[Federal Register Volume 63, Number 90 (Monday, May 11, 1998)]
[Rules and Regulations]
[Pages 25777-25778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 60

RIN 0906-AA49


National Vaccine Injury Compensation Program (VICP): Effective 
Date Provisions of Coverage of Certain Vaccines to the Vaccine Injury 
Table

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final rule.

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SUMMARY: Section 904(b) of the Taxpayer Relief Act of 1997 provides for 
an excise tax for three new vaccines, effective August 6, 1997. 
Petitions for compensation for injuries or deaths related to hepatitis 
B, Hib, and varicella vaccines may now be filed under the Vaccine 
Injury Compensation Program (VICP). This technical amendment amends the 
Code of Federal Regulations (CFR) to include a date certain (August 6, 
1997) in Sec. 100.3(c) of the Vaccine Injury Compensation regulations, 
so that there will be no uncertainty as to the coverage of these three 
vaccines.

EFFECTIVE DATE: This final rule is effective May 11, 1998.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Medical 
Director, 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: The National Vaccine Injury Compensation 
Program (VICP), established by Subtitle 2 of Title XXI of the Public 
Health Service Act (the Act), provides a system of no-fault 
compensation for certain individuals who have been injured by specific 
childhood vaccines. The Vaccine Injury Table (the Table) establishes 
presumptions about causation of certain illnesses and conditions which 
are used by the U.S. Court of Federal Claims to adjudicate petitions. 
The Act provides that a revision to the Table, based on addition of new 
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, Public 
Law 103-66, enacted August 10, 1993.)
    On August 5, 1997, the President signed Public Law 105-34, the

[[Page 25778]]

``Taxpayer Relief Act of 1997.'' Section 904(a) of this Act provides 
that the excise tax on all covered vaccines under the VICP is 75 cents 
per dose and that combinations of vaccines are subject to an excise tax 
which is the sum of the amounts for each vaccine included in the 
combination. The amendments of the Taxpayer Relief Act also make 
effective the coverage of three new vaccines under the VICP--hepatitis 
B, Hib, and varicella vaccines.
    On October 9, 1997, a Notice was published in the Federal Register 
(62 FR 52724) announcing the excise tax for these vaccines and that 
petitions for compensation for injuries or deaths related to hepatitis 
B, Hib, and varicella vaccines (items VIII, IX, X, and XI of the Table) 
may now be filed under the VICP. In accordance with section 2116(b) of 
the PHS Act, for injuries or deaths that occurred before August 6, 
1997, for these three vaccines, petitions may be filed no later than 
August 6, 1999, provided that the injury or death occurred no earlier 
than August 6, 1989.
    In accordance with section 904(b) of the Taxpayer Relief Act of 
1997 which provides for an excise tax for these three new vaccines, 
this final rule (technical amendment) amends the CFR to include a date 
certain (August 6, 1997) in Sec. 100.3(c) of the regulations for the 
coverage of these three new vaccines. Paragraph (c)(3) provides for 
inclusion of other new vaccines, as they may be added in the future 
under item XII of the Table.

Justification for Omitting Notice of Proposed Rulemaking

    Since these amendments are of a technical nature, the Secretary has 
determined, pursuant to 5 U.S.C. 553 and departmental policy, that it 
is unnecessary and impractical to follow proposed rulemaking procedures 
or to delay the effective date of this final rule.

Economic 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 maximize 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, costs, benefits, incentives, equity, and 
available information. Regulations that 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 Department has determined that no resources are required to 
implement the requirements in this regulation. 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 these regulations will not have a significant 
impact on a substantial number of small entities. The Secretary has 
also determined that this final rule does not meet the criteria for a 
major rule as defined by Executive Order 12866. This technical 
amendment sets forth the effective date provision of coverage of 
certain vaccines to the Vaccine Injury Table. As such, this rule would 
have no major effect on the economy or on Federal or State 
expenditures.

Paperwork Reduction Act of 1995

    This Final rule has no information collection requirements.

List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, Immunization.

    Approved: April 28, 1998.
Claude Earl Fox,
Acting Administrator, Health Resources and Services Administration.

    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); 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 (e) of the PHS Act, 100 Stat. 
3766 and 107 Stat. 645 (42 U.S.C. 300aa-14(c) and (e); and sec. 
904(b) of Pub. L. 105-34, 111 Stat. 873).

    2. Section 100.3(c) is amended by revising its title, by adding 
``or (3)'' in the first sentence of paragraph (c)(1) after the words 
``paragraph (c)(2)'', by revising paragraph (c)(2), and by adding a new 
paragraph (c)(3) to read as follows:


Sec. 100.3  Vaccine injury table.

* * * * *
    (c) Coverage provisions. * * *
    (c)(2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, X, 
and XI of the Table) are included in the Table as of August 6, 1997.
    (c)(3) Other new vaccines (Item XII of the Table) will be included 
in the Table as of the effective date of a tax enacted to provide funds 
for compensation paid with respect to such vaccines. An amendment to 
this section will be published in the Federal Register to announce the 
effective date of such a tax.

[FR Doc. 98-12389 Filed 5-8-98; 8:45 am]
BILLING CODE 4160-15-U