Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Rules and Regulations 12733

That airspace extending upward from 700

feet above the surface within a 6.3-mile

radius of Monroe City Regional Airport and

within 3.5 mules each side of the Quincy

VORTAC 239° radial extending from 6.3-mile

radius to 7 miles northeast of the airport.

* * * * *

Issued in Kansas City, MO, on February 8,

2001.

Richard L. Day,

Acting Manager, Air Traffic Division, Central

Region.

[FR Doc. 01–4677 Filed 2–27–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 00P–1675]

Clinical Chemistry and Clinical

Toxicology Devices; Classification of

B–Type Natriuretic Peptide Test

System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying the

B-type natriuretic peptide (BNP) test

system into class II (special controls).

The special control that will apply to

this device is a guidance document

entitled ‘‘Class II Special Control

Guidance Document for B–Type

Natriuretic Peptide Premarket

Notifications; Final Guidance for

Industry and FDA Reviewers.’’ The

agency is taking this action in response

to a petition submitted under the

Federal Food, Drug, and Cosmetic Act

(the act) as amended by the Medical

Device Amendments of 1976, the Safe

Medical Devices Act of 1990, and the

Food and Drug Administration

Modernization Act of 1997. The agency

is classifying these devices into class II

(special controls) in order to provide a

reasonable assurance of the safety and

effectiveness of the device.

DATES: This rule is effective February

28, 2001.

FOR FURTHER INFORMATION CONTACT: Jean

M. Cooper, 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

In accordance with section 513(f)(1) of

the act (21 U.S.C. 360c(f)(1)), devices

that were not in commercial distribution

before May 28, 1976, the date of

enactment of the Medical Device

Amendments of 1976 (the amendments),

generally referred to as postamendments

devices, are classified automatically by

statute into class III without any FDA

rulemaking process. These devices

remain in class III and require

premarket approval, unless and until

the device is classified or reclassified

into class I or II or FDA issues an order

finding the device to be substantially

equivalent, in accordance with 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 marketed

devices by means of premarket

notification procedures in section 510(k)

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

part 807 of FDA’s regulations.

Section 513(f)(2) of the act provides

that any person who submits a

premarket notification under section

510(k) of the act for a device that has not

previously been classified may, within

30 days after receiving an order

classifying the device in class III under

section 513(f)(1) of the act, request FDA

to classify the device under the criteria

set forth in section 513(a)(1) of the act.

FDA shall, within 60 days of receiving

such a request, classify the device by

written order. This classification shall

be the initial classification of the device.

Within 30 days after the issuance of an

order classifying the device, FDA must

publish a notice in the Federal Register

announcing such classification.

In accordance with section 513(f)(1) of

the act, FDA issued an order on

November 13, 2000, classifying the BNP

test in class III, because it was not

substantially equivalent to a device that

was introduced or delivered for

introduction into interstate commerce

for commercial distribution before May

28, 1976, or a device that was

subsequently reclassified into class I or

II. On November 15, 2000, FDA received

a petition submitted by Biosite

Diagnostic, Inc., requesting

classification of the BNP test system

into class II under section 513(f)(2) of

the act.

After review of the information

submitted in the petition, FDA

determined that the Biosite Diagnostics

BNP test system can be classified in

class II with the establishment of special

controls. This device is intended to

measure BNP in whole blood and

plasma as an aid in the diagnosis of

patients with congestive heart failure.

FDA believes that class II special

controls, in addition to the general

controls, will provide reasonable

assurance of the safety and effectiveness

of the device.

In addition to the general controls of

the act, the Biosite Diagnostics BNP test

system is subject to a special control

guidance document entitled ‘‘Class II

Special Control Guidance Document for

B–Type Natriuretic Peptide Premarket

Notifications; Final Guidance for

Industry and FDA Reviewers.’’

Section 510(m) of the act provides

that FDA may exempt a class II device

from the premarket notification

requirement under section 510(k) of the

act, if FDA determines that premarket

notification is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. FDA has

determined that premarket notification

is necessary to provide reasonable

assurance of the safety and effectiveness

of this type of device and, therefore, the

device is not exempt from the premarket

notification requirements. The test is

used in the diagnosis of patients with

congestive heart failure. FDA review of

data sets and labeling ensure that

minimum levels of performance are

obtained before marketing and are

subject to impartial external quality

control before labeling is put into place.

Thus, persons who intend to market this

device must submit to FDA a premarket

notification submission containing

information on the BNP test system

before marketing the device.

On November 20, 2000, FDA issued

an order to the petitioner classifying the

Biosite Diagnostics BNP test system, and

substantially equivalent devices of this

generic type, into class II under the

generic name, BNP test system. FDA

identifies this generic type of device as

a BNP test system, which is intended to

aid in the diagnosis of congestive heart

failure. FDA is codifying this device by

adding § 862.1117. This order also

identifies a special control applicable to

this device ‘‘Class II Special Control

Guidance Document for B–Type

Natriuretic Peptide Premarket

Notifications; Final Guidance for

Industry and FDA Reviewers.’’

II. Electronic Access

In order to receive the draft guidance

entitled ‘‘Class II Special Control

Guidance Document for B–Type

Natriuretic Peptide Premarket

Notifications; Final Guidance for

Industry and FDA Reviewers’’ via your

fax machine, call the CDRH Facts on

Demand System at 800–899–0381 or

301–827–0111 from a touch-tone

12734 Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Rules and Regulations

telephone. At the first voice prompt

press 1 to enter the system. At the

second voice prompt press 1 to order a

document. Enter the document number

(1183) followed by the pound sign (#).

Follow the remaining voice prompts to

complete your request.

Persons interested in obtaining a copy

of the draft 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. The CDRH home page may be

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

‘‘Class II Special Control Guidance

Document for B–Type Natriuretic

Peptide Premarket Notification; Final

Guidance for Industry and FDA

Reviewers’’ is available at http://

www.fda.gov/cdrh/ode/guidance/

1072.pdf.

III. 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.

IV. Analysis of Impacts

FDA has examined the impacts of the

final 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–

1210), 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 final rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

final rule is not a significant regulatory

action as defined by the Executive Order

and so it 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. FDA knows of only one

manufacturer of this type of device.

Classification of these devices in class II

will relieve this manufacturer of the

device of the cost of complying with the

premarket approval requirements of

section 515 of the act (21 U.S.C. 360e)

and may permit small potential

competitors to enter the market place by

lowering their costs. The agency,

therefore, certifies that this final rule

will not have a significant economic

impact on a substantial number of small

entities.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 requires

that agencies prepare a written

statement of anticipated costs and

benefits before proposing any rule that

may result in an expenditure by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million in any one year (adjusted

annually for inflation). The Unfunded

Mandates Reform Act does not require

FDA to prepare a statement of costs and

benefits for the final rule, because the

final rule is not expected to result in any

1-year expenditure that would exceed

$100 million.

V. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between the National

Government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Accordingly, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

VI. Paperwork Reduction Act of 1995

This final rule contains no collection

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects in 21 CFR Part 862

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 862 is

amended as follows:

PART 862—CLINICAL CHEMISTRY

AND CLINICAL TOXICOLOGY

DEVICES

1. The authority citation for 21 CFR

part 862 continues to read as follows:

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

360j, 371.

2. Section 862.1117 is added to

subpart B to read as follows:

§ 862.1117 B-type natriuretic peptide test

system.

(a) Identification. The B-type

natriuretic peptide (BNP) test system is

an in vitro diagnostic device intended to

measure BNP in whole blood and

plasma. Measurements of BNP are used

as an aid in the diagnosis of patients

with congestive heart failure.

(b) Classification. Class II (special

controls). The special control is ‘‘Class

II Special Control Guidance Document

for B–Type Natriuretic Peptide

Premarket Notifications; Final Guidance

for Industry and FDA Reviewers.’’

Dated: January 11, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–4847 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 97P–0354]

Medical Devices; Reclassification of

the Shoulder Joint Metal/Polymer/Metal

Nonconstrained or Semi-Constrained

Porous-Coated Uncemented

Prosthesis

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it is reclassifying the shoulder joint

metal/polymer/metal nonconstrained or

semi-constrained porous-coated

uncemented prosthesis intended to

replace a shoulder joint from class III to

class II (special controls). The agency is

also announcing that it has issued an

order in the form of a letter to the

Orthopedic Surgical Manufacturers

Association (OSMA) reclassifying the

device. The special control that will

apply is a guidance document entitled

‘‘Class II Special Controls Guidance:

Shoulder Joint Metal/Polymer/Metal

Nonconstrained or Semi-Constrained

Porous-Coated Uncemented Prosthesis.’’

The agency is classifying this device

into class II because special controls, in

addition to general controls, would

provide reasonable assurance of the

safety and effectiveness of the device,

and there is sufficient information to

establish special controls.