Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations 7685

[FR Doc. 97–4121 Filed 2–19–97; 8:45 am]

BILLING CODE 6560–50–P

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.

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 nofault 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
7686 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations

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 § 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

§ 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 vaccineassociated 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 § 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’’.
Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations 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/

mmwrlrr.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 vaccinerelated thrombocytopenic purpura had

been dismissed by the Claims Court to

file a new claim for the same vaccinerelated 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); § 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–
7688 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations

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:

§ 100.3 Vaccine injury table.

(a) * * *

VACCINE INJURY TABLE

Vaccine Illness, disability, injury or condition covered

Time period for first symptom or manifestation

of onset or of significant aggravation after vaccine administration

I. Vaccines containing tetanus toxoid (e.g.,

DTaP, DTP, DT, Td, or TT).

A. Anaphylaxis or anaphylactic shock ..............

B. Brachial Neuritis ...........................................

4 hours.

2–28 days.

C. 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.

Not applicable.

II. Vaccines containing whole cell pertussis

bacteria, extracted or partial cell pertussis

bacteria, or specific pertussis antigen(s)

(e.g., DTP, DTaP, P, DTP–Hib).

A. Anaphylaxis or anaphylactic shock ..............

B. Encephalopathy (or encephalitis) ................

C. 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.

4 hours.

72 hours.

Not applicable.

III. Measles, mumps, and rubella vaccine or

any of its components (e.g., MMR, MR, M,

R).

A. Anaphylaxis or anaphylactic shock ..............

B. Encephalopathy (or encephalitis) ................

4 hours.

5–15 days (not less than 5 days and not more

than 15 days).

C. 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.

Not applicable.

IV. Vaccines containing rubella virus (e.g.,

MMR, MR, R).

A. Chronic arthritis ............................................

B. 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.

7–42 days.

Not applicable.

V. Vaccines containing measles virus (e.g.,

MMR, MR, M).

A. Thrombocytopenic purpura ..........................

B. Vaccine-Strain Measles Viral Infection in an

immunodeficient recipient.

7–30 days.

6 months.

C. 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.

Not applicable.

VI. Vaccines containing polio live virus (OPV) A. Paralytic Polio

—in a non-immunodeficient recipient ........... 30 days.

—in an immunodeficient recipient ................. 6 months.

—in a vaccine associated community case .. Not applicable.

B. Vaccine-Strain Polio Viral Infection

—in a non-immunodeficient recipient ........... 30 days.

—in an immunodeficient recipient ................. 6 months.

—in a vaccine associated community case .. Not applicable.

C. 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.

Not applicable.

VII. Vaccines containing polio inactivated virus

(e.g., IPV).

A. Anaphylaxis or anaphylactic shock .............. 4 hours

B. 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..

Not applicable.

VIII. Hepatitis B. vaccines ................................. A. Anaphylaxis or anaphylactic shock .............. 4 hours.
Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations 7689

VACCINE INJURY TABLE—Continued

Vaccine Illness, disability, injury or condition covered

Time period for first symptom or manifestation

of onset or of significant aggravation after vaccine administration

B. 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.

Not applicable.

IX. Hemophilus influenzae type b polysaccharide vaccines (unconjugated, PRP

vaccines).

A. Early-onset Hib disease ...............................

B. 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.

7 days.

Not applicable.

X. Hemophilus influenzae type b polysaccharide conjugate vaccines.No Condition Specified ..................................... Not applicable.

XI. Varicella vaccine ......................................... No Condition Specified ..................................... Not applicable.

XII. Any new vaccine recommended by the

Centers for Disease Control and Prevention

for routine administration to children, after

publication by the Secretary of a notice of

coverage.

No Condition Specified ..................................... Not applicable.

(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.
7690 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations

(9) Vaccine-strain measles viral

infection. This term is defined as a

disease caused by the vaccine-strain that

should be determined by vaccinespecific 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 vaccinestrain 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 § 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

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Chapter I

[CC Docket No. 96–152; FCC 97–35]

Implementation of the

Telecommunications Act of 1996:

Telemessaging, Electronic Publishing,

and Alarm Monitoring Services

AGENCY: Federal Communications

Commission.

ACTION: Final rule; Clarification and

interpretation.

SUMMARY: The First Report and Order

(Order), released February 7, 1997,

implements the non-accounting

requirements prescribed by Congress in

sections 260 and 274 of the

Telecommunications Act of 1996 (the

Act), which respectively govern the

provision of telemessaging and

electronic publishing services. The

Order promotes the pro-competitive and

deregulatory objectives of the Act.

EFFECTIVE DATE: March 24, 1997. The

information collections in this Order

will not become effective until at least

May 1, 1997.

FOR FURTHER INFORMATION CONTACT: Lisa

Sockett, Attorney, Common Carrier

Bureau, Policy and Program Planning

Division, (202) 418–1580. For additional

information concerning the information

collections contained in this Order

contact Dorothy Conway at (202) 418–

0217, or via the Internet at

dconway@fcc.gov.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s Order

adopted February 6, 1997, and released

February 7, 1997. The full text of this

Order is available for inspection and

copying during normal business hours

in the FCC Reference Center, 1919 M

St., NW., Room 239, Washington, DC.

The complete text also may be obtained

through the World Wide Web, at http:/

/www.fcc.gov/Bureaus/Common

Carrier/Orders/fcc9735.wp, or may be

purchased from the Commission’s copy

contractor, International Transcription

Service, Inc., (202) 857–3800, 2100 M

St., NW., Suite 140, Washington, DC

20037.

This Order contains new or modified

information collections subject to the

Paperwork Reduction Act of 1995

(PRA). It has been submitted to the

Office of Management and Budget

(OMB) for review under the PRA. OMB,

the general public, and other federal

agencies are invited to comment on the

proposed or modified information

collections contained in this

proceeding.

Regulatory Flexibility Certification

As required by the Regulatory

Flexibility Act, the Order contains a

Final Regulatory Flexibility Certification

which is set forth in the Order. A brief

description of the certification follows.

The Commission certifies, pursuant to

5 U.S.C. 605(b), that the clarification

and interpretation adopted in this Order

will not have a significant economic

impact on a substantial number of

‘‘small entities,’’ as this term is defined

in 5 U.S.C. 601(6). The Commission

therefore is not required to prepare a

final regulatory flexibility analysis of

the clarification and interpretation

adopted in this Order. This certification

and a statement of its factual basis are

set forth in the Order, as required by 5

U.S.C. 605(b).

Paperwork Reduction Act

This Order contains either a new or

modified information collection. The

Commission, as part of its continuing

effort to reduce paperwork burdens,

invites the general public and OMB to

comment on the information collections

contained in this Order, as required by

the Paperwork Reduction Act of 1995,

Public Law No. 104–12. Written

comments by the public on the

information collections are due March

24, 1997. OMB notification of action is

due April 21, 1997. Comments should

address: (a) Whether the new or

modified collection of information is

necessary for the proper performance of

the functions of the Commission,

including whether the information shall

have practical utility; (b) the accuracy of

the Commission’s burden estimates; (c)

ways to enhance the quality, utility, and

clarity of the information collected; and

(d) ways to minimize the burden of the

collection of information on the

respondents including the use of

automated collection techniques or

other forms of information technology.

OMB Approval Number: 3060–0738

Title: Implementation of the

Telecommunications Act of 1996:

Telemessaging, Electronic Publishing,

and Alarm Monitoring Services, CC

Docket No. 96–152.

Form No.: N/A.

Type of Review: Revision.

Respondents: Business or other for

profit.

Public reporting burden for the

collection of information is estimated as

follows: