[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 6423-6425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 100


National Vaccine Injury Compensation Program: Statement of 
Reasons for Not Conducting a Rulemaking Proceeding

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

ACTION: Denial of petition for rulemaking.

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SUMMARY: In accordance with section 2114(c)(2)(B) of the Public Health 
Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given 
concerning the reasons for not conducting a rulemaking proceeding to 
add neurological disorders or conditions as injuries associated with 
seasonal influenza vaccines to the Vaccine Injury Table.

DATES: Written comments are not being solicited.

FOR FURTHER INFORMATION CONTACT: Narayan Nair, MD, Director, Division 
of Injury Compensation Programs (DICP), Healthcare Systems Bureau, 
Health Resources and Services Administration, 5600 Fishers Lane, Room 
8N146B, Rockville, Maryland 20857, or by telephone 301-443-6593.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986, (Vaccine Act), Title III of Public Law 99-660, established the 
National Vaccine Injury Compensation Program (VICP) for persons found 
to be injured by vaccines.\1\ Under this federal program, petitions for 
compensation are filed with the United States Court of Federal Claims 
(Court). The Court, acting through special masters, makes findings as 
to eligibility for, and amount of, compensation. To gain entitlement to 
compensation under VICP for a covered vaccine, a petitioner must 
establish a vaccine-related injury or death in one of the following 
ways (unless another cause is found): (1) By proving that the first 
symptom of an injury or condition, as defined by the Qualifications and 
Aids to Interpretation, occurred within the time period listed on the 
Vaccine Injury Table (Table), and, therefore, is presumed to be caused 
by a vaccine; (2) by proving vaccine causation, if the injury or 
condition is not on the Table or did not occur within the time period 
specified on the Table; or (3) by proving that the vaccine 
significantly aggravated a pre-existing condition.
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    \1\ 42 U.S.C. 300 aa-10 et seq.
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    The statute authorizing VICP provides for the inclusion of 
additional vaccines in VICP when they are recommended by the Centers 
for Disease Control and Prevention for routine administration to 
children.\2\ Consistent with section 13632(a)(3) of Public Law 103-66, 
the regulations governing VICP provide that such vaccines will be 
included in the Table as of the effective date of an excise tax to 
provide funds for the payment of compensation with respect to such 
vaccines.\3\ The statute authorizing VICP also authorizes the Secretary 
to create and modify a list of injuries, disabilities, illnesses, 
conditions, and deaths (and their associated time frames) associated 
with each category of vaccines included on the Table.\4\ Finally, the 
Vaccine Act provides that:
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    \2\ Section 2114(e)(2) of the PHS Act, 42 U.S.C. 300aa-14(e)(2).
    \3\ 42 CFR 100.3(c)(8).
    \4\ Sections 2114(c) and 2114(e)(2) of the PHS Act, 42 U.S.C. 
300aa-14(c) and 300aa-14(e)(2).

[a]ny person (including the Advisory Commission on Childhood 
Vaccines) [the Commission] may petition the Secretary to propose 
regulations to amend the Vaccine Injury Table. Unless clearly 
frivolous, or initiated by the Commission, any such petition shall 
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be referred to the Commission for its recommendations. Following--

    (A) Receipt of any recommendation of the Commission, or
    (B) 180 days after the date of the referral to the Commission,

whichever occurs first, the Secretary shall conduct a rule-making 
proceeding on the matters proposed in the petition or publish

[[Page 6424]]

in the Federal Register a statement or reasons for not conducting 
such proceeding.\5\
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    \5\ Section 2114(c)(2) of the PHS Act, 42 U.S.C. 300aa-14(c)(2).

    On January 28, 2016, a private citizen submitted a petition to the 
Department of Health and Human Services (HHS) requesting that: (1) Any 
adverse neurological disorder or condition be added to the Table for 
the seasonal influenza vaccines; and (2) if any adverse neurological 
disorder or condition was too broad in scope, then at least 
anaphylaxis, Shoulder Injury Related to Vaccine Administration (SIRVA), 
vasovagal syncope, multiple sclerosis (MS), Guillain-Barr[eacute] 
Syndrome (GBS), transverse myelitis (TM), and myelitis be added to the 
Table for the seasonal influenza vaccine. The petitioner asserted that 
based on Vaccine Adverse Event Reporting System (VAERS) data and 
Department of Justice (DOJ) quarterly reports on vaccine settlements, 
which were presented at Commission meetings, there is sufficient 
evidence to add these conditions as injuries associated with the 
seasonal influenza vaccine to the Table. The petitioner did not provide 
any medical or scientific literature to accompany the request.
    Pursuant to the Vaccine Act, the petition was referred to the 
Commission on June 3, 2016. The Commission voted unanimously to 
recommend that the Secretary not proceed with rulemaking to amend the 
Table to include ``any adverse neurological disorder or condition,'' 
MS, TM, or myelitis as injuries associated with seasonal influenza 
vaccines as requested in the petition.
    The petitioner requested the addition of any adverse neurological 
disorder or condition to the Table for the seasonal influenza vaccine. 
The petitioner alleged that the DOJ quarterly reports on vaccine 
settlement cases and VAERS data support the inclusion of all of these 
conditions to the Table. However, neither of these sources of data is 
sufficient to modify the Table. The DOJ quarterly report is the report 
that DOJ provides and discusses at the quarterly Commission meetings 
and is made available to the public at http://www.hrsa.gov/advisorycommittees/childhoodvaccines/meetings.html. The report includes 
a list of adjudicated settlements for the applicable quarter by vaccine 
and alleged injury, and time frame from petition filing to settlement 
filing. In negotiated settlements between the parties, HHS has not 
concluded, based upon review of the evidence, that the alleged 
vaccine(s) caused the alleged injury. These settlements are not an 
admission by the United States or the Secretary of Health and Human 
Services that the vaccine caused the petitioner's alleged injury, and, 
in settled cases, the Court does not determine that the vaccine caused 
the injury. Therefore, a settlement cannot be characterized as a 
decision by HHS or by the Court that the vaccine caused an injury. 
Thus, information from negotiated settlements cannot be used to 
establish that vaccines cause certain injuries.
    The purposes of VAERS data are to: Detect new, unusual, or rare 
vaccine adverse events; identify potential patient risk factors for 
particular types of adverse events; identify vaccine lots with 
increased numbers or types of reported adverse events; and assess the 
safety of newly licensed vaccines. The VAERS data are considered a 
useful tool in vaccine safety, but VAERS reports by themselves 
generally cannot demonstrate that vaccines cause injuries.
    In 2008, the Secretary contracted with the Institute of Medicine 
(IOM) to review the epidemiologic, clinical, and biological evidence 
regarding adverse health events associated with specific vaccines 
covered by VICP. The results of this review were published in the 2012 
IOM Report, ``Adverse Effects of Vaccines: Evidence and Causality.'' 
This report reviewed 8 of the 12 vaccines covered by the VICP and 
provided 158 causality conclusions. The 2012 IOM Report reviewed the 
medical and scientific literature regarding a causal relationship 
between seasonal influenza vaccines and the following conditions: 
Encephalopathy, encephalitis, seizures, acute disseminated 
encephalomyelitis, TM, optic neuritis, neuromyelitis optica, MS, MS 
relapse, GBS, chronic inflammatory demyelinating polyneuropathy, Bell's 
palsy, brachial neuritis, and small fiber neuropathy. The IOM concluded 
that the evidence is inadequate to accept or reject a causal 
relationship between influenza vaccines and the above conditions. 
Therefore, ``any adverse neurological disorder or condition,'' as 
suggested by the petitioner will not be added as injuries caused by the 
seasonal influenza vaccine to the Table since the medical and 
scientific literature is not sufficient to support this change.
    The petitioner also requested that certain conditions be added to 
the Table if ``any adverse neurological disorder or condition'' could 
not be added to the Table. These conditions include: Anaphylaxis, 
SIRVA, vasovagal syncope, MS, GBS, TM, and myelitis. The petitioner 
stated that VAERS and settlement data from quarterly reports support 
the inclusion of these conditions for seasonal influenza vaccines to 
the Table. However, as explained above, the VAERS data and the DOJ 
quarterly report do not demonstrate that vaccines cause injuries and do 
not establish causality. As stated previously, the 2012 IOM Report 
reviewed the medical and scientific literature regarding causal 
relationships between seasonal influenza vaccines and MS, TM, and 
myelitis. The IOM concluded that the evidence is inadequate to accept 
or reject a causal relationship between influenza vaccines and these 
conditions.
    More recent studies support the lack of an association between the 
seasonal influenza vaccine and neurologic conditions, such as MS. The 
Williamson, et al. study found no substantiation to reports suggesting 
a link between MS and vaccines and that most of the studies that 
purported an increased risk of MS or relapse of MS after vaccination 
were small case series, which are methodologically less robust than 
other epidemiologic studies.\6\ In addition, Langer-Gould, et al. 
conducted a nested case control study that found no long-term 
association between vaccines and MS or other central nervous system 
acquired demyelinating syndromes.\7\ Therefore, MS, TM, and myelitis 
will not be added to the Table as injuries associated with the seasonal 
influenza vaccine since the medical and scientific literature is not 
sufficient to support those changes.
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    \6\ Williamson et al. Vaccines in Multiple Sclerosis, Curr 
Neurol Neurosci Rep 2016 16:36.
    \7\ Langer-Gould et al., Vaccines and the risk of MS and other 
CNS Demyelinating Diseases, JAMA Neurol. 2014:71(12): 1506-13.
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    HHS proposed certain changes to the Vaccine Injury Table in a 
Notice of Proposed Rulemaking (NPRM) published in the Federal Register 
on July 29, 2015 (80 Fed. Reg. 45132 (July 29, 2015)). Among other 
proposed changes, anaphylaxis, SIRVA, GBS, and vasovagal syncope were 
proposed to be added as injuries for seasonal influenza vaccines. HHS 
is adding these injuries with the final rule, titled ``National Vaccine 
Injury Compensation Program: Revisions to the Vaccine Injury Table,'' 
concurrently publishing in the Federal Register.
    In conclusion, there is no reliable evidence to support the 
addition of ``any adverse neurological disorder or condition,'' MS, TM, 
or myelitis to the Table as injuries associated with the seasonal 
influenza vaccine. Therefore, the Table will not be amended at this 
time to include those injuries on the Table.


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    Dated: January 9, 2017.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-00700 Filed 1-18-17; 8:45 am]
 BILLING CODE 4165-15-P