[Federal Register Volume 66, Number 135 (Friday, July 13, 2001)]
[Proposed Rules]
[Pages 36735-36739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 100

RIN 0906-AA55


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

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Secretary has made findings as to a condition that can 
reasonably be determined in some circumstances to be caused by vaccines 
containing live, oral, rhesus-based rotavirus. Based on these findings, 
the Secretary proposes to amend the Vaccine Injury Table (Table) by 
adding to the Table vaccines containing live, oral, rhesus-based 
rotavirus as a distinct category, with intussusception listed as a 
covered Table injury. This proposal is based upon the recommendation by 
the Centers for Disease Control and Prevention (CDC) that Rotashield, 
the only U.S.-licensed rotavirus vaccine, no longer be administered to 
infants in the United States based on review of data indicating a 
strong association between Rotashield and intussusception in the 1 to 2 
weeks following vaccination. The Secretary also proposes several 
additional amendments to the Table described below under SUPPLEMENTARY 
INFORMATION.

DATES: Comments on this proposed rule must be submitted by January 9, 
2002. A public hearing on this proposed rule will be held before the 
end of the public comment period. A separate notice will be published 
in the Federal Register to provide the details of this hearing.

ADDRESSES: Written comments should be addressed to Samuel Shekar, 
Associate Administrator for Health Professions, Bureau of Health 
Professions (BHPr), Health Resources and Services Administration 
(HRSA), Parklawn Building, Room 8-05, 5600 Fishers Lane, Rockville, 
Maryland 20857. All comments received will be available for public 
inspection and copying at the Office of Planning and Program 
Development, BHPr, Room 8-67, Parklawn Building, at the above address 
weekdays (Federal holidays excepted) between the hours of 8:30 a.m. and 
5:00 p.m.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, Medical Director, 
Division of Vaccine Injury Compensation, BHPr, HRSA, Parklawn Building, 
Room 8A-46, 5600 Fishers Lane, Rockville, Maryland 20857; telephone 
number (301) 443-4198.

SUPPLEMENTARY INFORMATION:

Rotavirus Vaccine

    On August 31, 1998, the Food and Drug Administration (FDA) licensed 
a live, oral, rhesus-based rotavirus tetravelant vaccine for use in 
infants between the ages of 6 weeks and 1 year. Distribution of the 
vaccine began on October 1, 1998. Following a review by the Advisory 
Committee on Immunization Practices (ACIP), the CDC published its 
rotavirus recommendation in the March 19, 1999, issue of the Morbidity 
and Mortality Weekly Report (MMWR), calling for doses to be 
administered at 2, 4 and 6 months of age, the first dose to be 
administered between 6 weeks and 6 months. The series was not to be 
initiated in children who were 7 months of age or older due to an 
increased rate of febrile (fever) reactions after the first dose among 
older infants.
    Over the next 8 months, the Secretary's Vaccine Adverse Event 
Reporting System (VAERS) began receiving reports of intussusception (a 
type of bowel obstruction that occurs when the bowel folds in on 
itself) in infants receiving rotavirus vaccine, mostly after the first 
dose. Based on an analysis of 15 reports, CDC, in the July 16, 1999, 
issue of the MMWR, recommended that health-care providers and parents 
postpone use of the rotavirus vaccine. Additional epidemiological 
studies were undertaken by CDC to determine if there was a true 
association between the vaccine and intussusception. Also at that time, 
the manufacturer, in consultation with FDA, voluntarily ceased further 
distribution of the vaccine. Upon further consideration, and following 
consultation with CDC officials in preparation for the upcoming ACIP 
meeting, the manufacturer announced withdrawal of the only U.S.-
licensed rotavirus vaccine from the market on October 15, 1999, and 
requested the immediate return of all doses of the vaccine.
    At its October 22, 1999, meeting, the ACIP reviewed scientific data 
from several sources, including a 19-State case-control study which 
showed a statistically significant rate of intussusception among 
recipients of the live, oral, rhesus-based rotavirus vaccine in the 1- 
to 2-week period following vaccine administration. Beyond 14 days, 
there did not appear to be more cases than might occur by chance alone. 
The ACIP concluded that intussusception occurs with significantly 
increased frequency in the first 14 days following rotavirus 
administration and withdrew its recommendation for use of the rhesus-
based rotavirus vaccine in infants. CDC published the Committee's 
decision in the November 5, 1999, issue of the MMWR.
    As of December 2000, VAERS had received over 100 reports of 
confirmed and presumptive intussusception cases, 58 of which had onset 
within 7 days of vaccine receipt. No reports have been received thus 
far for vaccines administered after the July 1999 MMWR notice. Of the 
cases reported, approximately one-half required surgical intervention. 
Nearly all of the remaining cases of bowel obstruction were relieved 
through barium enema, a radiological procedure used to both diagnose 
and often rectify the telescoped bowel segment, or resolved without any 
intervention. At least one death associated with rotavirus vaccine was 
reported to VAERS.
    The general category of rotavirus vaccines was added for coverage 
under the VICP effective October 22, 1998. Section 2114(e)(2) of the 
Public Health Service (PHS) Act provides for the inclusion of 
additional vaccines in the VICP when they are recommended by the CDC 
for routine administration to children. In compliance with the 
requirements of the Omnibus Budget Reconciliation Act of 1993, which 
added a new section 2114(e)(3) to the Act, a vaccine added to the Table 
through section 2114(e) will be included in the Table, effective when 
an excise tax to provide funds for they payment of compensation with 
respect to such vaccines takes effect. This section, codified at 42 
U.S.C. 300aa-14(e)(3), read as follows:

    (3) Effective Date--A revision by the Secretary under section 
2114(e) of the Public Health Service Act (42 U.S.C. 300aa-14(e)) (as 
amended by paragraph (2)) shall take effect upon the effective date 
of a tax enacted to provide funds for compensation paid with respect 
to the vaccine to be added to the vaccine injury table in section 
2114(a) of the Public Health Service Act (42 U.S.C. 300aa-14(a)).

    The two prerequisites for adding rotavirus vaccine to the VICP were 
satisfied by enactment of Public Law 105-77, the Omnibus Consolidated 
and Emergency Supplemental Appropriations Act of 1999, which set

[[Page 36736]]

an excise tax of 75 cents per vaccine dose, and publication in the MMWR 
the following March of the CDC recommendation of the vaccine for 
``routine use in children.'' The effective date of coverage, however, 
was the date of imposition of the excise tax, which was October 22, 
1998.
    In order to gain entitlement to compensation under title XXI of the 
PHS Act for a covered vaccine, a petitioner must establish a vaccine-
related injury or death, either by showing an event listed on the Table 
(referred to as a ``Table injury'' case), and therefore presumed to be 
caused by a vaccine, or by proving causation in fact. In addition, 
section 2111(c) of the PHS Act requires that a petitioner must show 
(except in death cases) 6 months of residual effects of the injury or, 
as explained below, inpatient hospitalization and surgery resulting 
from the injury. With regard to a Table injury case, it must be shown 
that the vaccine recipient suffered an injury of the type enumerated in 
the ``Vaccine Injury Table'' corresponding to the vaccination in 
question, and that the onset of such injury took place within a time 
period from the vaccination also specified in the Table. If so, as set 
out in sections 2111(c)(1)(C)(i), 2113(a)(1)(B), and 2114(a) of the PHS 
Act, the Table injury is in effect given the legal presumption that it 
was caused by the vaccination, and the petitioner is entitled to 
compensation, unless it is affirmatively shown by the Secretary that 
the injury was caused by some factor unrelated to the vaccination.
    Based on the requirements of section 2114(e) of the PHS Act, the 
Secretary added rotavirus vaccine to the Table with ``no condition 
specified.'' (42 CFR 100.3). In other words, at the time rotavirus was 
included for coverage under the Program, no adverse events had been 
identified to include in the Table. Until specified injuries are added 
to the Table through the Secretary's rulemaking authority, individuals 
who receive newly recommended vaccines do not receive a legal 
presumption of causation for any claimed injury, and are required to 
prove that the vaccine actually caused the claimed injury.
    Consistent with the general process for revising the Table, once 
the Secretary determines that specific adverse events have been 
associated with newly recommended vaccines, the Secretary will propose 
further changes to the Vaccine Injury Table in order to confer the 
appropriate presumption of causation. Until the Table is amended, 
petitioners must prove causation in fact to prevail. However, once 
sufficient data is available to confirm a causal relationship between 
the newly added vaccine and the adverse event, the Secretary is able to 
concede causation in fact while the rulemaking process to revise the 
Table is underway.
    The Secretary has reviewed the epidemiological data showing a 
strong statistical association between the rotavirus vaccine 
administration and subsequent onset of intussusception within a 14-day 
time interval. In addition, the studies conducted are not precise 
enough to demonstrate that an intussusception occurring in the 15- to 
30-day interval is not caused by the rotavirus vaccine. For this 
reason, and because the evidence of a casual link between the 
Rotashield vaccine and the injury of intussusception is so strong, the 
Secretary is now proposing to add to the Table the category of 
``vaccines containing live, oral, rhesus-based rotavirus'' with the 
injury of intussusception. The Secretary proposes that this injury of 
intussusception have an onset interval of 30 days under sections 
2114(c) and (e) of the PHS Act. The Advisory Committee on Childhood 
Vaccines (ACCV) voted unanimously to approve this time interval at its 
December 1, 1999, meeting. Claims can be filed for alleged vaccine-
related cases whose onset is beyond 30 days, but petitioners will be 
required to prove causation in fact.
    Section XII of the Table in 42 U.S.C. 100.3(a) currently includes 
the broad category of ``rotavirus vaccine'' with no condition 
specified. At its December 1, 1999, meeting, the ACCV voted unanimously 
to retain this category of rotavirus vaccines on the Table, with no 
condition specified, and to add the category of ``vaccines containing 
live, oral, rhesus-based rotavirus'' with the injury of 
intussusception. In this Notice of Proposed Rulemaking, the Secretary 
proposes implementing this recommendation. Although the Secretary 
proposes retaining the current broad category of rotavirus vaccines on 
the Table in addition to adding the narrower category of ``vaccines 
containing live, oral, rhesus-based rotavirus,'' at this time the 
Secretary expects petitions for compensation relating only to this 
latter category, as the only rotavirus vaccine that has been licensed 
contains live, oral, rhesus-based rotavirus.
    Under this approach, the Department proposes including two 
different categories of rotavirus vaccines on the Table, with different 
effective dates of coverage. Of course, petitions must also be filed 
within the applicable statute of limitations. The statutes of 
limitations applicable to petitions filed with the VICP, which are set 
out in section 2116(a) of the PHS Act (42 U.S.C. 300aa-16(a)) continue 
to apply. In addition, section 2116(b) of the PHS Act lays out specific 
exceptions to these statutes of limitations that apply when the effect 
of a revision to the Table makes a previously ineligible person 
eligible to receive compensation or when an eligible person's 
likelihood of obtaining compensation significantly increases. Under 
this section, individuals who may be eligible to file petitions based 
on the revised Table may file a petition for 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 (42 U.S.C. 300aa-16(b)).
    The first category of rotavirus vaccines, the general category of 
``rotavirus vaccines,'' will continue to have an effective date of 
coverage for petitions filed beginning on October 22, 1998, with no 
corresponding ending date of coverage. Therefore, this category of 
vaccines will continue to be effective for vaccines administered in the 
future. The second category of rotavirus vaccines, those ``vaccines 
containing live, oral, rhesus-based rotavirus,'' will have an effective 
date of coverage beginning on October 22, 1998, provided that they were 
administered on or before the effective date of the final rule 
resulting from this Notice of Proposed Rulemaking. Because the only 
live, oral, rhesus-based rotavirus vaccine licensed in the United 
States has been withdrawn from the market and is no longer recommended 
for routine administration to children, the Department believes that 
all petitions arising from administrations of the Rotashield vaccine 
will fall within this covered period.
    Any rotovirus vaccines that are licensed in the future, including 
those containing live, oral, rhesus-based rotavirus, will automatically 
be covered under the Program under the Table's broad category of 
rotavirus vaccines. Because no injury is associated with this category 
of rotavirus vaccines, petitioners would retain the burden of showing 
causation in fact with respect to injuries unless and until the 
Department amended the Table through rulemaking. Thus, while both 
categories of vaccines will remain on the future Table resulting from 
the final rule, petitioners bringing claims concerning rotavirus 
vaccines administered after the effective date of that final rule will 
only be covered under the general category of rotavirus vaccines. The 
Department believes that this approach best maintains the scientific 
integrity of the Table because there is no evidence

[[Page 36737]]

that future rotavirus vaccines would be associated with the injury of 
intussusception. The Department presented this proposal, outlining the 
effective coverage dates for the two categories of rotavirus vaccines, 
to the ACCV at its December 2000 meeting. The ACCV reached consensus 
that this approach was appropriate.
    Recent legislation also affects petitioners filing claims 
concerning rotavirus vaccines. Until recently, the PHS Act required all 
claimants to establish either that the residual effects of an injury 
persisted for more than 6 months after the administration of the 
vaccine or that a death resulted from the administration of a vaccine. 
Since most patients with intussusception recover after immediate 
treatment and do not suffer lasting complications for more than 6 
months, some petitioners alleging intussusception from a rotavirus 
vaccine might have been denied compensation under that standard. 
However, a recent statutory amendment increases access to compensation 
for some petitions raising rotavirus-related intussusception claims. 
The Children's Health Act of 200 amends section 2111(c)(1)(D) of the 
PHS Act to permit payment of compensation for claims alleging injuries 
where the effects of the injury last less than 6 months if the 
petitioner demonstrates that the vaccine-related illness, disability, 
injury or condition ``resulted in inpatient hospitalization and 
surgical intervention.'' Pub. L. No. 106-310. This statutory change, 
which became effective on October 17, 2000, applies to new petitions 
for compensation as well as to petitions pending on that date. Thus, 
under current law, infants who experience intussusception following a 
rotavirus vaccine and do not suffer residual effects for more than 6 
months may qualify for compensation if their injury resulted in 
inpatient hospitalization and surgery.

Residual Seizure Disorder: Qualifications and Aids to 
Interpretation

    In a final rule published in the Federal Register on February 20, 
1997, which became effective on March 24, 1997, residual seizure 
disorder was removed from the Table as an adverse event for vaccines 
containing the components of measles, mumps, or rubella. Because 
residual seizure disorder is no longer listed on the Table in 42 CFR 
100.3 as an illness, disability, injury or condition for any covered 
vaccine, the Secretary proposes removing residual seizure disorder from 
the Table's Qualifications and Aids to Interpretation. The Secretary 
believes that his approach will minimize confusion about the Table. At 
its December 2000 meeting, the ACCV reached consensus that this 
technical change was appropriate.

Hemophilus Influenzae Type b (Hib) Polysaccharide (Unconjugated) 
Vaccines

    The Secretary proposes removing hemophilus influenzae type b (Hib) 
polysaccharide (unconjugated) vaccines from the Table. The first 
licensed Hib vaccine was an unconjugated polysaccharide vaccine, which 
was licensed in April 1985. Two other unconjugated Hib vaccines were 
licensed in December 1985. In December 1987, the first conjugate Hib 
vaccine was licensed. Several conjugate Hib vaccines have subsequently 
been licensed. Because studies demonstrated the superior immunogenicity 
of conjugate Hib vaccines as compared to unconjugated Hib vaccines, the 
Secretary, believes that unconjugated Hib vaccines had little, if any, 
use since 1989.
    In a February 20, 1997, final rule, the Secretary added both Hib 
conjugate and Hib unconjugated vaccines to the Table. Based on the 
Secretary's findings, early-onset Hib disease was listed as a table 
injury for unconjugated Hib vaccines. No condition was specified for 
Hib conjugate vaccines.
    Section 904(b) of the Taxpayer Relief Act of 1997, which was signed 
into law on August 5, 1997, provided an excise tax for Hib vaccines. 
Thus, petitioners alleging an injury or death as a result of a Hib 
vaccine, either conjugate or unconjugated, were able to seek 
compensation beginning on August 6, 1997, the effective date of the 
addition of the vaccine to the Table.
    The Secretary now proposes removing the unconjugated Hib vaccine 
from the Table for several reasons. First, under section 2116(b) of the 
PHS Act, petitions relating to unconjugated Hib vaccines administered 
before August 6, 1989, are not eligible for compensation. Under the 
terms of section 2116(b), petitions related to a vaccine added to the 
Table are compensable only if the vaccine-related injury or death 
occurred within the 8-year period before the date of the addition of 
the vaccine to the Table. Because Hib vaccines were added to the Table 
as of August 6, 1997, petitions relating to Hib vaccines administered 
before August 6, 1989, are ineligible for compensation. Second, because 
section 2116(b) imposes a 2-year statute of limitations for vaccines 
added to the Table, all petitions relating to a Hib vaccine 
administered between August 6, 1989, and August 5, 1997, had to be 
filed by August 6, 1999. Because this date has passed, such claims are 
no longer eligible for compensation. Third, the Department believes 
that unconjugated Hib vaccines have had little, if any, use since 1989 
and expects no petitions relating to unconjugated Hib vaccines 
administered after August 5, 1997. This belief is supported by the fact 
that the Department has never received any petitions for compensation 
relating to unconjugated Hib vaccines. In sum, the Secretary proposes 
removing unconjugated Hib vaccines from the Table because the Secretary 
believes that no potential claims relating to this category of vaccines 
exist.
    Because the Secretary proposes removing the unconjugated Hib 
vaccines from the Table, the Secretary further proposes removing early 
onset Hib disease from the Table's Qualifications and Aids to 
Interpretation. This proposal arises from the fact that early-onset Hib 
disease is associated with only the unconjugated polysaccaride Hib 
vaccine. Because the unconjugated Hib vaccine will no longer be listed 
on the Table, it is unnecessary to list any illness, disability, injury 
or condition for the unconjugated Hib vaccine. The Secretary believes 
this approach will minimize confusion about the Table. At its December 
2000 meeting, the ACCV reached consensus that these technical changes 
were appropriate.

Pneumococcal Conjugate Vaccine

    On December 17, 1999, the excise tax for pneumococcal conjugate 
vaccines was enacted by Public Law 106-170, the Ticket to Work and Work 
Incentives Improvement Act of 1999, with an effective date of December 
18, 1999. Section 523 of this Act provides that all conjugate vaccines 
against streptococcus pneumoniae (pneumococcus) are added to section 
4132(a)(1) of the Internal Revenue Code of 1986, which defines all 
taxable vaccines. On February 17, 2000, a pneumococcal conjugate 
vaccine, Prevnar, was licensed by the FDA. Following a review by the 
ACIP, the CDC recommended the pneumococcal conjugate vaccine for 
routine administration to children up to 23 months of age. This 
recommendation was published in the October 6, 2000, issue of the MMWR.
    Because the excise tax for the pneumococcal conjugate vaccines has 
been enacted, and because the CDC has recommended a licensed 
pneumococcal conjugate vaccine for routine administration to children, 
the Secretary proposes adding this vaccine to the Table listed at 42 
CFR 100.3(a). We have not identified any illness, disease,

[[Page 36738]]

injury, or condition which is caused by pneumococcal conjugate 
vaccines. Thus, the Secretary proposes adding this vaccine to the Table 
of Injuries with ``No Condition Specified.'' If we learn of any such 
illness, disease, injury, or condition which is caused by pneumococcal 
conjugate vaccines, we will consider amending the Table of Injuries to 
provide for its coverage, and a time period in which the first symptom 
or manifestation of its onset will be presumed to be vaccine-related. 
Pneumococcal conjugate vaccines are presently included in the Table 
under the Table's broad category XIII (notice published in the Federal 
Register on May 22, 2001, 66 FR 28166).
    Under section 2114(e)(3) of the PHS Act, as amended by section 
13632(a) of the Omnibus Budget Reconciliation Act of 1993, a revision 
to the Table adding a vaccine recommended by the CDC for routine 
administration to children shall take effect upon the effective date of 
the tax enacted to provide funds for compensation with respect to the 
vaccine added to the Table. Thus, the Secretary proposes covering 
pneumococcal conjugate vaccines under the Program effective for 
petitions filed beginning on December 18, 1999, the date the excise tax 
for these vaccines became effective. Because the addition of 
pneumococcal conjugate vaccines to the Table is mandated by the PHS 
Act, this Table change has not been submitted to the ACCV for review.

Economic and Regulatory Impact

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when rulemaking is 
necessary, to select regulatory approaches that provide the greatest 
net benefits (including potential economic, environmental, public 
health, safety distributive and equity effects). In addition, under the 
Regulatory Flexibility Act, if a rule has a significant economic effect 
on a substantial number of small entities the Secretary must 
specifically consider the economic effect of a rule on small entities 
and analyze regulatory options that could lessen the impact of the 
rule.
    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 an 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.
    The Secretary has determined that no resources are required to 
implement the requirements in this rule. Compensation will be made in 
the same manner. This proposed rule only lessens the burden of proof 
for potential petitioners. Therefore, in accordance with the Regulatory 
Flexibility Act of 1980 (RFA), and the Small Business Regulatory 
Enforcement Act of 1996, which amended the RFA, the Secretary certifies 
that this rule will not have a significant impact on a substantial 
number of small entities.
    The Secretary has also determined that this proposed rule does not 
meet the criteria for a major rule as defined by Executive Order 12866 
and would have no major effect on the economy or Federal expenditures. 
We have determined that the proposed rule is not a ``major rule'' 
within the meaning of the statute providing for Congressional Review of 
Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on 
State, local, and tribal governments and on the private sector such as 
to require consultation under the Unfunded Mandates Reform Act of 1995.
    Nor on the basis of family well-being will the provisions of this 
rule effect the following family elements: family safety, family 
stability, marital commitment; parental rights in the education, 
nurture and supervision of their children; family functioning, 
disposable income or poverty; or the behavior and personal 
responsibility of youth, as determined under section 654(c) of the 
Treasury and General Government Appropriations Act of 1999.
    As stated above, this proposed rule would modify the Vaccine Injury 
Table based on legal authority.

Impact of the New Rule

    To date, three petitions have been filed alleging a vaccine-related 
injury caused or aggravated by a rotavirus vaccine. This proposed rule 
will have the effect of decreasing the burden of proof on expected 
future petitioners. Under this proposed rule, future petitioners 
alleging the injury of intussusception as the result of a live, oral 
rhesus-based rotavirus vaccine, the only type of rotavirus vaccine 
licensed to date in the U.S., will be afforded a presumption of 
causation. This proposed rule will not change the burden of proof 
applicable to petitioners alleging other injuries related to a 
rotavirus vaccine, who must rely on a causation in fact analysis.
    Because the proposed rule limits the Table injury of 
intussusception to live, oral, rhesus-based rotavirus vaccines, 
administered on or before the effective date of the final rule, 
individuals seeking compensation for injuries related to such a vaccine 
administered after the final rule becomes effective will no longer 
receive the presumption of a Table injury for intussusception. Because 
the manufacturer of the only U.S.-licensed rotavirus vaccine 
voluntarily ceased distribution of the vaccine in July 1999, and 
because the CDC recommended that this vaccine no longer be recommended 
for infants in the United States on October 22, 1999, the Secretary has 
concluded that no potential claims arising after the final rule is 
published will be likely to exist. This proposed rule adds a Table 
injury only for rotavirus vaccines that contain live, oral, rhesus-
based rotavirus. Because the only U.S.-licensed rotavirus vaccine falls 
within this category, the Secretary has concluded that this will not 
negatively disadvantaged potential petitioners.
    This proposed rule will have a similar effect for petitioners 
seeking compensation for injuries related to hemophilus influenzae type 
b polysaccharide (unconjugated) vaccines. No claims relating to the 
administration of an unconjugated Hib vaccine before or on August 5, 
1997, are eligible for compensation under the Act. In addition, the 
Secretary believes that these vaccines were not administered after 
1997, and hence that no potential claims relating to this category of 
vaccines exist. Thus, it is very unlikely that the removal of 
unconjugated Hib vaccines from the Table will have an adverse impact 
upon potential petitioners. Removing early-onset Hib disease from the 
Table's Qualifications and Aids to Interpretation will not have an 
adverse effect on petitioners because it will no longer be listed as an 
adverse event for any vaccine on the Table.
    Similarly, because residual seizure disorder is not listed on the 
Table as an adverse event for any vaccine on the Table, removing 
residual seizure disorder will not have an adverse impact for future 
petitioners.
    Finally, this proposed rule will have the effect of making 
petitioners seeking compensation for injuries related to pneumococcal 
conjugate vaccines eligible for compensation under the PHS Act.

Paperwork Reduction Act of 1980

    This proposed rule has no information collection requirements.

List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, and Immunization.

[[Page 36739]]


    Dated: March 2, 2001.
Claude Earl Fox,
Administrator, Health Resources and Services Administration.
    Approved: March 23, 2001.
Tommy G. Thompson,
Secretary.
    Accordingly, 42 CFR part 100 is proposed to be amended as set forth 
below:

PART 100--VACCINE INJURY COMPENSATION

    1. The authority citation for 42 CFR 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-1 note); and sec. 2114(c) and (3) of the PHS Act, 100 Stat. 
3766 and 107 Stat. 645 (42 U.S.C. 300aa-14(c) and (e)); sec. 904(b) 
of Pub. L. 105-34, 111 Stat. 873; and sec. 523(a) of Pub. L. 106-
170, 113 Stat. 1860.

    2. Section 100.3 is amended as follows:
    a. In paragraph (a), the Table is amended by removing Item IX; 
redesignating Items X, XI, XII, and XIII as Items IX, X, XI, and XIV; 
and adding new Items XII and XIII to read as set forth below.
    b. Paragraph (b)(3) is removed and reserved.
    c. Paragraph (b)(4) is amended by revising the phrase ``paragraphs 
(b)(2) and (3)'' in the first sentence to read ``paragraph (b)(2)''.
    d. Paragraph (b)(11) is removed.
    e. Paragraph (c)(2) is amended by removing the words ``, and XI'' 
in the parenthetical and adding the word ``and'' before the number 
``X''.
    f. Paragraph (c)(3) is revised as set forth below.
    g. Paragraph (c)(4) is redesignated as (c)(5).
    h. A new paragraph (c)(4) is added to read as set forth below.


Sec. 100.3  Vaccine Injury Table.

    (a) * * *

                          Vaccine Injury Table
------------------------------------------------------------------------
                                                        Time period for
                                                       first symptom or
                                       Illness,        manifestation of
                                  disability, injury      onset or of
             Vaccine                 or  condition        significant
                                        covered        aggravation after
                                                            vaccine
                                                        administration
------------------------------------------------------------------------
 
*                  *                  *                  *
                  *                  *                  *
XII. Vaccines containing live,    Intussusception...  0-30 days.
 oral, rhesus-based rotavirus.
XIII. Pneumococcal conjugate      No condition        Not applicable
 vaccines.                         specified.
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

    (c) * * *
    (3) Rotavirus vaccines (Item XI of the Table) are included in the 
Table as of October 22, 1998. Vaccines containing live, oral, rhesus-
based rotavirus (Item XII of the Table) are included in the Table as of 
October 22, 1998, provided that they were administered on or before 
[Effective date of the final rule].
    (4) Pneumococcal conjugate vaccines (Item XIII of the Table) are 
included in the Table as of December 18, 1999.
* * * * *
[FR Doc. 01-16814 Filed 7-12-01; 8:45 am]
BILLING CODE 4165-15-M