[Federal Register Volume 67, Number 204 (Tuesday, October 22, 2002)]
[Notices]
[Pages 64926-64927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26830]


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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: [email protected]; 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 [email protected].

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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