[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Rules and Regulations]
[Pages 33901-33906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16658]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Rules
and Regulations
[[Page 33901]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[NRC-2009-0098]
RIN 3150-AI59
Medical Use of Byproduct Material--Authorized User Clarification
AGENCY: Nuclear Regulatory Commission.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending its
regulations to clarify that individuals who do not need to comply with
the training and experience requirements as described in the applicable
regulations for the medical use of byproduct material (i.e., are
``grandfathered'') may serve as preceptors and work experience
supervisors for individuals seeking recognition on NRC licenses for the
same medical uses of byproduct material. The regulations that govern
the medical use of byproduct material were amended in their entirety in
2002 and again in 2005. Currently, individuals who were identified on
an NRC or Agreement State license or permit before the regulations were
amended do not need to requalify by meeting the training and experience
(T&E) requirements of the applicable regulations. When the regulations
were revised, the NRC intended that those authorized individuals would
also be able to serve as preceptors and work experience supervisors.
However, the regulations as they are currently written do not
specifically state that grandfathered individuals can be work
experience supervisors and preceptors.
This direct final rule amends the regulations to clarify that all
individuals grandfathered under the applicable regulations may serve as
preceptors and work experience supervisors for individuals seeking
recognition on an NRC license for the same uses. Additionally, several
minor administrative changes are included in this rulemaking.
DATES: The final rule is effective September 28, 2009, unless a
significant adverse comment is received by August 13, 2009. 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, timely notice will be
published in the Federal Register.
ADDRESSES: Please include the number RIN 3150-AI59 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's Web site in the Agencywide Documents Access and Management
System (ADAMS) and at http://www.regulations.gov. Personal information,
such as your name, address, telephone number, e-mail address, etc.,
will not be removed from your submission. You may submit comments by
any one of the following methods:
Federal e-Rulemaking portal: Go to http://www.regulations.gov and
search for documents filed under Docket ID NRC-2009-0098 and follow
instructions for submitting comments. Address questions about NRC
dockets to Carol Gallagher at 301-492-3668, e-mail
[email protected].
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: [email protected]. If you do not
receive a reply e-mail confirming that we have received your comments,
contact us directly at 301-415-1677.
Hand-deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
301-415-1677).
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), Room O-1 F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor
will copy documents for a fee. Selected documents, including any
comments, may be viewed and downloaded via the e-Rulemaking Portal at
http://www.regulations.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 http://www.nrc.gov/reading-rm/adams.html. From this
site, the public can gain entry into 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 PDR Reference staff at 1-800-397-4209, 301-415-4737
or by e-mail to [email protected].
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, [email protected].
SUPPLEMENTARY INFORMATION:
Background
On April 24, 2002 (67 FR 20250), and again on March 30, 2005 (70 FR
16336), the NRC revised the T&E requirements contained in 10 CFR Part
35 for individuals seeking recognition on NRC medical licenses.
Individuals who were authorized on a license or permit at the time that
the 2002 and 2005 regulations went into effect were ``grandfathered''
under Sec. 35.57 (i.e., did not need to comply with the new training
and experience requirements). However, Sec. 35.57 does not
specifically state that those individuals may also provide work
experience supervision or preceptor attestations for individuals
seeking recognition for the same uses on NRC licenses or permits.
Discussion
The current language of the T&E requirements contained in 10 CFR
part 35 is inconsistent as to whether individuals grandfathered under
Sec. 35.57 may serve as preceptors and/or work experience supervisors.
Under Sec. 35.50, Training for Radiation Safety Officer, any
individual who is identified as the
[[Page 33902]]
Radiation Safety Officer on an NRC or Agreement State license or permit
may serve as a preceptor or work experience supervisor; however, only
those physicians who meet the current requirements for authorized users
(AUs) may serve as work experience supervisors. Under Sec. 35.51,
``Training for an authorized medical physicist,'' work experience may
be obtained under the supervision of an individual who meets the
requirements for an authorized medical physicist (AMP) for the type of
use for which the individual is seeking authorization; however,
individuals seeking recognition on an NRC license or permit must obtain
a written attestation that may be signed only by a preceptor AMP who
meets the current requirements. Section 35.55 does not limit work
experience supervisors or preceptors to individuals meeting the current
requirements, as it provides that supervised practical experience may
be in ``a nuclear pharmacy,'' and the written attestation may be signed
by ``a preceptor authorized nuclear pharmacist.'' With regard to AUs,
under Sec. Sec. 35.190, 35.290, 35.390, 35.392, 35.394, 35.396,
35.490, and 35.690, only those AUs who meet the current requirements
may serve as either preceptors or work experience supervisors. However,
under Sec. 35.491, while the preceptor must be an AU who meets the
current requirements, the regulation provides that supervised clinical
training may be under the supervision of ``an authorized user.''
The SUPPLEMENTARY INFORMATION section of the preamble to the final
rule amending 10 CFR part 35 in 2005 indicated that it was the NRC's
intent to permit individuals grandfathered under Sec. 35.57 to serve
as work experience supervisors and preceptors for individuals seeking
recognition on NRC licenses or permits for the same uses. Specifically,
in the Summary of Public Comments and Responses to Comments, a comment
from the public on the proposed rule stated that clarification was
needed for grandfathering AMPs so ``there could be an initial pool of
AMPs to serve as preceptors.'' In response to this comment, the NRC
stated: ``These individuals, who have been identified on a license,
would also be able to serve as preceptors for individuals to become
AMPs.'' However, Sec. 35.51, ``Training for an authorized medical
physicist,'' was not revised to implement that intent. Specifically,
Sec. 35.51(b)(2) states that individuals seeking recognition on an NRC
license or permit must have obtained a written attestation that ``must
be signed by a preceptor authorized medical physicist who meets the
requirements in section 35.51, or equivalent Agreement State
requirements for an authorized medical physicist * * *.''
Although the response to the comment addresses only AMPs, it was
the NRC's intent to allow other individuals authorized on NRC and
Agreement State licenses and permits to serve as both preceptors and
work experience supervisors for individuals seeking recognition on NRC
licenses or permits for the same uses. If individuals grandfathered
under Sec. 35.57 are unable to provide attestations and work
experience supervision for applicants, there will not be a sufficient
pool of professionals to provide attestations or work experience
supervision for new applicants to become authorized individuals on NRC
medical use licenses. This may create a serious shortage of authorized
individuals in the medical community, which may result in a negative
impact on health care. Therefore, the NRC is revising the T&E
regulations to implement its intent that all individuals grandfathered
under Sec. 35.57 may serve as preceptors and work experience
supervisors for individuals seeking recognition on NRC licenses or
permits for the same uses.
Discussion of Amendments by Section
1. Section 35.50 Training for Radiation Safety Officer.
This section is amended to clarify that radiation safety officers
may have practical training and/or supervised experience in medical
physics under the direction of physicians who meet the requirements for
authorized users in Sec. 35.57.
2. Section 35.51 Training for an authorized medical physicist.
This section is amended to clarify that authorized medical
physicists may have practical training and/or supervised experience in
medical physics under the direction of physicians who meet the
requirements for authorized users in Sec. 35.57 and that preceptors
for medical physicists may be medical physicists who meet the
requirements in Sec. 35.57. Additionally, a minor administrative
change is made for clarification.
3. Section 35.57 Training for experienced Radiation Safety Officer,
teletherapy or medical physicist, authorized medical physicist,
authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
This section is amended to clarify that individuals who need not
comply with training requirements as described in Sec. 35.57 may serve
as preceptors for, and supervisors of, applicants seeking authorization
on NRC licenses for the same uses for which these individuals are
authorized.
4. Section 35.190 Training for uptake, dilution, and excretion
studies.
This section is amended to clarify that authorized users may have
work experience under the supervision of authorized users who meet the
requirements in Sec. 35.57 and may obtain written attestations signed
by preceptor authorized users who meet the requirements in Sec. 35.57.
5. Section 35.290 Training for imaging and localization studies.
This section is amended to clarify that authorized users may have
work experience under the supervision of authorized users who meet the
requirements in Sec. 35.57 and obtain written attestations signed by
preceptor authorized users who meet the requirements in Sec. 35.57.
Additionally, a minor administrative change is made to the language to
make it consistent throughout the section.
6. Section 35.390 Training for use of unsealed byproduct material
for which a written directive is required.
This section is amended to clarify that authorized users may have
work experience under the supervision of authorized users who meet the
requirements in Sec. 35.57 and may obtain written attestations signed
by preceptor authorized users who meet the requirements in Sec. 35.57.
7. Section 35.392 Training for the oral administration of sodium
iodide I-131 requiring a written directive in quantities less than or
equal to 1.22 gigabecquerels (33 millicuries).
This section is amended to clarify that authorized users may have
work experience under the supervision of authorized users who meet the
requirements in Sec. 35.57 and may obtain written attestations signed
by preceptor authorized users who meet the requirements in Sec. 35.57.
Additionally, a minor administrative change is made for clarification.
8. Section 35.394 Training for the oral administration of sodium
iodide I-131 requiring a written directive in quantities greater than
1.22 gigabecquerels (33 millicuries).
This section is amended to clarify that authorized users may have
work experience under the supervision of authorized users who meet the
requirements in Sec. 35.57 and may obtain written attestations signed
by preceptor authorized users who meet the requirements in Sec. 35.57.
9. Section 35.396 Training for the parenteral administration of
unsealed byproduct material requiring a written directive.
[[Page 33903]]
This section is amended to clarify that authorized users may have
work experience under the supervision of authorized users who meet the
requirements in Sec. 35.57 and may obtain written attestations signed
by preceptor authorized users who meet the requirements in Sec. 35.57.
10. Section 35.490 Training for use of manual brachytherapy
sources.
This section is amended to clarify that authorized users may have
work experience under the supervision of authorized users who meet the
requirements in Sec. 35.57, may have supervised clinical experience in
radiation oncology under authorized users who meet the requirements in
Sec. 35.57, and may obtain written attestations signed by preceptor
authorized users who meet the requirements in Sec. 35.57.
Additionally, a minor administrative change is made for clarification.
11. Section 35.491 Training for ophthalmic use of strontium-90.
This section is amended to clarify that authorized users may obtain
written attestations signed by preceptor authorized users who meet the
requirements in Sec. 35.57. Additionally, a minor error in the text of
Sec. 35.491(b)(3) is corrected to clarify that the preceptor
authorized user does not need to attest that the individual has
completed the requirements in paragraph (a) and (b), but only that the
individual has completed the requirements in paragraph (b).
12. Section 35.690 Training for use of remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units.
This section is amended to clarify that authorized users may have
work experience under the supervision of authorized users who meet the
requirements in Sec. 35.57, may have supervised clinical experience in
radiation therapy under authorized users who meet the requirements in
Sec. 35.57, and may obtain written attestations signed by preceptor
authorized users who meet the requirements in Sec. 35.57.
Additionally, a minor administrative change is made for clarification.
Procedural Background
The amendments contained in this rule will become effective on
September 28, 2009. However, if the NRC receives a significant adverse
comment by August 13, 2009, then the NRC will publish a document that
withdraws this action 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.
Agreement State Compatibility
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 10 CFR 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 & Safety
(H&S) identifies program elements that are not required for purposes of
compatibility, but have particular health and safety significance.
States should adopt the essential objectives of such program elements
in order to maintain an adequate program.
Summary of NRC Rules With Compatibility or Health and Safety
Designations Under the Proposed Rule Covering 10 CFR Part 35
------------------------------------------------------------------------
Section Section title
------------------------------------------------------------------------
Category B
------------------------------------------------------------------------
Sec. 35.50.......................... Training for Radiation Safety
Officer.
Sec. 35.51.......................... Training for an authorized
medical physicist.
Sec. 35.57.......................... Training for experienced
Radiation Safety Officer,
teletherapy or medical
physicist, authorized medical
physicist, authorized user,
nuclear pharmacist, and
authorized nuclear pharmacist.
Sec. 35.190......................... Training for uptake, dilution,
and excretion studies.
Sec. 35.290......................... Training for imaging and
localization studies.
Sec. 35.390......................... Training for use of unsealed
byproduct material for which a
written directive is required.
Sec. 35.392......................... Training for the oral
administration of sodium iodide
I-131 requiring a written
directive in quantities less
than or equal to 1.22
gigabecquerels (33
millicuries).
[[Page 33904]]
Sec. 35.394......................... Training for the oral
administration of sodium iodide
I-131 requiring a written
directive in quantities greater
than 1.22 gigabecquerels (33
millicuries).
Sec. 35.396......................... Training for the parenteral
administration of unsealed
byproduct material requiring a
written directive.
Sec. 35.490......................... Training for use of manual
brachytherapy sources.
Sec. 35.491......................... Training for ophthalmic use of
strontium-90.
Sec. 35.690......................... Training for use of remote
afterloader units, teletherapy
units, and gamma stereotactic
radiosurgery units.
------------------------------------------------------------------------
Plain Language
The Presidential Memorandum ``Plain Language in Government
Writing'' published June 10, 1998 (63 FR 31883), directed that the
Government's documents be in clear and accessible 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 ADDRESSES heading.
Voluntary Consensus Standards
The National Technology Transfer and Advancement 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 direct final rule, the NRC is amending
its regulations to clarify that individuals who do not need to comply
with the training and experience requirements as described in Sec.
35.57 may serve as preceptors and work experience supervisors for
individuals seeking recognition on NRC licenses or permits for the same
medical uses of byproduct material. This action does not constitute the
establishment of a standard that establishes generally applicable
requirements.
Environmental Impact: Categorical Exclusion
The NRC has determined that this direct final rule is the type of
action described in categorical exclusion 10 CFR 51.22(c)(2). Therefore
neither an environmental impact statement nor an environmental
assessment has been prepared for this direct final rule.
Paperwork Reduction Act Statement
This direct final rule does not contain a new or amended
information collection requirement subject to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.). Existing information collection
requirements were approved by the Office of Management and Budget,
approval number 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
request 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 non-substantive amendment
and it has no economic impact on NRC licensees or the public. This rule
does not impose any new requirements. It only clarifies the rule
language in several sections in 10 CFR part 35.
Regulatory Flexibility Certification
In accordance with 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.
The majority of companies that own these facilities do not fall within
the scope of the definition of ``small entities'' set forth in the
Regulatory Flexibility Act or the size standards established by the NRC
(10 CFR 2.810). This rule does not impose any new requirements. It only
clarifies the rule language in several sections in 10 CFR part 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 because this
amendment does not involve any provisions that would impose backfits as
defined in 10 CFR Chapter I. Therefore, a backfit analysis is not
required.
Congressional Review Act
In accordance with 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 in 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 part 35.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
0
1. 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); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810
(42 U.S.C. 2014, 2021, 2021b, 2111).
0
2. In Sec. 35.50, paragraph (a)(2)(ii)(B) is revised to read as
follows:
Sec. 35.50 Training for Radiation Safety Officer.
* * * * *
(a) * * *
(2) * * *
(ii) * * *
(B) In clinical nuclear medicine facilities providing diagnostic
and/or therapeutic services under the direction of physicians who meet
the requirements for authorized users in Sec. Sec. 35.57, 35.290, or
35.390;
* * * * *
0
3. In Sec. 35.51, paragraphs (a)(2)(ii) and (b)(2) are revised to read
as follows:
Sec. 35.51 Training for an authorized medical physicist.
* * * * *
(a) * * *
(2) * * *
(ii) In clinical radiation facilities providing high-energy,
external beam therapy (photons and electrons with energies greater than
or equal to 1
[[Page 33905]]
million electron volts) and brachytherapy services under the direction
of physicians who meet the requirements in Sec. 35.57, 35.490, or
35.690; and
* * * * *
(b) * * *
(2) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (c) and (a)(1)
and (a)(2), or (b)(1) and (c) of this section, and has achieved a level
of competency sufficient to function independently as an authorized
medical physicist for each type of therapeutic medical unit for which
the individual is requesting authorized medical physicist status. The
written attestation must be signed by a preceptor authorized medical
physicist who meets the requirements in Sec. Sec. 35.51, 35.57, or
equivalent Agreement State requirements for an authorized medical
physicist for each type of therapeutic medical unit for which the
individual is requesting authorized medical physicist status; and
* * * * *
0
4. In Sec. 35.57, a new paragraph (c) is added to read as follows:
Sec. 35.57 Training for experienced Radiation Safety Officer,
teletherapy or medical physicist, authorized medical physicist,
authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
* * * * *
(c) Individuals who need not comply with training requirements as
described in this section may serve as preceptors for, and supervisors
of, applicants seeking authorization on NRC licenses for the same uses
for which these individuals are authorized.
0
5. In Sec. 35.190, the introductory text of paragraph (c)(1)(ii) and
paragraph (c)(2) are revised to read as follows:
Sec. 35.190 Training for uptake, dilution, and excretion studies.
* * * * *
(c)(1) * * *
(ii) Work experience, under the supervision of an authorized user
who meets the requirements in Sec. Sec. 35.57, 35.190, 35.290, 35.390,
or equivalent Agreement State requirements, involving--
* * * * *
(2) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.190,
35.290, or 35.390, or equivalent Agreement State requirements, that the
individual has satisfactorily completed the requirements in paragraph
(a)(1) or (c)(1) of this section and has achieved a level of competency
sufficient to function independently as an authorized user for the
medical uses authorized under Sec. 35.100.
0
6. In Sec. 35.290, the introductory text of paragraph (c)(1)(ii) and
paragraph (c)(2) are revised to read as follows:
Sec. 35.290 Training for imaging and localization studies.
* * * * *
(c)(1) * * *
(ii) Work experience, under the supervision of an authorized user
who meets the requirements in Sec. Sec. 35.57, 35.290, or 35.390 and
35.290(c)(1)(ii)(G), or equivalent Agreement State requirements,
involving--
* * * * *
(2) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.290,
or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State
requirements, that the individual has satisfactorily completed the
requirements in paragraph (a)(1) or (c)(1) of this section and has
achieved a level of competency sufficient to function independently as
an authorized user for the medical uses authorized under Sec. Sec.
35.100 and 35.200.
0
7. In Sec. 35.390, the introductory text of paragraph (b)(1)(ii) and
paragraph (b)(2) are revised to read as follows:
Sec. 35.390 Training for use of unsealed byproduct material for which
a written directive is required.
* * * * *
(b)(1) * * *
(ii) Work experience, under the supervision of an authorized user
who meets the requirements in Sec. Sec. 35.57, 35.390, or equivalent
Agreement State requirements. A supervising authorized user, who meets
the requirements in Sec. 35.390(b), must also have experience in
administering dosages in the same dosage category or categories (i.e.,
Sec. 35.390(b)(1)(ii)(G)) as the individual requesting authorized user
status. The work experience must involve--
* * * * *
(2) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (a)(1) and
(b)(1)(ii)(G) or (b)(1) of this section, and has achieved a level of
competency sufficient to function independently as an authorized user
for the medical uses authorized under Sec. 35.300. The written
attestation must be signed by a preceptor authorized user who meets the
requirements in Sec. Sec. 35.57, 35.390, or equivalent Agreement State
requirements. The preceptor authorized user, who meets the requirements
in Sec. 35.390(b) must have experience in administering dosages in the
same dosage category or categories (i.e., Sec. 35.390(b)(1)(ii)(G)) as
the individual requesting authorized user status.
0
8. In Sec. 35.392, the introductory text of paragraph (c)(2) and
paragraph (c)(3) are revised to read as follows:
Sec. 35.392 Training for the oral administration of sodium iodide I-
131 requiring a written directive in quantities less than or equal to
1.22 gigabecquerels (33 millicuries).
* * * * *
(c) * * *
(2) Has work experience, under the supervision of an authorized
user who meets the requirements in Sec. Sec. 35.57, 35.390, 35.392,
35.394, or equivalent Agreement State requirements. A supervising
authorized user who meets the requirements in Sec. 35.390(b) must also
have experience in administering dosages as specified in Sec. Sec.
35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2). The work experience
must involve--
* * * * *
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (c)(1) and
(c)(2) of this section, and has achieved a level of competency
sufficient to function independently as an authorized user for medical
uses authorized under Sec. 35.300. The written attestation must be
signed by a preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.390, 35.392, 35.394, or equivalent Agreement State
requirements. A preceptor authorized user, who meets the requirement in
Sec. 35.390(b), must also have experience in administering dosages as
specified in Sec. Sec. 35.390(b)(1)(ii)(G)(1) or
35.390(b)(1)(ii)(G)(2).
0
9. In Sec. 35.394, the introductory text of paragraph (c)(2) and
paragraph (c)(3) are revised to read as follows:
Sec. 35.394 Training for the oral administration of sodium iodide I-
131 requiring a written directive in quantities greater than 1.22
gigabecquerels (33 millicuries).
* * * * *
(c) * * *
(2) Has work experience, under the supervision of an authorized
user who meets the requirements in Sec. Sec. 35.57, 35.390, 35.394, or
equivalent Agreement State requirements. A supervising authorized user,
who meets the requirements in Sec. 35.390(b), must also have
experience in administering dosages as specified in Sec.
35.390(b)(1)(ii)(G)(2). The work experience must involve--
* * * * *
[[Page 33906]]
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (c)(1) and
(c)(2) of this section, and has achieved a level of competency
sufficient to function independently as an authorized user for medical
uses authorized under Sec. 35.300. The written attestation must be
signed by a preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.390, 35.394, or equivalent Agreement State
requirements. A preceptor authorized user, who meets the requirements
in Sec. 35.390(b), must also have experience in administering dosages
as specified in Sec. 35.390(b)(1)(ii)(G)(2).
0
10. In Sec. 35.396, the introductory text of paragraph (d)(2) and
paragraph (d)(3) are revised to read as follows:
Sec. 35.396 Training for the parenteral administration of unsealed
byproduct material requiring a written directive.
* * * * *
(d) * * *
(2) Has work experience, under the supervision of an authorized
user who meets the requirements in Sec. Sec. 35.57, 35.390, 35.396, or
equivalent Agreement State requirements, in the parenteral
administration, for which a written directive is required, of any beta
emitter, or any photon-emitting radionuclide with a photon energy less
than 150 keV, and/or parenteral administration of any other
radionuclide for which a written directive is required. A supervising
authorized user who meets the requirements in Sec. 35.390 must have
experience in administering dosages as specified in Sec. Sec.
35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4). The work
experience must involve--
* * * * *
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (b) or (c) of
this section, and has achieved a level of competency sufficient to
function independently as an authorized user for the parenteral
administration of unsealed byproduct material requiring a written
directive. The written attestation must be signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.390,
35.396, or equivalent Agreement State requirements. A preceptor
authorized user, who meets the requirements in Sec. 35.390, must have
experience in administering dosages as specified in Sec. Sec.
35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4).
0
11. In Sec. 35.490, the introductory text of paragraph (b)(1)(ii) and
paragraphs (b)(2) and (b)(3) are revised to read as follows:
Sec. 35.490 Training for use of manual brachytherapy sources.
* * * * *
(b)(1) * * *
(ii) 500 hours of work experience, under the supervision of an
authorized user who meets the requirements in Sec. Sec. 35.57, 35.490,
or equivalent Agreement State requirements at a medical institution,
involving--
* * * * *
(2) Has completed 3 years of supervised clinical experience in
radiation oncology, under an authorized user who meets the requirements
in Sec. Sec. 35.57, 35.490, or equivalent Agreement State
requirements, as part of a formal training program approved by the
Residency Review Committee for Radiation Oncology of the Accreditation
Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Committee on Postdoctoral
Training of the American Osteopathic Association. This experience may
be obtained concurrently with the supervised work experience required
by paragraph (b)(1)(ii) of this section; and
(3) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.490,
or equivalent Agreement State requirements, that the individual has
satisfactorily completed the requirements in paragraph (a)(1), or
paragraphs (b)(1) and (b)(2), of this section and has achieved a level
of competency sufficient to function independently as an authorized
user of manual brachytherapy sources for the medical uses authorized
under Sec. 35.400.
0
12. In Sec. 35.491, paragraph (b)(3) is revised to read as follows:
Sec. 35.491 Training for ophthalmic use of strontium-90.
* * * * *
(b) * * *
(3) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.490,
35.491, or equivalent Agreement State requirements, that the individual
has satisfactorily completed the requirements in paragraph (b) of this
section and has achieved a level of competency sufficient to function
independently as an authorized user of strontium-90 for ophthalmic use.
0
13. In Sec. 35.690, the introductory text of paragraph (b)(1)(ii) and
paragraphs (b)(2) and (b)(3) are revised to read as follows:
Sec. 35.690 Training for use of remote afterloader units, teletherapy
units, and gamma stereotactic radiosurgery units.
* * * * *
(b)(1) * * *
(ii) 500 hours of work experience, under the supervision of an
authorized user who meets the requirements in Sec. Sec. 35.57, 35.690,
or equivalent Agreement State requirements at a medical institution,
involving--
* * * * *
(2) Has completed 3 years of supervised clinical experience in
radiation therapy, under an authorized user who meets the requirements
in Sec. Sec. 35.57, 35.690, or equivalent Agreement State
requirements, as part of a formal training program approved by the
Residency Review Committee for Radiation Oncology of the Accreditation
Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Committee on Postdoctoral
Training of the American Osteopathic Association. This experience may
be obtained concurrently with the supervised work experience required
by paragraph (b)(1)(ii) of this section; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (a)(1) or
paragraphs (b)(1) and (b)(2), and paragraph (c), of this section, and
has achieved a level of competency sufficient to function independently
as an authorized user of each type of therapeutic medical unit for
which the individual is requesting authorized user status. The written
attestation must be signed by a preceptor authorized user who meets the
requirements in Sec. Sec. 35.57, 35.690, or equivalent Agreement State
requirements for an authorized user for each type of therapeutic
medical unit for which the individual is requesting authorized user
status; and
* * * * *
Dated at Rockville, Maryland, this 26th day of June 2009.
For the Nuclear Regulatory Commission.
R.W. Borchardt,
Executive Director for Operations.
[FR Doc. E9-16658 Filed 7-13-09; 8:45 am]
BILLING CODE 7590-01-P