24142 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

FAA’s Office of Rulemaking, (202) 267–

9677, for a copy of Advisory Circular

No. 11–2A, Notice of Proposed

Rulemaking Distribution System, which

describes the application procedure.

The Proposal

The FAA is proposing an amendment

to 14 CFR part 73 (part 73) to establish

R–3203D, Orchard, ID, adjacent to the

existing R–3203A, to assist the Idaho

Army National Guard’s annual training.

The proposed restricted area would be

effective for a period of time not

exceeding three weeks annually.

Expansion in the number of gun

batteries assigned to field artillery units,

along with requirements that each

assigned battery accomplish several

moves per day to different firing points,

has created the need to expand the

available restricted airspace, for a period

of time each year, to provide for more

effective annual training tests. All

artillery firing would be directed into

existing impact areas located

approximately in the center of R–3203A.

The restricted area is needed to provide

protected airspace to contain projectiles

during flight between the surface firing

point and entry into the existing

restricted area.

The proposed restricted area would be

utilized for a period of time not

exceeding three weeks per year by the

Idaho Army National Guard Field

Artillery and would be released to the

FAA for public use during the periods

when it is not required for military

training.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, this proposed

regulation: (1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under DOT Regulatory Policies

and Procedures (44 FR 11034; February

26, 1979); and (3) does not warrant

preparation of a regulatory evaluation as

the anticipated impact is so minimal.

Since this is a routine matter that will

only affect air traffic procedures and air

navigation, it is certified that this

proposed rule, when promulgated, will

not have a significant economic impact

on a substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

The coordinates for this airspace

docket are based on North American

Datum 83. Section 73.32 of part 73 of

the Federal Aviation Regulations was

republished in FAA Order 7400.8G

dated September 1, 1999.

Environmental Review

This proposal will be subject to

environmental review prior to any FAA

final regulatory action.

List of Subjects in 14 CFR Part 73

Airspace, Incorporation by reference,

Navigation (air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 73 as

follows:

PART 73—SPECIAL USE AIRSPACE

1. The authority citation for part 73

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 73.32 [Amended]

2. Section 73.32 is amended as

follows:

* * * * *

R–3203D Orchard Training Area, ID [New]

Boundaries. Beginning at lat. 43°14′00′′ N.,

long. 116°16′30′′ W.; at lat. 43°17′51′′ N., long.

116°16′25′′ W.; at lat. 43°19′02′′ N., long.

116°14′45′′ W.; at lat. 43°19′02′′ N., long.

116°06′36′′ W.; at lat. 43°15′58′′ N., long.

116°01′12′′ W.; at lat. 43°15′00′′ N., long.

116°01′00′′ W.; at lat. 43°17′00′′ N., long.

116°05′00′′ W.; at lat. 43°17′00′′ N., long.

116°12′00′′ W.; to point of beginning.

Designated altitudes. Surface to and

including 22,000 feet MSL.

Times of use. As scheduled by NOTAM 24

hours in advance not to exceed three weeks

annually.

Controlling agency. FAA Boise ATCT.

Using agency. Commanding General Idaho

Army National Guard.

* * * * *

Issued in Washington, DC, on April 14,

2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division.

[FR Doc. 00–10215 Filed 4–24–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Airspace Docket No. 99–ANM–15]

Proposed Reconfiguration, Revision,

and Establishment of Restricted Areas;

ID

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This action proposes to

reconfigure Restricted Area 3202A (R–

3202A), Saylor Creek, ID by establishing

a High area from FL 180 to FL 290 and

a Low area from the surface to, but not

including, FL 180 within the existing R–

3202A, and to revoke Restricted Areas

3202B and C (R–3202B and R–3202C).

Additionally, this action proposes to

establish three new Restricted Areas (R–

3204A, B, and C) at Juniper Butte, ID.

The FAA is proposing these efforts to

support the United States Air Force

(USAF) rapid-response air

expeditionary wing training.

DATES: Comments must be received on

or before June 9, 2000.

ADDRESSES: Send comments on the

proposal in triplicate to: Manager, Air

Traffic Division, ANM–500, Docket No.

99–ANM–15, Federal Aviation

Administration, 1601 Lind Avenue,

SW., Renton, WA 98055–4056.

The official docket may be examined

in the Rules Docket, Office of the Chief

Counsel, Room 916, 800 Independence

Avenue, SW., Washington, DC,

weekdays, except Federal holidays,

between 8:30 a.m. and 5:00 p.m.

An informal docket may also be

examined during normal business hours

at the office of the Regional Air Traffic

Division.

FOR FURTHER INFORMATION CONTACT: Ken

McElroy, Airspace and Rules Division,

ATA–400, Office of Air Traffic Airspace

Management, Federal Aviation

Administration, 800 Independence

Avenue, SW., Washington, DC 20591;

telephone: (202) 267–8783.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested parties are invited to

participate in this proposed rulemaking

by submitting such written data, views,

or arguments as they may desire.

Comments that provide the factual basis

supporting the views and suggestions

presented are particularly helpful in

developing reasoned regulatory

decisions on the proposal. Comments

are specifically invited on the overall

regulatory, aeronautical, economic,

environmental, and energy-related

aspects of the proposal.

Communications should identify the

airspace docket number and be

submitted in triplicate to the address

listed above. Commenters wishing the

FAA to acknowledge receipt of their

comments on this notice must submit

with those comments a self-addressed,

stamped postcard on which the

following statement is made:

‘‘Comments to Airspace Docket No. 99–

ANM–15.’’ The postcard will be date/

time stamped and returned to the

Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules 24143

commenter. Send comments on

environmental and land-use aspects to:

Headquarters ACC/DOR Air Combat

Command Airspace and Range

Management Division, 205 Dodd Blvd,

Ste 101, Langley AFB, VA 23665–2789.

All communications received on or

before the specified closing date for

comments will be considered before

taking action on the proposed rule. The

proposal contained in this notice may

be changed in light of comments

received. All comments submitted will

be available for examination in the

Rules Docket both before and after the

closing date for comments. A report

summarizing each substantive public

contact with FAA personnel concerned

with this rulemaking will be filed in the

docket.

Availability of NPRM’s

An electronic copy of this document

may be downloaded, using a modem

and suitable communications software,

from the FAA regulations section of the

Fedworld electronic bulletin board

service (telephone: 703–321–3339) or

the Federal Register’s electronic

bulletin board service (telephone: 202–

512–1661).

Internet users may reach the FAA’s

web page at http://www.faa.gov or the

Superintendent of Document’s web page

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

access to recently published rulemaking

documents.

Any person may obtain a copy of this

NPRM by submitting a request to the

Federal Aviation Administration, Office

of Air Traffic Airspace Management,

ATA–400, 800 Independence Avenue,

SW., Washington, DC 20591, or by

calling (202) 267–8783.

Communications must identify the

notice number of this NPRM. Persons

interested in being placed on a mailing

list for future NPRM’s should call the

FAA’s Office of Rulemaking, (202) 267–

9677, for a copy of Advisory Circular

No. 11–2A, Notice of Proposed

Rulemaking Distribution System, which

describes the application procedure.

The Proposal

The FAA is proposing an amendment

to 14 CFR part 73 (part 73) that would

reconfigure R–3202A, Saylor Creek, ID

by establishing a High area from FL 180

to FL 290 and a Low area from the

surface to, but not including, FL 180

within the existing R–3202A, and

revoke R–3202B and R–3202C. In

addition, this action proposes to

establish three new Restricted Areas (R–

3204A, from the surface to 100 feet

AGL; R–3204B, from 100 feet to, but not

including, FL 180; and R–3204C, from

FL 180 to FL 290) at Juniper, Butte, ID.

The proposed restricted airspace for the

Juniper Butte range would be

established over 12,000-acres with one

300-acre impact area at the approximate

center of the area. The proposed

restricted airspace would permit the

safe delivery of training ordinances into

the proposed R–3204A impact area.

This proposal eliminates restricted

airspace south of the existing Saylor

Creek Range and would result in an

overall reduction of restricted airspace.

The FAA is proposing these efforts to

support the USAF rapid-response air

expeditionary wing training.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, this proposed

regulation: (1) Is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under DOT Regulatory Policies

and Procedures (44 FR 11034; February

26, 1979); and (3) does not warrant

preparation of a regulatory evaluation as

the anticipated impact is so minimal.

Since this is a routine matter that will

only affect air traffic procedures and air

navigation, it is certified that this

proposed rule, when promulgated, will

not have a significant economic impact

on a substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

The coordinates for this airspace

Docket are based on North American

Datum 83. Section 73.32 of part 73 of

the Federal Aviation Regulations was

republished in FAA Order 7400.8G

dated September 1, 1999.

Environmental Review

This proposal will be subject to

environmental review prior to any FAA

final regulatory action.

List of Subjects in 14 CFR Part 73

Airspace, Incorporation by reference,

Navigation (air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 73 as

follows:

PART 73—Special Use Airspace

1. The authority citation for 14 CFR

part 73 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 73.32 [Amended]

2. Section 73.32 is amended as

follows:

* * * * *

R–3202A Saylor Creek, ID [Revoke]

R–3202B Saylor Creek, ID [Revoke]

R–3202C Saylor Creek, ID [Revoke]

R–3202 Saylor Creek Low, ID [New]

Boundaries: Beginning at lat. 42°53′00′′ N.,

long. 115°42′20′ W.;

at lat. 42°53′00′′ N., long. 115°24′15′′ W.;

at lat. 42°36′00′′ N., long. 115°24′15′′ W.;

at lat. 42°36′00′′ N., long. 115°42′20′′ W.; to

point of beginning.

Designated altitudes: Surface to, but not

including, FL 180.

Times of use: 0730–2200 local time, Monday

through Friday, other times by NOTAM.

Controlling agency: FAA Salt Lake City,

ARTCC.

Using agency: USAF, 366th Wing, Mountain

Home AFB, ID.

R–3202 Saylor Creek High, ID [New]

Boundaries: Beginning at lat. 42°53′00′′ N.,

long. 115°42′20′′ W.;

at lat. 42°53′00′′ N., long. 115°24′15′′ W.;

at lat. 42°36′00′′ N., long. 115°24′15′′ W.;

at lat. 42°36′00′′ N., long. 115°42′20′′ W.; to

point of beginning.

Designated altitudes: FL 180 to FL 290.

Times of use: 0730–2200 local time, Monday

through Friday, other times by NOTAM.

Controlling agency: FAA Salt Lake City,

ARTCC.

Using agency: USAF, 366th Wing, Mountain

Home AFB, ID.

R–3204A Juniper Buttes, ID [New]

Boundaries: Beginning at lat. 42°20′00′′ N.,

long. 115°22′30′′ W.;

at lat. 42°20′00′′ N., long. 115°18′00′′ W.;

at lat. 42°19′00′′ N., long. 115°17′00′′ W.;

at lat. 42°16′35′′ N., long. 115°17′00′′ W.;

at lat. 42°16′35′′ N., long. 115°22′30′′ W.; to

point of beginning.

Designated altitudes: Surface to 100 feet

AGL.

Times of use: 0730–2200 local time, Monday

through Friday, other times by NOTAM.

Controlling agency: FAA Salt Lake City,

ARTCC.

Using agency: USAF, 366th Wing, Mountain

Home AFB, ID.

R–3204B Juniper Buttes, ID [New]

Boundaries: The airspace within a 5 NM

radius centered on lat.42°18′00′′ N., long.

115°20′00′′ W.

Designated altitudes: 100 feet AGL to, but not

including, FL 180.

Times of use: 0730–2200 local time, Monday

through Friday, other times by NOTAM.

Controlling agency: FAA Salt Lake City,

ARTCC.

Using agency: USAF, 366th Wing, Mountain

Home AFB, ID.

R–3204C Juniper Buttes, ID [New]

Boundaries: The airspace within a 5 NM

radius centered on lat.42°18′00′′ N., long.

115°20′00′′ W.

Designated altitudes: FL 180 to FL 290.

Times of use: 0730–2200 local time, Monday

through Friday, other times by NOTAM.

Controlling agency: FAA Salt Lake City,

ARTCC.

24144 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

Using agency: USAF, 366th Wing, Mountain

Home AFB, ID.

* * * * *

Issued in Washington, DC, on April 19,

2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division.

[FR Doc. 00–10243 Filed 4–24–00; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 821

[Docket No. 00N–1034]

Medical Devices; Device Tracking

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the medical device tracking

regulations. The scope of the regulation

and certain patient confidentiality

requirements must be amended to

conform to changes made in section

519(e) of the Federal Food, Drug, and

Cosmetic Act (the act) by the FDA

Modernization Act of 1997 (FDAMA).

FDA also proposes nonsubstantive

revisions to remove outdated references

or simplify terminology.

DATES: Submit written comments by

July 24, 2000. See section IV of this

document for the proposed effective

date of a final rule based on this

document. Submit written comments on

the information collection requirements

by May 25, 2000.

ADDRESSES: Submit written comments

on the proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Submit written comments regarding the

information collection requirements to

the Office of Information and Regulatory

Affairs Office of Management and

Budget (OMB), New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Chester T. Reynolds, Center for Devices

and Radiological Health (HFZ–300),

Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301–

594–4618.

SUPPLEMENTARY INFORMATION:

I. Background

A. The SMDA and Device Tracking

Regulations

The Safe Medical Device Act of 1990

(the SMDA) (Public Law 101–629)

became law on November 28, 1990. It

added mandatory and discretionary

device tracking provisions to the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 301 et seq.) under

new section 519(e) (21 U.S.C. 360i(e)).

As added by the SMDA, new section

519(e)(1) mandated the adoption of a

method of tracking by any person

registered under section 510 of the act

(21 U.S.C. 360) and engaged in the

manufacture of a device if its failure

would be reasonably likely to have

serious adverse health consequences

and the device was either a permanently

implantable device or a life-sustaining

or life-supporting device used outside a

device user facility. New section

519(e)(2) authorized FDA, in its

discretion, to ‘‘designate’’ other devices

that must be tracked, to protect the

public health and safety.

On August 16, 1993, FDA published

in the Federal Register (58 FR 43442)

the final rule setting forth regulations

governing the tracking of medical

devices, as provided by the SMDA

under sections 519(e)(1) and (e)(2) of the

act. Elsewhere in the same Federal

Register (58 FR 43451), FDA published

a rule amending the illustrative list of

those devices FDA considered subject to

tracking under the mandatory criteria

under section 519(e)(1) and the list of

devices FDA designated as subject to

tracking under section 519(e)(2). The

final tracking regulations for medical

devices, including the amended lists of

tracked devices, went into effect on

August 29, 1993, and are currently

codified in part 821 of title 21 of the

Code of Federal Regulations (21 CFR

part 821).

B. FDAMA Tracking Provisions

FDAMA (Public Law 105–115) was

enacted on November 21, 1997. Section

211 of FDAMA amended the tracking

provision in section 519(e)(1) of the act

and became effective on February 19,

1998. Unlike the tracking provisions

under the SMDA, which required

tracking for any device meeting certain

criteria, FDAMA allows FDA discretion

in applying tracking requirements and

provides that tracking requirements can

be imposed only after issuance of an

order.

FDAMA authorizes FDA to issue

orders that require a manufacturer to

adopt a method of tracking a class II or

class III device if its failure would be

reasonably likely to have serious

adverse health consequences, or it is

intended to be implanted in the human

body for more than 1 year, or it is a lifesustaining or life-supporting device

used outside a device user facility. As

amended by FDAMA, section 519(e)(2)

of the act provides that patients

receiving a device subject to tracking

may refuse to release, or refuse

permission to release, their names,

addresses, social security numbers, or

other identifying information for

tracking purposes.

Section 519(e) of the act, as amended

by FDAMA, provides that FDA ‘‘ may by

order require a manufacturer to adopt a

method of tracking.’’ Such an order

specifies to the manufacturer the class II

or class III device(s) to be tracked. FDA

interprets the discretion inherent in

‘‘may’’ to allow the agency to consider

additional relevant factors in

determining whether to issue a tracking

order for a device that meets the criteria

in amended section 519(e)(1) of the act.

The discretionary authority to issue

tracking orders, and the three statutory

criteria that operate independently of

one another in section 519(e)(1) of the

act, allow the agency to accomplish the

intended purpose of device tracking

under FDAMA, as identified by

Congress, i.e., to facilitate the recall of

dangerous or defective devices, under

section 518(e) of the act (S. Rept. 108,

105th Cong., 1st sess. 37 (1997)).

II. Implementation of FDAMA Tracking

Authority

A. Public Meeting/Manufacturer

Notification

On December 18, 1997, FDA

published a Federal Register notice (62

FR 66373) announcing the agency’s

intention to hold a public meeting on

January 15, 1997, in Rockville, MD to

discuss changes in medical device

tracking and postmarket surveillance

authorities under FDAMA. In particular,

the agency was interested in discussing

whether it should consider additional

nonbinding factors to supplement the

statutory criteria, under FDAMA, in

determining whether tracking

requirements should be ordered by

FDA.

On December 19, 1997, FDA sent

letters to manufacturers having

responsibilities to track devices under

section 519(e) of the act. These letters

advised that FDAMA would implement

important statutory changes in medical

device tracking, which had been

authorized previously under the SMDA.

The letters noted FDA’s December 18,

1997, Federal Register notice

announcing the public meeting it would

conduct on January 15, 1998, to discuss