Smallpox
(Vaccinia) Vaccine Injury Table Interim
Final Rule
Federal
Register: August 27, 2003 (Volume 68,
Number 166)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
42 CFR Part 102
RIN 0906-AA60
ACTION: Interim Final Rule.
SUMMARY:
The Smallpox Emergency Personnel Protection
Act of 2003 (SEPPA), Public Law 108-20,
117 Stat. 638, authorized the Secretary
of Health and Human Services (the Secretary),
through the establishment of the Smallpox
Vaccine Injury Compensation Program (the
Program), to provide benefits and/or compensation
to certain persons who have sustained
injuries as a result of the administration
of smallpox covered countermeasures (including
the smallpox vaccine) or as a result of
vaccinia contracted through accidental
vaccinia inoculations. The SEPPA directed
the Secretary to establish, by interim
final rule, 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 manifest in order for such
presumption to apply.
As
mandated by law, the Secretary is establishing
such a Smallpox (Vaccinia) Vaccine Injury
Table (the Table) through this interim
final rule. The Secretary is also establishing
a set of Table Definitions and Requirements,
which define the terms and conditions
included on the Table and are to be read
in conjunction with the Table. The Secretary
is seeking public comment on the Table
established through this interim final
rule. At a later date, the Secretary will
publish a companion final rule setting
forth the administrative implementation
of the Program. The public will then be
afforded an additional opportunity to
comment on the procedures set forth therein.
DATES:
This regulation is effective on August
27, 2003. Written comments must be submitted
on or before October 27, 2003. The Secretary
will consider the comments received and
will decide whether to amend the Table
based upon such comments.
ADDRESSES:
All written comments concerning this interim
final rule should be submitted to the
Director,
Smallpox Vaccine Injury Compensation Program
Office of Special Programs
Health Resources and Services Administration
Parklawn Building
Room 16C-17
5600 Fishers Lane
Rockville, Maryland 20857
Express
and courier mail should be sent to
Smallpox Vaccine Injury Compensation Program
Office of Special Programs
Health Resources and Services Administration
4350 East West Highway
10th Floor
Bethesda, Maryland 20814
Electronic
comments should be sent to smallpox@hrsa.gov.
Comments
received will be available for public
inspection at the
Office of Special Programs,
Health Resources and Services Administration,
4350 East West Highway,
10th Floor,
Bethesda, Maryland 20814
between the hours of 8:30 a.m. and 5 p.m.
on Federal Government work days.
FOR
FURTHER INFORMATION CONTACT:
Dr. Vito Caserta, telephone 301-443-4956.
This is not a toll-free number. Electronic
inquiries should be sent to smallpox@hrsa.gov.
SUPPLEMENTARY
INFORMATION:
Background
Prior
to its eradication, smallpox (variola)
was a serious illness that manifested
either as outbreaks of variola major with
death rates of greater than 20 percent
or variola minor with death rates approaching
1 percent. Those who survived were frequently
left with significant disabilities, such
as blindness. Smallpox (vaccinia) vaccine
(referred to in this rule as the ``smallpox
vaccine'') was an essential tool for the
successful global eradication of smallpox
(variola), announced by the World Health
Organization in 1980.
Despite
such eradication, concern exists that
terrorists may have access to the smallpox
(variola) virus (referred to in this rule
as the ``smallpox virus''). On December
13, 2002, the President announced a plan
to protect the population of the United
States against the threat of a possible
smallpox attack. This plan was based on
heightened concerns, in the wake of the
attacks of September and October 2001,
that terrorists may have access to the
smallpox virus and may attempt to use
it against the population of the United
States and government facilities abroad.
Under
this plan, which the Secretary is actively
working to implement, State and local
governments have formed volunteer smallpox
response teams that will be prepared to
provide critical services to the population
of the United States in the event of a
smallpox virus attack.
In
furtherance of the President's plan, the
Secretary issued a Declaration Regarding
Administration of Smallpox Countermeasures
on January 24, 2003 (68 FR 4212). In this
Declaration, the Secretary declared that
``a potential bioterrorist incident makes
it advisable to administer, on a voluntary
basis, covered countermeasures specified
for prevention or treatment of smallpox
[(virus infection)] or control or treatment
of adverse events related to smallpox
vaccination, to [specified] categories
of individuals.
The
specific ``covered countermeasures'' described
in the Declaration are smallpox vaccines,
cidofovir and derivatives thereof, and
Vaccinia Immune Globulin. The categories
of persons to whom the Secretary recommended
the administration of such covered countermeasures,
on a voluntary basis, included certain
health care workers, members of smallpox
response teams identified by State or
local government entities or the Department
of Health and Human Services, certain
public safety personnel, and certain personnel
associated with certain Federal facilities
abroad. The Secretary recommended that
such persons volunteer to receive the
smallpox vaccine in order to ensure that
critical personnel would be able to mobilize
immediately and provide critical services
to the population of the United States
in the event of a smallpox virus attack.
The
Secretary's Declaration became effective
on January 24, 2003, and will remain effective
until January 23, 2004, unless the Secretary
extends or shortens the effective period
of the Declaration by amendment.
The
smallpox vaccine contains a live vaccinia
virus that induces immunity to smallpox
infection, but does not lead to variola
infection or disease. Vaccinia virus is
an orthopox type virus that is different
from, but related to, the smallpox virus.
Different
strains of vaccinia have been used in
the development of smallpox vaccines throughout
the world, with some strains causing more
injuries than other strains.
The
New York City Board of Health strain,
``the NYCBH strain,'' is the only strain
currently used in vaccines administered
in the United States. The NYCBH strain
was selected for use in such vaccines
because it has shown itself to be both
relatively safe and effective when compared
to other vaccinia strains. Nevertheless,
the routine use of smallpox vaccination
in the United States and several other
countries, irrespective of the strain
used, was discontinued prior to the certification
of global eradication of smallpox. This
was due to the relatively high complication
rate observed with the smallpox vaccine,
in addition to the lower risk of importation
of smallpox with the increasing success
of the global eradication program. Because
the vaccinia virus in the smallpox vaccine
is live, it can be transmitted to other
parts of the body of the vaccine recipient,
e.g., by touching a vaccination site before
it has healed and then touching another
part of the recipient's body (self-inoculation),
or to another person, e.g., by touching
a vaccination site in a recipient before
it has healed and then touching another
person (accidental person-to-person inoculation).
For
purposes of this rule, the term ``vaccination''
refers to the administration and receipt
of the smallpox vaccine and not through
contact. Likewise, for purposes of this
rule, the term ``inoculation'' is meant
to refer to transmission of and subsequent
infection with the vaccinia virus through
a means other than smallpox vaccination,
as described above.
Even
though several studies documented the
rate of serious complications after receipt
of the smallpox vaccine during the 1960s
and 1970s, these rates may be higher today
as more individuals are immunocompromised,
which has the same meaning for purposes
of this regulation as immunosuppressed
or immunodeficient.
Furthermore,
persons receiving primary smallpox vaccination
under a smallpox emergency response plan
will be doing so as adults. The earlier
studies also primarily sought information
only on what was known already to be caused
by the smallpox vaccine. Unrecognized
adverse reactions that may become more
clearly evident with improved surveillance
may not have been studied in the past.
The
SEPPA authorized the Secretary to establish
and implement the Smallpox Vaccine Injury
Compensation Program. Under the
Program, certain persons may receive benefits
and/or compensation for covered injuries,
described below, sustained as a result
of such vaccination or accidental vaccinia
inoculation.
Specifically,
SEPPA authorizes the Secretary to make
available such benefits and/or compensation
to two categories of persons who sustain
covered injuries, provided they
meet other legal requirements, e.g., filing
deadlines.
The
first category, described as ``recipients,''
includes certain persons who volunteer
for and are selected to be a member of
a smallpox emergency response plan and
are vaccinated with smallpox vaccine.
In the event that recipients sustain covered
injuries as the result of the administration
of the smallpox vaccine or other covered
countermeasures listed in the Secretary's
Declaration, they may be entitled to benefits
and/or compensation under the Program.
The
second category, described as ``contacts,''
includes certain persons who sustained
covered injuries as the result of vaccinia
contracted through accidental vaccinia
inoculation through contact with
categories of recipients described in
the SEPPA or the contacts of such recipients.
In
addition, survivors of deceased recipients
or contacts may be eligible for
benefits and/or compensation under the
Program in certain circumstances.
Persons
who do not meet the criteria for one of
these categories (e.g., individuals who
receive the smallpox vaccine, but not
as part of an approved smallpox emergency
response plan) will not be entitled to
benefits.
In
order to obtain benefits and/or compensation
under the Program, eligible individuals
in these categories must file a request
with the Program and demonstrate to the
Secretary in their requests that applicable
eligibility, benefits, and compensation
criteria are satisfied. Persons filing
such requests with the Program are described
as requesters.
The
benefits and compensation available under
the Program include compensation for medical
care, lost employment income, and a death
benefit for certain survivors
of persons who died as the result of a
covered injury. A requester's entitlement
to such benefits and compensation will
vary depending upon the nature of the
requester's condition, the requester's
particular personal circumstances, e.g.,
whether the requester has insurance coverage,
and the completeness of the request and
accompanying documentation.
Among
the criteria that must be satisfied in
order for a person to be entitled to such
benefits and/or compensation is the requirement
that a person sustained a ``covered injury''
as the result of the administration of
a covered countermeasure or as the result
of an accidental vaccinia inoculation.
A requester can demonstrate that such
a covered injury, an injury either proven
or presumed to be caused by the vaccinia
virus contained in the smallpox vaccine
or transmitted through accidental vaccinia
inoculation and meeting all applicable
requirements, occurred through two alternative
mechanisms.
First,
in accordance with the SEPPA, a recipient
or contact shall be presumed to have sustained
a covered injury as the result of the
administration of or exposure to the smallpox
vaccine if the requester submits sufficient
documentation demonstrating that the event
is included on an injury table (i.e.,
the Table) created by the Secretary with
the onset of the first symptom or manifestation
within the time interval specified on
the Table. For this reason, if an otherwise
eligible person sustained an injury listed
on the Table in the time interval listed
on the Table, the Secretary will presume,
solely for purposes of the Program, that
this event was caused by the smallpox
vaccine. Such a requester need not actually
demonstrate that the vaccine or the vaccinia
contracted from accidental vaccinia inoculation
caused the underlying injury, only that
an injury listed on the Table was sustained
with the first manifestation within the
time interval listed on the Table. This
presumption is not conclusive, however.
The Secretary may determine, based on
his review of the relevant evidence, that
an injury meeting the Table requirements
was most likely caused by other factors
and was not caused by the smallpox vaccine
or exposure to vaccinia in contact cases.
In these circumstances, the Table presumption
could be rebutted, and the requester may
not be entitled to benefits and/or compensation
under the Program.
The
alternative mechanism to demonstrate that
a covered injury was sustained is available
when a requester cannot demonstrate that
a Table injury occurred within the time
interval listed on the Table. In such
circumstances, the requester must submit
sufficient documentation showing that
the smallpox vaccine or other covered
countermeasures, or the vaccinia contracted
from accidental vaccinia inoculation,
actually caused the injury that is the
basis for the request. In evaluating such
claims, the Secretary will employ a preponderance
of the evidence standard, taking into
consideration all relevant medical and
scientific evidence, including all relevant
medical records.
As
authorized and mandated under the SEPPA,
the Secretary is herein establishing,
at 42 CFR 102.21, a Table that identifies
injuries, i.e., illnesses, disabilities,
injuries, or conditions, referred to as
``Table injuries,'' that shall be presumed
to result from the administration of or
exposure to the smallpox vaccine, as well
as the time interval in which the first
symptom or manifestation of each such
injury must manifest in order for this
presumption to apply. The Secretary is
further including Table Definitions and
Requirements, set forth in 42 CFR 102.21(b),
which define the terms and conditions
included in the Table and set forth the
requirements necessary to establish Table
injuries. As such, the Table Definitions
and Requirements are considered a part
of the Table.
At
this time, the Secretary is seeking public
comment on the Table established through
this interim final rule. The Secretary
will solicit comments on other matters
pertaining to the implementation of the
Program in the future, when the Secretary
publishes a companion rule detailing the
policies and procedures for the implementation
of the Smallpox Vaccine Injury Compensation
Program.
Summary
of Regulation Smallpox (Vaccinia) Vaccine
Injury Table
This
interim final rule establishes the Table,
which includes the covered injuries for
the smallpox vaccine and the relevant
time intervals for ``recipient requests''
(requests concerning injuries in relation
to the administration of the smallpox
vaccine) and ``contact requests'' (requests
concerning injuries in relation to vaccinia
contracted through accidental vaccinia
inoculation from another person). In order
to obtain the presumption of causation
afforded by the Table, a requester filing
a recipient request must demonstrate that
the onset of the recipient's first symptom
or manifestation of an injury listed on
the Table occurred within the timeframe
listed on the Table in relation to the
administration of the smallpox vaccine.
Likewise, in order to obtain the Table
presumption of causation, a requester
filing a contact request must demonstrate
that the onset of the contact's first
symptom or manifestation of the injury
listed on the Table occurred within the
time interval listed on the Table in relation
to any date in the exposure period. A
contact may be exposed to vaccinia on
any date in the exposure period, which
is the span of time during which transmission
of vaccinia virus from a vaccine recipient
or another contact shedding vaccinia can
occur. The risk of exposure from viral
shedding from a recipient or contact is
generally considered no longer to exist
when the scab from each vaccinial lesion
spontaneously falls off, which usually
occurs approximately three weeks after
vaccination or inoculation in a healthy
person and may be considerably longer
in the immunocompromised or those experiencing
injuries such as eczema vaccinatum.
The
time intervals listed on the Table for
recipients reflect the quantity of time
between vaccination and the onset of the
first symptom or manifestation of the
Table injury. For contacts, because the
exact time the vaccinia virus is transmitted
cannot generally be pinpointed, the time
intervals listed on the Table reflect
a comparable quantity of time between
exposure to vaccinia (i.e. any point in
the exposure period) and the onset of
the first symptom or manifestation of
the Table injury.
The
injuries included on the Table, as well
as the time intervals set forth for both
recipients and contacts, represent the
Secretary's best effort to include a comprehensive
listing of injuries believed to be causally
related to the smallpox vaccine. The Table
is meant to represent the known NYCBH
strain injuries where credible medical
evidence suggests that the smallpox vaccine
has a causal role in the injury and the
time intervals in which such known events
first manifest in relation to the administration
of the smallpox vaccine, or the exposure
to vaccinia in contact cases. However,
the Table covers all smallpox vaccines
administered under the Secretary's Declaration.
With
future generations of smallpox vaccines,
the Secretary may need to amend the Table
to fit the injury profile of the new vaccine.
Although the occurrence of many of the
injuries included on the Table appears
to be exceedingly rare, the Secretary
is including such injuries on the Table
in order to ensure that people who are
otherwise eligible for benefits and/or
compensation under the Program will receive
the Table's presumption of causation in
those instances in which the credible
medical literature persuasively suggests
a causal relationship between the smallpox
vaccine and the injury. The Table presumption
can be rebutted if the Secretary determines,
based on a review of the relevant evidence,
that an injury meeting the Table requirements
was not caused by the smallpox vaccine
or exposure to vaccinia in contact cases.
The Secretary is aware of anecdotal reports
of ischemic heart disease, such as angina
pectoris or myocardial infarction (heart
attacks) occurring in a few individuals
following receipt of the smallpox vaccine.
The Secretary has included vaccinia-related
myocarditis, pericarditis, and myopericarditis
as Table injuries but, at this time, there
is no clear scientific evidence to support
including ischemic heart disease as a
separate Table injury. Nevertheless, where
a requester can demonstrate that an ischemic
heart disease following a covered Table
injury was likely caused by, or was a
health complication (i.e., sequela) of,
the Table injury, we expect that the requester
will be eligible for benefits associated
with the ischemic heart disease. Should
sufficient scientific evidence be forthcoming
that ischemic heart disease (absent these
Table conditions) is caused by the vaccine,
the Secretary would amend the Table (see
discussion below), with retroactive effect,
to include this condition too.
Furthermore,
even absent a Table injury for ischemic
heart disease, requesters may provide
sufficient evidence of causation in fact
for this injury, which might also lead
to Program benefits. The Secretary will
provide further information in the forthcoming
companion regulation as to how he will
determine whether an event was caused
by, or was a health complication of, a
covered injury. In addition to specific
injuries, the Table includes a category
for any death resulting from an injury
included on the Table in which the injury
arose within the time interval set forth
on the Table. No time interval is specified
for the category of death. Therefore,
so long as the Secretary determines that
the death resulted from an injury meeting
the Table requirements, the death can
occur at any time subsequent to the injury
and not necessarily in the time interval
set forth on the Table. Table Definitions
and Requirements The Table's Definitions
and Requirements, set forth in 42 CFR
102.53(b), define and describe the scope
of the terms included on the Table. As
such, the listings included on the Table
are to be read in conjunction with the
Definitions and Requirements.
For
each Table injury, the Table Definitions
and Requirements must be satisfied. By
law, requesters will be required to provide
documentation showing that they meet other
eligibility criteria, separate from the
Table, in order to demonstrate eligibility
to receive benefits and/or compensation
under the Program. For example, each requester
filing a contact request is required by
law to demonstrate to the Secretary that
the contact contracted vaccinia through
accidental vaccinia inoculation during
the effective dates of the Secretary's
Declaration, or up to 30 days thereafter.
This requirement applies to all contact
requests filed, regardless of whether
the injury in question is included on
the Table. For this reason, the requirement
that a requester with a contact request
demonstrate that the contact contracted
vaccinia within the time interval specified
by law is not incorporated into the Table.
The
companion regulations that the Secretary
will issue in the future will provide
detailed information concerning this requirement
and other requirements that requesters
must satisfy beyond those that pertain
exclusively to injuries included on the
Table. Requests Based on Non-Table Injuries
A requester may be eligible to receive
benefits and/or compensation available
through the Program even if the underlying
injury is not included on the Table, as
defined through the Definitions and Requirements,
or did not occur within the time-frame
included on the Table. Because such requesters
will not be afforded the presumption of
causation given to requesters who establish
Table injuries, requesters filing requests
based on non-Table injuries must submit
documentation that demonstrates to the
Secretary that the injury underlying the
request was actually caused by the administration
of the covered countermeasure, or by vaccinia
through accidental vaccinia inoculation
in contact requests. The Secretary will
give full and fair review of all such
requests. Medical evidence available concerning
a possible causal link between the vaccinia
virus and particular conditions may not
be sufficient for the Secretary to add
such conditions to the Table. However,
such evidence together with medical documentation
introduced by particular requesters may
be sufficient for requesters with such
conditions to persuade the Secretary that
the vaccinia virus from vaccination or
inoculation was a significant factor in
causing the condition.
For
example, medical literature suggests that
the vaccinia virus has caused acute vaccinial
arthritis (VA) or vaccinial osteomyelitis
(VO) in isolated instances. As a result,
requesters with such conditions may be
entitled to compensation even when such
conditions are not included on the Table.
In order to demonstrate that a particular
person's condition was caused by the vaccinia
virus through vaccination or inoculation,
requesters must provide evidence demonstrating
such a link, e.g., evidence that the vaccinia
virus was present in an infected joint
in a case of alleged VA or in an osteomyelitis
in a case of alleged VO. Such evidence
may persuade the Secretary to determine
that the person sustained a covered, albeit
a non-Table, injury. Likewise, persons
in whom a malignant melanoma (MM), basal
cell carcinoma (BCC), or squamous cell
carcinoma (SCC) originated with the first
manifestation in a vaccination or inoculation
scar may be able to demonstrate to the
Secretary that the vaccinia virus caused
the MM, BCC, or SCC. This is consistent
with the rare cases in the medical literature
in which a causal link has been suggested
between the vaccinia virus and such skin
tumors, e.g., persons who developed new
tumors, i.e., MM, BCC, or SCC (as the
first manifestation of each tumor) in
separate vaccinial scars from separate
vaccinations given years apart.
To
decide whether benefits and/or compensation
under the Program are available in relation
to a request that does not concern a Table
injury, the Secretary will review the
materials provided in each case. In reviewing
these requests, the Secretary will employ
a preponderance of the evidence standard,
taking into consideration relevant medical
and scientific evidence. The Secretary
will provide further information concerning
such requests when he publishes the companion
final rule setting forth the administrative
implementation of the Program.
No
Table for Other Non-Vaccine Covered Countermeasures
The
Secretary was statutorily directed to
establish a Table identifying injuries
presumed to result from the administration
of or exposure to the smallpox vaccine.
The SEPPA did not direct the Secretary
to establish such a Table in relation
to injuries presumed to result from the
administration of other covered countermeasures.
Nonetheless, certain requesters may still
be entitled to benefits and/ or compensation
in relation to injuries that resulted
from covered countermeasures other than
the smallpox vaccine, i.e., Vaccinia Immune
Globulin, cidofovir and derivatives thereof.
Requesters filing requests in relation
to such injuries are not afforded the
presumption of causation given to requesters
who have sustained Table injuries. For
this reason, a requester filing a request
in relation to such non- vaccine covered
countermeasures, as with any non-Table
request, must demonstrate to the Secretary
that the administration of the covered
countermeasure actually caused an injury
for which benefits and/or compensation
may be available under the Program. Amendments
to Table In accordance with Section 263(a)(2)
of the Public Health Service Act (PHS
Act), as established by SEPPA, the Secretary
is authorized to amend by regulation the
Table established in this interim final
rule. The Secretary intends to monitor
injuries in relation to covered countermeasures,
including the smallpox vaccine. Based
upon the best scientific evidence available,
the Secretary will amend the Table to
add new injuries, to modify the governing
time intervals, or to modify Table definitions,
when the evidence supports doing so. Such
amendments will apply to pending requests
and to requests filed after the amendments
take effect. Requesters who become eligible
with respect to an injury on the Table
as the result of such an amendment may
file a request based on the amendment
within the time period prescribed by law.
Justification
for Omitting Notice of Proposed Rulemaking
and for Waiver of Delayed Effective Date
Through
the enactment by the SEPPA of Section
263(a)(1) of the PHS Act, the Secretary
was directed to establish by interim final
rule a table identifying injuries 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 such
injury must manifest in order for such
presumption to apply. In accordance with
that statutory directive, the Secretary
is herein establishing such a Table, including
Definitions and Requirements. As noted
earlier, the establishment of this Table
by interim final rule was authorized by
statute. The Secretary has further determined,
under 5 U.S.C. 553(b), that it is contrary
to the public interest to follow the notice
of proposed rulemaking procedures before
issuance of these regulations, because
such a process might delay the continuing
implementation of the President's plan
to protect the population of the United
States against the threat of a smallpox
(variola) attack. A significant element
of this plan, which is also an important
priority of the Secretary, is the increased
voluntary participation of persons in
smallpox emergency response plans throughout
the Nation, which includes voluntary immunization
with the smallpox vaccine. The companion
regulation, which will serve to implement
the Program, will be issued after this
regulation is in effect. The sooner that
this regulation becomes effective, the
sooner potential requesters will be able
to assess their eligibility to recover
benefits and/or compensation from the
Program and to recover such benefits and/or
compensation, if eligible.
For
the same reasons, the Secretary has determined
that there is good cause to waive a delay
in the rule's effective date. As noted
above, comments will be accepted at the
above listed address for a period of 60
days following the publication of this
rule. 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 (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.
Congress
has found it necessary to appropriate
$42,000,000 for the administration of,
and payment of the Program. Because any
resources required to implement the regulatory
requirements imposed by the SEPPA are
not required by virtue of the establishment
of a Table, and because the Secretary
will conduct an independent analysis concerning
any burdens associated with the implementation
of the Program when the Secretary publishes
the companion regulations setting forth
the Program's administrative implementation,
the Secretary has determined that no resources
are required to implement the provisions
included in this regulation. Therefore,
in accordance with the RFA of 1980, and
the Small Business Regulatory Enforcement
Fairness Act of 1996, which amended the
RFA, the Secretary certifies that this
rule will not have a significant impact
on a substantial number of small entities.
The Secretary has also determined that
this proposed interim final 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. The Secretary
has determined that the proposed interim
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 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.'' On the basis of
family well-being, the provisions of this
interim final rule will not 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 In this interim final rule,
the Secretary establishes a Smallpox (Vaccinia)
Vaccine Injury Table identifying injuries
that shall be presumed to result from
the administration of or exposure to the
smallpox vaccine, and the time interval
in which the onset of the first symptom
or manifestation of each such injury must
manifest in order for such presumption
to apply. The Secretary also is providing
Table Definitions and Requirements. This
interim final rule is based upon legal
authority. This interim final rule will
have the effect of affording certain persons
a presumption that particular injuries
were sustained as the result of the administration
of or exposure to the smallpox vaccine.
Because
the Table establishes a presumption of
causation, it relieves requesters of the
burden of demonstrating causation for
covered events. Paperwork Reduction Act
of 1995, as Amended This interim final
rule has no information collection requirements.
List of Subjects in 42 CFR Part 102 Benefits,
Biologics, Compensation, Immunization,
Public health, Smallpox, Vaccinia.
Dated:
July 18, 2003.
Elizabeth M. Duke, Administrator, Health
Resources and Services Administration.
Approved: July 22, 2003.
Tommy G. Thompson, Secretary.
For
the reasons stated above, the Department
of Health and Human Services adds to Subchapter
J of Chapter I of Title 42 CFR, a new
part 102 to read as follows: PART 102--SMALLPOX
COMPENSATION PROGRAM Sec. 102.1-102.20.
[Reserved] 102.21 Smallpox (Vaccinia)
Vaccine Injury Table.
Authority:
Sec. 215 of the Public Health Service
Act (42 U.S.C. 216); sec. 263 of the PHS
Act, as amended, Public Law No. 108-20,
117 Stat. 638. Sec. 102.21
(a)
Smallpox (Vaccinia)
Vaccine Injury Table |
Injury
(illness, disability, injury, or condition) |
Time
interval for first symptom or manifestation
of onset of injury after: (1) administration
of smallpox (vaccinia) vaccine in
recipients (R); or (2) exposure to
vaccinia in contacts (C) |
1.
Significant Local Skin Reaction |
R
or C: 1-21 days. |
2.
Stevens-Johnson Syndrome |
R
or C: 1-21 days. |
3.
Inadvertent Inoculation |
R
or C: 1-21 days. |
4.
Generalized Vaccinia |
R
or C: 1-21 days. |
5.
Eczema Vaccinatum |
R
or C: 1-21 days. |
6.
Progressive Vaccinia |
R
or C: 1-21 days. |
7.
Postvaccinial Encephalopathy, Encephalitis
or Encephalomyelitis |
R
or C: 1-21 days. |
8.
Fetal Vaccinia |
Maternal
R or C: any time in gestation until
7 days after birth. |
9.
Secondary Infection |
R
or C: 0-30 days. |
10.
Anaphylaxis or Anaphylactic Shock |
R:
0-4 hours. C: Not Covered. |
11.
Vaccinial Myocarditis, Pericarditis,
or Myopericarditis. |
R
or C: 1-21 days. |
12.
Death resulting from an injury referred
to above in which the injury arose
within the time interval referred
to above (except as specifically provided
in specified paragraph (b) of this
section). |
R
or C: No time interval specified.
|
(b)
Table Definitions and Requirements
The Table Definitions that follow shall
apply to, define and describe the scope
of, and be read in conjunction with paragraph
(a) of this section.
(1)
Significant local skin reaction.
(i) Definition. Significant
local skin reaction is, for purposes of
the Table, an unexpected and extreme response
at the vaccination or inoculation site
that results in a significant scar that
is serious enough to require surgical
intervention. The onset of this injury
is the initial skin lesion at the vaccination
or inoculation site that generally occurs
with smallpox vaccinations or inoculations.
Minor scarring or minor local reactions
do not constitute a Table injury. Even
a robust take, defined as an area of redness
at the vaccination site that exceeds 7.5
cm in diameter with associated swelling,
warmth and pain, in general is considered
an expected response to the vaccination
or inoculation. A robust take does not
in itself constitute a Table injury, even
when the redness and swelling involves
the entire upper arm with associated enlargement
and tenderness of the glands (lymph nodes)
in the underarm (axilla).
(ii) Table requirements.
A Table injury for a significant local
skin reaction in a recipient or contact
requires sufficient evidence in the medical
records of the occurrence of a significant
local skin reaction at the vaccination
or inoculation site and a permanent, disfiguring
scar that resulted from the significant
local skin reaction. The scar must be
of sufficient severity to require surgical
intervention to correct a significant
cosmetic (e.g., keloid) or functional
(e.g., contracture) deformity and such
surgery must be included in the treatment
plan documented in the medical records.
(2)
Stevens-Johnson Syndrome (SJS).
(i) Definition. SJS (sometimes
called erythema multiforme major) is an
acute hypersensitivity reaction that affects
skin, mucous membranes, and sometimes
internal organs (systemic toxicity). For
purposes of the Table, both skin and mucous
membrane rash or lesions must be present
and the rash or lesions may not cover
less than ten percent of body surface
area. In SJS, mucosal involvement generally
predominates. Mucosal lesions generally
occur at more than one location and manifest
as painful lesions in sites such as the
mouth or eyes. Skin rash or lesions in
SJS usually consist of red raised areas
(erythematous macules), blisters, and
ulcerations.
(ii) Table requirements.
A Table injury for SJS in a recipient
or contact requires sufficient evidence
in the medical records of the occurrence
of SJS. The SJS, or related complications,
must be of sufficient severity to require
inpatient hospitalization.
(3)
Inadvertent Inoculation (II).
(i) Definition. II is
the spread of vaccinia virus from an existing
vaccination or inoculation site to a second
location usually by scratching the vaccination
or inoculation site and subsequently spreading
the virus, which produces a new vaccinial
lesion on the same person. Alternatively,
II is the spread of vaccinia virus from
an existing vaccination or inoculation
site to another person usually by scratching
an existing vaccination or inoculation
site and subsequently spreading the virus,
resulting in a contact case.
(ii) Table requirements.
A Table injury for II in a recipient or
contact requires sufficient evidence in
the medical records of the occurrence
of II and the occurrence of one of the
following:
(A) Eye lesions, e.g., vaccinial keratitis
or vaccinial blepharitis, that resulted
from II and that led to a permanent sequela,
e.g., decrease in visual acuity;
(B) Permanent and disfiguring scar(s)
that resulted from II. The scar(s) must
be of sufficient severity to require surgical
intervention to correct a significant
cosmetic (e.g., keloid) or functional
(e.g., contracture) deformity and such
surgery must be included in the treatment
plan documented in the medical records;
or
(C) Acute II or related complications
of sufficient severity to require inpatient
hospitalization.
(4)
Generalized Vaccinia (GV).
(i) Definition. GV is
a vaccinial infection that occurs from
the spread of vaccinia from an existing
vaccination or inoculation site to otherwise
normal skin, resulting in multiple new
areas of vaccinial rash or lesions. The
vaccinia is believed to be spread through
the blood. The rash or lesions are characterized
by multiple blisters (vesicles or pustules)
that generally evolve in a similar sequence
or manner as the original vaccination
or inoculation site.
(ii) Table requirements.
A Table injury for GV in a recipient or
contact requires sufficient evidence in
the medical records of the occurrence
of GV and the occurrence of one of the
following:
(A) Permanent and disfiguring scar(s)
that resulted from GV. The scar(s) must
be of sufficient severity to require surgical
intervention to correct a significant
cosmetic (e.g., keloid) or functional
(e.g., contracture) deformity and such
surgery must be included in the treatment
plan documented in the medical records;
or
(B) Acute GV or related complications
of sufficient severity to require inpatient
hospitalization.
(5)
Eczema Vaccinatum (EV)
(i) Definition. EV is
the transmission or the spread of vaccinia
virus from a vaccination or inoculation
site to skin that has been affected by,
or is currently affected with, eczema
or atopic dermatitis. EV is characterized
by lesions that include multiple blisters
(vesicles or pustules), which generally
evolve in a similar sequence or manner
as the original vaccination or inoculation
site. The lesions may come together to
form larger lesions. Lesions may also
spread to patches of skin that have never
been involved with eczema or atopic dermatitis.
A person with EV may be quite ill with
signs and symptoms that involve the whole
body (systemic illness), such as fever,
malaise, or enlarged glands (lymph nodes).
(ii) Table requirements.
A Table injury for EV in a recipient or
contact requires sufficient evidence in
the medical records of the occurrence
of EV and the occurrence of one of the
following:
(A) Permanent and disfiguring scar(s)
that resulted from EV. The scar(s) must
be of sufficient severity to require surgical
intervention to correct a significant
cosmetic (e.g., keloid) or functional
(e.g., contracture) deformity and such
surgery must be included in the treatment
plan documented in the medical records;
or
(B) Acute EV or related complications
of sufficient severity to require inpatient
hospitalization.
(6)
Progressive Vaccinia (PV).
(i) Definition. PV is
the failure to initiate the healing process
in an initial vaccination or inoculation
site by 21 days after exposure to vaccinia
with progressive ulceration or necrosis
at the vaccination or inoculation site
leading to a large destructive ulcer.
PV is seen in people with an impaired
immune system (immunocompromised) and
is characterized by a complete or near
complete lack of inflammation or absence
of inflammatory cells in the dermis of
the skin at the vaccination or inoculation
site. The diagnosis of PV may be made
before 21 days after exposure, especially
in a known immunocompromised individual
who develops a lesion at the vaccination
or inoculation site. PV may spread through
the blood to any location in the body.
Any person who initiates a significant
healing process of the vaccination or
inoculation site by 21 days after receipt
of the smallpox vaccine or exposure to
vaccinia does not have PV.
(ii) Table requirements.
A Table injury for PV in a recipient or
contact requires sufficient evidence in
the medical records of the occurrence
of PV and the occurrence of one of the
following:
(A) Permanent and disfiguring scar(s)
that resulted from PV. The scar(s) must
be of sufficient severity to require surgical
intervention to correct a significant
cosmetic (e.g., keloid) or functional
(e.g., contracture) deformity and such
surgery must be included in the treatment
plan documented in the medical records;
or
(B) Acute PV or related complications
of sufficient severity to require inpatient
hospitalization.
(7)
Postvaccinial Encephalopathy, Encephalitis
or Encephalomyelitis (PVEM).--
(i) Definition. PVEM
is, for the purposes of the Table, an
autoimmune central nervous system injury.
In rare cases, the vaccinia virus is isolated
from the central nervous system. Manifestations
usually occur abruptly and may include
fever, vomiting, loss of appetite (anorexia),
headache, general malaise, impaired consciousness,
confusion, disorientation, delirium, drowsiness,
seizures, language difficulties (aphasia),
coma, muscular incoordination (ataxia),
urinary incontinence, urinary retention,
and clinical signs consistent with inflammation
of the spinal cord (myelitis) such as
paralysis or meningismus. Long term central
nervous system impairments such as paralysis,
seizure disorders, or developmental delays
are known to occur as sequelae of the
acute PVEM. No clinical criteria, radiographic
findings, or laboratory tests are specific
for the diagnosis of PVEM.
(ii) Table Requirements.
A Table injury for PVEM in a recipient
or contact requires sufficient evidence
in the medical records of the occurrence
of acute PVEM. The acute PVEM or related
complications must be of sufficient severity
to require inpatient hospitalization.
(8)
Fetal Vaccinia (FV).
(i) Definition. FV is
an intrauterine vaccinial infection subsequent
to vaccinia vaccination or inoculation
of the mother that results from the placental
transmission of the vaccinia virus during
any time in the pregnancy. FV manifests
as multiple skin lesions or organ involvement
and may result in significant scarring
or death. FV skin lesions are similar
to those seen in GV or PV and the lesions
may come together to form larger lesions.
Congenital malformations, other than those
described above, are not Table injuries.
(ii) Table requirements.
A Table injury for FV requires sufficient
evidence in the medical records of the
occurrence of the FV. The occurrence of
the FV or related complications must be
of sufficient severity to require inpatient
hospitalization or result in permanent
and disfiguring scar(s). In addition,
a Table injury for FV requires one of
the following:
(A) A maternal history of vaccinial vaccination
or inoculation, with the occurrence of
vaccinial skin or mucous membrane lesions
within the incubation period for vaccinia
during the pregnancy in a maternal recipient
or contact; or
(B) Isolation of vaccinia from intrauterine
or neonatal tissue.
(9)
Secondary Infection (SI).
(i) Definition. SI is,
for purposes of the Table, a non-vaccinial
bacterial, fungal, or viral infection
at the site of a vaccinial skin or mucous
membrane lesion. SI occurs because the
blister formation or ulceration that is
part of the normal progression of a vaccinial
skin or mucous membrane lesion disrupts
the surface of the skin or mucous membrane,
allowing potential germs to invade and
infect the vaccinial skin or mucous membrane
lesion leading to significant illness
requiring hospitalization.
(ii) Table requirements.
A Table injury for SI in a recipient or
contact requires sufficient evidence in
the medical records of the occurrence
of SI. The acute SI or related complications
must be of sufficient severity to require
inpatient hospitalization.
(10)
Anaphylaxis or Anaphylactic shock.
(i) Definition. Anaphylaxis
or anaphylactic shock is, for purposes
of the Table, as an acute, severe, and
potentially lethal systemic allergic reaction
to a component of the smallpox vaccine.
(ii) Table requirements.
A Table injury for anaphylaxis or anaphylactic
shock in a recipient requires sufficient
evidence in the medical records of the
occurrence of an acute anaphylaxis or
anaphylactic shock. The anaphylaxis or
anaphylactic shock must be of sufficient
severity to require inpatient hospitalization.
Anaphylaxis or anaphylactic shock is not
a Table injury for contacts.
(11)
Vaccinial Myocarditis, Pericarditis, or
Myopericarditis (MP).
(i) Definition. MP is,
for purposes of the Table, vaccinial myocarditis,
pericarditis, or myopericarditis. Myocarditis
is defined as an inflammation of the heart
muscle (myocardium). Pericarditis is defined
as an inflammation of the covering of
the heart (pericardium). Myopericarditis
is defined as an inflammation of both
the heart muscle and its covering. The
inflammation associated with MP may range
in severity from very mild (subclinical)
to life threatening. In many mild cases,
myocarditis is diagnosed solely by transient
electrocardiographic (EKG) abnormalities
(e.g., ST segment and T wave changes),
increased cardiac enzymes, or mild echocardiographic
abnormalities. Arrhythmias, abnormal heart
sounds, heart failure, and death may occur
in more severe cases. Pericarditis generally
manifests with chest pain, abnormal heart
sounds (pericardial friction rub), EKG
abnormalities (e.g., ST segment and T
wave changes), and/or increased fluid
accumulation around the heart.
(ii) Table requirements.
A Table injury for MP in a recipient or
contact requires sufficient evidence in
the medical records of the occurrence
of acute MP. The acute MP (or related
complications) must be of sufficient severity
to require inpatient hospitalization.
A death resulting from MP requires sufficient
microscopic (histopathologic) evidence
of MP or its sequela in heart tissue.
(c)
Glossary for Purposes of This Section
(1) Blister or vesicle means a circumscribed,
elevated skin or mucous membrane lesion
containing an accumulation of fluid.
(2)
Contact means a person who developed a
vaccinial lesion or infection through
inoculation (and not vaccination).
(3)
Exposure period means the span of time
during which vaccinia virus can be transmitted
from a vaccine recipient shedding vaccinia
or through a contact case shedding vaccinia.
(4)
Inoculation means transmission of and
infection with the vaccinia virus through
a means other than smallpox vaccination.
Spread (inoculation) of vaccinia virus
may occur in two ways: either self- inoculation
in which the vaccinia virus is spread
from the vaccinial lesion at the vaccination
site to one or more areas on the same
person or person-to-person inoculation
when the vaccinia virus is spread to another
person, a contact.
(5)
Inoculation site means the skin or mucous
membrane surface where the vaccinia virus
entered the body through means other than
vaccination.
(6)
Lesion means a pathologic change.
(7)
Pustule means a circumscribed, elevated
skin or mucous membrane lesion containing
an accumulation of white blood cells.
(8)
Recipient means a person to whom the smallpox
vaccine was administered.
(9)
Ulceration means a specific skin or mucous
membrane lesion characterized by erosion
of the skin or mucous membrane surface.
(10)
Vaccination means the administration and
receipt of the smallpox (vaccinia) vaccine,
and not through contact.
(11)
Vaccination site means the skin surface
where the vaccinia virus entered the body
through vaccination. [FR Doc. 03-21906
Filed 8-26-03; 8:45 am] |