Medical Use of Byproduct Material-Minor Corrections and Clarifications, 45181-45183 [E7-15762]
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Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules
(viii) Before leaving the premises of
origin, the cases in which the eggs were
packed were sealed with a seal of the
national government of the region of
origin by the salaried veterinarian of the
national government of the region of
origin who signed the certificate or, if
exported from Mexico, by the
veterinarian accredited by the national
government of Mexico who signed the
certificate.
(ix) In addition, if the eggs were laid
in any region where END is considered
to exist (see paragraph (a) of this
section), the certificate must also state:
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(C) The eggs are from a flock of origin
found free of END as follows: On the
seventh and fourteenth days of the 21day period before the certificate is
signed, at least 1 cull (sick or dead) bird
for each 10,000 live birds occupying
each poultry house certified for
exporting table eggs was tested for END
virus using a virus isolation test. The
weekly cull rate of birds of every
exporting poultry house within the
exporting farm does not exceed 0.1
percent. The tests present no clinical or
immunological evidence of END by
either embryonated egg inoculation
technique from tissues of dead birds or
negative hemagglutination inhibition
tests conducted on blood samples of
sick birds collected by a salaried
veterinary officer of the national
government of the region of origin, or by
an accredited veterinarian. All
examinations and virus isolation tests
were conducted in a laboratory located
in the region of origin, and the
laboratory was approved to conduct the
examinations and tests by the veterinary
services organization of the national
government of that region. All results
were negative for END.
(D) The certificate must state that egg
drop syndrome is notifiable in the
region of origin and there have been no
reports of egg drop syndrome in the
flocks of origin of the eggs, or within a
50 kilometer radius of the flock of
origin, for the 90 days prior to the
issuance of the certificate.
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sroberts on PROD1PC70 with PROPOSALS
§§ 94.8 and 94.9
[Amended]
5. In §§ 94.8 and 94.9, footnotes 8
through 11 are redesignated as footnotes
7 through 10, respectively.
6. Section 94.12 is amended as
follows:
a. In paragraph (b)(1)(iii)(B), by
redesignating footnote 12 as footnote 11.
b. In paragraph (b)(3), by
redesignating footnote 13 as footnote 12
and revising newly redesignated
footnote 12 to read as set forth below.
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§ 94.12 Pork and pork products from
regions where swine vesicular disease
exists.
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(b) * * *
(3) * * * 12
12 See
§ 94.16
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footnote 9 in § 94.9.
[Amended]
7. In § 94.16, footnote 14 is
redesignated as footnote 13.
8. Section 94.17 is amended as
follows:
a. In paragraph (e), by redesignating
footnote 15 as footnote 14.
b. In paragraph (p)(1)(i), by
redesignating footnote 16 as footnote 15
and revising newly redesignated
footnote 15 to read as set forth below.
§ 94.17 Dry-cured pork products from
regions where foot-and-mouth disease,
rinderpest, African swine fever, classical
swine fever, or swine vesicular disease
exists.
*
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(p) * * *
(1) * * *
(i) * * * 15
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15 See footnote 14 in paragraph (e) of this
section.
§§ 94.18 and 94.24
[Amended]
9. In §§ 94.18 and 94.24, footnotes 17,
18, 20, and 21 are redesignated as
footnotes 16 through 19, respectively.
Done in Washington, DC, this 8th day of
August 2007.
Cindy Smith,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–15815 Filed 8–10–07; 8:45 am]
BILLING CODE 3410–34–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: Proposed rule.
AGENCY:
SUMMARY: The Nuclear Regulatory
Commission (NRC) is proposing to
amend 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
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45181
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: Comments on the proposed rule
must be received on or before
September 12, 2007.
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
for public inspection. Because your
comments will not be edited to remove
any identifying or contact information,
the NRC cautions you against including
personal information such as social
security numbers and birth dates in
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
website to Carol Gallagher (301) 415–
5905; email 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 am and 4:15 pm
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 be viewed and
downloaded electronically via the NRC
rulemaking Web site at https://
ruleforum.llnl.gov.
E:\FR\FM\13AUP1.SGM
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sroberts on PROD1PC70 with PROPOSALS
45182
Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules
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: For
additional information see the Direct
Final Rule published in the Final Rules
section of this Federal Register.
Because NRC considers this action
noncontroversial and routine, we are
publishing this proposed rule
concurrently as a direct final rule. The
direct final rule will become effective on
October 29, 2007. However, if the NRC
receives significant adverse comments
on the proposed rule by September 12,
2007, then the NRC will publish a
document to withdraw the direct final
rule. If the direct final rule is
withdrawn, the NRC will address the
comments received in response to the
proposed revisions in a subsequent final
rule. Absent significant modifications to
the proposed revisions requiring
republication, the NRC will not initiate
a second comment period for this action
if the direct final rule is withdrawn.
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
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(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.
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.
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. 553; the NRC
is proposing to adopt 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:
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. No. 109–58, 119
Stat. 594 (2005).
2. In § 32.72, paragraph (b)(5) is
revised to read as follows:
§ 32.72 Manufacture, preparation, or
transfer for commercial distribution of
radioactive drugs containing byproduct
material for medical use under part 35.
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(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
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(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.
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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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PART 35—MEDICAL USE OF
BYPRODUCT MATERIAL
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).
5. In § 35.2, the definition of Medium
dose-rate remote afterloader is revised
to read as follows:
§ 35.2
Definitions.
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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.
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6. In § 35.41, paragraph (b)(4) is
revised to read as follows:
§ 35.41 Procedures for administrations
requiring a written directive.
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(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.
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7. In § 35.75, the text of paragraph (a)
is republished and footnote 1 is revised
to read as follows:
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Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules
§ 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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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).
8. In § 35.92, the introductory text of
paragraph (a) is revised to read as
follows:
§ 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-instorage before disposal without regard to
its radioactivity if it—
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9. In § 35.190, paragraph (a)(1) is
revised to read as follows:
§ 35.190 Training for uptake, dilution, and
excretion studies.
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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
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10. In § 35.290, paragraph (a)(1) is
revised to read as follows:
§ 35.290 Training for imaging and
localization studies.
sroberts on PROD1PC70 with PROPOSALS
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(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
*
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*
Dated at Rockville, Maryland, this 31st day
of July, 2007.
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For the Nuclear Regulatory Commission.
Martin J. Virgilio,
Acting Executive Director for Operations.
[FR Doc. E7–15762 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–2006–26491; Directorate
Identifier 2006–CE–76–AD]
RIN 2120–AA64
Airworthiness Directives; Alpha
Aviation Design Limited (Type
Certificate No. A48EU Previously Held
by APEX Aircraft and AVIONS PIERRE
ROBIN) Model R2160 Airplanes
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Supplemental notice of
proposed rulemaking (NPRM);
reopening of the comment period.
AGENCY:
45183
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Examining the AD Docket
You may examine the AD docket on
the Internet at https://dms.dot.gov; or in
person at the Docket Management
Facility between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays. The AD docket contains this
proposed AD, the regulatory evaluation,
any comments received, and other
information. The street address for the
Docket Office (telephone (800) 647–
5527) is in the ADDRESSES section.
Comments will be available in the AD
docket shortly after receipt.
FOR FURTHER INFORMATION CONTACT: Karl
Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust,
Room 301, Kansas City, Missouri 64106;
telephone: (816) 329–4146; fax: (816)
329–4090.
SUPPLEMENTARY INFORMATION:
The proposed AD would require
actions that are intended to address the
unsafe condition described in the MCAI.
DATES: We must receive comments on
this proposed AD by September 12,
2007.
Comments Invited
We invite you to send any written
relevant data, views, or arguments about
this proposed AD. Send your comments
to an address listed under the
ADDRESSES section. Include ‘‘Docket No.
FAA–2006–26491; Directorate Identifier
2006–CE–76–AD’’ at the beginning of
your comments. We specifically invite
comments on the overall regulatory,
economic, environmental, and energy
aspects of this proposed AD. We will
consider all comments received by the
closing date and may amend this
proposed AD because of those
comments.
We will post all comments we
receive, without change, to https://
dms.dot.gov, including any personal
information you provide. We will also
post a report summarizing each
substantive verbal contact we receive
about this proposed AD.
You may send comments by
any of the following methods:
• DOT Docket Web Site: Go to https://
dms.dot.gov and follow the instructions
for sending your comments
electronically.
• Fax: (202) 493–2251.
• 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.
• Hand Delivery: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
Discussion
We proposed to amend 14 CFR part
39 with an earlier NPRM for the
specified products, which was
published in the Federal Register on
January 8, 2007 (72 FR 676). That earlier
NPRM proposed to require actions
intended to address the unsafe
condition for the products listed above.
Since that NPRM was issued, we
determined that replacing any type 1
fuel fittings with type 2 fuel fittings, not
just leaking type 1 fuel fittings, is
needed in order to eliminate future fuel
leaks.
The Civil Aviation Authority of New
Zealand, which is the airworthiness
authority for New Zealand, has issued
AD DCA/R2000/12, dated June 29, 2006
SUMMARY: We are revising an earlier
NPRM for the products listed above.
This proposed AD results from
mandatory continuing airworthiness
information (MCAI) originated by an
aviation authority of another country to
identify and correct an unsafe condition
on an aviation product. The MCAI
describes the unsafe condition as:
To prevent fuel system leaks inspect the
bronze/brass hollow threaded fuel line
fittings for type and leaks, per Avions Pierre
Robin Service Bulletin (SB) No. 86.
ADDRESSES:
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]]>Agencies
[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Proposed Rules]
[Pages 45181-45183]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15762]
=======================================================================
-----------------------------------------------------------------------
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: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
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: Comments on the proposed rule must be received on or before
September 12, 2007.
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 for public inspection. Because
your comments will not be edited to remove any identifying or contact
information, the NRC cautions you against including personal
information such as social security numbers and birth dates in 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 website to Carol Gallagher (301) 415-5905; email
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 am and 4:15 pm 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 be viewed and downloaded electronically via the NRC rulemaking Web
site at https://ruleforum.llnl.gov.
[[Page 45182]]
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: For additional information see the Direct
Final Rule published in the Final Rules section of this Federal
Register.
Because NRC considers this action noncontroversial and routine, we
are publishing this proposed rule concurrently as a direct final rule.
The direct final rule will become effective on October 29, 2007.
However, if the NRC receives significant adverse comments on the
proposed rule by September 12, 2007, then the NRC will publish a
document to withdraw the direct final rule. If the direct final rule is
withdrawn, the NRC will address the comments received in response to
the proposed revisions in a subsequent final rule. Absent significant
modifications to the proposed revisions requiring republication, the
NRC will not initiate a second comment period for this action if the
direct final rule is withdrawn.
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.
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.
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. 553; the NRC is proposing to
adopt 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:
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. No. 109-58,
119 Stat. 594 (2005).
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.
* * * * *
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:
* * * * *
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
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).
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.
* * * * *
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.
* * * * *
7. In Sec. 35.75, the text of paragraph (a) is republished and
footnote 1 is revised to read as follows:
[[Page 45183]]
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).
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--
* * * * *
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
* * * * *
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. E7-15762 Filed 8-10-07; 8:45 am]
BILLING CODE 7590-01-P
