[Federal Register Volume 59, Number 57 (Thursday, March 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6858]


[[Page Unknown]]

[Federal Register: March 24, 1994]


  
  
  
  
=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 100

 

National Vaccine Injury Compensation Program: Revision to Vaccine 
Injury Table

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of Extension of Public Comment Period.

-----------------------------------------------------------------------

SUMMARY: This document affords interested members of the public an 
additional 30 days to comment on proposed regulations to amend the 
Vaccine Injury Table governing the National Vaccine Injury Compensation 
Program (VICP) due to recent publication of a study that may be 
relevant to the vaccine injury table.

DATES: Comments must be submitted on or before April 25, 1994.

ADDRESSES: Written comments should be addressed to Fitzhugh Mullan, 
M.D., Director, Bureau of Health Professions (BHPr), Health Resources 
and Services Administration (HRSA), room 8-05, Parklawn Building, 5600 
Fishers Lane, Rockville, MD 20857. All comments received will be 
available for public inspection and copying at the Office of Program 
Development, BHPr, room 8A-55, Parklawn Building, at the above address 
weekdays (Federal holidays excepted) between the hours of 8:30 a.m. and 
5 p.m.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Deputy Director, 
Division of Vaccine Injury Compensation, BHPr, (301) 443-6593. David 
Benor, Senior Attorney, Office of the General Counsel, (301) 443-2006.

SUPPLEMENTARY INFORMATION: The Agency is publishing this Notice to 
afford members of the public an additional 30 days to provide comments 
on proposed regulations to amend the Vaccine Injury Table governing the 
National Vaccine Injury Compensation Program (hereinafter ``VICP'' or 
``Program''). The VICP was established by the National Childhood 
Vaccine Injury Act of 1986, Pub. L. 99-660 [42 U.S.C. 300aa-10 et seq.] 
(Act), and provides a system of no-fault compensation for certain 
individuals who have been injured by specific childhood vaccines. 
Petitions for compensation under this Program are filed with the United 
States Court of Federal Claims, with a copy served on the Secretary, 
who is denominated the ``Respondent.'' The Vaccine Injury Table (Table) 
included in the Act establishes presumptions about causation of certain 
illnesses and conditions, which are used by the U.S. Court of Federal 
Claims to adjudicate petitions.
    Under section 312 of the Act, Congress mandated that the Secretary 
review the scientific literature and other information on specific 
adverse consequences of pertussis and rubella vaccines. In accordance 
with the requirements of that law, the Secretary entered into a 
contract with the Institute of Medicine (IOM) to perform this review. 
The IOM published on August 27, 1991 a report of its review entitled, 
``Adverse Effects of Pertussis and Rubella Vaccines'' (hereinafter 
``IOM Report.'')
    Section 312 also required the Secretary to propose regulations to 
amend the Table as a result of such findings. Accordingly, on August 
14, 1992, the Assistant Secretary for Health, with the approval of the 
Secretary of Health and Human Services (the Secretary) published in the 
Federal Register (57 FR 36878) a Notice of Proposed Rulemaking (NPRM) 
to amend the Table. The NPRM was issued pursuant to section 2114 of the 
Act, which authorizes the Secretary to promulgate regulations to modify 
the Table. As required by section 2114(c) of the Act, the Department 
provided for a 6-month comment period which closed on February 11, 
1993. In addition, on December 3, 1992, the Department held a public 
hearing for the purpose of receiving oral testimony on the proposed 
rule.
    The Agency analyzed the comments received in preparation for 
publication of the final rule. During this process, however, the Agency 
became aware of the imminent publication of a 10-year follow-up study 
to the National Childhood Encephalopathy Study (Madge N., Diamond J., 
Miller D., Ross E., McManus C., Wadsworth J., Yule W. The National 
Childhood Encephalopathy Study: A 10-year follow-up. A report of the 
medical, social, behavioural and educational outcomes after serious, 
acute, neurologic illness in early childhood. Developmental Medicine 
and Child Neurology 1993; Supplement No. 68;35(7):1-118; Miller D.L., 
Madge N., Diamond J., Wadsworth J., Ross E. Pertussis immunization and 
serious acute neurological illness in children. British medical Journal 
1993; 307:1171-1176, hereinafter ``Miller study.''). Because the 
National Childhood Encephalopathy Study (NCES) was reviewed initially 
by the IOM, and because the Miller study looked specifically at the 
relationship between vaccine administration and resulting neurological 
damage, the Department determined that it should not proceed with 
publication of the final rule until there had been a sufficient 
opportunity to consider the conclusions of the new Miller study. 
Accordingly, the Department asked the IOM to convene a Committee for 
purposes of evaluating the Miller study in light of the conclusions of 
its initial report. On March 2, 1994, the Institute of Medicine issued 
a report entitled ``DPT Vaccine and Chronic Nervous System Dysfunction: 
A New Analysis.''
    The Agency has determined that the public should have an additional 
30 days to comment on the conclusions of this report prior to 
publication of the final rule. Only those comments addressing the 
conclusions of this latest IOM report will be considered. Commenters 
should address whether the proposed rule should be modified in light of 
the conclusions of this latest IOM report. The Department will consider 
carefully all comments received, and will address these comments in the 
preamble to the final rule.
    The Department is not able to reproduce herein the entire study for 
review by the public. Set forth below, however, is the Executive 
Summary of the report containing the IOM's conclusions. Copies of the 
full report can be obtained by contacting the National Academy of 
Sciences, 2101 Constitution Avenue, NW., Washington, DC 20077-5576.

Executive Summary

    An Institute of Medicine (IOM) committee recently concluded that 
the evidence is consistent with a causal relation between vaccination 
with DPT and acute encephalopathy (IOM, 1991), and the excess risk was 
estimated to range from 0 to 10.5 per million DPT immunizations. 
However, the same IOM committee also concluded that the evidence was 
insufficient to indicate a causal relation between DPT and permanent 
neurologic damage (IOM, 1991). In fact, the relation between DPT and 
chronic nervous system dysfunction had not been studied in a rigorous 
scientific manner until recently. Because the evidence has been so 
limited, the appearance of a single new report, a 10-year follow-up to 
the National Childhood Encephalopathy Study (NCES, Miller et al., 
1993), prompted the U.S. Public Health Service to ask IOM to convene 
the Committee to Study New Research on Vaccines with the charge of 
studying the new data and, if warranted, reevaluating the causal 
relation between DPT and chronic nervous system dysfunction.
    The NCES reported that the occurrence of hospitalization for 
serious neurologic disorders among 2- to 35-month-old children is very 
strongly related to the occurrence of death or nervous system 
dysfunction (neurologic, behavioral, educational, motor, sensory, or 
self-care impairment) up to 10 years (Madge et al., 1993; Miller et al. 
1993). Children who experienced the rare but serious acute neurologic 
disorder within 7 days after receiving DPT were no more or less likely 
to experience documented chronic nervous system dysfunction or to have 
died within 10 years of the acute disorder than children who had not 
received DPT within 7 days prior to the onset of the disorder. There 
were no special characteristics associated with the acute or chronic 
nervous system illnesses linked to DPT exposure.
    The NCES did not investigate the possibility of a direct relation 
between DPT and chronic nervous system dysfunction, that is, in the 
absence of a serious acute neurologic illness that occurs within 7 days 
after receiving DPT. The NCES provides data only on the limited case of 
a possible relation between DPT and chronic nervous system dysfunction 
in those children in whom a serious acute neurologic illness followed 
DPT vaccination within 7 days.
    The committee posits three possible scenarios whereby the acute 
neurologic illnesses that follow DPT might be related to chronic 
nervous system dysfunction.
    1. DPT administration might cause serious acute neurologic illness 
and subsequent chronic dysfunction in children who might not have 
otherwise experienced either an acute neurologic illness or chronic 
dysfunction in the absence of DPT.
    2. DPT might trigger (and thereby be an immediate or proximate 
cause) an acute neurologic illness and subsequent chronic dysfunction 
in children with underlying brain or metabolic abnormalities. Such 
children might experience acute neurologic illness and subsequent 
chronic dysfunction in association with some trigger other than DPT.
    3. DPT might cause an acute neurologic illness in children with 
underlying brain or metabolic abnormalities that would themselves 
eventually have led to chronic dysfunction even in the absence of an 
acute neurologic illness.
    The Committee believes its conclusions take into account the fact 
that the data do not support any one of these scenarios over the 
others. Because the NCES did not (and probably could not) rule out the 
possibility that only children with underlying brain or metabolic 
abnormalities react to stimuli such as DPT with acute neurologic 
illness, and no other studies establish or rule out such a possibility, 
the committee concludes that the evidence is insufficient to indicate 
whether or not DPT increases the overall risk in children of chronic 
nervous system dysfunction.
    The NCES data are consistent with the possibility that some 
children without underlying brain or metabolic abnormalities might 
experience serious, acute neurologic illness within 7 days after 
receiving DPT and that acute neurologic illness will have chronic 
nervous system sequelae. The NCES data also are consistent with the 
possibility that some children with underlying brain or metabolic 
abnormalities (which foster a ``triggering'' by DPT of an acute 
neurologic illness) might go on to develop chronic nervous system 
dysfunction due to a DPT-triggered acute illness. Therefore, the 
committee concludes that the balance of evidence is consistent with a 
causal relation between DPT and the forms of chronic nervous system 
dysfunction described in the NCES in those children who experience a 
serious, acute neurologic illness within 7 days after receiving DPT 
vaccine. This serious, acute neurologic response to DPT is a rare 
event. The excess risk has been estimated to range from 0 to 10.5 per 
million immunizations (IOM, 1991). The evidence does not ``establish'' 
or ``prove'' a causal relation. The evidence remains insufficient to 
indicate the presence or absence of a causal relation between DPT and 
chronic nervous system dysfunction under any other circumstances. That 
is, because the NCES is the only systematic study of long-term 
dysfunctions after DPT, the committee can only comment on the causal 
relation between DPT and those long-term dysfunctions under the 
conditions studied by the NCES. In particular, it should be noted that 
the long term dysfunctions associated with DPT followed a serious acute 
neurologic illness that occurred in children within 7 days after 
receiving DPT.

    Dated: March 18, 1994.
Ciro V. Sumaya,
Administrator.
[FR Doc. 94-6858 Filed 3-23-94; 8:45 am]
BILLING CODE 4160-15-P