20734 Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Rules and Regulations

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.95 [Amended]

2. Section 558.95 Bambermycins is

amended in paragraph (d)(4)(ii) by

removing ‘‘4 to 20’’ and adding in its

place ‘‘2 to 40’’.

Dated: March 17, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–9579 Filed 4–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 94P–0347]

Medical Devices; Reclassification and

Codification of the Nonabsorbable

Expanded Polytetrafluoroethylene

Surgical Suture

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it has issued an order in the form

of a letter to W. L. Gore and Associates,

Inc., reclassifying the nonabsorbable

expanded polytetrafluoroethylene

(ePTFE) surgical suture intended for use

in soft tissue approximation and

ligation, including cardiovascular

surgery, from class III (premarket

approval) to class II (special controls).

Accordingly, the order is being codified

in the Code of Federal Regulations

(CFR).

EFFECTIVE DATES: The rule is effective

May 18, 2000. The reclassification was

effective September 9, 1999.

FOR FURTHER INFORMATION CONTACT:

Anthony D. Watson, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–3090.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

The Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 301 et seq.), as

amended by the Medical Device

Amendments of 1976 (the 1976

amendments) (Public Law 94–295), the

Safe Medical Devices Act of 1990 (the

SMDA) (Public Law 101–629), and the

Food and Drug Administration

Modernization Act of 1997 (the

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).

The 1976 amendments broadened the

definition of ‘‘device’’ in 201(h) of the

act (21 U.S.C. 321(h)) to include certain

articles that were once regulated as

drugs. Under the 1976 amendments,

Congress classified all transitional

devices, i.e., those devices previously

regulated as new drugs, including the

nonabsorbable ePTFE surgical suture,

into class III. The legislative history of

the SMDA reflects congressional

concern that many transitional devices

were being overregulated in class III (H.

Rept. 808, 101st Cong., 2d sess. 26–27

(1990); S. Rept. 513, 101st Cong., 2d

sess. 27 (1990)). Congress amended

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

360j(l)) to direct FDA to collect certain

safety and effectiveness information

from the manufacturers of transitional

devices still remaining in class III to

determine whether the devices should

be reclassified into class II (special

controls) or class I (general controls).

Accordingly, in the Federal Register Of

November 14, 1991 (56 FR 57960), FDA

issued an order under section

520(l)(5)(A) of the act, requiring

manufacturers of transitional devices,

including the nonabsorbable ePTFE

surgical suture, to submit to FDA a

summary of, and a citation to, any

information known or otherwise

available to them respecting the devices,

including adverse safety or effectiveness

information which had not been

submitted under section 519 of the act

(21 U.S.C. 360i). Manufacturers were to

submit the summaries and citations to

FDA by January 13, 1992. However,

because of misunderstandings and

uncertainties regarding the information

required by the order, and whether the

order applied to certain manufacturers’

devices, many transitional class III

device manufacturers failed to comply

with the reporting requirement by

January 13, 1992. Consequently, in the

Federal Register of March 10, 1992 (57

FR 8462), FDA extended the reporting

period to March 31, 1992.

Section 520(l)(5)(B) of the act

provides that, after the issuance of an

order requiring manufacturers to submit

a summary of, and citation to, any

information known or otherwise

available respecting the devices, but

before December 1, 1992, FDA was to

publish regulations either leaving

transitional class III devices in class III

or reclassifying them into class I or II.

Subsequently, as permitted by section

520(l)(5)(C) of the act, in the Federal

Register of November 30, 1992 (57 FR

56586), the agency published a notice

extending the period for issuing such

regulations until December 1, 1993. Due

to limited resources, FDA was unable to

publish the regulations before the

December 1, 1993, deadline.

Nevertheless, in accordance with

sections 520(l)(5)(B) and 513(a) of the

act, FDA is now reclassifying the

nonabsorbable ePTFE surgical suture

from class III to class II.

On September 14, 1994, FDA filed the

reclassification petition submitted by W.

L. Gore and Associates, Inc., requesting

reclassification of the nonabsorbable

ePTFE surgical suture from class III to

class II.

FDA consulted with members of the

General and Plastic Surgery Devices

Panel (the Panel) of the Medical Devices

Advisory Committee about the

requested reclassification. The Panel

members recommended that the

nonabsorbable ePTFE surgical suture

intended for use in soft tissue

approximation and ligation, including

cardiovascular surgery, be reclassified

from class III to class II. They also

recommended FDA recognized

consensus standards and device-specific

labeling as the special controls for this

device.

After reviewing the data in the

petition and considering the Panel

members’ recommendations, FDA

agreed with their recommendations to

reclassify the device from class III into

class II with the recommended special

controls. Based on the available

information, FDA issued an order to the

petitioner on September 9, 1999,

reclassifying the nonabsorbable ePTFE

Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Rules and Regulations 20735

surgical suture, and substantially

equivalent devices of this generic type,

from class III to class II.

FDA identified the following FDA

recognized consensus standards and

labeling as special controls for the

device:

1. United States Pharmacopoeia (USP) 21:

a. Monograph for Nonabsorbable Surgical

Sutures;

b. Suture—Diameter <861>;

c. Suture—Needle Attachment <871>; and

d. Tensile Strength <881>.

2. Labeling:

a. Contraindication: ‘‘This device is

contraindicated for use in ophthalmic and

neural tissues and for use in microsurgery.’’

b. ‘‘For Single Use Only.’’

c. If the marketed suture has a different

diameter than the diameter specified in USP

21—Suture Diameter <861>, then a tabular

comparison of its diameter and USP suture

sizes should be included in the labeling.

Accordingly, as required by 21 CFR

860.136(b)(6) of the regulations, FDA is

announcing the reclassification of the

generic nonabsorbable ePTFE surgical

suture from class III into class II. In

addition, FDA is codifying the

reclassification of the device by adding

new § 878.5040.

II. Environmental Impact

The agency has determined under 21

CFR 25.34(b) that this reclassification 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.

III. 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), 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 notice 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 the 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 (21 U.S.C. 360e). 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 final

rule will not have a significant

economic impact on a substantial

number of small entities. In addition,

this final rule 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.

IV. Paperwork Reduction Act of 1995

FDA concludes that this final rule

contains no information that is subject

to review by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995. The special

controls do not require the respondent

to submit additional information to the

public. Therefore, no burden is placed

on the public.

List of Subjects in 21 CFR Part 878

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 878 is

amended as follows:

PART 878—GENERAL AND PLASTIC

SURGERY DEVICES

1. The authority citation for 21 CFR

part 878 continues to read as follows:

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

360j, 360l, 371.

2. Section 878.5035 is added to

subpart E to read as follows:

§ 878.5035 Nonabsorbable expanded

polytetrafluoroethylene surgical suture.

(a) Identification. Nonabsorbable

expanded polytetrafluoroethylene

(ePTFE) surgical suture is a

monofilament, nonabsorbable, sterile,

flexible thread prepared from ePTFE

and is intended for use in soft tissue

approximation and ligation, including

cardiovascular surgery. It may be

undyed or dyed with an approved color

additive and may be provided with or

without an attached needle(s).

(b) Classification. Class II (special

controls). FDA recognized consensus

standards and device-specific labeling:

(1) United States Pharmacopoeia (USP) 21:

(i) Monograph for Nonabsorbable Surgical

Sutures;

(ii) Sutures—Diameter <861>;

(iii) Sutures Needle Attachment <871>;

and

(iv) Tensile Strength <881>.

(2) Labeling:

(i) Contraindication: ‘‘This device is

contraindicated for use in ophthalmic and

neural tissues and for use in microsurgery.’’

(ii) ‘‘For Single Use Only.’’

(iii) If the marketed suture has a different

diameter than the diameter specified in USP

21—Suture Diameter <861>, then a tabular

comparison of its diameter and USP sizes

should be included in the labeling.

Dated: April 5, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–9577 Filed 4–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Part 1952

[Docket No. T–033]

Nevada State Plan; Final Approval

Determination

AGENCY: Occupational Safety and Health

Administration (OSHA), U.S.

Department of Labor.

ACTION: Final State plan approval—

Nevada.

SUMMARY: This document amends

OSHA’s regulations to reflect the

Assistant Secretary’s decision granting

final approval to the Nevada State plan.

As a result of this affirmative

determination under section 18(e) of the

Occupational Safety and Health Act of

1970, Federal OSHA’s standards and

enforcement authority no longer apply

to occupational safety and health issues

covered by the Nevada plan, and

authority for Federal concurrent

jurisdiction is relinquished. Federal

enforcement jurisdiction is retained

over any private sector maritime

employment, private sector employers

on Indian land, and any contractors or

subcontractors on any Federal

establishment where the land is

exclusive Federal jurisdiction. Federal

jurisdiction remains in effect with

respect to Federal government

employers and employees. Federal

OSHA will also retain authority for

coverage of the United States Postal