[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Proposed Rules]
[Pages 8830-8831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2777]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

RIN 3150-AI26
[NRC-2008-0071]


Medical Use of Byproduct Material--Amendments/Medical Event 
Definitions

AGENCY: Nuclear Regulatory Commission.

ACTION: Advance notice of proposed rulemaking.

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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 [email protected].
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: [email protected]. 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 
301-415-1966).
    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

[[Page 8831]]

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 
[email protected].

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 (301) 415-
0253, e-mail, [email protected].

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.
 [FR Doc. E8-2777 Filed 2-14-08; 8:45 am]
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