[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.

------------------------------------------------------------------------
                                                     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)
------------------------------------------------------------------------
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