National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury TableII

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.

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(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