injury table

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Oklahoma
The statutory provisions include:
Oklahoma Hazardous Waste
Management Act, as amended, 27A
Oklahoma Statute 1997 Edition,
Sections 2–7–103, 2–7–108(A), 2–7–
108(B)(1), 2–7–108(B)(3), 2–7–108(C), 2–
7–110(B), 2–7–110(C), 2–7–111(A), 2–7–
111(B) (except the last sentence and the
phrase, ‘‘recycling’’ in the first
sentence), 2–7–111(C)(2)(a) (except the
phrase ‘‘Except as provided in
subparagraph b of this paragraph’’ and
the word ‘‘recycling’’ in the first
sentence), 2–7–111(D), 2–7–111(E)
(except the word ‘‘recycling’’ in the first
sentence), 2–7–112, 2–7–116(B) through
2–7–116(F), 2–7–116(H)(2), 2–7–118(A),
2–7–124, 2–7–125, 2–7–127 and 2–10–
301(G).
Copies of the Oklahoma statutes that
are incorporated by reference are
available from West Publishing
Company, 610 Opperman Drive, PO Box
64526, St. Paul, Minnesota 55164–0526.
The regulatory provisions include:
The Oklahoma Administrative Code,
Title 252, Chapter 205, effective June 12,
2000: Subchapter 1, Sections 252:205–
1–1(a), 252:205–1–1(c) introductory
paragraph, 252:205–1–1(c)(1), 252:205–
1–2 introductory paragraph, 252:205–1–
2 ‘‘OHWMA’’, 252:205–1–2 ‘‘Postclosure permit’’, 252:205–1–3(c);
Subchapter 3, Sections 252:205–3–1,
252:205–3–2(a)(2), 252:205–3–2(b)–(m),
252:205–3–4, 252:205–3–5 and 252:205–
3–6; Subchapter 5, Sections 252:205–5–
1 (except 252:205–5–1(4)), 252:205–5–2
through 252:205–5–5; Subchapter 7,
Sections 252:205–7–1 through 252:205–
7–3 and 252:205–7–4 (except the phrase
‘‘or in accordance with 252:205–15–
1(d)); Subchapter 9 (except 252:205–9–
5 and 252:205–9–6); Subchapter 11,
252:205–11–1(a) (except the word
‘‘recycling’’), 252:205–11–1(b) through
252:205–11–1(e) and 252:205–11–2; and
Subchapter 13, Sections 252:205–13–
1(a)—(e).
Copies of the Oklahoma regulations
that are incorporated by reference can
be obtained from The Oklahoma
Register, Office of Administrative Rules,
Secretary of State, 101 State Capitol,
Oklahoma City, Oklahoma 73105.
*
*
*
*
*
[FR Doc. 03–21592 Filed 8–26–03; 8:45 am]
BILLING CODE 6560–50–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
42 CFR Part 102
RIN 0906–AA60

Smallpox Vaccine Injury
Compensation Program: Smallpox
(Vaccinia) Vaccine Injury Table
AGENCY: Health Resources and Services
Administration, HHS.
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.

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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

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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

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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

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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

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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

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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

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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

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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

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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 nonTable 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

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51495

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 nonvaccine 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

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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.

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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

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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.

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Federal Register / Vol. 68, No. 166 / Wednesday, August 27, 2003 / Rules and Regulations
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:

51497

102.21 Smallpox (Vaccinia) Vaccine Injury
Table.

PART 102—SMALLPOX
COMPENSATION PROGRAM

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.
102.1–102.20.

§102.21 Smallpox (Vaccinia) Vaccine
Injury Table.

[Reserved]

(a) SMALLPOX (VACCINIA) VACCINE INJURY TABLE
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)

Injury (illness, disability, injury, or condition)

1.
2.
3.
4.
5.
6.
7.
8.

Significant Local Skin Reaction ........................................................................................
Stevens-Johnson Syndrome .............................................................................................
Inadvertent Inoculation ......................................................................................................
Generalized Vaccinia ........................................................................................................
Eczema Vaccinatum .........................................................................................................
Progressive Vaccinia .........................................................................................................
Postvaccinial Encephalopathy, Encephalitis or Encephalomyelitis ..................................
Fetal Vaccinia ....................................................................................................................

9. Secondary Infection ..........................................................................................................
10. Anaphylaxis or Anaphylactic Shock ................................................................................
11. Vaccinial Myocarditis, Pericarditis, or Myopericarditis ....................................................
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).

(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

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R or C: 1–21 days.
R or C: 1–21 days.
R or C: 1–21 days.
R or C: 1–21 days.
R or C: 1–21 days.
R or C: 1–21 days.
R or C: 1–21 days.
Maternal R or C: any time in gestation until 7 days
after birth.
R or C: 0–30 days.
R: 0–4 hours.
C: Not Covered.
R or C: 1–21 days.
R or C: No time interval specified.

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

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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.,

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51498

Federal Register / Vol. 68, No. 166 / Wednesday, August 27, 2003 / Rules and Regulations

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

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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

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(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

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Federal Register / Vol. 68, No. 166 / Wednesday, August 27, 2003 / Rules and Regulations
(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.

of decisions or actions taken by the
Director, Great Lakes Pilotage. We have
not received an adverse comment, or
notice of intent to submit an adverse
comment, on this rule. Therefore, the
rule will go into effect as scheduled.
DATES: The effective date of the direct
final rule is confirmed as August 22,
2003.

[FR Doc. 03–21906 Filed 8–26–03; 8:45 am]

47 CFR Parts 1 and 25

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.

Coast Guard, DHS.
Direct final rule; confirmation of
effective date.

(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.

SUMMARY: On June 23, 2003, we
published a direct final rule that
notified the public of the Coast Guard’s
intent to amend its appellate procedures
to provide explicit authority for appeal

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51499

BILLING CODE 4165–15–P

Coast Guard
46 CFR Part 1
[USCG 2003–15137]
RIN 1625–AA71

Right To Appeal; Director, Great Lakes
Pilotage
AGENCY:
ACTION:

Frm 00071

Fmt 4700

On June
23, 2003, we published a direct final
rule [68 FR 37091] that notified the
public of the Coast Guard’s intent to
amend its appellate procedures to
provide explicit authority for appeal of
decisions or actions taken by the
Director, Great Lakes Pilotage. We have
not received an adverse comment, or
notice of intent to submit an adverse
comment, on this rule. Therefore, the
rule will go into effect as scheduled.

SUPPLEMENTARY INFORMATION:

Dated: August 21, 2003.
T.H. Gilmour,
Rear Admiral, U.S. Coast Guard, Assistant
Commandant for Marine Safety, Security and
Environmental Protection.
[FR Doc. 03–21966 Filed 8–26–03; 8:45 am]
BILLING CODE 4910–15–P

FEDERAL COMMUNICATIONS
COMMISSION

[IB Docket Nos. 02–34 and 02–54, FCC 03–
102]

DEPARTMENT OF HOMELAND
SECURITY

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FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call Mr.
Tom Lawler, Coast Guard, telephone
202–267–1241. If you have questions on
viewing the docket, call Andrea M.
Jenkins, Program Manager, Docket
Operations, Department of
Transportation, telephone 202–366–
0271.

Sfmt 4700

Satellite Licensing Procedures
AGENCY: Federal Communications
Commission.
ACTION: Final rule.
SUMMARY: In this document, the
Commission adopts new satellite
licensing procedures, intended to enable
the Commission to issue satellite
slicenses more quickly. In addition, the
Commission eliminates the antitrafficking rule for satellites, together
with new safeguards to protect against
speculation. These actions are necessary
to expedite provision of satellite
services to the public, without allowing
satellite license applicants to abuse the
Commission’s licensing procedures.
DATES: Effective August 27, 2003, except
for §§ 25.137(d)(4), 25.164 (c) through

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