Rule2021-17216
Countermeasures Injury Compensation Program: Smallpox Countermeasures Injury Table
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Published
August 16, 2021
Effective
September 15, 2021
Issuing agencies
Health and Human Services Department
Abstract
HHS is establishing the Smallpox Countermeasures Injury Table (Table) as authorized by the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). Through this final rule, the Secretary of the U.S. Department of Health and Human Services (Secretary) adds the Smallpox Countermeasures Injury Table to the agency's regulations. The Table includes a list of covered smallpox countermeasures, required time intervals for the first symptom or manifestation of onset of injuries, and the accompanying Qualifications and Aids to Interpretation (QAI), which set forth definitions and other requirements necessary to establish Table injuries.
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<title>Federal Register, Volume 86 Issue 155 (Monday, August 16, 2021)</title>
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[Federal Register Volume 86, Number 155 (Monday, August 16, 2021)]
[Rules and Regulations]
[Pages 45655-45660]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17216]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 110
RIN 0906-AB22
Countermeasures Injury Compensation Program: Smallpox
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 Smallpox Countermeasures Injury Table
(Table) as authorized by the Public Readiness and Emergency
Preparedness Act of 2005 (PREP Act). Through this final rule, the
Secretary of the U.S. Department of Health and Human Services
(Secretary) adds the Smallpox Countermeasures Injury Table to the
agency's regulations. The Table includes a list of covered smallpox
countermeasures, required time
[[Page 45656]]
intervals for the first symptom or manifestation of onset of injuries,
and the accompanying Qualifications and Aids to Interpretation (QAI),
which set forth definitions and other requirements necessary to
establish Table injuries.
DATES: This rule is effective September 15, 2021.
FOR FURTHER INFORMATION CONTACT: Tamara Overby, Acting Director,
Division of Injury Compensation Programs, Healthcare Systems Bureau,
HRSA, 5600 Fishers Lane, 8N146B, Rockville, MD 20857, or by telephone
(855) 266-2427. This is a toll-free number.
SUPPLEMENTARY INFORMATION: On October 15, 2020, HHS published a notice
of proposed rulemaking (NPRM) in the Federal Register (85 FR 65311)
proposing to add the Table for designated covered smallpox
countermeasures identified in the Smallpox Medical Countermeasures PREP
Act declaration. The Table includes a list of smallpox countermeasures,
proposed time intervals for the first symptom or manifestation of onset
of injury, and Qualifications and Aids to Interpretation which set
forth the definitions and requirements necessary to establish the Table
injuries. The NPRM provided a 60-day comment period, and HHS received
one out-of-scope comment.
I. Background and Purpose
The PREP Act authorizes the Countermeasures Injury Compensation
Program (CICP) to provide compensation to certain individuals who
develop serious physical injuries or to certain survivors of
individuals who die as a direct result of the administration or use of
a covered countermeasure identified in a PREP Act declaration.\1\ In
carrying out the CICP, the 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.'' \2\
The Table informs the public about serious physical injuries known to
be directly caused by covered countermeasures and creates a rebuttable
presumption of causation for eligible individuals whose injuries are
listed on the Table and meet the Table's requirements.
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\1\ See Department of Defense, Emergency Supplemental
Appropriation to Address Hurricanes in the Gulf of Mexico, and
Pandemic Influenza Act of 2006, Part C (Pub. L. 109-148); 42. U.S.C.
247d-6e.
\2\ 42 U.S.C. 247d-6e (b)(5)(A).
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The CICP's regulations, which detail the Program's requirements,
are found at 42 CFR part 110. The provision at 42 CFR 110.20(a) states
that individuals must establish that a covered injury occurred 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.\3\ This includes a
covered countermeasure causing a serious aggravation of a pre-existing
condition.\4\ 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.\5\
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\3\ 42 CFR 110.3(g).
\4\ Id.
\5\ 42 CFR 110.3(z).
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Individuals with injuries not meeting the requirements of the Table
may still pursue their claims as non-Table injuries under the
Program.\6\ In that instance, the requester does not receive the
presumption of causation for a Table injury and must demonstrate that
the administration or use of the covered countermeasure directly caused
the injury.\7\ Proof of a causal association for the non-Table injury
must be based on compelling, reliable, valid, medical and scientific
evidence.\8\
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\6\ 42 CFR 110.20(c).
\7\ Id.
\8\ Id.
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II. Summary of the Final Rule
Through this final rule, the Secretary adds the Smallpox
Countermeasures Injury Table to subpart K of 42 CFR part 110. The Table
established in this final rule is limited to smallpox covered
countermeasures identified in the Secretary's PREP Act Declaration for
Smallpox Medical Countermeasures.\9\
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\9\ 80 FR 76546 (Dec. 9, 2015).
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The Smallpox Countermeasures Injury Table lists several smallpox
covered countermeasures and serious physical injuries that, based on
compelling, reliable, valid, medical and scientific evidence, are
directly caused by the administration or use of the associated covered
countermeasures. The Table provides the serious injuries associated
with a specific countermeasure and the time interval within which the
first symptom or manifestation of onset of injury must appear. The QAI,
which accompany the Table, are definitions included to further explain
the requirements for each covered injury and the level of severity
necessary to qualify as a Table injury. The Secretary will stay
informed of updates in the scientific and medical field concerning
potential new information about causal associations between injuries
and covered countermeasures and update the Table as needed.
In accordance with 42 CFR 110.42(f), in addition to the standard
filing deadline, with the publication of this new Table, certain
eligible requesters have one year from the effective date of the
publication of the Table to file claims for injuries that meet the
Table's requirements. Individuals who sustained injuries that are not
included on the Table or that do not meet all of the requirements for a
Table injury, but who may prove causation of the injury through other
means, are not eligible for the additional one-year filing deadline
based on the Table's publication. Because the new Table would not
enable such individuals to establish a Table injury, they would be
subject to the standard filing deadline in 42 CFR 100.42(a) (i.e., one
year from the date of administration or use of the covered
countermeasure).
In this final rule, the Secretary has made the following change
from what was proposed in the NPRM for the purposes of clarity.
a. Changed paragraph (d)(6) by adding a comma after ``pustules)''
and before ``generally'' to the second sentence. The revised sentence
states, ``The rash or lesions, characterized by multiple blisters
(vesicles or pustules), generally evolve in a similar sequence or
manner as the original vaccination site.
b. Changed paragraph (d)(9) by adding ``to'' after ``attributed''
and before ``it'' to the seventh sentence. The revised sentence states,
``Symptoms that occur before 5 days or more than 14 days after
receiving the smallpox vaccine should not be attributed to it.''
III. Comments and Responses
The NPRM set forth a 60-day public comment period, which ended on
December 14, 2020. During the comment period, HHS received one comment
that was not relevant to the NPRM. As noted above, the only
[[Page 45657]]
changes made to the final rule are to paragraphs (d)(6) and (9) for
clarity.
IV. Regulatory Impact Analysis
HHS examined the impact of this final rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Congressional Review Act (5 U.S.C. 804(2)), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 202 of the Unfunded Mandates Reform Act of 1995 (March 2, 1995;
Pub. L. 104-4), section 654(c) of the Treasury and General Government
Appropriations Act of 1999, and Executive Order 13132 on Federalism
(August 4, 1999).
Executive Orders 12866 and 13563
Executive Order 12866 requires 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.
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 online access to both proposed and final
rules of the rulemaking docket on <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>,
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. Objective scientific
evidence guides regulations and should be 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.
Summary of Impacts
In this final rule, the Secretary establishes a Table identifying
serious physical injuries that are presumed to result from the
administration or use of certain covered countermeasures, required
definitions of those injuries, and the time interval in which the onset
of the first symptom or manifestation of each injury must manifest for
the presumption of causation to apply. The Table establishes a
presumption of causation for requesters meeting the Table's
requirements and relieves requesters of the burden of demonstrating
causation. However, this presumption is rebuttable if, based on the
Secretary's review of the evidence, a source other than the
countermeasure is found to be the more likely cause of the injury. The
publication of this Table may afford some requesters a new filing
deadline.
The Secretary has determined that minimal staff and funding
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 final rule will not have a significant impact on a
substantial number of small entities.
The Secretary has determined that this final rule does not meet the
criteria for an ``economically significant'' regulatory action as
defined by Executive Order 12866 and would have no major effect on the
economy or Federal expenditures. The Secretary also has determined that
this final rule is not a ``major rule'' within the meaning of the
statute providing for Congressional Review of Agency Rulemaking, 5
U.S.C. 801. The Office of Information and Regulatory Affairs within the
Office of Management and Budget has determined that this rule is not a
``significant regulatory action'' within the meaning of section 3(f) of
the Executive order.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This final rule would
not result in an expenditure in any year that meets or exceeds this
amount.
Executive Order 13132--Federalism
The Secretary 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.''
Paperwork Reduction Act of 1995
This final rule has no information collection requirements.
List of Subjects in 42 CFR Part 110
Biologics, Immunization.
Dated: August 9, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
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. Amend Sec. 110.100 by revising paragraph (b) introductory text and
paragraph (c) and adding paragraph (d) to read as follows:
Sec. 110.100 Injury Tables.
* * * * *
(b) Qualifications and aids to interpretation (table definitions
and requirements). The following definitions and requirements shall
apply to the Table set forth in paragraph (a) of this section and only
apply for purposes of this subpart.
* * * * *
(c) Smallpox countermeasures injury table.
[[Page 45658]]
Table 2 to Paragraph (c)
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Time interval (for
first symptom or
manifestation of
Serious physical onset of injury
Covered countermeasures under injury (illness, after
declarations disability, administration or
injury, or use of covered
condition) \1\ countermeasure,
unless otherwise
specified)
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I. Smallpox Vaccines Replication- A. Anaphylaxis.... A. 0-4 hours.
Deficient. B. Vasovagal B. 0-1 hour.
Syncope.
II. Smallpox Vaccines A. Anaphylaxis.... A. 0-4 hours.
Replication-Competent. B. Vasovagal B. 0-1 hour.
Syncope.
C. Significant C. 1-21 days.
Local Skin
Reaction.
D. Stevens-Johnson D. 4-28 days.
Syndrome/Toxic
Epidermal
Necrolysis.
E. Inadvertent E. 1-21 days.
Autoinoculation.
F. Generalized F. 6-9 days.
Vaccinia.
G. Eczema G. 3-21 days.
Vaccinatum.
H. Progressive H. 3-21 days.
Vaccinia.
I. Post-vaccinial I. 5-14 days.
Encephalopathy,
Encephalitis or
Encephalomyelitis
(PVEM).
J. Vaccinial J. 0-21 days.
Myocarditis,
Pericarditis, or
Myopericarditis
(MP).
III. Vaccinia Immunoglobulin A. Anaphylaxis.... A. 0-4 hours.
Intravenous (VIGIV). B. Transfusion- B. 0-72 hours.
Related Acute
Lung Injury
(TRALI).
C. Acute Renal C. 0-10 days.
Failure (ARF).
D. Drug-Induced D. Within 48 hours
Aseptic after the first
Meningitis (DIAM). dose and up to 48
hours after the
last dose of
VIGIV.
E. Hemolysis...... E. 12 hours to 14
days.
IV. Cidofovir................... A. No Condition A. Not Applicable.
Covered \2\.
V. Tecovirimat.................. A. No Condition A. Not Applicable.
Covered \2\.
VI. Brincidofovir............... A. No Condition A. Not Applicable.
Covered \2\.
VII. Smallpox Infection A. No Condition A. Not Applicable.
Diagnostic Testing Devices. Covered \2\.
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\1\ Serious physical injury as defined in Sec. 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 this Table 2 reflects that
the Secretary evaluated the countermeasure, but 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 2
injury, requesters must demonstrate that the injury occurred as the
direct result of the administration or use of the covered
countermeasure. See Sec. 110.20(b) and (c).
(d) Qualifications and aids to interpretation (table definitions
and requirements). The following definitions and requirements shall
apply to the Table set forth in paragraph (c) of this section 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 within minutes to a
few hours after exposure. 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) 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 (sweating), 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 as other conditions that are not
associated with the vaccine also may cause loss of consciousness.
Episodes of recurrent syncope occurring after the applicable timeframe
are not considered to be sequelae of an episode of syncope meeting the
Table 2 requirements.
(3) Significant local skin reaction. Significant local skin
reaction is an unexpected and extreme response at the vaccination or
inoculation site that results in a significant scar that is serious
enough to require surgical intervention. The onset of this injury is
the initial skin lesion at the vaccination site that generally occurs
with replication-competent smallpox vaccinations. Minor scarring or
minor local reactions do not constitute a Table 2 injury. A robust
take, defined as an area of redness at the vaccination site that
exceeds 7.5 cm in diameter with associated swelling, warmth and pain,
is generally considered an expected response to the vaccination or
inoculation. A robust take, in itself, does not constitute a Table 2
injury, even when the redness and swelling involves the entire upper
arm with associated enlargement and tenderness of the glands (lymph
nodes) in the underarm (axilla).
[[Page 45659]]
(4) Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN).
SJS/TEN is a spectrum of acute hypersensitivity reactions that affects
skin, mucous membranes, and sometimes, internal organs (systemic
toxicity) associated with the use or administration of replication-
competent smallpox vaccines. For purposes of Table 2, both skin and
mucous membrane rash or lesions must be present. Rash or lesion
distribution must be widespread. Rash must not have a symmetric acral
distribution (affecting arms, hands, legs or feet). Two or more mucosal
sites must be involved. Mucosal lesions generally manifest as painful
lesions in sites, such as the mouth or eyes. Skin rash or lesions in
SJS/TEN usually consist of red or purple raised areas (erythematous
macules), blisters, and ulcerations.
(5) Inadvertent autoinoculation (IA). IA is the spread of vaccinia
virus from an existing vaccination site to a second location usually by
scratching the vaccination site and subsequently spreading the virus,
which produces a new vaccinial lesion on the same person who received
the vaccination. IA is the most common adverse event associated with
the replication-competent smallpox vaccine.
(6) Generalized vaccinia (GV). GV is a vaccinial infection that
occurs from the spread of vaccinia from an existing vaccination or
inoculation site, with the use or administration of a replication-
competent smallpox vaccine, to otherwise normal skin, resulting in
multiple new areas of vaccinial rash or lesions. The vaccinia is
believed to be spread through the blood. The rash or lesions,
characterized by multiple blisters (vesicles or pustules), generally
evolve in a similar sequence or manner as the original vaccination
site.
(7) Eczema vaccinatum (EV). EV is the transmission or the spread of
vaccinia virus from a vaccination site, after the use or administration
of a replication-competent smallpox vaccine, to skin that has been
affected by, or is currently affected with, eczema or atopic
dermatitis. EV is characterized by lesions that include multiple
blisters (vesicles or pustules), which generally evolve in a similar
sequence or manner as the original vaccination site. The lesions may
come together to form larger lesions. Lesions may also spread to
patches of skin that have never been involved with eczema or atopic
dermatitis. The new lesions, if cultured, will be positive for vaccinia
virus. A person with EV may become severely ill with signs and symptoms
that involve the whole body (systemic illness), such as fever, malaise,
or enlarged glands (lymph nodes).
(8) Progressive vaccinia (PV). PV is the failure to initiate the
healing process in an initial vaccination or inoculation site, after
the use or administration of a replication-competent smallpox vaccine,
by 21 days after exposure to vaccinia, with progressive ulceration or
necrosis at the vaccination site leading to a large destructive ulcer.
PV is seen in people who are immunocompromised (have an impaired immune
system) and is characterized by a complete or near complete lack of
inflammation or absence of inflammatory cells in the dermis of the skin
at the vaccination site. The diagnosis of PV may be made before 21 days
after exposure, especially in a known immunocompromised individual who
develops a lesion at the vaccination site. PV may spread through the
blood to any location in the body. No one who experiences a significant
healing process of the vaccination site within 21 days after receipt of
the replication-competent smallpox vaccine or exposure to vaccinia has
PV.
(9) Post-vaccinial encephalopathy, encephalitis, and
encephalomyelitis (PVEM). PVEM is a spectrum of overlapping conditions
that includes post-vaccinial encephalopathy, encephalitis, and
encephalomyelitis, and, for the purposes of Table 2, is treated as one
injury. For the purposes of Table 2, PVEM is an autoimmune central
nervous system injury that occurs after the use or administration of a
replication-competent smallpox vaccine. In rare cases, the vaccinia
virus is isolated from the central nervous system. Manifestations
usually occur abruptly and may include fever, vomiting, loss of
appetite (anorexia), headache, general malaise, impaired consciousness,
confusion, disorientation, delirium, drowsiness, seizures, language
difficulties (aphasia), coma, muscular incoordination (ataxia), urinary
incontinence, urinary retention, and clinical signs consistent with
inflammation of the spinal cord (myelitis), such as paralysis or
meningismus (meningeal irritation). Long-term central nervous system
impairments, such as paralysis, seizure disorders, or developmental
delays are known to occur as sequelae of the acute PVEM. No clinical
criteria, radiographic findings, or laboratory tests are specific for
the diagnosis of PVEM. Symptoms that occur before 5 days or more than
14 days after receiving the smallpox vaccine should not be attributed
to it. In addition, encephalopathy caused by an infection, a toxin, a
metabolic disturbance, a structural lesion, a genetic disorder, or
trauma would not meet the Table 2 definition.
(10) Vaccinial myocarditis, pericarditis, or myopericarditis (MP).
For purposes of Table 2, MP is vaccinial myocarditis, pericarditis, or
myopericarditis. Vaccinial myocarditis is defined as an inflammation of
the heart muscle (myocardium) because of receiving the replication-
competent smallpox vaccine. Vaccinial pericarditis is defined as an
inflammation of the covering of the heart (pericardium) because of
receiving the smallpox vaccine. Vaccinial myopericarditis is defined as
an inflammation of both the heart muscle and its covering because of
receiving the smallpox vaccine. The inflammation associated with MP may
range in severity from very mild (subclinical) to life threatening. In
many mild cases, myocarditis is diagnosed solely by transient
electrocardiographic (EKG) abnormalities (e.g., ST segment and T wave
changes), increased cardiac enzymes, or mild echocardiographic
abnormalities. Arrhythmias, abnormal heart sounds, heart failure, and
death may occur in more severe cases. Pericarditis generally manifests
with chest pain, abnormal heart sounds (pericardial friction rub), EKG
abnormalities (e.g., ST segment and T wave changes), and/or increased
fluid accumulation around the heart. A Table 2 injury of MP requires
sufficient evidence in the medical records of the occurrence of acute
MP.
(11) Transfusion-related acute lung injury (TRALI). TRALI is
defined as the onset of respiratory distress within 6 hours in non-
critically ill patients, and 72 hours in critically ill patients, after
receipt of blood products containing plasma, in this case, VIGIV. The
relative level of illness will be determined on a case-by-case basis
after reviewing the medical records and the medical history. The
respiratory distress is the result of receiving a plasma containing
transfusion (VIGIV) and subsequently developing pulmonary edema,
respiratory distress, and hypoxia. TRALI occurs as the result of an
antibody response in the host to the donor antibodies within the plasma
product. Pulmonary edema is non-cardiac in nature and does not occur
more than 72 hours after receiving VIGIV. Pulmonary edema occurring
more than 72 hours after receiving a blood product containing plasma
(VIGIV) or associated with cardiac dysfunction is not TRALI and is
excluded as a countermeasure-related injury. TRALI has been identified
as a major cause of mortality in those individual receiving plasma-
containing transfusions. A Table 2 injury for TRALI has occurred in a
[[Page 45660]]
recipient if there is sufficient evidence in the medical record of an
occurrence of TRALI and the pulmonary edema is not caused by cardiac
dysfunction or other causes and occurs within 72 of receiving a blood
product containing plasma, in this case VIGIV.
(12) Acute renal failure (ARF). ARF is the sudden loss of the
kidneys' ability to perform their main function of eliminating excess
fluids and electrolytes (salts), as well as waste material from the
blood. ARF, which is also called acute kidney injury, develops rapidly
over a few hours or a few days. ARF can be fatal and requires intensive
treatment; however, ARF may be reversible. ARF may cause permanent loss
of kidney function, or end-stage renal disease necessitating dialysis
or transplant. A Table 2 injury for ARF has occurred if there is
sufficient evidence in the medical record of an occurrence of ARF
within the identified timeframe and the individual received the
associated countermeasure (VIGIV).
(13) Drug-induced aseptic meningitis (DIAM). (i) DIAM is an
inflammation of the meninges (linings of the brain) that is not caused
by a bacteria or virus, but is caused by a drug or medication. The
symptoms of meningitis include severe headache, nuchal (neck) rigidity,
drowsiness, fever, photophobia (light sensitivity), painful eye
movements, nausea, and vomiting. Discontinuation of the medication
leads to a resolution of the symptoms. DIAM is thought to occur because
of an immunological hypersensitivity reaction to a specific medication.
In the case of immunoglobulins, DIAM may be precipitated by the
immunologically active components within the plasma or because of the
stabilizers used within the product. The symptoms of DIAM may reoccur
with another exposure to the offending agent.
(ii) A Table 2 injury for DIAM has occurred in a recipient if there
is sufficient evidence in the medical record of an occurrence of DIAM
within the identified timeframe and the individual received the
associated countermeasure (VIGIV). DIAM occurring in the absence of the
use of VIGIV, or DIAM occurring with the use of VIGIV outside the
established timeframe of onset, which is any time after the first dose
and up to 48 hours after the last dose of this medication, is not a
Table 2 injury.
(14) Hemolysis. Hemolysis is the physical breakdown of red blood
cells (RBCs) either through natural attrition or as caused by external
factors. The RBC's function is to transport oxygen throughout the body
in the hemoglobin contained within the RBC. Additionally, the RBCs
contain the majority of the body's potassium stores. With hemolysis,
the body is unable to transport oxygen effectively, and the person
develops hypoxia. Additionally, the rapid breakdown of the cell
releases large amounts of potassium into the blood stream, which can
cause abnormal heart rhythms and cardiac arrest. In severe cases of
hemolysis, a blood transfusion may be required to correct the resulting
anemia. A Table 2 injury for hemolysis has occurred if there is
sufficient evidence in the medical record of an occurrence of
hemolysis, and the patient received the associated countermeasure
(VIGIV). Hemolysis occurring in the absence of the use of VIGIV and
outside of the timeframe of 12 hours to 14 days after receiving VIGIV
is not a Table 2 injury. Hemolysis occurring from a more likely
alternative diagnosis, such as infections, toxins, poisons,
hemodialysis, or medications, is not a Table 2 injury. This list of
conditions that can cause hemolysis, not associated with VIGIV, is not
exhaustive, and all additional diagnoses within the medical
documentation will be evaluated.
[FR Doc. 2021-17216 Filed 8-13-21; 8:45 am]
BILLING CODE 4165-15-P
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</html>Indexed from Federal Register on August 16, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.