[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                          
------------------------------------------------------------------------
                                                       Time period for  
                                                      first symptom or  
                                                      manifestation of  
                              Illness, disability,       onset or of    
           Vaccine             injury or condition       significant    
                                     covered          aggravation after 
                                                           vaccine      
                                                       administration   
------------------------------------------------------------------------
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/mm<SUP>3. 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