[Federal Register Volume 71, Number 100 (Wednesday, May 24, 2006)]
[Rules and Regulations]
[Pages 29805-29808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4761]


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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 (HRSA), HHS.

ACTION: Adoption of interim final rule as final rule with an amendment.

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SUMMARY: This document adopts the Smallpox (Vaccinia) Vaccine Injury 
Table (the Table) Interim Final Rule as the Final Rule with an 
amendment, as follows: the Final Rule clarifies that, in order for the 
presumption of causation to apply, the time intervals listed on the 
Table refer specifically to the period in which the first symptom or 
manifestation of onset of injury must appear following administration 
of the smallpox vaccine or exposure to vaccinia, and that the time 
intervals listed have no relevance to time of diagnosis of the injury.

DATES: The Interim Final Rule, published on August 27, 2003, was 
effective on that date, and is adopted as the Final Rule with an 
amendment effective May 24, 2006.

FOR FURTHER INFORMATION CONTACT: Paul T. Clark, Director, Smallpox 
Vaccine Injury Compensation Program, Healthcare Systems Bureau, Health 
Resources and Services Administration, (301) 443-2330.

SUPPLEMENTARY INFORMATION: 

Background

    The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), 
Pub. L. 108-20, 117 Stat. 638, directed the Secretary of Health and 
Human Services (the Secretary) to establish the Smallpox Vaccine Injury 
Compensation Program (the Program). Secondary to other payers, the 
Program provides medical, lost employment income, and death benefits 
for eligible individuals who sustained covered injuries as a result of 
receiving smallpox vaccine or other covered countermeasures, or as a 
result of accidental exposure to vaccinia. Congress appropriated $42 
million in fiscal year (FY) 2003 for the administration of, and payment 
of benefits under, the Program. The Consolidated Appropriations Act of 
2005 reduced this appropriation to $22 million. The Departments of 
Labor, Health and Human Services, and Education, and Related Agencies 
Appropriations Act, 2006 (Pub. L. 109-149) further reduced the 
Program's appropriation by $10 million to a total of $12 million.
    Individuals who receive a smallpox vaccination under a Department 
of Health and Human Services (HHS), State, or local emergency response 
plan approved by HHS within the period described in the Secretary's 
Declaration, and who sustain a covered injury may be eligible for 
benefits under SEPPA. Individuals who contracted vaccinia through 
contact with such individuals or other eligible vaccinia contacts and 
who sustain a covered injury may also be eligible for benefits. In the 
case of death resulting directly from receipt of the smallpox vaccine 
or exposure to vaccinia by eligible individuals, certain of their 
survivors may be considered for death benefits. If an eligible 
individual who sustained a covered injury dies from another cause 
before payment of benefits has been made under the Program, the estate 
may qualify for payment of unreimbursed medical expenses incurred and 
employment income lost as a result of the covered injury, secondary to 
other payers. SEPPA directed the Secretary to establish a table 
identifying adverse effects (including injuries, disabilities,

[[Page 29806]]

conditions, and deaths) that shall be presumed to result from the 
administration of, or exposure to, the smallpox vaccine, and the time 
interval in which the first symptom or manifestation of each listed 
injury must appear in order for such presumption to apply. An Interim 
Final Rule for the Table was published in the Federal Register on 
August 27, 2003 (68 FR 51492), with public comments sought on these 
provisions.
    Based on the comments received, this Final Rule clarifies that the 
Table is not the sole standard for determining medical eligibility for 
benefits under the Program. Therefore, an individual who sustains an 
injury that is not on the Table or not within the timeframes on the 
Table, and believes it was caused by a smallpox vaccination, is 
encouraged to submit a Request Package to the Program. This Final Rule 
makes it clear that the time intervals on the Table refer specifically 
to the first symptom or manifestation of onset of illness or injury, 
not to the date of the diagnosis. It also clarifies that any component 
of a smallpox vaccine, not only the vaccinia, could be the possible 
cause of a covered injury. Further, this regulation updates the Interim 
Final Rule to reflect that the Secretary has extended the effective 
period of the Declaration Regarding Administration of Smallpox 
Countermeasures (the Declaration). Finally, this Final Rule also 
updates the change in name of the Special Programs Bureau to the 
Healthcare Systems Bureau; and provides the new address of the Program 
Office.

Discussion of Comments

    The public comment period ended on October 27, 2003. HHS received a 
total of 11 public comments. Four were from professional associations; 
three were from medical professionals; two were from the general 
public; one was from a State health department; and one was from a 
nonprofit community health organization. The issues raised and HHS's 
responses appear below.

A. Time Intervals for the First Symptom or Manifestation of Onset of 
Injury

    The Secretary received two comments suggesting that the time 
intervals listed on the Table be lengthened. One commenter requested 
that the Secretary extend the time limit for the onset of myocarditis 
and pericarditis from 21 days to 60 days. The other commenter indicated 
concern that the time intervals listed on the Table seem potentially 
short, and should be determined in consultation with the Centers for 
Disease Control and Prevention (CDC) and the military regarding all the 
Table time intervals, independent of how long it takes for a scab to 
fall off. The Secretary received a third comment related to the time 
intervals on the Table requesting an appeal process to the Table time 
intervals.
    The Secretary does not concur with changing the time intervals on 
the Table, whether it be for the onset of myocarditis or pericarditis 
from 21 to 60 days, or any other seemingly short time intervals. The 
Secretary did consult with the Department of Defense (DoD) and CDC, as 
well as with other HHS components and the private sector. Their 
scientific data support the time intervals as specified on the Table. 
The commenters did not provide evidence to support lengthening the time 
intervals beyond that which the Secretary had already considered and, 
therefore, they remain as currently listed. However, as discussed 
below, if any individual has symptoms that manifest outside of those 
time intervals, he or she may still be considered for benefits under 
the Program.
    The third commenter expressed the hope that the Table permits 
adequate time for injured individuals to seek compensation, and 
recommended that language be added to the regulations to provide an 
avenue for appeal to the timeframes established in the Table, should an 
individual become ill or exhibit symptoms related to the vaccine beyond 
the established Table timeframes.
    The Secretary wishes to emphasize that an injury that manifests 
itself outside of the timeframe listed on the Table may still be a 
covered injury. The Secretary recognizes that symptoms can occur 
subsequent to the Table timeframes in some cases. In this event, the 
individual may be found medically eligible if he or she submits 
evidence to show that it is more likely than not that the smallpox 
vaccine or other covered countermeasure, or the vaccinia contracted 
from accidental vaccinia exposure, actually caused the injury. SEPPA 
does not provide an avenue for appeal of the timeframes established in 
the Table. Thus, the Secretary disagrees with the commenter that there 
is a need for an appeal process for the time intervals. However, the 
Secretary has established a reconsideration process for re-review of 
the Program's determinations on medical/program and financial 
eligibility requirements through the Administrative Regulations for 
this Program published in the Federal Register on December 16, 2003. If 
a requester is not satisfied with the Program's decisions, the 
requester has the right to seek reconsideration of any adverse 
determination.
    There were two additional comments regarding time intervals. One 
commenter wanted to make sure that HHS clarifies that the time 
intervals relate to the timeframe of the first symptom or manifestation 
of onset of injury, not to the timeframe of the diagnosis. The 
Secretary agrees with this comment and has clarified this issue by 
inserting appropriate language into this Final Rule.
    The other commenter requested that the time intervals of 21 days be 
extended because it may take 6 to 8 weeks for the scab at the 
vaccination site to fall off. The Secretary does not agree to change 
the time intervals on the Table because these timeframes are not 
related to the time it takes for the scab to fall off spontaneously.

B. Additions of Injuries to the Table

    There were three comments pertaining to the injuries listed on the 
Table. Two comments suggested that the Table should be amended to 
include myocardial infarction and tremors, respectively. The other 
commenter indicated that the list of injuries limited to those 
published in the August 27, 2003, Interim Final Rule, was incomplete.
    The Secretary does not concur with these comments. At this time, 
there is no clear scientific evidence to support the inclusion of 
myocardial infarction, tremors, or other conditions as additional Table 
injuries, and the commenters did not provide additional evidence 
showing it would be appropriate to add more Table injuries. Should an 
individual have any injury believed to have resulted from the 
administration of, or exposure to, the smallpox vaccine that is not 
listed on the Table, he or she may nevertheless be eligible for 
benefits and should submit a request to the Program.

C. The Documentation Requirements

    One commenter raised the issue that the Table regulations exceed 
the statute's requirements in terms of medical injury documentation 
burden and related cost. The commenter believes that these regulations 
are far more onerous than SEPPA requires, specifying that the issues of 
documenting method of treatment, identification of injury, etc., are 
not even referenced in the statute. The commenter stated that the 
burdensome and costly requirements for first responders should 
immediately be rescinded.
    The Secretary disagrees with the commenter that the documentation 
requirement is onerous and exceeds legislative intent. The specific 
comment

[[Page 29807]]

relates to the requirement for a treatment plan in order to be 
considered for a Table injury. This language appears in five of the 
twelve Table injuries. The requirement for a treatment plan is case-
specific and applies only in certain circumstances where there is an 
issue of needed long-term medical/surgical care. Requesters do not need 
to provide one in order to be considered for a Table injury.
    The commenter also wrote that first responders are obligated to pay 
out of their own pockets for immediate treatment and again for a 
detailed surgical treatment plan. Section 264(b) of the Smallpox 
Emergency Personnel Protection Act of 2003 establishes that the 
government is the payer of last resort after all other payments have 
been or will be made to an individual for medical care directly 
resulting from an injury caused by the smallpox vaccination. 
Individuals are reimbursed for their out-of-pocket medical expenses in 
accordance with the Act.

D. Other Issues Raised by Commenters

    One commenter raised the concern that the Table regulations cover 
only those injuries caused by the vaccinia virus and not all components 
of the smallpox vaccine. Another commenter was concerned about the 
scope of the Program and if it would cover the general population.
    In reference to the issue of the components in the smallpox 
vaccine, the Secretary concurs that the components of a smallpox 
vaccine may cause a covered injury. Therefore, the Secretary has 
clarified in this final regulation that a covered injury can be caused 
not only by vaccinia, but by any component or constituent of the 
smallpox vaccine.
    In response to the concern about the scope of the legislation, 
SEPPA only covers individuals who are members of HHS-approved smallpox 
emergency response plans and individuals who contracted vaccinia from 
them or from other eligible contacts. SEPPA is not designed to provide 
benefits to the general population.

Explanation of Provisions

    Some of the comments received indicate to the Secretary that there 
may be confusion as to the significance of the Table. Therefore, this 
Final Rule clarifies that having an injury listed on the Table is only 
one of the ways that an individual can show medical eligibility for 
Program benefits. The Secretary emphasizes that the purpose of the 
Table is merely to provide potential requesters who can demonstrate 
that they sustained a Table injury within the specified time interval 
with the presumption that the smallpox vaccine caused the injury. 
However, sustaining an injury not listed on the Table (including an 
injury resulting from administration of another covered 
countermeasure), or manifesting a Table injury outside of the time 
interval listed, simply means that the presumption does not apply. In 
those cases, the individual must show that it is more likely than not 
(i.e., by a preponderance of the evidence), that administration of the 
smallpox vaccine (or other covered countermeasure), or exposure to the 
vaccine in the case of contacts, was the cause of the injury. The 
Secretary encourages such individuals to file a request for benefits. 
The Program has found individuals with Table or non-Table injuries to 
be medically eligible.
    As previously mentioned, this Final Rule also clarifies that the 
time intervals listed on the Table refer specifically to the period in 
which the first symptom or manifestation of onset of injury must appear 
following administration of the smallpox vaccine or exposure to 
vaccinia, in order for the presumption of causation to apply. The time 
intervals listed have no relevance whatsoever to when the injury is 
diagnosed.
    Thus, the Secretary herein amends Sec.  102.21(a) of the Interim 
Final Rule by adding language to the subheading of the Table that lists 
the time intervals. This additional language makes it clear that these 
time intervals refer only to the first symptom or manifestation of 
onset of the injury, not to the time interval within which a diagnosis 
of the injury must be made.
    The Secretary also wishes to make it clear that a covered injury 
can be caused not only by the vaccinia component of the smallpox 
vaccine, but by any component or constituent of the vaccine.
    Further, this Final Rule updates the effective period of the 
Secretary's Declaration. The Secretary has amended the effective period 
of the Declaration by extending it each year. The Secretary will 
continue to publish a Notice in the Federal Register as needed to 
update any further amendments to the effective period. These amendments 
to the Declaration are made pursuant to the Secretary's authority under 
section 261(a)(5) of SEPPA (section 224(p)(2)(A) of the Public Health 
Service Act).
    Additionally, this Final Rule reflects the change in name of the 
Special Programs Bureau, which has been renamed the Healthcare Systems 
Bureau. Finally, this regulation updates the address of the Program 
Office. The new address, to which all mail to the Program should be 
sent, whether by U.S. Postal Service, commercial carrier, or private 
courier service, is: Parklawn Building, Room 11C-06, 5600 Fishers Lane, 
Rockville, Maryland 20857.

Justification of Waiver of Delay of Effective Date

    The Secretary has found that a delay in the effective date of this 
Final Rule with an amendment is unnecessary and contrary to the public 
interest. The adoption of the Interim Final Rule as a Final Rule 
reflects an amendment and clarifications that are a result of comments 
received on the Interim Final Rule and, therefore, will be helpful to 
requesters without imposing additional burdens. It has no effect on any 
individual's rights or responsibilities.

Economic and Regulatory Impact

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when rulemaking is 
necessary, to select regulatory approaches that provide the greatest 
net benefits (including potential economic, environmental, public 
health, safety distributive and equity effects). In addition, under the 
Regulatory Flexibility Act of 1980 (RFA), if a rule has a significant 
economic effect on a substantial number of small entities, the 
Secretary must specifically consider the economic effect of a rule on 
small entities and analyze regulatory options that could lessen the 
impact of the rule.
    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, of costs, of benefits, of incentives, of 
equity, and of available information. Regulations must meet certain 
standards, such as avoiding an unnecessary burden. Regulations that are 
``significant'' because of cost, adverse effects on the economy, 
inconsistency with other agency actions, effects on the budget, or 
novel legal or policy issues, require special analysis.
    The Secretary has determined that minimal resources are required to 
implement the provisions included in this regulation. Therefore, in 
accordance with the RFA, and the Small Business Regulatory Enforcement 
Fairness Act of 1996, which amended the RFA, the Secretary certifies 
that this Final Rule will not have a significant impact on a 
substantial number of small entities.
    The Secretary has also determined that this rule does not meet the 
criteria for a major rule as defined by Executive Order 12866 and would 
have no major effect on the economy or Federal expenditures. This rule 
is not a ``major rule'' within the meaning of the statute providing for 
Congressional Review of Agency Rulemaking, 5 U.S.C. 801.

[[Page 29808]]

Unfunded Mandates Reform Act of 1995

    The Secretary has determined that this Final Rule will not have 
effects on State, local, or tribal governments or on the private sector 
such as to require consultation under the Unfunded Mandates Reform Act 
of 1995.

Federalism Impact Statement

    The Secretary has also reviewed this rule in accordance with 
Executive Order 13132 regarding federalism, and has determined that it 
does not have ``federalism implications.'' The rule does not ``have 
substantial direct effects on the States, or on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government.''

Impact on Family Well-Being

    This rule will not adversely affect the following elements of 
family well-being: Family safety, family stability, marital commitment; 
parental rights in the education, nurture and supervision of their 
children; family functioning, disposable income or poverty; or the 
behavior and personal responsibility of youth, as determined under 
section 654(c) of the Treasury and General Government Appropriations 
Act of 1999. In fact, this Final Rule may have a positive impact on the 
disposable income and poverty elements of family well-being to the 
extent that injured persons (or their survivors who are eligible to 
receive compensation) receive benefits without a corresponding burden 
being imposed on them.

Paperwork Reduction Act

    The information collection requirements remain unchanged.

List of Subjects in 42 CFR Part 102

    Benefits, Biologics, Compensation, Immunization, Public health, 
Smallpox, Vaccinia.

    Dated: November 14, 2005.
Elizabeth M. Duke,
Administrator.

    Approved: December 22, 2005.
Michael O. Leavitt,
Secretary.

    Editorial Note: This document was received at the Office of the 
Federal Register on May 18, 2006.


0
For the reasons stated above, the Secretary is adopting the Interim 
Final Rule adding 42 CFR part 102, published at 68 FR 51492 on 
Wednesday, August 27, 2003, as a Final Rule with the following 
amendment:

PART 102--SMALLPOX COMPENSATION PROGRAM

0
1. The authority citation for part 102 continues to read as follows:

    Authority: 42 U.S.C. 216, 42 U.S.C. 239-239h.

0
2. In section 102.21, the table in paragraph (a) is amended by adding 
the following sentence at the end of the time interval description 
subheading:


Sec.  102.21  Smallpox (Vaccinia) Vaccine Injury Table.

    (a) * * *
    Please note that these time intervals do not refer to time periods 
for the date of diagnosis of the injury.
* * * * *
[FR Doc. 06-4761 Filed 5-23-06; 8:45 am]
BILLING CODE 4165-15-P