[Federal Register Volume 68, Number 76 (Monday, April 21, 2003)]
[Rules and Regulations]
[Pages 19321-19326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9601]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 68, No. 76 / Monday, April 21, 2003 / Rules
and Regulations
[[Page 19321]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
RIN 3150-AH08
Medical Use of Byproduct Material: Clarifying and Minor
Amendments
AGENCY: Nuclear Regulatory Commission.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its
regulations regarding the medical use of byproduct material. The direct
final rule will clarify the definitions of authorized users, authorized
medical physicists, authorized nuclear pharmacists, and radiation
safety officers; clarify the notification requirements if the patient
is in a medical emergency or dies; clarify the recordkeeping
requirements for calibration of brachytherapy sources; correct the
title for the National Institute of Standards and Technology; clarify
that prior to October 24, 2004, individuals who meet the training and
experience requirements in Subpart J may undertake responsibilities
specified in certain sections in Subparts B and D-H; and eliminate a
restriction that training for ophthalmic use of strontium-90 can only
be conducted in medical institutions. These amendments are necessary to
clarify certain inconsistencies within the regulations and to allow
training in ophthalmic treatment to be conducted in eye clinics or
private practices, in addition to medical institutions.
DATES: The final rule is effective on July 7, 2003 unless significant
adverse comments are received by May 21, 2003.
ADDRESSES: You may submit comments by any one of the following methods.
Please include the following number (RIN 3150-AHO8) in the subject line
of your comments. Comments on rulemakings submitted in writing or in
electronic form will be made available to the public in their entirety
on the NRC rulemaking Web site. Personal information will not be
removed from your comments.
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) 415-1966. You may also submit comments via the NRC's
rulemaking Web site at http://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher (301) 415-5905; email
[email protected].
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
(301) 415-1966).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
(301) 415-1101.
Publicly available documents related to this rulemaking may be
examined and copied for a fee at the NRC's Public Document Room (PDR),
Public File Area O1 F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland. Selected documents, including comments, can be
viewed and downloaded electronically via the NRC rulemaking web site at
http://ruleforum.llnl.gov.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/NRC/ADAMS/index.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 [email protected].
FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, telephone (301) 415-6233, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
Procedural Information
Because NRC considers this action to be noncontroversial, the NRC
is using the direct final rule process for this rule. The amendments in
this rule will become effective on July 7, 2003. However, if the NRC
receives significant adverse comments on this direct final rule by May
21, 2003, then the NRC will publish a document that withdraws this
action and will subsequently address the comments received in a final
rule as a response to the companion proposed rule published elsewhere
in this 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 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 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.
Background
The NRC published in the Federal Register a final rule amending 10
CFR part 35 regarding medical use of byproduct material on April 24,
2002 (67 FR 20249) (final rule). Subsequently, the NRC staff (staff)
identified typographical and editorial errors as well as
inconsistencies in the Part 35 final rule. The staff published a
document correcting the typographical
[[Page 19322]]
and editorial errors on October 9, 2002 (67 FR 62872). Both the final
rule and the correction became effective on October 24, 2002. This
amendment addresses certain inconsistencies that have been identified
in the Part 35 final rule and implements a minor change to eliminate a
restriction that training for ophthalmic use of strontium-90 can only
be conducted in a medical institution.
Section-by-Section Analysis
(1) Section 35.2, Definitions. In this section, ``Authorized
medical physicist'' (AMP), ``Authorized nuclear pharmacist'' (ANP),
``Authorized user'' (AU), and ``Radiation Safety Officer'' (RSO) are
defined as individuals who meet the criteria in certain referenced
sections of this final rule. However, the staff has specifically
reinserted subpart J (as contained in the proposed rule (63 FR 43516;
August 13, 1998)) for a two-year transition period. Therefore, until
October 24, 2004, individuals certified by medical boards listed in
that subpart are also qualified as authorized users. It is inconsistent
to recognize as authorized users individuals who meet Subpart J
requirements, but not include them in the relevant definitions in Sec.
35.2.
The definition of AU is therefore amended to include individuals
qualified under Sec. Sec. 35.910(a), 35.920(a), 35.930(a), 35.940(a),
35.950(a) and 35.960(a), until October 24, 2004. Similarly, the
definitions of AMP, ANP, and RSO are amended to include individuals
authorized pursuant to Sec. Sec. 35.961(a) and (b), 35.980(a), and
35.900(a), respectively.
(2) Section 35.51, Training for an authorized medical physicist.
The second sentence in paragraph (b)(2) states: ``The written
certification must be signed by a preceptor authorized medical
physicist who meets the requirements in Sec. 35.51 or equivalent
Agreement State requirements. * * *'' However, during the two-year
transition period, an individual who meets the requirements of Sec.
35.961 in Subpart J is also qualified to be a preceptor authorized
medical physicist. Therefore, this sentence is amended by replacing the
phrase ``in Sec. 35.51 or equivalent Agreement State requirement''
with the phrase ``in Sec. 35.51, or, before October 24, 2004, Sec.
35.961, or equivalent Agreement State requirements. * * *''
The following additional sections reflect similar inconsistencies:
Sec. Sec. 35.190(b), (c)(1)(ii), (c)(2); 35.290(b), (c)(1)(ii),
(c)(2); 35.390(b)(1)(ii), (b)(2); 35.392(b), (c)(2), (c)(3); 35.394(b),
(c)(2), (c)(3); 35.490(b)(1)(ii), (b)(2), (b)(3); 35.491(a), (b)(3);
and 35.690(b)(1)(ii), (b)(2), (b)(3). Therefore, these sections are
also amended to include the corresponding sections from subpart J.
(3) Section 35.100, Use of unsealed byproduct material for uptake,
dilution, and excretion studies for which a written directive is not
required. Paragraph (b) states: ``Prepared by an authorized nuclear
pharmacist, a physician who is an authorized user and who meets the
requirements specified in Sec. Sec. 35.290 or 35.390, or an individual
under the supervision of either as specified in Sec. 35.27.'' However,
during the two-year transition period, an authorized user who meets the
requirements of Sec. 35.920 in Subpart J is also qualified to prepare
unsealed byproduct material for medical use. Therefore, this sentence
is amended by replacing the phrase ``in Sec. Sec. 35.290 or 35.390''
with the phrase ``in Sec. Sec. 35.290 or 35.390, or, before October
24, 2004, Sec. 35.920.'' In addition, the format of this paragraph has
been modified to clearly identify the three categories of persons who
can prepare unsealed byproduct material for medical use for uptake,
dilution, or excretion.
The following additional sections reflect similar inconsistencies:
Sec. Sec. 35.200(b) and 35.300(b). Therefore, these sections are also
amended to include Sec. 35.920.
(4) Section 35.310, Safety instruction. Paragraph (a)(5) provides
that a licensee must notify ``the'' AU if the patient has a medical
emergency or dies. However, corresponding sections for brachytherapy
and external beam therapy (i.e., Sec. Sec. 35.410(a)(5), 35.415(c),
and 35.615(f)(4)) require that ``an'' AU, instead of ``the'' AU, be
notified. Section III of the Supplementary Information in the April 24,
2002, final rule states: ``Therefore, because of the type of dosages
that are administered under Sec. 35.300, we believe it is important
that an AU be available to be contacted in case of a medical emergency
or death.'' Notifying ``an'' AU should meet this requirement because
``the'' AU who treats the patient may be unavailable when the patient
has a medical emergency or dies. This section is revised to replace the
words ``the'' AU with the words ``an'' AU.
(5) Section 35.315, Safety precautions. Paragraph (b) provides that
a licensee must notify the RSO, or his or her designee, and ``the'' AU
if the patient has a medical emergency or dies. This section is
modified to replace the words ``the'' AU with the words ``an'' AU for
the reasons explained in (4), above.
(6) Section 35.432, Calibration measurements of brachytherapy
sources. Paragraph (a) provides in part that a licensee shall determine
the source output and source positioning accuracy. Paragraph (b) states
that a licensee may use measurements provided by the source
manufacturer or by a calibration laboratory. However, it is not clear
that the licensee may perform its own measurement or, as an
alternative, use measurements from manufacturer or calibration
laboratory. For clarification, this section is therefore revised to add
a phrase to the beginning of paragraph (b) to read as follows:
``Instead of a licensee making its own measurements as required in (a),
the licensee may use measurements provided by * * *.''
(7) Section 35.491, Training for ophthalmic use of strontium-90.
Paragraph (b)(2) currently provides in part that an authorized user of
strontium-90 for ophthalmic radiotherapy must have completed supervised
clinical training under the supervision of an authorized user at a
medical institution that includes the use of strontium-90 for the
ophthalmic treatment of five individuals. This current requirement
unnecessarily excludes authorized users at eye clinics and private
practices from being allowed to provide training. This restriction
should be eliminated because many authorized users for ophthalmic
treatment work in clinics or private practices. This section is
therefore revised to add ``clinic or private practice'' to ``medical
institution'' as acceptable locations where the requisite supervised
clinical training may be provided.
(8) Section 35.630. Paragraph (a)(1) states: ``The system must have
been calibrated using a system or source traceable to the National
Institute of Science and Technology (NIST) and * * *.'' The title of
NIST is ``National Institute of Standards and Technology.'' Thus, the
word ``Science'' is replaced by the word ``Standards.''
(9) Section 35.2432, Records of calibration measurements of
brachytherapy sources. This section provides that a licensee must
maintain a record of the calibration of brachytherapy sources required
by Sec. 35.432. Paragraph 35.2432(b)(5) requires that the record must
include the signature of the authorized medical physicist (AMP).
Section 35.432, Calibration measurements of brachytherapy sources,
requires that a licensee shall have a brachytherapy source calibrated
or the licensee may use measurements provided by the source
manufacturer or by a calibration laboratory. However, Sec. 35.432 does
not specify that an AMP must perform the calibration. Thus, it is
inconsistent to require a record of the signature of the AMP in Sec.
35.2432 without a
[[Page 19323]]
requirement for the AMP to perform the calibration in Sec. 35.432.
In the proposed rule (63 FR 43516; August 13, 1998), Sec. 35.2432
would have provided that the record of calibration must contain ``the
name of the individual or the source manufacturer who performed the
calibration.'' This language was consistent with the language of
proposed Sec. 35.432.
In the final rule, (67 FR 20249; April 24, 2002), Sec. 35.432 was
changed from that in the proposed rule to allow the licensee to rely on
measurements provided by a calibration laboratory, in addition to those
provided by a manufacturer. The language in Sec. 35.2432 was also
changed but was not consistent with Sec. 35.432.
The Supplementary Information to the final rule includes a
discussion of the changes made to Sec. 35.2432 between the proposed
rule and the final rule. That discussion does not include any rationale
for changing the proposed rule language requiring ``the name of the
individual or the source manufacturer who performed the calibration''
to the final rule language requiring ``the signature of the authorized
medical physicist.'' Section 35.2432(b)(5) is therefore modified to
replace the phrase ``the signature of the authorized medical
physicist'' with the phrase ``the name of the individual, the source
manufacturer, or the calibration laboratory who performed the
calibration.'' This modification resolves inconsistency between Sec.
35.2432 and Sec. 35.432.
Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register on September 3, 1997 (62 FR
46517), this direct final rule is a matter of compatibility between NRC
and the Agreement States, thereby providing consistency among Agreement
State and NRC requirements. A Compatibility Category ``B'' designation
means the requirement has significant direct transboundary
implications. Compatibility Category ``B'' designated Agreement State
requirements should be essentially identical to those of NRC. A
Compatibility Category ``D'' designation means the requirement does not
need to be adopted by an Agreement State for purposes of compatibility.
The Compatibility Category Health and Safety (H&S) identifies
requirements that are not required for compatibility, but which have
particular health and safety significance. Agreement States should
adopt the essential objectives of such requirements in order to
maintain an adequate program.
The Compatibility Categories for the sections amended in this
direct final rule are the same as the sections in the current
regulations. The revisions to Sec. Sec. 35.2, 35.51, 35.190, 35.290,
35.390, 35.392, 35.394, 35.490, 35.491, and 35.690 are classified as
Category B. The revisions to Sec. Sec. 35.100, 35.200, 35.300,
35.310(a), 35.315, and 35.630 are classified as Category H&S. The
revision to Sec. 35.2432 is classified as Category D.
Voluntary Consensus Standards
The National Technology Transfer Act of 1995 (Pub. L. 104-113)
requires that Federal agencies use technical standards that are
developed or adopted by voluntary consensus standards bodies unless the
use of such a standard is inconsistent with applicable law or otherwise
impractical. In this direct final rule, NRC is amending 10 CFR part 35
to clarify certain inconsistencies with the regulations and to allow
training in ophthalmic treatment to be conducted in eye clinics or
private practices, in addition to medical institutions. This action
does not constitute the establishment of a standard that establishes
generally-applicable requirements.
Environmental Impact: Categorical Exclusion
The Commission 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.). However, the rule makes a
technical change to correct an error in a record requirement that
appeared in the Part 35 final rule. Existing requirements were approved
by the Office of Management and Budget, approval number 3150-0010.
Public Protection Notification
If a means used to impose an information collection does not
display a currently valid OMB control number, NRC may not conduct or
sponsor, and a person is not required to respond to, the information
collection.
Regulatory Analysis
A regulatory analysis has not been prepared for this direct final
rule. The clarifying amendments are for ease of understanding of
certain aspects of part 35. The minor amendment on ophthalmic treatment
is to provide flexibility that clinical training can be conducted under
supervision of an authorized user in clinics or private practices, in
addition to medical institutions. This flexibility could potentially
result in a small reduction in burden for an individual who is
undertaking the clinic training.
Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), NRC certifies that this rule will not, if promulgated, have a
significant economic impact on a substantial number of small entities.
This direct final rule simply amends present regulations to clarify
certain inconsistencies with the regulations and to allow training in
ophthalmic treatment to be conducted in eye clinics or private
practices, in addition to medical institutions. The 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 adopted by NRC (10 CFR 2.810).
Backfit Analysis
NRC has determined that the backfit rule does not apply to this
direct final rule because these amendments do not involve any
provisions that would impose backfits as defined in 10 CFR Chapter 1.
Small Business Regulatory Enforcement Fairness Act
In accordance with the Small Business Regulatory Enforcement
Fairness Act of 1996, NRC has determined that this action is not a
major rule and has verified this determination with the Office of
Information and Regulatory Affairs, Office of Management and Budget.
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 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; NRC is adopting the
following amendments to 10 CFR part 35.
[[Page 19324]]
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).
0
2. In Sec. 35.2, the definitions for authorized medical physicist,
authorized nuclear pharmacist, authorized user, and radiation safety
officer, are amended by revising paragraph (1) of each definition to
read as follows:
Sec. 35.2 Definitions.
* * * * *
Authorized medical physicist means an individual who--
(1) Meets the requirements in Sec. Sec. 35.51(a) and 35.59; or,
before October 24, 2004, meets the requirements in Sec. Sec.
35.961(a), or (b), and 35.59; or
* * * * *
Authorized nuclear pharmacist means a pharmacist who--
(1) Meets the requirements in Sec. Sec. 35.55(a) and 35.59; or,
before October 24, 2004, meets the requirements in Sec. Sec. 35.980(a)
and 35.59; or
* * * * *
Authorized user means a physician, dentist, or podiatrist who--
(1) Meets the requirements in Sec. Sec. 35.59 and 35.190(a),
35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or
35.690(a); or, before October 24, 2004, meets the requirements in
Sec. Sec. 35.910(a), 35.920(a), 35.930(a), 35.940(a), 35.950(a), or
35.960(a) and 35.59; or
* * * * *
Radiation Safety Officer means an individual who--
(1) Meets the requirements in Sec. Sec. 35.50(a) and 35.59; or,
before October 24, 2004, meets the requirements in Sec. Sec. 35.900(a)
and 35.59; or
* * * * *
0
3. In Sec. 35.51, the second sentence of paragraph (b)(2) is revised
to read as follows:
Sec. 35.51 Training for an authorized medical physicist.
* * * * *
(b) * * *
(2) * * * The written certification must be signed by a preceptor
authorized medical physicist who meets the requirements in Sec. 35.51,
or, before October 24, 2004, Sec. 35.961, 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.
0
4. In Sec. 35.100, paragraph (b) is revised to read as follows:
Sec. 35.100 Use of unsealed byproduct material for uptake, dilution,
and excretion studies for which a written directive is not required.
* * * * *
(b) Prepared by:
(1) An authorized nuclear pharmacist;
(2) A physician who is an authorized user and who meets the
requirements specified in Sec. Sec. 35.290, 35.390, or, before October
24, 2004, Sec. 35.920; or
(3) An individual under the supervision, as specified in Sec.
35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this
section or the physician who is an authorized user in paragraph (b)(2)
of this section; or
* * * * *
0
5. In Sec. 35.190, paragraph (b), 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.
* * * * *
(b) Is an authorized user under Sec. Sec. 35.290, 35.390, or,
before October 24, 2004, Sec. Sec. 35.910, 35.920, or 35.930, or
equivalent Agreement State requirements; or
* * * * *
(c) * * *
(1) * * *
(ii) Work experience, under the supervision of an authorized user
who meets the requirements in Sec. Sec. 35.190, 35.290, 35.390, or,
before October 24, 2004, Sec. Sec. 35.910, 35.920, or 35.930, or
equivalent Agreement State requirements, involving--
* * * * *
(2) Has obtained written certification, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.190,
35.290, 35.390, or, before October 24, 2004, Sec. Sec. 35.910, 35.920,
or 35.930, or equivalent Agreement State requirements, that the
individual has satisfactorily completed the requirements in paragraph
(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. 35.200, paragraph (b) is revised to read as follows:
Sec. 35.200 Use of unsealed byproduct material for imaging and
localization studies for which a written directive is not required.
* * * * *
(b) Prepared by:
(1) An authorized nuclear pharmacist;
(2) A physician who is an authorized user and who meets the
requirements specified in Sec. Sec. 35.290, 35.390, or, before October
24, 2004, Sec. 35.920; or
(3) An individual under the supervision, as specified in Sec.
35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this
section or the physician who is an authorized user in paragraph (b)(2)
of this section;
* * * * *
0
7. In Sec. 35.290, paragraph (b), 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.
* * * * *
(b) Is an authorized user under Sec. 35.390, or, before October
24, 2004, Sec. 35.920, or equivalent Agreement State requirements; or
(c) * * *
(1) * * *
(ii) Work experience, under the supervision of an authorized user,
who meets the requirements in Sec. Sec. 35.290, 35.390, or, before
October 24, 2004, Sec. 35.920, or equivalent Agreement State
requirements, involving--
* * * * *
(2) Has obtained written certification, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.290,
35.390, or, before October 24, 2004, Sec. 35.920, or equivalent
Agreement State requirements, that the individual has satisfactorily
completed the requirements in paragraph (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
8. In Sec. 35.300, paragraph (b) is revised to read as follows:
Sec. 35.300 Use of unsealed byproduct material for which a written
directive is required.
* * * * *
(b) Prepared by:
(1) An authorized nuclear pharmacist;
(2) A physician who is an authorized user and who meets the
requirements specified in Sec. Sec. 35.290, 35.390, or, before October
24, 2004, Sec. 35.920; or
(3) An individual under the supervision, as specified in Sec.
35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this
section or the physician who is an authorized user in paragraph (b)(2)
of this section; or
* * * * *
0
9. In Sec. 35.310, paragraph (a)(5) is revised to read as follows:
[[Page 19325]]
Sec. 35.310 Safety instruction.
(a) * * *
(5) Notification of the Radiation Safety Officer, or his or her
designee, and an authorized user if the patient or the human research
subject has a medical emergency or dies.
* * * * *
0
10. In Sec. 35.315, paragraph (b) is revised to read as follows:
Sec. 35.315 Safety precautions.
* * * * *
(b) A licensee shall notify the Radiation Safety Officer, or his or
her designee, and an authorized user as soon as possible if the patient
or human research subject has a medical emergency or dies.
0
11. 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. 35.390(a), 35.390(b), or,
before October 24, 2004, Sec. 35.930, or equivalent Agreement State
requirements. A supervising authorized user, who meets the requirements
in Sec. 35.390(b) or, before October 24, 2004, Sec. 35.930(b), must
also have experience in administering dosages in the same dosage
category or categories (i.e., Sec. 35.390(b)(1)(ii)(G)(1), (2), (3),
or (4)) as the individual requesting authorized user status. The work
experience must involve--
* * * * *
(2) Has obtained written certification that the individual has
satisfactorily completed the requirements in paragraph (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 certification must be signed by a
preceptor authorized user who meets the requirements in Sec. Sec.
35.390(a), 35.390(b), or, before October 24, 2004, Sec. 35.930, or
equivalent Agreement State requirements. The preceptor authorized user,
who meets the requirements in Sec. 35.390(b) or, before October 24,
2004, Sec. 35.930(b), must also have experience in administering
dosages in the same dosage category or categories (i.e., Sec.
35.390(b)(1)(ii)(G)(1), (2), (3), or (4)) as the individual requesting
authorized user status.
0
12. In Sec. 35.392, paragraph (b), 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 Gigabecquereis (33 millicuries).
* * * * *
(b) Is an authorized user under Sec. Sec. 35.390(a), 35.390(b) for
uses listed in Sec. 35.390(b)(1)(ii)(G)(1) or (2), Sec. 35.394, or,
before October 24, 2004, Sec. Sec. 35.930, 35.932, or 35.934, or
equivalent Agreement State requirements; or
(c) * * *
(2) Has work experience, under the supervision of an authorized
user who meets the requirements in Sec. Sec. 35.390(a), 35.390(b),
35.392, 35.394, or, before October 24, 2004, Sec. Sec. 35.930, 35.932,
or 35.934, 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)(1) or (2). The work experience must involve--
* * * * *
(3) Has obtained written certification 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 certification must be
signed by a preceptor authorized user who meets the requirements in
Sec. Sec. 35.390(a), 35.390(b), 35.392, 35.394, or, before October 24,
2004, Sec. Sec. 35.930, 35.932, or 35.934, 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. 35.390(b)(1)(ii)(G)(1) or
(2).
0
13. In Sec. 35.394, paragraph (b), 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
Gigabecquereis (33 millicuries).
* * * * *
(b) Is an authorized user under Sec. Sec. 35.390(a), 35.390(b) for
uses listed in Sec. 35.390(b)(1)(ii)(G)(2), or, before October 24,
2004, Sec. Sec. 35.930 or 35.934, or equivalent Agreement State
requirements; or
(c) * * *
(2) Has work experience, under the supervision of an authorized
user who meets the requirements in Sec. Sec. 35.390(a), 35.390(b),
35.394, or, before October 24, 2004, Sec. Sec. 35.930 or 35.934, 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--
* * * * *
(3) Has obtained written certification 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 certification must be
signed by a preceptor authorized user who meets the requirements in
Sec. Sec. 35.390(a), 35.390(b), 35.394, or, before October 24, 2004,
Sec. Sec. 35.930 or 35.934, 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
14. In Sec. 35.432, paragraph (b) is revised to read as follows:
Sec. 35.432 Calibration measurements of brachytherapy sources.
* * * * *
(b) Instead of a licensee making its own measurements as required
in paragraph (a) of this section, the licensee may use measurements
provided by the source manufacturer or by a calibration laboratory
accredited by the American Association of Physicists in Medicine that
are made in accordance with paragraph (a) of this section.
* * * * *
0
15. In Sec. 35.490, the introductory text of paragraph (b)(1)(ii),
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. 35.490, or, before
October 24, 2004, Sec. 35.940, or equivalent Agreement State
requirements at a medical institution, involving--
* * * * *
(2) Has obtained 3 years of supervised clinical experience in
radiation oncology, under an authorized user who meets the requirements
in Sec. 35.490, or, before October 24, 2004, Sec. 35.940, or
[[Page 19326]]
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 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 certification, signed by a preceptor
authorized user who meets the requirements in Sec. 35.490, or, before
October 24, 2004, Sec. 35.940, or equivalent Agreement State
requirements, that the individual has satisfactorily completed the
requirements in 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
16. In Sec. 35.491, paragraph (a), the introductory text of paragraph
(b)(2), and paragraph (b)(3) are revised to read as follows:
Sec. 35.491 Training for ophthalmic use of strontium-90.
* * * * *
(a) Is an authorized user under Sec. 35.490, or, before October
24, 2004, Sec. Sec. 35.940 or 35.941, or equivalent Agreement State
requirements; or
(b) * * *
(2) Supervised clinical training in ophthalmic radiotherapy under
the supervision of an authorized user at a medical institution, clinic,
or private practice that includes the use of strontium-90 for the
ophthalmic treatment of five individuals. This supervised clinical
training must involve--
* * * * *
(3) Has obtained written certification, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.490,
35.491, or, before October 24, 2004, Sec. Sec. 35.940 or 35.941, or
equivalent Agreement State requirements, that the individual has
satisfactorily completed the requirements in paragraphs (a) and (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
17. In Sec. 35.630, paragraph (a)(1) is revised to read as follows:
Sec. 35.630 Dosimetry equipment.
(a) * * *
(1) The system must have been calibrated using a system or source
traceable to the National Institute of Standards and Technology (NIST)
and published protocols accepted by nationally recognized bodies; or by
a calibration laboratory accredited by the American Association of
Physicists in Medicine (AAPM). The calibration must have been performed
within the previous 2 years and after any servicing that may have
affected system calibration; or
* * * * *
0
18. 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. 35.690, or, before
October 24, 2004, Sec. 35.960, 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. 35.690, or, before October 24, 2004, Sec. 35.960, 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 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 certification that the individual has
satisfactorily completed the requirements in 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 each type
of therapeutic medical unit for which the individual is requesting
authorized user status. The written certification must be signed by a
preceptor authorized user who meets the requirements in Sec. 35.690,
or, before October 24, 2004, Sec. 35.960, 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.
0
19. In Sec. 35.2432, paragraph (b)(5) is revised to read as follows:
Sec. 35.2432 Records of calibration measurements of brachytherapy
sources.
* * * * *
(b) * * *
(5) The name of the individual, the source manufacturer, or the
calibration laboratory that performed the calibration.
Dated at Rockville, Maryland, this 31st day of March, 2003.
For the Nuclear Regulatory Commission.
William D. Travers,
Executive Director for Operations.
[FR Doc. 03-9601 Filed 4-18-03; 8:45 am]
BILLING CODE 7590-01-P