Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 /Rules and Regulations 25777

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Objections and hearing requests will

also be accepted on disks in

WordPerfect 51/6.1 or ASCII file format.

All copies of objections and hearing

requests in electronic form must be

identified by the docket control number

[OPP–300646]. No CBI should be

submitted through e-mail. Electronic

copies of objections and hearing

requests on this rule may be filed online

at many Federal Depository Libraries.

III. Regulatory Assessment

Requirements

This final rule extends a time-limited

tolerance that was previously extended

by EPA under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). In addition, this final

rule does not contain any information

collections subject to OMB approval

under the Paperwork Reduction Act

(PRA), 44 U.S.C. 3501 et seq., or impose

any enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

Since this extension of an existing

time-limited tolerance does not require

the issuance of a proposed rule, the

requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

IV. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, EPA

submitted a report containing this rule

and other required information to the

U.S. Senate, the U.S. House of

Representatives, and the Comptroller

General of the General Accounting

Office prior to publication of this rule in

today’s Federal Register. This is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: April 27, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180— [AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

§ 180.355 [Amended]

2. In § 180.355, the table to paragraph

(b) is amended by changing the date ‘‘6/

30/98’’ to read ‘‘6/30/99’’.

[FR Doc. 98–12425 Filed 5–8–98; 8:45 am]

BILLING CODE 6560–50–F

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.

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 § 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
25778 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 /Rules and Regulations

‘‘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

§ 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); § 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:

§ 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

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part O

[GC Docket No. 97–143; FCC 97–332]

Implementation of the Electronic

Freedom of Information Act

Amendments of 1996; Correction

AGENCY: Federal Communications

Commission.

ACTION: Final rule; correction.

SUMMARY: The Federal Communications

Commission (FCC) published in the

Federal Register of October 3, 1997, a

document amending its Freedom of

Information Act (FOIA) regulations to

implement the Electronic Freedom of

Information Act Amendments of 1996

(EFOIA). Inadvertently, in § 0.461

paragraphs (i)(2) through (i)(5) were

deleted from the rules. This document

restores those rules.

EFFECTIVE DATE: May 11, 1998.

FOR FURTHER INFORMATION CONTACT:

Laurence H. Schecker, Office of General

Counsel, (202) 418–1720.

SUPPLEMENTARY INFORMATION: The FCC

published a document in the Federal

Register of October 3, 1997 (62 FR

51795), amending its FOIA regulations

to conform to the EFOIA. In FR Doc. 97–

26205, published in the Federal

Register of October 3, 1997, in § 0.461

paragraphs (i)(2) through (i)(5) were

inadvertently deleted from the

regulations. This correction restores

those rules.

In rule FR Doc. 97–26205 published

on October 3, 1997, (62 FR 51795) make

the following corrections.

1. On page 51797, in the second

column, revise amendatory instruction

7. to read as follows: ‘‘Section 0.461 is

amended by redesignating paragraph (a)

as paragraph (a)(1) and adding

paragraph (a)(2), revising paragraphs