E8-2777. Medical Use of Byproduct Material-Amendments/Medical Event Definitions

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Advance notice of proposed rulemaking.

SUMMARY:

The Nuclear Regulatory Commission (NRC) is making available preliminary draft rule language to amend its regulations concerning medical use of byproduct material. The goal of this rulemaking is to better define medical events arising from permanent implant brachytherapy procedures. The proposed amendments will change the criteria for defining a medical event for permanent implant brachytherapy from dose based to activity based, will add a requirement to report as a medical event any administration requiring a written directive if a written directive was not prepared, and will make certain administrative and clarification changes. The availability of the preliminary draft rule language is intended to inform stakeholders of the current status of the NRC's activities and solicit public comments on the information at this time. Comments may be provided as indicated under the ADDRESSES heading. The NRC may post updates periodically under Docket # NRC-2008-0071 on the Federal eRulemaking Portal at http://www.regulations.gov that may be of interest to stakeholders.

DATES:

Submit comments by February 26, 2008. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.

ADDRESSES:

Please include the following number RIN 3150-AI26 in the subject line of your comments. Comments on rulemakings submitted in writing or in electronic form will be made available to the public in their entirety on the NRC's Web site in the Agencywide Documents Access and Management System (ADAMS) and on regulations.gov. Personal information, such as your name, address, telephone number, e-mail address, etc., will not be removed from your submission. You may submit comments by any one of the following methods.

Electronically: Via the Federal eRulemaking Portal (Docket # NRC-2008-0071) and follow instructions for submitting comments. Address questions about this docket to Carol Gallagher 301-415-5905; e-mail [e-mail].

Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

E-mail comments to: [e-mail]. If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at 301-415-1966.

Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone [phone]).

Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

Publicly available documents related to this rulemaking may be viewed electronically on the public computers located at the NRC's Public Document Room (PDR), O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR reproduction contractor will copy documents for a fee.

Publicly available documents created or received at the NRC after November 1, 1999, are available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/​reading-rm/​adams.html. From this site, the public can gain entry into ADAMS, which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the PDR Reference staff at 1-800-397-4209, 301-415-4737 or by e-mail to [e-mail].

FOR FURTHER INFORMATION CONTACT:

Edward M. Lohr, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone [phone], e-mail, [e-mail].

SUPPLEMENTARY INFORMATION:

The preliminary draft rule language can be viewed and downloaded electronically via the Federal eRulemaking Portal at http://www.regulations.gov by searching for Docket # NRC-2008-0071 as well as in ADAMS (ML080350090).

The goal of this rulemaking is to better define medical events arising from permanent implant brachytherapy procedures. The proposed amendments will change the criteria for defining a medical event for permanent implant brachytherapy from dose based to activity based, will add a requirement to report as a medical event any administration requiring a written directive if a written directive was not prepared, and will make certain administrative and clarification changes.

The NRC is making a preliminary version of the draft proposed rule language available to inform stakeholders of the current status of this proposed rulemaking. This preliminary draft rule language may be subject to significant revisions during the rulemaking process. NRC is inviting stakeholders to comment on the draft revisions. The NRC may post updates to the draft proposed rule language on the Federal eRulemaking Portal. Stakeholders will also have an opportunity to comment on the rule language when it is published as a proposed rule.

Dated at Rockville, Maryland, this 8th day of February, 2008.

For the Nuclear Regulatory Commission.

Dennis K. Rathbun,

Director, Division of Intergovernmental Liaison and Rulemaking, Office of Federal and State Materials and Environmental Management Programs.