82 FR 6294 - National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range		6294-6305
FR Document		2017-00701

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.

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)

[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Rules and Regulations]
[Pages 6294-6305]
From the Federal Register Online [www.thefederalregister.org]
[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

6294 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

Administrator. The training must ■ c. By adding paragraph (a)(8). laboratory notebooks, institutional
address the particular needs of the ■ d . By revising paragraph (b). biosafety and/or animal use committee
individual, the work they will do, and ■ e. By revising paragraph (c). minutes and approved protocols, and
the risks posed by the select agents or The revision and additions read as records associated with occupational
toxins. The training must be follows: health and suitability programs. All
accomplished prior to the individual’s records created under this part must be
entry into an area where a select agent § 73.17 Records. maintained for 3 years.
is handled or stored, or within 12 (a) * * *
Dated: January 9, 2017.
months of the date the individual was (1) * * *
Sylvia M. Burwell,
approved by the HHS Secretary or the (v) The select agent used, purpose of
use, and, when applicable, final Secretary.
Administrator for access, whichever is
disposition, [FR Doc. 2017–00726 Filed 1–18–17; 8:45 am]
earlier.
(2) Each individual not approved for BILLING CODE 4163–18–P
* * * * *
access to select agents and toxins by the (8) For select agents or material
HHS Secretary or Administrator before containing select agents or regulated
DEPARTMENT OF HEALTH AND
that individual enters areas under escort nucleic acids that can produce
HUMAN SERVICES
where select agents or toxins are infectious forms of any select agent
handled or stored (e.g., laboratories, virus that have been subjected to a 42 CFR Part 100
growth chambers, animal rooms, validated inactivation procedure or a
greenhouses, storage areas, shipping/ procedure for removal of viable select RIN 0906–AB01
receiving areas, production facilities, agent:
etc.). Training for escorted personnel National Vaccine Injury Compensation
(i) A written description of the
must be based on the risk associated Program: Revisions to the Vaccine
validated inactivation procedure or
with accessing areas where select agents Injury Table
viable select agent removal method
and toxins are used and/or stored. The used, including validation data; AGENCY: Health Resources and Services
training must be accomplished prior to (ii) A written description of the Administration (HRSA), HHS.
the individual’s entry into where select viability testing protocol used; ACTION: Final rule.
agents or toxins are handled or stored (iii) A written description of the
(e.g., laboratories, growth chambers, investigation conducted by the entity SUMMARY: On July 29, 2015, the
animal rooms, greenhouses, storage Responsible Official involving an Secretary of Health and Human Services
areas, shipping/receiving areas, inactivation or viable select agent (the Secretary) published in the Federal
production facilities, etc.). removal failure and the corrective Register a Notice of Proposed
* * * * * actions taken; Rulemaking (NPRM) to amend the
(e) The Responsible Official must (iv) The name of each individual regulations governing the National
ensure and document that individuals performing the validated inactivation or Vaccine Injury Compensation Program
are provided the contact information of viable select agent removal method; (VICP or program) by proposing
the HHS Office of Inspector General (v) The date(s) the validated revisions to the Vaccine Injury Table
Hotline and the USDA Office of inactivation or viable select agent (Table). The Secretary based the Table
Inspector General Hotline so that they removal method was completed; revisions primarily on the 2012 Institute
may anonymously report any safety or (vi) The location where the validated of Medicine (IOM) report, ‘‘Adverse
security concerns related to select inactivation or viable select agent Effects of Vaccines: Evidence and
agents and toxins. removal method was performed; and Causality,’’ the work of nine HHS
■ 14. Section 73.16 is amended by (vii) A certificate, signed by the workgroups who reviewed the IOM
revising paragraph (l)(1) to read as Principal Investigator, that includes the findings, and consideration of the
follows: date of inactivation or viable select Advisory Commission on Childhood
agent removal, the validated Vaccines’ (ACCV) recommendations.
§ 73.16 Transfers. inactivation or viable select agent The Secretary amends the Table through
* * * * * removal method used, and the name of the changes in this final rule. These
(l) * * * the Principal Investigator. A copy of the changes will apply only to petitions for
(1) Transfer the amounts only after the certificate must accompany any transfer compensation under the VICP filed after
transferor uses due diligence and of inactivated or select agent removed this final rule becomes effective.
documents that the recipient has a material. DATE: This rule is effective February 21,
legitimate need (e.g., prophylactic, * * * * * 2017.
protective, bona fide research, or other (b) The individual or entity must FOR FURTHER INFORMATION CONTACT: Dr.
peaceful purpose) to handle or use such implement a system to ensure that all Narayan Nair, Acting Director, Division
toxins. Information to be documented records and data bases created under of Injury Compensation Programs,
includes, but is not limited, to the this part are accurate and legible, have Healthcare Systems Bureau, HRSA,
recipient information, toxin and amount controlled access, and authenticity may 5600 Fishers Lane, Room 8N146B,
transferred, and declaration that the be verified. Rockville, MD 20857, or by telephone
recipient has legitimate purpose to store (c) The individual or entity must (855) 266–2427. This is a toll-free
asabaliauskas on DSK3SPTVN1PROD with RULES

and use such toxins. promptly produce upon request any number.
* * * * * information that is related to the SUPPLEMENTARY INFORMATION:
■ 15. Section 73.17 is amended as requirements of this part but is not
follows: otherwise contained in a record I. Background
■ a. In paragraphs (a)(1)(iii) and (a)(3)(v) required to be kept by this section. The The National Childhood Vaccine
by adding ‘‘or other storage container’’ location of such information may Injury Act of 1986, title III of Public Law
after ‘‘freezer’’. include, but is not limited to, 99–660 (42 U.S.C. 300aa–10 et seq.),
■ b. By revising paragraph (a)(1)(v). biocontainment certifications, established the VICP, a Federal

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6296 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

continues to apply. However, the statute effects and conduct studies to determine injection. The portion of the QAI
identifies a specific exception to this whether health problems are caused by limiting the pain and reduced range of
statute of limitations that applies when vaccines. CDC’s ISO data show that the motion to the shoulder in which the
the effect of a revision to the Table current U.S. vaccine supply is the safest vaccine was administered is necessary
makes a previously ineligible person in history.1 Also, regulating clinical to accurately reflect the vaccine-
eligible to receive compensation or research and reviewing the safety of associated condition.
when an eligible person’s likelihood of vaccines are responsibilities of the FDA, Comment: A commenter recommends
obtaining compensation significantly not the VICP, and changes in vaccine revising the statute of limitations for
increases. Under this exception, an research and how vaccines are studied filing complex cases, with additional
individual who may be eligible to file a and tested are beyond the scope of this consideration given to the aggravation of
petition based on the revised Table may final rule. preexisting conditions not active until
file the petition for compensation not As previously indicated, the Table post vaccine(s).
later than 2 years after the effective date revisions were based primarily on the Response: Revision of the statute of
of the revision if the alleged injury or 2012 IOM report which was developed limitations would require a statutory
death occurred not more than 8 years after the IOM committee conducted a amendment and thus is not within the
before the effective date of the revision comprehensive review of the scientific scope of this final rule.
of the Table (42 U.S.C. 300aa–16(b)). literature on vaccines and adverse Comment: A commenter stated that
This is true even if such individual events. The committee charged with there is a problem with the VICP’s 3-
previously filed a petition for undertaking this review consisted of 16 year statute of limitations for filing a
compensation, and is thus an exception members with expertise in the following claim and the military’s 5-year program
to the ‘‘one petition per injury’’ fields: Pediatrics, internal medicine, titled, Temporary Disabled Retirement
limitation of 42 U.S.C. 300aa–11(b)(2). neurology, immunology, Listing (TDRL), where active duty
For any vaccine-adverse event pairs immunotoxicology, neurobiology, military personnel injured by vaccines
for which future scientific evidence rheumatology, epidemiology, are placed. The commenter stated that
develops to support a finding of a causal biostatistics, and law. The members of the rules need to be amended and/or
relationship, the Secretary will consider the review committee were subject to waivers granted to military personnel
future rulemaking to revise the Table stringent conflict of interest criteria by who are severely injured by vaccines so
accordingly. the IOM. In addition, the proposed they can seek compensation for
Table changes were developed by HHS damages.
III. Comments and Responses
workgroups and reviewed by the ACCV, Response: Amending the Act’s statute
The NPRM provided a 180-day the membership of which, by statute, of limitations is not within the scope of
comment period that resulted in the reflects a variety of stakeholders with this final rule.
receipt of 14 written comments—13 different perspectives. Comment: A commenter
from individuals and one from a Comment: A commenter suggested recommended the addition of SIRVA to
national organization. In addition, a that shoulder injury related to vaccine the vaccine court [sic]. The commenter
public hearing on the proposed rule was administration (SIRVA) as defined in also indicated a belief that SIRVA is due
held on January 14, 2016, during which the QAI is too restrictive because the to lack of education on proper injection
a representative from the above recipient’s pain and reduced range of technique. The commenter further
mentioned national organization motion must be limited to the shoulder stated that the CDC should make SIRVA,
presented comments. The organization’s in which the intramuscular vaccine was which the commenter believes is 100
oral comments were an expansion of the administered. The commenter stated percent preventable, a priority.
organization’s previously submitted that such language was an artificial and Response: This final rule will add
written comments. The Secretary unnecessary qualification, and SIRVA as an injury associated with
carefully considered all received expressed concern that recipients who certain vaccines on the Table. In the
comments in the development of this have other symptoms, such as shoulder VICP, claims are adjudicated by special
final rule. Below is a summary of the pain radiating to the neck or upper back, masters in the Court. SIRVA prevention
comments and the Secretary’s will not have the benefits of a Table activities are not within the scope of
responses: injury. The commenter suggested that this final rule.
Comment: One commenter suggested the QAI be expanded to include the Comment: A commenter
that vaccines are unsafe, disagreed with shoulder and parts of the body recommended that the VICP transfer a
the process for predicting vaccine harm attributed to that injury. fraction of its compensation
to humans, and disagreed with the Response: SIRVA is a musculoskeletal responsibilities to pharmaceutical
makeup of the ‘‘group assembled to condition caused by injection of a companies, which would incentivize
force changes in this Table,’’ calling it vaccine intended for intramuscular these companies to develop safer
a biased group. administration into the shoulder, and, vaccines to avoid claim compensation.
Response: The United States has a as its name suggests, the condition is Response: The source of funding for
long-standing vaccine safety program localized to the shoulder in which the the VICP is the Vaccine Injury
that closely monitors the safety of vaccine was administered. In other Compensation Trust Fund (Trust Fund).
vaccines on an ongoing basis. Before words, pain in the neck or back without The Trust Fund is funded by an excise
vaccines are approved by the Food and an injury to the shoulder in which an tax on each dose of vaccines
Drug Administration (FDA), they are individual received a vaccine would not recommended by the CDC for routine
asabaliauskas on DSK3SPTVN1PROD with RULES

tested and studied extensively by be considered SIRVA. Shoulder injuries administration to children. To the
scientists to help ensure they are safe that are not caused by injection occur extent that the commenter is proposing
and effective. After vaccines are frequently in the population. Thus, it is a change to the funding mechanism for
approved, a critical part of the vaccine important to have a definition of SIRVA the VICP, effectuating such a change is
safety program is that the Centers for that is clearly associated with vaccine beyond the scope of this final rule.
Disease Control and Prevention (CDC)’s Comment: A commenter agreed with
Immunization Safety Office (ISO) and 1 http://www.cdc.gov/vaccinesafety/ the Secretary’s proposal that SIRVA
FDA monitor for possible vaccine side ensuringsafety/history/index.html injuries be added to the Table for the

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6299

amendment and thus is not within the greatest net benefits (including potential Order 12866. Accordingly, the rule has
purview of this final rule. economic, environmental, public health, not been reviewed by the Office of
Comment: One commenter stated that safety, distributive, and equity effects). Management and Budget.
thimerosal (a preservative added to In addition, under the Regulatory As stated above, this final rule will
vaccines) causes nerve damage. Flexibility Act, if a rule has a significant modify the Vaccine Injury Table and its
Response: The Secretary disagrees economic effect on a substantial number Qualifications and Aids to
with the comment that thimerosal in of small entities the Secretary must Interpretation based on legal authority.
vaccines causes nerve damage to specifically consider the economic
immunized individuals. Currently, no Impact of the New Rule
effect of a rule on small entities and
childhood vaccines used in the U.S. analyze regulatory options that could This final rule will have the effect of
include thimerosal as a preservative, lessen the impact of the rule. making it easier for future petitioners
except for some formulations of Executive Order 12866 requires that alleging injuries that meet the criteria in
influenza vaccine in multi-dose vials. all regulations reflect consideration of the Vaccine Injury Table to receive the
When exposure to thimerosal occurs alternatives, costs, benefits, incentives, Table’s presumption of causation
through vaccination, it is at a very low equity, and available information. (which relieves them of having to prove
dose, which is readily eliminated from Regulations must meet certain that the vaccine actually caused or
the body. Thimerosal has been used standards, such as avoiding an significantly aggravated the injury).
safely in vaccines since the 1930s. unnecessary burden. Regulations that
Paperwork Reduction Act of 1995
According to the CDC, scientists have are ‘‘significant’’ because of cost,
been studying the use of thimerosal in adverse effects on the economy, This final rule has no information
vaccines for many years. They have not inconsistency with other agency actions, collection requirements.
found any evidence that thimerosal effects on the budget, or novel legal or Dated: January 6, 2017.
causes any harm. Thimerosal use in policy issues require special analysis. James Macrae,
medical products has a record of being The Secretary has determined that no Acting Administrator, Health Resources and
very safe. Data from many studies show resources are required to implement the Services Administration.
no evidence of harm caused by low requirements in this rule. Compensation
Approved: January 9, 2017.
doses of thimerosal in vaccines.3 will be made in the same manner. This
final rule only lessens the burden of Sylvia M. Burwell,
Economic and Regulatory Impact proof for potential petitioners. Secretary, Department of Health and Human
Executive Order 12866 directs Therefore, in accordance with the Services.
agencies to assess all costs and benefits Regulatory Flexibility Act of 1980 List of Subjects in 42 CFR Part 100
of available regulatory alternatives and, (RFA), and the Small Business
when rulemaking is necessary, to select Regulatory Enforcement Act of 1996, Biologics, Health insurance,
regulatory approaches that provide the which amended the RFA, the Secretary Immunization.
certifies that this rule will not have a National Vaccine Injury Compensation
3 Following are referenced thimerosal studies: significant impact on a substantial Program: Revisions to the Vaccine
1. Thimerosal Exposure in Infants and number of small entities. Injury Table
Developmental Disorders: A Retrospective Cohort The Secretary has also determined
Study in the United Kingdom Does Not Support a Therefore, for the reasons stated in the
Causal Association by Nick Andrews et al.
that this final rule does not meet the
preamble, the Department of Health and
Pediatrics. September 2004. Vol 114: pp. 584–591. criteria for a major rule as defined by
Executive Order 12866 and would have Human Services amends 42 CFR part
http://pediatrics.aappublications.org/cgi/content/
full/114/3/584. no major effect on the economy or 100 as follows:
2. Pervasive Developmental Disorders in Federal expenditures. We have
Montreal, Quebec, Canada: Prevalence and Links PART 100—VACCINE INJURY
with Immunizations by Eric Frombonne et al. determined that the final rule is not a COMPENSATION
Pediatriacs. July 2006. Vol 118: e139–e150. http:// ‘‘major rule’’ within the meaning of the
pediatrics.aappublications.org/cgi/content/full/118/ statute providing for Congressional ■ 1. The authority citation for 42 CFR
1/e139. Review of Agency Rulemaking, 5 U.S.C. part 100 continues to read as follows:
3. Association between Thimerosal-Containing
Vaccine and Autism by Anders Hviid et al. Journal
801. Similarly, it will not have effects Authority: Secs. 312 and 313 of Public
of the American Medical Association. October 2003. on State, local, and tribal governments Law 99–660 (42 U.S.C. 300aa–1 note); 42
Vol 290: pp. 1763–1766. http://jama.ama-assn.org/ and on the private sector such as to U.S.C. 300aa–10 to 300aa–34; 26 U.S.C.
cgi/content/full/290/13/1763. require consultation under the 4132(a); and sec. 13632(a)(3) of Public Law
4. Immunization Safety Review: Vaccines and Unfunded Mandates Reform Act of 103–66.
Autism. Institute of Medicine. The National
Academies Press: 2004. http://www.iom.edu/ 1995. ■ 2. Revise § 100.3 to read as follows:
Reports/2004/Immunization-SafetyReview- The provisions of this rule do not, on
Vaccines-and-Autism.aspx. the basis of family well-being, affect the § 100.3 Vaccine injury table.
5. Prenatal and Infant Exposure to Thimerosal following family elements: Family (a) In accordance with section 312(b)
from Vaccines and Immunoglobulins and Risk of safety; family stability; marital of the National Childhood Vaccine
Autism by Cristofer Price et al. Pediatrics.
September 2010. Vol 126: pp. 656–664, http:// commitment; parental rights in the Injury Act of 1986, title III of Public Law
pediatrics.aappublications.org/cgi/reprint peds. education, nurture and supervision of 99–660, 100 Stat. 3779 (42 U.S.C.
20100309v1. their children; family functioning; 300aa–1 note) and section 2114(c) of the
6. Continuing Increases in Autism Reported to disposable income or poverty; or the Public Health Service Act, as amended
asabaliauskas on DSK3SPTVN1PROD with RULES

California’s Developmental Services System by (PHS Act) (42 U.S.C. 300aa–14(c)), the
Robert Schechter et al. Archives of General
behavior and personal responsibility of
Psychiatry. January 2008. Vol 65: pp. 19–24. http:// youth, as determined under section following is a table of vaccines, the
archpsyc.ama-assn.org/cgi/content/full/65/1/19. 654(c) of the Treasury and General injuries, disabilities, illnesses,
7. Early Thimerosal Exposure and Government Appropriations Act of conditions, and deaths resulting from
Neuropsychological Outcomes at 7 to 10 Years by 1999. the administration of such vaccines, and
William Thompson et al. The New England Journal
of Medicine. September 2007. Vol 357: pages 1281–
This rule is not being treated as a the time period in which the first
1292. http://www.nejm.org/doi/pdf/10.1056/ ‘‘significant regulatory action’’ as symptom or manifestation of onset or of
NEJMoa071434. defined under section 3(f) of Executive the significant aggravation of such

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6300 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

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

VACCINE INJURY TABLE
Time period for first symptom or manifestation
Vaccine Illness, disability, injury or condition covered of onset or of significant aggravation after
vaccine administration

I. Vaccines containing tetanus toxoid (e.g., A. Anaphylaxis ................................................. ≤4 hours.
DTaP, DTP, DT, Td, or TT). B. Brachial Neuritis .......................................... 2–28 days (not less than 2 days and not more
than 28 days).
C. Shoulder Injury Related to Vaccine Admin- ≤48 hours.
istration.
D. Vasovagal syncope ..................................... ≤1 hour.
II. Vaccines containing whole cell pertussis A. Anaphylaxis ................................................. ≤4 hours.
bacteria, extracted or partial cell pertussis
bacteria, or specific pertussis antigen(s)
(e.g., DTP, DTaP, P, DTP-Hib).
B. Encephalopathy or encephalitis .................. ≤72 hours.
C. Shoulder Injury Related to Vaccine Admin- ≤48 hours.
istration.
D. Vasovagal syncope ..................................... ≤1 hour.
III. Vaccines containing measles, mumps, and A. Anaphylaxis ................................................. ≤4 hours.
rubella virus or any of its components (e.g., B. Encephalopathy or encephalitis .................. 5–15 days (not less than 5 days and not more
MMR, MM, MMRV). than 15 days).
C. Shoulder Injury Related to Vaccine Admin- ≤48 hours.
istration.
D. Vasovagal syncope ..................................... ≤1 hour.
IV. Vaccines containing rubella virus (e.g., A. Chronic arthritis ........................................... 7–42 days (not less than 7 days and not more
MMR, MMRV). than 42 days).
V. Vaccines containing measles virus (e.g., A. Thrombocytopenic purpura .......................... 7–30 days (not less than 7 days and not more
MMR, MM, MMRV). than 30 days).
B. Vaccine-Strain Measles Viral Disease in an
immunodeficient recipient.
—Vaccine-strain virus identified ....................... Not applicable.
—If strain determination is not done or if lab- ≤12 months.
oratory testing is inconclusive.
VI. Vaccines containing polio live virus (OPV) .. A. Paralytic Polio.
—in a non-immunodeficient recipient .............. ≤30 days.
—in an immunodeficient recipient .................... ≤6 months.
—in a vaccine associated community case ..... Not applicable.
B. Vaccine-Strain Polio Viral Infection.
—in a non-immunodeficient recipient .............. ≤30 days.
—in an immunodeficient recipient .................... ≤6 months.
—in a vaccine associated community case ..... Not applicable.
VII. Vaccines containing polio inactivated virus A. Anaphylaxis ................................................. ≤4 hours.
(e.g., IPV).
B. Shoulder Injury Related to Vaccine Admin- ≤48 hours.
istration.
C. Vasovagal syncope ..................................... ≤1 hour.
VIII. Hepatitis B vaccines ................................... A. Anaphylaxis ................................................. ≤4 hours.
B. Shoulder Injury Related to Vaccine Admin- ≤48 hours.
istration.
C. Vasovagal syncope ..................................... ≤1 hour.
IX. Haemophilus influenzae type b (Hib) vac- A. Shoulder Injury Related to Vaccine Admin- ≤48 hours.
cines. istration.
B. Vasovagal syncope ..................................... ≤1 hour.
X. Varicella vaccines .......................................... A. Anaphylaxis ................................................. ≤4 hours.
B. Disseminated varicella vaccine-strain viral
disease.
—Vaccine-strain virus identified ....................... Not applicable.
—If strain determination is not done or if lab- 7–42 days (not less than 7 days and not more
asabaliauskas on DSK3SPTVN1PROD with RULES

oratory testing is inconclusive. than 42 days).
C. Varicella vaccine-strain viral reactivation .... Not applicable.
D. Shoulder Injury Related to Vaccine Admin- ≤48 hours.
istration.
E. Vasovagal syncope ..................................... ≤1 hour.
XI. Rotavirus vaccines ....................................... A. Intussusception ............................................ 1–21 days (not less than 1 day and not more
than 21 days).
XII. Pneumococcal conjugate vaccines ............. A. Shoulder Injury Related to Vaccine Admin- ≤48 hours.
istration.

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6302 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

perinatal central nervous system (CNS) the Table if it is shown that the (D) Onset in a person with
injury); or encephalitis was caused by: abnormalities of the bowel, including
(B) An acute event shown to be (A) An underlying malignancy that congenital anatomic abnormalities,
unrelated to the vaccine such as a head led to a paraneoplastic encephalitis; anatomic changes after abdominal
trauma, stroke, transient ischemic (B) An infectious disease associated surgery, and other anatomic bowel
attack, complicated migraine, drug use with encephalitis, including a bacterial, abnormalities caused by mucosal
(illicit or prescribed) or an infectious parasitic, fungal or viral illness (such as hemorrhage, trauma, or abnormal
disease. herpes viruses, adenovirus, enterovirus, intestinal blood vessels (such as Henoch
(3) Encephalitis. A vaccine recipient West Nile Virus, or human Scholein purpura, hematoma, or
shall be considered to have suffered immunodeficiency virus), which may be hemangioma); or
encephalitis if an injury meeting the demonstrated by clinical signs and (E) Onset in a person with underlying
description below of acute encephalitis symptoms and need not be confirmed conditions or systemic diseases
occurs within the applicable time by culture or serologic testing; or associated with intussusception (such as
period and results in a chronic (C) Acute disseminated cystic fibrosis, celiac disease, or
encephalopathy, as described in encephalomyelitis (ADEM). Although Kawasaki disease).
paragraph (d) of this section. early ADEM may have laboratory and (5) Chronic arthritis. Chronic arthritis
(i) Acute encephalitis. Encephalitis is clinical characteristics similar to acute is defined as persistent joint swelling
indicated by evidence of neurologic encephalitis, findings on MRI are with at least two additional
dysfunction, as described in paragraph distinct with ADEM displaying manifestations of warmth, tenderness,
(c)(3)(i)(A) of this section, plus evidence evidence of acute demyelination pain with movement, or limited range of
of an inflammatory process in the brain, (scattered, focal, or multifocal areas of motion, lasting for at least 6 months.
as described in paragraph (c)(3)(i)(B) of (i) Chronic arthritis may be found in
inflammation and demyelination within
this section. a person with no history in the 3 years
cerebral subcortical and deep cortical
(A) Evidence of neurologic prior to vaccination of arthropathy (joint
white matter; gray matter involvement
dysfunction consists of either: disease) on the basis of:
may also be seen but is a minor (A) Medical documentation recorded
(1) One of the following neurologic
component); or within 30 days after the onset of
findings referable to the CNS: Focal
(D) Other conditions or abnormalities objective signs of acute arthritis (joint
cortical signs (such as aphasia, alexia,
that would explain the vaccine swelling) that occurred between 7 and
agraphia, cortical blindness); cranial
recipient’s symptoms. 42 days after a rubella vaccination; and
nerve abnormalities; visual field defects;
(4) Intussusception. (i) For purposes (B) Medical documentation (recorded
abnormal presence of primitive reflexes
of paragraph (a) of this section, within 3 years after the onset of acute
(such as Babinski’s sign or sucking
intussusception means the invagination arthritis) of the persistence of objective
reflex); or cerebellar dysfunction (such
of a segment of intestine into the next signs of intermittent or continuous
as ataxia, dysmetria, or nystagmus); or
(2) An acute encephalopathy as set segment of intestine, resulting in bowel arthritis for more than 6 months
forth in paragraph (c)(2)(i) of this obstruction, diminished arterial blood following vaccination; and
section. supply, and blockage of the venous (C) Medical documentation of an
(B) Evidence of an inflammatory blood flow. This is characterized by a antibody response to the rubella virus.
process in the brain (central nervous sudden onset of abdominal pain that (ii) The following shall not be
system or CNS inflammation) must may be manifested by anguished crying, considered as chronic arthritis:
include cerebrospinal fluid (CSF) irritability, vomiting, abdominal Musculoskeletal disorders such as
pleocytosis (>5 white blood cells swelling, and/or passing of stools mixed diffuse connective tissue diseases
(WBC)/mm3 in children >2 months of with blood and mucus. (including but not limited to
age and adults; >15 WBC/mm3 in (ii) For purposes of paragraph (a) of rheumatoid arthritis, juvenile idiopathic
children <2 months of age); or at least this section, the following shall not be arthritis, systemic lupus erythematosus,
two of the following: considered to be a Table systemic sclerosis, mixed connective
(1) Fever (temperature ≥ 100.4 degrees intussusception: tissue disease, polymyositis/
Fahrenheit); (A) Onset that occurs with or after the determatomyositis, fibromyalgia,
(2) Electroencephalogram findings third dose of a vaccine containing necrotizing vasculitis and
consistent with encephalitis, such as rotavirus; vasculopathies and Sjogren’s
diffuse or multifocal nonspecific (B) Onset within 14 days after an Syndrome), degenerative joint disease,
background slowing and periodic infectious disease associated with infectious agents other than rubella
discharges; or intussusception, including viral disease (whether by direct invasion or as an
(3) Neuroimaging findings consistent (such as those secondary to non-enteric immune reaction), metabolic and
with encephalitis, which include, but or enteric adenovirus, or other enteric endocrine diseases, trauma, neoplasms,
are not limited to brain/spine magnetic viruses such as Enterovirus), enteric neuropathic disorders, bone and
resonance imaging (MRI) displaying bacteria (such as Campylobacter jejuni), cartilage disorders, and arthritis
diffuse or multifocal areas of or enteric parasites (such as Ascaris associated with ankylosing spondylitis,
hyperintense signal on T2-weighted, lumbricoides), which may be psoriasis, inflammatory bowel disease,
diffusion-weighted image, or fluid- demonstrated by clinical signs and Reiter’s Syndrome, blood disorders, or
attenuation inversion recovery symptoms and need not be confirmed arthralgia (joint pain), or joint stiffness
asabaliauskas on DSK3SPTVN1PROD with RULES

sequences. by culture or serologic testing; without swelling.
(ii) Exclusionary criteria for (C) Onset in a person with a (6) Brachial neuritis. This term is
encephalitis. Regardless of whether or preexisting condition identified as the defined as dysfunction limited to the
not the specific cause of the underlying lead point for intussusception such as upper extremity nerve plexus (i.e., its
condition, systemic disease, or acute intestinal masses and cystic structures trunks, divisions, or cords). A deep,
event (including an infectious organism) (such as polyps, tumors, Meckel’s steady, often severe aching pain in the
is known, encephalitis shall not be diverticulum, lymphoma, or duplication shoulder and upper arm usually heralds
considered to be a condition set forth in cysts); onset of the condition. The pain is

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6303

typically followed in days or weeks by virus, cytomegalovirus, hepatitis A and if the condition causing the neurological
weakness in the affected upper B, human immunodeficiency virus, abnormality is not known). A vaccine
extremity muscle groups. Sensory loss adenovirus, and dengue virus. An recipient shall be considered to have
may accompany the motor deficits, but antecedent viral infection may be suffered SIRVA if such recipient
is generally a less notable clinical demonstrated by clinical signs and manifests all of the following:
feature. Atrophy of the affected muscles symptoms and need not be confirmed (i) No history of pain, inflammation or
may occur. The neuritis, or plexopathy, by culture or serologic testing. However, dysfunction of the affected shoulder
may be present on the same side or on if culture or serologic testing is prior to intramuscular vaccine
the side opposite the injection. It is performed, and the viral illness is administration that would explain the
sometimes bilateral, affecting both attributed to the vaccine-strain measles alleged signs, symptoms, examination
upper extremities. A vaccine recipient virus, the presumption of causation will findings, and/or diagnostic studies
shall be considered to have suffered remain in effect. Bone marrow occurring after vaccine injection;
brachial neuritis as a Table injury if examination, if performed, must reveal (ii) Pain occurs within the specified
such recipient manifests all of the a normal or an increased number of time-frame;
following: megakaryocytes in an otherwise normal (iii) Pain and reduced range of motion
(i) Pain in the affected arm and marrow. are limited to the shoulder in which the
shoulder is a presenting symptom and (8) Vaccine-strain measles viral intramuscular vaccine was
occurs within the specified time-frame; disease. This term is defined as a administered; and
(ii) Weakness; measles illness that involves the skin (iv) No other condition or abnormality
(A) Clinical diagnosis in the absence and/or another organ (such as the brain is present that would explain the
of nerve conduction and or lungs). Measles virus must be isolated patient’s symptoms (e.g. NCS/EMG or
electromyographic studies requires from the affected organ or clinical evidence of radiculopathy,
weakness in muscles supplied by more histopathologic findings characteristic brachial neuritis, mononeuropathies, or
than one peripheral nerve. for the disease must be present. Measles any other neuropathy).
(B) Nerve conduction studies (NCS) viral strain determination may be (11) Disseminated varicella vaccine-
and electromyographic (EMG) studies performed by methods such as strain viral disease. Disseminated
localizing the injury to the brachial polymerase chain reaction test and varicella vaccine-strain viral disease is
plexus are required before the diagnosis vaccine-specific monoclonal antibody. If defined as a varicella illness that
can be made if weakness is limited to strain determination reveals wild-type involves the skin beyond the dermatome
muscles supplied by a single peripheral measles virus or another, non-vaccine- in which the vaccination was given and/
nerve. strain virus, the disease shall not be or disease caused by vaccine-strain
(iii) Motor, sensory, and reflex considered to be a condition set forth in varicella in another organ. For organs
findings on physical examination and the Table. If strain determination is not other than the skin, the disease must be
the results of NCS and EMG studies, if done or if the strain cannot be demonstrated in the involved organ and
performed, must be consistent in identified, onset of illness in any organ not just through mildly abnormal
confirming that dysfunction is must occur within 12 months after laboratory values. If there is
attributable to the brachial plexus; and vaccination. involvement of an organ beyond the
(iv) No other condition or abnormality (9) Vaccine-strain polio viral skin, and no virus was identified in that
is present that would explain the infection. This term is defined as a organ, the involvement of all organs
vaccine recipient’s symptoms. disease caused by poliovirus that is must occur as part of the same, discrete
(7) Thrombocytopenic purpura. This isolated from the affected tissue and illness. If strain determination reveals
term is defined by the presence of should be determined to be the vaccine- wild-type varicella virus or another,
clinical manifestations, such as strain by oligonucleotide or polymerase non-vaccine-strain virus, the viral
petechiae, significant bruising, or chain reaction. Isolation of poliovirus disease shall not be considered to be a
spontaneous bleeding, and by a serum from the stool is not sufficient to condition set forth in the Table. If strain
platelet count less than 50,000/mm3 establish a tissue specific infection or determination is not done or if the strain
with normal red and white blood cell disease caused by vaccine-strain cannot be identified, onset of illness in
indices. Thrombocytopenic purpura poliovirus. any organ must occur 7– 42 days after
does not include cases of (10) Shoulder injury related to vaccine vaccination.
thrombocytopenia associated with other administration (SIRVA). SIRVA (12) Varicella vaccine-strain viral
causes such as hypersplenism, manifests as shoulder pain and limited reactivation disease. Varicella vaccine-
autoimmune disorders (including range of motion occurring after the strain viral reactivation disease is
alloantibodies from previous administration of a vaccine intended for defined as the presence of the rash of
transfusions) myelodysplasias, intramuscular administration in the herpes zoster with or without
lymphoproliferative disorders, upper arm. These symptoms are thought concurrent disease in an organ other
congenital thrombocytopenia or to occur as a result of unintended than the skin. Zoster, or shingles, is a
hemolytic uremic syndrome. injection of vaccine antigen or trauma painful, unilateral, pruritic rash
Thrombocytopenic purpura does not from the needle into and around the appearing in one or more sensory
include cases of immune (formerly underlying bursa of the shoulder dermatomes. For organs other than the
called idiopathic) thrombocytopenic resulting in an inflammatory reaction. skin, the disease must be demonstrated
purpura that are mediated, for example, SIRVA is caused by an injury to the in the involved organ and not just
asabaliauskas on DSK3SPTVN1PROD with RULES

by viral or fungal infections, toxins or musculoskeletal structures of the through mildly abnormal laboratory
drugs. Thrombocytopenic purpura does shoulder (e.g. tendons, ligaments, values. There must be laboratory
not include cases of thrombocytopenia bursae, etc.). SIRVA is not a confirmation that the vaccine-strain of
associated with disseminated neurological injury and abnormalities the varicella virus is present in the skin
intravascular coagulation, as observed on neurological examination or nerve or in any other involved organ, for
with bacterial and viral infections. Viral conduction studies (NCS) and/or example by oligonucleotide or
infections include, for example, those electromyographic (EMG) studies would polymerase chain reaction. If strain
infections secondary to Epstein Barr not support SIRVA as a diagnosis (even determination reveals wild-type

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6304 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

varicella virus or another, non-vaccine- (ii) The most common subtype in (iv) Evidence that is supportive, but
strain virus, the viral disease shall not North America and Europe, comprising not required, of a diagnosis of all
be considered to be a condition set forth more than 90 percent of cases, is acute subtypes of GBS includes
in the Table. inflammatory demyelinating electrophysiologic findings consistent
(13) Vasovagal syncope. Vasovagal polyneuropathy (AIDP), which has the with GBS or an elevation of cerebral
syncope (also sometimes called pathologic and electrodiagnostic spinal fluid (CSF) protein with a total
neurocardiogenic syncope) means loss features of focal demyelination of motor CSF white blood cell count below 50
of consciousness (fainting) and postural and sensory peripheral nerves and nerve cells per microliter. Both CSF and
tone caused by a transient decrease in roots. Another subtype called acute electrophysiologic studies are frequently
blood flow to the brain occurring after motor axonal neuropathy (AMAN) is normal in the first week of illness in
the administration of an injected generally seen in other parts of the otherwise typical cases of GBS.
vaccine. Vasovagal syncope is usually a world and is predominated by axonal (v) To qualify as any subtype of GBS,
benign condition but may result in damage that primarily affects motor there must not be a more likely
falling and injury with significant nerves. AMAN lacks features of alternative diagnosis for the weakness.
sequela. Vasovagal syncope may be demyelination. Another less common (vi) Exclusionary criteria for the
preceded by symptoms such as nausea, subtype of GBS includes acute motor diagnosis of all subtypes of GBS include
lightheadedness, diaphoresis, and/or and sensory neuropathy (AMSAN), the ultimate diagnosis of any of the
pallor. Vasovagal syncope may be which is an axonal form of GBS that is following conditions: chronic immune
associated with transient seizure-like similar to AMAN, but also affects the demyelinating polyradiculopathy
activity, but recovery of orientation and sensory nerves and roots. AIDP, AMAN, (CIDP), carcinomatous meningitis, brain
consciousness generally occurs and AMSAN are typically characterized stem encephalitis (other than Bickerstaff
simultaneously with vasovagal syncope. by symmetric motor flaccid weakness, brainstem encephalitis), myelitis, spinal
Loss of consciousness resulting from the sensory abnormalities, and/or cord infarct, spinal cord compression,
following conditions will not be autonomic dysfunction caused by anterior horn cell diseases such as polio
autoimmune damage to peripheral or West Nile virus infection, subacute
considered vasovagal syncope: organic
nerves and nerve roots. The diagnosis of inflammatory demyelinating
heart disease, cardiac arrhythmias,
AIDP, AMAN, and AMSAN requires: polyradiculoneuropathy, multiple
transient ischemic attacks,
(A) Bilateral flaccid limb weakness sclerosis, cauda equina compression,
hyperventilation, metabolic conditions,
and decreased or absent deep tendon metabolic conditions such as
neurological conditions, and seizures.
reflexes in weak limbs; hypermagnesemia or
Episodes of recurrent syncope occurring
(B) A monophasic illness pattern; hypophosphatemia, tick paralysis,
after the applicable time period are not (C) An interval between onset and heavy metal toxicity (such as arsenic,
considered to be sequela of an episode nadir of weakness between 12 hours and gold, or thallium), drug-induced
of syncope meeting the Table 28 days; neuropathy (such as vincristine,
requirements. (D) Subsequent clinical plateau (the platinum compounds, or
(14) Immunodeficient recipient. clinical plateau leads to either nitrofurantoin), porphyria, critical
Immunodeficient recipient is defined as stabilization at the nadir of symptoms, illness neuropathy, vasculitis,
an individual with an identified defect or subsequent improvement without diphtheria, myasthenia gravis,
in the immunological system which significant relapse; however, death may organophosphate poisoning, botulism,
impairs the body’s ability to fight occur without a clinical plateau); and, critical illness myopathy, polymyositis,
infections. The identified defect may be (E) The absence of an identified more dermatomyositis, hypokalemia, or
due to an inherited disorder (such as likely alternative diagnosis. hyperkalemia. The above list is not
severe combined immunodeficiency (iii) Fisher Syndrome (FS), also exhaustive.
resulting in absent T lymphocytes), or known as Miller Fisher Syndrome, is a (d) Glossary for purposes of
an acquired disorder (such as acquired subtype of GBS characterized by ataxia, paragraph (c) of this section—(1)
immunodeficiency syndrome resulting areflexia, and ophthalmoplegia, and Chronic encephalopathy. (i) A chronic
from decreased CD4 cell counts). The overlap between FS and AIDP may be encephalopathy occurs when a change
identified defect must be demonstrated seen with limb weakness. The diagnosis in mental or neurologic status, first
in the medical records, either preceding of FS requires: manifested during the applicable Table
or postdating vaccination. (A) Bilateral ophthalmoparesis; time period as an acute encephalopathy
(15) Guillain-Barré Syndrome (GBS). (B) Bilateral reduced or absent tendon or encephalitis, persists for at least 6
(i) GBS is an acute monophasic reflexes; months from the first symptom or
peripheral neuropathy that encompasses (C) Ataxia;
(D) The absence of limb weakness (the manifestation of onset or of significant
a spectrum of four clinicopathological aggravation of an acute encephalopathy
subtypes described below. For each presence of limb weakness suggests a
diagnosis of AIDP, AMAN, or AMSAN); or encephalitis.
subtype of GBS, the interval between (ii) Individuals who return to their
(E) A monophasic illness pattern;
the first appearance of symptoms and (F) An interval between onset and baseline neurologic state, as confirmed
the nadir of weakness is between 12 nadir of weakness between 12 hours and by clinical findings, within less than 6
hours and 28 days. This is followed in 28 days; months from the first symptom or
all subtypes by a clinical plateau with (G) Subsequent clinical plateau (the manifestation of onset or of significant
stabilization at the nadir of symptoms, clinical plateau leads to either aggravation of an acute encephalopathy
asabaliauskas on DSK3SPTVN1PROD with RULES

or subsequent improvement without stabilization at the nadir of symptoms, or encephalitis shall not be presumed to
significant relapse. Death may occur or subsequent improvement without have suffered residual neurologic
without a clinical plateau. Treatment significant relapse; however, death may damage from that event; any subsequent
related fluctuations in all subtypes of occur without a clinical plateau); chronic encephalopathy shall not be
GBS can occur within 9 weeks of GBS (H) No alteration in consciousness; presumed to be a sequela of the acute
symptom onset and recurrence of (I) No corticospinal track signs; and encephalopathy or encephalitis.
symptoms after this time-frame would (J) The absence of an identified more (2) Injected refers to the
not be consistent with GBS. likely alternative diagnosis. intramuscular, intradermal, or

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6305

subcutaneous needle administration of a as of the effective date of a tax enacted I. Background
vaccine. to provide funds for compensation paid II. Calculation of Adjustment
(3) Sequela means a condition or with respect to such vaccines. An III. Procedural Requirements
event which was actually caused by a amendment to this section will be A. Regulatory Planning and Review (E.O.
12866 and 13563)
condition listed in the Vaccine Injury published in the Federal Register to B. Regulatory Flexibility Act
Table. announce the effective date of such a C. Small Business Regulatory Enforcement
(4) Significantly decreased level of tax. Fairness Act
consciousness is indicated by the [FR Doc. 2017–00701 Filed 1–18–17; 8:45 am] D. Unfunded Mandates Reform Act
presence of one or more of the following BILLING CODE 4160–15–P E. Takings (E.O. 12630)
clinical signs: F. Federalism (E.O. 13132)
(i) Decreased or absent response to G. Civil Justice Reform (E.O. 12988)
environment (responds, if at all, only to H. Consultation with Indian Tribes (E.O.
loud voice or painful stimuli); DEPARTMENT OF THE INTERIOR 13175 and Departmental Policy)
(ii) Decreased or absent eye contact I. Paperwork Reduction Act
Bureau of Land Management J. National Environmental Policy Act
(does not fix gaze upon family members
K. Effects on the Energy Supply (E.O.
or other individuals); or
(iii) Inconsistent or absent responses 43 CFR Part 3160 13211)
L. Administrative Procedure Act
to external stimuli (does not recognize [17X.LLWO310000.L13100000.PP0000]
familiar people or things). I. Background
RIN 1004–AE49
(5) Seizure includes myoclonic, On November 2, 2015, the President
generalized tonic-clonic (grand mal), Onshore Oil and Gas Operations— signed the Act into law (Sec. 701 of Pub.
and simple and complex partial Annual Civil Penalties Inflation L. 114–74). The Act requires agencies to:
seizures, but not absence (petit mal), or Adjustments 1. Adjust the level of civil monetary
pseudo seizures. Jerking movements or penalties with an initial ‘‘catch-up’’
staring episodes alone are not AGENCY: Bureau of Land Management,
adjustment through an interim final
necessarily an indication of seizure Interior.
rulemaking in 2016;
activity. ACTION: Final rule. 2. Make subsequent annual
(e) Coverage provisions. (1) Except as
SUMMARY: This rule adjusts the level of adjustments for inflation beginning in
provided in paragraph (e)(2), (3), (4), (5),
civil monetary penalties contained in 2017; and
(6), (7), or (8) of this section, this section
the Bureau of Land Management’s 3. Report annually in Agency
applies only to petitions for
regulations governing onshore oil and Financial Reports on these inflation
compensation under the program filed
gas operations as required by the adjustments.
with the United States Court of Federal
Federal Civil Penalties Inflation In July 2016, the BLM issued an
Claims on or after February 21, 2017.
(2) Hepatitis B, Hib, and varicella Adjustment Act Improvements Act of interim final rule that adjusted the level
vaccines (Items VIII, IX, and X of the 2015 (the ‘‘Act’’). The adjustments made of civil monetary penalties with the
Table) are included in the Table as of by this final rule constitute the annual initial ‘‘catch-up’’ adjustment, which is
August 6, 1997. inflation adjustments contemplated by reflected in the table below in the
(3) Rotavirus vaccines (Item XI of the the Act, and are consistent with ‘‘Previous Penalty’’ column.
Table) are included in the Table as of applicable Office of Management and With this final rule, the BLM is
October 22, 1998. Budget (OMB) guidance. adjusting civil monetary penalties for
(4) Pneumococcal conjugate vaccines inflation. The adjustments made by this
DATES: This rule is effective on January
(Item XII of the Table) are included in rule are consistent with the
19, 2017. requirements of the Act and OMB
the Table as of December 18, 1999.
FOR FURTHER INFORMATION CONTACT: guidance.
(5) Hepatitis A vaccines (Item XIII of
the Table) are included on the Table as Steven Wells, Division Chief, Fluid The purpose of these adjustments is to
of December 1, 2004. Minerals Division, 202–912–7143, for maintain the deterrent effect of civil
(6) Trivalent influenza vaccines information regarding the BLM’s Fluid penalties found in existing regulations,
(Included in item XIV of the Table) are Minerals Program. For questions in order to further the policy goals of the
included on the Table as of July 1, 2005. relating to regulatory process issues, underlying statutes. The BLM has
All other seasonal influenza vaccines please contact Jennifer Noe, Division of reviewed its existing regulations and
(Item XIV of the Table) are included on Regulatory Affairs, at 202–912–7442. determined that only the civil monetary
the Table as of November 12, 2013. Persons who use a telecommunications penalties found at 43 CFR 3163.2 are
(7) Meningococcal vaccines and device for the deaf (TDD) may call the subject to the Act’s requirements.
human papillomavirus vaccines (Items Federal Information Relay Service The adjustments made by this final
XV and XVI of the Table) are included (FIRS) at 1–800–877–8339, 24 hours a rule constitute the first annual
on the Table as of February 1, 2007. day, 7 days a week to contact the above adjustment contemplated by the Act,
(8) Other new vaccines (Item XVII of individuals. and include the following changes to
the Table) will be included in the Table SUPPLEMENTARY INFORMATION: the penalties:

Previous Adjusted
CFR Citation Description of the penalty
asabaliauskas on DSK3SPTVN1PROD with RULES

penalty penalty

43 CFR 3163.2(a) ............................ Failure to comply ....................................................................................... $1,031 $1,048
43 CFR 3163.2(b) ............................ If corrective action is not taken ................................................................. 10,314 10,483
43 CFR 3163.2(d) ............................ If transporter fails to permit inspection for documentation ....................... 1,031 1,048
43 CFR 3163.2(e) ............................ Failure to permit inspection, failure to notify ............................................. 20,628 20,965
43 CFR 3163.2(f) ............................. False or inaccurate documents; unlawful transfer or purchase ................ 51,570 52,414
43 CFR 3163.2(g)(1) ....................... Initial penalty under 43 CFR 3163.2(a) for a major violation ................... 1,031 1,048
43 CFR 3163.2(g)(1) ....................... Maximum penalty under 43 CFR 3163.2(a) for a major violation ............ 2,063 2,097

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Document Created: 2018-02-01 15:15:24
Document Modified: 2018-02-01 15:15:24

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This rule is effective February 21, 2017.
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.
FR Citation		82 FR 6294
RIN Number		0906-AB01
CFR Associated		Biologics; Health Insurance and Immunization