45326 Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Rules and Regulations

paragraphs (f)(10)(i) through (f)(10)(v) of

this section is appropriate or relevant to

the labeling of a particular drug, the

sponsor shall provide reasons for

omission of the statements and may

propose an alternative statement. FDA

may permit omission of the statements

if FDA determines that no statement

described in those paragraphs is

appropriate or relevant to the drug’s

labeling. FDA may permit use of an

alternative statement if the agency

determines that such statement is

accurate and appropriate.

* * * * *

Dated: July 31, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22701 Filed 8–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

23 CFR Parts 140 and 646

[FHWA Docket No. FHWA–97–2681]

RIN 2125–AD86

Railroad/Highway Projects

AGENCY: Federal Highway

Administration (FHWA), DOT.

ACTION: Interim final rule; request for

comments.

SUMMARY: The FHWA is amending its

regulations on railroad/highway projects

and reimbursement for railroad work on

Federal-aid highway projects. The

amendments require railroads to:

Submit final billings within one year

following completion of the railroad

work; remove the requirement of a

State’s certification that work is

complete; remove the ‘‘G’’ Funds

terminology; increase the ceiling for

lump sum agreements from $25,000 to

$100,000; incorporate changes brought

about by the Intermodal Surface

Transportation Efficiency Act of 1991

(ISTEA), Public Law 102–240, 105 Stat.

1914; and show dimensions for

participation limits in metric units. The

FHWA makes these changes to conform

the existing railroad/highway

regulations to more recent laws or

regulations, and to provide State

highway agencies with clarification and

more flexibility in implementing the

current law. This rulemaking is part of

the FHWA’s effort to implement the

President’s Regulatory Reinvention

Initiative.

DATES: This interim final rule is

effective August 27, 1997. Written

comments must be submitted on or

before October 27, 1997.

ADDRESSES: Submit written, signed

comments to the docket number that

appears in the heading of this document

to the Docket Clerk, U.S. DOT Dockets,

Room PL–401, 400 Seventh Street, SW.,

Washington, D.C. 20590–0001. All

comments received will be available for

examination at the above address

between 10 a.m. and 5 p.m., e.t.,

Monday through Friday, except Federal

holidays. Those desiring notification of

receipt of comments must include a selfaddressed, stamped envelope or

postcard.

FOR FURTHER INFORMATION CONTACT:

Robert Winans, Office of Engineering,

(202) 366–0450, or Wilbert Baccus,

Office of the Chief Counsel, (202) 366–

0780, FHWA, 400 Seventh Street, SW.,

Washington, D.C. 20590. Office hours

are from 7:45 a.m. to 4:15 p.m., e.t.,

Monday through Friday, except Federal

holidays.

SUPPLEMENTARY INFORMATION: Present

FHWA regulations regarding railroad/

highway projects and reimbursement for

railroad work on Federal-aid highway

projects have evolved from basic

principles established decades ago, with

many of the policies remaining

unchanged. The present regulations are

found at 23 CFR part 140, subpart I, and

part 646, subpart B. The FHWA amends

these regulations in the following

manner and for the reasons set forth

below.

In part 140, subpart I, § 140.904,

paragraph (b)(1) is amended to clarify

that the approved program of projects is

the approved statewide transportation

improvement program, as is now

required under 23 U.S.C. 135.

In § 140.922, paragraph (b) is

amended to require railroads to submit

final billings within one year following

completion of the railroad work.

Otherwise, previous payments to

railroads may be considered final and

projects may be closed out. This change

will assist highway agencies in their

efforts to obtain timely final billings

from the railroads. Prior to this action,

it had been common for some railroad

bills to be received years after the work

was completed, thus delaying audit

activity and project closure. With the

amended language, billings received

from railroads after one year following

completion of the railroad work can be

paid at the discretion of the highway

agency. Paragraph (b) is further

amended to remove the requirement for

State certification that the work is

complete, acceptable, and in accordance

with the terms of the agreement. The

FHWA believes that such certificates are

not necessary on individual projects.

Instead, compliance can be reviewed on

a program basis.

In part 646, subpart B, § 646.200,

paragraph (c) is amended to refer to

current sections of highway law. Section

405 of title 23, U.S.C., was repealed and

section 203 of the Highway Safety Act

of 1973 (Pub. L. 93–87, 87 Stat. 282) was

codified as part of 23 U.S.C. 130.

Paragraph (f) is removed because part

170 of title 23, CFR, no longer exists.

Section 646.202, Authority, is

removed and reserved. This section is

removed because the authority citation

is placed at the part level and, therefore,

redundant as a separate section in

subpart B.

Section 646.204 is amended to

remove paragraph (d) which defines

obsolete terminology, to remove the

paragraph designations from all

definitions, and to place the definitions

in alphabetical order.

In § 646.208, paragraphs (a) and (b)

are revised to describe only funding

sources for rail/highway crossing

projects. Information contained in this

section on Federal share is moved to

§ 646.212.

The current text of § 646.212,

paragraph (b) is removed. Section

1012(a) of the ISTEA amended 23 U.S.C.

120 by removing subsection (d)

concerning Federal share payable for

reconstruction of existing grade

separation projects on railway/highway

crossings. Such projects are no longer

eligible for 100 percent Federal funding.

Regulatory text from § 646.208(b) is

redesignated and revised as a new

paragraph (b) in § 646.212 in order to

provide information on Federal share in

one place.

In § 646.214, paragraph (a)(2) is

amended to clarify that the FHWA no

longer is required to approve standards

for all Federal-aid projects. Section

1016(d) of the ISTEA amended 23

U.S.C. 109 by adding a new subsection

(p) which provided that non-NHS

projects now follow State approved

standards.

In § 646.216, paragraph (d)(3)(ii) is

amended to increase the ceiling from

$25,000 to $100,000 for using the lump

sum payment arrangement for

reimbursement for railroad adjustments

(other than installation or improvement

of grade crossing warning devices and/

or grade crossing surfaces) on Federalaid and direct Federal highway projects.

The amendment provides the States

greater flexibility in utilizing the lump

sum payment arrangement. The purpose

of allowing lump sum agreements, in

lieu of agreements based on an

accounting of actual costs, is to reduce

the administrative burden associated
Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Rules and Regulations 45327

with railroad adjustment projects.

Under the lump sum process, cost

accounting is easier, project billings are

simplified, and final audit of detailed

cost records is not required. Typically,

final project costs are quite close to the

costs estimated for small, routine

projects. If more detailed cost

accounting methods were followed,

however, the FHWA believes that the

small degree of accuracy that might be

realized would not justify the extra cost

involved in carrying out detailed audits.

This revision increases the number of

railroad adjustments potentially eligible

for lump sum payment, anticipates

future needs and responds, in part, to

the fact that since the $25,000 limit was

established in 1982, inflation has

reduced the number and limited the

scope of projects eligible for lump sum

payments.

In § 646.216, paragraph (e)(1) is

amended to clarify that the approved

program of projects is the approved

statewide transportation improvement

program now required under 23 U.S.C.

135.

The appendix to subpart B is

amended to change the dimensions for

horizontal and vertical clearances to

metric units, in keeping with FHWA’s

metric transition timetable of September

30, 1996, published on August 31, 1993,

at 58 FR 46036. Since that time, section

205(c) of the National Highway System

Designation Act of 1995, Public Law

104–59, 109 Stat. 568, 577, amended the

compliance date for use of the metric

system (SI) on Federal-aid projects to

September 30, 2000.

Rulemaking Analyses and Notices

The Administrative Procedure Act

(APA), 5 U.S.C. 551 et seq., allows

agencies engaged in rulemaking to

dispense with prior notice and

opportunity for comment when the

agency for good cause finds that such

procedures are impracticable,

unnecessary, or contrary to the public

interest. 5 U.S.C. 553(b)(3)(B). For the

reasons set further below, the FHWA

has determined that prior notice to the

public and opportunity for comment on

this action are unnecessary and contrary

to the pubic interest.

The changes made by this rulemaking

provide greater flexibility to the States

and conform the existing regulations to

current law. First, the changes provide

the States with greater flexibility in their

billing procedures by allowing them to

require railroads to submit final billings

on a timely basis and by removing the

requirement that States certify that work

is complete for each project. Second, the

changes increase the ceiling for lump

sum agreements, which gives States

greater flexibility in utilizing the lump

sum payment arrangement, an option

already available to them. Finally, the

changes set forth in this interim final

rule conform existing regulations to

more current laws or regulations. Given

the nature of these changes, the FHWA

is not exercising its discretion in such

a way that could meaningfully be

affected by public comment. Moreover,

the FHWA believes that it is in the

public interest to make these changes

effective without the delay associated

with prior notice and opportunity for

comment.

Under the APA, 5 U.S.C. 553(d)(3),

agencies can, upon a finding of good

cause, make a rule effective immediately

and avoid the 30-day delay effective

requirement. The FHWA has

determined that good cause exists to

make this rule effective upon

publication for the following reasons.

First, the FHWA finds that good cause

exists to dispense with the 30-day delay

effective requirement because the

changes adopted by this action give the

States greater flexibility in billing and

rid the States of the burden to provide

certification that railroad work is

complete. Second, good cause further

exists because the increased ceiling for

lump sum agreements reduces the

administrative burden on the States

associated with railroad adjustment

projects. Finally, the additional changes

made by this rulemaking are merely

technical in nature, ensuring that the

existing regulations conform to current

law.

For these same reasons, the FHWA

has also determined that prior notice

and opportunity for comment are not

required under the Department of

Transportation’s regulatory policies and

procedures, as it is not anticipated that

such action would result in the receipt

of useful information. Therefore, the

FHWA is proceeding directly to an

interim final rule which is effective

upon publication. Nevertheless, in

issuing an interim final rule, the FHWA

affords interested persons with an

opportunity to comment on this action.

Comments received will be carefully

considered in evaluating whether any

change to this interim final rule is

needed.

Executive Order 12866 (Regulatory

Planning and Review) and DOT

Regulatory Policies and Procedures

The FHWA has determined that this

action is not a significant regulatory

action within the meaning of Executive

Order 12866 or significant within the

meaning of Department of

Transportation regulatory policies and

procedures. It is anticipated that the

economic impact of this rulemaking will

be minimal; therefore, a full regulatory

evaluation is not required. The FHWA

does not consider this action to be a

significant regulatory action because the

amendments would merely update the

railroad regulations for Federal-aid

highway projects to conform to recent

laws or regulations, and provide States

with clarification and flexibility to

implement the current law.

Regulatory Flexibility Act

In compliance with the Regulatory

Flexibility Act (5 U.S.C. 601–612), the

FHWA has evaluated the effects of this

rule on small entities. Based on that

evaluation, the FHWA certifies that this

action will not have a significant

economic impact on a substantial

number of small entities. The

amendments only clarify or simplify

procedures used by State highway

agencies in accordance with existing

laws or regulations.

Executive Order 12612 (Federalism

Assessment)

This action has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612, and it has been determined that

this action does not have sufficient

federalism implications to warrant the

preparation of a separate federalism

assessment. This rule does not impose

additional costs or burdens on the

States, including the likely sources of

funding for the States, nor does it affect

the ability of the States to discharge the

traditional State government functions.

This document merely assists the States

by giving them additional flexibility and

clarification in implementing railroad/

highway regulations.

Executive Order 12372

(Intergovernmental Review)

Catalog of Federal Domestic

Assistance Program Number 20.205,

Highway Planning and Construction.

The regulations implementing Executive

Order 12372 regarding

intergovernmental consultation on

Federal programs and activities apply to

this program.

Paperwork Reduction Act

This action does not contain a

collection of information requirement

for purposes of the Paperwork

Reduction Act of 1995, 44 U.S.C. 3501–

3520.

National Environmental Policy Act

The agency has analyzed this action

for the purpose of the National

Environmental Policy Act of 1969 (42

U.S.C. 4321 et seq.) and has determined
45328 Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Rules and Regulations

that this action would not have any

effect on the quality of the environment.

Regulation Identification Number

A regulation identification number

(RIN) is assigned to each regulatory

action listed in the Unified Agenda of

Federal Regulations. The Regulatory

Information Service Center publishes

the Unified Agenda in April and

October of each year. The RIN contained

in the heading of this document can be

used to cross reference this action with

the Unified Agenda.

List of Subjects

23 CFR Part 140

Bonds, Claims, Grant programs—

transportation, Highways and roads,

Railroads.

23 CFR Part 646

Grant programs—transportation,

Highways and roads, Insurance,

Railroads.

Issued on: August 20, 1997.

Gloria J. Jeff,

Acting Administrator.

In consideration of the foregoing, the

FHWA amends title 23, Code of Federal

Regulations, by revising part 140,

subpart I, and part 646, subpart B, to

read as set forth below.

PART 140—REIMBURSEMENT

1. The authority citation for part 140

continues to read as follows:

Authority: 23 U.S.C. 101(e), 106(c), 109(e),

114(a), 120(g), 121(d), 122, 130, and 315; and

49 CFR 1.48(b).

Subpart I—Reimbursement for

Railroad Work

2. In § 140.904, paragraph (b)(1) is

revised to read as follows:

§ 140.904 Reimbursement basis.

* * * * *

(b) * * *

(1) For work which is included in an

approved statewide transportation

improvement program.

* * * * *

3. In § 140.922, paragraph (b) is

revised to read as follows:

§ 140.922 Billings.

* * * * *

(b) The company shall provide one

final and complete billing of all

incurred costs, or of the agreed-to lump

sum, within one year following

completion of the reimbursable railroad

work. Otherwise, previous payments to

the company may be considered final,

except as agreed to between the SHA

and the railroad.

* * * * *

PART 646—RAILROADS

4. The authority citation for part 646

is revised to read as follows:

Authority: 23 U.S.C. 109(e), 120(c), 130,

133(d)(1), and 315; 49 CFR 1.48(b).

Subpart B—Railroad-Highway Projects

5. In § 646.200, paragraph (f) is

removed and paragraph (c) is revised to

read as follows:

§ 646.200 Purpose and applicability.

* * * * *

(c) Additional instructions for projects

involving the elimination of hazards of

railroad/highway grade crossings

pursuant to 23 U.S.C. 130 are set forth

in 23 CFR part 924.

* * * * *

§ 646.202 [Removed and Reserved]

6. Section 646.202 is removed and

reserved.

7. Section 646.204 is amended by

removing paragraph (d); by removing

the paragraph designations; and by

placing the definitions in alphabetical

order.

8. Section 646.208 is revised to read

as follows:

§ 646.208 Funding.

(a) Railroad/highway crossing projects

may be funded through the Federal-aid

funding source appropriate for the

involved project.

(b) Projects for the elimination of

hazards at railroad/highway crossings

may, at the option of the State, be

funded with the funds provided by 23

U.S.C. 133(d)(1).

9. In § 646.212, paragraph (b) is

revised to read as follows:

§ 646.212 Federal share.

* * * * *

(b) The Federal share of railroad/

highway crossing projects may be:

(1) Regular pro rata sharing as

provided by 23 U.S.C. 120(a) and 120(b).

(2) One hundred percent Federal

share, as provided by 23 U.S.C. 120(c).

(3) Ninety percent Federal share for

funds made available through 23 U.S.C.

133(d)(1).

10. In § 646.214, paragraph (a)(2) is

revised to read as follows:

§ 646.214 Design.

(a) * * *

(2) Facilities that are the

responsibility of the highway agency for

maintenance and operation shall

conform to the specifications and design

standards and guides used by the

highway agency in its normal practice

for Federal-aid projects.

* * * * *

11. Section 646.216 is amended in

paragraph (d)(3)(ii) by replacing the

figure ‘‘$25,000’’ with the figure

‘‘$100,000’’; and by revising paragraph

(e)(1) to read as follows:

§ 646.216 General procedures.

* * * * *

(e) Authorizations. (1) The costs of

preliminary engineering, right-of-way

acquisition, and construction incurred

after the date each phase of the work is

included in an approved statewide

transportation improvement program

and authorized by the FHWA are

eligible for Federal-aid participation.

Preliminary engineering and right-ofway acquisition costs which are

otherwise eligible, but incurred by a

railroad prior to authorization by the

FHWA, although not reimbursable, may

be included as part of the railroad share

of project cost where such a share is

required.

* * * * *

Appendix to Subpart B—Horizontal

and Vertical Clearance Provisions for

Overpass and Underpass Structures—

[Amended]

12. The appendix to subpart B is amended

as follows:

A. By replacing the words ‘‘20 feet’’ with

‘‘6.1 meters’’ wherever they appear;

B. By replacing the words ‘‘20-foot’’ with

‘‘6.1-meters’’ wherever they appear;

C. By replacing the words ‘‘8 feet’’ with

‘‘2.5 meters’’ wherever they appear;

D. By replacing the words ‘‘9 feet’’ with

‘‘2.8 meters’’ wherever they appear;

E. By replacing the words ‘‘23 feet’’ with

‘‘7.1 meters’’ wherever they appear;

F. By replacing the words ‘‘24 feet 3

inches’’ with ‘‘7.4 meters’’ wherever they

appear; and

G. By replacing the words ‘‘26 feet’’ with

‘‘8.0 meters’’ wherever they appear.

F. By replacing the words ‘‘Nine feet’’ with

‘‘Two and eight tenths meters’’ wherever they

appear.

[FR Doc. 97–22797 Filed 8–26–97; 8:45 am]

BILLING CODE 4910–22–P

FEDERAL EMERGENCY

MANAGEMENT AGENCY

44 CFR Part 206

RIN 3067–AC58

Disaster Assistance; Snow Assistance

AGENCY: Federal Emergency

Management Agency (FEMA).

ACTION: Final rule.