[Federal Register Volume 63, Number 164 (Tuesday, August 25, 1998)]
[Notices]
[Pages 45270-45271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22765]


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NUCLEAR REGULATORY COMMISSION


Consolidated Guidance About Materials Licenses: Program-Specific 
Guidance About Medical Use Licenses, Availability of Draft NUREG

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability and request for comments.

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SUMMARY: The Nuclear Regulatory Commission is announcing the 
availability of and requesting comment on draft NUREG-1556, Volume 9, 
``Consolidated Guidance about Materials Licenses: Program-Specific 
Guidance About Medical Use Licenses,'' dated August 1998. This draft 
guide has been developed in parallel with the proposed revision of 10 
CFR Part 35, ``Medical Use of Byproduct Material.'' Comments received 
in response to publication of this draft will be considered in 
developing the final guide. Finalization of the guidance will continue 
to parallel the rulemaking; resulting in a guidance document that is 
consistent with the final rule. It is intended for use by applicants, 
licensees, NRC license reviewers, and other NRC personnel.
    This draft guidance, where applicable, provides a more risk-
informed, performance-based approach to medical use licensing 
consistent with the proposed regulations. It combines and supersedes 
the guidance previously found in Regulatory Guide (RG) 10.8, Revision 
2, ``Guide for the Preparation of Applications for Medical Use 
Programs''; Appendix X to RG 10.8, Revision 2, ``Guidance on Complying 
With New Part 20 Requirements''; Draft RG DG-0009, ``Supplement to 
Regulatory Guide 10.8, Revision 2, Guide for the Preparation of 
Applications for Medical Use Programs''; Draft RG FC 414-4, ``Guide for 
the Preparation of Applications for Licenses for Medical Teletherapy 
Programs''; Policy and Guidance Directive (P&GD) FC 87-2, ``Standard 
Review Plan for License Applications for the Medical Use of Byproduct 
Material''; P&GD FC 86-4, Revision 1, ``Information Required for 
Licensing Remote Afterloading Devices''; Addendum to Revision 1 to P&GD 
FC 86-4, ``Information Required for Licensing Remote Afterloading 
Devices-Increased Source Possession Limits''; P&GD 3-15, ``Standard 
Review Plan for Review of Quality Management Programs''; RG 8.39, 
``Release of Patients Administered Radioactive Materials''; RG 8.33, 
``Quality Management Program''; P&GD 3-17, ``Review of Training and 
Experience Documentation Submitted by Proposed Physician User 
Applicants''; and RG 8.23, ``Radiation Safety Surveys at Medical 
Institutions, Revision 1''.
    This draft guide has been distributed for public comment to 
encourage participation in its development. It is NOT for use in 
preparing or reviewing applications until it is published in final 
form. This guidance represents the current position of NRC staff, which 
is subject to change after the review of public comments. Comments 
received will be considered in developing the final guide that 
represents the official NRC staff position.

DATES: The comment period ends on November 12, 1998, to be consistent 
with the rulemaking. Comments received after that time will be 
considered if practicable.

ADDRESSES: Submit written comments to: Chief, Rules and Directives 
Branch, Division of Administrative Services, Office of Administration, 
U. S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Hand 
deliver

[[Page 45271]]

comments to 11545 Rockville Pike, Rockville, Maryland, between 7:15 
a.m. and 4:30 p.m. on Federal workdays. Comments may also be submitted 
through the Internet by addressing electronic mail to [email protected].
    Those considering public comment may request a free single copy of 
draft NUREG-1556, Volume 9, by writing to the U.S. Nuclear Regulatory 
Commission, ATTN: Mrs. Sally L. Merchant, Mail Stop TWFN 9-F-31, 
Washington, DC 20555-0001. Alternatively, submit requests through the 
Internet by addressing electronic mail to [email protected]. A copy of draft 
NUREG-1556, Volume 9, is also available for inspection and/or copying 
for a fee in the NRC Public Document Room, 2120 L Street, NW. (Lower 
Level), Washington, DC 20555-0001.

FOR FURTHER INFORMATION CONTACT: Mrs. Sally L. Merchant, Mail Stop TWFN 
9-F-31, Division of Industrial and Medical Nuclear Safety, Office of 
Nuclear Materials Safety and Safeguards, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555, telephone (301) 415-7874; electronic 
mail address: [email protected].

Electronic Access

    Draft NUREG-1556, Vol. 9 will be available electronically by 
visiting NRC's Home Page (http://www.nrc.gov/NRC/nucmat.html) 
approximately two weeks after the publication date of this notice.

    Dated at Rockville, Maryland, this 17th day of August, 1998.

For the Nuclear Regulatory Commission.
Donald A. Cool,
Director, Division of Industrial and Medical Nuclear Safety, Office of 
Nuclear Material Safety and Safeguards.
[FR Doc. 98-22765 Filed 8-24-98; 8:45 am]
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