23636 Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Proposed Rules

applications and manufacturers’

addresses), small manufacturers’

assistance, information on video

conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh.

X. FDA’s Tentative Findings

FDA agrees with the recommendation

of the Panel and believes ADCCs should

be classified into class II because special

controls, in addition to general controls,

provide reasonable assurance of the

safety and effectiveness of the device,

and there is sufficient information to

establish special controls to provide

such assurance.

XI. Environmental Impact

The agency has determined under 21

CFR 25.34(b) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

XII. Analysis of Impacts

FDA has examined the impacts of this

proposed rule under Executive Order

12866, and the Regulatory Flexibility

Act (5 U.S.C. 601–612) (as amended by

subtitle D of the Small Business

Regulatory Fairness Act of 1996 (Public

Law 104–121)), and the Unfunded

Mandates Reform Act of 1995 (Public

Law 104–4). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this reclassification action

is consistent with the regulatory

philosophy and principles identified in

the Executive order. In addition, the

reclassification action is not a

significant regulatory action as defined

by the Executive order and so is not

subject to review under the Executive

order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Reclassification of this device

from class III to class II will relieve all

manufacturers of the device of the cost

of complying with the premarket

approval requirements in section 515 of

the act. Because reclassification will

reduce regulatory costs with respect to

this device, it will impose no significant

economic impact on any small entities,

and it may permit small potential

competitors to enter the marketplace by

lowering their costs. The agency

therefore certifies that this

reclassification action, if finalized, will

not have a significant economic impact

on a substantial number of small

entities. In addition, this reclassification

action will not impose costs of $100

million or more on either the private

sector or State, local, and tribal

governments in the aggregate, and

therefore a summary statement or

analysis under section 202(a) of the

Unfunded Mandates Reform Act of 1995

is not required.

XIII. Paperwork Reduction Act of 1995

The proposed rule does not contain

information collection provisions that

are subject to review by the Office of

Management and Budget under the

Paperwork Reduction Act of 1995 (44

U.S.C 3501–3520).

XIV. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

proposal by August 7, 2001. Two copies

of any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

XV. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 am. and 4 p.m., Monday

through Friday:

1. Various authors, ‘‘The White Blood Cell

Differential,’’ Parts I & II, Blood Cells 11:1–

314, 1985.

2. Dutcher, T. F., ‘‘Leukocyte Differentials,

Are They Worth The Effort?’’ Clinics in

Laboratory Medicine 4 (1): 71–87, 1984.

3. Rumke, C. L., ‘‘The Statistically

Expected Variability in Differential

Leukocyte Counting,’’ In: Differential

Leukocyte Counting,’’ edited by J. A. Koepke,

College of American Pathologists, Skokie, IL,

pp. 39–45, 1977.

4. Rumke, C. L., ‘‘Statistical Reflections in

Finding Atypical Cells,’’ Blood Cells 11: 141–

144, 1985.

List of Subjects in 21 CFR Part 864

Biologics, Blood, Laboratories,

Medical devices, Packaging and

containers.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, FDA proposes that

21 CFR part 864 be amended as follows:

PART 864—HEMATOLOGY AND

PATHOLOGY DEVICES

1. The authority citation for 21 CFR

part 864 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Section 864.5220 is revised to read

as follows:

§ 864.5220 Automated differential cell

counter.

(a) Identification. An automated

differential cell counter is a device used

to identify one or more of the formed

elements of the blood. The device may

also have the capability to flag, count,

or classify immature or abnormal

hematopoietic cells of the blood, bone

marrow, or other body fluids. These

devices may combine an electronic

particle counting method, optical

method, or a flow cytometric method

utilizing monoclonal CD (cluster

designation) markers. The device

includes accessory CD markers.

(b) Classification. Class II (special

controls). The special control for this

device is the FDA guidance document

entitled ‘‘Guidance for Premarket

Notification for Automated Differential

Cell Counters for Immature or Abnormal

Blood Cells.’’

Dated: April 28, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–11580 Filed 5–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

23 CFR Part 710

[FHWA Docket No. FHWA 2001–8624]

RIN 2125–AE82

Right-of-Way and Real Estate; Program

Administration

AGENCY: Federal Highway

Administration (FHWA), DOT.

ACTION: Notice of proposed rulemaking

(NPRM); request for comments.

SUMMARY: The FHWA is proposing to

amend its right-of-way regulations for

federally assisted transportation projects

to provide a clarification. The proposed

amendment would make it clear that

Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Proposed Rules 23637

Federal financial assistance, provided

by the FHWA pursuant to title 23, U.S.

Code, may be applied to relocation

assistance benefits, provided by State

and local agencies pursuant to State

law, that are in addition to the

relocation benefits prescribed by the

Uniform Relocation Assistance and Real

Property Acquisition Policies Act of

1970, as amended (Uniform Act).

DATES: Comments in response to this

notice must be received on or before

July 9, 2001.

ADDRESSES: Mail or hand deliver

comments to the docket number that

appears in the heading of this document

to the U.S. Department of

Transportation, Dockets Management

Facility, Room PL–4301, 400 Seventh

Street, SW., Washington, D.C. 20590, or

submit electronically at http/

ddmeses.dot.gov/submit. All comments

received will be available for

examination and copying at the above

address 9 a.m. to 5 p.m., e.t., Monday

through Friday, except Federal

Holidays. Those desiring notification of

receipt of comments must include a preaddressed, stamped envelope or post

card or you may print the

acknowledgement page that appears

after submitting comments

electronically.

FOR FURTHER INFORMATION CONTACT: Ms.

Barbara Satorius, Office of Real Estate

Services, HEPR–10, (303) 969–5772,

extension 333; FHWA, 555 Zang Street,

Lakewood, CO 80228, office hours are

from 8 a.m. to 5 p.m., m.t., Monday

through Friday, except Federal holidays;

or Mr. Reid Alsop, Office of Chief

Counsel, HCC–30, (202) 366–1371;

FHWA, 400 Seventh Street, SW.,

Washington, DC 20590, office hours are

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

through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access and Filing

You may submit or retrieve comments

online through the Document

Management System (DMS) at: http://

dms.dot.gov/submit. Acceptable formats

include: MS Word (versions 95 to 97),

MS Word for Mac (versions 6 to 8), Rich

Text File (RTF), American Standard

Code Information Interchange

(ASCII)(TXT), Portable Document

Format (PDF), and WordPerfect

(versions 7 to 8). The DMS is available

24 hours each day, 365 days each year.

Electronic submission and retrieval help

and guidelines are available under the

help section of the web site.

An electronic copy of this document

may also be downloaded by using a

computer, modem and suitable

communications software from the

Government Printing Office’s Electronic

Bulletin Board Service at (202) 512–

1661. Internet users my also reach the

Federal Register’s home page at http://

www.nara.gov/fedreg and the

Government Printing Office’s web page

at: http://www.access.gpo.gov/nara.

Background

The FHWA published a final rule on

Right-of-Way Program Administration

on December 21, 1999 (64 FR 71284).

The final rule in 23 CFR 710.203 revised

the FHWA’s policy on participation in

costs incurred by States in the

acquisition of real property for federally

assisted projects, funded pursuant to

title 23 U.S. Code. The reasons for this

change are described in the preamble to

both the final rule and the NPRM that

preceded it (63 FR 71238). The final rule

provides that the FHWA can participate

in those acquisition costs that are

required by State law, as well as in

relocation assistance and payments

provided pursuant to the Uniform Act to

assist persons required to move by such

projects.

Basically the change was based on a

desire to increase State flexibility and to

reduce administrative burdens.

Additionally, because Federal-aid

highway funds are allocated to States on

the basis of a statutory formula, the

FHWA participation in costs required

by State law will not result in any

changes in the amount of funds

available to a State.

Since publication of the final rule,

questions have arisen concerning the

FHWA participation in relocation

payments made by some States,

pursuant to State law, that are beyond

and in addition to those required by the

Uniform Act.

The Uniform Act prescribes benefits

that the State must provide as a

condition of the receipt of Federal

financial assistance. It provides a floor

not a ceiling, and does not prevent a

State, if it so chooses, from providing

relocation benefits in addition to those

provided by the Uniform Act. It also

does not prevent a Federal agency from

participating in such additional benefits

if it has the programmatic authority to

do so.

The FHWA believes that its

participation in such relocation

payments is permissible based on the

broad language in § 710.203(b)(1), as

well as the FHWA’s general authority to

participate in costs of ‘‘construction,’’

which term is defined in 23 U.S.C.

101(a)(3) to include both costs of rightof-way acquisition and relocation

assistance.

Further, since acquisition and

relocation are closely linked, it would

be more equitable and consistent for the

FHWA to participate in both the real

property acquisition costs and the

relocation assistance costs required by

State law. It is also less administratively

burdensome.

However, we recognize that the final

rule may lack clarity as to this matter,

and accordingly are proposing to amend

§ 710.203 (b)(2) to clearly state that

financial assistance provided by the

FHWA may participate in relocation

assistance payments that are made by a

State or local agency pursuant to State

law. Such payments may include

relocation payments that are in addition

to those prescribed by the Uniform Act.

This proposal would also correct an

inaccurate citation in § 710.409(a).

Rulemaking Analyses and Notices

All comments received before the

close of business on the comment

closing date indicated above will be

considered and will be available for

examination using the docket room at

the above address. The FHWA will file

comments received after the comment

closing date in the docket and will

consider late comments to the extent

practicable. The FHWA may, however,

issue a final rule at any time after the

close of the comment period. In

addition to late comments, the FHWA

will also continue to file, in the docket,

relevant information becoming available

after the comment closing date, and

interested persons should continue to

examine the docket for new material.

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, nor is it a significant

regulatory policy and procedure. 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 this proposal

would clarify existing requirements

relating to FHWA reimbursement for

certain expenditures that are required

by State law. Rather, this action would

make certain State expenditures eligible

for reimbursement by the Federal

government under title 23.

Regulatory Flexibility Act

In compliance with the Regulatory

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

agency has evaluated the effects of this

rule on small entities and determined

that this action will not have a

significant economic impact on a

23638 Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Proposed Rules

substantial number of small entities.

This action proposes to increase the

flexibility provided to States on how

they choose to spend their Federal-aid

highway funds. For this reason, the

FHWA certifies that this action would

not have a significant economic impact

on a substantial number of small

entities.

Environmental Impact

The FHWA has also analyzed this

action for the purpose of the National

Environmental Policy Act (42 U.S.C.

4321 et seq.), and has determined that

this action would not have any effect on

the quality of the human environment.

Executive Order 13132 (Federalism)

The FHWA has analyzed this action

in accordance with the principles and

criteria contained in Executive Order

13132 dated August 4, 1999, and

determined that this action does not

have sufficient federalism implications

on States that would limit the

policymaking discretion of the States.

Nothing in this document directly

preempts any State law or regulation.

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.

Unfunded Mandates Reform Act of

1995

This rule does not impose a Federal

mandate resulting in the expenditure by

State, local, and tribal governments, in

the aggregate, or by the private sector, or

$100 million or more in any one year.

(2 U.S.C. 1531 et seq.).

Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act

of 1995 (PRA) (44 U.S.C. 3501 et seq.),

Federal agencies must obtain approval

from the Office of Management and

Budget (OMB) for each collection of

information they conduct, sponsor, or

require through regulations. The FHWA

has reviewed this proposal and

determined that it does not contain

additional collection of information

requirements for the purposes of the

PRA. The requirements to collect

information relating to the current

provisions of the right-of-way regulation

are covered by a currently approved

information collection entitled ‘‘State

Right-of-Way Operations Manuals.’’

OMB Approval No. 2125–0586, Expires

August 31, 2003. This information

collection covers the burden for the

States to prepare and update their rightof-way operations manuals.

Changes in this proposal would

clarify the right-of-way regulations for

federally assisted transportation projects

and would, therefore, not affect the

current information collection burden

estimates.

Executive Order 12988 (Civil Justice

Reform)

This action meets applicable

standards in sections 3(a) and 3(b)(2) of

Executive Order 12988, Civil Justice

Reform, to minimize litigation,

eliminate ambiguity, and reduce

burden.

Executive Order 13045 (Protection of

Children)

The FHWA has analyzed this action

under Executive Order 13045,

Protection of Children from

Environmental Health Risks and Safety

Risks. This rule is not an economically

significant rule and does not concern an

environmental risk to health or safety

that may disproportionately affect

children.

Executive Order 12630 (Taking of

Private Property)

This rule will not affect a taking of

private or otherwise have taking

implications under Executive Order

12630. Governmental Actions and

Interference with Constitutionally

Protected Property Rights.

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 in 23 CFR Part 710

Grant programs-transportation,

Highways and roads, Real property

acquisition, Rights-of-way.

In consideration of the foregoing, the

FHWA proposes to amend title 23, Code

of Federal Regulations, Chapter 1, by

amending Part 710 as set forth below.

Issued on: May 2, 2001.

Vincent F. Schimmoller,

Deputy Executive Director, Federal Highway

Administration.

PART 710—[AMENDED]

1. The authority citation for part 710

continues to read as follows:

Authority: 23 U.S.C. 101(a), 107, 108, 111,

114, 133, 142(f), 145, 156, 204, 210, 308, 315,

317, and 323; 42 U.S.C. 2000d et seq., 4633,

4651–4655; 49 CFR 1.48(b) and (cc), 18.31,

and parts 21 and 24; 23 CFR 1.32.

2. Revise § 710.203(b)(2) to read as

follows:

§ 710.203 Funding and reimbursement.

* * * * *

(b) * * *

(2) Relocation assistance and

payments. Usual cost and

disbursements associated with

relocation assistance and payments

required under 49 CFR part 24 and

under the laws of the State, including

payments under State law that may

exceed the requirements of 49 CFR part

24.

* * * * *

§ 710.409 [Amended]

3. Amend § 710.409(a) by revising the

reference ‘‘§ 710.403(c)’’ to read

‘‘§ 710.403(d).’’

[FR Doc. 01–11710 Filed 5–8–01; 8:45 am]

BILLING CODE 4910–22–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD01–01–038]

RIN 2115–AE47

Drawbridge Operation Regulations;

West Bay, MA

AGENCY: Coast Guard, DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Coast Guard proposes to

change the drawbridge operating

regulations for the West Bay Bridge, at

mile 1.2, across West Bay in Osterville,

Massachusetts. This proposed rule

would allow the bridge owner to

increase the advance notice requirement

for April and extend the evening

operating hours at the bridge during the

boating season. This action is expected

to better meet the present needs of

navigation.

DATES: Comments must reach the Coast

Guard on or before July 9, 2001.

ADDRESSES: You may mail comments to

Commander (obr), First Coast Guard