2011-8395. National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting Rule-Making Proceedings

AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Notice.

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-Barré 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 [phone].

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, 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-Barré 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.