02-32630. Service of Process: Amendment for Materials Related to Petitions Under the National Vaccine Injury Compensation Program

AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Final rule.

SUMMARY:

Current regulations regarding service of legal process provide that all service of process relating to petitions for compensation under the National Vaccine Injury Compensation Program (VICP) are to be sent to the Director, Bureau of Health Professions (BHPr), Health Resources and Services Administration (HRSA). Because the Acting Administrator, HRSA has recently reestablished the Division of Vaccine Injury Compensation (DVIC) within the Office of Special Programs (OSP), this final rule amends the regulations regarding service of process to provide that all petitions for compensation under the VICP are to be sent to the Director, Division of Vaccine Injury Compensation, Office of Special Programs, Health Resources and Services Administration. This amendment is purely technical.

DATES:

This regulation is effective on January 27, 2003.

FOR FURTHER INFORMATION CONTACT:

Thomas E. Balbier, Jr., Director, DVIC, OSP, HRSA, 4350 East West Highway, 10th Floor, Bethesda, Maryland 20814; telephone number: [phone]. For information about how to file petitions for compensation, contact the Clerk, United States Court of Federal Claims, 717 Madison Place, N.W., Washington, D.C. 20005, telephone number: [phone].

SUPPLEMENTARY INFORMATION:

45 CFR 4.6 provides that service of the Secretary's copies of petitions for compensation under the VICP and of related filings are to be served upon the Director, BHPr, which until October 15, 2001, included DVIC. DVIC administers all of the statutory authorities of the Secretary related to the operation of the VICP. On October 15, 2001, the Acting Administrator, HRSA, published in the Federal Register a “Statement of Organization, Functions, and Delegations of Authority (66 FR 52421),” which set forth organizational changes within BHPr and other organizations within HRSA. Included among those changes was the reorganization of DVIC from BHPr into OSP, HRSA.

Because DVIC has been reorganized from BHPr to OSP within HRSA, the Secretary is amending the regulations governing service of process of materials relating to petitions under the VICP to reflect the appropriate addressee for proper service of such materials.

Justification for Omitting Notice of Proposed Rulemaking

This amendment to 45 CFR 4.6 is a technical amendment to reflect a reorganization of HRSA. Since this is a technical amendment, related solely to internal Departmental management, the Secretary has determined, under 5 U.S.C. 553 and departmental policy, that it is unnecessary to follow proposed rulemaking procedures.

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 (RFA), 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 Secretary has determined that no resources are required to implement the requirements in this rule. Therefore, in accordance with the RFA of 1980, and the Small Business Regulatory Enforcement Fairness 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.

The Secretary has further 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. Major rules are those that impose a cost on the economy of $100 million or more a year or have certain other economic impacts. 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 1995

This regulation is not subject to the Paperwork Reduction Act because it deals solely with internal management of the Department of Health and Human Services.

List of Subjects in 45 CFR Part 4

• Courts, vaccine injury petitions

Dated: November 29, 2002.

Elizabeth M. Duke,

Administrator, Health Resources and Services Administration.

Approved: December 16, 2002.

Tommy G. Thompson,

Secretary.

Accordingly, 45 CFR part 4 is amended as set forth below:

PART 4—SERVICE OF PROCESS

1. The authority citation for 45 CFR part 4 continues to read as follows:

Authority: 5 U.S.C. 301, 42 U.S.C. 300aa-11.

2. Section 4.6 is revised to read as follows:

§ 4.6

Materials related to petitions under the National Vaccine Injury Compensation Program.

Notwithstanding the provisions of §§ 4.1, 4.2, and 4.3, service of the Secretary's copies of petitions for compensation under the VICP and of related filings, by mail, shall be served upon the Director, Division of Vaccine Injury Compensation, Office of Special Programs, Health Resources and Services Administration 5600 Fishers Lane, Parklawn Building, Room 16C-17, Rockville, Maryland 20857, or in person, shall be served upon the Director, Division of Vaccine Injury Compensation, Office of Special Programs, Health Resources and Services Administration, 4350 East West Highway, 10th Floor, Bethesda, Maryland 20814.