[Federal Register Volume 76, Number 68 (Friday, April 8, 2011)]
[Notices]
[Pages 19778-19779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


National Vaccine Injury Compensation Program: Statement of 
Reasons for Not Conducting Rule-Making Proceedings

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In accordance with section 2114(c)(2)(B) of the Public Health 
Service Act, notice is hereby given of the reasons for not conducting a 
rule-making proceeding for adding Guillain-Barr[eacute] Syndrome (GBS) 
to the Vaccine Injury Table at this time.

DATES: Written comments are not being solicited.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Director, 
Division of Vaccine Injury Compensation, Healthcare Systems Bureau, 
Health Resources and Services Administration (HRSA), Room 11C-26, 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; 
telephone number (301) 443-6593.

SUPPLEMENTARY INFORMATION: 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 National Vaccine Injury Compensation Program (VICP) for 
persons found to be injured by vaccines. 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. In 
order to gain entitlement to compensation under title XXI of the Public 
Health Service (PHS) Act for a covered vaccine, a petitioner must 
establish a vaccine-related injury or death, either by proving that the 
first symptom of an injury/condition, as defined by the Qualifications 
and Aids to Interpretation, occurred within the time period listed on 
the Vaccine Injury Table (Table), and therefore presumed to be caused 
by a vaccine (unless another cause is found), or by proof of vaccine 
causation, if the injury/condition is not on the Table or did not occur 
within the time period specified on the Table.
    The statute authorizing the VICP provides for the inclusion of 
additional vaccines in the VICP when they are recommended by the 
Centers for Disease Control and Prevention (CDC) for routine 
administration to children. See section 2114(e)(2) of the PHS Act, 42 
U.S.C. 300aa-14(e)(2). Consistent with section 13632(a)(3) of Public 
Law 103-66, the regulations governing the 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. 42 CFR 100.3(c)(5). The statute authorizing 
the VICP also authorizes the Secretary to create and modify a list of 
injuries,

[[Page 19779]]

disabilities, illnesses, conditions, and deaths (and their associated 
time frames) associated with each category of vaccines included on the 
Table. See sections 2114(c) and 2114(e)(2) of the PHS Act, 42 U.S.C. 
300aa-14(c) and 30aa-14(e)(2). Finally, section 2114(c)(2) of the PHS 
Act, 42 U.S.C. 300aa-14(c)(2) provides that:

[a]ny person (including the Advisory Commission on Childhood 
Vaccines) 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 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 in the 
Federal Register a statement of reasons for not conducting such 
proceeding.

On September 9, 2010, a private person submitted a petition to amend 
the Table. This petition was submitted to the Chief Special Master, 
Sandra Lord, with a copy to Dr. Geoffrey Evans, Director, Division of 
Vaccine Injury Compensation. Pursuant to the VICP statute, Dr. Evans 
referred the petition to the Commission on October 28, 2010. The 
Commission discussed the petition at its meeting on March 3, 2011. At 
the conclusion of this discussion, the Commission voted unanimously to 
recommend that the Secretary not proceed with rule-making to amend the 
Table as requested in the petition.
    The petition requests that the Secretary amend the Table to include 
Guillain-Barr[eacute] Syndrome (GBS) as an injury following certain 
vaccines. The petition asserts that ``[e]very drug company admits that 
GBS is linked to many different vaccines including influenza, 
meningitis, and cervical cancer [human papillomavirus].'' The 
petitioner asserts that her mother received the seasonal influenza 
vaccine, and was subsequently diagnosed with GBS. Other than the 
assertion cited, the petition does not cite scientific support, nor 
indicate specifically for which vaccines GBS should be added as an 
injury, nor indicate any appropriate time-frame.
    Nonetheless, the Secretary takes very seriously proposals to modify 
the Table. Prior to receipt of the petition, in 2008, the Secretary 
contracted with the Institute of Medicine (IOM) to review the 
epidemiological, clinical, and biological evidence regarding adverse 
health events associated with specific vaccines covered by the VICP. 
The vaccines to be reviewed are:
     Varicella vaccines,
     influenza vaccines,
     hepatitis B vaccine,
     human papillomavirus vaccines,
     hepatitis A vaccines,
     meningococcal vaccines,
     measles-mumps rubella vaccines, and
     diphtheria, tetanus, pertussis vaccines.
    The IOM committee will author a consensus report with conclusions 
on the evidence bearing on causality and the evidence regarding the 
biological mechanisms that underlie specific theories for how a 
specific vaccine is related to a specific adverse event. In particular, 
the report will contain updated findings on the possible causal 
relationship between certain VICP-covered vaccines and GBS, as well as 
other possible injuries/medical conditions. The Secretary expects to 
receive the IOM consensus report in early summer. After receipt of the 
consensus report, and a careful analysis of the important scientific 
and policy considerations raised by the findings in the report, the 
Secretary will consider whether to engage in a rule-making proceeding 
to modify the Table. As required by law, any such rule-making 
proceeding would include notice and opportunity for a public hearing 
and at least 180 days of public comment. See section 2114(c)(1) of the 
PHS Act, 42 U.S.C. 300aa-14(c)(1). Also as required by law, the 
Secretary would provide to the Commission a copy of the proposed 
regulation or revision, request recommendations and comments by the 
Commission, and afford the Commission at least 90 days to make such 
recommendations. See section 2114(d) of the PHS Act, 42 U.S.C. 300aa-
14(d).
    The Secretary intends to consider whether to engage in a rule-
making process with the benefit of the important scientific information 
soon to be provided by the IOM; to begin the lengthy process without 
such additional information would not result in rule-making founded on 
the best and most recent scientific knowledge. For these reasons, it 
has been determined not to conduct a rule-making proceeding based on 
the petition received at this time.

    Dated: April 1, 2011.
Mary K. Wakefield,
Administrator.
[FR Doc. 2011-8395 Filed 4-7-11; 8:45 am]
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