[Federal Register Volume 71, Number 100 (Wednesday, May 24, 2006)]
[Rules and Regulations]
[Pages 29808-29811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4762]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 102

RIN 0906--AA61


Smallpox Vaccine Injury Compensation Program: Administrative 
Implementation

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Adoption of interim final rule as final rule with amendments.

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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 Sec.  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 Sec.  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:

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 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, Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  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, Sec. Sec.  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, Sec. Sec.  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 Sec. Sec.  
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, Sec.  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 
Sec.  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.


0
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

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. Amend Sec.  102.3 to read as follows:
0
A. Redesignate paragraphs (e) through (bb) as paragraphs (f) through 
(cc) and add new paragraph (e) to read as set forth below; and
0
B. Amend newly designated paragraph (l) (formerly designated paragraph 
(k)) to read as set forth below:


Sec.  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.
* * * * *


Sec.  102.20  [Amended]

0
3. Amend Sec.  102.20, paragraph (d) introductory text by adding the 
words ``the first symptom or manifestation of'' before the word 
``onset'' in the parenthetical example.


Sec.  102.40  [Amended]

0
4. Amend Sec.  102.40 as follows:
0
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'';
0
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''.


Sec.  102.41  [Amended]

0
5. Amend Sec.  102.41 as follows:
0
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'';
0
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''.

0
6. Revise Sec.  102.44 paragraph (d) to read as follows:


Sec.  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.


Sec.  102.83  [Amended]

0
7. Amend Sec.  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.


Sec.  102.90  [Amended]

0
8. Amend Sec.  102.90 as follows:
0
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'';
0
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'';
0
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