This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

33388

Vol. 61, No. 125

Thursday, June 27, 1996

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 928

[Docket No. FV–96–928–2]

Papayas Grown in Hawaii;

Continuance Referendum

AGENCY: Agricultural Marketing Service,

USDA.

ACTION: Referendum order.

SUMMARY: This document directs that a

referendum be conducted among

eligible growers of Hawaiian papayas to

determine whether they favor

continuance of the marketing order

regulating the handling of papayas

grown in the production area.

DATES: The referendum will be

conducted from July 1 through July 26,

1996. The representative production

period is from July 1, 1994, through

June 30, 1995.

ADDRESSES: Copies of the text of the

aforesaid marketing order may be

obtained from the office of the

referendum agent at 2202 Monterey

Street, Suite 102B, Fresno, California

93721, or the Office of the Docket Clerk,

Marketing Order Administration

Branch, Fruit and Vegetable Division,

AMS, USDA, P.O. Box 96456, Room

2525–S, Washington, D.C., 20090–6456.

FOR FURTHER INFORMATION CONTACT:

Martin J. Engeler, California Marketing

Field Office, Marketing Order

Administration Branch, Fruit and

Vegetable Division, Agricultural

Marketing Service, U.S. Department of

Agriculture, 2202 Monterey Street, Suite

102B, Fresno, California, 93721;

telephone: (209) 487–5901; or Charles L.

Rush, Marketing Order Administration

Branch, Fruit and Vegetable Division,

Agricultural Marketing Service, U.S.

Department of Agriculture, room 2522–

S, P.O. Box 96456, Washington, D.C.

20090–6456; telephone: (202) 720–2431.

SUPPLEMENTARY INFORMATION: Pursuant

to Marketing Order No. 928 (7 CFR Part

928), hereinafter referred to as the

‘‘order,’’ and the applicable provisions

of the Agricultural Marketing

Agreement Act of 1937, as amended (7

U.S.C. 601–674), hereinafter referred to

as the ‘‘Act,’’ it is hereby directed that

a referendum be conducted to ascertain

whether continuance of the order is

favored by growers. The referendum

shall be conducted during the period

July 1 through July 26, 1996, among

growers in the production area. Only

growers who were engaged in the

production of papayas during the period

July 1, 1994, through June 30, 1995, may

participate in the continuance

referendum.

The Secretary of Agriculture has

determined that continuance referenda

are an effective means for ascertaining

whether growers favor continuation of

marketing order programs. The

Secretary would consider termination of

the order if less than two-thirds of the

growers voting in the referendum and

growers of less than two-thirds of the

volume of papayas represented in the

referendum favor continuance. In

evaluating the merits of continuance

versus termination, the Secretary would

not only consider the results of the

continuance referendum. The Secretary

would also consider all other relevant

information concerning the operation of

the order and the relative benefits and

disadvantages to growers, handlers, and

consumers in order to determine

whether continued operation of the

order would tend to effectuate the

declared policy of the Act.

In any event, section 608c(16)(B) of

the Act requires the Secretary to

terminate an order whenever the

Secretary finds that a majority of all

growers favor termination, and such

majority produced for market more than

50 percent of the commodity covered

under such order.

The order requires that a referendum

be held every 6 years to determine

whether growers favor continuance of

their marketing order program. The

most recent referendum was held in

May 1993. The next referendum was

scheduled for 1999. However, due to

concerns regarding the operation of the

order including program compliance,

the Department has determined that a

referendum should be held at this time

to ascertain whether growers favor

continuance of the order.

In accordance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 38), the ballot materials to be

used in the referendum herein ordered

have been submitted to and approved by

the Office of Management and Budget

(OMB) and have been assigned OMB

No. 0581–0102. It has been estimated

that it will take an average of 20 minutes

for each of the approximately 400

growers of papayas to participate in the

voluntary referendum balloting. Ballots

postmarked after July 26, 1996 will not

be included in the vote tabulation.

Martin J. Engeler, California

Marketing Field Office, Fruit and

Vegetable Division, Agricultural

Marketing Service, USDA, is hereby

designated as the referendum agent of

the Secretary of Agriculture to conduct

such referendum. The procedure

applicable to the referendum shall be

the ‘‘Procedure for the Conduct of

Referenda in Connection With

Marketing Orders for Fruits, Vegetables,

and Nuts Pursuant to the Agricultural

Marketing Agreement Act of 1937, as

Amended’’ (7 CFR Part 900.400 et seq.).

Ballots will be mailed to all known

growers and may also be obtained from

the referendum agent and from his

appointees at the above address.

List of Subjects in 7 CFR Part 928

Marketing agreements, Papayas,

Reporting and recordkeeping

requirements.

Authority: Agricultural Marketing

Agreement Act of 1937, 48 Stat. 31, as

amended; 7 U.S.C. 601–674.

Dated: June 24, 1996.

Michael V. Dunn,

Assistant Secretary, Marketing and

Regulatory Programs.

[FR Doc. 96–16431 Filed 6–26–96; 8:45 am]

BILLING CODE 3410–02–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 35

[Docket No. PRM–35–14]

IsoStent, Inc., Receipt of a Petition for

Rulemaking

AGENCY: Nuclear Regulatory

Commission.

ACTION: Petition for rulemaking; Notice

of receipt.

SUMMARY: The Nuclear Regulatory

Commission (NRC) has received and
Federal Register / Vol. 61, No. 125 / Thursday, June 27, 1996 / Proposed Rules 33389

requests public comment on a petition

for rulemaking filed by IsoStent, Inc.

The petition has been docketed by the

Commission and assigned Docket No.

PRM–35–14. The petitioner requests

that the NRC amend its regulations by

adding a new section to address

permanently implanted intraluminal

stents, including phosphorus-32 and

strontium-89 radioisotope stents. These

stents would be permanently implanted

in the patient’s vessels and arteries. The

petitioner also requests that the NRC

add a new section to specify training

and experience requirements for

qualified physicians responsible for

placing radioisotope stents in patients.

The petitioner believes the suggested

amendments would address an

innovative approach for the treatment of

stenotic arteries and vessels with lowactivity, beta-emitting stents.

DATES: Submit comments by September

10, 1996. Comments received after this

date will be considered if it is practical

to do so, but assurance of consideration

cannot be given except to those

comments received on or before this

date.

ADDRESSES: For a copy of the petition,

write: Rules Review Section, Rules

Review and Directives Branch, Division

of Freedom of Information and

Publications Services, Office of

Administration, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001.

Submit comments to: Secretary, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555–0001. Attention:

Docketing and Service Branch.

Deliver comments to 11555 Rockville

Pike, Rockville, Maryland, between 7:45

am and 4:15 pm on Federal workdays.

For information on sending comments

by electronic format, see ‘‘Electronic

Access,’’ under the Supplementary

Information section of this notice.

FOR FURTHER INFORMATION CONTACT:

Michael T. Lesar, Office of

Administration, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001. Telephone: 301–415–7163 or Toll

Free: 800–368–5642, or E-mail

MTL@NRC.GOV.

SUPPLEMENTARY INFORMATION:

Receipt of Petition for Rulemaking

The NRC received the IsoStent, Inc.,

petition for rulemaking on May 10,

1996. The petition is dated May 9, 1996,

and was docketed as PRM–35–14 on

May 20, 1996.

Background

The petitioner states that preliminary

data indicates that stents, combined

with a low-activity, beta-emitting source

(less than 3 microcuries per millimeter

of length), may significantly reduce

restenosis of the vessel following

therapeutic intervention. The petitioner

refers to a source that estimates total

societal costs of restenosis in the United

States is somewhere between $800

million and $2 billion a year.

The petitioner states that it is

important to ensure that the stents are

appropriately classified and regulated

because radioactive stents could

significantly benefit the healthcare

system and the quality of life of patients

suffering from restenosis of the vessel

following therapeutic intervention. The

petitioner believes, after reviewing

existing NRC regulations pertaining to

the medical uses of byproduct materials,

that a new section is necessary to

address permanently implanted

radioisotope intraluminal stents. The

petitioner states that standard coronary

stents, 15 millimeters in length, would

contain less than 20 microcuries (740

kBq) of beta-emitting isotope, and longer

and larger diameter stents for other

anatomical sites would contain less than

3 microcuries of beta-emitting isotope

per millimeter of length.

Petitioner’s Suggested Amendments

The petitioner requests that the NRC

amend its regulations by adding a new

section that would be applicable to

permanently implanted intraluminal

stents. The new section would govern

stents that include phosphorus-32 and

strontium-89 radioisotope sealed

sources. These sealed sources would

have removable contamination of less

than 1 percent of the total device

activity. The petitioner further requests

a new section be created on training and

experience requiring the stents to be

placed in the patient by a licensed

physician who—

(1) Is certified either by the American

Board of Radiology in diagnostic

radiology with additional specialization

in intravascular radiology or by the

American Board of Internal Medicine

with special competence in cardiology;

and

(2) Has received 8 hours of classroom

and laboratory training in the basic

handling of beta-emitting sources.

Discussion of the Petition

The petitioner states that the existing

regulations do not include phosphorus32 and strontium-89 as sealed sources

for medical therapeutic use. Therefore,

the petitioner believes that these sources

would be regulated under sources used

for traditional brachytherapy. The

petitioner believes this category is not

appropriate to control low-activity, betaemitting stents for the following

reasons:

1. Training and Competency

Requirements.

Low-activity, beta-emitting stents

differ significantly from those sources

that are used for traditional

brachytherapy. Traditional

brachytherapy sources have higher

activity and require significant dose

calculations. To be used safely,

traditional brachytherapy sources

require extensive knowledge in

radiobiology, radiation physics, and

radiation protection. Low-activity betaemitting stents do not require this same

level of radiation expertise because they

have significantly lower radioactivity

levels and are permanently implanted

devices that do not require any

calculation of dose or dwell time.

Under current NRC regulations, any

procedure using a source defined under

§ 35.400 would require the supervision

of a certified radiation oncologist. Stents

are currently prescribed and implanted

by physicians trained in cardiovascular

specialties. Once given required training

in the proper handling of these low

dose-rate, beta-emitting sources, these

physicians could safely and effectively

implant radioactive stents. Access to

low-activity, beta-emitting stents should

be allowed for those physicians who are

already certified for stent implantation

specialties. Requiring the additional

oversight of a radiation oncologist for

these stent applications could

potentially limit the accessibility of this

technology and add significant cost to

each procedure. Such a requirement

would unnecessarily burden the

medical system.

2. Safety Requirements

Low-activity, beta-emitting stents can

be shielded with approximately 1

centimeter of plastic material and have

half-lives of less than two months, and,

when shielded, should not pose a

significant hazard to the public or

medical staff. The radioactive stent

remains within the shield until it is

passed into the patient by means of a

stent delivery catheter. Once in the

patient, these beta-emitters are shielded

by the patient’s tissues, and because of

their shorter half-lives, do not represent

a significant long-term risk to the public

or to medical personnel. A precedent for

the release of patients with such short

half-life sources has been set with

sources such as iodine-125 seeds having

a 60-day half-life and 103 to 104 times

higher activity per seed, as well as with

the more penetrating photon radiation.
33390 Federal Register / Vol. 61, No. 125 / Thursday, June 27, 1996 / Proposed Rules

3. Facility Licensing Requirements

Medical facilities without a broadscope license also should have access to

low-activity, beta-emitting stents, as do

facilities with a broad-scope license

under current regulations. There are a

large number of medical facilities that

currently implant stents, but do not

meet these licensing requirements.

Therefore, maintaining these

requirements also could limit the

accessibility of this technology.

The petitioner believes that these

suggested changes would have a

potentially large benefit to patients and

the healthcare system.

Electronic Access

Comments may be submitted

electronically in either ASCII text or

WordPerfect format (version 5.1 or later)

by calling the NRC Electronic Bulletin

Board (BBS) on FedWorld. The bulletin

board may be accessed using a personal

computer, a modem, and one of the

commonly available communications

software packages, or directly via

Internet. Background documents on the

petition for rulemaking also are

available, as practical, for downloading

and viewing on the bulletin board.

If using a personal computer and

modem, the NRC rulemaking subsystem

on FedWorld can be accessed directly

by dialing the toll free number 800–

303–9672. Communication software

parameters should be set as follows:

parity to none, data bits to 8, and stop

bits to 1 (N,8,1). Using ANSI or VT–100

terminal emulation, the NRC

rulemaking subsystem can then be

accessed by selecting the ‘‘Rules Menu’’

option from the ‘‘NRC Main Menu.’’

Users will find the ‘‘FedWorld Online

User’s Guides’’ particularly helpful.

Many NRC subsystems and data bases

also have a ‘‘Help/Information Center’’

option that is tailored to the particular

subsystem.

The NRC subsystem on FedWorld also

can be accessed by a direct-dial

telephone number for the main

FedWorld BBS, 703–321–3339, or by

using Telnet via Internet: fedworld.gov.

If using 703–321–3339 to contact

FedWorld, the NRC subsystem will be

accessed from the main FedWorld menu

by selecting the ‘‘Regulatory,

Government Administration and State

Systems,’’ then selecting ‘‘Regulatory

Information Mall.’’ At that point, a

menu will be displayed that has an

option ‘‘U.S. Nuclear Regulatory

Commission’’ that will take the user to

the NRC online main menu. The NRC

online area also can be accessed directly

by typing ‘‘/go nrc’’ at a FedWorld

command line. If NRC is accessed from

FedWorld’s main menu, the user may

return to FedWorld by selecting the

‘‘Return to FedWorld’’ option from the

NRC online main menu. However, if

NRC is accessed at FedWorld by using

NRC’s toll-free number, the user will

have full access to all NRC systems, but

will not have access to the main

FedWorld system.

If FedWorld is contacted using Telnet,

the user will see the NRC area and

menus, including the Rules Menu.

Although the user will be able to

download documents and leave

messages, he or she will not be able to

write comments or upload files

(comments). If FedWorld is contacted

using FTP, all files can be accessed and

downloaded, but uploads are not

allowed. Only a list of files will be

shown without descriptions (normal

Gopher look). An index file listing all

files within a subdirectory, with

descriptions, is available. There is a 15-

minute time limit for FTP access.

Although FedWorld also can be

accessed through the World Wide Web,

like FTP, that mode only provides

access for downloading files and does

not display the NRC Rules Menu.

For more information on NRC bulletin

boards, call Mr. Arthur Davis, Systems

Integration and Development Branch,

NRC, Washington, DC 20555–0001,

telephone 301–415–5780; E-mail

AXD3@nrc.gov.

Single copies of this petition for

rulemaking may be obtained by written

request or telefax (301–415–5144) from

the Rules Review and Directives Branch,

Division of Freedom of Information and

Publications Services, Office of

Administration, Mail Stop T6–D59, U.S.

Nuclear Regulatory Commission,

Washington DC 20555–0001. Certain

documents related to this petition for

rulemaking, including comments

received, may be examined at the NRC

Public Document Room, 2120 L Street

NW. (Lower Level), Washington, DC.

These same documents also may be

viewed and downloaded electronically

via the Electronic Bulletin Board

established by NRC for this petition for

rulemaking as indicated above.

Dated at Rockville, Maryland, this 21st day

of June 1996.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 96–16397 Filed 6–26–96; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 95–AWP–40]

Proposed Establishment of Class E

Airspace; Coolidge, AZ

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This notice proposes to

establish Class E airspace area at

Coolidge, AZ. The development of a

Global Positioning System (GPS)

Standard Instrument Approach

Procedure (SIAP) to Runway (RWY) 23

and a VHF Omnidirectional Range/

Distance Measuring Equipment (VOR/

DME) to RWY 05 has made this

proposal necessary. The intended effect

of this proposal is to provide adequate

controlled airspace for Instrument Flight

Rules (IFR) operations at Coolidge

Municipal Airport, Coolidge, AZ.

DATES: Comments must be received on

or before July 29, 1996.

ADDRESSES: Send comments on the

proposal in triplicate to: Federal

Aviation Administration, Attn:

Manager, Operations Branch, AWP–530,

Docket No. 95–AWP–40, Air Traffic

Division, P.O. Box 92007, Worldway

Postal Center, Los Angeles, California

90009.

The official docket may be examined

in the Office of the Assistant Chief

Counsel, Western Pacific Region,

Federal Aviation Administration, Room

6007, 15000 Aviation Boulevard,

Lawndale, California 90261.

An informal docket may also be

examined during normal business at the

Office of the Manager, Operations

Branch, Air Traffic Division at the above

address.

FOR FURTHER INFORMATION CONTACT:

William Buck, Airspace Specialist,

Operations Branch, AWP–530, Air

Traffic Division, Western-Pacific

Region, Federal Aviation

Administration, 15000 Aviation

Boulevard, Lawndale, California, 90261,

telephone (310) 725—6556..

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