[Federal Register Volume 64, Number 143 (Tuesday, July 27, 1999)]
[Rules and Regulations]
[Pages 40517-40518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19114]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 100

RIN 0906-AA50


National Vaccine Injury Compensation Program: Addition of 
Vaccines Against Rotavirus to the Program

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule amends the existing regulations governing the 
National Vaccine Injury Compensation Program (VICP) by adding vaccines 
against rotavirus to the Table of Injuries, which lists the vaccines 
covered under the VICP. This action is taken under section 2114(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 two prerequisites for adding vaccines against rotavirus to the 
VICP have been satisfied. An excise tax of 75 cents per dose was 
enacted on October 21, 1998, and took effect for sales of the vaccines 
after October 21, 1998. The Centers for Disease Control and Prevention 
(CDC) has recommended to the Secretary of HHS that this vaccine be 
routinely administered to children. Thus, vaccines against rotavirus 
are now included in the VICP.

EFFECTIVE DATE: This regulation is effective on July 27, 1999. As 
provided by section 13632(a)(3) of Public Law 103-66, the Omnibus 
Budget Reconciliation Act of 1993, the addition of the vaccines against 
rotavirus to the VICP took effect on October 22, 1998, the effective 
date of the excise tax. See the discussion under SUPPLEMENTARY 
INFORMATION, for an explanation of the implications of this 
applicability date.

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

SUPPLEMENTARY INFORMATION: The statute authorizing the VICP provides 
for the inclusion of additional vaccines in the Program when they are 
recommended by the CDC to the Secretary for routine administration to 
children. See section 2114(e) of the Act, 42 U.S.C. 300aa-14(e). 
Consistent with section 13632(a)(3) of Public Law 103-66, the 
regulations governing the Program provide that such vaccines will be 
included in the Table of Injuries when an excise tax to provide funds 
for the payment of compensation with respect to such vaccines takes 
effect. 42 CFR 100.3(c)(3) (1998).
    The CDC recommendation regarding vaccines against rotavirus was 
published in the Morbidity and Mortality Weekly Report on March 19, 
1999. The excise tax for such vaccines was enacted by Public Law 105-
277, the Omnibus Consolidated and Emergency Supplemental Appropriations 
Act, 1999, and became effective for sales after October 21, 1998. 
Accordingly, we are amending the regulations to include specific 
reference to rotavirus vaccines in the Table of Injuries and in the 
``coverage'' portion of the regulations.
    We have not identified any illness, disease, injury or condition 
which is caused by vaccines against rotavirus. Thus, the vaccine is 
added to the Table of Injuries with ``No Condition Specified.'' If we 
learn of any such illness, disease, injury or condition, 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.
    Section 2116(b) of the Act, 42 U.S.C. 300aa-16(b), provides that 
individuals who were not previously eligible to file a petition before 
a revision to the Table of Injuries may file a petition for 
compensation for a vaccine added to the Table of Injuries. Such a 
petition must be filed not later than 2 years after the effective date 
of the revision if the injury or death occurred not more than

[[Page 40518]]

8 years before the effective date of the revision. Thus, for injuries 
or deaths related to rotavirus vaccine which occurred before October 
22, 1998, petitions may be filed no later than October 22, 2000, 
provided that the injury or death occurred no earlier than October 22, 
1990. Filing deadlines for injuries or deaths related to rotavirus 
vaccines administered after October 21, 1998, are governed by section 
2116(a)(2) and (3) of the Act, 42 U.S.C. 300aa-16(a)(2) and (3).

Justification for Omitting Notice of Proposed Rulemaking

    This amendment to 42 CFR 100.3 is required by section 2114(e) of 
the Act and 42 CFR 100.3, Vaccine injury table. Since this is a 
technical amendment, the Secretary has determined, under 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 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 Department has determined that no resources are required to 
implement the requirements in this rule. 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 final 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. This technical amendment adds a 
new item to the Vaccine Injury Table.
    We have determined that the 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.

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: July 15, 1999.
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 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.


Sec. 100.3  [Amended]

    2. The Vaccine Injury Table at Sec. 100.3(a) is amended by 
redesignating Item XII as Item XIII, and by adding a new Item XII as 
follows:

------------------------------------------------------------------------
                                                        Time period for
                                                       first symptom or
                                       Illness,        manifestation of
                                  disability, injury      onset or of
             Vaccine                 or condition         significant
                                        covered        aggravation after
                                                            vaccine
                                                        administration
------------------------------------------------------------------------
 
                   *        *        *        *        *
XII. Rotavirus vaccine..........  No condition        Not applicable.
                                   specified.
------------------------------------------------------------------------

Sec. 100.3  [Amended]

    3. Section 100.3(c) is amended as follows:
    a. Remove in paragraph (c)(1) the words ``paragraph (c)(2) or (3) 
of this section'' and add in its place the words ``paragraph (c)(2), 
(3) or (4) of this section'';
    b. Redesignate paragraph (c)(3) as paragraph (c)(4);
    c. Remove in paragraph (c)(4), as redesignated, the words ``(Item 
XII of the Table)'' and add in its place the words ``(Item XIII of the 
Table)''; and
    d. Add a new paragraph (c)(3) to read as follows:
* * * * *
    (c) Coverage provisions. * * *
    (3) Rotavirus vaccines (Item XII of the Table) are included in the 
Table as of October 22, 1998.
* * * * *
[FR Doc. 99-19114 Filed 7-26-99; 8:45 am]
BILLING CODE 4160-15-U