[Federal Register Volume 67, Number 143 (Thursday, July 25, 2002)]
[Rules and Regulations]
[Pages 48558-48560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18827]


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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: Final rule.

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SUMMARY: On July 13, 2001, the Secretary of Health and Human Services 
(the Secretary) published in the Federal Register a Notice of Proposed 
Rulemaking (NPRM) proposing changes to the regulations governing the 
National Vaccine Injury Compensation Program (VICP). Specifically, the 
Secretary proposed revisions to the Vaccine Injury Table (the Table). 
The primary proposal made in the NPRM was that vaccines containing 
live, oral, rhesus-based rotavirus be added to the Table as a distinct 
category, with intussusception listed as a covered Table injury. This 
proposal was based upon the Secretary's determination that the 
condition of intussusception can reasonably be determined in some 
circumstances to be caused by vaccines containing live, oral, rhesus-
based rotavirus. The Secretary is now making this amendment to the 
Table by final rule. The Secretary is also making additional amendments 
to the Table and to the Table's Qualifications and Aids to 
Interpretation (Qualifications and Aids), described below under 
SUPPLEMENTARY INFORMATION, as proposed in the NPRM. The changes 
implemented here are authorized by section 2114(c) and (e) of the 
Public Health Service Act (the Act).

DATES: This regulation is effective on August 26, 2002. Applicability 
dates: As provided by section 13632(a)(3) of Public Law 103-66, the 
Omnibus Budget Reconciliation Act of 1993, the addition of vaccines 
containing live, oral, rhesus-based rotavirus took effect on October 
22, 1998, the effective date of the excise tax for rotavirus vaccines, 
provided that they were administered on or before August 26, 2002. 
Under the same authority, the addition of pneumococcal conjugate 
vaccines took effect on December 18, 1999, the effective date of the 
excise tax for this categories of vaccines. See discussion under 
SUPPLEMENTARY INFORMATION in the NPRM underlying this final rule (66 FR 
36735, July 13, 2001) for an explanation of these applicability dates.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Medical 
Director, Division of Vaccine Injury Compensation, Office of Special 
Programs, Health Resources and Services Administration (HRSA), Parklawn 
Building, Room 8A-46, 5600 Fishers Lane, Rockville, Maryland 20857; 
telephone number (301) 443-4198.

SUPPLEMENTARY INFORMATION:

Introductory and Procedural History

    On July 13, 2001, the Secretary published in the Federal Register 
(66 FR 36735, July 13, 2001) an NPRM to revise and amend the Table and 
the 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 (CDC) for routine administration to children.
    The Department held a 6-month comment period, which ended on 
January 9, 2002, in connection with this NPRM. The Secretary did not 
receive any comments in response to the NPRM. A public hearing was held 
on December 6, 2001, as announced in the Federal Register (66 FR 58154, 
Nov. 20, 2001), but no individual or organization appeared to testify.
    Because the Secretary has not received any comments, either written 
or oral, from any interested individual or organization on the 
proposals made in the NPRM, and because the Secretary continues to 
believe in the advisability of effectuating such proposals, this final 
rule implements the proposals made in the NPRM. One technical amendment 
to 42 CFR 100.3(c)(4), which was inadvertently omitted from the NPRM, 
is being implemented in this final rule. In addition, we are modifying 
the authority citation for 42 CFR part 100. The rationales for all 
other revisions and additions made in this final rule were explained 
fully in the Preamble to the NPRM. For the reasons set forth in the 
NPRM, the Secretary makes several amendments affecting the operation of 
the VICP in this rule.

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.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget. 
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. The final rule only lessens the burden of proof for 
certain 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.

[[Page 48559]]

    The Secretary has also determined that this rule does not meet the 
criteria for a major rule as defined by Executive Order 12866 and will 
have no major effect on the economy or Federal expenditures. We have 
determined that this 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 affect 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.
    The Department has also reviewed this rule in accordance with 
Executive Order 13132 regarding federalism, and has determined that it 
does not have ``federalism implications.'' The rule does not ``have 
substantial direct effects on the States, or on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government.''
    As stated above, this rule will modify the Vaccine Injury Table and 
the Qualifications and Aids based on legal authority.

Impact of the New Rule

    The final rule will have the effect of decreasing the burden of 
proof on expected future petitioners filing petitions alleging a 
vaccine-related injury caused or aggravated by a rotavirus vaccine. 
Under this 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 
United States, will be afforded a presumption of causation. This 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 final 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 in 
October 1999, the Secretary has concluded that no potential claims 
arising after this rule is published will be likely to exist.
    This final rule will have a similar effect for petitioners seeking 
compensation for injuries related to hemophilus influenzae type b 
polysaccharide (unconjugated) vaccines. As explained in the NPRM, the 
Secretary believes 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 upon future 
petitioners.
    Finally, this rule will have the effect of making petitioners 
seeking compensation for injuries related to pneumococcal conjugate 
vaccines eligible for compensation under a separate category on the 
Table.

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: March 14, 2002.
Elizabeth M. Duke,
Administrator, Health Resources and Services Administration.
    Approved: May 17, 2002.
Tommy G. Thompson,
Secretary.

    Accordingly, 42 CFR part 100 is 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); secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-3782 (42 
U.S.C. 300aa-1 note); sec. 2114(c) and (e) of the PHS Act, 100 Stat. 
3766 and 107 Stat. 645-646 (42 U.S.C. 300aa-14(c) and (e)); sec. 
904(b) of Pub. L. 105-34, 111 Stat. 873; sec. 1503 of Pub. L. 105-
277, 112 Stat. 2681-741; and sec. 523(a) of Pub. L. 106-170, 113 
Stat. 1927-1928.

    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 phrase 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) and is amended by 
revising the phrase ``Item XIII'' in the parenthetical phrase to read 
``Item XIV''.
    h. A new paragraph (c)(4) is added to read as set forth below.


Sec. 100.3  Vaccine injury table.

    (a) * * *

[[Page 48560]]



                                              Vaccine Injury Table
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                                                                           Time period for first symptom or
               Vaccine                  Illness, disability, injury    manifestation of onset or of significant
                                            or condition covered       aggravation after vaccine administration
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*                  *                  *                  *                  *                  *
                                                        *
XII. Vaccines containing live, oral,   Intussusception..............  0-30 days.
 rhesus-based rotavirus.
XIII. Pneumococcal conjugate vaccines  No condition specified.......  Not applicable.
 
*                  *                  *                  *                  *                  *
                                                        *
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    (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 
August 26, 2002.
    (4) Pneumococcal conjugate vaccines (Item XIII of the Table) are 
included in the Table as of December 18, 1999.
* * * * *
[FR Doc. 02-18827 Filed 7-24-02; 8:45 am]
BILLING CODE 4165-15-P