Vaccine Injury Compensation Program: Rotavirus vaccines addition,

[Federal Register: July 27, 1999 (Volume 64, Number 143)]

[Rules and Regulations]

[Page 40517-40518]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr27jy99-7]

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 filednot 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 filedno 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:

   1. 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'';

   2. Redesignate paragraph (c)(3) as paragraph (c)(4);

   3. 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

   4. 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. 99-19114Filed7-26-99; 8:45 am]

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