NUREG-1556, Volume 9, Revision 2, “Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses; Draft Guidance Document for Comment, 42442-42444 [E7-15049]
Download as PDF
<![CDATA[
42442
Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices
1. Robert D. Skowronek, Michigan
Department of Environmental Quality,
letter to Patricia Pelke, U.S. Nuclear
Regulatory Commission, February 22,
2007 (ADAMS Accession No.
ML070590426).
2. Telephone Conversation Record,
Initiated by William Snell, U.S. Nuclear
Regulatory Commission, to Robert
Skowronek, Michigan Department of
Environmental Quality, on July 11, 2007
(ADAMS Accession No. ML071930403).
3. U.S. Nuclear Regulatory
Commission, ‘‘Environmental Review
Guidance for Licensing Actions
Associated with NMSS Programs,’’
NUREG–1748, August 2003.
4. U.S. Nuclear Regulatory
Commission, ‘‘Generic Environmental
Impact Statement in Support of
Rulemaking on Radiological Criteria for
License Termination of NRC-Licensed
Nuclear Facilities,’’ NUREG–1496,
August 1994.
5. NRC, NUREG–1757, ‘‘Consolidated
NMSS Decommissioning Guidance,’’
Volumes 1–3, September 2003.
Documents may also be viewed
electronically on the public computers
located at the NRC’s PDR, O 1 F21, One
White Flint North, 11555 Rockville
Pike, Rockville, MD 20852. The PDR
reproduction contractor will copy
documents for a fee.
Dated at Lisle, Illinois, this 20th day of July
2007.
For the Nuclear Regulatory Commission.
Patrick L. Louden,
Chief, Decommissioning Branch, Division of
Nuclear Materials Safety, Region III.
[FR Doc. E7–15040 Filed 8–1–07; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
Clarification to Regulatory Guide 1.200,
Revision 1
Nuclear Regulatory
Commission.
ACTION: Clarification to Regulatory
Guide.
AGENCY:
FOR FURTHER INFORMATION CONTACT:
mstockstill on PROD1PC66 with NOTICES
Mary Drouin, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001. Telephone: 301–415–6675; e-mail:
MXD@nrc.gov.
Introduction
The U.S. Nuclear Regulatory
Commission (NRC) is issuing a
clarification to an existing guide in the
agency’s regulatory guide (RG) series.
The NRC has developed this series to
describe and make available to the
public such information as methods that
VerDate Aug<31>2005
17:42 Aug 01, 2007
Jkt 211001
are acceptable to the NRC staff for
implementing specific parts of the
NRC’s regulations, techniques that the
staff uses in evaluating specific
problems or postulated accidents, and
data that the staff needs in its review of
applications for permits and licenses.
At this time, the NRC is issuing a
clarification to Revision 1 of RG 1.200,
‘‘An Approach for Determining the
Technical Adequacy of Probabilistic
Risk Assessment Results for RiskInformed Activities,’’ issued January
2007. The purpose of this clarification is
to provide additional explanation to the
staff’s regulatory position with regard to
defining the technical acceptability of a
probabilistic risk assessment (PRA),
specifically with respect to the
treatment of the sources of model
uncertainty and the related assumptions
in the base PRA.
The clarification to RG 1.200,
Revision 1 can be found in Agencywide
Documents Access and Management
System (ADAMS) Accession Number
ML071940235.
The clarification to Regulatory Guide
1.200, Revision 1, is intended for
licensees of nuclear power plants.
Revision 1 of this RG remains in effect
for licensees of nuclear power plants.
The NRC staff encourages and
welcomes comments and suggestions in
connection with improvements to
published RGs, as well as items for
inclusion in RGs that are currently
under development. You may submit
comments by any of the following
methods.
1. Mail comments to: Rulemaking,
Directives and Editing Branch, Office of
Administration, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001.
2. Hand-deliver comments to:
Rulemaking, Directives and Editing
Branch, Office of Administration, U.S.
Nuclear Regulatory Commission, 11555
Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m.
on Federal workdays.
3. Fax comments to: Rulemaking,
Directives and Editing Branch, Office of
Administration, U.S. Nuclear Regulatory
Commission at (301) 415–5144.
4. Direct requests for technical
information about this clarification to
Revision 1 of RG 1.200 to Ms. Mary
Drouin at (301) 415–6675 or
MXD@nrc.gov.
RGs are available for inspection or
downloading through the NRC’s public
Web site at https://www.nrc.gov/readingrm/doc-collections/reg-guides/. In
addition, this clarification to Revision 1
of RG 1.200 is available for inspection
or downloading through the
Agencywide Documents Access and
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
Management System (ADAMS) at
https://www.nrc.gov/reading-rm/
adams.html under ADAMS Accession
No. ML071940235.
The clarification to Revision 1 of RG
1.200 and other related publicly
available documents can also be viewed
electronically on computers in the
NRC’s Public Document Room (PDR),
which is located at 11555 Rockville
Pike, Rockville, Maryland. The
reproduction contractor at the PDR will
make copies of documents for a fee. The
mailing address for the PDR is USNRC,
PDR, Washington, DC 20555–0001. The
PDR can also be reached by telephone
at (301) 415–4737 or (800) 397–4205, by
fax at (301) 415–3548, and by e-mail to
PDR@nrc.gov.
RGs are not copyrighted, and
Commission approval is not required to
reproduce them.
(5 U.S.C. 552(a))
Dated at Rockville, Maryland, this 27th day
of July, 2007.
For the U.S. Nuclear Regulatory
Commission.
Farouk Eltawila,
Director, Division of Risk Assessment and
Special Projects, Office of Nuclear Regulatory
Research.
[FR Doc. E7–15036 Filed 8–1–07; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
NUREG–1556, Volume 9, Revision 2,
‘‘Consolidated Guidance About
Materials Licenses Program-Specific
Guidance About Medical Use Licenses;
Draft Guidance Document for
Comment
Nuclear Regulatory
Commission.
ACTION: Notice of availability for public
comment.
AGENCY:
SUMMARY: The Nuclear Regulatory
Commission (NRC) has amended its
regulations to include jurisdiction over
certain radium sources, acceleratorproduced radioactive materials, and
certain naturally occurring radioactive
material, as required by the Energy
Policy Act of 2005 (EPAct), which was
signed into law on August 8, 2005. The
EPAct expanded the Atomic Energy Act
of 1954 definition of byproduct material
to include these radioactive materials.
Subsequently, these radioactive
materials were placed under NRC’s
regulatory authority. NRC is revising its
regulations to provide a regulatory
framework that includes these newly
added radioactive materials. See SECY–
07–0062, ‘‘Final Rule: Requirements for
E:\FR\FM\02AUN1.SGM
02AUN1
mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices
Expanded Definition of Byproduct
Material,’’ dated April 3, 2007, for
information on that rulemaking.
Two licensing guidance documents in
the NUREG–1556 series are being
revised along with these new
regulations to provide guidance related
to the new requirements: (1) NUREG–
1556, Volume 13, Revision 1,
‘‘Consolidated Guidance About
Materials Licenses—Program-Specific
Guidance About Commercial
Radiopharmacy Licenses,’’ and (2)
NUREG–1556, Volume 9, Revision 2,
‘‘Consolidated Guidance About
Materials Licenses—Program Specific
Guidance About Medical Use Licenses.’’
A new volume in the NUREG–1556
series has also been developed to
address the production of radioactive
material using an accelerator. This
NUREG is entitled NUREG–1556,
Volume 21, ‘‘Consolidated Guidance
About Materials Licenses—ProgramSpecific Guidance About Possession
Licenses for Production of Radioactive
Material Using an Accelerator.’’
This notice is announcing the
availability of one of these three
licensing guidance documents for
public comment: NUREG–1556, Volume
9, Revision 2. The other two NUREGs
were previously noticed for public
comment: (1) NUREG–1556, Volume 13,
Revision 1, on July 3, 2007 (72 FR
36526), and (2) NUREG–1556, Volume
21, on May 29, 2007 (72 FR 29555).
DATES: Please submit comments on
NUREG–1556, Volume 9, Revision 2, by
September 4, 2007. Comments received
after this date will be considered if
practical to do so, but the NRC staff is
able to ensure consideration only for
those comments received on or before
this date.
ADDRESSES: NUREG–1556, Volume 9,
Revision 2, ‘‘Consolidated Guidance
About Materials Licenses—ProgramSpecific Guidance About Medical Use
Licenses,’’ Draft Report for Comment, is
available for inspection and copying for
a fee at the NRC’s Public Document
Room (PDR), Public File Area O–1F21,
One White Flint North, 11555 Rockville
Pike, Rockville, Maryland. Publicly
available documents created or received
at the NRC after November 1, 1999, are
available electronically at the NRC’s
Electronic Reading Room at https://
www.nrc.gov/NRC/ADAMS/.
From this site, the public can gain entry
into the NRC’s Agencywide Document
Access and Management System
(ADAMS), which provides text and
image files of the NRC’s public
documents. The ADAMS Accession
Number for NUREG–1556, Volume 9,
Revision 2, is ML071860070. If you do
VerDate Aug<31>2005
17:42 Aug 01, 2007
Jkt 211001
not have access to ADAMS or if there
are problems in accessing the
documents located in ADAMS, contact
the NRC PDR Reference staff at 1–800–
397–4209, 301–415–4737, or by e-mail
to pdr@nrc.gov.
The document will also be posted on
NRC’s public Web site at: (1) https://
www.nrc.gov/reading-rm/doccollections/nuregs/staff/sr1556/ on the
‘‘Consolidated Guidance About
Materials Licenses (NUREG–1556)’’ Web
site page, and (2) https://www.nrc.gov/
reading-rm/doc-collections/nuregs/
docs4comment.html on the ‘‘Draft
NUREG Series Publications for
Comment.’’ It will also be posted on the
Office of Federal and State Materials
and Environmental Management
Programs’ NARM (Naturally-Occurring
and Accelerator-Produced Radioactive
Material) Toolbox Web site page at:
https://nrc-stp.ornl.gov/
narmtoolbox.html under the heading of
‘‘Licensing Guidance.’’
A free single copy, to the extent of
supply, may be requested by writing to
the Office of the Chief Information
Officer, Reproduction and Distribution
Services, U.S. Nuclear Regulatory
Commission, Printing and Graphics
Branch, Washington, DC 20555–0001;
facsimile: 301–415–2289; e-mail:
Distribution@nrc.gov.
Please submit comments to Chief,
Rulemaking, Directives and Editing
Branch, Division of Administrative
Services, Office of Administration, U.S.
Nuclear Regulatory Commission,
Washington, DC, 20555–0001. You may
also deliver comments to 11545
Rockville Pike, Rockville, MD, between
7:30 a.m. and 4:30 p.m. Federal
workdays, or by e-mail to:
nrcrep@nrc.gov.
FOR FURTHER INFORMATION CONTACT:
Torre Taylor, Division of
Intergovernmental Liaison and
Rulemaking, Office of Federal and State
Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001, telephone (301) 415–
7900, e-mail: tmt@nrc.gov.
SUPPLEMENTARY INFORMATION:
Background
On August 8, 2005, the President
signed into law the EPAct. Among other
provisions, section 651(e) of the EPAct
expanded the definition of byproduct
material as defined in section 11e. of the
Atomic Energy Act of 1954 (AEA),
placing additional byproduct material
under the NRC’s jurisdiction, and
required the Commission to provide a
regulatory framework for licensing and
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
42443
regulating this additional byproduct
material.
Specifically, section 651(e) of the
EPAct expanded the definition of
byproduct material by: (1) Adding any
discrete source of radium-226 that is
produced, extracted, or converted after
extraction, before, on, or after the date
of enactment of the EPAct for use for a
commercial, medical, or research
activity; or any material that has been
made radioactive by use of a particle
accelerator and is produced, extracted,
or converted after extraction, before, on,
or after the date of enactment of the
EPAct for use for a commercial,
medical, or research activity (Section
11e.(3) of the AEA); and (2) adding any
discrete source of naturally occurring
radioactive material, other than source
material, that the Commission, in
consultation with the Administrator of
the Environmental Protection Agency,
the Secretary of the Department of
Energy, the Secretary of the Department
of Homeland Security, and the head of
any other appropriate Federal agency,
determines would pose a threat similar
to the threat posed by a discrete source
of radium-226 to the public health and
safety or the common defense and
security; and is extracted or converted
after extraction before, on, or after the
date of enactment of the EPAct for use
in a commercial, medical, or research
activity (Section 11e.(4) of the AEA).
NRC is revising its regulations to
provide a regulatory framework that
includes these newly added radioactive
materials. See SECY–07–0062, ‘‘Final
Rule: Requirements for Expanded
Definition of Byproduct Material,’’
dated April 3, 2007, for information on
that rulemaking.
Discussion
As part of the rulemaking effort to
address the mandate of the EPAct, the
NRC also evaluated the need to revise
certain licensing guidance documents to
provide necessary guidance to
applicants in preparing license
applications to include the use of the
newly added radioactive material as
byproduct material. Two NUREG–1556
documents are being revised to provide
additional guidance to licensees: (1)
NUREG–1556, Volume 13, Revision 1,
‘‘Consolidated Guidance About
Materials Licenses—Program-Specific
Guidance About Commercial
Radiopharmacy Licenses,’’ and (2)
NUREG–1556, Volume 9, Revision 2,
‘‘Consolidated Guidance About
Materials Licenses—Program-Specific
Guidance About Medical Use Licenses.’’
Additionally, a new NUREG–1556
volume has been developed as Volume
21 to address production of radioactive
E:\FR\FM\02AUN1.SGM
02AUN1
mstockstill on PROD1PC66 with NOTICES
42444
Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices
material using an accelerator. This
NUREG–1556, Volume 21, is entitled:
‘‘Consolidated Guidance About
Materials Licenses—Program-Specific
Guidance About Possession Licenses for
Production of Radioactive Material
Using an Accelerator.’’
At this time, NRC is announcing the
availability for public comment
NUREG–1556, Volume 9, Revision 2,
‘‘Consolidated Guidance About
Materials Licenses—Program-Specific
Guidance About Medical Use Licenses,’’
Draft Report for Comment. The other
two NUREGs were previously noticed
for public comment: (1) NUREG–1556,
Volume 13, Revision 1, on July 3, 2007
(72 FR 36526) and (2) NUREG–1556,
Volume 21, on May 29, 2007 (72 FR
29555).
NUREG–1556, Volume 9, Revision 2,
‘‘Consolidated Guidance About
Materials Licenses—Program-Specific
Guidance About Medical Use Licenses,’’
provides guidance for applicants in
preparing their license applications for
the medical use of byproduct material.
Volume 9 is being revised primarily to
provide additional guidance related to
the NARM rule, as discussed above.
In the draft final rule for the NARM
rulemaking, the concept of consortiums
and noncommercial distribution was
addressed. In summary, because of the
short-lived radionuclides associated
with Positron Emission Tomography
(PET), the source of these radioactive
materials needs to be produced in the
facility of use or within close proximity.
The NRC developed a new regulatory
process based on existing practices for
consortiums and noncommercial
distribution. For this purpose,
educational institutions, medical use
facilities or Federal facilities may form
consortiums with adjacent or nearby
hospitals to jointly own or share in the
operation and maintenance costs of the
PET radionuclide production facility.
This is discussed in more detail in
SECY–07–0062, ‘‘Final Rule:
Requirements for Expanded Definition
of Byproduct Material,’’ dated April 3,
2007, and within the draft Federal
Register notice that is provided as an
attachment to SECY–07–0062.
NUREG–1556, Volume 9, Revision 2,
provides guidance for applicants in
licensees about consortiums and
noncommercial distribution in Sections
1 and 8, and in Appendix AA. NRC is
requesting specific comments on this
guidance to ensure that it is clear and
easily understood by affected
stakeholders.
It is also being revised to clarify
training and experience requirements,
replaces NRC Form 313A with six new
NRC Form 313A forms specific to types
VerDate Aug<31>2005
17:42 Aug 01, 2007
Jkt 211001
of authorizations. References and
information related to Subpart J of 10
CFR Part 35 have been removed since
these regulatory requirements expired
on October 25, 2005.
Additionally, other minor changes are
being made that are administrative in
nature, such as updating the Agreement
State section and updating references.
Also, information related to identifying
and protecting sensitive information is
being updated.
NRC is only requesting comments on
the specific changes in this document
related to those revisions discussed
above. NRC will make corrections if any
errors or editorial corrections are noted;
however, any comments not related to
these specific changes will be evaluated
during the next routine review of
NUREG–1556, Volume 9.
Dated at Rockville, Maryland, this 26th day
of July, 2007.
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. E7–15049 Filed 8–1–07; 8:45 am]
BILLING CODE 7590–01–P
OFFICE OF MANAGEMENT AND
BUDGET
Amending Federal Financial
Assistance-Related Forms to Include
Universal Identifier
Office of Federal Financial
Management and Office of Information
and Regulatory Affairs, Office of
Management and Budget.
ACTION: Notice; request for comments.
AGENCY:
SUMMARY: The Office of Management
and Budget (OMB) proposes to
authorize each Federal agency that
receives applications for Federal
financial assistance to add a field for the
applicant’s Dun and Bradstreet Data
Universal Numbering System (DUNS)
number to application forms previously
approved by OMB. This proposed
update would broaden the directive’s
effect to all forms of Federal financial
assistance covered by the Federal
Funding Accountability and
Transparency Act (the ‘‘Act’’) including
grants, subgrants, loans, awards,
cooperative agreements, and other forms
of financial assistance.
DATES: Comments are due by September
4, 2007.
ADDRESSES: Comments should be
addressed to Marguerite Pridgen, Office
of Federal Financial Management,
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Office of Management and Budget, 725
17th Street, NW., Washington, DC
20503; telephone 202–395–7844; fax
202–395–3952; e-mail
mpridgen@omb.eop.gov. Due to
potential delays in OMB’s receipt and
processing of mail sent through the U.S.
Postal Service, we encourage
respondents to submit comments
electronically to ensure timely receipt.
We cannot guarantee that comments
mailed will be received before the
comment closing date. Please include
‘‘Amending Forms for DUNS’’ in the
subject line of the email message; please
also include the full body of your
comments in the text of the message and
as an attachment. Include your name,
title, organization, postal address,
telephone number, and e-mail address
in your message.
FOR FURTHER INFORMATION CONTACT:
Marguerite Pridgen at the addresses
noted above.
Authority: Sec. 2, Pub. L. 109–282, 102
Stat. 1186.
The Office
of Management and Budget (OMB)
proposes to authorize each Federal
agency that receives applications for
Federal financial assistance to add a
field for the applicant’s Dun and
Bradstreet Data Universal Numbering
System (DUNS) number to application
forms previously approved by OMB.
The intent of authorizing agencies to
add the field without additional OMB
approval is to enable the agencies to
require applicants other than individual
persons to provide DUNS numbers for
all applications submitted on or after
October 1, 2007. This proposal thereby
would update the policy in the OMB
directive issued on June 27, 2003 [68 FR
38403], ‘‘Use of a Universal Identifier by
Grant Applicants.’’ That directive
authorized agencies to add the DUNS
number as a required field for
applications leading to the award of two
specific forms of Federal financial
assistance: Grants and cooperative
agreements. This proposed update
would broaden the directive’s effect to
all forms of Federal financial assistance
covered by the Federal Funding
Accountability and Transparency Act
(the ‘‘Act’’) including grants, subgrants,
loans, awards, cooperative agreements,
and other forms of financial assistance.
The reason for the proposed update is
that the DUNS number will be used as
the unique identifier for recipient
entities that is required by the Federal
Funding Accountability and
Transparency Act of 2006 (Pub. L. 109–
282). Under that Act, OMB must ensure
the establishment and maintenance of a
location on the World Wide Web
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Notices]
[Pages 42442-42444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15049]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About
Materials Licenses Program-Specific Guidance About Medical Use
Licenses; Draft Guidance Document for Comment
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of availability for public comment.
-----------------------------------------------------------------------
SUMMARY: The Nuclear Regulatory Commission (NRC) has amended its
regulations to include jurisdiction over certain radium sources,
accelerator-produced radioactive materials, and certain naturally
occurring radioactive material, as required by the Energy Policy Act of
2005 (EPAct), which was signed into law on August 8, 2005. The EPAct
expanded the Atomic Energy Act of 1954 definition of byproduct material
to include these radioactive materials. Subsequently, these radioactive
materials were placed under NRC's regulatory authority. NRC is revising
its regulations to provide a regulatory framework that includes these
newly added radioactive materials. See SECY-07-0062, ``Final Rule:
Requirements for
[[Page 42443]]
Expanded Definition of Byproduct Material,'' dated April 3, 2007, for
information on that rulemaking.
Two licensing guidance documents in the NUREG-1556 series are being
revised along with these new regulations to provide guidance related to
the new requirements: (1) NUREG-1556, Volume 13, Revision 1,
``Consolidated Guidance About Materials Licenses--Program-Specific
Guidance About Commercial Radiopharmacy Licenses,'' and (2) NUREG-1556,
Volume 9, Revision 2, ``Consolidated Guidance About Materials
Licenses--Program Specific Guidance About Medical Use Licenses.'' A new
volume in the NUREG-1556 series has also been developed to address the
production of radioactive material using an accelerator. This NUREG is
entitled NUREG-1556, Volume 21, ``Consolidated Guidance About Materials
Licenses--Program-Specific Guidance About Possession Licenses for
Production of Radioactive Material Using an Accelerator.''
This notice is announcing the availability of one of these three
licensing guidance documents for public comment: NUREG-1556, Volume 9,
Revision 2. The other two NUREGs were previously noticed for public
comment: (1) NUREG-1556, Volume 13, Revision 1, on July 3, 2007 (72 FR
36526), and (2) NUREG-1556, Volume 21, on May 29, 2007 (72 FR 29555).
DATES: Please submit comments on NUREG-1556, Volume 9, Revision 2, by
September 4, 2007. Comments received after this date will be considered
if practical to do so, but the NRC staff is able to ensure
consideration only for those comments received on or before this date.
ADDRESSES: NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance
About Materials Licenses--Program-Specific Guidance About Medical Use
Licenses,'' Draft Report for Comment, is available for inspection and
copying for a fee at the NRC's Public Document Room (PDR), Public File
Area O-1F21, One White Flint North, 11555 Rockville Pike, Rockville,
Maryland. Publicly available documents created or received at the NRC
after November 1, 1999, are available electronically at the NRC's
Electronic Reading Room at https://www.nrc.gov/NRC/ADAMS/.
From this site, the public can gain entry into the NRC's Agencywide
Document Access and Management System (ADAMS), which provides text and
image files of the NRC's public documents. The ADAMS Accession Number
for NUREG-1556, Volume 9, Revision 2, is ML071860070. If you do not
have access to ADAMS or if there are problems in accessing the
documents located in ADAMS, contact the NRC PDR Reference staff at 1-
800-397-4209, 301-415-4737, or by e-mail to pdr@nrc.gov.
The document will also be posted on NRC's public Web site at: (1)
https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/ on
the ``Consolidated Guidance About Materials Licenses (NUREG-1556)'' Web
site page, and (2) https://www.nrc.gov/reading-rm/doc-collections/
nuregs/docs4comment.html on the ``Draft NUREG Series Publications for
Comment.'' It will also be posted on the Office of Federal and State
Materials and Environmental Management Programs' NARM (Naturally-
Occurring and Accelerator-Produced Radioactive Material) Toolbox Web
site page at: https://nrc-stp.ornl.gov/narmtoolbox.html under the
heading of ``Licensing Guidance.''
A free single copy, to the extent of supply, may be requested by
writing to the Office of the Chief Information Officer, Reproduction
and Distribution Services, U.S. Nuclear Regulatory Commission, Printing
and Graphics Branch, Washington, DC 20555-0001; facsimile: 301-415-
2289; e-mail: Distribution@nrc.gov.
Please submit comments to Chief, Rulemaking, Directives and Editing
Branch, Division of Administrative Services, Office of Administration,
U.S. Nuclear Regulatory Commission, Washington, DC, 20555-0001. You may
also deliver comments to 11545 Rockville Pike, Rockville, MD, between
7:30 a.m. and 4:30 p.m. Federal workdays, or by e-mail to:
nrcrep@nrc.gov.
FOR FURTHER INFORMATION CONTACT: Torre Taylor, Division of
Intergovernmental Liaison and Rulemaking, Office of Federal and State
Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
7900, e-mail: tmt@nrc.gov.
SUPPLEMENTARY INFORMATION:
Background
On August 8, 2005, the President signed into law the EPAct. Among
other provisions, section 651(e) of the EPAct expanded the definition
of byproduct material as defined in section 11e. of the Atomic Energy
Act of 1954 (AEA), placing additional byproduct material under the
NRC's jurisdiction, and required the Commission to provide a regulatory
framework for licensing and regulating this additional byproduct
material.
Specifically, section 651(e) of the EPAct expanded the definition
of byproduct material by: (1) Adding any discrete source of radium-226
that is produced, extracted, or converted after extraction, before, on,
or after the date of enactment of the EPAct for use for a commercial,
medical, or research activity; or any material that has been made
radioactive by use of a particle accelerator and is produced,
extracted, or converted after extraction, before, on, or after the date
of enactment of the EPAct for use for a commercial, medical, or
research activity (Section 11e.(3) of the AEA); and (2) adding any
discrete source of naturally occurring radioactive material, other than
source material, that the Commission, in consultation with the
Administrator of the Environmental Protection Agency, the Secretary of
the Department of Energy, the Secretary of the Department of Homeland
Security, and the head of any other appropriate Federal agency,
determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and is extracted or converted after
extraction before, on, or after the date of enactment of the EPAct for
use in a commercial, medical, or research activity (Section 11e.(4) of
the AEA).
NRC is revising its regulations to provide a regulatory framework
that includes these newly added radioactive materials. See SECY-07-
0062, ``Final Rule: Requirements for Expanded Definition of Byproduct
Material,'' dated April 3, 2007, for information on that rulemaking.
Discussion
As part of the rulemaking effort to address the mandate of the
EPAct, the NRC also evaluated the need to revise certain licensing
guidance documents to provide necessary guidance to applicants in
preparing license applications to include the use of the newly added
radioactive material as byproduct material. Two NUREG-1556 documents
are being revised to provide additional guidance to licensees: (1)
NUREG-1556, Volume 13, Revision 1, ``Consolidated Guidance About
Materials Licenses--Program-Specific Guidance About Commercial
Radiopharmacy Licenses,'' and (2) NUREG-1556, Volume 9, Revision 2,
``Consolidated Guidance About Materials Licenses--Program-Specific
Guidance About Medical Use Licenses.'' Additionally, a new NUREG-1556
volume has been developed as Volume 21 to address production of
radioactive
[[Page 42444]]
material using an accelerator. This NUREG-1556, Volume 21, is entitled:
``Consolidated Guidance About Materials Licenses--Program-Specific
Guidance About Possession Licenses for Production of Radioactive
Material Using an Accelerator.''
At this time, NRC is announcing the availability for public comment
NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About
Materials Licenses--Program-Specific Guidance About Medical Use
Licenses,'' Draft Report for Comment. The other two NUREGs were
previously noticed for public comment: (1) NUREG-1556, Volume 13,
Revision 1, on July 3, 2007 (72 FR 36526) and (2) NUREG-1556, Volume
21, on May 29, 2007 (72 FR 29555).
NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About
Materials Licenses--Program-Specific Guidance About Medical Use
Licenses,'' provides guidance for applicants in preparing their license
applications for the medical use of byproduct material. Volume 9 is
being revised primarily to provide additional guidance related to the
NARM rule, as discussed above.
In the draft final rule for the NARM rulemaking, the concept of
consortiums and noncommercial distribution was addressed. In summary,
because of the short-lived radionuclides associated with Positron
Emission Tomography (PET), the source of these radioactive materials
needs to be produced in the facility of use or within close proximity.
The NRC developed a new regulatory process based on existing practices
for consortiums and noncommercial distribution. For this purpose,
educational institutions, medical use facilities or Federal facilities
may form consortiums with adjacent or nearby hospitals to jointly own
or share in the operation and maintenance costs of the PET radionuclide
production facility. This is discussed in more detail in SECY-07-0062,
``Final Rule: Requirements for Expanded Definition of Byproduct
Material,'' dated April 3, 2007, and within the draft Federal Register
notice that is provided as an attachment to SECY-07-0062.
NUREG-1556, Volume 9, Revision 2, provides guidance for applicants
in licensees about consortiums and noncommercial distribution in
Sections 1 and 8, and in Appendix AA. NRC is requesting specific
comments on this guidance to ensure that it is clear and easily
understood by affected stakeholders.
It is also being revised to clarify training and experience
requirements, replaces NRC Form 313A with six new NRC Form 313A forms
specific to types of authorizations. References and information related
to Subpart J of 10 CFR Part 35 have been removed since these regulatory
requirements expired on October 25, 2005.
Additionally, other minor changes are being made that are
administrative in nature, such as updating the Agreement State section
and updating references. Also, information related to identifying and
protecting sensitive information is being updated.
NRC is only requesting comments on the specific changes in this
document related to those revisions discussed above. NRC will make
corrections if any errors or editorial corrections are noted; however,
any comments not related to these specific changes will be evaluated
during the next routine review of NUREG-1556, Volume 9.
Dated at Rockville, Maryland, this 26th day of July, 2007.
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. E7-15049 Filed 8-1-07; 8:45 am]
BILLING CODE 7590-01-P
