[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This draft guidance, where applicable, provides a more risk-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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