[Federal Register Volume 61, Number 125 (Thursday, June 27, 1996)]
[Proposed Rules]
[Pages 33388-33390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16397]


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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.

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SUMMARY: The Nuclear Regulatory Commission (NRC) has received and

[[Page 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 low-activity, 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 [email protected].

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 
phosphorus-32 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, beta-emitting 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 beta-emitting 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 Sec. 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 10\3\ to 10\4\ times higher 
activity per seed, as well as with the more penetrating photon 
radiation.

[[Page 33390]]

3. Facility Licensing Requirements

    Medical facilities without a broad-scope 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 AXD[email protected].
    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