23634 Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Proposed Rules

§ 39.13 [Amended]

2. The FAA amends § 39.13 by adding

the following new airworthiness

directive:

Eurocopter France: Docket No. 2001–SW–

03–AD.

Applicability: Model AS–365N3

helicopters, certificated in any category.

Note 1: This AD applies to each helicopter

identified in the preceding applicability

provision, regardless of whether it has been

otherwise modified, altered, or repaired in

the area subject to the requirements of this

AD. For helicopters that have been modified,

altered, or repaired so that the performance

of the requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (b) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Within 90 days after the

effective date of this AD, unless previously

accomplished.

To prevent loss of the Full Authority

Digital Engine Control (FADEC) one-engineinoperative power and subsequent loss of

control of the helicopter, accomplish the

following:

(a) Modify the FADEC software in

accordance with the Accomplishment

Instructions of Eurocopter France Service

Bulletin 71.00.13, Revision 1, dated October

17, 2000 (except this AD does not require

contact with the manufacturer as specified in

the caution statement in paragraph 2.B. and

the Note I in paragraph 2.B.2.).

(b) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Regulations

Group, Rotorcraft Directorate, FAA.

Operators shall submit their requests through

an FAA Principal Maintenance Inspector,

who may concur or comment and then send

it to the Manager, Regulations Group.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Regulations Group.

(c) Special flight permits may be issued in

accordance with 14 CFR 21.197 and 21.199

to operate the helicopter to a location where

the requirements of this AD can be

accomplished.

Note 3: The subject of this AD is addressed

in Direction Generale De L’Aviation Civile

(France) AD Nos. 2000–517–051(A) and

1998–517–048(A) R2, both dated December

13, 2000; 1998–517–048(A) R1, dated April 5,

2000; and 1998–517–048(A), dated January

13, 1999.

Issued in Fort Worth, Texas, on April 26,

2001.

Mark R. Schilling,

Acting Manager, Rotorcraft Directorate,,

Aircraft Certification Service.

[FR Doc. 01–11585 Filed 5–8–01; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. 95P–0351]

Hematology and Pathology Devices;

Reclassification of Automated

Differential Cell Counters

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

reclassify from class III (premarket

approval) to class II (special controls)

the automated differential cell counter

(ADCC). The ADCC is a device intended

to identify and classify one or more of

the formed elements of the blood, or to

flag, count, or classify immature or

abnormal hematopoietic cells of the

blood, bone marrow, or other body

fluids. FDA is basing this

reclassification on new information

submitted in a reclassification petition

from the International Society for

Laboratory Hematology (ISLH). The

agency is taking this action under the

Federal Food, Drug, and Cosmetic Act

(the act), as amended by the Medical

Device Amendments of 1976 (the 1976

amendments), the Safe Medical Devices

Act of 1990 (the SMDA), and the Food

and Drug Administration Modernization

Act of 1997 (FDAMA).

DATES: Submit written comments by

August 7, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Larry J. Brindza, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1293.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

The act, as amended by the 1976

amendments (Public Law 94–295), the

SMDA (Public Law 101–629), and

FDAMA (Public Law 105–115),

established a comprehensive system for

the regulation of medical devices

intended for human use. Section 513 of

the act (21 U.S.C. 360c) established

three categories (classes) of devices,

depending on the regulatory controls

needed to provide reasonable assurance

of their safety and effectiveness. The

three categories of devices are class I

(general controls), class II (special

controls), and class III (premarket

approval).

Under section 513 of the act, devices

that were in commercial distribution

before May 28, 1976 (the date of

enactment of the 1976 amendments),

generally referred to as preamendments

devices, are classified after FDA has: (1)

Received a recommendation from a

device classification panel (an FDA

advisory committee); (2) published the

panel’s recommendation for comment,

along with a proposed regulation

classifying the device; and (3) published

a final regulation classifying the device.

FDA has classified most

preamendments devices under these

procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as postamendments

devices, are classified automatically by

statute (section 513(f) of the act) into

class III without any FDA rulemaking

process. Those devices remain in class

III and require premarket approval,

unless and until: (1) The device is

reclassified into class I or II; (2) FDA

issues an order classifying the device

into class I or II in accordance with

section 513(f)(2) of the act, as amended

by FDAMA; or (3) FDA issues an order

finding the device to be substantially

equivalent, under section 513(i) of the

act, to a predicate device that does not

require premarket approval. The agency

determines whether new devices are

substantially equivalent to previously

offered devices by means of premarket

notification procedures in section 510(k)

of the act (21 U.S.C. 360(k)) and part 807

of the regulations (21 CFR part 807).

A preamendments device that has

been classified into class III may be

marketed, by means of premarket

notification procedures, without

submission of a premarket approval

application (PMA) until FDA issues a

final regulation under section 515(b) of

the act (21 U.S.C. 360e(b)) requiring

premarket approval.

Reclassification of classified

preamendments devices is governed by

section 513(e) of the act. This section

provides that FDA may, by rulemaking,

reclassify a device (in a proceeding that

parallels the initial classification

proceeding) based upon ‘‘new

information.’’ The reclassification can

be initiated by FDA or by the petition

of an interested person. The term ‘‘new

information,’’ as used in section 513(e)

of the act, includes information

developed as a result of a reevaluation

of the data before the agency when the

device was originally classified, as well

as information not presented, not

Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Proposed Rules 23635

available, or not developed at that time.

(See, e.g., Holland Rantos v. United

States Department of Health, Education,

and Welfare, 587 F.2d 1173, 1174 n.1

(D.C. Cir. 1978); Upjohn v. Finch, 422

F.2d 944 (6th Cir. 1970); and Bell v.

Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previously

before the agency is an appropriate basis

for subsequent regulatory action where

the reevaluation is made in light of

newly available regulatory authority

(see Bell v. Goddard, supra, 366 F.2d at

181; Ethicon, Inc. v. FDA, 762 F.Supp.

382, 389–91 (D.D.C. 1991)), or in light

of changes in ‘‘medical science.’’ (See

Upjohn v. Finch, supra, 422 F.2d at

951.) Regardless of whether data before

the agency are past or new data, ‘‘new

information’’ to support reclassification

under section 513(e) of the act must be

‘‘valid scientific evidence,’’ as defined

in section 513(a)(3) of the act and 21

CFR 860.7(c)(2). (See, e.g., General

Medical Co. v. FDA, 770 F.2d 214 (D.C.

Cir. 1985); Contact Lens Assoc. v. FDA,

766 F.2d 592 (D.C. Cir.), cert. denied,

474 U.S. 1062 (1985).) FDA relies upon

‘‘valid scientific evidence’’ in the

classification process to determine the

level of regulation for devices. For the

purpose of reclassification, the valid

scientific evidence upon which the

agency relies must be publicly available.

Publicly available information excludes

trade secret and/or confidential

commercial information, e.g., nonpublic

information in a pending PMA. (See

section 520(c) of the act (21 U.S.C.

360j(c).)

II. Regulatory History of the Device

In the Federal Register of June 8, 1990

(55 FR 23510), FDA issued a final rule

that amended 21 CFR 864.5220 to

reclassify the ADCC intended to flag or

identify specimens containing abnormal

blood cells from class III into class II.

The rule continued to classify the ADCC

intended for all other uses into class III.

FDA based the rule on new information

in a petition from the Health Industry

Manufacturers Association.

On September 22, 1995, Abbott

Laboratories, Santa Clara, CA 95054,

submitted a petition under sections

513(e) and 515(b) of the act to reclassify

the ADCC from class III to class II for its

general uses in identifying and counting

blood elements and cells. On September

4, 1997, FDA received a letter from ISLH

announcing that ISLH was replacing

Abbott Laboratories as the petitioner.

Consistent with the act and the

regulations, FDA referred the petition to

the Hematology and Pathology Device

Panel (the Panel) for its

recommendation on the change in

classification requested by the

petitioner. The Panel based its

recommendation to reclassify the ADCC

from class III to class II on the belief that

special controls, including voluntary

standards and guidance documents, as

well as published references, and the

clinical experience of the Panel, are

sufficient to provide reasonable

assurance of the safety and effectiveness

of the ADCC. Accordingly, FDA is now

proposing to reclassify the ADCC from

class III (premarket approval) to class II

(special controls) when the device is

intended to be used to identify and

classify one or more of the formed

elements of the blood, or to flag, count,

or classify immature or abnormal

hematopoietic cells of the blood, bone

marrow, or other body fluids.

III. Proposed Dates

FDA proposes that any final

regulation based on this proposal

become effective 30 days after its date

of publication in the Federal Register.

IV. Device Description

An ADCC is a device used to identify

one or more of the formed elements of

the blood. These devices 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 may include accessory CD

markers.

V. Recommendation of the Panel

On January 20, 1999, the Panel

recommended that the ADCC be

reclassified from class III to class II. The

Panel believed that classification in

class II with the special control

‘‘Guidance for Premarket Notification

for Automated Differential Cell Counters

for Immature or Abnormal Blood Cells’’

would provide reasonable assurance of

the safety and effectiveness of the

device.

VI. Risks to Health

Failure of the device to perform

satisfactorily may lead to an error in the

diagnosis of a blood cell disorder.

Inappropriate therapy based on

inaccurate diagnostic data may place the

patient at risk.

VII. Summary of Reasons for

Recommendation

The Panel believes that the ADCC

should be reclassified 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. Adherence to

‘‘Guidance for Premarket Notification

for Automated Differential Cell Counters

for Immature or Abnormal Blood Cells’’

can control the risk of misdiagnosis and

inappropriate therapy by having the

manufacturer provide appropriate data

to support all claims for substantial

equivalence and performance of ADCC.

VIII. Summary of Data Upon Which the

Recommendation Is Based

The performance characteristics of the

technology used in ADCCs over many

years of experience plus the proven

safety and effectiveness of the device are

well documented in the medical

literature (Ref. 1). FDA can evaluate

performance characteristics for

abnormal cell types such as nucleated

red blood cells and immature

reticulocyte fraction in 510(k)

submissions (Refs. 2, 3, and 4). Based on

the available information, FDA believes

that the special control discussed below

is capable of providing reasonable

assurance of the safety and effectiveness

of the automated differential cell

counter for the identified risks to health

of this device.

IX. Special Controls

In addition to general controls, FDA

believes that the ‘‘Guidance for

Premarket Notification for Automated

Differential Cell Counters for Immature

or Abnormal Blood Cells’’ is an

adequate special control to address the

risks to health described above.

In order to receive ‘‘Guidance for

Premarket Notification for Automated

Differential Cell Counters for Immature

or Abnormal Blood Cells’’ via your fax

machine, call the CDRH Facts-OnDemand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. Press 1 to enter the system.

At second voice prompt press 1 to order

a document. Enter the document

number (1184) followed by the pound

sign (#). Follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy of

the guidance may also do so using the

Internet. CDRH maintains an entry on

the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. Updated on a regular basis, the

CDRH home page includes ‘‘Guidance

for Premarket Notification for

Automated Differential Cell Counters for

Immature or Abnormal Blood Cells,’’

device safety alerts, Federal Register

reprints, information on premarket

submissions (including lists of approved

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