[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Rules and Regulations]
[Pages 47411-47418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19228]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 110
RIN 0906-AA79
Countermeasures Injury Compensation Program: Pandemic Influenza
Countermeasures Injury Table
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: HHS is establishing the Pandemic Influenza Countermeasures
Injury Table as authorized by the Public Readiness and Emergency
Preparedness Act (PREP Act). Through this final rule, the Secretary of
the U.S. Department of Health and Human Services (Secretary) adds
regulations for the purpose of creating Covered Countermeasures Injury
Tables. The pandemic influenza countermeasures are identified in
Secretarial declarations relating to pandemic influenza, including
influenza caused by the 2009 H1N1 pandemic influenza virus (hereafter
referred to as the 2009 H1N1 virus) and other potential pandemic
strains, such as H5N1 avian influenza.
DATES: This rule is effective September 8, 2015.
FOR FURTHER INFORMATION CONTACT: Dr. Avril M. Houston, Director,
Division of Injury Compensation Programs, Healthcare Systems Bureau,
HRSA, Parklawn Building, Room 11C-26, 5600 Fishers Lane, Rockville, MD
20857, or by telephone (855) 266-2427. This is a toll-free number.
SUPPLEMENTARY INFORMATION: On March 30, 2014, HHS published the Notice
of Proposed Rulemaking (NPRM) in the Federal Register to amend the
Countermeasures Injury Compensation Program's (CICP or Program)
implementing regulation and establish a table of injuries resulting
from the administration or use of covered
[[Page 47412]]
pandemic influenza countermeasures. The NPRM provided a 60-day comment
period resulting in HHS receipt of five sets of comments--one set from
a physicians' organization and four sets from individuals. HHS
carefully considered these comments when developing this final rule. In
``Section III, Comments and Responses'' of this final rule, the
comments are summarized and HHS provides responses to them.
I. Background
The Public Readiness and Emergency Preparedness Act of 2005 (PREP
Act) directs the Secretary to establish, through regulation, a Covered
Countermeasures Injury Table (Table) identifying serious physical
injuries that are presumed to be directly caused by the administration
or use of covered countermeasures identified in PREP Act declarations
issued by the Secretary.
The Secretary may only add to a Table injuries that are directly
caused by the administration or use of the covered countermeasure based
on ``compelling, reliable, valid, medical and scientific evidence.''
\1\ This Table informs the public about serious physical injuries known
to be directly caused by covered countermeasures through support by
compelling, reliable, valid, medical and scientific evidence. In
addition, this Table creates a rebuttable presumption of causation for
eligible individuals whose injuries are listed on a Table and meet the
requirements of a Table.
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\1\ 42 U.S.C. 247d-6e(b)(5)(A).
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The PREP Act authorizes both liability protections and compensation
based on the terms of the PREP Act declarations, but this final rule
concerns only the compensation program, not the liability protections
set forth therein.
The Secretary published the interim final rule implementing the
Program on October 15, 2010.\2\ The final rule, which was published on
October 7, 2011, explains the Program's policies, procedures, and
requirements. Title 42 of the Code of Federal Regulations (CFR) Sec.
110.20(a) states that individuals must establish that a covered injury
occurred in order to be eligible for benefits under the Program. A
covered injury is death or a serious injury determined by the Secretary
to be: (1) An injury meeting the requirements of a Table, which is
presumed to be the direct result of the administration or use of a
covered countermeasure unless the Secretary determines there is another
more likely cause; or (2) an injury (or its health complications) that
is the direct result of the administration or use of a covered
countermeasure. This includes a covered countermeasure causing a
serious aggravation of a pre-existing condition.\3\ In general, only
injuries that warranted hospitalization (whether or not the person was
actually hospitalized), or injuries that led to a significant loss of
function or disability are considered serious injuries.\4\
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\2\ 42 CFR part 110.
\3\ 42 CFR 110.3(g)(2).
\4\ 42 CFR 110.3(z).
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Individuals with injuries not meeting the requirements listed on
the Table may still pursue their claims as non-Table injuries under the
Program. In this instance, the requester does not receive the
presumption of causation for a Table injury and must demonstrate that
the use or administration of the covered countermeasure directly caused
the injury. Proof of a causal association for the non-Table injury must
be based on compelling, reliable, valid, medical and scientific
evidence.
II. Summary of the Final Rule
Through this final rule, the Secretary will be adding subpart K to
42 CFR part 110, which had been reserved for the purpose of creating a
Covered Countermeasures Injury Table. The Table established in this
final rule is limited to pandemic influenza covered countermeasures.
These countermeasures are identified in Secretarial declarations
relating to pandemic influenza, including influenza caused by the 2009
H1N1 virus, and other potential pandemic strains, such as H5N1 avian
influenza. The Secretary may create and publish Tables in the Federal
Register through separate amendments to 42 CFR part 110 in the future.
Tables may be created for other countermeasures in accordance with the
PREP Act. To date, declarations have been issued with respect to
countermeasures against pandemic influenza A viruses, anthrax,
botulism, smallpox, acute radiation syndrome, and the Ebola virus.
Through the Pandemic Influenza Countermeasures Injury Table Final
Rule, the Secretary provides, as authorized by statute, a Table for
several covered countermeasures listing serious physical injuries. The
serious physical injuries included on the Table are injuries that are
supported by compelling, reliable, valid, medical and scientific
evidence showing that the administration or use of the covered
countermeasures directly causes such injuries. The Table lists the
serious injuries directly caused by a specific countermeasure, the time
interval within which the first symptom or manifestation of onset of
injury must appear, and the definition of the injury. Table definitions
are included to further explain each covered injury and the level of
severity necessary to qualify as a Table injury.
The injuries, time intervals, definitions, and requirements reflect
the Secretary's efforts to identify those serious physical injuries
causally related to the covered countermeasures. The causal linkages
between the covered countermeasures and these associated injuries are
based on compelling, reliable, valid, medical and scientific evidence.
The Secretary will stay informed of updates in the scientific and
medical field concerning new information about causal associations
between injuries and covered countermeasures.
In this final rule, the Secretary has made the following changes to
the Qualifications and Aids to Interpretation (QAI) of the Table for
purposes of clarity.
a. Changed section (b)(4)(i) by adding an accent over the ``e'' in
Guillain-Barre Syndrome (GBS). The revised section term reads,
``Guillain-Barr[eacute] Syndrome.'' In the first sentence, added
``currently is known to encompass'' after ``that'' and delete
``encompasses.'' The revised sentence states, ``GBS is an acute
monophasic peripheral neuropathy that currently is known to encompass a
spectrum of four clinicopathological subtypes described below.'' In the
fourth sentence, changed ``nine'' to ``9.'' The revised sentence
states, ``Treatment related fluctuations in all subtypes of GBS can
occur within 9 weeks of GBS symptom onset and recurrence of symptoms
after this time frame would not be consistent with GBS.''
b. Changed section (b)(4)(iv) by adding ``The results of both . .
.'' to the beginning of the second sentence. The revised sentence
states, ``The results of both CSF and electrophysiologic studies are
frequently normal in the first week of illness in otherwise typical
cases of GBS.''
c. Deleted section (b)(4)(v) which states, ``For all types of GBS,
the onset of symptoms less than three days (72 hours) after exposure to
the influenza vaccine excludes vaccine exposure as a cause'' because
timeframes for serious physical injuries to be Table injuries are
listed in the Table, not in the QAI.
d. Changed section (b)(4)(vi) to (b)(4)(v) since (b)(4)(v) has been
deleted as stated above and added to the beginning of the first
sentence of section (b)(4)(v), ``For GBS to qualify as a Table
injury.'' The revised sentence states, ``For GBS to qualify as a Table
injury, there must not be a more likely alternative diagnosis for the
weakness.''
[[Page 47413]]
e. Changed section (b)(5)(i)(A) by adding ``or'' after ``tube;''.
The revised statement states, ``(A) trauma or necrosis from an
endotracheal tube; or.''
f. Changed section (b)(6)(i) by deleting ``Definition -'' before
``VAP'' at the beginning of the first sentence. In the fourth sentence,
changed the phrase ``radiographic infiltrate in the lungs that is
consistent with pneumonia'' to ``radiographic infiltrate that is in the
lungs and consistent with pneumonia.''
g. Changed section (b)(7) by adding ``To qualify as Table
injuries,'' before ``these'' to the beginning of the last sentence. The
revised sentence states, ``To qualify as Table injuries, these
manifestations must occur in patients who are being mechanically
ventilated at the time of initial manifestation of the VILI.'' VILI is
Ventilator-Induced Lung Injury.
h. Changed section (b)(8) by adding ``who are'' after ``patients''
and before ``under'' to the first sentence. The revised sentence
states, ``Bleeding events are defined as excessive or abnormal bleeding
in patients who are under the pharmacologic effects of anticoagulant
therapy provided for extracorporeal membrane oxygenation (ECMO)
treatment.''
III. Comments and Responses
The NPRM set forth a 60-day public comment period, which ended on
May 30, 2014. During this comment period, HHS received five sets of
comments--one set from a physicians' organization and four sets from
individuals. Below is a summary of the comments and HHS's responses.
1. Anaphylaxis
Comment: A commenter suggested expanding to 12 hours the time frame
within which the first symptom or manifestation of anaphylaxis must
appear, stating that some cases of anaphylaxis may exhibit a late phase
response up to 8-12 hours after exposure, and thus the 0-4 hour time
frame is not long enough.
Response: HHS respectfully disagrees with this comment. There is no
consensus within the medical and scientific community about the time
frame in which the late phase response starts. As stated in the NPRM,
anaphylaxis after immunization is serious, but it occurs rarely. After
initial treatment and clinical improvement, some patients with allergic
reactions may develop a late phase or ``biphasic'' reaction, which may
be more severe than the initial presentation. Little is known of the
pathophysiology of biphasic reactions. The variations and the
subjective nature of definitions used for determining the incidence of
biphasic reactions in various studies are likely a major contributor to
differing results, ranging from a 0.5 percent to 20 percent incidence
rate. This makes comparisons of data across studies problematic.
Previous guidelines have advocated the monitoring of patients post-
anaphylaxis, with recommended durations varying between 4 and 24 hours.
This is likely a testament to the uncertainty in the literature. Hence
there is no compelling, reliable, valid, medical and scientific
evidence upon which to base a Table time frame for biphasic
anaphylactic reactions. HHS recognizes the occurrence of biphasic
anaphylactic reactions in a minority of cases. Therefore, the Program
will consider a claim for anaphylaxis occurring after the 4-hour time
frame leading to a serious injury or death on a case-by-case basis as a
non-Table claim.
2. Pandemic Influenza Intranasal Vaccines
Comment: A commenter asked if a child would be eligible to receive
compensation if he/she is injured from the intranasal vaccine, which
was administered because the child was advised by his/her doctor to
have the intranasal vaccine, even if perhaps, the child would have been
more suited for the vaccine injection.
Response: Under the CICP, any person who meets the appropriate
declaration's definition of covered population, is administered or used
a covered countermeasure in accordance with the terms of that
declaration (or in good faith belief of such), and is seriously injured
as a direct result of the countermeasure, may be eligible for CICP
benefits.
3. Antiviral Usage in Individuals Younger Than 2 Years of Age
Comment: A commenter was concerned that the guidelines for
administration of Tamiflu (oseltamivir), Relenza (zanamivir), and
peramivir for infants are not uniform. The commenter stated that the
Food and Drug Administration has approved Tamiflu for children as young
as 2 weeks of age but that the Centers for Disease Control and
Prevention (CDC) recommends Tamiflu, through its safety profile, for
treatment of both term and preterm infants from birth, as benefits for
therapy are likely to outweigh possible risks of treatment. The
commenter suggested that this rule establish the minimum age for
administration of these countermeasures to children so that children
are not denied compensation because of conflicting policy
recommendations about the appropriate administration of these antiviral
medications.
Response: The CICP is not authorized to establish age ranges for
the administration of any drug, and therefore, cannot do so through
this rule, as suggested by the commenter. The Program can only provide
benefits to the population of individuals set forth in the applicable
Secretarial declaration.
4. Incorporation of Children and Infants in Overall Guidelines
Comment: A commenter made the statement that his organization
``firmly believes that the Table should better incorporate the needs of
children.'' The commenter wants HHS and HRSA to ensure that children
are being considered in all aspects of the proposed countermeasures, as
well as in this Table.
Response: As indicated above, Secretarial declarations describe the
covered countermeasures and the covered population. Under the CICP, any
person who meets the definition of the covered population in the
relevant declaration, who receives or uses a covered countermeasure in
accordance with the terms of that declaration (or in good faith belief
of such), and is seriously injured as a direct result of the
countermeasure may be eligible for CICP benefits.
5. Guillain-Barr[eacute] Syndrome
Comment: One commenter was concerned that the description of
Guillain-Barr[eacute] Syndrome (GBS) is incomplete because it does not
address the fact that GBS affects the peripheral nervous system.
Response: HHS respectfully disagrees with this comment. The
description of GBS as stated in the NPRM and final rule is complete and
explicitly addresses that GBS affects the peripheral nervous system. It
is an acute monophasic peripheral neuropathy that currently is known to
encompass a spectrum of four clinicopathological subtypes described in
the Qualifications and Aids to Interpretation section of the Table. GBS
may manifest with weakness, abnormal sensations, and/or abnormality in
the autonomic (involuntary) nervous system.
Comment: A commenter was concerned that this allegedly incomplete
description of GBS may make it difficult for requesters to prove
injuries such as Miller-Fisher Syndrome or other variants of GBS that
include attacks that lead to organ damage. Another commenter noted that
the variants of GBS should be considered.
[[Page 47414]]
Response: HHS respectfully disagrees with the comments that the
variants of GBS were not considered. The Table, including its
Qualifications and Aids to Interpretation, explicitly addresses how
variants of GBS, including Miller-Fisher Syndrome, can meet the Table
requirements. GBS may present as one of a spectrum of four
clinicopathological subtypes or variants. The most common type in North
America and Europe, comprising more than 90 percent of cases, is acute
inflammatory demyelinating polyneuropathy (AIDP), which has the
pathologic and electrodiagnostic features of focal demyelination of
motor and sensory peripheral nerves and roots.
Another subtype called acute motor axonal neuropathy (AMAN) is
generally seen in other parts of the world and is predominated by
axonal damage that primarily affects motor nerves. AMAN lacks features
of demyelination. The axon is a portion of the nerve cell that
transmits nerve impulses away from the nerve cell body. Another less
common subtype of GBS includes acute motor and sensory neuropathy
(AMSAN), which is an axonal form of GBS that is similar to AMAN, but
also affects the axons of sensory nerves and roots.
According to the Brighton Collaboration, Fisher Syndrome (FS), also
known as Miller-Fisher Syndrome, is a subtype of GBS characterized by
ataxia, areflexia, and ophthalmoplegia, and overlap between FS and GBS
may be seen with limb weakness.
GBS is proposed for inclusion on the Table because it is a serious
physical injury, and the fact that it may be directly caused by the use
of the monovalent 2009 H1N1 influenza vaccine (hereafter 2009 H1N1
vaccine) is supported by compelling, reliable, valid, medical and
scientific evidence. Further, GBS is characterized by various degrees
of weakness, sensory abnormality and autonomic dysfunction due to
damage to peripheral nerves and nerve roots. These variants or subtypes
of GBS were addressed fully in the NPRM and are adopted in the final
rule.
Furthermore, as explained above, the description of GBS as stated
in the NPRM, and adopted in this final rule, is complete. To the extent
that one comment suggested that organ damage should be included as a
Table injury, HHS respectfully disagrees. Although demyelination of
peripheral nerves or axonal damage can lead to disruption of organ
function, they do not lead directly to organ damage. At this time,
there is no compelling, reliable, valid, medical and scientific
evidence to support including organ damage on the Table.
Comment: A commenter was concerned that the 3- to 42-day window of
GBS onset is unreasonable because some cases of GBS have been reported
to have an onset outside of this interval. The commenter cited the
article, ``Chart-Confirmed Guillain-Barr[eacute] Syndrome After 2009
H1N1 Influenza Vaccination Among the Medicare Population, 2009-2010,
American Journal of Epidemiology, (2014), 179(5): 660.''
Response: HHS respectfully disagrees with this comment. The study
that was cited by the commenter and published in the American Journal
of Epidemiology looked at the risk of GBS development within 119 days
of vaccination. The researchers found a slightly increased
statistically significant risk of GBS only within the 6-week period
after 2009 H1N1 vaccination when compared with the post-vaccination
control period.
As stated in the NPRM, multiple studies performed to monitor the
safety of 2009 H1N1 vaccine provide evidence that demonstrates a small
statistically significant increased risk of GBS in the 6 weeks
following administration of the 2009 H1N1 vaccine.\5\ Additionally, a
meta-analysis was performed of the Emerging Infections Program, the
Vaccine Safety Datalink, and the Post-Licensure Rapid Immunization
Safety Monitoring System data, together with additional data from
safety surveillance studies performed by the Centers for Medicare &
Medicaid Services, the Department of Defense, and the Department of
Veterans Affairs, which analyzed data from 23 million vaccinated
people. The meta-analysis found that the 2009 H1N1 inactivated vaccine
was associated with a small increased risk of GBS within 6 weeks of
vaccination.
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\5\ Lawrence B. Schonberger, et al., ``Guillain-Barr[eacute]
Syndrome Following Vaccination in the National Influenza
Immunization Program, United States, 1976-1977, American Journal of
Epidemiology, 25 Apr. 1979, 118; IOM, ``Immunization Safety Review:
Influenza Vaccines and Neurological Complications,'' (Washington,
DC: The National Academies Press, 2004) 25; Sharon K. Greene, et
al., ``Risk of Confirmed Guillain-Barr[eacute] Syndrome Following
Receipt of Monovalent Inactivated Influenza A (H1N1) and Seasonal
Influenza Vaccines in the Vaccine Safety Datalink Project, 2009-
2010; and American Journal of Epidemiology, Jun. 1, 2012, 1100.
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The symptoms of GBS do not develop immediately after exposure to
the causative agent. The immune system requires a specified time to
complete the steps leading to nerve injury and dysfunction and the
early symptoms of GBS. A minimum of 3 days would be necessary from the
time of exposure and immune system stimulation to the first symptoms of
GBS. Therefore, onset of GBS within less than 72 hours or 3 days of
immunization would be strong evidence that the vaccine is not the
causative agent.\6\
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\6\ Peripheral Neuropathy, 4th edition, 2005; Dyck & Thomas,
eds. 626.
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HHS believes that the American Journal of Epidemiology study cited
by the commenter is consistent with the other studies referenced above
in indicating that the window of onset for GBS on the Table is
appropriate based on current compelling, reliable, valid medical and
scientific evidence.
6. Comparison of CICP Table Injuries to the VICP Table Injuries
Comment: A commenter compared the CICP Table injuries with the
National Vaccine Injury Compensation Program (VICP) Table injuries
because the 2009 H1N1 strain has been included in the seasonal
influenza vaccine since 2010 and questioned why the Tables are
different.
Response: The VICP and CICP are different programs authorized by
two distinct federal statutes. The VICP covers certain vaccines that
are recommended by the CDC for routine administration to children and
are subject to an excise tax, whereas the CICP covers certain
countermeasures, including pandemic influenza vaccines, as identified
in Secretarial declarations. Accordingly, the VICP covers seasonal
influenza vaccines, such as the quadravalent influenza vaccine, and the
CICP covers pandemic vaccines, such as the 2009 monovalent H1N1
vaccine. Presently, the VICP's Table does not include any associated
injuries for seasonal influenza vaccines.
7. West Nile Virus (WNV)
Comment: A commenter stated ``I strongly believe it is beneficial
to have an injury compensation program implemented for those who have
been extremely touched by West Nile and other harmful influenzas . .
.'' HHS' understanding is that the commenter wants a compensation
program established that would cover the adverse effects of the
underlying pandemic or epidemic condition itself.
Response: Injuries from the WNV or any influenza infection are not
covered by the CICP. As stated in the NPRM, only serious injuries
directly caused by the administration or use of the covered
countermeasure--not injuries that result from the disease (or health
condition or threat to health) itself--are covered injuries. For more
information, see 42 CFR 110.20(d).
[[Page 47415]]
8. Notification to Individuals Who Have Been Deemed Ineligible for
Compensation
Comment: A commenter suggested that HHS inform all individuals who
have previously applied but were deemed ineligible for compensation
that they can reapply for compensation.
Response: HHS agrees with the commenter. Previous requesters, who
were deemed ineligible for compensation, will be notified of the new
Table by its publication in the Federal Register. The published final
rule also will be posted on the CICP Web site at www.hrsa.gov/cicp.
Such requesters may have an additional 1-year filing deadline from the
effective date of the Table amendment or publication. This additional
filing deadline will apply only if the new or amended Table enables a
requester, who could not establish a Table injury before the new or
amended Table, to establish a covered injury.\7\
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\7\ 42 CFR 110.42(f).
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IV. Regulatory Impact Analysis
HHS has examined the impact of this rulemaking as required by
Executive Order 12866 on Regulatory Planning and Review, Executive
Order 13563 on Improving Regulation and Regulatory Review, the
Congressional Review Act (5 U.S.C. 804(2)), the Regulatory Flexibility
Act (RFA), section 202 of the Unfunded Mandates Reform Act of 1995,
section 654(c) of the Treasury and General Government Appropriations
Act of 1999, and Executive Order 13132 on Federalism.
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, costs, benefits, incentives, equity, and
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. In 2011, President Obama supplemented
and reaffirmed Executive Order 12866. This rulemaking is not being
treated as a significant regulatory action under section 3(f) of
Executive Order 12866. Accordingly, the final rule has not been
reviewed by the Office of Management and Budget.
Executive Order 13563 provides that, to the extent feasible and
permitted by law, the public must be given a meaningful opportunity to
comment on any proposed regulations, with at least a 60-day comment
period. In addition, to the extent feasible and permitted by law,
agencies must provide timely on-line access to both proposed and final
rules of the rulemaking docket on Regulations.gov, including relevant
scientific and technical findings, in an open format that can be
searched and downloaded. Federal agencies must consider approaches to
maintain the freedom of choice and flexibility, including disclosure of
relevant information to the public. Regulations must be guided by
objective scientific evidence, easy to understand, consistent, and
written in plain language. Furthermore, Federal agencies must attempt
to coordinate, simplify, and harmonize regulations to reduce costs and
promote certainty for the public.
In this final rule, the Secretary specifies a Table identifying
serious physical injuries that shall be presumed to result from the
administration or use of the covered countermeasures, and the time
interval in which the onset of the first symptom or manifestation of
each such serious physical injury must manifest in order for such
presumption to apply. The Secretary is also specifying Table
definitions and requirements. This final rule would have the effect of
affording certain persons a presumption that particular serious
physical injuries were sustained as the result of the administration or
use of covered pandemic influenza countermeasures. The Table will
establish a presumption of causation and relieve requesters of the
burden of demonstrating causation for covered injuries listed on the
Table. However, this presumption is rebuttable based on the Secretary's
review of the evidence. In addition, this Table may afford some
requesters a new filing deadline.
Other than showing that a serious physical injury or death directly
resulted from an injury included on the Table, individuals may, in the
alternative, be eligible for compensation if they otherwise meet the
CICP's requirements and can show a causation-in-fact relationship
between an injury or death and a covered countermeasure. This rule is
based upon legal authority.
Because any resources required to implement the regulatory
requirements imposed by the Program are not required by virtue of the
establishment of a Table, and because the Secretary conducted an
independent analysis concerning any burdens associated with the
implementation of the Program when the Secretary published the
companion regulation setting forth the Program's administrative
implementation,\8\ the Secretary has determined that no resources are
required to implement the provisions included in this final rule.
Therefore, in accordance with the 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 rule
will not have a significant impact on a substantial number of small
entities.
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\8\ 75 FR 64955.
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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. The
Secretary has determined that 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. Similarly, it will not have effects on State,
local, and tribal governments or on the private sector such as to
require consultation under the Unfunded Mandates Reform Act of 1995.
This final rule comports with the 2011 supplemental requirements.
Unfunded Mandates Reform Act of 1995
The Secretary has determined that this final rule will not have
effects on State, local, and 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 final rule in accordance with
Executive Order 13132 regarding federalism, and has determined that it
does not have ``federalism implications.'' This final rule will 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 final 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 rule may have a positive impact on the
disposable
[[Page 47416]]
income and poverty elements of family well-being to the extent that
injured persons or their families may receive medical, lost employment
income, and/or death benefits paid under this part without imposing a
corresponding burden on them.
Paperwork Reduction Act of 1995, as Amended
This final rule has no information collection requirements.
List of Subjects in 42 CFR Part 110
Anaphylaxis, Anticoagulation, Antiviral, Avian, Benefits,
Biologics, Bleeding, Bursitis, Compensation, Countermeasure,
Declaration, Deltoid, Diagnostics, Device, Eligibility, Extra-Corporeal
Membrane Oxygenation (ECMO), Fisher Syndrome, Guillain-Barr[eacute]
Syndrome, 2009 H1N1, Influenza, Injury Table, Immunization,
Oseltamivir, Pandemic, Peramivir, Public Readiness and Emergency
Preparedness Act (PREP Act), Radiation syndrome, Respiratory
protection, Relenza, Respirator, Respirator support, Tamiflu, Tracheal
Stenosis, Vaccine, Vasovagal Syncope, Ventilator, Ventilator-Associated
Pneumonia and Tracheobronchitis, Ventilator-Induced Lung Injury,
Zanamivir.
Dated: July 24, 2015.
James Macrae,
Acting Administrator, Health Resources and Services Administration.
Approved: July 30, 2015.
Sylvia M. Burwell,
Secretary.
Therefore, for the reasons stated, the Department of Health and
Human Services amends 42 CFR part 110 as follows:
PART 110--COUNTERMEASURES INJURY COMPENSATION PROGRAM
0
1. The authority citation for part 110 continues to read as follows:
Authority: 42 U.S.C. 247d-6e.
0
2. Add Sec. 110.100 to subpart K to read as follows:
Sec. 110.100 Injury Tables.
(a) Pandemic influenza countermeasures injury table.
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Time interval (for
first symptom or
manifestation of
Covered countermeasures Serious physical onset of injury
under Secretarial injury (illness, after administration
declarations disability, injury, or use of covered
or condition) \1\ countermeasure,
unless otherwise
specified)
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I. Pandemic influenza A. Anaphylaxis...... A. 0-4 hours.
vaccines administered by B. Deltoid Bursitis. B. 0-48 hours.
needle into or through the C. Vasovagal Syncope C. 0-1 hour.
skin.
II. Pandemic influenza A. Anaphylaxis...... A. 0-4 hours.
intranasal vaccines.
III. Pandemic influenza 2009 A. Guillain- A. 3-42 days (not
H1N1 vaccine. Barr[eacute] less than 72 hours
Syndrome. and not more than
42 days).
IV. Oseltamivir Phosphate A. Anaphylaxis...... A. 0-4 hours.
(Tamiflu) when administered
or used for pandemic
influenza.
V. Zanamivir (Relenza) when A. Anaphylaxis...... A. 0-4 hours.
administered or used for
pandemic influenza.
VI. Peramivir when A. Anaphylaxis...... A. 0-4 hours.
administered or used for
2009 H1N1 influenza.
VII. Pandemic influenza A. No condition A. Not applicable.
personal respiratory covered \2\.
protection devices.
VIII. Pandemic influenza A. Postintubation A. 2-42 days (not
respiratory support devices. Tracheal Stenosis. less than 48 hours
and not more than
42 days) after
extubation (removal
of a tracheostomy
or endotracheal
tube).
B. Ventilator- B. More than 48
Associated hours after
Pneumonia and intubation
Ventilator- (placement of an
Associated endotracheal or
Tracheobronchitis. tracheostomy tube)
and up to 48 hours
after extubation
(removal of the
tube).
C. Ventilator- C. Throughout the
Induced Lung Injury. time of intubation
(breathing through
an endotracheal or
tracheostomy tube)
and up to 48 hours
after extubation
(removal of the
tube).
IX. Pandemic influenza A. Bleeding Events.. A. Throughout the
respiratory support device: time of
Extra-corporeal membrane anticoagulation
oxygenation (ECMO). treatment for ECMO
therapy, including
the time needed to
clear the effect of
the anti-coagulant
treatment from the
body.
X. Pandemic influenza A. No condition A. Not applicable.
diagnostic testing devices. covered.
------------------------------------------------------------------------
\1\ Serious physical injury as defined in 42 CFR 110.3(z). Only injuries
that warranted hospitalization (whether or not the person was actually
hospitalized) or injuries that led to a significant loss of function
or disability will be considered serious physical injuries.
\2\ The use of ``No condition covered'' in the Table reflects that the
Secretary at this time does not find compelling, reliable, valid,
medical and scientific evidence to support that any serious injury is
presumed to be caused by the associated covered countermeasure. For
injuries alleged to be due to covered countermeasures for which there
is no associated Table injury, requesters must demonstrate that the
injury occurred as the direct result of the administration or use of
the covered countermeasure. See 42 CFR 110.20(b), (c).
(b) Qualifications and aids to interpretation (table definitions
and requirements). The following definitions and requirements shall
apply to the Table set forth in this subpart and only apply for
purposes of this subpart.
(1) Anaphylaxis. Anaphylaxis is an acute, severe, and potentially
lethal systemic reaction that occurs as a single discrete event with
simultaneous involvement of two or more organ systems. Most cases
resolve without sequelae. Signs and symptoms begin minutes to a few
hours after exposure.
[[Page 47417]]
Death, if it occurs, usually results from airway obstruction caused by
laryngeal edema or bronchospasm and may be associated with
cardiovascular collapse. Other significant clinical signs and symptoms
may include the following: Cyanosis, hypotension, bradycardia,
tachycardia, arrhythmia, edema of the pharynx and/or trachea and/or
larynx with stridor and dyspnea. There are no specific pathological
findings to confirm a diagnosis of anaphylaxis.
(2) Deltoid bursitis. Deltoid bursitis is an inflammation of the
bursa that lies beneath the deltoid muscle and between the acromion
process and the rotator cuff. Subdeltoid bursitis manifests with pain
in the lateral aspect of the shoulder similar to rotator cuff
tendonitis. The presence of tenderness on direct palpation beneath the
acromion process distinguishes this bursitis from rotator cuff
tendonitis. Similar to tendonitis, isolated bursitis will have full
passive range of motion. Other causes of bursitis such as trauma (other
than from vaccination), metabolic disorders, and systemic diseases such
as rheumatoid arthritis, dialysis, and infection will not be considered
Table injuries. This list is not exhaustive. The deltoid bursitis must
occur in the same shoulder that received the pandemic influenza
vaccine.
(3) Vasovagal syncope. Vasovagal syncope (also sometimes called
neurocardiogenic syncope) means loss of consciousness (fainting) and
loss of postural tone caused by a transient decrease in blood flow to
the brain occurring after the administration of an injected
countermeasure. Vasovagal syncope is usually a benign condition but may
result in falling and injury with significant sequelae. Vasovagal
syncope may be preceded by symptoms such as nausea, lightheadedness,
diaphoresis, and/or pallor. Vasovagal syncope may be associated with
transient seizure-like activity, but recovery of orientation and
consciousness generally occurs simultaneously. Loss of consciousness
resulting from the following conditions will not be considered
vasovagal syncope: Organic heart disease; cardiac arrhythmias;
transient ischemic attacks; hyperventilation; metabolic conditions;
neurological conditions; psychiatric conditions; seizures; trauma; and
situational as can occur with urination, defecation, or cough. This
list is not complete. Episodes of recurrent syncope occurring after the
applicable time period are not considered to be sequelae of an episode
of syncope meeting the Table requirements.
(4) Guillain-Barr[eacute] Syndrome (GBS). (i) GBS is an acute
monophasic peripheral neuropathy that currently is known to encompass a
spectrum of four clinicopathological subtypes described below. For each
subtype of GBS, the interval between the first appearance of symptoms
and the nadir of weakness is between 12 hours and 28 days. This is
followed in all subtypes by a clinical plateau with stabilization at
the nadir of symptoms, or subsequent improvement without significant
relapse. Death may occur without a clinical plateau. Treatment related
fluctuations in all subtypes of GBS can occur within 9 weeks of GBS
symptom onset and recurrence of symptoms after this time frame would
not be consistent with GBS.
(ii) The most common subtype in North America and Europe,
comprising more than 90 percent of cases, is acute inflammatory
demyelinating polyneuropathy (AIDP) which has the pathologic and
electrodiagnostic features of focal demyelination of motor and sensory
peripheral nerves and nerve roots. Another subtype called acute motor
axonal neuropathy (AMAN) is generally seen in other parts of the world
and is predominated by axonal damage that primarily affects motor
nerves. AMAN lacks features of demyelination. Another less common
subtype of GBS includes acute motor and sensory neuropathy (AMSAN),
which is an axonal form of GBS that is similar to AMAN, but also
affects the sensory nerves and roots. AIDP, AMAN, and AMSAN are
typically characterized by symmetric motor flaccid weakness, sensory
abnormalities, and/or autonomic dysfunction caused by autoimmune damage
to peripheral nerves and nerve roots. The diagnosis of AIDP, AMAN, and
AMSAN requires bilateral flaccid limb weakness and decreased or absent
deep tendon reflexes in weak limbs; a monophasic illness pattern; an
interval between onset and nadir of weakness between 12 hours and 28
days; subsequent clinical plateau (the clinical plateau leads to either
stabilization at the nadir of symptoms, or subsequent improvement
without significant relapse); and, the absence of an identified more
likely alternative diagnosis. Death may occur without a clinical
plateau.
(iii) Fisher syndrome (FS), also known as Miller-Fisher Syndrome,
is a subtype of GBS characterized by ataxia, areflexia, and
ophthalmoplegia, and overlap between FS and AIDP may be seen with limb
weakness. The diagnosis of FS requires bilateral ophthalmoparesis;
bilateral reduced or absent tendon reflexes; ataxia; the absence of
limb weakness (the presence of limb weakness suggests a diagnosis of
AIDP); a monophasic illness pattern; an interval between onset and
nadir of weakness between 12 hours and 28 days; subsequent clinical
plateau (the clinical plateau leads to either stabilization at the
nadir of symptoms, or subsequent improvement without significant
relapse); no alteration in consciousness; no corticospinal track signs;
and, the absence of an identified more likely alternative diagnosis.
Death may occur without a clinical plateau.
(iv) Evidence that is supportive, but not required, of a diagnosis
of all subtypes of GBS includes electrophysiologic findings consistent
with GBS or an elevation of cerebral spinal fluid (CSF) protein with a
total CSF white blood cell count below 50 cells per microliter. The
results of both CSF and electrophysiologic studies are frequently
normal in the first week of illness in otherwise typical cases of GBS.
(v) For GBS to qualify as a Table injury there must not be a more
likely alternative diagnosis for the weakness. Exclusionary criteria
for the diagnosis of all subtypes of GBS include the ultimate diagnosis
of any of the following conditions: Chronic immune demyelinating
polyradiculopathy (``CIDP''), carcinomatous meningitis, brain stem
encephalitis (other than Bickerstaff brainstem encephalitis), myelitis,
spinal cord infarct, spinal cord compression, anterior horn cell
diseases such as polio or West Nile virus infection, subacute
inflammatory demyelinating polyradiculoneuropathy, multiple sclerosis,
cauda equina compression, metabolic conditions such as hypermagnesemia
or hypophosphatemia, tick paralysis, heavy metal toxicity (such as
arsenic, gold, or thallium), drug-induced neuropathy (such as
vincristine, platinum compounds, or nitrofurantoin), porphyria,
critical illness neuropathy, vasculitis, diphtheria, myasthenia gravis,
organophosphate poisoning, botulism, critical illness myopathy,
polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above
list is not exhaustive.
(5) Tracheal stenosis. (i) Postintubation tracheal stenosis means
an iatrogenic (caused by medical treatment) and symptomatic stricture
of the airway (narrowing of the windpipe) resulting from:
(A) Trauma or necrosis from an endotracheal tube; or
(B) Stomal injury from a tracheostomy; or
(C) A combination of the two.
(ii) Tracheal stenosis or narrowing due to tumors (malignant or
benign), infections of the trachea (such as
[[Page 47418]]
tuberculosis, fungal diseases), radiotherapy, tracheal surgery, trauma,
congenital, and inflammatory or autoimmune diseases will not be
considered post-intubation tracheal stenosis. Post-intubation tracheal
stenosis requires either tracheostomy with placement of a tracheostomy
tube or endotracheal intubation. Diagnosis requires symptoms of upper
airway obstruction such as stridor (inspiratory wheeze) or exertional
dyspnea (increased shortness of breath with exertion), and positive
radiologic studies showing abnormal narrowing of the trachea or
bronchoscopic evaluation that demonstrates abnormal narrowing.
(6) Ventilator-Associated Pneumonia (VAP) and Ventilator-Associated
Tracheobronchitis (VAT). (i) VAP is defined as an iatrogenic pneumonia
caused by the medical treatment of mechanical ventilation. Similarly,
VAT is an iatrogenic infection of the trachea and/or bronchi caused by
mechanical ventilation. The initial manifestation of VAP and VAT must
occur more than 48 hours after intubation (placement of the breathing
tube) and up to 48 hours after extubation (removal of the breathing
tube). VAP will be considered to be present when the patient
demonstrates a new or progressive radiographic infiltrate that is in
the lungs and consistent with pneumonia, fever, leukocytosis (increased
white blood cell count) or leucopenia (decreased white blood cell
count), purulent (containing pus) tracheal secretions from a tracheal
aspirate, and a positive lower respiratory tract culture. The positive
lower respiratory tract culture is a diagnostic requirement only if
there has not been a change in antibiotics in the 72 hours prior to
collection of the culture. In addition, a tracheal aspirate that does
not demonstrate bacteria or inflammatory cells in a patient without a
change in antibiotics in the previous 72 hours is unlikely to be VAP
and shall not be considered a condition set forth in the Table.
(ii) VAT will be considered to be present when the patient
demonstrates fever, leukocytosis or leukopenia, purulent tracheal
secretions, and a positive tracheal aspirate culture in the absence of
a change of antibiotics within the 72 hours prior to culture. Tracheal
colonization with microorganisms is common in intubated patients, but
in the absence of clinical findings is not a sign of VAT.
(7) Ventilator-Induced Lung Injury (VILI). VILI results from
mechanical trauma such as volutrauma leading to rupture of alveoli (air
sacs in the lungs where oxygen and carbon dioxide are exchanged with
the blood) with subsequent abnormal leakage of air. VILI manifests as
iatrogenic pneumothorax (abnormal air from alveolar rupture in the
pleural space), pneumomediastinum (abnormal air from alveolar rupture
in the mediastinum (middle part of the chest between the lungs)),
pulmonary interstitial emphysema (abnormal air in the lung interstitial
space between the alveoli), subpleural air cysts (an extreme form of
pulmonary emphysema where the abnormal air in the interstitial space
has pooled into larger pockets), subcutaneous emphysema (abnormal air
from alveolar rupture that has dissected into the skin),
pneumopericardium (abnormal air from alveolar rupture that has traveled
to the pericardium (covering of the heart)), pneumoperitoneum (abnormal
air from alveolar rupture that has moved into the abdominal space), or
systemic air embolism (abnormal air from alveolar rupture that has
moved into the blood). To qualify as Table injuries, these
manifestations must occur in patients who are being mechanically
ventilated at the time of initial manifestation of the VILI.
(8) Bleeding events. Bleeding events are defined as excessive or
abnormal bleeding in patients who are under the pharmacologic effects
of anticoagulant therapy provided for extracorporeal membrane
oxygenation (ECMO) treatment.
(c) Covered countermeasures. The Office of the Secretary publishes
Secretarial declarations on the following covered countermeasures in
the Federal Register:
(1) Pandemic influenza vaccines;
(2) Tamiflu;
(3) Relenza;
(4) Peramivir;
(5) Personal respiratory protection devices;
(6) Respiratory support devices;
(7) Diagnostic testing devices.
[FR Doc. 2015-19228 Filed 8-6-15; 8:45 am]
BILLING CODE 4165-15-P