Medical Use of Byproduct Material-Minor Corrections and Clarifications, 45147-45151 [07-3976]
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45147
Rules and Regulations
Federal Register
Vol. 72, No. 155
Monday, August 13, 2007
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
U.S. Office of Personnel Management.
Linda M. Springer,
Director.
Under the authority of 5 CFR chapter
I, OPM is removing and reserving 5 CFR
part 990 as follows:
I
RIN 3206–AJ97
General and Miscellaneous
Office of Personnel
Management.
ACTION: Final rule.
AGENCY:
PART 990—[REMOVED AND
RESERVED]
I
The Office of Personnel
Management (OPM) is issuing final
regulations to remove its regulation
concerning the submission of claims by
preference eligibles to OPM and the
recognition of representatives by OPM.
The purpose of this revision to part 990
is to eliminate the part because it is
obsolete. OPM no longer adjudicates
claims or appeals under sections 3502,
3503, or 7701 of title 5, United States
Code. That appellate function was
vested in the Merit Systems Protection
Board, created by the Civil Service
Reform Act of 1978. Accordingly, there
is no basis to retain the provisions of
part 990 in the Code of Federal
Regulations.
SUMMARY:
Effective Date: August 13, 2007.
FOR FURTHER INFORMATION CONTACT:
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Hakeem Basheerud-Deen at (202) 606–
1434, Fax: (202) 606–2329, TTY: (202)
418–3134, or e-mail: hakeem.basheeruddeen@opm.gov.
SUPPLEMENTARY INFORMATION: On May
27, 2003, OPM issued proposed
regulations at Federal Register 68 FR
28806 to remove and reserve part 990
from the Code of Federal Regulations.
No comments were received and the
proposed rule is adopted as a final rule
without change.
Regulatory Flexibility Act
I certify that this regulation will not
have a significant economic impact on
a substantial number of small entities
16:17 Aug 10, 2007
This rule has been reviewed by the
Office of Management and Budget in
accordance with Executive Order 12866.
Administrative practice and
procedure, Claims, Government
employees, Veterans.
5 CFR Part 990
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Executive Order 12866, Regulatory
Review
List of Subjects in 5 CFR Part 990
OFFICE OF PERSONNEL
MANAGEMENT
DATES:
because it affects only certain Federal
employees.
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1. Part 990 is removed and reserved.
[FR Doc. E7–15662 Filed 8–10–07; 8:45 am]
BILLING CODE 6325–39–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Parts 32 and 35
RIN 3150–AI14
Medical Use of Byproduct Material—
Minor Corrections and Clarifications
Nuclear Regulatory
Commission.
ACTION: Direct final rule.
AGENCY:
SUMMARY: The Nuclear Regulatory
Commission (NRC) is amending its
regulations to correct or clarify the rule
language in several sections in the
regulations that govern specific
domestic licenses to manufacture or
transfer certain items containing
byproduct material and medical use of
byproduct material. The regulations that
govern medical use of byproduct
materials were amended in their
entirety on April 24, 2002 (67 FR
20249). Subsequently, these regulations
were amended again to revise the
training and experience requirements
for the medical use of byproduct
material on March 30, 2005 (70 FR
16336). Through implementation of
these revised regulations, the NRC has
identified additional changes that need
to be made to these regulations. This
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action is necessary to clarify certain
provisions and to make certain
conforming changes to the regulations.
DATES: The final rule is effective on
October 29, 2007, unless significant
adverse comments are received by
September 12, 2007. A significant
adverse comment is a comment where
the commenter explains why the rule
would be inappropriate, including
challenges to the rule’s underlying
premise or approach, or would be
ineffective or unacceptable without a
change. If the rule is withdrawn due to
significant adverse comments, timely
notice will be provided in the Federal
Register.
ADDRESSES: You may submit comments
by any one of the following methods.
Please include the following number
(RIN 3150–AI14) in the subject line of
your comments. Comments on
rulemakings submitted in writing or in
electronic form will be made available
to the public in their entirety on the
NRC rulemaking Web site. Personal
information, such as name, address,
phone, e-mail address, etc., will not be
removed from your submission.
Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, ATTN:
Rulemakings and Adjudications Staff.
E-mail comments to: SECY@nrc.gov. If
you do not receive a reply e-mail
confirming that we have received your
comments, contact us directly at (301)
415–1966. You may also submit
comments via the NRC’s rulemaking
Web site at https://ruleforum.llnl.gov.
Address questions about our rulemaking
Web site to Carol Gallagher (301) 415–
5905; e-mail cag@nrc.gov. Comments
can also be submitted via the Federal
eRulemaking Portal https://
www.regulations.gov.
Hand deliver comments to: 11555
Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m.
Federal workdays. (Telephone (301)
415–1966.) Fax comments to: Secretary,
U.S. Nuclear Regulatory Commission at
(301) 415–1101. Publicly available
documents related to this rulemaking
may be viewed electronically on the
public computers located at the NRC’s
Public Document Room (PDR), O1 F21,
One White Flint North, 11555 Rockville
Pike, Rockville, Maryland. The PDR
reproduction contractor will copy
documents for a fee. Selected
documents, including comments, may
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Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Rules and Regulations
be viewed and downloaded
electronically via the NRC rulemaking
Web site at https://ruleforum.llnl.gov.
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/reading-rm/
adams.html. 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 NRC’s
public documents. If you do not have
access to ADAMS or if there are
problems in accessing the documents
located in ADAMS, contact the NRC
Public Document Room (PDR) Reference
staff at 1–800–397–4209, 301–415–4737,
or by e-mail to pdr@nrc.gov.
FOR FURTHER INFORMATION CONTACT:
Edward M. Lohr, Office of Federal and
State Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001, telephone (301) 415–
0253, e-mail eml1@nrc.gov.
SUPPLEMENTARY INFORMATION:
Background
The purpose of these amendments is
to amend 10 CFR Parts 32 and 35 to
clarify and make certain conforming
changes related to the NRC’s
requirements for the medical use of
byproduct material.
Discussion
This direct final rule revises several
sections in 10 CFR Parts 32 and 35 to
correct or clarify rule language. It also
includes conformatory changes that
should have been incorporated in the
regulations but were inadvertently left
out. The changes and clarifications are
minor in nature and noncontroversial.
The following changes are being made
to the regulations:
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Section by Section Analysis
1. Section 32.72 Manufacture,
Preparation, or Transfer for Commercial
Distribution of Radioactive Drugs
Containing Byproduct Material for
Medical Use Under Part 35
During the rulemaking completed in
2005, conforming changes to § 32.72, to
reflect the changes made in § 35.55,
were inadvertently omitted. The 2005
revision of the training and experience
requirements for an authorized nuclear
pharmacist (ANP) in § 35.55 removed
the requirement for a preceptor
statement as a condition for recognition
of a specialty board’s certification
process. Instead, an individual seeking
ANP status on an NRC license must
provide a preceptor statement, in
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addition to documentation of the board
certification. This amendment makes
the necessary conforming changes to
§ 32.72.
Additionally, certification by the
Board of Pharmaceutical Specialties is
removed from § 32.72 because specialty
boards recognized by the Commission or
Agreement States are posted on the
NRC’s web page and are no longer listed
in NRC regulations.
2. Section 32.74 Manufacture and
Distribution of Sources or Devices
Containing Byproduct Material for
Medical Use
Section 32.74(a) states that an
application will be approved for a
specific license to manufacture and
distribute sources and devices
containing byproduct material to
persons licensed under Part 35 of this
chapter for use as a calibration or
reference source or for the uses listed in
§§ 35.400, 35.500, and 35.600 if certain
conditions are met. When Part 35 was
amended on April 24, 2002 (67 FR
20249), a new section, § 35.1000, ‘‘Other
medical uses of byproduct material or
radiation from byproduct material,’’ was
added to address radiation safety issues
associated with new modalities. A
conforming change should have been
made in § 32.74(a) to reference
§ 35.1000, but was inadvertently left
out. This change amends this section by
adding § 35.1000 after §§ 35.400, 35.500,
35.600.
3. Section 35.2
Definitions
The definitions in this section include
both medium-dose rate remote
afterloader and high-dose rate remote
afterloader. The medium-dose rate
remote afterloader is defined as a device
that remotely delivers a dose rate of
greater than 2 gray (200 rads), but less
than 12 gray (1200 rads) per hour at the
point or surface where the dose is
prescribed. The high-dose rate remote
afterloader is defined as delivering a
dose rate in excess of 12 gray (1200
rads) per hour at the point or surface
where the dose is prescribed. The dose
rate of equal to 12 gray (1200 rads) per
hour was inadvertently excluded. This
section is being amended to revise the
definition of medium dose-rate remote
afterloader to include ‘‘equal to’’ 12
gray. In addition, for clarification, the
phrase ‘‘per hour’’ will be added after
the phrase ‘‘delivers a dose rate of
greater than 2 gray (200 rads)’’ to read
as ‘‘delivers a dose rate of greater than
2 gray (200 rads) per hour.’’
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4. Section 35.41 Procedures for
Administrations Requiring a Written
Directive
Section 35.41(b)(4) requires a licensee
to have procedures verifying that any
computer-generated dose calculations
are correctly transferred into the
consoles of therapeutic medical units
authorized by § 35.600. When Part 35
was amended on April 24, 2002 (67 FR
20249), a new section, § 35.1000, ‘‘Other
medical uses of byproduct material or
radiation from byproduct material,’’ was
added to address radiation safety issues
associated with new modalities. A
conforming change should have been
made in § 35.41(b)(4) to reference
§ 35.1000, but was inadvertently left
out. This changes this section by adding
§ 35.1000 after § 35.600.
5. Section 35.75 Release of Individuals
Containing Unsealed Byproduct
Material or Implants Containing
Byproduct Material
In § 35.75(a), the footnote states that
NUREG–1556, Vol. 9, ‘‘Consolidated
Guidance About Materials Licenses:
Program-Specific Guidance About
Medical Licenses,’’ describes methods
for calculating doses to other
individuals and contains tables of
activities not likely to cause doses
exceeding 5 mSv (0.5 rem). NUREG–
1556, Vol. 9, is not the current version
of this NUREG. The current version,
‘‘Revision 1,’’ is expected to be revised.
Thus, the footnote is revised to add the
phrase ‘‘The current version of’’ before
the phrase ‘‘NUREG–1556, Vol. 9.’’
6. Section 35.92 Decay-in-Storage
This section permits decay-in-storage
by medical use licensees for
radionuclides with half-lives of less
than 120 days. This section
inadvertently excluded radionuclides
with half-lives equal to 120 days. This
change revises this section to include
‘‘equal to’’ 120 days.
7. Section 35.190 Training for Uptake,
Dilution, and Excretion Studies
Section 35.190(a)(1) provides that in
order for a specialty board’s certification
process to be recognized, the board must
require all candidates for certification to
complete 60 hours of training and
experience ‘‘that includes the topics
listed in paragraphs (c)(1)(i) and
(c)(1)(ii) of this section.’’ The intent of
the regulation is that candidates must
obtain their work experience involving
the topics listed in (c)(1)(ii) under the
supervision of a specified authorized
user. The change of the phrase to ‘‘as
described in paragraphs (c)(1)(i) through
(c)(1)(ii)(F) of this section,’’ clarifies that
all of the requirements in
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§ 35.190(c)(1)(ii), including that
candidates must obtain their work
experience under the supervision of a
specified authorized user, are also
applicable to the board certification
pathway.
8. Section 35.290 Training for Imaging
and Localization Studies
Section 35.290(a)(1) provides that in
order for a specialty board’s certification
process to be recognized, the board must
require all candidates for certification to
complete 700 hours of training and
experience ‘‘that includes the topics
listed in paragraphs (c)(1)(i) and
(c)(1)(ii) of this section.’’ The intent of
the regulation is that candidates must
obtain their work experience involving
the topics listed in (c)(1)(ii) under the
supervision of a specified authorized
user. The change of the phrase to ‘‘as
described in paragraphs (c)(1)(i) through
(c)(1)(ii)(G) of this section,’’ clarifies that
all of the requirements in
§ 35.290(c)(1)(ii), including that
candidates must obtain their work
experience under the supervision of a
specified authorized user, are also
applicable to the board certification
pathway.
Procedural Background
This rulemaking will become effective
on October 29, 2007. However, if the
NRC receives significant adverse
comments by September 12, 2007, then
the NRC will publish a document that
withdraws the direct final rule and will
address the comments received in a
final rule as a response to the
companion proposed rule published
elsewhere in this issue of the Federal
Register. Absent significant
modifications to the proposed revisions
requiring republication, the NRC will
not initiate a second comment period on
this action.
A significant adverse comment is a
comment where the commenter
explains why the rule would be
inappropriate, including challenges to
the rule’s underlying premise or
approach, or would be ineffective or
unacceptable without a change. A
comment is adverse and significant if:
(1) The comment opposes the rule and
provides a reason sufficient to require a
substantive response in a notice-andcomment process. For example, a
substantive response is required when:
(a) The comment causes the NRC staff
to reevaluate (or reconsider) its position
or conduct additional analysis;
(b) The comment raises an issue
serious enough to warrant a substantive
response to clarify or complete the
record; or
(c) The comment raises a relevant
issue that was not previously addressed
or considered by the NRC staff.
(2) The comment proposes a change
or an addition to the rule, and it is
apparent that the rule would be
ineffective or unacceptable without
incorporation of the change or addition.
(3) The comment causes the staff to
make a change (other than editorial) to
the rule.
Voluntary Consensus Standards
The National Technology Transfer Act
of 1995 (Pub. L. 104–113) requires that
Federal agencies use technical standards
that are developed or adopted by
voluntary consensus standards bodies
unless the use of such a standard is
inconsistent with applicable law or
otherwise impractical. In this final rule,
the NRC corrects and clarifies the rule
language in several sections in 10 CFR
Parts 32 and 35. This action does not
constitute the establishment of a
standard that contains generally
applicable requirements.
Issues of Compatibility for Agreement
States
Under the ‘‘Policy Statement on
Adequacy and Compatibility of
45149
Agreement State Programs’’ approved by
the Commission on June 30, 1997 (62 FR
46517), specific requirements within
this rule should be adopted by
Agreement States for purposes of
compatibility or because of health and
safety significance. Implementing
procedures for the Policy Statement
establish specific categories which have
been applied to categorize the
requirements in Parts 32 and 35. A
Compatibility Category ‘‘A’’ designation
means the requirement is a basic
radiation protection standard or deals
with related definitions, signs, labels, or
terms necessary for a common
understanding of radiation protection
principles. Compatibility Category ‘‘A’’
designated Agreement State
requirements should be essentially
identical to those of the NRC. A
Compatibility Category ‘‘B’’ designation
means the requirement has significant
transboundary implications.
Compatibility Category ‘‘B’’ designated
Agreement State requirements should be
essentially identical to those of the NRC.
A Compatibility Category ‘‘C’’
designation means the essential
objectives of the requirement should be
adopted by the State to avoid conflicts,
duplications, or gaps. The manner in
which the essential objectives are
addressed in the Agreement State
requirement need not be the same as
NRC provided the essential objectives
are met. A Compatibility Category ‘‘D’’
designation means the requirement does
not have to be adopted by an Agreement
State for purposes of compatibility. The
Compatibility Category Health and
Safety (H&S) identifies requirements
that are not required for compatibility,
but which have particular health and
safety significance. Agreement States
should adopt the essential objectives of
such requirements in order to maintain
an adequate program.
SUMMARY OF NRC RULES WITH COMPATIBILITY OR HEALTH AND SAFETY DESIGNATIONS UNDER THE DIRECT FINAL RULE
COVERING 10 CFR PARTS 32 AND 35
Section and paragraph
Section title
Category B
§ 32.72(b)(5) .........................................
§ 32.74(a) ..............................................
§ 35.190 ................................................
§ 35.290 ................................................
Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35.
Manufacture and distribution of sources or devices containing byproduct material for medical use.
Training for uptake, dilution, and excretion studies.
Training for imaging and localization studies.
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Category C
§ 35.75(a) ..............................................
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Release of individuals containing unsealed byproduct material or implants containing byproduct material.
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Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Rules and Regulations
SUMMARY OF NRC RULES WITH COMPATIBILITY OR HEALTH AND SAFETY DESIGNATIONS UNDER THE DIRECT FINAL RULE
COVERING 10 CFR PARTS 32 AND 35—Continued
Section and paragraph
Section title
Category D
§ 35.2 ....................................................
§ 35.41(b)(4) .........................................
Definitions—Medium dose-rate remote afterloader.
Procedures for administrations requiring a written directive.
Category H&S
§ 35.92 ..................................................
Decay-in-storage is an ‘‘H&S’’ for States authorizing this activity and ‘‘D’’ for States that do not authorize this activity.
Plain Language
The Presidential Memorandum dated
June 1, 1998, entitled, ‘‘Plain Language
in Government Writing’’ directed that
the Government’s writing be in plain
language. The NRC requests comments
on this direct final rule specifically with
respect to the clarity and effectiveness
of the language used. Comments should
be sent to the address listed under the
heading ADDRESSES above.
Environmental Impact: Categorical
Exclusion
The NRC has determined that this
final rule is the type of action described
in the categorical exclusion at 10 CFR
51.22(c)(2). Therefore neither an
environmental impact statement nor an
environmental assessment has been
prepared for this final rule.
Paperwork Reduction Act Statement
This direct final rule does not contain
new or amended information collection
requirements subject to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). Existing requirements were
approved by the Office of Management
and Budget, approval numbers 3150–
0001 and 3150–0010.
Public Protection Notification
The NRC may not conduct or sponsor,
and a person is not required to respond
to, a request for information or an
information collection requirement
unless the requesting document
displays a currently valid OMB control
number.
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Regulatory Analysis
A regulatory analysis has not been
prepared for this direct final rule
because this rule is considered a minor
nonsubstantive amendment and it has
no economic impact on NRC licensees
or the public.
Regulatory Flexibility Certification
Under the Regulatory Flexibility Act
of 1980 (5 U.S.C. 605(b)), the
Commission certifies that this rule does
not have a significant economic impact
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on a substantial number of small
entities. This rule merely corrects or
clarifies the rule language in several
sections in 10 CFR parts 32 and 35.
Backfit Analysis
The NRC has determined that the
backfit rule (§§ 50.109, 70.76, 72.62, or
76.76) does not apply to this final rule
and therefore, a backfit analysis is not
required because these amendments do
not involve any provisions that would
impose backfits as defined in 10 CFR
Chapter I.
Congressional Review Act
Under the Congressional Review 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 OMB.
List of Subjects
10 CFR Part 32
Byproduct material, Criminal
penalties, Labeling, Nuclear materials,
Radiation protection, Reporting and
recordkeeping requirements.
10 CFR Part 35
Byproduct material, Criminal
penalties, Drugs, Health facilities,
Health professions, Medical devices,
Nuclear materials, Occupational safety
and health, Radiation protection,
Reporting and recordkeeping
requirements.
I For the reasons set out in the
preamble and under the authority of the
Atomic Energy Act of 1954, as amended;
the Energy Reorganization Act of 1974,
as amended; and 5 U.S.C. 552 and 553;
the NRC is adopting the following
amendments to 10 CFR parts 32 and 35.
PART 32—SPECIFIC DOMESTIC
LICENSES TO MANUFACTURE OR
TRANSFER CERTAIN ITEMS
CONTAINING BYPRODUCT MATERIAL
1. The authority citation for part 32
continues to read as follows:
I
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Authority: Secs. 81, 161, 182, 183, 68 Stat.
935, 948, 953, 954, as amended (42 U.S.C.
2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); sec. 1704,
112 Stat. 2750 (44 U.S.C. 3504 note), Energy
Policy Act of 2005, Pub. L. 109–58, 119 Stat.
594 (2005).
2. In § 32.72, paragraph (b)(5) is
revised to read as follows:
I
§ 32.72 Manufacture, preparation, or
transfer for commercial distribution of
radioactive drugs containing byproduct
material for medical use under part 35.
*
*
*
*
*
(b) * * *
(5) Shall provide to the Commission
a copy of each individual’s:
(i)(A) Certification by a specialty
board whose certification process has
been recognized by the Commission or
an Agreement State as specified in
§ 35.55(a) of this chapter with the
written attestation signed by a preceptor
as required by § 35.55(b)(2) of this
chapter; or
(B) The Commission or Agreement
State license; or
(C) The permit issued by a licensee of
broad scope; and
(ii) State pharmacy licensure or
registration, no later than 30 days after
the date that the licensee allows, under
paragraphs (b)(2)(i) and (b)(2)(iii) of this
section, the individual to work as an
authorized nuclear pharmacist.
*
*
*
*
*
I 3. In § 32.74, the introductory text of
paragraph (a) is revised to read as
follows:
§ 32.74 Manufacture and distribution of
sources or devices containing byproduct
material for medical use.
(a) An application for a specific
license to manufacture and distribute
sources and devices containing
byproduct material to persons licensed
under part 35 of this chapter for use as
a calibration, transmission, or reference
source or for the uses listed in
§§ 35.400, 35.500, 35.600, and 35.1000
of this chapter will be approved if:
*
*
*
*
*
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§ 35.92
PART 35—MEDICAL USE OF
BYPRODUCT MATERIAL
4. The authority citation for part 35
continues to read as follows:
I
Authority: Secs. 81, 161, 182, 183, 68 Stat.
935, 948, 953, 954, as amended (42 U.S.C.
2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); sec. 1704,
112 Stat. 2750 (44 U.S.C. 3504 note).
5. In § 35.2, the definition of Medium
dose-rate remote afterloader is revised
to read as follows:
I
§ 35.2
Definitions.
*
*
*
*
*
Medium dose-rate remote afterloader,
as used in this part, means a
brachytherapy device that remotely
delivers a dose rate of greater than 2
gray (200 rads) per hour, but less than
or equal to 12 gray (1200 rads) per hour
at the point or surface where the dose
is prescribed.
*
*
*
*
*
*
*
*
*
*
(b) * * *
(4) Verifying that any computergenerated dose calculations are correctly
transferred into the consoles of
therapeutic medical units authorized by
§§ 35.600 or 35.1000.
*
*
*
*
*
7. In § 35.75, the text of paragraph (a)
is republished and footnote 1 is revised
to read as follows:
I
§ 35.75 Release of individuals containing
unsealed byproduct material or implants
containing byproduct material.
(a) A licensee may authorize the
release from its control of any
individual who has been administered
unsealed byproduct material or
implants containing byproduct material
if the total effective dose equivalent to
any other individual from exposure to
the released individual is not likely to
exceed 5 mSv (0.5 rem).1
*
*
*
*
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current revision of NUREG–1556,
Vol. 9, ‘‘Consolidated Guidance About
Materials Licenses: Program-Specific
Guidance About Medical Licenses’’ describes
methods for calculating doses to other
individuals and contains tables of activities
not likely to cause doses exceeding 5 mSv
(0.5 rem).
8. In § 35.92, the introductory text of
paragraph (a) is revised to read as
follows:
I
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*
*
*
*
*
(a) * * *
(1) Complete 60 hours of training and
experience in basic radionuclide
handling techniques and radiation
safety applicable to the medical use of
unsealed byproduct material for uptake,
dilution, and excretion studies as
described in paragraphs (c)(1)(i) through
(c)(1)(ii)(F) of this section; and
*
*
*
*
*
I 10. In § 35.290, paragraph (a)(1) is
revised to read as follows:
*
§ 35.41 Procedures for administrations
requiring a written directive.
1 The
§ 35.190 Training for uptake, dilution, and
excretion studies.
§ 35.290 Training for imaging and
localization studies.
6. In § 35.41, paragraph (b)(4) is
revised to read as follows:
I
*
Decay-in-storage.
(a) A licensee may hold byproduct
material with a physical half-life of less
than or equal to 120 days for decay-instorage before disposal without regard to
its radioactivity if it—
*
*
*
*
*
I 9. In § 35.190, paragraph (a)(1) is
revised to read as follows:
*
*
*
*
(a) * * *
(1) Complete 700 hours of training
and experience in basic radionuclide
handling techniques and radiation
safety applicable to the medical use of
unsealed byproduct material for imaging
and localization studies as described in
paragraphs (c)(1)(i) through (c)(1)(ii)(G)
of this section; and
*
*
*
*
*
Dated at Rockville, Maryland, this 31st day
of July, 2007.
For the Nuclear Regulatory Commission.
Martin J. Virgilio,
Acting Executive Director for Operations.
[FR Doc. 07–3976 Filed 8–10–07; 8:45 am]
BILLING CODE 7590–01–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2007–28940; Directorate
Identifier 2007–NM–131–AD; Amendment
39–15158; AD 2007–16–19]
RIN 2120–AA64
Airworthiness Directives; Boeing
Model 747–200B, 747–300, and 747–
400 Series Airplanes
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule; request for
comments.
AGENCY:
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
45151
SUMMARY: The FAA is adopting a new
airworthiness directive (AD) for certain
Boeing Model 747–200B, 747–300, and
747–400 series airplanes. This AD
requires doing repetitive detailed
inspections for cracking of the aft
tension tie channels from body station
(BS) 1120 to BS 1220 and from BS 880
to BS 1100, and corrective actions if
necessary. This AD results from cracks
found in the aft tension tie channels at
four station locations, on a Model 747–
200B series airplane that had been
modified to a special freighter. We are
issuing this AD to detect and correct
cracking of the aft tension tie channels;
failure of more than one tension tie
could result in rapid depressurization of
the airplane.
DATES: This AD becomes effective
August 28, 2007.
The Director of the Federal Register
approved the incorporation by reference
of certain publications listed in the AD
as of August 28, 2007.
We must receive comments on this
AD by October 12, 2007.
ADDRESSES: Use one of the following
addresses to submit comments on this
AD.
• DOT Docket Web site: Go to
https://dms.dot.gov and follow the
instructions for sending your comments
electronically.
• Government-wide rulemaking Web
site: Go to https://www.regulations.gov
and follow the instructions for sending
your comments electronically.
• Mail: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.
• Fax: (202) 493–2251.
• Hand Delivery: Room W12–140 on
the ground floor of the West Building,
1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.
Contact Boeing Commercial
Airplanes, P.O. Box 3707, Seattle,
Washington 98124–2207, for service
information identified in this AD.
FOR FURTHER INFORMATION CONTACT: Ivan
Li, Aerospace Engineer, Airframe
Branch, ANM–120S, FAA, Seattle
Aircraft Certification Office, 1601 Lind
Avenue, SW., Renton, Washington
98057–3356; telephone (425) 917–6437;
fax (425) 917–6590.
SUPPLEMENTARY INFORMATION:
Discussion
We have received a report indicating
that cracks were found in the aft tension
tie channels at four station locations, on
a Model 747–200B series airplane that
E:\FR\FM\13AUR1.SGM
13AUR1
]]>Agencies
[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Rules and Regulations]
[Pages 45147-45151]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-3976]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 32 and 35
RIN 3150-AI14
Medical Use of Byproduct Material--Minor Corrections and
Clarifications
AGENCY: Nuclear Regulatory Commission.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its
regulations to correct or clarify the rule language in several sections
in the regulations that govern specific domestic licenses to
manufacture or transfer certain items containing byproduct material and
medical use of byproduct material. The regulations that govern medical
use of byproduct materials were amended in their entirety on April 24,
2002 (67 FR 20249). Subsequently, these regulations were amended again
to revise the training and experience requirements for the medical use
of byproduct material on March 30, 2005 (70 FR 16336). Through
implementation of these revised regulations, the NRC has identified
additional changes that need to be made to these regulations. This
action is necessary to clarify certain provisions and to make certain
conforming changes to the regulations.
DATES: The final rule is effective on October 29, 2007, unless
significant adverse comments are received by September 12, 2007. A
significant adverse comment is a comment where the commenter explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. If the rule is withdrawn due to significant adverse
comments, timely notice will be provided in the Federal Register.
ADDRESSES: You may submit comments by any one of the following methods.
Please include the following number (RIN 3150-AI14) in the subject line
of your comments. Comments on rulemakings submitted in writing or in
electronic form will be made available to the public in their entirety
on the NRC rulemaking Web site. Personal information, such as name,
address, phone, e-mail address, etc., will not be removed from your
submission.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: SECY@nrc.gov. If you do not receive a reply e-
mail confirming that we have received your comments, contact us
directly at (301) 415-1966. You may also submit comments via the NRC's
rulemaking Web site at https://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail
cag@nrc.gov. Comments can also be submitted via the Federal eRulemaking
Portal https://www.regulations.gov.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
(301) 415-1966.) Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at (301) 415-1101. Publicly available documents related to
this rulemaking may be viewed electronically on the public computers
located at the NRC's Public Document Room (PDR), O1 F21, One White
Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR
reproduction contractor will copy documents for a fee. Selected
documents, including comments, may
[[Page 45148]]
be viewed and downloaded electronically via the NRC rulemaking Web site
at https://ruleforum.llnl.gov.
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/reading-rm/adams.html. 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 NRC's public documents. If you do not have access to ADAMS or
if there are problems in accessing the documents located in ADAMS,
contact the NRC Public Document Room (PDR) Reference staff at 1-800-
397-4209, 301-415-4737, or by e-mail to pdr@nrc.gov.
FOR FURTHER INFORMATION CONTACT: Edward M. Lohr, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
0253, e-mail eml1@nrc.gov.
SUPPLEMENTARY INFORMATION:
Background
The purpose of these amendments is to amend 10 CFR Parts 32 and 35
to clarify and make certain conforming changes related to the NRC's
requirements for the medical use of byproduct material.
Discussion
This direct final rule revises several sections in 10 CFR Parts 32
and 35 to correct or clarify rule language. It also includes
conformatory changes that should have been incorporated in the
regulations but were inadvertently left out. The changes and
clarifications are minor in nature and noncontroversial. The following
changes are being made to the regulations:
Section by Section Analysis
1. Section 32.72 Manufacture, Preparation, or Transfer for Commercial
Distribution of Radioactive Drugs Containing Byproduct Material for
Medical Use Under Part 35
During the rulemaking completed in 2005, conforming changes to
Sec. 32.72, to reflect the changes made in Sec. 35.55, were
inadvertently omitted. The 2005 revision of the training and experience
requirements for an authorized nuclear pharmacist (ANP) in Sec. 35.55
removed the requirement for a preceptor statement as a condition for
recognition of a specialty board's certification process. Instead, an
individual seeking ANP status on an NRC license must provide a
preceptor statement, in addition to documentation of the board
certification. This amendment makes the necessary conforming changes to
Sec. 32.72.
Additionally, certification by the Board of Pharmaceutical
Specialties is removed from Sec. 32.72 because specialty boards
recognized by the Commission or Agreement States are posted on the
NRC's web page and are no longer listed in NRC regulations.
2. Section 32.74 Manufacture and Distribution of Sources or Devices
Containing Byproduct Material for Medical Use
Section 32.74(a) states that an application will be approved for a
specific license to manufacture and distribute sources and devices
containing byproduct material to persons licensed under Part 35 of this
chapter for use as a calibration or reference source or for the uses
listed in Sec. Sec. 35.400, 35.500, and 35.600 if certain conditions
are met. When Part 35 was amended on April 24, 2002 (67 FR 20249), a
new section, Sec. 35.1000, ``Other medical uses of byproduct material
or radiation from byproduct material,'' was added to address radiation
safety issues associated with new modalities. A conforming change
should have been made in Sec. 32.74(a) to reference Sec. 35.1000, but
was inadvertently left out. This change amends this section by adding
Sec. 35.1000 after Sec. Sec. 35.400, 35.500, 35.600.
3. Section 35.2 Definitions
The definitions in this section include both medium-dose rate
remote afterloader and high-dose rate remote afterloader. The medium-
dose rate remote afterloader is defined as a device that remotely
delivers a dose rate of greater than 2 gray (200 rads), but less than
12 gray (1200 rads) per hour at the point or surface where the dose is
prescribed. The high-dose rate remote afterloader is defined as
delivering a dose rate in excess of 12 gray (1200 rads) per hour at the
point or surface where the dose is prescribed. The dose rate of equal
to 12 gray (1200 rads) per hour was inadvertently excluded. This
section is being amended to revise the definition of medium dose-rate
remote afterloader to include ``equal to'' 12 gray. In addition, for
clarification, the phrase ``per hour'' will be added after the phrase
``delivers a dose rate of greater than 2 gray (200 rads)'' to read as
``delivers a dose rate of greater than 2 gray (200 rads) per hour.''
4. Section 35.41 Procedures for Administrations Requiring a Written
Directive
Section 35.41(b)(4) requires a licensee to have procedures
verifying that any computer-generated dose calculations are correctly
transferred into the consoles of therapeutic medical units authorized
by Sec. 35.600. When Part 35 was amended on April 24, 2002 (67 FR
20249), a new section, Sec. 35.1000, ``Other medical uses of byproduct
material or radiation from byproduct material,'' was added to address
radiation safety issues associated with new modalities. A conforming
change should have been made in Sec. 35.41(b)(4) to reference Sec.
35.1000, but was inadvertently left out. This changes this section by
adding Sec. 35.1000 after Sec. 35.600.
5. Section 35.75 Release of Individuals Containing Unsealed Byproduct
Material or Implants Containing Byproduct Material
In Sec. 35.75(a), the footnote states that NUREG-1556, Vol. 9,
``Consolidated Guidance About Materials Licenses: Program-Specific
Guidance About Medical Licenses,'' describes methods for calculating
doses to other individuals and contains tables of activities not likely
to cause doses exceeding 5 mSv (0.5 rem). NUREG-1556, Vol. 9, is not
the current version of this NUREG. The current version, ``Revision 1,''
is expected to be revised. Thus, the footnote is revised to add the
phrase ``The current version of'' before the phrase ``NUREG-1556, Vol.
9.''
6. Section 35.92 Decay-in-Storage
This section permits decay-in-storage by medical use licensees for
radionuclides with half-lives of less than 120 days. This section
inadvertently excluded radionuclides with half-lives equal to 120 days.
This change revises this section to include ``equal to'' 120 days.
7. Section 35.190 Training for Uptake, Dilution, and Excretion Studies
Section 35.190(a)(1) provides that in order for a specialty board's
certification process to be recognized, the board must require all
candidates for certification to complete 60 hours of training and
experience ``that includes the topics listed in paragraphs (c)(1)(i)
and (c)(1)(ii) of this section.'' The intent of the regulation is that
candidates must obtain their work experience involving the topics
listed in (c)(1)(ii) under the supervision of a specified authorized
user. The change of the phrase to ``as described in paragraphs
(c)(1)(i) through (c)(1)(ii)(F) of this section,'' clarifies that all
of the requirements in
[[Page 45149]]
Sec. 35.190(c)(1)(ii), including that candidates must obtain their
work experience under the supervision of a specified authorized user,
are also applicable to the board certification pathway.
8. Section 35.290 Training for Imaging and Localization Studies
Section 35.290(a)(1) provides that in order for a specialty board's
certification process to be recognized, the board must require all
candidates for certification to complete 700 hours of training and
experience ``that includes the topics listed in paragraphs (c)(1)(i)
and (c)(1)(ii) of this section.'' The intent of the regulation is that
candidates must obtain their work experience involving the topics
listed in (c)(1)(ii) under the supervision of a specified authorized
user. The change of the phrase to ``as described in paragraphs
(c)(1)(i) through (c)(1)(ii)(G) of this section,'' clarifies that all
of the requirements in Sec. 35.290(c)(1)(ii), including that
candidates must obtain their work experience under the supervision of a
specified authorized user, are also applicable to the board
certification pathway.
Procedural Background
This rulemaking will become effective on October 29, 2007. However,
if the NRC receives significant adverse comments by September 12, 2007,
then the NRC will publish a document that withdraws the direct final
rule and will address the comments received in a final rule as a
response to the companion proposed rule published elsewhere in this
issue of the Federal Register. Absent significant modifications to the
proposed revisions requiring republication, the NRC will not initiate a
second comment period on this action.
A significant adverse comment is a comment where the commenter
explains why the rule would be inappropriate, including challenges to
the rule's underlying premise or approach, or would be ineffective or
unacceptable without a change. A comment is adverse and significant if:
(1) The comment opposes the rule and provides a reason sufficient
to require a substantive response in a notice-and-comment process. For
example, a substantive response is required when:
(a) The comment causes the NRC staff to reevaluate (or reconsider)
its position or conduct additional analysis;
(b) The comment raises an issue serious enough to warrant a
substantive response to clarify or complete the record; or
(c) The comment raises a relevant issue that was not previously
addressed or considered by the NRC staff.
(2) The comment proposes a change or an addition to the rule, and
it is apparent that the rule would be ineffective or unacceptable
without incorporation of the change or addition.
(3) The comment causes the staff to make a change (other than
editorial) to the rule.
Voluntary Consensus Standards
The National Technology Transfer Act of 1995 (Pub. L. 104-113)
requires that Federal agencies use technical standards that are
developed or adopted by voluntary consensus standards bodies unless the
use of such a standard is inconsistent with applicable law or otherwise
impractical. In this final rule, the NRC corrects and clarifies the
rule language in several sections in 10 CFR Parts 32 and 35. This
action does not constitute the establishment of a standard that
contains generally applicable requirements.
Issues of Compatibility for Agreement States
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997
(62 FR 46517), specific requirements within this rule should be adopted
by Agreement States for purposes of compatibility or because of health
and safety significance. Implementing procedures for the Policy
Statement establish specific categories which have been applied to
categorize the requirements in Parts 32 and 35. A Compatibility
Category ``A'' designation means the requirement is a basic radiation
protection standard or deals with related definitions, signs, labels,
or terms necessary for a common understanding of radiation protection
principles. Compatibility Category ``A'' designated Agreement State
requirements should be essentially identical to those of the NRC. A
Compatibility Category ``B'' designation means the requirement has
significant transboundary implications. Compatibility Category ``B''
designated Agreement State requirements should be essentially identical
to those of the NRC. A Compatibility Category ``C'' designation means
the essential objectives of the requirement should be adopted by the
State to avoid conflicts, duplications, or gaps. The manner in which
the essential objectives are addressed in the Agreement State
requirement need not be the same as NRC provided the essential
objectives are met. A Compatibility Category ``D'' designation means
the requirement does not have to be adopted by an Agreement State for
purposes of compatibility. The Compatibility Category Health and Safety
(H&S) identifies requirements that are not required for compatibility,
but which have particular health and safety significance. Agreement
States should adopt the essential objectives of such requirements in
order to maintain an adequate program.
Summary of NRC Rules With Compatibility or Health and Safety
Designations Under the Direct Final Rule Covering 10 CFR Parts 32 and 35
------------------------------------------------------------------------
Section and paragraph Section title
------------------------------------------------------------------------
Category B
------------------------------------------------------------------------
Sec. 32.72(b)(5)........... Manufacture, preparation, or transfer for
commercial distribution of radioactive
drugs containing byproduct material for
medical use under Part 35.
Sec. 32.74(a).............. Manufacture and distribution of sources
or devices containing byproduct material
for medical use.
Sec. 35.190................ Training for uptake, dilution, and
excretion studies.
Sec. 35.290................ Training for imaging and localization
studies.
------------------------------------------------------------------------
Category C
------------------------------------------------------------------------
Sec. 35.75(a).............. Release of individuals containing
unsealed byproduct material or implants
containing byproduct material.
------------------------------------------------------------------------
[[Page 45150]]
Category D
------------------------------------------------------------------------
Sec. 35.2.................. Definitions--Medium dose-rate remote
afterloader.
Sec. 35.41(b)(4)........... Procedures for administrations requiring
a written directive.
------------------------------------------------------------------------
Category H&S
------------------------------------------------------------------------
Sec. 35.92................. Decay-in-storage is an ``H&S'' for States
authorizing this activity and ``D'' for
States that do not authorize this
activity.
------------------------------------------------------------------------
Plain Language
The Presidential Memorandum dated June 1, 1998, entitled, ``Plain
Language in Government Writing'' directed that the Government's writing
be in plain language. The NRC requests comments on this direct final
rule specifically with respect to the clarity and effectiveness of the
language used. Comments should be sent to the address listed under the
heading ADDRESSES above.
Environmental Impact: Categorical Exclusion
The NRC has determined that this final rule is the type of action
described in the categorical exclusion at 10 CFR 51.22(c)(2). Therefore
neither an environmental impact statement nor an environmental
assessment has been prepared for this final rule.
Paperwork Reduction Act Statement
This direct final rule does not contain new or amended information
collection requirements subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). Existing requirements were approved by the
Office of Management and Budget, approval numbers 3150-0001 and 3150-
0010.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting document displays a currently valid
OMB control number.
Regulatory Analysis
A regulatory analysis has not been prepared for this direct final
rule because this rule is considered a minor nonsubstantive amendment
and it has no economic impact on NRC licensees or the public.
Regulatory Flexibility Certification
Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the
Commission certifies that this rule does not have a significant
economic impact on a substantial number of small entities. This rule
merely corrects or clarifies the rule language in several sections in
10 CFR parts 32 and 35.
Backfit Analysis
The NRC has determined that the backfit rule (Sec. Sec. 50.109,
70.76, 72.62, or 76.76) does not apply to this final rule and
therefore, a backfit analysis is not required because these amendments
do not involve any provisions that would impose backfits as defined in
10 CFR Chapter I.
Congressional Review Act
Under the Congressional Review 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
OMB.
List of Subjects
10 CFR Part 32
Byproduct material, Criminal penalties, Labeling, Nuclear
materials, Radiation protection, Reporting and recordkeeping
requirements.
10 CFR Part 35
Byproduct material, Criminal penalties, Drugs, Health facilities,
Health professions, Medical devices, Nuclear materials, Occupational
safety and health, Radiation protection, Reporting and recordkeeping
requirements.
0
For the reasons set out in the preamble and under the authority of the
Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of
1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the
following amendments to 10 CFR parts 32 and 35.
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
0
1. The authority citation for part 32 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44
U.S.C. 3504 note), Energy Policy Act of 2005, Pub. L. 109-58, 119
Stat. 594 (2005).
0
2. In Sec. 32.72, paragraph (b)(5) is revised to read as follows:
Sec. 32.72 Manufacture, preparation, or transfer for commercial
distribution of radioactive drugs containing byproduct material for
medical use under part 35.
* * * * *
(b) * * *
(5) Shall provide to the Commission a copy of each individual's:
(i)(A) Certification by a specialty board whose certification
process has been recognized by the Commission or an Agreement State as
specified in Sec. 35.55(a) of this chapter with the written
attestation signed by a preceptor as required by Sec. 35.55(b)(2) of
this chapter; or
(B) The Commission or Agreement State license; or
(C) The permit issued by a licensee of broad scope; and
(ii) State pharmacy licensure or registration, no later than 30
days after the date that the licensee allows, under paragraphs
(b)(2)(i) and (b)(2)(iii) of this section, the individual to work as an
authorized nuclear pharmacist.
* * * * *
0
3. In Sec. 32.74, the introductory text of paragraph (a) is revised to
read as follows:
Sec. 32.74 Manufacture and distribution of sources or devices
containing byproduct material for medical use.
(a) An application for a specific license to manufacture and
distribute sources and devices containing byproduct material to persons
licensed under part 35 of this chapter for use as a calibration,
transmission, or reference source or for the uses listed in Sec. Sec.
35.400, 35.500, 35.600, and 35.1000 of this chapter will be approved
if:
* * * * *
[[Page 45151]]
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
0
4. The authority citation for part 35 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44
U.S.C. 3504 note).
0
5. In Sec. 35.2, the definition of Medium dose-rate remote afterloader
is revised to read as follows:
Sec. 35.2 Definitions.
* * * * *
Medium dose-rate remote afterloader, as used in this part, means a
brachytherapy device that remotely delivers a dose rate of greater than
2 gray (200 rads) per hour, but less than or equal to 12 gray (1200
rads) per hour at the point or surface where the dose is prescribed.
* * * * *
0
6. In Sec. 35.41, paragraph (b)(4) is revised to read as follows:
Sec. 35.41 Procedures for administrations requiring a written
directive.
* * * * *
(b) * * *
(4) Verifying that any computer-generated dose calculations are
correctly transferred into the consoles of therapeutic medical units
authorized by Sec. Sec. 35.600 or 35.1000.
* * * * *
0
7. In Sec. 35.75, the text of paragraph (a) is republished and
footnote 1 is revised to read as follows:
Sec. 35.75 Release of individuals containing unsealed byproduct
material or implants containing byproduct material.
(a) A licensee may authorize the release from its control of any
individual who has been administered unsealed byproduct material or
implants containing byproduct material if the total effective dose
equivalent to any other individual from exposure to the released
individual is not likely to exceed 5 mSv (0.5 rem).\1\
* * * * *
\1\ The current revision of NUREG-1556, Vol. 9, ``Consolidated
Guidance About Materials Licenses: Program-Specific Guidance About
Medical Licenses'' describes methods for calculating doses to other
individuals and contains tables of activities not likely to cause
doses exceeding 5 mSv (0.5 rem).
0
8. In Sec. 35.92, the introductory text of paragraph (a) is revised to
read as follows:
Sec. 35.92 Decay-in-storage.
(a) A licensee may hold byproduct material with a physical half-
life of less than or equal to 120 days for decay-in-storage before
disposal without regard to its radioactivity if it--
* * * * *
0
9. In Sec. 35.190, paragraph (a)(1) is revised to read as follows:
Sec. 35.190 Training for uptake, dilution, and excretion studies.
* * * * *
(a) * * *
(1) Complete 60 hours of training and experience in basic
radionuclide handling techniques and radiation safety applicable to the
medical use of unsealed byproduct material for uptake, dilution, and
excretion studies as described in paragraphs (c)(1)(i) through
(c)(1)(ii)(F) of this section; and
* * * * *
0
10. In Sec. 35.290, paragraph (a)(1) is revised to read as follows:
Sec. 35.290 Training for imaging and localization studies.
* * * * *
(a) * * *
(1) Complete 700 hours of training and experience in basic
radionuclide handling techniques and radiation safety applicable to the
medical use of unsealed byproduct material for imaging and localization
studies as described in paragraphs (c)(1)(i) through (c)(1)(ii)(G) of
this section; and
* * * * *
Dated at Rockville, Maryland, this 31st day of July, 2007.
For the Nuclear Regulatory Commission.
Martin J. Virgilio,
Acting Executive Director for Operations.
[FR Doc. 07-3976 Filed 8-10-07; 8:45 am]
BILLING CODE 7590-01-P
