Voglio sapere a riguardo di…

45658

Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations TABLE 2 TO PARAGRAPH c
Covered countermeasures under declarations
Serious physical injury illness, disability, injury, or condition 1

I. Smallpox Vaccines Replication-Deficient

A. Anaphylaxis
B. Vasovagal Syncope
A. Anaphylaxis
B. Vasovagal Syncope
C. Significant Local Skin Reaction
D. Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis.
E. Inadvertent Autoinoculation
F. Generalized Vaccinia
G. Eczema Vaccinatum
H. Progressive Vaccinia
I. Post-vaccinial Encephalopathy, Encephalitis or Encephalomyelitis PVEM.
J. Vaccinial Myocarditis, Pericarditis, or Myopericarditis MP.
A. Anaphylaxis
B. Transfusion-Related Acute Lung Injury TRALI.
C. Acute Renal Failure ARF
D. Drug-Induced Aseptic Meningitis DIAM

II. Smallpox Vaccines Replication-Competent ..

III. Vaccinia VIGIV.

Immunoglobulin
Intravenous
IV. Cidofovir
V. Tecovirimat
VI. Brincidofovir
VII. Smallpox Infection Diagnostic Testing Devices.

E.
A.
A.
A.
A.

Hemolysis
No Condition Covered 2
No Condition Covered 2
No Condition Covered 2
No Condition Covered 2

Time interval for first symptom or manifestation of onset of injury after administration or use of covered countermeasure, unless otherwise specified A. 04 hours.
B. 01 hour.
A. 04 hours.
B. 01 hour.
C. 121 days.
D. 428 days.
E. 121 days.
F. 69 days.
G. 321 days.
H. 321 days.
I. 514 days.
J. 021 days.
A. 04 hours.
B. 072 hours.
C. 010 days.
D. Within 48 hours after the first dose and up to 48 hours after the last dose of VIGIV.
E. 12 hours to 14 days.
A. Not Applicable.
A. Not Applicable.
A. Not Applicable.
A. Not Applicable.

lotter on DSK11XQN23PROD with RULES1

1 Serious physical injury as defined in 110.3z. 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 110.20b 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
VerDate Sep<11>2014

16:35 Aug 13, 2021

Jkt 253001

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.

PO 00000

Frm 00038

Fmt 4700

Sfmt 4700

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.

E:FRFM16AUR1.SGM

16AUR1