[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Rules and Regulations]
[Pages 6294-6305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AB01


National Vaccine Injury Compensation Program: Revisions to the 
Vaccine Injury Table

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Final rule.

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SUMMARY: On July 29, 2015, the Secretary of Health and Human Services 
(the Secretary) published in the Federal Register a Notice of Proposed 
Rulemaking (NPRM) to amend the regulations governing the National 
Vaccine Injury Compensation Program (VICP or program) by proposing 
revisions to the Vaccine Injury Table (Table). The Secretary based the 
Table revisions primarily on the 2012 Institute of Medicine (IOM) 
report, ``Adverse Effects of Vaccines: Evidence and Causality,'' the 
work of nine HHS workgroups who reviewed the IOM findings, and 
consideration of the Advisory Commission on Childhood Vaccines' (ACCV) 
recommendations. The Secretary amends the Table through the changes in 
this final rule. These changes will apply only to petitions for 
compensation under the VICP filed after this final rule becomes 
effective.

DATE:  This rule is effective February 21, 2017.

FOR FURTHER INFORMATION CONTACT: Dr. Narayan Nair, Acting Director, 
Division of Injury Compensation Programs, Healthcare Systems Bureau, 
HRSA, 5600 Fishers Lane, Room 8N146B, Rockville, MD 20857, or by 
telephone (855) 266-2427. This is a toll-free number.

SUPPLEMENTARY INFORMATION:

I. Background

    The National Childhood Vaccine Injury Act of 1986, title III of 
Public Law 99-660 (42 U.S.C. 300aa-10 et seq.), established the VICP, a 
Federal

[[Page 6295]]

compensation program for persons thought to be injured by vaccines. The 
statute governing the VICP has been amended several times since 1986 
and is hereinafter referred to as ``the Act.'' Petitions for 
compensation under the VICP are filed in the United States Court of 
Federal Claims (Court), with a copy served on the Secretary, who is 
designated as the ``Respondent.'' The Court, acting through judicial 
officers called Special Masters, makes decisions as to eligibility for, 
and the amount of, compensation.
    To gain entitlement to compensation under this program, a 
petitioner must establish that a vaccine-related injury or death has 
occurred, either by proving that a vaccine actually caused or 
significantly aggravated an injury (causation-in-fact) or by 
demonstrating the occurrence of what is referred to as a ``Table 
Injury.'' That is, a petitioner may show that the vaccine recipient 
suffered an injury of the type enumerated in the regulations at 42 CFR 
100.3--the ``Vaccine Injury Table''--corresponding to the vaccination 
in question and that the onset of such injury took place within a time 
period also specified in the Table. If so, the injury is presumed to 
have been caused by the vaccination and the petitioner is entitled to 
compensation (assuming that other requirements are satisfied) unless 
the Respondent affirmatively shows that the injury was caused by some 
factor other than the vaccination (see 42 U.S.C. 300aa-11(c)(1)(C)(i), 
300aa-13(a)(1)(B)), and 300aa-14(a)).
    In prior Table revisions, the Secretary determined that the 
appropriate framework for making changes to the Table is to make 
specific findings as to the illnesses or conditions that can reasonably 
be determined, in some circumstances, to be caused or significantly 
aggravated by the vaccines under review and the circumstances under 
which such causation or aggravation can reasonably be determined to 
occur. The Secretary continues this approach through the use of the 
2012 IOM report, the work of the nine workgroups who reviewed the IOM 
findings, and consideration of the ACCV's recommendations. After 
consultation with the ACCV, the Secretary may modify the Table by 
promulgating regulations, with notice and opportunity for a public 
hearing and at least 180 days of public comment. See 42 U.S.C. 300aa-
14(c) and (d).

II. Summary of the Final Rule

    After the IOM released its 2012 report, 9 HHS workgroups comprising 
HRSA and Centers for Disease Control and Prevention (CDC) medical staff 
reviewed IOM's conclusions for 158 vaccine-adverse events, as well as 
any newly published scientific literature not contained in the report, 
and developed a set of proposed changes to the Table and its 
definitional counterpart, the Qualifications and Aids to Interpretation 
(QAI). For the vast majority of the vaccine-adverse event pairs 
reviewed (135), the IOM determined that the evidence was inadequate to 
accept or reject a causal relationship. Considering the remaining IOM 
conclusions and the ACCV Guiding Principles, the Secretary in this 
final rule is adopting certain additions or changes to the Table where 
the scientific evidence either convincingly supports or favors 
acceptance of a causal relationship between certain conditions and 
covered vaccines, which are unchanged from the proposed rule. As 
required by the Act, the changes in the proposed rule were presented to 
the ACCV, which reviewed and concurred with the Table changes set forth 
in this final rule.
    Additionally, the Secretary, following the recommendation of the 
ACCV, is finalizing the Table change, as proposed, to add the injury of 
Guillain-Barr[eacute] Syndrome (GBS) for seasonal influenza 
vaccinations, which is consistent with the approach taken in the 
Countermeasures Injury Compensation Program (CICP). Studies have 
demonstrated a causal association between the monovalent 2009 H1N1 
vaccine and the 1976 swine flu vaccine and GBS. These causal 
associations were the basis of the 2015 decision by the Secretary in 
the CICP Pandemic Influenza A Countermeasures Injury Table Final Rule 
(80 FR 47411) to include GBS as an injury associated with the 2009 H1N1 
influenza. With respect to that vaccine, the Secretary found that there 
was compelling, reliable, and valid medical and scientific evidence of 
an association between the 2009 H1N1 vaccine and GBS, which is required 
to add an injury to the CICP's Injury Table. To date, the H1N1 antigen 
has been included in all seasonal influenza vaccines beginning with the 
2010-2011 flu season. HHS notes that seasonal influenza vaccine 
formulations, unlike other vaccines, include multiple antigens that 
change from year-to-year, and enhanced surveillance activities to 
detect the incidence of GBS that occurred during the 2009 H1N1 pandemic 
may not occur with each virus strain change. In light of this 
information and other information as discussed in the proposed rule, 
the ACCV recommended that the Secretary add GBS consistent with one of 
its Guiding Principles: That where there is credible evidence to both 
support and reject a change to the Table, the change should, whenever 
possible, be made to the benefit of petitioners.
    In addition, in the final rule, the Secretary adopts the proposed 
rule's new paragraph (b), Provision that applies to all vaccines 
listed. To streamline the Table, this paragraph includes any acute 
complication or sequela, including death, of the illness, disability, 
injury, or condition listed, as a Table injury (absent an exclusion as 
set forth under the QAI) rather than adding the provision to every line 
of the Table. To further streamline the Table, the Secretary deleted 
redundant wording in the various definitions, particularly with regard 
to any references to the presumption of causation, and the importance 
of the entire medical record. These elements have been included in 
paragraph (b) and are unchanged from the proposed rule. Finally, in 
this final rule, the Secretary adopts changes in the proposed rule that 
simplify and expand applicability of a provision that previously 
applied only to an encephalopathy. This provision, which indicates that 
idiopathic conditions do not rebut the Table presumption, now applies 
(through inclusion in paragraph (b)), to all injuries, while continuing 
to apply to an encephalopathy.
    In this final rule, in addition to the changes described in the 
proposed rule, the Secretary has made the following non-substantive 
changes to the proposed rule for purposes of clarity:
    a. Added headings to (c)(2)(ii) and (c)(3)(ii).
    b. Moved text from the end of paragraph (c)(3)(ii)(C) to create a 
new (c)(3)(ii)(D).
    c. Changed paragraphs (c)(11) and (12) by revising the sentence 
regarding organs other than the skin by adding ``the'' before '' 
disease'', inserting ``and'' after ``organ'', and moving ``, not just 
mildly abnormal laboratory values'' to the end of the sentence.
    d. Revised paragraph (c)(15)(i) by changing ``nine weeks'' to ``9 
weeks''.
    e. Changed paragraph (e)(1) (``Coverage Provisions'') for purpose 
of clarity and consistency with 42 U.S.C. 300aa-14(c)(4) by adding 
``only'' before ``to petitions for compensation.''
    The modified Table applies only to petitions filed under the VICP 
after the effective date of this final rule. Also, petitions must be 
filed within the applicable statute of limitations. The general statute 
of limitations applicable to petitions filed under the VICP, set forth 
in 42 U.S.C. 300aa-16(a),

[[Page 6296]]

continues to apply. However, the statute identifies a specific 
exception to this statute of limitations that applies when the effect 
of a revision to the Table makes a previously ineligible person 
eligible to receive compensation or when an eligible person's 
likelihood of obtaining compensation significantly increases. Under 
this exception, an individual who may be eligible to file a petition 
based on the revised Table may file the petition for compensation not 
later than 2 years after the effective date of the revision if the 
alleged injury or death occurred not more than 8 years before the 
effective date of the revision of the Table (42 U.S.C. 300aa-16(b)). 
This is true even if such individual previously filed a petition for 
compensation, and is thus an exception to the ``one petition per 
injury'' limitation of 42 U.S.C. 300aa-11(b)(2).
    For any vaccine-adverse event pairs for which future scientific 
evidence develops to support a finding of a causal relationship, the 
Secretary will consider future rulemaking to revise the Table 
accordingly.

III. Comments and Responses

    The NPRM provided a 180-day comment period that resulted in the 
receipt of 14 written comments--13 from individuals and one from a 
national organization. In addition, a public hearing on the proposed 
rule was held on January 14, 2016, during which a representative from 
the above mentioned national organization presented comments. The 
organization's oral comments were an expansion of the organization's 
previously submitted written comments. The Secretary carefully 
considered all received comments in the development of this final rule. 
Below is a summary of the comments and the Secretary's responses:
    Comment: One commenter suggested that vaccines are unsafe, 
disagreed with the process for predicting vaccine harm to humans, and 
disagreed with the makeup of the ``group assembled to force changes in 
this Table,'' calling it a biased group.
    Response: The United States has a long-standing vaccine safety 
program that closely monitors the safety of vaccines on an ongoing 
basis. Before vaccines are approved by the Food and Drug Administration 
(FDA), they are tested and studied extensively by scientists to help 
ensure they are safe and effective. After vaccines are approved, a 
critical part of the vaccine safety program is that the Centers for 
Disease Control and Prevention (CDC)'s Immunization Safety Office (ISO) 
and FDA monitor for possible vaccine side effects and conduct studies 
to determine whether health problems are caused by vaccines. CDC's ISO 
data show that the current U.S. vaccine supply is the safest in 
history.\1\ Also, regulating clinical research and reviewing the safety 
of vaccines are responsibilities of the FDA, not the VICP, and changes 
in vaccine research and how vaccines are studied and tested are beyond 
the scope of this final rule.
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    \1\ http://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html
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    As previously indicated, the Table revisions were based primarily 
on the 2012 IOM report which was developed after the IOM committee 
conducted a comprehensive review of the scientific literature on 
vaccines and adverse events. The committee charged with undertaking 
this review consisted of 16 members with expertise in the following 
fields: Pediatrics, internal medicine, neurology, immunology, 
immunotoxicology, neurobiology, rheumatology, epidemiology, 
biostatistics, and law. The members of the review committee were 
subject to stringent conflict of interest criteria by the IOM. In 
addition, the proposed Table changes were developed by HHS workgroups 
and reviewed by the ACCV, the membership of which, by statute, reflects 
a variety of stakeholders with different perspectives.
    Comment: A commenter suggested that shoulder injury related to 
vaccine administration (SIRVA) as defined in the QAI is too restrictive 
because the recipient's pain and reduced range of motion must be 
limited to the shoulder in which the intramuscular vaccine was 
administered. The commenter stated that such language was an artificial 
and unnecessary qualification, and expressed concern that recipients 
who have other symptoms, such as shoulder pain radiating to the neck or 
upper back, will not have the benefits of a Table injury. The commenter 
suggested that the QAI be expanded to include the shoulder and parts of 
the body attributed to that injury.
    Response: SIRVA is a musculoskeletal condition caused by injection 
of a vaccine intended for intramuscular administration into the 
shoulder, and, as its name suggests, the condition is localized to the 
shoulder in which the vaccine was administered. In other words, pain in 
the neck or back without an injury to the shoulder in which an 
individual received a vaccine would not be considered SIRVA. Shoulder 
injuries that are not caused by injection occur frequently in the 
population. Thus, it is important to have a definition of SIRVA that is 
clearly associated with vaccine injection. The portion of the QAI 
limiting the pain and reduced range of motion to the shoulder in which 
the vaccine was administered is necessary to accurately reflect the 
vaccine-associated condition.
    Comment: A commenter recommends revising the statute of limitations 
for filing complex cases, with additional consideration given to the 
aggravation of preexisting conditions not active until post vaccine(s).
    Response: Revision of the statute of limitations would require a 
statutory amendment and thus is not within the scope of this final 
rule.
    Comment: A commenter stated that there is a problem with the VICP's 
3-year statute of limitations for filing a claim and the military's 5-
year program titled, Temporary Disabled Retirement Listing (TDRL), 
where active duty military personnel injured by vaccines are placed. 
The commenter stated that the rules need to be amended and/or waivers 
granted to military personnel who are severely injured by vaccines so 
they can seek compensation for damages.
    Response: Amending the Act's statute of limitations is not within 
the scope of this final rule.
    Comment: A commenter recommended the addition of SIRVA to the 
vaccine court [sic]. The commenter also indicated a belief that SIRVA 
is due to lack of education on proper injection technique. The 
commenter further stated that the CDC should make SIRVA, which the 
commenter believes is 100 percent preventable, a priority.
    Response: This final rule will add SIRVA as an injury associated 
with certain vaccines on the Table. In the VICP, claims are adjudicated 
by special masters in the Court. SIRVA prevention activities are not 
within the scope of this final rule.
    Comment: A commenter recommended that the VICP transfer a fraction 
of its compensation responsibilities to pharmaceutical companies, which 
would incentivize these companies to develop safer vaccines to avoid 
claim compensation.
    Response: The source of funding for the VICP is the Vaccine Injury 
Compensation Trust Fund (Trust Fund). The Trust Fund is funded by an 
excise tax on each dose of vaccines recommended by the CDC for routine 
administration to children. To the extent that the commenter is 
proposing a change to the funding mechanism for the VICP, effectuating 
such a change is beyond the scope of this final rule.
    Comment: A commenter agreed with the Secretary's proposal that 
SIRVA injuries be added to the Table for the

[[Page 6297]]

measles, mumps, and rubella (MMR) and varicella vaccines that are 
currently administered only by percutaneous injection in case an 
intramuscular injection is available in the future. The commenter 
suggested that the Table make clear that SIRVA only pertains to 
intramuscular injection so there is no confusion with respect to 
vaccines administered using a different method. The commenter also 
suggested that syncope be added as an injury for vaccines that are 
administered by jet injectors. The commenter expressed support for the 
revision of the Table based on new medical findings and for the 
organizational changes to paragraph (b) of the Table.
    Response: The Secretary agrees that SIRVA should be an injury 
listed on the Table for potential future formulations of MMR and 
varicella vaccines that are administered by intramuscular injection, 
and, therefore, has added SIRVA to the Table for those vaccines despite 
the fact that currently there are no MMR or varicella vaccines that are 
administered by intramuscular injection. As such, if an intramuscular 
formulation of those vaccines is developed in the future, the Table 
will not need to be amended to allow petitioners to potentially meet 
the definition for SIRVA in the QAI with respect to those vaccines. The 
QAI specifically states that SIRVA is a condition related to 
``administration of a vaccine intended for intramuscular administration 
in the upper arm.'' Thus, the Secretary believes it is clear that to 
meet the definition of SIRVA in the QAI, the vaccine administered must 
be one intended for intramuscular injection in the upper arm.
    The Secretary is not aware of any reliable and persuasive evidence 
demonstrating that syncope occurs following administration of a vaccine 
via a needleless jet device. While it may be plausible for syncope to 
occur with this route of administration, given the lack of evidence of 
syncope following administration of a vaccine via a needleless jet 
device, the Secretary will not include syncope as a Table injury for 
vaccines that are administered by a needleless jet device at this time. 
However, this does not preclude a claim alleging syncope after the 
administration of a vaccine via needleless jet device from being filed 
with the program as a non-Table injury.
    Comment: One commenter opposed the revision of the Vaccine Injury 
Table's QAI for encephalopathy, stating that it is not based on sound 
science and that it creates a restrictive and exclusionary guideline 
that unfairly discriminates against children and adults born with 
certain genes or pre-existing conditions (which may be triggered or 
significantly aggravated following vaccination). The commenter further 
contends that due to lack of knowledge about biological mechanisms and 
high risk factors for vaccine injury, the proposed changes are without 
ethical, scientific, or legal justification.
    Response: The Secretary respectfully disagrees with the comment 
that the revised definition for encephalopathy and the new definition 
for encephalitis in the QAI are not based on firm science. The previous 
definition of encephalopathy in the QAI was imprecise and did not 
include the comprehensive criteria used by medical providers, 
particularly specialists, to diagnose encephalopathy or encephalitis. 
In addition, the previous QAI did not include any definition for 
encephalitis, and, therefore, new and more accurate criteria and 
definitions were necessary. To develop precise definitions for the QAI, 
an extensive literature search was conducted for reliable, reputable, 
evidence-based criteria consistently used by medical specialists in the 
fields of infectious disease and neurology. The Secretary also 
evaluated information from organizations and publications to formulate 
definitions, including those responsible for publishing case 
definitions for the Vaccine Adverse Event Reporting System (2002) and 
other significant guidelines.
    The commenter also stated that the proposed revisions create a 
restrictive and exclusionary guideline, unfairly discriminating against 
children and adults born with certain genes or pre-existing conditions 
which may be triggered or significantly aggravated following 
vaccination. The Secretary understands these concerns and agrees that 
individuals should not be disqualified from potentially receiving VICP 
compensation due to biodiversity and individual susceptibilities. 
Certain individuals may not meet the QAI definition, as it is 
impossible to develop a scientifically sound definition that allows for 
inclusion of every circumstance, particularly those that may arise when 
unique and sometimes complex pre-vaccination medical conditions 
exist.\2\ However, individuals who do not meet the Table criteria are 
not precluded from filing a petition, and may be found entitled to 
receive compensation if they demonstrate that their condition was 
caused or significantly aggravated by a covered vaccine.
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    \2\ 2012 IOM Report, pp. 52, and 82-84.
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    Comment: One commenter also noted that, historically, acute and 
chronic encephalopathy have been acknowledged as a serious complication 
of pertussis, measles and measles containing vaccines, and have been 
reported following receipt of other vaccines.
    Response: With regard to this comment, it is important to note that 
the initial Table and QAI set forth in the 1986 Act reflected 
Congress's initial determination of vaccine-related injuries for whole 
cell diphtheria, tetanus, and pertussis (DTwP) vaccine, which is no 
longer used. Additionally, modifications to the Table and QAI by the 
Secretary in 1995 were based on scientific findings--the National 
Childhood Encephalopathy Study and its 10-year follow-up study--related 
to DTwP vaccine. The IOM committee's conclusions in both 1991 and 1994 
were mixed regarding the statistically significant findings of 
encephalopathy in these studies. After reviewing the evidence, the 
National Vaccine Advisory Committee (NVAC) voted to remove 
encephalopathy from the Table. However, in the end, the Secretary, for 
both scientific and policy reasons, and with support of the ACCV, 
retained the condition on the Table, but clarified the definition of 
encephalopathy to make it more clinically precise.
    While the initial Table and QAI were based on studies using DTwP 
vaccine, the acellular (aP) diphtheria, tetanus, and pertussis (DTaP) 
vaccine has been the primary formulation used in the United States 
since 1997 when it was recommended for routine use in children younger 
than 7 years of age. Current DTaP vaccines were developed because of 
concerns of reactogenicity with whole cell pertussis.
    To date, no adequate scientific study has been published that 
demonstrates a causal relationship between either acellular pertussis 
vaccines or MMR vaccines and encephalopathy or encephalitis. As a 
result, in its most recent evaluation of adverse events after vaccines 
(2012), the IOM found that the evidence was inadequate to accept or 
reject a causal association between either acellular pertussis 
containing vaccines or MMR vaccines and encephalopathy or encephalitis. 
Of the large scale studies that have been conducted on DTaP, none have 
shown an increased risk of encephalopathy or encephalitis after 
receiving the DTaP vaccine. Furthermore, these studies have 
demonstrated a significant reduction in the number of common adverse 
events with acellular pertussis, such as crying and fevers, and less 
common ones, such as febrile seizures.

[[Page 6298]]

    With regard to the MMR vaccine, because natural infection of 
measles, mumps and/or rubella virus is thought to lead to neurologic 
illness by damaging neurons through direct viral infection and/or 
reactivation, it is theorized that the same mechanisms may be 
responsible for vaccine-associated encephalopathy and encephalitis. 
However, of the studies examined and described by the IOM in its 2012 
report, none identified causality between the MMR vaccine and 
encephalopathy or encephalitis. Similarly, the IOM concluded that the 
mechanistic evidence for an association is weak, based on knowledge 
about natural infection and only a few case reports. Accordingly, the 
Secretary does not agree that brain inflammation or acute and chronic 
encephalopathy have been acknowledged as a serious complication of 
either the DTaP or MMR vaccines. However, for the reasons discussed in 
the NPRM, the Secretary chose to retain these conditions in the 
revisions to the Table and QAI.
    Comment: One commenter, when conveying views on acute 
encephalopathy as ``one of the most serious complications of 
vaccination . . .'' also referenced both encephalitis and 
encephalomyelitis in the discussion.
    Response: The Secretary would like to clarify that encephalitis and 
encephalomyelitis (which is referred to as acute disseminated 
encephalomyelitis or ADEM) are distinct conditions. While they share 
some clinical characteristics, ADEM is a demyelinating condition with 
distinct differences from other types of encephalitis, as demonstrated 
on brain magnetic resonance imaging (MRI). The type of encephalitis 
that was initially attributed to DTwP was not described as 
demyelinating. Although early ADEM may have laboratory and clinical 
characteristics similar to acute encephalitis, findings on an MRI are 
distinct, with only ADEM displaying evidence of acute demyelination. 
For scientific accuracy, we have excluded ADEM from the Table 
definition of encephalitis.
    Comment: One commenter, while applauding the expansion of the 
Vaccine Injury Table and agreeing with the IOM's recommendations, 
stated that the Table remains wholly inadequate to properly address 
``the widespread epidemic of vaccine adverse events.'' The commenter 
stated that the reason for this is that science has been corrupted by 
commercial interests, by financial ties between industry, regulators, 
and academic institutions and that health care delivery has been 
compromised by financial ties between industry, physicians, and their 
trade publications.
    Response: The Secretary believes that the revisions to the Table 
and QAI increase clarity and scientific accuracy regarding those 
injuries that will be afforded the Table's presumption of vaccine 
causation. As previously indicated, the revisions to the Table and QAI 
were based primarily on the 2012 IOM report which was developed after 
the IOM committee conducted a comprehensive review of the scientific 
literature on vaccines and adverse events. The committee charged with 
undertaking this review consisted of 16 members with expertise in the 
following fields: pediatrics, internal medicine, neurology, immunology, 
immunotoxicology, neurobiology, rheumatology, epidemiology, 
biostatistics, and law. The members of the review committee were 
subject to stringent conflict of interest criteria by the IOM. In 
addition, the proposed Table changes were developed by HHS workgroups 
and reviewed by the ACCV, the membership of which, by statute, reflects 
a variety of stakeholders with different perspectives.
    Comment: One commenter stated that the Secretary should not make 
changes to the Vaccine Injury Table that would make it more difficult 
for ``victims'' to be compensated.
    Response: The Secretary believes that the revisions to the Table 
and QAI set forth in this final rule, such as the addition of injuries, 
will make it easier for petitioners alleging injuries that meet the 
criteria in the Table and QAI to receive the Table's presumption of 
causation (which relieves them of having to prove that the vaccine 
actually caused or significantly aggravated the injury). This will make 
it easier for such petitioners to receive compensation under the VICP.
    Comment: One commenter asked that additional consideration be given 
to the human papillomavirus (HPV) vaccination as a cause of postural 
orthostatic tachycardia syndrome (POTS), a condition where individuals 
can experience fainting and lightheadedness. The commenter also stated 
that the ``review period'' should be indefinite for the HPV vaccine.
    Response: Like all vaccines used in the United States, HPV vaccines 
are required to go through years of safety testing before they are 
approved by the FDA. After they are approved and made available to the 
public, CDC and FDA continue to evaluate vaccines to ensure their 
safety. To date, there is no medical or scientific evidence that the 
HPV vaccine causes POTS and safety monitoring has not shown any other 
problems. Extending the review period for alleged injuries due to the 
HPV vaccine would require a statutory amendment to the Act's statute of 
limitations which is not within the scope of the final rule.
    Comment: A commenter requested that food allergies be added to the 
Table asserting that food proteins that are present in vaccines cause 
the development of food allergies. The commenter also requested removal 
of the time limit that compensation is not provided for injuries or 
death that occurred more than ``8 years before the effective date of 
the revision of the Table'' because the commenter believes that ``food 
proteins in vaccines have been causing injury for decades.''
    Response: The Secretary does not agree that food allergies should 
be added to the Table as injuries. HHS conducted a literature search of 
the major medical databases for any articles linking the development of 
food allergies to vaccinations (81 FR 17423, March 29, 2016). Despite 
an extensive search, HHS found no published research addressing any 
linkages or potential causality between vaccinations covered by VICP 
and the development of food allergies in any population. In addition, 
revision of the Act's statute of limitations would require a statutory 
amendment and thus is not within the scope of this final rule.
    Comment: One commenter suggested that autism spectrum disorders be 
added to the Vaccine Injury Table. The commenter also requested removal 
of the time limit that compensation not be provided for injuries or 
death that occurred more than ``8 years before the effective date of 
the revision of the Table'' because the commenter believes that 
``bovine milk contaminated vaccines have been causing injury for 
decades.''
    Response: The Secretary does not agree that autism spectrum 
disorders should be added as an injury to the Table. The 2012 IOM 
report found that the epidemiologic and mechanistic evidence favored 
rejection of a causal relationship between the MMR vaccine and autism. 
Moreover, in opinions that were upheld on appeal to the U.S. Court of 
Appeals for the Federal Circuit, special masters of the U.S. Court of 
Federal Claims held that the MMR, whether administered alone or in 
conjunction with thimerosal-containing vaccines, is not a causal factor 
in the development of autism or autism spectrum disorders. In addition, 
revision of the Act's statute of limitations would require a statutory

[[Page 6299]]

amendment and thus is not within the purview of this final rule.
    Comment: One commenter stated that thimerosal (a preservative added 
to vaccines) causes nerve damage.
    Response: The Secretary disagrees with the comment that thimerosal 
in vaccines causes nerve damage to immunized individuals. Currently, no 
childhood vaccines used in the U.S. include thimerosal as a 
preservative, except for some formulations of influenza vaccine in 
multi-dose vials. When exposure to thimerosal occurs through 
vaccination, it is at a very low dose, which is readily eliminated from 
the body. Thimerosal has been used safely in vaccines since the 1930s. 
According to the CDC, scientists have been studying the use of 
thimerosal in vaccines for many years. They have not found any evidence 
that thimerosal causes any harm. Thimerosal use in medical products has 
a record of being very safe. Data from many studies show no evidence of 
harm caused by low doses of thimerosal in vaccines.\3\
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    \3\ Following are referenced thimerosal studies:
    1. Thimerosal Exposure in Infants and Developmental Disorders: A 
Retrospective Cohort Study in the United Kingdom Does Not Support a 
Causal Association by Nick Andrews et al. Pediatrics. September 
2004. Vol 114: pp. 584-591. http://pediatrics.aappublications.org/cgi/content/full/114/3/584.
    2. Pervasive Developmental Disorders in Montreal, Quebec, 
Canada: Prevalence and Links with Immunizations by Eric Frombonne et 
al. Pediatriacs. July 2006. Vol 118: e139-e150. http://pediatrics.aappublications.org/cgi/content/full/118/1/e139.
    3. Association between Thimerosal-Containing Vaccine and Autism 
by Anders Hviid et al. Journal of the American Medical Association. 
October 2003. Vol 290: pp. 1763-1766. http://jama.ama-assn.org/cgi/content/full/290/13/1763.
    4. Immunization Safety Review: Vaccines and Autism. Institute of 
Medicine. The National Academies Press: 2004. http://www.iom.edu/Reports/2004/Immunization-SafetyReview-Vaccines-and-Autism.aspx.
    5. Prenatal and Infant Exposure to Thimerosal from Vaccines and 
Immunoglobulins and Risk of Autism by Cristofer Price et al. 
Pediatrics. September 2010. Vol 126: pp. 656-664, http://pediatrics.aappublications.org/cgi/reprint peds. 20100309v1.
    6. Continuing Increases in Autism Reported to California's 
Developmental Services System by Robert Schechter et al. Archives of 
General Psychiatry. January 2008. Vol 65: pp. 19-24. http://archpsyc.ama-assn.org/cgi/content/full/65/1/19.
    7. Early Thimerosal Exposure and Neuropsychological Outcomes at 
7 to 10 Years by William Thompson et al. The New England Journal of 
Medicine. September 2007. Vol 357: pages 1281-1292. http://www.nejm.org/doi/pdf/10.1056/NEJMoa071434.
---------------------------------------------------------------------------

Economic and Regulatory Impact

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when rulemaking is 
necessary, to select regulatory approaches that provide the greatest 
net benefits (including potential economic, environmental, public 
health, safety, distributive, and equity effects). In addition, under 
the Regulatory Flexibility Act, if a rule has a significant economic 
effect on a substantial number of small entities the Secretary must 
specifically consider the economic effect of a rule on small entities 
and analyze regulatory options that could lessen the impact of the 
rule.
    Executive Order 12866 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.
    The Secretary has determined that no resources are required to 
implement the requirements in this rule. Compensation will be made in 
the same manner. This final rule only lessens the burden of proof for 
potential petitioners. Therefore, in accordance with the Regulatory 
Flexibility Act of 1980 (RFA), and the Small Business Regulatory 
Enforcement 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.
    The Secretary has also determined that this final 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. 
We have determined that the 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. Similarly, it will not have effects on State, 
local, and tribal governments and on the private sector such as to 
require consultation under the Unfunded Mandates Reform Act of 1995.
    The provisions of this rule do not, on the basis of family well-
being, affect the following family elements: Family safety; family 
stability; marital commitment; parental rights in the education, 
nurture and supervision of their children; family functioning; 
disposable income or poverty; or the behavior and personal 
responsibility of youth, as determined under section 654(c) of the 
Treasury and General Government Appropriations Act of 1999.
    This rule is not being treated as a ``significant regulatory 
action'' as defined under section 3(f) of Executive Order 12866. 
Accordingly, the rule has not been reviewed by the Office of Management 
and Budget.
    As stated above, this final rule will modify the Vaccine Injury 
Table and its Qualifications and Aids to Interpretation based on legal 
authority.

Impact of the New Rule

    This final rule will have the effect of making it easier for future 
petitioners alleging injuries that meet the criteria in the Vaccine 
Injury Table to receive the Table's presumption of causation (which 
relieves them of having to prove that the vaccine actually caused or 
significantly aggravated the injury).

Paperwork Reduction Act of 1995

    This final rule has no information collection requirements.

    Dated: January 6, 2017.
James Macrae,
Acting Administrator, Health Resources and Services Administration.

    Approved: January 9, 2017.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.

List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, Immunization.

National Vaccine Injury Compensation Program: Revisions to the Vaccine 
Injury Table

    Therefore, for the reasons stated in the preamble, the Department 
of Health and Human Services amends 42 CFR part 100 as follows:

PART 100--VACCINE INJURY COMPENSATION

0
1. The authority citation for 42 CFR part 100 continues to read as 
follows:

    Authority:  Secs. 312 and 313 of Public Law 99-660 (42 U.S.C. 
300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a); 
and sec. 13632(a)(3) of Public Law 103-66.

0
2. Revise Sec.  100.3 to read as follows:


Sec.  100.3   Vaccine injury table.

    (a) In accordance with section 312(b) of the National Childhood 
Vaccine Injury Act of 1986, title III of Public Law 99-660, 100 Stat. 
3779 (42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health 
Service Act, as amended (PHS Act) (42 U.S.C. 300aa-14(c)), the 
following is a table of vaccines, the injuries, disabilities, 
illnesses, conditions, and deaths resulting from the administration of 
such vaccines, and the time period in which the first symptom or 
manifestation of onset or of the significant aggravation of such

[[Page 6300]]

injuries, disabilities, illnesses, conditions, and deaths is to occur 
after vaccine administration for purposes of receiving compensation 
under the Program. Paragraph (b) of this section sets forth additional 
provisions that are not separately listed in this Table but that 
constitute part of it. Paragraph (c) of this section sets forth the 
qualifications and aids to interpretation for the terms used in the 
Table. Conditions and injuries that do not meet the terms of the 
qualifications and aids to interpretation are not within the Table. 
Paragraph (d) of this section sets forth a glossary of terms used in 
paragraph (c).

                          Vaccine Injury Table
------------------------------------------------------------------------
                                                        Time period for
                                                       first symptom or
                                       Illness,        manifestation of
                                  disability, injury      onset or of
             Vaccine                 or condition         significant
                                        covered        aggravation after
                                                            vaccine
                                                        administration
------------------------------------------------------------------------
I. Vaccines containing tetanus    A. Anaphylaxis....  <=4 hours.
 toxoid (e.g., DTaP, DTP, DT,     B. Brachial         2-28 days (not
 Td, or TT).                       Neuritis.           less than 2 days
                                                       and not more than
                                                       28 days).
                                  C. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  D. Vasovagal        <=1 hour.
                                   syncope.
II. Vaccines containing whole     A. Anaphylaxis....  <=4 hours.
 cell pertussis bacteria,
 extracted or partial cell
 pertussis bacteria, or specific
 pertussis antigen(s) (e.g.,
 DTP, DTaP, P, DTP-Hib).
                                  B. Encephalopathy   <=72 hours.
                                   or encephalitis.
                                  C. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  D. Vasovagal        <=1 hour.
                                   syncope.
III. Vaccines containing          A. Anaphylaxis....  <=4 hours.
 measles, mumps, and rubella      B. Encephalopathy   5-15 days (not
 virus or any of its components    or encephalitis.    less than 5 days
 (e.g., MMR, MM, MMRV).                                and not more than
                                                       15 days).
                                  C. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  D. Vasovagal        <=1 hour.
                                   syncope.
IV. Vaccines containing rubella   A. Chronic          7-42 days (not
 virus (e.g., MMR, MMRV).          arthritis.          less than 7 days
                                                       and not more than
                                                       42 days).
V. Vaccines containing measles    A.                  7-30 days (not
 virus (e.g., MMR, MM, MMRV).      Thrombocytopenic    less than 7 days
                                   purpura.            and not more than
                                                       30 days).
                                  B. Vaccine-Strain
                                   Measles Viral
                                   Disease in an
                                   immunodeficient
                                   recipient.
                                  --Vaccine-strain    Not applicable.
                                   virus identified.
                                  --If strain         <=12 months.
                                   determination is
                                   not done or if
                                   laboratory
                                   testing is
                                   inconclusive.
VI. Vaccines containing polio     A. Paralytic Polio
 live virus (OPV).
                                  --in a non-         <=30 days.
                                   immunodeficient
                                   recipient.
                                  --in an             <=6 months.
                                   immunodeficient
                                   recipient.
                                  --in a vaccine      Not applicable.
                                   associated
                                   community case.
                                  B. Vaccine-Strain
                                   Polio Viral
                                   Infection.
                                  --in a non-         <=30 days.
                                   immunodeficient
                                   recipient.
                                  --in an             <=6 months.
                                   immunodeficient
                                   recipient.
                                  --in a vaccine      Not applicable.
                                   associated
                                   community case.
VII. Vaccines containing polio    A. Anaphylaxis....  <=4 hours.
 inactivated virus (e.g., IPV).
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.
VIII. Hepatitis B vaccines......  A. Anaphylaxis....  <=4 hours.
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.
IX. Haemophilus influenzae type   A. Shoulder Injury  <=48 hours.
 b (Hib) vaccines.                 Related to
                                   Vaccine
                                   Administration.
                                  B. Vasovagal        <=1 hour.
                                   syncope.
X. Varicella vaccines...........  A. Anaphylaxis....  <=4 hours.
                                  B. Disseminated
                                   varicella vaccine-
                                   strain viral
                                   disease.
                                  --Vaccine-strain    Not applicable.
                                   virus identified.
                                  --If strain         7-42 days (not
                                   determination is    less than 7 days
                                   not done or if      and not more than
                                   laboratory          42 days).
                                   testing is
                                   inconclusive.
                                  C. Varicella        Not applicable.
                                   vaccine-strain
                                   viral
                                   reactivation.
                                  D. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  E. Vasovagal        <=1 hour.
                                   syncope.
XI. Rotavirus vaccines..........  A. Intussusception  1-21 days (not
                                                       less than 1 day
                                                       and not more than
                                                       21 days).
XII. Pneumococcal conjugate       A. Shoulder Injury  <=48 hours.
 vaccines.                         Related to
                                   Vaccine
                                   Administration.

[[Page 6301]]

 
                                  B. Vasovagal        <=1 hour.
                                   syncope.
XIII. Hepatitis A vaccines......  A. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  B. Vasovagal        <=1 hour.
                                   syncope.
XIV. Seasonal influenza vaccines  A. Anaphylaxis....  <=4 hours.
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.
                                  D. Guillain-        3-42 days (not
                                   Barr[eacute]        less than 3 days
                                   Syndrome.           and not more than
                                                       42 days).
XV. Meningococcal vaccines......  A. Anaphylaxis....  <=4 hours.
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.
XVI. Human papillomavirus (HPV)   A. Anaphylaxis....  <=4 hours.
 vaccines.
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.
XVII. Any new vaccine             A. Shoulder Injury  <=48 hours.
 recommended by the Centers for    Related to
 Disease Control and Prevention    Vaccine
 for routine administration to     Administration.
 children, after publication by
 the Secretary of a notice of
 coverage.
                                  B. Vasovagal        <=1hour.
                                   syncope.
------------------------------------------------------------------------

    (b) Provisions that apply to all conditions listed. (1) Any acute 
complication or sequela, including death, of the illness, disability, 
injury, or condition listed in paragraph (a) of this section (and 
defined in paragraphs (c) and (d) of this section) qualifies as a Table 
injury under paragraph (a) except when the definition in paragraph (c) 
requires exclusion.
    (2) In determining whether or not an injury is a condition set 
forth in paragraph (a) of this section, the Court shall consider the 
entire medical record.
    (3) An idiopathic condition that meets the definition of an 
illness, disability, injury, or condition set forth in paragraph (c) of 
this section shall be considered to be a condition set forth in 
paragraph (a) of this section.
    (c) Qualifications and aids to interpretation. The following 
qualifications and aids to interpretation shall apply to, define and 
describe the scope of, and be read in conjunction with paragraphs (a), 
(b), and (d) of this section:
    (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 sequela. Signs and symptoms begin 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) Encephalopathy. A vaccine recipient shall be considered to have 
suffered an encephalopathy if an injury meeting the description below 
of an acute encephalopathy occurs within the applicable time period and 
results in a chronic encephalopathy, as described in paragraph (d) of 
this section.
    (i) Acute encephalopathy. (A) For children less than 18 months of 
age who present:
    (1) Without a seizure, an acute encephalopathy is indicated by a 
significantly decreased level of consciousness that lasts at least 24 
hours.
    (2) Following a seizure, an acute encephalopathy is demonstrated by 
a significantly decreased level of consciousness that lasts at least 24 
hours and cannot be attributed to a postictal state--from a seizure or 
a medication.
    (B) For adults and children 18 months of age or older, an acute 
encephalopathy is one that persists at least 24 hours and is 
characterized by at least two of the following:
    (1) A significant change in mental status that is not medication 
related (such as a confusional state, delirium, or psychosis);
    (2) A significantly decreased level of consciousness which is 
independent of a seizure and cannot be attributed to the effects of 
medication; and
    (3) A seizure associated with loss of consciousness.
    (C) The following clinical features in themselves do not 
demonstrate an acute encephalopathy or a significant change in either 
mental status or level of consciousness: Sleepiness, irritability 
(fussiness), high-pitched and unusual screaming, poor feeding, 
persistent inconsolable crying, bulging fontanelle, or symptoms of 
dementia.
    (D) Seizures in themselves are not sufficient to constitute a 
diagnosis of encephalopathy and in the absence of other evidence of an 
acute encephalopathy seizures shall not be viewed as the first symptom 
or manifestation of an acute encephalopathy.
    (ii) Exclusionary criteria for encephalopathy. Regardless of 
whether or not the specific cause of the underlying condition, systemic 
disease, or acute event (including an infectious organism) is known, an 
encephalopathy shall not be considered to be a condition set forth in 
the Table if it is shown that the encephalopathy was caused by:
    (A) An underlying condition or systemic disease shown to be 
unrelated to the vaccine (such as malignancy, structural lesion, 
psychiatric illness, dementia, genetic disorder, prenatal or

[[Page 6302]]

perinatal central nervous system (CNS) injury); or
    (B) An acute event shown to be unrelated to the vaccine such as a 
head trauma, stroke, transient ischemic attack, complicated migraine, 
drug use (illicit or prescribed) or an infectious disease.
    (3) Encephalitis. A vaccine recipient shall be considered to have 
suffered encephalitis if an injury meeting the description below of 
acute encephalitis occurs within the applicable time period and results 
in a chronic encephalopathy, as described in paragraph (d) of this 
section.
    (i) Acute encephalitis. Encephalitis is indicated by evidence of 
neurologic dysfunction, as described in paragraph (c)(3)(i)(A) of this 
section, plus evidence of an inflammatory process in the brain, as 
described in paragraph (c)(3)(i)(B) of this section.
    (A) Evidence of neurologic dysfunction consists of either:
    (1) One of the following neurologic findings referable to the CNS: 
Focal cortical signs (such as aphasia, alexia, agraphia, cortical 
blindness); cranial nerve abnormalities; visual field defects; abnormal 
presence of primitive reflexes (such as Babinski's sign or sucking 
reflex); or cerebellar dysfunction (such as ataxia, dysmetria, or 
nystagmus); or
    (2) An acute encephalopathy as set forth in paragraph (c)(2)(i) of 
this section.
    (B) Evidence of an inflammatory process in the brain (central 
nervous system or CNS inflammation) must include cerebrospinal fluid 
(CSF) pleocytosis (>5 white blood cells (WBC)/mm\3\ in children >2 
months of age and adults; >15 WBC/mm3 in children <2 months of age); or 
at least two of the following:
    (1) Fever (temperature >= 100.4 degrees Fahrenheit);
    (2) Electroencephalogram findings consistent with encephalitis, 
such as diffuse or multifocal nonspecific background slowing and 
periodic discharges; or
    (3) Neuroimaging findings consistent with encephalitis, which 
include, but are not limited to brain/spine magnetic resonance imaging 
(MRI) displaying diffuse or multifocal areas of hyperintense signal on 
T2-weighted, diffusion-weighted image, or fluid-attenuation inversion 
recovery sequences.
    (ii) Exclusionary criteria for encephalitis. Regardless of whether 
or not the specific cause of the underlying condition, systemic 
disease, or acute event (including an infectious organism) is known, 
encephalitis shall not be considered to be a condition set forth in the 
Table if it is shown that the encephalitis was caused by:
    (A) An underlying malignancy that led to a paraneoplastic 
encephalitis;
    (B) An infectious disease associated with encephalitis, including a 
bacterial, parasitic, fungal or viral illness (such as herpes viruses, 
adenovirus, enterovirus, West Nile Virus, or human immunodeficiency 
virus), which may be demonstrated by clinical signs and symptoms and 
need not be confirmed by culture or serologic testing; or
    (C) Acute disseminated encephalomyelitis (ADEM). Although early 
ADEM may have laboratory and clinical characteristics similar to acute 
encephalitis, findings on MRI are distinct with ADEM displaying 
evidence of acute demyelination (scattered, focal, or multifocal areas 
of inflammation and demyelination within cerebral subcortical and deep 
cortical white matter; gray matter involvement may also be seen but is 
a minor component); or
    (D) Other conditions or abnormalities that would explain the 
vaccine recipient's symptoms.
    (4) Intussusception. (i) For purposes of paragraph (a) of this 
section, intussusception means the invagination of a segment of 
intestine into the next segment of intestine, resulting in bowel 
obstruction, diminished arterial blood supply, and blockage of the 
venous blood flow. This is characterized by a sudden onset of abdominal 
pain that may be manifested by anguished crying, irritability, 
vomiting, abdominal swelling, and/or passing of stools mixed with blood 
and mucus.
    (ii) For purposes of paragraph (a) of this section, the following 
shall not be considered to be a Table intussusception:
    (A) Onset that occurs with or after the third dose of a vaccine 
containing rotavirus;
    (B) Onset within 14 days after an infectious disease associated 
with intussusception, including viral disease (such as those secondary 
to non-enteric or enteric adenovirus, or other enteric viruses such as 
Enterovirus), enteric bacteria (such as Campylobacter jejuni), or 
enteric parasites (such as Ascaris lumbricoides), which may be 
demonstrated by clinical signs and symptoms and need not be confirmed 
by culture or serologic testing;
    (C) Onset in a person with a preexisting condition identified as 
the lead point for intussusception such as intestinal masses and cystic 
structures (such as polyps, tumors, Meckel's diverticulum, lymphoma, or 
duplication cysts);
    (D) Onset in a person with abnormalities of the bowel, including 
congenital anatomic abnormalities, anatomic changes after abdominal 
surgery, and other anatomic bowel abnormalities caused by mucosal 
hemorrhage, trauma, or abnormal intestinal blood vessels (such as 
Henoch Scholein purpura, hematoma, or hemangioma); or
    (E) Onset in a person with underlying conditions or systemic 
diseases associated with intussusception (such as cystic fibrosis, 
celiac disease, or Kawasaki disease).
    (5) Chronic arthritis. Chronic arthritis is defined as persistent 
joint swelling with at least two additional manifestations of warmth, 
tenderness, pain with movement, or limited range of motion, lasting for 
at least 6 months.
    (i) Chronic arthritis may be found in a person with no history in 
the 3 years prior to vaccination of arthropathy (joint disease) on the 
basis of:
    (A) Medical documentation recorded within 30 days after the onset 
of objective signs of acute arthritis (joint swelling) that occurred 
between 7 and 42 days after a rubella vaccination; and
    (B) Medical documentation (recorded within 3 years after the onset 
of acute arthritis) of the persistence of objective signs of 
intermittent or continuous arthritis for more than 6 months following 
vaccination; and
    (C) Medical documentation of an antibody response to the rubella 
virus.
    (ii) The following shall not be considered as chronic arthritis: 
Musculoskeletal disorders such as diffuse connective tissue diseases 
(including but not limited to rheumatoid arthritis, juvenile idiopathic 
arthritis, systemic lupus erythematosus, systemic sclerosis, mixed 
connective tissue disease, polymyositis/determatomyositis, 
fibromyalgia, necrotizing vasculitis and vasculopathies and Sjogren's 
Syndrome), degenerative joint disease, infectious agents other than 
rubella (whether by direct invasion or as an immune reaction), 
metabolic and endocrine diseases, trauma, neoplasms, neuropathic 
disorders, bone and cartilage disorders, and arthritis associated with 
ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's 
Syndrome, blood disorders, or arthralgia (joint pain), or joint 
stiffness without swelling.
    (6) Brachial neuritis. This term is defined as dysfunction limited 
to the upper extremity nerve plexus (i.e., its trunks, divisions, or 
cords). A deep, steady, often severe aching pain in the shoulder and 
upper arm usually heralds onset of the condition. The pain is

[[Page 6303]]

typically followed in days or weeks by weakness in the affected upper 
extremity muscle groups. Sensory loss may accompany the motor deficits, 
but is generally a less notable clinical feature. Atrophy of the 
affected muscles may occur. The neuritis, or plexopathy, may be present 
on the same side or on the side opposite the injection. It is sometimes 
bilateral, affecting both upper extremities. A vaccine recipient shall 
be considered to have suffered brachial neuritis as a Table injury if 
such recipient manifests all of the following:
    (i) Pain in the affected arm and shoulder is a presenting symptom 
and occurs within the specified time-frame;
    (ii) Weakness;
    (A) Clinical diagnosis in the absence of nerve conduction and 
electromyographic studies requires weakness in muscles supplied by more 
than one peripheral nerve.
    (B) Nerve conduction studies (NCS) and electromyographic (EMG) 
studies localizing the injury to the brachial plexus are required 
before the diagnosis can be made if weakness is limited to muscles 
supplied by a single peripheral nerve.
    (iii) Motor, sensory, and reflex findings on physical examination 
and the results of NCS and EMG studies, if performed, must be 
consistent in confirming that dysfunction is attributable to the 
brachial plexus; and
    (iv) No other condition or abnormality is present that would 
explain the vaccine recipient's symptoms.
    (7) Thrombocytopenic purpura. This term is defined by the presence 
of clinical manifestations, such as petechiae, significant bruising, or 
spontaneous bleeding, and by a serum platelet count less than 50,000/
mm\3\ with normal red and white blood cell indices. Thrombocytopenic 
purpura does not include cases of thrombocytopenia associated with 
other causes such as hypersplenism, autoimmune disorders (including 
alloantibodies from previous transfusions) myelodysplasias, 
lymphoproliferative disorders, congenital thrombocytopenia or hemolytic 
uremic syndrome. Thrombocytopenic purpura does not include cases of 
immune (formerly called idiopathic) thrombocytopenic purpura that are 
mediated, for example, by viral or fungal infections, toxins or drugs. 
Thrombocytopenic purpura does not include cases of thrombocytopenia 
associated with disseminated intravascular coagulation, as observed 
with bacterial and viral infections. Viral infections include, for 
example, those infections secondary to Epstein Barr virus, 
cytomegalovirus, hepatitis A and B, human immunodeficiency virus, 
adenovirus, and dengue virus. An antecedent viral infection may be 
demonstrated by clinical signs and symptoms and need not be confirmed 
by culture or serologic testing. However, if culture or serologic 
testing is performed, and the viral illness is attributed to the 
vaccine-strain measles virus, the presumption of causation will remain 
in effect. Bone marrow examination, if performed, must reveal a normal 
or an increased number of megakaryocytes in an otherwise normal marrow.
    (8) Vaccine-strain measles viral disease. This term is defined as a 
measles illness that involves the skin and/or another organ (such as 
the brain or lungs). Measles virus must be isolated from the affected 
organ or histopathologic findings characteristic for the disease must 
be present. Measles viral strain determination may be performed by 
methods such as polymerase chain reaction test and vaccine-specific 
monoclonal antibody. If strain determination reveals wild-type measles 
virus or another, non-vaccine-strain virus, the disease shall not be 
considered to be a condition set forth in the Table. If strain 
determination is not done or if the strain cannot be identified, onset 
of illness in any organ must occur within 12 months after vaccination.
    (9) Vaccine-strain polio viral infection. This term is defined as a 
disease caused by poliovirus that is isolated from the affected tissue 
and should be determined to be the vaccine-strain by oligonucleotide or 
polymerase chain reaction. Isolation of poliovirus from the stool is 
not sufficient to establish a tissue specific infection or disease 
caused by vaccine-strain poliovirus.
    (10) Shoulder injury related to vaccine administration (SIRVA). 
SIRVA manifests as shoulder pain and limited range of motion occurring 
after the administration of a vaccine intended for intramuscular 
administration in the upper arm. These symptoms are thought to occur as 
a result of unintended injection of vaccine antigen or trauma from the 
needle into and around the underlying bursa of the shoulder resulting 
in an inflammatory reaction. SIRVA is caused by an injury to the 
musculoskeletal structures of the shoulder (e.g. tendons, ligaments, 
bursae, etc.). SIRVA is not a neurological injury and abnormalities on 
neurological examination or nerve conduction studies (NCS) and/or 
electromyographic (EMG) studies would not support SIRVA as a diagnosis 
(even if the condition causing the neurological abnormality is not 
known). A vaccine recipient shall be considered to have suffered SIRVA 
if such recipient manifests all of the following:
    (i) No history of pain, inflammation or dysfunction of the affected 
shoulder prior to intramuscular vaccine administration that would 
explain the alleged signs, symptoms, examination findings, and/or 
diagnostic studies occurring after vaccine injection;
    (ii) Pain occurs within the specified time-frame;
    (iii) Pain and reduced range of motion are limited to the shoulder 
in which the intramuscular vaccine was administered; and
    (iv) No other condition or abnormality is present that would 
explain the patient's symptoms (e.g. NCS/EMG or clinical evidence of 
radiculopathy, brachial neuritis, mononeuropathies, or any other 
neuropathy).
    (11) Disseminated varicella vaccine-strain viral disease. 
Disseminated varicella vaccine-strain viral disease is defined as a 
varicella illness that involves the skin beyond the dermatome in which 
the vaccination was given and/or disease caused by vaccine-strain 
varicella in another organ. For organs other than the skin, the disease 
must be demonstrated in the involved organ and not just through mildly 
abnormal laboratory values. If there is involvement of an organ beyond 
the skin, and no virus was identified in that organ, the involvement of 
all organs must occur as part of the same, discrete illness. If strain 
determination reveals wild-type varicella virus or another, non-
vaccine-strain virus, the viral disease shall not be considered to be a 
condition set forth in the Table. If strain determination is not done 
or if the strain cannot be identified, onset of illness in any organ 
must occur 7- 42 days after vaccination.
    (12) Varicella vaccine-strain viral reactivation disease. Varicella 
vaccine-strain viral reactivation disease is defined as the presence of 
the rash of herpes zoster with or without concurrent disease in an 
organ other than the skin. Zoster, or shingles, is a painful, 
unilateral, pruritic rash appearing in one or more sensory dermatomes. 
For organs other than the skin, the disease must be demonstrated in the 
involved organ and not just through mildly abnormal laboratory values. 
There must be laboratory confirmation that the vaccine-strain of the 
varicella virus is present in the skin or in any other involved organ, 
for example by oligonucleotide or polymerase chain reaction. If strain 
determination reveals wild-type

[[Page 6304]]

varicella virus or another, non-vaccine-strain virus, the viral disease 
shall not be considered to be a condition set forth in the Table.
    (13) Vasovagal syncope. Vasovagal syncope (also sometimes called 
neurocardiogenic syncope) means loss of consciousness (fainting) and 
postural tone caused by a transient decrease in blood flow to the brain 
occurring after the administration of an injected vaccine. Vasovagal 
syncope is usually a benign condition but may result in falling and 
injury with significant sequela. 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 with vasovagal syncope. 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, and seizures. Episodes of recurrent syncope 
occurring after the applicable time period are not considered to be 
sequela of an episode of syncope meeting the Table requirements.
    (14) Immunodeficient recipient. Immunodeficient recipient is 
defined as an individual with an identified defect in the immunological 
system which impairs the body's ability to fight infections. The 
identified defect may be due to an inherited disorder (such as severe 
combined immunodeficiency resulting in absent T lymphocytes), or an 
acquired disorder (such as acquired immunodeficiency syndrome resulting 
from decreased CD4 cell counts). The identified defect must be 
demonstrated in the medical records, either preceding or postdating 
vaccination.
    (15) Guillain-Barr[eacute] Syndrome (GBS). (i) GBS is an acute 
monophasic peripheral neuropathy that encompasses 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:
    (A) Bilateral flaccid limb weakness and decreased or absent deep 
tendon reflexes in weak limbs;
    (B) A monophasic illness pattern;
    (C) An interval between onset and nadir of weakness between 12 
hours and 28 days;
    (D) Subsequent clinical plateau (the clinical plateau leads to 
either stabilization at the nadir of symptoms, or subsequent 
improvement without significant relapse; however, death may occur 
without a clinical plateau); and,
    (E) The absence of an identified more likely alternative diagnosis.
    (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:
    (A) Bilateral ophthalmoparesis;
    (B) Bilateral reduced or absent tendon reflexes;
    (C) Ataxia;
    (D) The absence of limb weakness (the presence of limb weakness 
suggests a diagnosis of AIDP, AMAN, or AMSAN);
    (E) A monophasic illness pattern;
    (F) An interval between onset and nadir of weakness between 12 
hours and 28 days;
    (G) Subsequent clinical plateau (the clinical plateau leads to 
either
    stabilization at the nadir of symptoms, or subsequent improvement 
without significant relapse; however, death may occur without a 
clinical plateau);
    (H) No alteration in consciousness;
    (I) No corticospinal track signs; and
    (J) The absence of an identified more likely alternative diagnosis.
    (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. Both 
CSF and electrophysiologic studies are frequently normal in the first 
week of illness in otherwise typical cases of GBS.
    (v) To qualify as any subtype of GBS, there must not be a more 
likely alternative diagnosis for the weakness.
    (vi) 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.
    (d) Glossary for purposes of paragraph (c) of this section--(1) 
Chronic encephalopathy. (i) A chronic encephalopathy occurs when a 
change in mental or neurologic status, first manifested during the 
applicable Table time period as an acute encephalopathy or 
encephalitis, persists for at least 6 months from the first symptom or 
manifestation of onset or of significant aggravation of an acute 
encephalopathy or encephalitis.
    (ii) Individuals who return to their baseline neurologic state, as 
confirmed by clinical findings, within less than 6 months from the 
first symptom or manifestation of onset or of significant aggravation 
of an acute encephalopathy or encephalitis shall not be presumed to 
have suffered residual neurologic damage from that event; any 
subsequent chronic encephalopathy shall not be presumed to be a sequela 
of the acute encephalopathy or encephalitis.
    (2) Injected refers to the intramuscular, intradermal, or

[[Page 6305]]

subcutaneous needle administration of a vaccine.
    (3) Sequela means a condition or event which was actually caused by 
a condition listed in the Vaccine Injury Table.
    (4) Significantly decreased level of consciousness is indicated by 
the presence of one or more of the following clinical signs:
    (i) Decreased or absent response to environment (responds, if at 
all, only to loud voice or painful stimuli);
    (ii) Decreased or absent eye contact (does not fix gaze upon family 
members or other individuals); or
    (iii) Inconsistent or absent responses to external stimuli (does 
not recognize familiar people or things).
    (5) Seizure includes myoclonic, generalized tonic-clonic (grand 
mal), and simple and complex partial seizures, but not absence (petit 
mal), or pseudo seizures. Jerking movements or staring episodes alone 
are not necessarily an indication of seizure activity.
    (e) Coverage provisions. (1) Except as provided in paragraph 
(e)(2), (3), (4), (5), (6), (7), or (8) of this section, this section 
applies only to petitions for compensation under the program filed with 
the United States Court of Federal Claims on or after February 21, 
2017.
    (2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, and X 
of the Table) are included in the Table as of August 6, 1997.
    (3) Rotavirus vaccines (Item XI of the Table) are included in the 
Table as of October 22, 1998.
    (4) Pneumococcal conjugate vaccines (Item XII of the Table) are 
included in the Table as of December 18, 1999.
    (5) Hepatitis A vaccines (Item XIII of the Table) are included on 
the Table as of December 1, 2004.
    (6) Trivalent influenza vaccines (Included in item XIV of the 
Table) are included on the Table as of July 1, 2005. All other seasonal 
influenza vaccines (Item XIV of the Table) are included on the Table as 
of November 12, 2013.
    (7) Meningococcal vaccines and human papillomavirus vaccines (Items 
XV and XVI of the Table) are included on the Table as of February 1, 
2007.
    (8) Other new vaccines (Item XVII of the Table) will be included in 
the Table as of the effective date of a tax enacted to provide funds 
for compensation paid with respect to such vaccines. An amendment to 
this section will be published in the Federal Register to announce the 
effective date of such a tax.

[FR Doc. 2017-00701 Filed 1-18-17; 8:45 am]
 BILLING CODE 4160-15-P