National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 55503-55507 [2010-22745]
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Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Proposed Rules
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revisions in the form specified in EPA’s
proposed approval, referenced above.
The State’s submittal indicates in
Section 4, ‘‘Interfere with Prevention of
Significant Deterioration of Air Quality,’’
that the State’s SIP provisions include
an EPA-approved PSD program. Idaho’s
regulations for its PSD program were
last approved by EPA and made part of
the SIP on January 16, 2003 (68 FR
2217), 40 CFR 52.670, effective February
18, 2003. On March 18, 2010, EPA
proposed to approve Idaho’s PSD rule
revisions incorporating into the State’s
rules the provisions of EPA’s PSD
requirements as of July 1, 2008,
including the November 29, 2005, Phase
2 rule for the 1997 8-hour ozone
NAAQS (70 FR 71612), and the May 16,
2008, PM2.5 Implementation Rule (73 FR
28321) for the 1997 PM2.5 NAAQS. We
anticipate taking final action approving
Idaho’s PSD rule revisions before taking
final action on this interstate transport
proposal. Therefore, EPA proposes to
approve this SIP provision as adequate
for purposes of section 110(a)(2)(D)(i)(II)
if EPA has taken final action to approve
the revisions to Idaho’s PSD
requirements that are consistent with
our proposed action.
EPA believes that the PSD revision for
the 1997 8-hour ozone NAAQS that
makes NOX a precursor for ozone for
PSD purposes and the PSD revision for
the 1997 PM2.5 NAAQS that makes SO2
and NOX precursors for PM2.5 for PSD
purposes, taken together with the
revised PSD SIP that EPA proposed to
approve on March 18, 2010, and the
Interstate Transport SIP that EPA is
proposing to approve in this action,
satisfy the requirements of the third
element of section 110(a)(2)(D)(i) for the
1997 8-hour ozone NAAQS and the
1997 PM2.5 NAAQS. That is, these
provisions ensure that there will be no
interference with any other state’s
required PSD measures because Idaho’s
SIP, as proposed for approval in this
action along with the March 18, 2010
proposed action on the revised PSD
rules, will meet current CAA
requirements for PSD.
V. Proposed Action
In light of the data and the weight of
the evidence analysis presented above,
EPA is proposing to approve revisions
to the Idaho SIP, submitted on June 28,
2010, which adequately demonstrate
that for the 1997 8-hour ozone and 1997
PM2.5 NAAQS, air pollutant emissions
from sources within Idaho do not (1)
significantly contribute to
nonattainment of the NAAQS in any
other state, (2) interfere with
maintenance of the NAAQS by any
other state, and (3) interfere with any
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other state’s required measures to
prevent significant deterioration of its
air quality, as required by section
110(a)(2)(D)(i).
As noted previously, EPA will
address element (4), interference with
any other state’s required measures to
protect visibility, in a separate action.
EPA will also take action on the portion
of Idaho’s SIP that addresses the 2006
PM2.5 NAAQS in a separate action.
VI. Statutory and Executive Order
Reviews
Under the Clean Air Act, the
Administrator is required to approve a
SIP submission that complies with the
provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP
submissions, EPA’s role is to approve
state choices, provided that they meet
the criteria of the Clean Air Act.
Accordingly, this action merely
proposes to approve state law as
meeting Federal requirements and does
not impose additional requirements
beyond those imposed by state law. For
that reason, this action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Order 12866 (58 FR 51735,
October 4, 1993);
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act
(5 U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
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55503
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, this proposed rule does
not have tribal implications as specified
by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is
not approved to apply in Indian country
located in the state, and EPA notes that
it will not impose substantial direct
costs on tribal governments or preempt
tribal law.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Ozone, Particulate matter, Reporting
and recordkeeping requirements,
Volatile organic compounds.
Dated: September 2, 2010.
Dennis J. McLerran,
Regional Administrator, Region 10.
[FR Doc. 2010–22773 Filed 9–10–10; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 100
RIN 0906–AA74
National Vaccine Injury Compensation
Program: Revisions to the Vaccine
Injury Table
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of proposed rulemaking.
AGENCY:
Through this proposed rule,
the Secretary proposes to change the
Vaccine Injury Table (Table) to create
distinct and separate listings for
hepatitis A, trivalent influenza,
meningococcal, and human
papillomavirus (HPV) vaccines. The
Table includes a list of covered vaccines
under the National Vaccine Injury
Compensation Program (VICP). The
VICP provides a system of no-fault
compensation for certain individuals
who have been injured by covered
childhood vaccines. This proposed rule
is technical in nature. The four
categories of vaccines described in this
notice are already covered vaccines
under the VICP (starting in 2004) and
are currently listed in a placeholder
category (box XIII) in the Table. This
document proposes to list these
vaccines as separate categories on the
Table, with no associated injuries noted
at this time, in order to make the Table
more clear to the public.
SUMMARY:
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Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Proposed Rules
Comments on this proposed rule
must be submitted by March 14, 2011.
A public hearing on this proposed rule
will be held before the end of the public
comment period. A separate notice will
be published in the Federal Register to
provide the details of this hearing.
ADDRESSES: You may submit comments,
identified by the Regulatory Information
Number (RIN) 0907–AA74, by any of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: gevans@hrsa.gov. Include
RIN 0907–AA74 in the subject line of
the message.
• Mail: Geoffrey Evans, M.D.,
Director, Division of Vaccine Injury
Compensation, Healthcare Systems
Bureau, Health Resources and Services
Administration, Room 11C–26,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857.
Instructions: All submissions received
must include the agency name and RIN
for this rulemaking. All comments
received will be available for public
inspection and copying without charge,
including any personal information
provided, at Parklawn Building, 5600
Fishers Lane, Room 11C–26, Rockville,
Maryland 20857, weekdays (Federal
holidays excepted) between the hours of
8:30 a.m. and 5 p.m.
FOR FURTHER INFORMATION CONTACT:
Geoffrey Evans, M.D. at the mail or email address above or by telephone at
(301) 443–6593.
SUPPLEMENTARY INFORMATION: The
National Childhood Vaccine Injury Act
of 1986, Title III of Public Law 99–660,
as amended (42 U.S.C. 300aa–10 et
seq.), established the National Vaccine
Injury Compensation Program (VICP) for
persons found to be injured by vaccines.
Under this Federal program, petitions
for compensation are filed with the
United States Court of Federal Claims
(Court). The Court, acting through
special masters, makes findings as to
eligibility for, and amount of,
compensation. In order to gain
entitlement to compensation under Title
XXI of the Public Health Service (PHS)
Act for a covered vaccine, a petitioner
must establish a vaccine-related injury
or death, either by proving: (1) That the
first symptom of an injury/condition, as
defined by the Vaccine Injury Table’s
(Table’s) Qualifications and Aids to
Interpretation (QAI), occurred within
the time period listed on the Table
(copy of the Table can be found at
https://www.hrsa.gov/
vaccinecompensation), and is therefore
the injury or death presumed to be
caused by a vaccine (unless another
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cause is found); or (2) proof of vaccine
causation, if the injury/condition is not
on the Table or did not meet the QAIs
or the time frame period specified on
the Table.
The statute authorizing the VICP
provides for the inclusion of additional
vaccines in the VICP when they are
recommended by the Centers for Disease
Control and Prevention (CDC) for
routine administration to children. See
section 2114(e)(2) of the Public Health
Service (PHS) Act, 42 U.S.C. 300aa–
14(e)(2). Consistent with section
13632(a)(3) of the Omnibus Budget
Reconciliation Act of 1993 (Pub. L. 103–
66), the regulations governing the VICP
provide that such vaccines will be
included in the Table as of the effective
date of an excise tax to provide funds
for the payment of compensation with
respect to such vaccines. See 42 CFR
100.3(c)(5). The statute authorizing the
VICP also authorizes the Secretary to
create and modify a list of injuries,
disabilities, illnesses, conditions, and
deaths (and their associated time
frames) associated with each category of
vaccines included on the Table. See
sections 2114(c)(3) and 2114(e)(2) of the
PHS Act, 42 U.S.C. 300aa–14(c)(3) and
300aa–14(e)(2).
The prerequisites for adding the
hepatitis A, trivalent influenza,
meningococcal, and human
papillomavirus (HPV) vaccines to the
VICP have already occurred. The
Secretary previously published notices
announcing that each of these categories
of vaccines is covered under the VICP
(under the Table’s provisional category)
and explaining that the Secretary
planned on adding these vaccines as
separate categories to the Table through
rulemaking, as proposed in this notice.
On December 1, 2004, the Secretary
published a notice in the Federal
Register announcing that hepatitis A
vaccines were covered under the VICP,
with an effective date of December 1,
2004. 69 FR 69945. On April 12, 2005,
the Secretary published a notice in the
Federal Register announcing that
trivalent influenza vaccines were
covered under the VICP, with an
effective date of July 1, 2005. 70 FR
19092. On April 20, 2007, the Secretary
published a notice in the Federal
Register announcing that
meningococcal vaccines and human
papillomavirus vaccines were covered
under the VICP, with an effective date
of February 1, 2007. 72 FR 19937.
Although the vaccines described in
this notice are officially covered by the
VICP, their placement in the provisional
box XIII, rather than as distinct and
separate listings, has sometimes led to
confusion regarding their coverage
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status. We propose to add these four
vaccines in their own separate
categories to the Table in order to help
the public identify clearly that these
vaccines are covered by the VICP.
To date, the Secretary has not
identified any illness, disease, injury, or
condition caused by these four vaccines.
For this reason, the Secretary proposes
adding these four categories of vaccines
to the Table with ‘‘[n]o condition
specified.’’ If the Secretary learns of any
such illness, disease, injury, or
condition, she would consider
amending the Table. The Secretary
views this proposed rule as technical in
nature because it will, if implemented,
move the four categories of vaccine
described in this notice from the
placeholder category (category XIII) to
separate and distinct listings on the
Table with no associated Table injuries.
If implemented, the proposals in this
rule would not change the fact that
these four categories of vaccine are
covered under the VICP and will not
change the rights of any current or
potential VICP petitioners. The
Advisory Commission on Childhood
Vaccines (ACCV) voted unanimously to
approve this proposal at its December 4,
2009 meeting.
Economic and Regulatory Impact
Executive Order 12866, as amended
by Executive Orders 13258 and 13422,
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, 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, as amended by Executive
Orders 13258 and 13422, 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 which
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 no
resources are required to implement the
requirements in this proposed rule.
Therefore, in accordance with the
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Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Proposed Rules
Regulatory Flexibility Act of 1980
(RFA), and the Small Business
Regulatory Enforcement Fairness Act of
1996, which amended the RFA, the
Secretary certifies that this proposed
rule will not, if implemented, have a
significant impact on a substantial
number of small entities.
The Secretary has also determined
that this proposed rule does not meet
the criteria for a major rule as defined
by Executive Order 12866, as amended
by Executive Orders 13258 and 13422,
and would have no major effect on the
economy or Federal expenditures. The
Secretary has determined that this
proposed rule is not a ‘‘major rule’’
within the meaning of the statute
providing for Congressional Review of
Agency Rulemaking, 5 U.S.C. 801.
Similarly, it will not have effects on
State, local, and tribal governments and
on the private sector such as to require
consultation under the Unfunded
Mandates Reform Act of 1995.
The Secretary has reviewed this
proposed rule in accordance with
Executive Order 13132 regarding
federalism, and has determined that it
does not have ‘‘federalism implications.’’
This rule would 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.’’
The proposals made in this notice of
proposed rulemaking, if implemented,
would not adversely affect the following
family elements: Family safety, family
stability, marital commitment; parental
rights in the education, nurture and
supervision of their children; family
functioning, disposable income, or
poverty; or the behavior and personal
responsibility of youth, as determined
under section 654(c) of the Treasury and
General Government Appropriations
Act of 1999.
Impact of the New Rule
This proposed rule is technical in
nature. Because the vaccines being
added to the Table as separate categories
are already included on the Table under
Category XIII, this Table will have no
effect on current or potential petitioners
other than to help clarify which
vaccines are covered by the VICP. If
implemented, the proposals made in
this notice would not prevent otherwise
eligible individuals with claims of
injuries or deaths allegedly resulting
from the hepatitis A, trivalent influenza,
meningococcal and human
papillomavirus (HPV) vaccines from
filing claims with the VICP and would
not otherwise affect such petitioners.
Paperwork Reduction Act
This proposed rule does not have any
information collection requirements.
55505
Dated: May 12, 2010.
Mary Wakefield,
Administrator, Health Resources and Services
Administration.
Approved: June 8, 2010.
Kathleen Sebelius,
Secretary.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, and
Immunization.
Accordingly, 42 CFR part 100 is
proposed to be amended as set forth
below:
PART 100—VACCINE INJURY
COMPENSATION
1. The authority citation for 42 CFR
part 100 continues to read as follows:
Authority: Secs. 312 and 313 of Pub. L.
99–660, 100 Stat. 3779–3782 (42 U.S.C.
300aa–1 note); sec. 2114(c) and (e) of the PHS
Act (42 U.S.C. 300aa–14(c) and (e)); sec.
2115(a)(3)(B) of the PHS Act (42 U.S.C.
300aa–15(a)(3)(B)); sec. 904(b) of Pub. L. 105–
34, 111 Stat. 873; sec. 1503 of Pub. L. 105–
277, 112 Stat. 2681–741; and sec. 523(a) of
Pub. L. 106–170, 113 Stat. 1927–1928.
2. Amend § 100.3 by revising the
Vaccine Injury Table following
paragraph (a), revising paragraph (c) (1),
redesignating paragraph (c) (5) as
paragraph (c) (8) and revising newly
designated paragraph (c) (8), and adding
new paragraphs (c) (5), (c) (6), and (c)
(7), to read as follows:
§ 100.3
Vaccine injury table
(a) * * *
VACCINE INJURY TABLE
Time period for first symptom or manifestation
of onset or of significant aggravation after
vaccine administration
Vaccine
Illness, disability, injury or condition covered
I. Vaccines containing tetanus toxoid (e.g.,
DTaP, DTP, DT, Td, or TT).
A. Anaphylaxis or anaphylactic shock .............
4 hours.
B. Brachial Neuritis ..........................................
C. Any acute complication or sequela (including death) of an illness, disability, injury, or
condition referred to above which illness,
disability, injury, or condition arose within
the time period prescribed.
A. Anaphylaxis or anaphylactic shock .............
2–28 days.
Not applicable.
B. Encephalopathy (or encephalitis) ................
C. Any acute complication or sequela (including death) of an illness, disability, injury, or
condition referred to above which illness,
disability, injury, or condition arose within
the time period prescribed.
A. Anaphylaxis or anaphylactic shock .............
72 hours.
Not applicable.
B. Encephalopathy (or encephalitis) ................
5–15 days (not less than 5 days and not more
than 15 days).
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II. Vaccines containing whole cell pertussis bacteria, extracted or partial cell pertussis bacteria, or specific pertussis antigen(s) (e.g.,
DTP, DTaP, P, DTP–Hib).
III. Measles, mumps, and rubella vaccine or
any of its components (e.g., MMR, MR, M, R).
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4 hours.
4 hours.
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Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Proposed Rules
VACCINE INJURY TABLE—Continued
Vaccine
Illness, disability, injury or condition covered
IV. Vaccines containing rubella virus (e.g.,
MMR, MR, R).
V. Vaccines containing measles virus (e.g.,
MMR, MR, M).
VI. Vaccines containing polio live virus (OPV) ...
VII. Vaccines containing polio inactivated virus
(e.g., IPV).
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VIII. Hepatitis B. vaccines ..................................
IX. Hemophilus influenzae type b polysaccharide conjugate vaccines.
X. Varicella vaccine ............................................
XI. Rotavirus vaccine .........................................
XII. Pneumococcal conjugate vaccines ..............
XIII. Hepatitis A vaccines ...................................
XIV. Trivalent influenza vaccines .......................
XV. Meningococcal vaccines ..............................
XVI. Human papillomavirus (HPV) vaccines ......
XVII. Any new vaccine recommended by the
Centers for Disease Control and Prevention
for routine administration to children, after
publication by the Secretary of a notice of
coverage.
*
*
*
*
*
(c) * * * (1) Except as provided in
paragraph (c) (2), (3), (4), (5), (6), or (7)
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C. Any acute complication or sequela (including death) of an illness, disability, injury, or
condition referred to above which illness,
disability, injury, or condition arose within
the time period prescribed.
A. Chronic arthritis ...........................................
B. Any acute complication or sequela (including death) of an illness, disability, injury, or
condition referred to above which illness,
disability, injury, or condition arose within
the time period prescribed.
A. Thrombocytopenic purpura .........................
B. Vaccine-Strain Measles Viral Infection in
an immunodeficient recipient.
C. Any acute complication or sequela (including death) of an illness, disability, injury, or
condition referred to above which illness,
disability, injury, or condition arose within
the time period prescribed.
A. Paralytic Polio
—in a non-immunodeficient recipient .......
—in an immunodeficient recipient ............
—in a vaccine associated community
case.
B. Vaccine-Strain Polio Viral Infection
—in a non-immunodeficient recipient .......
—in an immunodeficient recipient ............
—in a vaccine associated community
case.
C. Any acute complication or sequela (including death) of an illness, disability, injury, or
condition referred to above which illness,
disability, injury, or condition arose within
the time period prescribed.
A. Anaphylaxis or anaphylactic shock .............
Time period for first symptom or manifestation
of onset or of significant aggravation after
vaccine administration
Not applicable.
7–42 days.
Not applicable.
7–30 days.
6 months.
Not applicable.
30 days.
6 months.
Not applicable.
30 days.
6 months.
Not applicable.
Not applicable.
4 hours.
B. Any acute complication or sequela (including death of an illness, disability, injury, or
condition referred to above which illness,
disability, injury, or condition arose within
the time period prescribed.
A. Anaphylaxis or anaphylactic shock .............
B. Any acute complication or sequela (including death) of an illness, disability, injury, or
condition referred to above which illness,
disability, injury, or condition arose within
the time period prescribed.
No Condition Specified ....................................
4 hours.
Not applicable.
No
No
No
No
No
No
No
No
Not
Not
Not
Not
Not
Not
Not
Not
Condition
Condition
Condition
Condition
Condition
Condition
Condition
Condition
Specified
Specified
Specified
Specified
Specified
Specified
Specified
Specified
....................................
....................................
....................................
....................................
....................................
....................................
....................................
....................................
of this section, the revised Table of
Injuries set forth in paragraph (a) of this
section and the Qualifications and Aids
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Not applicable.
Not applicable.
applicable.
applicable.
applicable.
applicable.
applicable.
applicable.
applicable.
applicable.
to Interpretation set forth in paragraph
(b) of this section apply to petitions for
compensation under the Program filed
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with the United States Court of Federal
Claims on or after March 24, 1997.
Petitions for compensation filed before
such date shall be governed by section
2114(a) and (b) of the Public Health
Service Act as in effect on January 1,
1995, or by § 100.3 as in effect on March
10, 1995 (see 60 FR 7678, et seq.,
February 8, 1995), as applicable.
*
*
*
*
*
(5) Hepatitis A vaccines (Item XIII of
the Table) are included on the Table as
of December 1, 2004.
(6) Trivalent influenza vaccines (Item
XIV of the Table) are included on the
Table as of July 1, 2005.
(7) Meningococcal vaccines and
human papillomavirus (HPV) vaccines
(Items XV and XVI of the Table) are
included on the Table as of February 1,
2007.
(8) Other new vaccines (Item XVII of
the Table) will be included in the Table
as of the effective date of a tax enacted
to provide funds for compensation paid
with respect to such vaccines. An
amendment to this section will be
published in the Federal Register to
announce the effective date of such a
tax.
[FR Doc. 2010–22745 Filed 9–10–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 67
[Docket ID FEMA–2010–0003; Internal
Agency Docket No. FEMA–B–1128]
Proposed Flood Elevation
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Proposed rule.
AGENCY:
Comments are requested on
the proposed Base (1% annual-chance)
Flood Elevations (BFEs) and proposed
BFE modifications for the communities
listed in the table below. The purpose
of this notice is to seek general
information and comment regarding the
proposed regulatory flood elevations for
the reach described by the downstream
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and upstream locations in the table
below. The BFEs and modified BFEs are
a part of the floodplain management
measures that the community is
required either to adopt or to show
evidence of having in effect in order to
qualify or remain qualified for
participation in the National Flood
Insurance Program (NFIP). In addition,
these elevations, once finalized, will be
used by insurance agents and others to
calculate appropriate flood insurance
premium rates for new buildings and
the contents in those buildings.
DATES: Comments are to be submitted
on or before December 13, 2010.
ADDRESSES: The corresponding
preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each
community is available for inspection at
the community’s map repository. The
respective addresses are listed in the
table below.
You may submit comments, identified
by Docket No. FEMA–B–1128, to Roy E.
Wright, Deputy Director, Risk Analysis
Division, Federal Insurance and
Mitigation Administration, Federal
Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472,
(202) 646–3461, or (e-mail)
roy.e.wright@dhs.gov.
FOR FURTHER INFORMATION CONTACT: Roy
E. Wright, Deputy Director, Risk
Analysis Division, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472,
(202) 646–3461, or (e-mail)
roy.e.wright@dhs.gov.
SUPPLEMENTARY INFORMATION: The
Federal Emergency Management Agency
(FEMA) proposes to make
determinations of BFEs and modified
BFEs for each community listed below,
in accordance with section 110 of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed BFEs and modified
BFEs, together with the floodplain
management criteria required by 44 CFR
60.3, are the minimum that are required.
They should not be construed to mean
that the community must change any
existing ordinances that are more
stringent in their floodplain
management requirements. The
community may at any time enact
stricter requirements of its own or
pursuant to policies established by other
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
55507
Federal, State, or regional entities.
These proposed elevations are used to
meet the floodplain management
requirements of the NFIP and also are
used to calculate the appropriate flood
insurance premium rates for new
buildings built after these elevations are
made final, and for the contents in those
buildings.
Comments on any aspect of the Flood
Insurance Study and FIRM, other than
the proposed BFEs, will be considered.
A letter acknowledging receipt of any
comments will not be sent.
National Environmental Policy Act.
This proposed rule is categorically
excluded from the requirements of 44
CFR part 10, Environmental
Consideration. An environmental
impact assessment has not been
prepared.
Regulatory Flexibility Act. As flood
elevation determinations are not within
the scope of the Regulatory Flexibility
Act, 5 U.S.C. 601–612, a regulatory
flexibility analysis is not required.
Executive Order 12866, Regulatory
Planning and Review. This proposed
rule is not a significant regulatory action
under the criteria of section 3(f) of
Executive Order 12866, as amended.
Executive Order 13132, Federalism.
This proposed rule involves no policies
that have federalism implications under
Executive Order 13132.
Executive Order 12988, Civil Justice
Reform. This proposed rule meets the
applicable standards of Executive Order
12988.
List of Subjects in 44 CFR Part 67
Administrative practice and
procedure, Flood insurance, Reporting
and recordkeeping requirements.
Accordingly, 44 CFR part 67 is
proposed to be amended as follows:
PART 67—[AMENDED]
1. The authority citation for part 67
continues to read as follows:
Authority: 42 U.S.C. 4001 et seq.;
Reorganization Plan No. 3 of 1978, 3 CFR,
1978 Comp., p. 329; E.O. 12127, 44 FR 19367,
3 CFR, 1979 Comp., p. 376.
§ 67.4
[Amended]
2. The tables published under the
authority of § 67.4 are proposed to be
amended as follows:
E:\FR\FM\13SEP1.SGM
13SEP1
]]>Agencies
[Federal Register Volume 75, Number 176 (Monday, September 13, 2010)]
[Proposed Rules]
[Pages 55503-55507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22745]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 100
RIN 0906-AA74
National Vaccine Injury Compensation Program: Revisions to the
Vaccine Injury Table
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: Through this proposed rule, the Secretary proposes to change
the Vaccine Injury Table (Table) to create distinct and separate
listings for hepatitis A, trivalent influenza, meningococcal, and human
papillomavirus (HPV) vaccines. The Table includes a list of covered
vaccines under the National Vaccine Injury Compensation Program (VICP).
The VICP provides a system of no-fault compensation for certain
individuals who have been injured by covered childhood vaccines. This
proposed rule is technical in nature. The four categories of vaccines
described in this notice are already covered vaccines under the VICP
(starting in 2004) and are currently listed in a placeholder category
(box XIII) in the Table. This document proposes to list these vaccines
as separate categories on the Table, with no associated injuries noted
at this time, in order to make the Table more clear to the public.
[[Page 55504]]
DATES: Comments on this proposed rule must be submitted by March 14,
2011. A public hearing on this proposed rule will be held before the
end of the public comment period. A separate notice will be published
in the Federal Register to provide the details of this hearing.
ADDRESSES: You may submit comments, identified by the Regulatory
Information Number (RIN) 0907-AA74, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: gevans@hrsa.gov. Include RIN 0907-AA74 in the
subject line of the message.
Mail: Geoffrey Evans, M.D., Director, Division of Vaccine
Injury Compensation, Healthcare Systems Bureau, Health Resources and
Services Administration, Room 11C-26, Parklawn Building, 5600 Fishers
Lane, Rockville, Maryland 20857.
Instructions: All submissions received must include the agency name
and RIN for this rulemaking. All comments received will be available
for public inspection and copying without charge, including any
personal information provided, at Parklawn Building, 5600 Fishers Lane,
Room 11C-26, Rockville, Maryland 20857, weekdays (Federal holidays
excepted) between the hours of 8:30 a.m. and 5 p.m.
FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D. at the mail or e-
mail address above or by telephone at (301) 443-6593.
SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of
1986, Title III of Public Law 99-660, as amended (42 U.S.C. 300aa-10 et
seq.), established the National Vaccine Injury Compensation Program
(VICP) for persons found to be injured by vaccines. Under this Federal
program, petitions for compensation are filed with the United States
Court of Federal Claims (Court). The Court, acting through special
masters, makes findings as to eligibility for, and amount of,
compensation. In order to gain entitlement to compensation under Title
XXI of the Public Health Service (PHS) Act for a covered vaccine, a
petitioner must establish a vaccine-related injury or death, either by
proving: (1) That the first symptom of an injury/condition, as defined
by the Vaccine Injury Table's (Table's) Qualifications and Aids to
Interpretation (QAI), occurred within the time period listed on the
Table (copy of the Table can be found at http:[sol][sol]www.hrsa.gov/
vaccinecompensation), and is therefore the injury or death presumed to
be caused by a vaccine (unless another cause is found); or (2) proof of
vaccine causation, if the injury/condition is not on the Table or did
not meet the QAIs or the time frame period specified on the Table.
The statute authorizing the VICP provides for the inclusion of
additional vaccines in the VICP when they are recommended by the
Centers for Disease Control and Prevention (CDC) for routine
administration to children. See section 2114(e)(2) of the Public Health
Service (PHS) Act, 42 U.S.C. 300aa-14(e)(2). Consistent with section
13632(a)(3) of the Omnibus Budget Reconciliation Act of 1993 (Pub. L.
103-66), the regulations governing the VICP provide that such vaccines
will be included in the Table as of the effective date of an excise tax
to provide funds for the payment of compensation with respect to such
vaccines. See 42 CFR 100.3(c)(5). The statute authorizing the VICP also
authorizes the Secretary to create and modify a list of injuries,
disabilities, illnesses, conditions, and deaths (and their associated
time frames) associated with each category of vaccines included on the
Table. See sections 2114(c)(3) and 2114(e)(2) of the PHS Act, 42 U.S.C.
300aa-14(c)(3) and 300aa-14(e)(2).
The prerequisites for adding the hepatitis A, trivalent influenza,
meningococcal, and human papillomavirus (HPV) vaccines to the VICP have
already occurred. The Secretary previously published notices announcing
that each of these categories of vaccines is covered under the VICP
(under the Table's provisional category) and explaining that the
Secretary planned on adding these vaccines as separate categories to
the Table through rulemaking, as proposed in this notice. On December
1, 2004, the Secretary published a notice in the Federal Register
announcing that hepatitis A vaccines were covered under the VICP, with
an effective date of December 1, 2004. 69 FR 69945. On April 12, 2005,
the Secretary published a notice in the Federal Register announcing
that trivalent influenza vaccines were covered under the VICP, with an
effective date of July 1, 2005. 70 FR 19092. On April 20, 2007, the
Secretary published a notice in the Federal Register announcing that
meningococcal vaccines and human papillomavirus vaccines were covered
under the VICP, with an effective date of February 1, 2007. 72 FR
19937.
Although the vaccines described in this notice are officially
covered by the VICP, their placement in the provisional box XIII,
rather than as distinct and separate listings, has sometimes led to
confusion regarding their coverage status. We propose to add these four
vaccines in their own separate categories to the Table in order to help
the public identify clearly that these vaccines are covered by the
VICP.
To date, the Secretary has not identified any illness, disease,
injury, or condition caused by these four vaccines. For this reason,
the Secretary proposes adding these four categories of vaccines to the
Table with ``[n]o condition specified.'' If the Secretary learns of any
such illness, disease, injury, or condition, she would consider
amending the Table. The Secretary views this proposed rule as technical
in nature because it will, if implemented, move the four categories of
vaccine described in this notice from the placeholder category
(category XIII) to separate and distinct listings on the Table with no
associated Table injuries. If implemented, the proposals in this rule
would not change the fact that these four categories of vaccine are
covered under the VICP and will not change the rights of any current or
potential VICP petitioners. The Advisory Commission on Childhood
Vaccines (ACCV) voted unanimously to approve this proposal at its
December 4, 2009 meeting.
Economic and Regulatory Impact
Executive Order 12866, as amended by Executive Orders 13258 and
13422, 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,
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, as amended
by Executive Orders 13258 and 13422, 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 which 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 no resources are required to
implement the requirements in this proposed rule. Therefore, in
accordance with the
[[Page 55505]]
Regulatory Flexibility Act of 1980 (RFA), and the Small Business
Regulatory Enforcement Fairness Act of 1996, which amended the RFA, the
Secretary certifies that this proposed rule will not, if implemented,
have a significant impact on a substantial number of small entities.
The Secretary has also determined that this proposed rule does not
meet the criteria for a major rule as defined by Executive Order 12866,
as amended by Executive Orders 13258 and 13422, and would have no major
effect on the economy or Federal expenditures. The Secretary has
determined that this proposed rule is not a ``major rule'' within the
meaning of the statute providing for Congressional Review of Agency
Rulemaking, 5 U.S.C. 801.
Similarly, it will not have effects on State, local, and tribal
governments and on the private sector such as to require consultation
under the Unfunded Mandates Reform Act of 1995.
The Secretary has reviewed this proposed rule in accordance with
Executive Order 13132 regarding federalism, and has determined that it
does not have ``federalism implications.'' This rule would 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.''
The proposals made in this notice of proposed rulemaking, if
implemented, would not adversely affect the following family elements:
Family safety, family stability, marital commitment; parental rights in
the education, nurture and supervision of their children; family
functioning, disposable income, or poverty; or the behavior and
personal responsibility of youth, as determined under section 654(c) of
the Treasury and General Government Appropriations Act of 1999.
Impact of the New Rule
This proposed rule is technical in nature. Because the vaccines
being added to the Table as separate categories are already included on
the Table under Category XIII, this Table will have no effect on
current or potential petitioners other than to help clarify which
vaccines are covered by the VICP. If implemented, the proposals made in
this notice would not prevent otherwise eligible individuals with
claims of injuries or deaths allegedly resulting from the hepatitis A,
trivalent influenza, meningococcal and human papillomavirus (HPV)
vaccines from filing claims with the VICP and would not otherwise
affect such petitioners.
Paperwork Reduction Act
This proposed rule does not have any information collection
requirements.
Dated: May 12, 2010.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
Approved: June 8, 2010.
Kathleen Sebelius,
Secretary.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, and Immunization.
Accordingly, 42 CFR part 100 is proposed to be amended as set forth
below:
PART 100--VACCINE INJURY COMPENSATION
1. The authority citation for 42 CFR part 100 continues to read as
follows:
Authority: Secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-
3782 (42 U.S.C. 300aa-1 note); sec. 2114(c) and (e) of the PHS Act
(42 U.S.C. 300aa-14(c) and (e)); sec. 2115(a)(3)(B) of the PHS Act
(42 U.S.C. 300aa-15(a)(3)(B)); sec. 904(b) of Pub. L. 105-34, 111
Stat. 873; sec. 1503 of Pub. L. 105-277, 112 Stat. 2681-741; and
sec. 523(a) of Pub. L. 106-170, 113 Stat. 1927-1928.
2. Amend Sec. 100.3 by revising the Vaccine Injury Table following
paragraph (a), revising paragraph (c) (1), redesignating paragraph (c)
(5) as paragraph (c) (8) and revising newly designated paragraph (c)
(8), and adding new paragraphs (c) (5), (c) (6), and (c) (7), to read
as follows:
Sec. 100.3 Vaccine injury table
(a) * * *
Vaccine Injury Table
------------------------------------------------------------------------
Time period for
first symptom or
manifestation of
Illness, disability, onset or of
Vaccine injury or condition significant
covered aggravation after
vaccine
administration
------------------------------------------------------------------------
I. Vaccines containing A. Anaphylaxis or 4 hours.
tetanus toxoid (e.g., DTaP, anaphylactic shock.
DTP, DT, Td, or TT).
B. Brachial Neuritis 2-28 days.
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
II. Vaccines containing A. Anaphylaxis or 4 hours.
whole cell pertussis anaphylactic shock.
bacteria, extracted or
partial cell pertussis
bacteria, or specific
pertussis antigen(s) (e.g.,
DTP, DTaP, P, DTP-Hib).
B. Encephalopathy 72 hours.
(or encephalitis).
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
III. Measles, mumps, and A. Anaphylaxis or 4 hours.
rubella vaccine or any of anaphylactic shock.
its components (e.g., MMR,
MR, M, R).
B. Encephalopathy 5-15 days (not less
(or encephalitis). than 5 days and not
more than 15 days).
[[Page 55506]]
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
IV. Vaccines containing A. Chronic arthritis 7-42 days.
rubella virus (e.g., MMR,
MR, R).
B. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
V. Vaccines containing A. Thrombocytopenic 7-30 days.
measles virus (e.g., MMR, purpura.
MR, M).
B. Vaccine-Strain 6 months.
Measles Viral
Infection in an
immunodeficient
recipient.
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
VI. Vaccines containing A. Paralytic Polio
polio live virus (OPV).
--in a non- 30 days.
immunodeficient
recipient.
--in an 6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
B. Vaccine-Strain
Polio Viral
Infection
--in a non- 30 days.
immunodeficient
recipient.
--in an 6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
VII. Vaccines containing A. Anaphylaxis or 4 hours.
polio inactivated virus anaphylactic shock.
(e.g., IPV).
B. Any acute Not applicable.
complication or
sequela (including
death of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
VIII. Hepatitis B. vaccines. A. Anaphylaxis or 4 hours.
anaphylactic shock.
B. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
IX. Hemophilus influenzae No Condition Not applicable.
type b polysaccharide Specified.
conjugate vaccines.
X. Varicella vaccine........ No Condition Not applicable.
Specified.
XI. Rotavirus vaccine....... No Condition Not applicable.
Specified.
XII. Pneumococcal conjugate No Condition Not applicable.
vaccines. Specified.
XIII. Hepatitis A vaccines.. No Condition Not applicable.
Specified.
XIV. Trivalent influenza No Condition Not applicable.
vaccines. Specified.
XV. Meningococcal vaccines.. No Condition Not applicable.
Specified.
XVI. Human papillomavirus No Condition Not applicable.
(HPV) vaccines. Specified.
XVII. Any new vaccine No Condition Not applicable.
recommended by the Centers Specified.
for Disease Control and
Prevention for routine
administration to children,
after publication by the
Secretary of a notice of
coverage.
------------------------------------------------------------------------
* * * * *
(c) * * * (1) Except as provided in paragraph (c) (2), (3), (4),
(5), (6), or (7) of this section, the revised Table of Injuries set
forth in paragraph (a) of this section and the Qualifications and Aids
to Interpretation set forth in paragraph (b) of this section apply to
petitions for compensation under the Program filed
[[Page 55507]]
with the United States Court of Federal Claims on or after March 24,
1997. Petitions for compensation filed before such date shall be
governed by section 2114(a) and (b) of the Public Health Service Act as
in effect on January 1, 1995, or by Sec. 100.3 as in effect on March
10, 1995 (see 60 FR 7678, et seq., February 8, 1995), as applicable.
* * * * *
(5) Hepatitis A vaccines (Item XIII of the Table) are included on
the Table as of December 1, 2004.
(6) Trivalent influenza vaccines (Item XIV of the Table) are
included on the Table as of July 1, 2005.
(7) Meningococcal vaccines and human papillomavirus (HPV) vaccines
(Items XV and XVI of the Table) are included on the Table as of
February 1, 2007.
(8) Other new vaccines (Item XVII of the Table) will be included in
the Table as of the effective date of a tax enacted to provide funds
for compensation paid with respect to such vaccines. An amendment to
this section will be published in the Federal Register to announce the
effective date of such a tax.
[FR Doc. 2010-22745 Filed 9-10-10; 8:45 am]
BILLING CODE 4165-15-P
