Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations 28053

Advisory Panel Meeting transcripts,

Gaithersburg, MD, July 22, 1994.

3. K932029, Sofamor Danek TSRH Spinal

System.

IV. Environmental Impact

The agency had determined under 21

CFR 25.30(i) that this final rule 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.

V. Analysis of Impacts

FDA has examined the impact 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–

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 rule is

consistent with the regulatory

philosophy and principles identified in

the Executive order. In addition, this

rule 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. The only effect of this

correction is to delay the requirement

for manufacturers of pedicle screw

spinal systems intended for certain uses

to submit PMA’s for these devices until

FDA issues a regulation requiring such

submissions. Therefore, the agency

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities.

This rule also does not trigger the

requirement for a written statement

under section 202(a) of the Unfunded

Mandates Reform Act because it does

not impose a mandate that results in an

expenditure of $100 million or more by

State, local, or tribal governments in the

aggregate, or by the private sector, in

any one year.

List of Subjects in 21 CFR Part 888

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 888 is

amended as follows:

PART 888—ORTHOPEDIC DEVICES

1. The authority citation for 21 CFR

part 888 continues to read as follows:

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

360j, 371.

2. Section 888.3070 is revised to read

as follows:

§ 888.3070 Pedicle screw spinal system.

(a) Identification. Pedicle screw spinal

systems are multiple component

devices, made from a variety of

materials, including alloys such as 316L

stainless steel, 316LVM stainless steel,

22Cr-13Ni-5Mn stainless steel, Ti-6Al4V, and unalloyed titanium, that allow

the surgeon to build an implant system

to fit the patient’s anatomical and

physiological requirements. Such a

spinal implant assembly consists of a

combination of anchors (e.g., bolts,

hooks, and/or screws); interconnection

mechanisms incorporating nuts, screws,

sleeves, or bolts; longitudinal members

(e.g., plates, rods, and/or plate/rod

combinations); and/or transverse

connectors.

(b) Classification. (1) Class II (special

controls), when intended to provide

immobilization and stabilization of

spinal segments in skeletally mature

patients as an adjunct to fusion in the

treatment of the following acute and

chronic instabilities or deformities of

the thoracic, lumbar, and sacral spine:

severe spondylolisthesis (grades 3 and

4) of the L5–S1 vertebra; degenerative

spondylolisthesis with objective

evidence of neurologic impairment;

fracture; dislocation; scoliosis; kyphosis;

spinal tumor; and failed previous fusion

(pseudarthrosis). These pedicle screw

spinal systems must comply with the

following special controls:

(i) Compliance with material

standards;

(ii) Compliance with mechanical

testing standards;

(iii) Compliance with

biocompatibility standards; and

(iv) Labeling that contains these two

statements in addition to other

appropriate labeling information:

‘‘Warning: The safety and effectiveness of

pedicle screw spinal systems have been

established only for spinal conditions with

significant mechanical instability or

deformity requiring fusion with

instrumentation. These conditions are

significant mechanical instability or

deformity of the thoracic, lumbar, and sacral

spine secondary to severe spondylolisthesis

(grades 3 and 4) of the L5–S1 vertebra,

degenerative spondylolisthesis with objective

evidence of neurologic impairment, fracture,

dislocation, scoliosis, kyphosis, spinal tumor,

and failed previous fusion (pseudarthrosis).

The safety and effectiveness of these devices

for any other conditions are unknown.’’

‘‘Precaution: The implantation of pedicle

screw spinal systems should be performed

only by experienced spinal surgeons with

specific training in the use of this pedicle

screw spinal system because this is a

technically demanding procedure presenting

a risk of serious injury to the patient.’’

(2) Class III (premarket approval),

when intended to provide

immobilization and stabilization of

spinal segments in the thoracic, lumbar,

and sacral spine as an adjunct to fusion

in the treatment of degenerative disc

disease and spondylolisthesis other than

either severe spondylolisthesis (grades 3

and 4) at L5–S1 or degenerative

spondylolisthesis with objective

evidence of neurologic impairment.

(c)Date PMA or notice of completion

of a PDP is required. No effective date

has been established of the requirement

for premarket approval for the devices

described in paragraph (b)(2) of this

section. See § 888.3.

Dated: May 11, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12769 Filed 5–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF COMMERCE

United States Patent and Trademark

Office

37 CFR Part 1

[Docket No.: 010202029–1112–02]

RIN 0651–AB35

Revision of Patent Cooperation Treaty

Application Procedure; Correction

AGENCY: United States Patent and

Trademark Office, Commerce.

ACTION: Final rule; correction.

SUMMARY: The United States Patent and

Trademark Office (Office) published a

final rule in the Federal Register of

March 22, 2001, revising the rules of

practice relating to applications filed

under the Patent Cooperation Treaty

(PCT) to conform the United States rules

of practice to the PCT Regulations that

became effective on March 1, 2001. This

document corrects three errors in that

final rule.

EFFECTIVE DATE: March 22, 2001.

FOR FURTHER INFORMATION CONTACT:

Charles Pearson, Director, Office of PCT

Legal Administration, by telephone at

(703) 306–4145; or by mail addressed to:

Box PCT, Commissioner for Patents,

28054 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations

Washington, DC 20231; or by facsimile

to (703) 308–6459, marked to the

attention of Charles Pearson.

SUPPLEMENTARY INFORMATION: The Office

published a final rule in the Federal

Register of March 22, 2001 (66 FR

16004), entitled ‘‘Revision of Patent

Cooperation Treaty Application

Procedure.’’ This document corrects

errors in §§ 1.494(c)(2), 1.495(c)(2), and

1.497(a)(1).

Specifically, §§ 1.494(c)(2) and

1.495(c)(2) as revised in the above final

rule inadvertently omitted the

provisions that:

The payment of the processing fee set forth

in § 1.492(f) is required for acceptance of an

English translation later than the expiration

of 20 [or 30] months after the priority date.

The payment of the surcharge set forth in

§ 1.492(e) is required for acceptance of the

oath or declaration of the inventor later than

the expiration of 20 [or 30] months after the

priority date. A ‘‘Sequence Listing’’ need not

be translated if the ‘‘Sequence Listing’’

complies with PCT Rule 12.1(d) and the

description complies with PCT Rule 5.2(b).

Section 1.497(a)(1) as revised in the

above final rule inadvertently omitted

the section symbols before the reference

to §§ 1.66 or 1.68.

In rule FR Doc. 01–7132, published

on March 22, 2001 (66 FR 16004), make

the following corrections:

1. On page 16006, in the second

column, in § 1.494, in paragraph (c)(2),

add the following sentences to the end

thereof:

§ 1.494 Entering the national stage in the

United States of America as a designated

office.

* * * * *

(c) * * *

(2) * * * The payment of the

processing fee set forth in § 1.492(f) is

required for acceptance of an English

translation later than the expiration of

20 months after the priority date. The

payment of the surcharge set forth in

§ 1.492(e) is required for acceptance of

the oath or declaration of the inventor

later than the expiration of 20 months

after the priority date. A ‘‘Sequence

Listing’’ need not be translated if the

‘‘Sequence Listing’’ complies with PCT

Rule 12.1(d) and the description

complies with PCT Rule 5.2(b).

* * * * *

2. On page 16006, in the third

column, in § 1.495, in paragraph (c)(2),

add the following sentences to the end

thereof:

§ 1.495 Entering the national stage in the

United States of America as an elected

office.

* * * * *

(c) * * *

(2) * * * The payment of the

processing fee set forth in § 1.492(f) is

required for acceptance of an English

translation later than the expiration of

30 months after the priority date. The

payment of the surcharge set forth in

§ 1.492(e) is required for acceptance of

the oath or declaration of the inventor

later than the expiration of 30 months

after the priority date. A ‘‘Sequence

Listing’’ need not be translated if the

‘‘Sequence Listing’’ complies with PCT

Rule 12.1(d) and the description

complies with PCT Rule 5.2(b).

* * * * *

1.497 [Corrected]

3. On page 16006, in the third

column, in § 1.497, in paragraph (a)(1),

line 2, correct ‘‘either 1.66 or 1.68’’ to

read ‘‘either §§ 1.66 or 1.68’’.

Dated: May 15, 2001.

Nicholas P. Godici,

Acting Under Secretary of Commerce for

Intellectual Property and Acting Director of

the United States Patent and Trademark

Office.

[FR Doc. 01–12764 Filed 5–21–01; 8:45 am]

BILLING CODE 3510–16–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[MD116–3067a; FRL–6979–6]

Approval and Promulgation of Air

Quality Implementation Plans; State of

Maryland; Repeal of Petroleum

Refinery Regulations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is taking direct final

action on a revision to the State of

Maryland State Implementation Plan

(SIP) submitted on January 4, 2001 by

the Maryland Department of the

Environment (MDE). This revision

repeals the requirements for petroleum

refineries in the State of Maryland.

There are no petroleum refineries

located in the State of Maryland. EPA is

approving this SIP in accordance with

the requirements of the Clean Air Act.

DATES: This rule is effective on July 23,

2001 without further notice, unless EPA

receives adverse written comment by

June 21, 2001. If EPA receives such

comments, it will publish a timely

withdrawal of the direct final rule in the

Federal Register and inform the public

that the rule will not take effect.

ADDRESSES: Written comments should

be mailed to David L. Arnold, Chief, Air

Quality Planning & Information Services

Branch, Mailcode 3AP21, U.S.

Environmental Protection Agency,

Region III, 1650 Arch Street,

Philadelphia, Pennsylvania 19103. You

may inspect copies of the documents

relevant to this action during normal

business hours at the following

locations: Air Protection Division, U.S.

Environmental Protection Agency,

Region III, 1650 Arch Street,

Philadelphia, Pennsylvania 19103; the

Air and Radiation Docket and

Information Center, U.S. Environmental

Protection Agency, 401 M Street, SW.,

Washington, DC 20460; and the

Maryland Department of the

Environment, 2500 Broening Highway,

Baltimore, Maryland, 21224.

FOR FURTHER INFORMATION CONTACT:

Ellen Wentworth, (215) 814–2034 at the

EPA Region III address above, or by email at wentworth.ellen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Description of the SIP Revision and

EPA’s Action

The information in this section is

organized as follows:

A. What Action Is EPA Taking Today?

B. Why is EPA Taking This Action?

C. Why Is the Request Approvable?

D. What Is the Process for EPA Approval of

This Action?

A. What Action Is EPA Taking Today?

EPA is approving a revision to the

State of Maryland SIP which was

submitted on January 4, 2001 by MDE.

This revision repeals Regulation .04,

Petroleum Refineries, under Maryland’s

Code of Maryland Administrative

Regulations (COMAR) 26.11.11, Control

of Petroleum Products Installations,

including Asphalt Paving and Asphalt

Concrete Plants. At one time there was

the possibility of a petroleum refinery

being constructed in the State of

Maryland which would have required

regulation under COMAR 26.11.11.04,

and under Maryland’s SIP. However, a

facility was never constructed, and at

the present time there are no petroleum

refineries located in Maryland.

B. Why Is EPA Taking This Action?

EPA is approving this SIP revision at

the request of MDE. Since there are no

petroleum refineries located in the State

of Maryland, Maryland repealed its

petroleum refinery regulation, COMAR

26.11.11.04, Petroleum Refineries,

under COMAR 26.11.11, Control of

Petroleum Products Installations,

including Asphalt Paving and Asphalt

Concrete Plants. Because there are no oil

refineries in the State of Maryland, EPA

is approving the SIP revision to amend