Smallpox Vaccine Injury Compensation Program:
Administrative
Implementation
Federal
Register: May 24, 2006 (Volume
71, Number 100)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
AGENCY: Health Resources and Services
Administration (HRSA), HHS
ACTION: Adoption
of interim final rule as final rule with
amendments.
SUMMARY: This document adopts the
Smallpox Vaccine Injury Compensation Program
(the Program) Administrative Implementation
Interim Final Rule
as the Final Rule with amendments, as follows: explains how the term
``child'' survivor is defined; updates the effective period of the
Secretary's Declaration Regarding Administration of Smallpox
Countermeasures (the Declaration); corrects an error in § 102.20(d)
to clarify that one of the Smallpox (Vaccinia) Vaccine Injury Table
requirements to establish a covered Table injury is the first symptom
or manifestation of onset of the injury in the Table time period
specified; reflects the change in name from the Special Programs Bureau
to the Healthcare Systems Bureau; provides the new address of the
Bureau's Associate Administrator, and the new address of the Program
Office; clarifies that no payments are authorized for fees or costs of
personal representatives, including those of attorneys; and corrects a
typographical error in § 102.83(c) to make clear that the Secretary
determines the timeframe for submission of required documentation.
DATES: The interim final rule, published
on December 16, 2003, was effective on
that date, and is adopted as the final
rule with an
amendment effective May 24, 2006.
FOR FURTHER INFORMATION CONTACT: Paul
T. Clark, Director, Smallpox Vaccine Injury
Compensation Program, Healthcare Systems
Bureau, Health
Resources and Services Administration, (301) 443-2330.
SUPPLEMENTARY INFORMATION: The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA),
Pub. L. 108-20, 117 Stat. 638, directed the Secretary of Health and
Human Services (the Secretary) to establish the 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 amount by $20
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. Section 220 of the Appropriations Act of 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 time 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
[[Page 29809]]
Program, the estate may qualify for payment of unreimbursed medical
expenses incurred and employment income lost as a result of the covered
injury, secondary to other payers.
SEPPA directed the Secretary to establish
a table identifying adverse effects (including
injuries, disabilities, conditions, and
deaths) that shall be presumed to result
from the administration of,
or exposure to, the smallpox vaccine,
and the time interval in which the
first symptom or manifestation of each listed injury must appear in
order for such presumption to apply. An
Interim Final Rule for the
Smallpox (Vaccinia) Vaccine Injury Table was published in the Federal
Register on August 27, 2003 (68 FR 51492). Following a public comment
period, the Final Rule was published on May 24, 2006.
An Interim Final Rule for the Administrative
Implementation of the Program was published
in the Federal Register on December 16,
2003 (42
CFR Part 102), with a 60-day public comment period. The public comment
period ended on February 17, 2004. HHS
received no comments.
Technical corrections to the Interim Final
Rule were published in the Federal
Register on February 17,
2004 (69 FR 7376).
Explanation of Provisions
In accordance with section 266(a)(2)(A)
of the Public Health Service Act, added
by SEPPA, death benefit amounts payable
under
the Program are equal to those available
under the Public Safety Officers'
Benefits (PSOB) Program. The PSOB Program death benefit amount
is subject to change on October 1 each
year.
For example, in fiscal year
(FY) 2003, the amount was $262,100; by FY 2006 the amount had
increased to $283,385. To keep the public
informed
of the current amount, the
Secretary will publish a Notice in the Federal Register announcing
the new amount for each fiscal year
consistent with the rate established
under the PSOB Program. In accordance with PSOB Program provisions,
the amount payable is determined
by the date of death of the smallpox
vaccine recipient or vaccinia contact, not the date of payment.
Also, this Final Rule is adding to the
definition section, § 102.3, a new paragraph
(e) to
clarify that,
for purposes of
survivorship benefits under the Program, the term ``child''
is defined in accordance with the PSOB
Program's
statutory
definition in 42 U.S.C.
at § 3796b(3), as implemented in 28 CFR Part 32, as amended.
An adult child survivor of a deceased
smallpox vaccine recipient or vaccinia contact may claim eligibility for death benefits if, at the
time of the recipient or contact's death, he or she is over 18 years of
age and incapable of self-support because of physical or mental
disability. Examples of the types of supporting documentation
requesters should submit to support eligibility as a disabled adult
child survivor include, but are not limited to: Determination of
disability letter, or award letter, issued by the Social Security
Administration; determination of disability by a court of competent
jurisdiction (e.g., requiring the need for a guardianship or
conservatorship); and medical documentation of the physical or mental
condition that precludes the capacity for self-support.
The Secretary has amended the Declaration
by extending the dates of its effective
period each year. The Secretary will continue
to publish
a notice in the Federal Register as needed to update further
the effective period of the Declaration.
These amendments to the
Declaration are made pursuant to the Secretary's authority
under section 261(a)(5) of the Public Health
Service Act, added by SEPPA and
section 224(p)(2)(A) of the Public Health Service Act.
Therefore, this Final Rule updates the
definition of the effective period of the
Declaration in § 102.3(k) of the Interim
Final Rule (redesignated
now as paragraph (l) to accommodate insertion of the new
paragraph (e)).
For the presumption to apply that an injury
resulted from the administration of, or
exposure
to, the smallpox vaccine, the injury
must be listed on the Smallpox (Vaccinia) Vaccine Injury
Table, and the first symptom or manifestation
of onset of the injury must occur within
the time interval listed on the Table.
Otherwise, the presumption of
causation does not apply, and the requester must prove causation.
The parenthetical example given in § 102.20(d) of the Interim
Final
Rule erroneously states that one of the Table requirements
to establish a covered injury is ``onset of the injury within
the time interval
included on the Table.'' However, it is not the onset of the
injury that must manifest within that time interval. Rather,
the requirement
is that the onset of the first symptom or manifestation
of the injury must manifest within the specified time period.
Therefore, this Final
Rule herein amends the parenthetical example in § 102.20(d)
to reflect the inadvertent omission of this language.
This Final Rule also reflects the change
in name of the HRSA Bureau that operates
the Program. The Special Programs
Bureau has been renamed
the Healthcare Systems Bureau. Therefore, § §
102.40(a) and (b), 102.41(a) and (b), and
102.90(b)(1),(2), and (c))
are amended
accordingly.
Further, the Program Office has a new
address: Parklawn Building, Room 11C-06,
5600 Fishers
Lane, Rockville, Maryland
20857. This is the
address to which all mail to the Program should be
sent, whether by U.S. Postal Service,
commercial carrier, or private courier
service.
Thus, § § 102.40(a) and (b), and 102.41(a)
and (b)) are amended to reflect this change.
Program telephone numbers
remain unchanged.
In addition, this Final Rule updates
the address for the Associate Administrator
of the
Healthcare Systems Bureau listed
in § §
102.90(b)(1) and (2). All letters seeking reconsideration
of the Secretary's eligibility or benefits
determinations, whether
sent by
U.S. Postal Service, commercial carrier, or private
courier service, should be sent to the
Associate Administrator, Healthcare
Systems
Bureau, Health Resources and Services Administration,
Parklawn Building, Room 12-105, 5600 Fishers Lane, Rockville, Maryland
20857.
The Program is not authorized to pay,
or reimburse a requester for
fees or costs incurred by the requester in using
a personal representative, including legal
fees, to file for benefits
on his or
her behalf (see Frequently Asked Questions on the
Program's Web site at http://www.hrsa.gov/smallpoxinjury).
Therefore, for clarification
purposes, § 102.44(d) of the Interim Final Rule is changed in this
Final Rule to read as follows: ``No payment or
reimbursement for representatives' fees
or costs. The Act does
not authorize the
Secretary to pay, or reimburse for, any fees or
costs associated with a requester's use
of a personal representative
under
this Program, including those of an attorney.''
The Program does
not provide
guidelines for legal fees.
Finally, this regulation also corrects
a typographical error in
§ 102.83(c) of the Interim Final Rule regarding
interim payments of benefits. The fourth sentence
of that subsection
should read:
``If a
requester's documentation is incomplete, the
requester must submit the
required documentation within the timeframe
determined by the Secretary'' not ``determined
by the requester''
as erroneously
stated.
Justification of Waiver of Delay of Effective
Date
The Secretary has found that a delay
in the effective date of this Final Rule
is unnecessary and contrary to the
public interest. The adoption of the
Interim Final Rule
as a Final Rule
[[Page 29810]]
reflects amendments, updates, and clarifications that will be helpful
to requesters without imposing additional
burdens. It has no effect on any individual's
rights
or responsibilities.
Economic and Regulatory Impact
Executive Order 12866 directs agencies
to assess all costs and benefits of available
regulatory alternatives
and, when
rulemaking is necessary, to select regulatory
approaches that provide
the
greatest net benefits (including potential
economic, environmental,
public
health, safety distributive and equity
effects). In addition, under the
Regulatory Flexibility Act of 1980 (RFA),
if a rule has a significant
economic effect on a substantial number of small
entities, the Secretary must specifically consider
the economic effect of a rule on
small entities and analyze regulatory options that
could lessen the impact of the rule.
Executive Order 12866 requires that all
regulations reflect consideration of alternatives,
of costs,
of benefits, of incentives, of
equity, and of available information.
Regulations must meet certain standards,
such as avoiding
an unnecessary burden. Regulations that
are ``significant'' because of cost, adverse
effects
on the economy, inconsistency with other
agency actions, effects on the budget,
or
novel legal or policy issues, require
special analysis.
The Secretary has determined
that minimal resources
are required to implement the provisions
included in this regulation. Therefore,
in
accordance with the RFA, and the Small
Business Regulatory Enforcement Fairness
Act of 1996, which
amended the RFA, the Secretary certifies
that this Final Rule will not have a
significant impact on a substantial number
of small
entities.
The Secretary has also determined
that this rule does not meet the
criteria for a major rule as defined
by Executive Order 12866 and would have
no major effect on
the economy or Federal expenditures.
This rule
is not a ``major rule'' within the meaning of
the statute providing for Congressional
Review of Agency Rulemaking, 5 U.S.C.
801.
Unfunded Mandates Reform Act of 1995
The Secretary has determined that this
Final Rule will not have effects on State,
local, or tribal
governments or on the private sector
such as to
require consultation
under the Unfunded Mandates Reform
Act of 1995.
Federalism Impact Statement
The Secretary has also reviewed this
rule in accordance with Executive Order
13132 regarding
federalism, and has determined that it
does not have ``federalism implications.'' The
rule does not ``have substantial direct effects
on the States, or on the relationship
between the national government and the States,
or on the distribution of power and responsibilities
among the various levels of government.''
Impact on Family Well-Being
This rule will not adversely affect the
following elements of family well-being:
Family safety,
family stability, marital commitment; parental
rights in the education,
nurture and supervision of their
children; family functioning, disposable
income
or poverty; or the behavior
and personal responsibility of youth, as
determined under
section 654(c) of the Treasury
and General Government Appropriations Act
of 1999. In fact, this Final
Rule may have a positive impact
on the disposable income and poverty elements
of family
well-being to the extent that
injured persons (or their survivors who
are eligible to
receive compensation) receive
benefits without a corresponding burden
being imposed on them.
Paperwork Reduction Act
The information collection requirements
remain unchanged.
List of Subjects in 42 CFR Part
102
Benefits, Biologics, Compensation, Immunization,
Public health, Smallpox, Vaccinia.
Dated: November 14, 2005.
Elizabeth M. Duke,
Administrator
Approved: December
22, 2005.
Michael O. Leavitt,
Secretary Editorial
Note: This document was received
at the Office of the Federal Register on
May
18, 2006.
For the reasons stated
above, the Secretary is adopting the
Interim Final
Rule adding 42 CFR
part 102, published at
68
FR 70080 on Tuesday,
December 16, 2003, as amended on February
17, 2004, at 69 FR 7376, as a Final Rule
with the following amendments:
PART 102--SMALLPOX VACCINE
INJURY COMPENSATION PROGRAM
1. The authority citation
for part 102 continues to read
as follows:
Authority: 42
U.S.C. 216, 42 U.S.C.
239-239h.
2. Amend
§ 102.3 to read as follows:
A. Redesignate paragraphs
(e) through
(bb)
as paragraphs
(f) through (cc)
and add new paragraph
(e) to read
as
set
forth below;
and
B. Amend newly designated
paragraph
(l)
(formerly designated
paragraph (k)) to read as set
forth below: § 102.3 Definitions
(e) Child means any
natural,
illegitimate,
adopted, or posthumous
child or stepchild of
a deceased
smallpox
vaccine recipient or vaccinia
contact
who,
at the
time of
the recipient or contact's death
is:
(1)
18 years
of age or under; or
(2) Over 18 years
of age and a student
as
defined in section
8101 of title
5, United
States
Code; or
(3) Over 18
years of age and incapable of
self-support
because
of
physical
or mental disability.
(l)
Effective period
of the
Declaration means
the time
span specified in the Declaration,
as
amended by the Secretary.
§ 102.20
[Amended]
3. Amend § 102.20, paragraph
(d) introductory
text
by adding
the
words
``the
first
symptom
or manifestation of'' before
the
word
``onset''
in
the
parenthetical
example.
§ 102.40 [Amended]
4. Amend § 102.40 as
follows:
A. In paragraph
(a), remove the words ``Special
Programs
Bureau'', and
add
in
their place
``Healthcare
Systems Bureau'', and remove
the
words
Room
``16C-17'',
and
add
in their
place
``Room
11C-06'';
B. In
paragraph (b),
remove the words ``Special
Programs
Bureau,
Health
Resources
and
Services Administration,
4350 East-West
Highway, 10th
Floor, Bethesda,
Maryland 20814''
and
add in their
place ``Healthcare
Systems
Bureau, Health
Resources
and Services
Administration,
Parklawn
Building,
Room 11C-06,
5600 Fishers Lane, Rockville,
Maryland
20857''.
§
102.41 [Amended]
5. Amend §
102.41
as follows:
A. In paragraph (a),
remove
the
words ``Special
Programs Bureau'',
and
add in their place ``Healthcare
Systems Bureau'',
and remove the
words Room ``16C-17'',
and add in their
place ``Room 11C-06'';
B. In paragraph (b),
remove
the
words ``Special
Programs Bureau,
Health
Resources
and Services Administration,
Parklawn
Building,
4350 East-
West Highway,
10th Floor, Bethesda, Maryland
20814''
and add in their place
``Healthcare
Systems Bureau,
Health Resources
and
Services
Administration,
[[Page
29811]]
Parklawn Building,
Room
11C-06, 5600
Fishers Lane,
Rockville,
Maryland 20857''.
6. Revise
§ 102.44 paragraph
(d)
to read
as
follows:
§ 102.44 Representatives
of requesters.
(d) No payment
or
reimbursement
for representatives'
fees or
costs. The Act does
not
authorize
the Secretary to pay,
or reimburse
for, any
fees or costs associated
with the requester's
use of
a personal
representative
under this
Program, including those
of
an
attorney.
§
102.83
[Amended]
7. Amend §
102.83, paragraph (c), by
removing
the
second
occurance
of the word ``requester''
and
in its
place add
the word
``Secretary''
at the end
of
the fourth sentence
of that
section.
§
102.90 [Amended]
8. Amend
§
102.90
as follows:
A. In
paragraph
(b)(1)
remove
the
words
``Special
Programs
Bureau'',
and add
in
their place
``Healthcare
Systems Bureau,'' and
remove
the
words
``Room
16C-17,
and
add
in
their
place
``Room
12-105'';
B.
In paragraph
(b)(2)
remove
the
words
``Special
Programs
Bureau,
Health
Resources
and
Services
Administration,
4350
East-West
Highway,
10th
Floor,
Bethesda,
Maryland
20814,''
and
add
in
their
place
``Healthcare
Systems
Bureau,
Parklawn
Building,
Room
12-105,
5600
Fishers
Lane,
Rockville,
Maryland
20857'';
C.
In paragraph
(c),
remove
the
words
``Special
Programs Bureau''
and
add
in
their
place
``Healthcare
Systems
Bureau''.
[FR Doc. 06-4762 Filed
5-23-06;
8:45
am]
BILLING CODE 4165-15-P
|