Medical Use of Byproduct Material-Authorized User Clarification, 33901-33906 [E9-16658]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Rules and Regulations]
[Pages 33901-33906]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16658]



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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 https://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 https://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 
Carol.Gallagher@nrc.gov.
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: Rulemaking.Comments@nrc.gov. 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 
https://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 https://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 pdr.resource@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_Edward.Lohr@nrc.gov.

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