NUREG-1556, Volume 9, Revision 2, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses”, 8909-8910 [E8-2946]
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Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices
Comments: Comments are invited on
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appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Dated: February 12, 2008.
Suzanne H. Plimpton,
Reports Clearance Officer, National Science
Foundation.
[FR Doc. E8–2872 Filed 2–14–08; 8:45 am]
BILLING CODE 7555–01–P
NUCLEAR REGULATORY
COMMISSION
Independent External Review Panel To
Identify Vulnerabilities in the U.S.
Nuclear Regulatory Commission’s
Materials Licensing Program; Meeting
Notice
U.S. Nuclear Regulatory
Commission.
ACTION: Notice of meeting.
rwilkins on PROD1PC63 with NOTICES
AGENCY:
SUMMARY: The U.S. Nuclear Regulatory
Commission (NRC) will convene a
meeting of the Independent External
Review Panel to Identify Vulnerabilities
in the NRC’s Materials Licensing
Program on March 5 through 7, 2008. A
copy of the agenda for the meeting can
be obtained by e-mailing Mr. Aaron T.
McCraw at the contact information
below.
Purpose: To initiate the Panel’s
discussions and deliberations in
developing their final report and to
allow members of the public an
opportunity to provide comments to the
Panel on its draft report. The Panel’s
draft report is located in the NRC’s
Agencywide Document Access and
Management System (ADAMS) using
Accession Number ML080230554.
Date and Time for Closed Sessions:
There will be no closed sessions during
this meeting.
Date and Time for Open Session:
March 5, 2008, from 2 p.m. to 4:30 p.m.;
March 6, 2008, from 9 a.m. to 4:30 p.m.;
VerDate Aug<31>2005
15:58 Feb 14, 2008
Jkt 214001
and March 7, 2008, from 9 a.m. to 12
p.m.
Address for Public Meeting: NRC,
Two White Flint North Building, 11545
Rockville Pike, Rockville, Maryland
20852. Specific room locations will be
indicated on the agenda.
Public Participation: Any member of
the public who wishes to participate in
the meeting should contact Mr. McCraw
using the information below.
Contact Information: Aaron T.
McCraw, e-mail: atm@nrc.gov,
telephone: (301) 415–1277.
Conduct of the Meeting
Mr. Thomas E. Hill will chair the
meeting. Mr. Hill will conduct the
meeting in a manner that will facilitate
the orderly conduct of business. The
following procedures apply to public
participation in the meeting:
1. Persons who wish to provide a
written statement should submit an
electronic copy to Mr. McCraw at the
contact information listed above. All
submittals must be received by February
29, 2008, and must pertain to the topics
on the agenda for the meeting.
2. Questions and comments from
members of the public will be permitted
during the meeting, at the discretion of
the Chairman.
3. The transcript and written
comments will be available for
inspection at the NRC Public Document
Room, 11555 Rockville Pike, Rockville,
Maryland 20852–2738, telephone (800)
397–4209, on or about June 15, 2008.
4. Persons who require special
services, such as those for the hearing
impaired, should notify Mr. McCraw of
their planned attendance.
This meeting will be held in
accordance with the Atomic Energy Act
of 1954, as amended (primarily Section
161a); the Federal Advisory Committee
Act (5 U.S.C. App); and the
Commission’s regulations in Title 10,
U.S. Code of Federal Regulations, Part 7.
Dated: February 11, 2008.
Andrew L. Bates,
Advisory Committee Management Officer.
[FR Doc. E8–2889 Filed 2–14–08; 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’’
Nuclear Regulatory
Commission.
ACTION: Notice of availability.
AGENCY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
8909
SUMMARY: The Nuclear Regulatory
Commission (NRC) is announcing the
completion and availability of NUREG–
1556, Volume 9, Revision 2,
‘‘Consolidated Guidance About
Materials Licenses: Program-Specific
Guidance About Medical Use Licenses,’’
dated January 2008.
ADDRESSES: Copies of NUREG–1556,
Volume 9, Revision 2, may be
purchased from the Superintendent of
Documents, U.S. Government Printing
Office, P.O. Box 37082, Washington, DC
20402–9328; https://
www.access.gpo.gov/su _docs 202–512–
1800 or The National Technical
Information Service, Springfield,
Virginia 22161–0002; https://
www.ntis.gov 1–800–533–6847 or,
locally, 703–805–6000.
A copy of the document is also
available for inspection and/or copying
for a fee in the NRC Public Document
Room (PDR), 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 ML073400289. 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 initially 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.’’ Subsequently, it
will be posted on NRC’s public Web site
at: https://www.nrc.gov/reading-rm/doccollections/nuregs/staff/sr1556 on the
‘‘Consolidated Guidance About
Materials Licenses (NUREG–1556)’’ Web
site page. Some publications in the
NUREG series that are posted at NRC’s
Web site address https://www.nrc.gov are
updated regularly and may differ from
the last printed version.
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
E:\FR\FM\15FEN1.SGM
15FEN1
8910
Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices
Commission, Printing and Graphics
Branch, Washington, DC 20555–0001;
facsimile: 301–415–2289; e-mail:
Distribution@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; or DonnaBeth Howe, Ph.D., Division of Materials
Safety and State Agreements, Office of
Federal and State Materials and
Environmental Management Programs,
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001, telephone
(301) 415–7848, e-mail: dbh@nrc.gov.
On August
8, 2005, the President signed into law
the Energy Policy Act of 2005 (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
these additional byproduct materials.
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).
rwilkins on PROD1PC63 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
15:58 Feb 14, 2008
Jkt 214001
NRC revised its regulations to provide
a regulatory framework that includes
these newly added radioactive
materials. See Federal Register notice
72 FR 55864, dated October 1, 2007. As
part of the rulemaking effort to address
the mandate of the EPAct, the NRC also
evaluated the need to revise certain
licensing guidance to provide necessary
guidance to applicants in preparing
license applications to include the use
of the newly added radioactive
materials as byproduct material. Two
NUREG–1556 documents have been
revised to provide additional guidance
to licensees: (1) NUREG–1556, Volume
13, Revision 1, ‘‘Consolidated Guidance
About Materials Licenses: ProgramSpecific 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 was developed to address
production of radioactive material using
an accelerator. This NUREG–1556
volume is entitled: Volume 21,
‘‘Consolidated Guidance About
Materials Licenses: Program-Specific
Guidance About Possession Licenses for
Production of Radioactive Material
Using an Accelerator. ‘‘
NUREG–1556, Volume 9, Revision 2,
provides guidance for applicants in
preparing their license applications for
the medical use of byproduct material.
Volume 9 has been revised primarily to
provide additional guidance related to
the NARM rule, including guidance
about consortiums and noncommercial
distribution. It is also revised to clarify
training and experience requirements,
and to replace 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 were 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 was
updated.
NUREG–1556, Volume 9, Revision 2,
‘‘Consolidated Guidance About
Materials Licenses: Program-Specific
Guidance About Medical Use Licenses,’’
was noticed for public comment on
August 2, 2007 (72 FR 42442).
The remaining two NUREG–1556
volumes were noticed for public
comment separately: (1) NUREG–1556,
Volume 21, on May 29, 2007 (72 FR
29555), and (2) NUREG–1556, Volume
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
13, Revision 1, on July 3, 2007 (72 FR
36526). NUREG–1556, Volume 21 was
finalized and published in October
2007. NUREG–1556, Volume 13,
Revision 1, was finalized and published
in November 2007.
Dated at Rockville, Maryland, this 5th day
of February, 2008.
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. E8–2946 Filed 2–14–08; 8:45 am]
BILLING CODE 7590–01–P
OFFICE OF THE UNITED STATES
TRADE REPRESENTATIVE
Anti-Counterfeiting Trade Agreement
(ACTA): Request for Public Comments
Office of the United States
Trade Representative.
ACTION: Request for written submissions
from the public.
AGENCY:
SUMMARY: The Office of the United
States Trade Representative (USTR)
seeks to negotiate an anti-counterfeiting
trade agreement to strengthen
international cooperation, enforcement
practices, and participants’ legal
frameworks to address counterfeiting
and piracy. USTR requests written
comments from the public concerning
specific matters that should be the focus
of such an agreement.
DATES: Submissions must be received on
or before 5 p.m. on Friday, March 21,
2008.
ADDRESS: All comments should be sent
(i) electronically, to the following e-mail
address: ACTA@ustr.eop.gov, with
‘‘Anti-Counterfeiting Trade Agreement
(ACTA): Request for Public Comments’’
in the subject line, or (ii) by fax, to
Rachel Bae, at (202) 395–3891, with a
confirmation copy sent electronically to
the e-mail address above.
FOR FURTHER INFORMATION CONTACT:
Rachel S. Bae, Director for Intellectual
Property and Innovation, Office of the
United States Trade Representative, at
(202) 395–4510.
SUPPLEMENTARY INFORMATION: On
October 23, 2008, USTR announced that
the United States, along with a group of
trading partners, would pursue
negotiation of a new Anti-Counterfeiting
Trade Agreement (ACTA) to provide
international leadership in the fight
against IPR counterfeiting and piracy.
The United States and other interested
parties intend to seek an agreement with
provisions in three main areas:
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8909-8910]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2946]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About
Materials Licenses: Program-Specific Guidance About Medical Use
Licenses''
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Nuclear Regulatory Commission (NRC) is announcing the
completion and availability of NUREG-1556, Volume 9, Revision 2,
``Consolidated Guidance About Materials Licenses: Program-Specific
Guidance About Medical Use Licenses,'' dated January 2008.
ADDRESSES: Copies of NUREG-1556, Volume 9, Revision 2, may be purchased
from the Superintendent of Documents, U.S. Government Printing Office,
P.O. Box 37082, Washington, DC 20402-9328; https://www.access.gpo.gov/su
_docs 202-512-1800 or The National Technical Information Service,
Springfield, Virginia 22161-0002; https://www.ntis.gov 1-800-533-6847
or, locally, 703-805-6000.
A copy of the document is also available for inspection and/or
copying for a fee in the NRC Public Document Room (PDR), 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 ML073400289. 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 initially 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.'' Subsequently, it will be posted on NRC's public Web site
at: https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556
on the ``Consolidated Guidance About Materials Licenses (NUREG-1556)''
Web site page. Some publications in the NUREG series that are posted at
NRC's Web site address https://www.nrc.gov are updated regularly and may
differ from the last printed version.
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
[[Page 8910]]
Commission, Printing and Graphics Branch, Washington, DC 20555-0001;
facsimile: 301-415-2289; e-mail: Distribution@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; or Donna-Beth Howe, Ph.D., Division of
Materials Safety and State Agreements, Office of Federal and State
Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
7848, e-mail: dbh@nrc.gov.
SUPPLEMENTARY INFORMATION: On August 8, 2005, the President signed into
law the Energy Policy Act of 2005 (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 these additional byproduct
materials.
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 revised its regulations to provide a regulatory framework that
includes these newly added radioactive materials. See Federal Register
notice 72 FR 55864, dated October 1, 2007. As part of the rulemaking
effort to address the mandate of the EPAct, the NRC also evaluated the
need to revise certain licensing guidance to provide necessary guidance
to applicants in preparing license applications to include the use of
the newly added radioactive materials as byproduct material. Two NUREG-
1556 documents have been 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 was developed to address production of radioactive
material using an accelerator. This NUREG-1556 volume is entitled:
Volume 21, ``Consolidated Guidance About Materials Licenses: Program-
Specific Guidance About Possession Licenses for Production of
Radioactive Material Using an Accelerator. ``
NUREG-1556, Volume 9, Revision 2, provides guidance for applicants
in preparing their license applications for the medical use of
byproduct material. Volume 9 has been revised primarily to provide
additional guidance related to the NARM rule, including guidance about
consortiums and noncommercial distribution. It is also revised to
clarify training and experience requirements, and to replace 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 were
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 was updated.
NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About
Materials Licenses: Program-Specific Guidance About Medical Use
Licenses,'' was noticed for public comment on August 2, 2007 (72 FR
42442).
The remaining two NUREG-1556 volumes were noticed for public
comment separately: (1) NUREG-1556, Volume 21, on May 29, 2007 (72 FR
29555), and (2) NUREG-1556, Volume 13, Revision 1, on July 3, 2007 (72
FR 36526). NUREG-1556, Volume 21 was finalized and published in October
2007. NUREG-1556, Volume 13, Revision 1, was finalized and published in
November 2007.
Dated at Rockville, Maryland, this 5th day of February, 2008.
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. E8-2946 Filed 2-14-08; 8:45 am]
BILLING CODE 7590-01-P
