[Federal Register: October 22, 2002 (Volume 67, Number 204)]
[Notices]
[Page 64926-64927]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc02-120]
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NUCLEAR REGULATORY COMMISSION
Consolidated Guidance About Materials Licenses: Program-Specific
Guidance About Medical Use Licenses, Issuance and Availability of NUREG
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of availability.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is announcing the
availability of NUREG-1556, Volume 9, ``Consolidated Guidance About
Materials Licenses: Program-Specific
[[Page 64927]]
Guidance About Medical Use Licenses.'' This document consolidates
guidance on medical licensing into a single, comprehensive source and
provides guidance for licensing under revised 10 CFR Part 35, ``Medical
Use of Byproduct Material,'' which will be effective on October 24,
2002 (67 FR 20249; April 24, 2002; corrections to rule were published
in the Federal Register on October 9, 2002; 67 FR 62872). A Summary of
Public Comments and NRC Responses will be published as a separate
document, Appendix BB to NUREG-1556 Volume 9. These documents will also
be available in electronic form on CD-rom.
ADDRESSES: A free single copy of final NUREG-1556, Volume 9, and
Appendix BB (on paper or CD-rom), may be requested by writing to the
U.S. Nuclear Regulatory Commission, ATTN: Mrs. Carrie Brown, Mail Stop
T 9-C24, Washington, DC 20555-0001; e-mail: CXB@nrc.gov; telephone:
(301) 415-8092. Single copies of the documents, in paper form and on
CD-rom, are also available for inspection and/or copying for a fee in
the NRC Public Document Room, 11555 Rockville Pike, Rockville,
Maryland. NUREG-1556, Volume 9, and Appendix BB will be available on
the NRC's website at <http://www.nrc.gov in the electronic
reading room and at http://www.nrc.gov/materials/miau/miau-reg-
initiatives/by-product.html.
FOR FURTHER INFORMATION CONTACT: Roger W. Broseus, Rulemaking and
Guidance Branch, M/S T 9-C24, Division of Industrial and Medical
Nuclear Safety, Office of Nuclear Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone
(301) 415-7608; e-mail RWB@nrc.gov.
SUPPLEMENTARY INFORMATION: On August 25, 1998 (63 FR 45270), NRC
announced the availability of draft NUREG-1556, Volume 9,
``Consolidated Guidance About Materials Licenses: Program-Specific
Guidance About Medical Use Licenses,'' dated August 1998. This draft
document, which was prepared by a team composed of NRC staff and staff
from State Departments of Health, was published for public comment in
parallel with the proposed revision of Part 35, ``Medical Use of
Byproduct Material.'' As a result of comments received on the August
1998 draft, it was revised and published as draft NUREG-1556, Volume 9,
``Consolidated Guidance About Materials Licenses: Program-Specific
Guidance About Medical Use Licenses'' (March 2002). The notice of
availability of the March 2002 draft was published on April 5, 2002 (67
FR 16467), and input on the guidance was requested. The NRC invited the
public to comment on questions pertaining to the level of detail and
format in the guidance, model procedures, licensing guidance specific
to diagnostic nuclear medicine, and other guidance that should be
considered for reference in NUREG-1556, Volume 9, such as additional
voluntary industry consensus standards or other publicly available
documents. The March 2002 draft NUREG included Appendix Z, which
provided a summary of comments on the 1998 draft and NRC responses.
On April 25, 2002, NRC held a public workshop to obtain stakeholder
comments on the March 2002 draft, with emphasis on therapeutic
applications of byproduct materials. A second public workshop was held
on April 30, 2002, to receive stakeholder input on guidance, with
emphasis on diagnostic applications of byproduct materials. In addition
to the feedback from the workshops, the NRC also received written
public comments during a 60-day comment period (April 5 to June 4,
2002). A summary of comments and NRC responses will be published as a
separate Appendix BB to NUREG-1556, Volume 9, which will also include
the summary of comments and NRC responses on the August 1998 draft
NUREG. The staff considered all comments, including constructive
suggestions to improve the document, in the preparation of the final
NUREG report.
The final version of NUREG-1556, Volume 9, is now available for use
by applicants, licensees, NRC license reviewers, and other NRC staff.
This document supersedes the guidance previously found in--
(1) Regulatory Guide (RG) 10.8, Revision 2, ``Guide for the
Preparation of Applications for Medical Use Programs'';
(2) Appendix X to RG 10.8, Revision 2, ``Guidance on Complying With
New Part 20 Requirements'';
(3) Draft RG DG-0009, ``Supplement to Regulatory Guide 10.8,
Revision 2, Guide for the Preparation of Applications for Medical Use
Programs'';
(4) Draft RG FC 414-4, ``Guide for the Preparation of Applications
for Licenses for Medical Teletherapy Programs'';
(5) RG 8.23, ``Radiation Safety Surveys at Medical Institutions,
Revision 1'';
(6) RG 8.33, ``Quality Management Program'';
(7) RG 8.39, ``Release of Patients Administered Radioactive
Materials'';
(8) Policy and Guidance Directive (P&GD) 03-02, ``Licensing
Lixiscope and BMA'';
(9) Policy and Guidance Directive (P&GD) 03-08, ``Standard Review
Plan for Teletherapy'';
(10) Policy and Guidance Directive (P&GD) 3-17, ``Review of
Training and Experience Documentation Submitted by Proposed Physician
User Applicants'';
(11) Policy and Guidance Directive (P&GD) FC 87-2, ``Standard
Review Plan for License Applications for the Medical Use of Byproduct
Material'';
(12) Policy and Guidance Directive (P&GD) FC 86-4, Revision 1,
``Information Required for Licensing Remote Afterloading Devices'';
(13) Addendum to Revision 1 to P&GD FC 86-4, ``Information Required
for Licensing Remote Afterloading Devices--Increased Source Possession
Limits'';
(14) Policy and Guidance Directive (P&GD) FC 92-01 ``Information
Required for Licensing Mobile Nuclear Medicine Services,'' and
(15) Policy and Guidance Directive (P&GD) 3-15, ``Standard Review
Plan for Review of Quality Management Programs.''
Small Business Regulatory Enforcement Fairness Act
In accordance with the Small Business Regulatory Enforcement Act of
1996, the NRC has determined that this action is not a major rule and
has verified this determination with the Office of Information and
Regulatory Affairs of the Office of Management and Budget.
Dated in Rockville, Maryland, this 15th day of October, 2002.
For the Nuclear Regulatory Commission.
Patricia K. Holahan,
Chief, Rulemaking and Guidance Branch, Division of Industrial and
Medical Nuclear Safety, NMSS.
[FR Doc. 02-26830 Filed 10-21-02; 8:45 am]
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