[Federal Register Volume 62, Number 34 (Thursday, February 20, 1997)]
[Rules and Regulations]
[Pages 7685-7690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4088]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
42 CFR Part 100
RIN 0906-AA36
National Vaccine Injury Compensation Program: Revisions and
Additions to the Vaccine Injury Table--II
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Secretary has made findings as to certain illnesses and
conditions that can reasonably be determined in some circumstances to
be caused or significantly aggravated by certain vaccines. Based on
these findings, the Secretary is amending, by final rule, the existing
regulations governing the National Vaccine Injury Compensation Program
(VICP) by revising the Vaccine Injury Table (Table) as authorized under
section 313 of the National Childhood Vaccine Injury Act of 1986 and
section 2114 (c) and (e) of the Public Health Service Act (the Act).
The VICP provides a system of no-fault compensation for certain
individuals who have been injured by specific childhood vaccines. The
Vaccine Injury Table included in the Act establishes presumptions about
causation of certain illnesses and conditions, which are used by the
Court to adjudicate petitions.
EFFECTIVE DATE: This regulation is effective March 24, 1997.
FOR FURTHER INFORMATION CONTACT:
Geoffrey Evans, M.D., Chief Medical Officer, Division of Vaccine Injury
Compensation, Bureau of Health Professions, (301) 443-4198, or David
Benor, Senior Attorney, Office of the General Counsel (301) 443-2006.
SUPPLEMENTARY INFORMATION:
Introduction and Procedural History
On November 8, 1995, the Assistant Secretary for Health, with the
approval of the Secretary of Health and Human Services (the Secretary),
published in the Federal Register (60 FR 56289) A Notice of Proposed
Rulemaking (NPRM) to amend the Vaccine Injury Table (the Table) and to
revise the Qualifications and Aids to Interpretation of the Table
(Qualifications and Aids). The NPRM was issued pursuant to section
2114(c) of the Act, which authorizes the Secretary to promulgate
regulations to modify the Table, and section 2114(e), which directed
the Secretary to add to the Table, by rulemaking, coverage of
additional vaccines which are recommended by the Centers for Disease
Control and Prevention for routine administration to children.
As stated in the preamble to the NPRM, under section 313 of the
Act, Congress mandated that the Secretary review the scientific
literature and other relevant information to determine whether, based
upon the available evidence, a causal relationship exists between
certain adverse events examined and exposure to vaccines against
diphtheria, measles, mumps, poliomyelitis, and tetanus. The review was
broadened to include the vaccines against hepatitis B, and Hemophilus
influenzae type b (Hib). The Secretary entered into a contract with the
Institute of Medicine (IOM), as recommended by Congress, to perform
this review. The IOM issued its findings in a report entitled Adverse
Events Associated with Childhood Vaccines; Evidence Bearing on
Causality. (Institute of Medicine, K.R. Stratton, C.J. Howe, R.B.
Johnson, Eds., 1994.) Upon consideration of the IOM report,
consultations with the Advisory Committee on Childhood Vaccines (ACCV),
and the National Vaccine Advisory Committee (NVAC), and review of other
relevant scientific information, the Secretary published the proposed
changes to the Table and the Qualifications and Aids.
There was a 6-month comment period after publication. The Secretary
received three written comments in response to the NPRM. A public
hearing was scheduled for February 29, 1996, as announced in the
Federal Register on February 5, 1996 (61 FR 4249), but no individual or
organization appeared to testify.
One of the commenters, an association representing pediatricians,
extended its full support for the proposed additions and revisions to
the Table.
A second comment was submitted by a manufacturer of several
childhood vaccines. The manufacturer's comment was that the proposed
revisions to the Table did not definitively state how the proposed
revisions would affect persons who have pending civil actions against
vaccine manufacturers or administrators when the revisions to the Table
become effective. The manufacturer suggested that language should be
added to the rule which affirmatively gives plaintiffs in the tort
system the ability to file a claim, within 2 years after the effective
date of the revision or before judgment, if the injury or death
allegedly attributable to the vaccine occurred no more than 8 years
before the effective date of the revision. Section 2116(b) of the Act
provides a 2-year period after the effective date of a revision to the
Table for a petition to be filed based on the revision. The injury or
death alleged to be related to the vaccine must have occurred no more
than 8 years before the date of the revision. However, section
2111(a)(5)(B) of the Act states that ``[i]f a plaintiff has pending a
civil action for damages for a vaccine-related injury or death, such
person may not file a petition under the subsection (b) (of the Act)
for such injury or death.'' reading these provisions together, it
appears that if a plaintiff in such a case dismisses the civil action
and files a Program petition within the applicable time limit, the
petition may proceed. (If the civil action led to an award of damages
or a settlement, section 2111(a)(7) of the Act would prohibit the
filing of the petition.) In the light of these statutory provisions, we
believe that the issue raised by the commenter is adequately addressed.
The final comment was from a group representing vaccine-injured
persons and their families. The group had comments in several areas.
The Secretary has carefully considered these comments and responds to
them below. The first assertion of the group was that two independent
IOM committees concluded that the scientific evidence favors a causal
relationship between oral polio vaccine and tetanus vaccine and
Guillain-Barre Syndrome (GBS). The commenter questions why, given this
information, the Secretary is proposing to remove GBS from the Table.
First, it is worth noting that this condition has never been included
in the Table. Moreover, the preamble to the NPRM explained in detail
the Department's reasons for proposing not to extend the Table's
coverage to this condition. (60 FR 56292-3 and 56296-7.) The
commenter's reference to the IOM committee's report does not provide a
sufficient basis to reverse the Department's analysis, given that this
analysis fully considered the IOM committee's report, as well as other
relevant data.
The commenter's second concern asked for an explanation of why
anaphylaxis is the only Table injury for hepatitis B vaccine when the
IOM review stated that no scientific studies have been conducted to
determine if there is a causal relationship between hepatitis B and
arthritis, Sudden Infant Death Syndrome (SIDS), GBS, myoptic (sic:
optic) neuritis, multiple sclerosis, transverse myelitis or other
central
[[Page 7686]]
demyelinating disease. Similarly, the group questions why there is no
Table injury for Hemophilus influenzae type b (Hib) vaccine when no
scientific studies have been done to determine whether there is a
causal connection between the Hib vaccine and transverse myelitis, GBS,
thrombocytopenia, anaphylaxis and SIDS. The Secretary is charged with
revising the Table where such revisions are in keeping with scientific
evidence. The goal is to have the Table and Qualifications and Aids
reflect current scientific knowledge on the relationship between
certain adverse events and covered vaccines. Where that scientific
research concerning the relationship between a disorder and a vaccine
is incomplete or nonexistent, the Secretary believes it would be
inappropriate and inconsistent with her statutory responsibility to
revise the Table to establish a presumption that a relationship exists.
The group also commented upon the ability of the Vaccine Adverse
Events Reporting System (VAERS) to capture adequately the frequency and
severity of vaccine reactions. VAERS is a passive reporting system for
events that are temporally related to vaccine administration. See
section 2125 of the Act. VAERS is not, however, a matter within the
scope of this rulemaking.
Finally, the group states that no vaccine should be added to the
Table until credible scientific studies have been conducted to
determine which chronic health problems are being caused by new
vaccines. Under section 2114(e) of the Act, the Secretary is required
to revise the Table to include vaccines recommended to the Secretary by
the Centers for Disease Control and Prevention (CDC), for routine
administration to children. If the scientific evidence is insufficient
to establish that an illness or condition is associated with such a
vaccine, then it is appropriate to include the vaccine on the Table
without establishing that such illness or condition is presumed to be
caused by the vaccine. The addition of vaccines to the Table allows
individuals alleging injury by such vaccines to file petitions for
compensation and to prevail on the basis of the Act's ``causation in
fact'' standard. See section 2111(c)(1)(C)(ii)(I) of the Act. Such
petitioners benefit from participating in the Program in that they need
not show negligence or some other standard of liability, as would be
required in a civil action. Should the Department learn that these new
vaccines have associated illnesses or conditions, rulemaking will be
initiated to amend the Table.
Other Information
The Act provides that a revision to the Table based on the addition
of vaccines under section 2114(e) of the Act shall take effect upon the
effective date of a tax enacted to provide funds for compensation for
injuries from vaccines that are added to the Table. See section
13632(a)(3) of the Omnibus Budget Reconciliation Act of 1993, Pub. L.
103-66 enacted August 10, 1993. The tax for the hepatitis B, the Hib
and the varicella vaccines has not been enacted yet; accordingly,
claimants alleging an injury or death as a result of a hepatitis B,
Hib, or varicella vaccination will not have a cause of action against
the Secretary until the tax is enacted and become effective. See
Sec. 100.3(c)(2). However, the other changes to the Qualifications and
Aids to Interpretation of the Table and the addition of certain
illnesses, disabilities or conditions to the Table, e.g., brachial
neuritis as a Table injury for DPT, will become effective on March 24,
1997. See Sec. 100.3(c)(1). Thus, there will be some delay between the
time the final rule becomes effective and the time the hepatitis B,
Hib, and varicella vaccines provide a cause of action for petitioners.
As soon as the tax becomes effective, a petitioner may file a claim for
an injury or death allegedly caused by these vaccines. The Clerk of the
U.S. Court of Federal Claims will determine how a filing will be
processed when a petitioner files a claim for hepatitis B, Hib, or
varicella injuries before the tax becomes effective.
Hemophilus Influenzae Type B (Hib) Vaccine
As noted in the preamble to the NPRM (p. 56297), unconjugated Hib
polysaccharide vaccine (PRP) was found to be associated with early
onset invasive Hib disease. As discussed elsewhere in this preamble,
the option to file a petition for an injury associated with vaccines
now being added to the Table is limited to cases based on vaccine-
related injuries or deaths that occurred within the 8-year period
before the effective date of the addition. As almost all cases of early
onset invasive Hib disease which are vaccine-related will be associated
with vaccines given before December 1987 (when the Hib conjugate
vaccine took the place of the PRP vaccine for routine administration),
the result of this 8-year limitation means that the likely cases of
this vaccine-associated condition will not be able to file for
compensation under the Program, absent a change to the statute.
Nevertheless, we are retaining this as a Table injury in case the
vaccine has been administered within the 8-year period or is
administered in the future.
Varicella Vaccine
As provided in the NPRM, the Table includes any new vaccine
recommended by the CDC for routine administration to children. Since
the publication of the NPRM, CDC has recommended the varicella vaccine
for routine administration to children and, consistent with the
Secretary's obligations under section 2114(e), the varicella vaccine
has been added to the Table as item XI. No adverse reactions for the
varicella vaccine are being added to the table, as there is no evidence
of any serious illness or condition related to this vaccine. However,
should the Department become aware of any adverse events associated
with the varicella vaccine, rulemaking will be initiated to revise the
Table accordingly.
Technical Amendments
In the Notice of Proposed Rulemaking published in the Federal
Register on November 8, 1995, items I.C, II.C., III.C., IV.B, and V.C.
of the Table read: ``[a]ny sequela (including death) of an illness,
disability, injury, or condition referred to above which illness,
disability, injury, or condition arose within the time period
prescribed.'' These items are being revised to read: ``[a]any acute
complication or sequela (including death) of an illness, disability,
injury, or condition referred to above which illness, disability,
injury, or condition arose within the time period prescribed.'' The
additional language does not represent a change in the available Table
injuries; rather, the language is added to provide internal consistency
within the Table. In addition, because the varicella vaccine has been
added to the Table as item XI, former item XI designated in the NPRM is
now renumbered as item XII in the final rule. Further, we have revised
the format of the Table to make it more readable.
Finally, as we indicated in the preamble to the 1995 regulation, we
did not intend that hospitalization be viewed as an absolute
requirement to establish an acute encephalopathy, but rather as an
indicator of the severity of the acute event. (See the qualifications
and aids to interpretation at Sec. 100.3 (b)(2)(i)). To allay concerns
in this regard, we have made this explicit in the regulation itself by
adding the following parenthetical phrase at the end of the sentence in
paragraph (i): ``whether or not a hospitalization occurred''.
[[Page 7687]]
Guidelines
As noted in the NPRM, section 313 requires that the Secretary
establish guidelines based on the results of the 313 report
``respecting the administration'' of the vaccines that were reviewed,
which guidelines shall include:
``(i) The circumstances under which any such vaccine should not be
administered,
``(ii) The circumstances under which administration of any such
vaccine should be delayed beyond its usual time of administration, and
``(iii) The groups, categories, or characteristics of potential
recipients of such vaccine who may be at significantly higher risk of
major adverse reactions to such vaccine than the general population of
potential recipients.''
We have examined the recommendations of the Advisory Committee on
Immunization Practices (ACIP) of the CDC, as set forth in the Morbidity
and Mortality Weekly Reports Recommendations and Reports, dated
September 6, 1996 entitled, ``Update: Vaccine Side Effects, Adverse
Reactions, Contraindications and Precautions.'' Members of the public
may obtain copies of the report by writing to MS Publications, C.S.P.O.
Box 9120, Waltham, MA 02254, telephone 1-800-843-6356, 617-893-3800
(Massachusetts). The cost of the publication is $4.00. It may be
obtained without charge through use of the World-Wide Web (WWW). The
address is ``http://www.cdc.gov/epo/mmwr/mmwr__rr.html.'' We find that
the ACIP recommendations are consistent with the findings that the
Department made as part of section 313 NPRM and this final rule, and
that they satisfy the statutory requirements for guidelines.
Accordingly, we proposed that the ACIP recommendations will constitute
the guidelines called for by section 313.
Section 313 calls for consultation with the ACCV and notice and
opportunity for public hearing with respect to these guidelines. The
ACIP recommendations were submitted to the ACCV at its meeting of June
6-7, 1996. We will also offer the opportunity for public comment on the
use of the ACIP recommendations as the section 313 guidelines at a
hearing which we anticipate will be scheduled in conjunction with a
future ACCV meeting. A separate notice will be published in the Federal
Register to invite public comment at that hearing. After consideration
of any comments which we receive, we will publish a notice about the
final adoption of these guidelines.
Future revisions of the ACIP recommendations will also be effective
for 313 purposes and a notice to that effect will accompany the
publication of the ACIP recommendations in the MMWR.
Economic Impact
The Secretary certifies that this final rule will not have a
significant impact on a substantial number of small businesses, because
it will have only small effects, and those primarily on individuals.
The effects will be primarily on the ability of certain individuals to
obtain compensation without having a burden of proving causation in
fact. Attorneys who represent such individuals will be affected only to
the extent that they may have a harder or easier burden of proof with
respect to the petitions filed. However, under section 2115(e) of the
Act, in almost all cases, attorneys' reasonable fees and costs are
reimbursed from the Vaccine Injury Compensation Trust Fund.
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, of costs, of benefits, of incentives, of
equity, and of available information. Regulations must meet certain
standards, such as avoiding unnecessary burden. Regulations which are
``significant'' because of cost, adverse effects on the economy,
inconsistency with other agency actions, effects on the budget, or
novel legal or policy issues, require special analysis.
As stated above, this final rule would modify the Vaccine Injury
Table based on legal authority, and under that authority the Court will
award such fees and costs as appropriate under the law. As such, the
regulation would have little direct effect on the economy or on Federal
or State expenditures. For the same reasons, the Secretary has also
determined that this is not a ``significant'' rule under Executive
Order 12866.
Effect of the New Rule
The final rule will have an effect for individuals who were not
eligible to file petitions based on the earlier versions of the Vaccine
Injury Table, but who may be eligible to file petitions based on the
revised Table. The Act permits such individuals to file a petition for
such compensation not later than 2 years after the effective date of
the revision if the injury or death occurred not more than 8 years
before the effective date of the revision of the Table. See 42 U.S.C.
300aa-16(b). As part of the Omnibus Budget Reconciliation Act of 1993
(Pub. L. 103-66), Congress amended this section to permit individuals
to file claims within this 2-year period, even if they had already
filed a claim involving a particular vaccine, but only if the Table
revision will ``significantly increase the likelihood of obtaining
compensation.'' See Pub. L. 103-66, sec. 13632(a)(1). For example, this
amendment would permit an individual whose claim alleging MMR vaccine-
related thrombocytopenic purpura had been dismissed by the Claims Court
to file a new claim for the same vaccine-related injury, if the
individual can show that the addition of thrombocytopenic purpura to
the Table as a MMR vaccine-related condition has significantly
increased the likelihood of obtaining compensation.
Possible Effect on Other Legislation
This rule will not have an effect on the Vaccine for Children
Program, implemented by the CDC under section 1928 of the Social
Security Act, as enacted by section 13631 of Pub. L. 103-66. This
section provides for the establishment of a program to distribute free
vaccines to all vaccine-eligible children, as defined by this section.
The rule modifies the existing Vaccine Injury Table, a mechanism by
which compensation is awarded to individuals who have been found to
have suffered from vaccine-related injuries. Because the two
authorities are not related, the publication of this rule should not
have any impact on the Vaccines for Children Program.
Paperwork Reduction Act of 1980
This final rule has no information collection requirements.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, and Immunization.
Dated: September 23, 1996.
Ciro V. Sumaya,
Administrator, Health Resources and Services Administration.
Approved: November 22, 1996.
Donna E. Shalala,
Secretary.
Accordingly, 42 CFR part 100 is amended as set forth below.
PART 100--VACCINE INJURY COMPENSATION
1. The authority citation for part 100 is revised to read as
follows:
Authority: Sec. 215 of the Public Health Service Act (42 U.S.C.
216); sec. 2115 of the PHS Act, 100 Stat. 3767, as revised (42
U.S.C. 300aa-15); Sec. 100.3, Vaccine Injury Table, issued under
secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779--3782 (42 U.S.C.
300aa-
[[Page 7688]]
1 note) and sec. 2114(c) and (e) of the PHS Act, 100 Stat. 3766 and
107 Stat. 645 (42 U.S.C. 300aa-14(c) and (e)).
2. Section 100.3 is amended by revising the Vaccine Injury Table in
paragraph (a); by republishing the introductory text in paragraph (b);
by revising paragraph (b)(2)(i); by revising paragraph (b)(6); by
adding paragraphs (b)(7), (b)(8), (b)(9), (b)(10), and (b)(11); and by
revising paragraph (c) to read as follows:
Sec. 100.3 Vaccine injury table.
(a) * * *
Vaccine Injury Table
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Time period for
first symptom or
manifestation of
Illness, disability, onset or of
Vaccine injury or condition significant
covered aggravation after
vaccine
administration
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I. Vaccines containing A. Anaphylaxis or 4 hours.
tetanus toxoid (e.g., DTaP, anaphylactic shock. 2-28 days.
DTP, DT, Td, or TT). B. Brachial Neuritis
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
II. Vaccines containing A. Anaphylaxis or 4 hours.
whole cell pertussis anaphylactic shock. 72 hours.
bacteria, extracted or B. Encephalopathy Not applicable.
partial cell pertussis (or encephalitis).
bacteria, or specific C. Any acute
pertussis antigen(s) (e.g., complication or
DTP, DTaP, P, DTP-Hib). sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
III. Measles, mumps, and A. Anaphylaxis or 4 hours.
rubella vaccine or any of anaphylactic shock. 5-15 days (not less
its components (e.g., MMR, B. Encephalopathy than 5 days and not
MR, M, R). (or encephalitis). more than 15 days).
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
IV. Vaccines containing A. Chronic arthritis 7-42 days.
rubella virus (e.g., MMR, B. Any acute Not applicable.
MR, R). complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
V. Vaccines containing A. Thrombocytopenic 7-30 days.
measles virus (e.g., MMR, purpura. 6 months.
MR, M). B. Vaccine-Strain
Measles Viral
Infection in an
immunodeficient
recipient.
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
VI. Vaccines containing A. Paralytic Polio
polio live virus (OPV).
--in a non- 30 days.
immunodeficient
recipient.
--in an 6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
B. Vaccine-Strain
Polio Viral
Infection
--in a non- 30 days.
immunodeficient
recipient.
--in an 6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
VII. Vaccines containing A. Anaphylaxis or 4 hours
polio inactivated virus anaphylactic shock.
(e.g., IPV).
B. Any acute Not applicable.
complication or
sequela (including
death of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed..
VIII. Hepatitis B. vaccines. A. Anaphylaxis or 4 hours.
anaphylactic shock.
[[Page 7689]]
B. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
IX. Hemophilus influenzae A. Early-onset Hib 7 days.
type b polysaccharide disease. Not applicable.
vaccines (unconjugated, PRP B. Any acute
vaccines). complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
X. Hemophilus influenzae No Condition Not applicable.
type b polysaccharide Specified.
conjugate vaccines.
XI. Varicella vaccine....... No Condition Not applicable.
Specified.
XII. Any new vaccine No Condition Not applicable.
recommended by the Centers Specified.
for Disease Control and
Prevention for routine
administration to children,
after publication by the
Secretary of a notice of
coverage.
------------------------------------------------------------------------
(b) Qualifications and aids to interpretation. The following
qualifications and aids to interpretation shall apply to the Vaccine
Injury Table to paragraph (a) of this section:
* * * * *
(2) * * *
(i) An acute encephalopathy is one that is sufficiently severe so
as to require hospitalization (whether or not hospitalization
occurred).
* * * * *
(6) Chronic Arthritis. (i) For purposes of paragraph (a) of this
section, chronic arthritis may be found in a person with no history in
the 3 years prior to vaccination of arthropathy (joint disease) on the
basis of:
(A) Medical documentation, recorded within 30 days after the onset,
of objective signs of acute arthritis (joint swelling) that occurred
between 7 and 42 days after a rubella vaccination;
(B) Medical documentation (recorded within 3 years after the onset
of acute arthritis) of the persistence of objective signs of
intermittent or continuous arthritis for more than 6 months following
vaccination; and
(C) Medical documentation of an antibody response to the rubella
virus.
(ii) For purposes of paragraph (a) of this section, the following
shall not be considered as chronic arthritis: Musculoskeletal disorders
such as diffuse connective tissue diseases (including but not limited
to rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus
erythematosus, systemic sclerosis, mixed connective tissue disease,
polymyositis/determatomyositis, fibromyalgia, necrotizing vascultitis
and vasculopathies and Sjogren's Syndrome), degenerative joint disease,
infectious agents other than rubella (whether by direct invasion or as
an immune reaction) metabolic and endocrine diseases, trauma,
neoplasms, neuropathic disorders, bone and cartilage disorders and
arthritis associated with ankylosing spondylitis, psoriasis,
inflammatory bowel disease, Reiter's syndrome, or blood disorders.
(iii) Arthralgia (joint pain) or stiffness without joint swelling
shall not be viewed as chronic arthritis for purposes of paragraph (a)
of this section.
(7) Brachial neuritis. (i) This term is defined as dysfunction
limited to the upper extremity nerve plexus (i.e., its trunks,
divisions, or cords) without involvement of other peripheral (e.g.,
nerve roots or a single peripheral nerve) or central (e.g., spinal
cord) nervous system structures. A deep, steady, often severe aching
pain in the shoulder and upper arm usually heralds onset of the
condition. The pain is followed in days or weeks by weakness and
atrophy in upper extremity muscle groups. Sensory loss may accompany
the motor deficits, but is generally a less notable clinical feature.
The neuritis, or plexopathy, may be present on the same side as or the
opposite side of the injection; it is sometimes bilateral, affecting
both upper extremities.
(ii) Weakness is required before the diagnosis can be made. Motor,
sensory, and reflex findings on physical examination and the results of
nerve conduction and electromyographic studies must be consistent in
confirming that dysfunction is attributable to the brachial plexus. The
condition should thereby be distinguishable from conditions that may
give rise to dysfunction of nerve roots (i.e., radiculopathies) and
peripheral nerves (i.e., including multiple monoeuropathies), as well
as other peripheral and central nervous system structures (e.g.,
cranial neuropathies and myelopathies).
(8) Thrombocytopenic purpura. This term is defined by a serum
platelet count less than 50,000/mm3. Thrombocytopenic purpura does
not include cases of thrombocytopenia associated with other causes such
as hypersplenism, autoimmune disorders (including alloantibodies from
previous transfusions) myelodysplasias, lymphoproliferative disorders,
congenital thrombocytopenia or hemolytic uremic syndrome. This does not
include cases of immune (formerly called idiopathic) thrombocytopenic
purpura (ITP) that are mediated, for example, by viral or fungal
infections, toxins or drugs. Thrombocytopenic purpura does not include
cases of thrombocytopenia associated with disseminated intravascular
coagulation, as observed with bacterial and viral infections. Viral
infections include, for example, those infections secondary to Epstein
Barr virus, cytomegalovirus, hepatitis A and B, rhinovirus, human
immunodeficiency virus (HIV), adenovirus, and dengue virus. An
antecedent viral infection may be demonstrated by clinical signs and
symptoms and need not be confirmed by culture or serologic testing.
Bone marrow examination, if performed, must reveal a normal or an
increased number of megakaryocytes in an otherwise normal marrow.
[[Page 7690]]
(9) Vaccine-strain measles viral infection. This term is defined as
a disease caused by the vaccine-strain that should be determined by
vaccine-specific monoclonal antibody or polymerase chain reaction
tests.
(10) Vaccine-strain polio viral infection. This term is defined as
a disease caused by poliovirus that is isolated from the affected
tissue and should be determined to be the vaccine-strain by
oligonucleotide or polymerase chain reaction. Isolation of poliovirus
from the stoll is not sufficient to establish a tissue specific
infection or disease caused by vaccine-strain poliovirus.
(11) Early-onset Hib disease. This term is defined as invasive
bacterial illness associated with the presence of Hib organism on
culture of normally sterile body fluids or tissue, or clinical findings
consistent with the diagnosis of epiglottitis. Hib pneumonia qualifies
as invasive Hib disease when radiographic findings consistent with the
diagnosis of pneumonitis are accompanied by a blood culture positive
for the Hib organism. Otitis media, in the absence of the above
findings, does not qualify as invasive bacterial disease. A child is
considered to have suffered this injury only if the vaccine was the
first Hib immunization received by the child.
(c) Effective date provisions. (1) Except as provided in paragraph
(c)(2) of this section, the revised Table of Injuries set forth in
paragraph (a) of this section and the Qualifications and Aids to
Interpretation set forth in paragraph (b) of this section apply to
petitions for compensation under the Program filed with the United
States Court of Federal Claims on or after March 24, 1997. Petitions
for compensation filed before such date shall be governed by section
2114(a) and (b) of the Public Health Service Act as in effect on
January 1, 1995, or by Sec. 100.3 as in effect on March 10, 1995 (see
60 FR 7678, et seq., February 8, 1995), as applicable.
(2) The inclusion of hepatitis B, Hib, and varicella vaccines and
other new vaccines (Items VIII, IX, X, XI and XII of the Table) will be
effective on the effective date of a tax enacted to provide funds for
compensation paid with respect to such vaccines. A notice will be
published in the Federal Register to announce the effective date of
such a tax.
[FR Doc. 97-4088 Filed 2-19-97; 8:45 am]
BILLING CODE 4160-15-M
