Smallpox Vaccine Injury Compensation
Program: Smallpox (Vaccinia) Vaccine Injury
Table
Federal
Register: May 24, 2006 (Volume 71,
Number 100)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services Administration
AGENCY: Health Resources and Services Administration (HRSA), HHS
ACTION: Adoption of interim final rule
as final rule with an amendment.
SUMMARY: This document adopts the Smallpox (Vaccinia) Vaccine Injury
Table (the Table) Interim Final Rule as the Final Rule with an
amendment, as follows: the Final Rule clarifies that, in order for the
presumption of causation to apply, the time intervals listed on the
Table refer specifically to the period in which the first symptom or
manifestation of onset of injury must appear following administration
of the smallpox vaccine or exposure to vaccinia, and that the time
intervals listed have no relevance to time of diagnosis of the injury.
DATES: The Interim Final Rule, published
on August 27, 2003, was effective on that
date, and is adopted as the Final Rule
with an
amendment effective May 24, 2006.
FOR FURTHER INFORMATION CONTACT: Paul
T. Clark, Director, Smallpox Vaccine Injury
Compensation Program, Healthcare Systems
Bureau, Health
Resources and Services Administration,
(301) 443-2330.
SUPPLEMENTARY INFORMATION:
The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA),
Pub. L. 108-20, 117 Stat. 638, directed the Secretary of Health and
Human Services (the Secretary) to establish
the Smallpox Vaccine Injury
Compensation Program (the Program).
Secondary to other payers, the
Program provides medical, lost employment income, and death benefits
for eligible individuals who sustained
covered injuries as a result of
receiving smallpox vaccine or other
covered countermeasures, or as a
result of accidental exposure to vaccinia. Congress appropriated
$42 million in fiscal year (FY) 2003 for
the administration of, and payment
of benefits under, the Program. The
Consolidated Appropriations Act of
2005 reduced this appropriation to $22 million. The Departments of
Labor, Health and Human Services, and
Education, and Related Agencies
Appropriations Act, 2006 (Pub. L. 109-149)
further reduced the
Program's appropriation by $10 million to a total of $12 million.
Individuals who receive a smallpox vaccination
under a Department of Health and Human
Services (HHS),
State,
or local emergency response
plan approved by HHS within the
period described in the Secretary's
Declaration, and who sustain a covered injury may be eligible for
benefits under SEPPA. Individuals who contracted
vaccinia through
contact with such individuals or other eligible vaccinia contacts
and who sustain a covered injury may also
be eligible for benefits. In the
case of death resulting directly
from
receipt of the smallpox vaccine
or exposure to vaccinia by eligible individuals, certain of their
survivors may be considered for death benefits.
If an eligible
individual who sustained a covered injury dies from another cause
before payment of benefits has been made
under the Program, the estate
may qualify for payment of unreimbursed
medical expenses incurred and
employment income lost as a result of the covered injury, secondary
to other payers. SEPPA directed the Secretary
to establish a table
identifying adverse effects (including injuries, disabilities,
conditions, and deaths) that shall be presumed to result from the
administration of, or exposure to, the smallpox vaccine, and the
time interval in which the first symptom
or
manifestation of each listed
injury must appear in order for such presumption to apply. An Interim
Final Rule for the Table was published
in the Federal Register on
August 27, 2003 (68 FR 51492), with public comments sought on these
provisions.
Based on the comments received, this
Final Rule clarifies that the Table is
not the sole standard for
determining
medical eligibility for
benefits under the Program. Therefore, an individual who sustains
an injury that is not on the Table or not
within the timeframes on the
Table, and believes it was caused by a smallpox vaccination, is
encouraged to submit a Request Package to the Program. This Final Rule
makes it clear that the time intervals on the Table refer specifically
to the first symptom or manifestation of onset of illness or injury,
not to the date of the diagnosis. It also clarifies that any component
of a smallpox vaccine, not only the vaccinia, could be the possible
cause of a covered injury. Further, this regulation updates the Interim
Final Rule to reflect that the Secretary has extended the effective
period of the Declaration Regarding Administration of Smallpox
Countermeasures (the Declaration). Finally, this Final Rule also
updates the change in name of the Special Programs Bureau to the
Healthcare Systems Bureau; and provides the new address of the Program
Office.
Discussion of Comments
The public comment period ended on October
27, 2003. HHS received a total of 11 public
comments. Four were from professional associations;
three were from medical professionals;
two were from the general
public; one was from a State health department; and one was from
a nonprofit community health organization.
The issues raised and HHS's
responses appear below.
A. Time Intervals for the First Symptom
or Manifestation of Onset of Injury
The Secretary received two comments suggesting
that the time intervals listed on the Table
be lengthened. One commenter
requested that the Secretary extend the
time limit
for the onset of myocarditis
and pericarditis from 21 days to 60 days. The other commenter
indicated
concern that the time intervals listed
on the Table seem potentially
short, and should be determined in consultation with the
Centers for Disease Control and Prevention
(CDC) and the military regarding all
the
Table time intervals, independent of how long it takes for
a
scab to fall off. The Secretary received
a third
comment related to the time
intervals on the Table requesting an appeal process to the
Table time intervals.
The Secretary does not concur with changing
the time intervals on the Table, whether
it be for
the
onset of myocarditis or pericarditis
from 21 to 60 days, or any other seemingly short time intervals.
The Secretary did consult with
the Department of Defense (DoD) and CDC,
as well as with other HHS components
and
the private sector. Their
scientific data support the time
intervals as specified on the Table.
The commenters did not provide evidence to support lengthening
the time intervals beyond that
which the Secretary had already considered
and,
therefore, they remain as currently listed. However, as
discussed
below, if any individual has symptoms
that
manifest outside of those
time intervals, he or she may still be considered for benefits
under the Program.
The third commenter expressed the hope
that the Table permits adequate time for
injured individuals
to seek compensation, and
recommended that language be added to the regulations to
provide
an avenue for appeal to the timeframes
established in the Table, should
an individual become ill or exhibit symptoms
related to the vaccine
beyond the established Table timeframes.
The Secretary wishes to emphasize that
an injury that manifests itself outside
of the timeframe
listed
on the Table may still be a
covered injury. The Secretary recognizes that symptoms
can occur subsequent to the Table timeframes
in
some cases. In this event, the
individual may be found medically eligible if he or she
submits
evidence to show that it is more
likely than not that the smallpox
vaccine or other covered countermeasure, or the vaccinia
contracted from accidental vaccinia exposure,
actually caused the injury. SEPPA
does not provide an avenue for appeal of the timeframes
established in the Table. Thus, the Secretary
disagrees
with the commenter that there
is a need for an appeal process for the time intervals.
However,
the Secretary has established a
reconsideration process for re-review of
the Program's determinations on medical/program and financial
eligibility requirements through
the
Administrative
Regulations for this Program published
in the Federal Register on December 16,
2003. If
a requester is not satisfied with the Program's decisions, the
requester has the right to seek reconsideration
of any adverse
determination.
There were two additional comments regarding
time intervals. One commenter wanted to
make sure that
HHS clarifies that the time
intervals relate to the timeframe of the first symptom
or manifestation of onset of injury, not
to the timeframe
of the diagnosis. The
Secretary agrees with this comment and has clarified this
issue by inserting appropriate language
into
this Final Rule.
The other commenter requested that the
time intervals of 21 days be extended because
it may take
6 to 8 weeks for the scab at the
vaccination site to fall off. The Secretary does not agree
to change the time intervals on the Table
because these timeframes are not
related to the time it takes for the scab to fall off spontaneously.
B. Additions of Injuries to the Table
There were three comments pertaining
to the injuries listed on the Table. Two
comments suggested that the Table should
be amended to include myocardial infarction
and tremors,
respectively. The other
commenter indicated that the list of injuries limited
to those published in the August 27,
2003,
Interim
Final Rule, was incomplete.
The Secretary does not concur with these
comments. At this time, there is no clear
scientific
evidence
to support the inclusion of
myocardial infarction, tremors, or other
conditions
as additional Table injuries, and the
commenters did
not provide additional evidence
showing it would be appropriate to
add more Table injuries.
Should an individual have any injury
believed to have resulted from the
administration of, or exposure to, the smallpox vaccine
that
is not listed on the Table,
he
or she may nevertheless be eligible
for benefits and should submit a request
to the Program.
C. The Documentation Requirements
One commenter raised the issue that the
Table regulations exceed the statute's
requirements in terms of medical
injury documentation
burden and related cost.
The commenter believes that these regulations
are far more onerous than SEPPA
requires, specifying that
the issues of documenting method
of treatment,
identification of injury,
etc.,
are not even referenced in the
statute. The
commenter stated that
the burdensome and costly
requirements for first responders should
immediately be rescinded.
The Secretary disagrees with the commenter
that the documentation requirement is
onerous and exceeds legislative
intent. The specific
comment
relates to the requirement for a treatment plan in order to be
considered for a Table injury. This language
appears in five of the twelve Table injuries.
The
requirement
for a treatment plan is
case-
specific and applies only in certain circumstances
where there is an issue of needed
long-term medical/surgical
care. Requesters do not
need
to provide one in order to be considered for a Table
injury.
The commenter also wrote
that
first responders are
obligated
to pay out of their own
pockets for immediate treatment and again
for a detailed surgical treatment plan.
Section
264(b) of the Smallpox
Emergency Personnel Protection
Act
of 2003 establishes that the
government is the payer of last resort after
all other payments have been or will be
made
to an individual
for medical care directly
resulting from an injury caused by the
smallpox vaccination.
Individuals are reimbursed
for
their out-of-pocket medical expenses
in accordance with the Act.
D. Other Issues Raised by Commenters
One commenter raised the concern that
the Table regulations cover only those
injuries caused by the vaccinia
virus and not
all components of the smallpox
vaccine. Another
commenter was concerned
about the scope of the Program and
if it would cover the general population.
In reference to the issue of the components
in the
smallpox vaccine, the Secretary
concurs that the
components of a smallpox
vaccine may cause a covered injury. Therefore, the Secretary
has clarified in this final regulation that a covered injury
can be caused
not only by vaccinia, but by any component or constituent of
the smallpox vaccine.
In response to the concern about the scope
of the legislation, SEPPA only covers individuals
who are members of HHS-approved
smallpox
emergency response plans and individuals
who contracted vaccinia from them or from
other eligible contacts. SEPPA is not designed
to provide
benefits to the general population.
Explanation of Provisions
Some of the comments received indicate
to the Secretary that there may be confusion
as to the significance
of the Table. Therefore,
this Final Rule clarifies that having
an injury listed on the Table is only
one of the ways that an individual can
show medical eligibility for Program
benefits. The Secretary emphasizes that
the purpose
of the
Table is merely to provide potential
requesters who can demonstrate
that they sustained a Table injury within
the specified time interval
with the presumption that the smallpox
vaccine caused the injury. However, sustaining
an injury not listed on the Table (including
an
injury resulting from administration
of another covered
countermeasure), or manifesting a Table
injury outside of the time interval listed,
simply means that the presumption does
not apply. In
those cases, the individual must show
that it is more likely than not (i.e.,
by a
preponderance of the evidence), that
administration of the
smallpox vaccine (or other covered countermeasure),
or exposure
to the vaccine in the case of contacts,
was the cause of the injury. The
Secretary encourages such individuals
to file a request for benefits. The Program
has found individuals with Table or non-Table
injuries
to
be medically eligible.
As previously mentioned, this Final
Rule also clarifies that the time intervals
listed on the Table refer specifically
to
the period in
which the first symptom or manifestation
of onset of injury must appear following
administration of the smallpox vaccine
or exposure
to
vaccinia, in order for the presumption
of causation to apply. The time intervals
listed have no relevance whatsoever to
when
the injury is
diagnosed.
Thus, the Secretary herein amends § 102.21(a) of the Interim Final Rule
by adding language to the subheading of
the Table that lists
the time intervals. This additional
language
makes it clear that
these time intervals refer only to
the first symptom or manifestation of
onset of the injury, not to the time
interval within which a diagnosis of
the injury
must be made.
The Secretary also wishes to make
it clear that a covered injury can be
caused not only by the vaccinia component
of
the
smallpox
vaccine, but by any component or constituent
of the vaccine.
Further, this Final Rule updates
the effective period of the Secretary's
Declaration.
The Secretary has amended the effective
period
of the Declaration by extending it
each year. The Secretary will
continue to publish a Notice in the
Federal Register as needed to
update any further amendments to the
effective period. These amendments to
the Declaration
are made pursuant to the Secretary's
authority under
section 261(a)(5) of SEPPA (section
224(p)(2)(A) of the Public Health Service
Act).
Additionally, this Final Rule reflects
the change in name of the Special Programs
Bureau, which has been renamed the
Healthcare Systems
Bureau. Finally, this regulation updates
the address of the Program
Office. The new address, to which
all mail to the Program should be
sent, whether by U.S. Postal Service,
commercial carrier, or private courier
service, is:
Parklawn Building, Room 11C-06,
5600 Fishers Lane,
Rockville, Maryland 20857.
Justification of Waiver of Delay of Effective
Date
The Secretary has found that a delay
in the effective date of this Final Rule
with an amendment is unnecessary
and contrary to the public interest.
The adoption of the Interim Final Rule
as a
Final Rule
reflects an amendment and clarifications that are a result of
comments received on the Interim Final Rule and, therefore,
will be helpful to
requesters without imposing additional burdens. It has no effect
on any individual's rights or responsibilities.
Economic and Regulatory Impact
Executive Order 12866 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 of 1980
(RFA), 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 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
that 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 minimal resources are required
to implement the provisions
included in this regulation. Therefore,
in
accordance with the 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 rule does not meet the criteria
for a major rule as defined by Executive
Order
12866 and would
have no major effect on the
economy or Federal expenditures. This rule
is
not
a ``major rule'' within the meaning
of the
statute providing for
Congressional Review of Agency
Rulemaking, 5 U.S.C. 801.
Unfunded Mandates Reform Act of 1995
The Secretary has determined that this
Final Rule will not have effects on State,
local,
or tribal governments or on the private
sector
such as to require consultation under
the
Unfunded
Mandates
Reform Act
of 1995.
Federalism Impact Statement
The Secretary has also reviewed this
rule in accordance with Executive Order
13132 regarding
federalism, and has determined
that it does not have ``federalism implications.''
The rule
does 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.''
Impact on Family Well-Being
This rule will not adversely affect the
following elements of family well-being:
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. In fact,
this Final Rule may have a positive impact
on the
disposable income and
poverty
elements of family well-being to
the
extent that
injured persons (or their survivors
who are
eligible to
receive compensation)
receive benefits without a corresponding
burden being imposed
on them.
Paperwork Reduction Act
The information collection requirements
remain unchanged.
List of Subjects in 42 CFR Part 102
Benefits, Biologics, Compensation, Immunization,
Public health, Smallpox, Vaccinia.
Dated: November 14, 2005
Elizabeth M. Duke,
Administrator
Approved: December 22, 2005.
Michael O. Leavitt,
Secretary
Editorial Note: This document was received
at the Office of the Federal Register
on May 18, 2006.
For the reasons
stated above, the Secretary is adopting
the Interim
Final Rule adding 42 CFR part
102, published at 68 FR 51492
on Wednesday, August 27,
2003, as a Final Rule with
the following
amendment:
PART 102--SMALLPOX COMPENSATION PROGRAM
1. The authority
citation for part 102 continues
to read as follows:
Authority: 42 U.S.C. 216, 42 U.S.C. 239-239h.
2. In section
102.21, the table in paragraph (a)
is amended by adding
the following sentence at the
end of the time interval
description
subheading:
§ 102.21
Smallpox (Vaccinia) Vaccine Injury
Table.
(a) * * *
Please note that these time intervals
do
not refer to time
periods for the date of diagnosis
of the injury.
[FR
Doc. 06-4761 Filed 5-23-06; 8:45 am]
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