[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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