(a)(3)(B)); sec. 904(b) of Pub. L. 105-34, 111
Stat. 873; sec. 1503 of Pub. L. 105-277, 112 Stat. 2681-741; and
sec. 523(a) of Pub. L. 106-170, 113 Stat. 1927-1928.
0
2. Amend Sec. 100.3 by revising the Vaccine Injury Table following
paragraph (a), revising paragraph (c)(1), redesignating paragraph
(c)(5) as paragraph (c)(8) and revising newly designated paragraph
(c)(8), and adding new paragraphs (c)(5), (c)(6), and (c)(7), to read
as follows:
Sec. 100.3 Vaccine injury table
(a) * * *
Vaccine Injury Table
------------------------------------------------------------------------
Time period for
first symptom or
manifestation of
Illness, disability, onset or of
Vaccine injury or condition significant
covered aggravation
after vaccine
administration
------------------------------------------------------------------------
I. Vaccines containing tetanus A. Anaphylaxis or 4 hours.
toxoid (e.g., DTaP, DTP, DT, anaphylactic shock.
Td, or TT).
B. Brachial Neuritis.. 2-28 days.
C. Any acute Not applicable.
complication or
sequela (including
death) of an illness,
disability, injury,
or condition referred
to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
II. Vaccines containing whole A. Anaphylaxis or 4 hours.
cell pertussis bacteria, anaphylactic shock.
extracted or partial cell
pertussis bacteria, or
specific pertussis antigen(s)
(e.g., DTP, DTaP, P, DTP-Hib).
B. Encephalopathy (or 72 hours.
encephalitis).
C. Any acute Not applicable.
complication or
sequela (including
death) of an illness,
disability, injury,
or condition referred
to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
III. Measles, mumps, and A. Anaphylaxis or 4 hours.
rubella vaccine or any of its anaphylactic shock.
components (e.g., MMR, MR, M,
R).
B. Encephalopathy (or 5-15 days (not
encephalitis). less than 5
days and not
more than 15
days).
C. Any acute Not applicable.
complication or
sequela (including
death) of an illness,
disability, injury,
or condition referred
to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
IV. Vaccines containing A. Chronic arthritis.. 7-42 days.
rubella virus (e.g., MMR, MR,
R).
B. Any acute Not applicable.
complication or
sequela (including
death) of an illness,
disability, injury,
or condition referred
to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
V. Vaccines containing measles A. Thrombocytopenic 7-30 days.
virus (e.g., MMR, MR, M). purpura.
B. Vaccine-Strain 6 months.
Measles Viral
Infection in an
immunodeficient
recipient.
C. Any acute Not applicable.
complication or
sequela (including
death) of an illness,
disability, injury,
or condition referred
to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
VI. Vaccines containing polio A. Paralytic Polio.... ................
live virus (OPV).
--in a non- 30 days.
immunodeficient
recipient.
--in an 6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
B. Vaccine-Strain
Polio Viral Infection.
--in a non- 30 days.
immunodeficient
recipient.
--in an 6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
C. Any acute Not applicable.
complication or
sequela (including
death) of an illness,
disability, injury,
or condition referred
to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
[[Page 36369]]
VII. Vaccines containing polio A. Anaphylaxis or 4 hours
inactivated virus (e.g., IPV). anaphylactic shock.
B. Any acute Not applicable.
complication or
sequela (including
death of an illness,
disability, injury,
or condition referred
to above which
illness, disability,
injury, or condition
arose within the time
period prescribed..
VIII. Hepatitis B. vaccines... A. Anaphylaxis or 4 hours.
anaphylactic shock.
B. Any acute Not applicable.
complication or
sequela (including
death) of an illness,
disability, injury,
or condition referred
to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
IX. Hemophilus influenzae type No Condition Specified Not applicable.
b polysaccharide conjugate
vaccines.
X. Varicella vaccine.......... No Condition Specified Not applicable.
XI. Rotavirus vaccine......... No Condition Specified Not applicable.
XII. Pneumococcal conjugate No Condition Specified Not applicable.
vaccines.
XIII. Hepatitis A vaccines.... No Condition Specified Not applicable.
XIV. Trivalent influenza No Condition Specified Not applicable.
vaccines.
XV. Meningococcal vaccines.... No Condition Specified Not applicable.
XVI. Human papillomavirus No Condition Specified Not applicable.
(HPV) vaccines.
XVII. Any new vaccine No Condition Specified Not applicable.
recommended by the Centers
for Disease Control and
Prevention for routine
administration to children,
after publication by the
Secretary of a notice of
coverage.
------------------------------------------------------------------------
* * * * *
(c) * * * (1) Except as provided in paragraph (c)(2), (3), (4),
(5), (6), or (7) of this section, the revised Table of Injuries set
forth in paragraph (a) of this section and the Qualifications and Aids
to Interpretation set forth in paragraph (b) of this section apply to
petitions for compensation under the Program filed with the United
States Court of Federal Claims on or after March 24, 1997. Petitions
for compensation filed before such date shall be governed by section
2114(a) and (b) of the Public Health Service Act as in effect on
January 1, 1995, or by Sec. 100.3 as in effect on March 10, 1995 (see
60 FR 7678, et seq., February 8, 1995), as applicable.
* * * * *
(5) Hepatitis A vaccines (Item XIII of the Table) are included on
the Table as of December 1, 2004.
(6) Trivalent influenza vaccines (Item XIV of the Table) are
included on the Table as of July 1, 2005.
(7) Meningococcal vaccines and human papillomavirus vaccines (Items
XV and XVI of the Table) are included on the Table as of February 1,
2007.
(8) Other new vaccines (Item XVII of the Table) will be included in
the Table as of the effective date of a tax enacted to provide funds
for compensation paid with respect to such vaccines. An amendment to
this section will be published in the Federal Register to announce the
effective date of such a tax.
* * * * *
[FR Doc. 2011-15617 Filed 6-21-11; 8:45 am]
BILLING CODE 4165-15-P
