[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
