[Federal Register Volume 68, Number 166 (Wednesday, August 27, 2003)]
[Rules and Regulations]
[Pages 51492-51499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21906]


=======================================================================
-----------------------------------------------------------------------

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.

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 [email protected]. 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 [email protected].

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

[[Page 51493]]

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

[[Page 51494]]

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

[[Page 51495]]

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

[[Page 51496]]

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.


[[Page 51497]]


    Dated: July 18, 2003.
Elizabeth M. Duke,
Administrator, Health Resources and Services Administration.
    Approved: July 22, 2003.
Tommy G. Thompson,
Secretary.


0
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  Smallpox (Vaccinia) Vaccine Injury Table.

                                  (a) Smallpox (Vaccinia) Vaccine Injury Table
----------------------------------------------------------------------------------------------------------------
                                          Time interval for first symptom or manifestation of onset of injury
 Injury (illness, disability, injury,    after: (1) administration of smallpox (vaccinia) vaccine in recipients
            or condition)                           (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,       R or C: 1-21 days.
 Encephalitis or Encephalomyelitis.
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,             R or C: 1-21 days.
 Pericarditis, or Myopericarditis.
12. Death resulting from an injury     R or C: No time interval specified.
 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 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.,

[[Page 51498]]

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

[[Page 51499]]

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]
BILLING CODE 4165-15-P