Smallpox Vaccine Injury Compensation Program: Administrative Implementation, 29808-29811 [06-4762]
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29808
Federal Register / Vol. 71, No. 100 / Wednesday, May 24, 2006 / Rules and Regulations
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 51492 on Wednesday, August
27, 2003, as a Final Rule with the
following amendment:
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PART 102—SMALLPOX
COMPENSATION PROGRAM
1. The authority citation for part 102
continues to read as follows:
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Authority: 42 U.S.C. 216, 42 U.S.C. 239–
239h.
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:
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§ 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
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
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Adoption of interim final rule as
final rule with amendments.
AGENCY:
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
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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
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Federal Register / Vol. 71, No. 100 / Wednesday, May 24, 2006 / Rules and Regulations
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).
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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.
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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 selfsupport 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
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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 https://
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
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Federal Register / Vol. 71, No. 100 / Wednesday, May 24, 2006 / Rules and Regulations
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.
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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
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Jkt 208001
‘‘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:
I
PART 102—SMALLPOX VACCINE
INJURY COMPENSATION PROGRAM
1. The authority citation for part 102
continues to read as follows:
I
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
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B. Amend newly designated
paragraph (l) (formerly designated
paragraph (k)) to read as set forth below:
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§ 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.
I
§ 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’’;
I 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’’.
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§ 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’’;
I 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,
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Federal Register / Vol. 71, No. 100 / Wednesday, May 24, 2006 / Rules and Regulations
Parklawn Building, Room 11C–06, 5600
Fishers Lane, Rockville, Maryland
20857’’.
I 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.
I
§ 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’’;
I 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’’;
I C. In paragraph (c), remove the words
‘‘Special Programs Bureau’’ and add in
their place ‘‘Healthcare Systems
Bureau’’.
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[FR Doc. 06–4762 Filed 5–23–06; 8:45 am]
BILLING CODE 4165–15–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 1, 2, and 87
[ET Docket No. 00–258, WT Docket No. 02–
8; FCC 06–43]
Advanced Wireless Service
Federal Communications
Commission.
ACTION: Final rule.
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AGENCY:
SUMMARY: This document denies
Petitions for Reconsideration and
affirms the Commission’s decision that
the Broadcast Auxiliary Service and
other incumbent services will share the
2025–2110 MHz band with relocated
Department of Defense facilities.
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DATES:
Effective June 23, 2006.
FOR FURTHER INFORMATION CONTACT:
Ted
Ryder, Office of Engineering and
Technology, Policy and Rules Division,
(202) 418–2803, e-mail:
Ted.Ryder@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Fourth
Memorandum Opinion and Order, ET
Docket No. 00–258, and WT Docket No.
02–8, FCC 06–43, adopted April 5, 2006,
and released April 11, 2006. The full
text of this document is available on the
Commission’s Internet site at https://
www.fcc.gov. It is also available for
inspection and copying during regular
business hours in the FCC Reference
Center (Room CY–A257), 445 12th
Street., SW., Washington, DC 20554.
The full text of this document also may
be purchased from the Commission’s
duplication contractor, Best Copy and
Printing Inc., Portals II, 445 12th St.,
SW., Room CY–B402, Washington, DC
20554; telephone (202) 488–5300; fax
(202) 488–5563; e-mail
FCC@BCPIWEB.COM.
Summary of the Report and Order
1. The Commission considered two
petitions for reconsideration
(‘‘Petitions’’) of the Seventh Report and
Order, 69 FR 77938, December 29, 2004,
in this proceeding, one filed by the
Association for Maximum Service
Television and National Association of
Broadcasters (together, ‘‘MSTV/NAB’’)
and the other by the Society of
Broadcast Engineers, Inc. (‘‘SBE’’). In
the Seventh Report and Order (‘‘AWS
Seventh Report and Order’’) in this
proceeding, the Commission, among
other things, allowed primary access to
the band 2025–2110 MHz for
Department of Defense (‘‘DOD’’) uplink
earth stations at 11 sites to support
military space operations (also known
as tracking, telemetry, and commanding
or ‘‘TT&C’’) on a co-equal basis with
stations in the incumbent Television
Broadcast Auxiliary Service (‘‘BAS’’),
Cable Television Relay Service
(‘‘CARS’’), and Local Television
Transmission Service (‘‘LTTS’’). For
simplicity, in the remainder of this
document the BAS, LTTS, and CARS
services collectively will be referred to
as BAS. The actions taken in the AWS
Seventh Report and Order were
specifically designed to facilitate the
introduction of new advanced wireless
services (‘‘AWS’’) in the band 1710–
1755 MHz by providing replacement
spectrum for clearing that band of
incumbent Federal Government
operations that would otherwise impede
the development of new nationwide
AWS services. These actions were
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29811
consistent with proposals made in the
AWS Fourth NPRM, 68 FR 52156,
September 2, 2003, and previous actions
in this proceeding and with the United
States Department of Commerce,
National Telecommunications and
Information Administration (‘‘NTIA’’)
2002 Viability Assessment, which
adderssed relocation and
reaccommodation options for Federal
Government operations in the band
1710–1755 MHz.
2. In the Memorandum Opinion and
Order, the Commission denied both the
MSTV/NAB and the SBE petitions. In
this regard, the Commission found that
the Petitioners have not raised any new
arguments or concerns that were not
already considered by the Commission
in its adoption of the AWS Seventh
Report and Order and that the
Commission’s decision properly
addressed the relevant facts in order to
reach its conclusion that BAS and
Federal Government operations will be
able to co-exist in the band. The
Commission, however, provided
additional clarification on a matter
raised in the SBE petition.
3. In the AWS Seventh Report and
Order, the Commission undertook the
specific task of reaccommodating
Federal users in order to make the band
1710–1755 MHz available for AWS use.
This decision was part of a larger and
substantially more complex proceeding
designed to make spectrum available for
a variety of new and innovative wireless
services and involving a variety of
bodies, including this Commission,
Federal stakeholders as represented
through NTIA, and Congress.
4. In the AWS Seventh Report and
Order decision, the Commission
recognized the concerns of the
broadcasting community that sharing of
the band 2025–2110 MHz (‘‘the 2 GHz
band’’) by TV BAS stations and DOD
TT&C uplink earth stations would be
challenging in some instances, given the
high power and close proximity of some
of these earth stations to nearby cities
served by BAS. However, it affirmed its
confidence that such sharing is feasible
and will promote the public interest,
particularly in the ultimate provision of
AWS to the public. To maintain its
longstanding policy that first-licensed
facilities have the right of protection
from later-licensed facilities operating
in the same band, and to facilitate
compatible operations, the Commission
required each DOD earth station to
coordinate with all potentially affected
BAS stations prior to earth station
authorization. Additionally, for the rare
situation where no reasonable
coordination can be negotiated, the
Commission stated that the issue may be
E:\FR\FM\24MYR1.SGM
24MYR1
]]>Agencies
[Federal Register Volume 71, Number 100 (Wednesday, May 24, 2006)]
[Rules and Regulations]
[Pages 29808-29811]
From the Federal Register Online via the Government Printing 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
https://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
