[Federal Register Volume 76, Number 98 (Friday, May 20, 2011)]
[Proposed Rules]
[Pages 29171-29176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12048]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 76, No. 98 / Friday, May 20, 2011 / Proposed 
Rules  

[[Page 29171]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

[NRC-2008-0071 and NRC-2008-0175]
RIN 3150-AI28, RIN 3150-AI63


Medical Use Regulations

AGENCY: Nuclear Regulatory Commission.

ACTION: Availability of preliminary draft rule language and notice of 
public workshops.

-----------------------------------------------------------------------

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or Commission) 
plans to hold a public workshop on June 20-21, 2011, in New York, New 
York, to solicit comments on certain issues under consideration to 
amend the medical use regulations, including reporting and 
notifications of Medical Events (MEs) for permanent implant 
brachytherapy. The NRC plans to hold a second public workshop on the 
same subject matter in August 2011 in Houston, Texas. The specific 
location and dates for the second workshop in Houston are currently 
being determined. The NRC is also making available for comment 
preliminary draft rule language concerning the NRC's proposed 
amendments to the medical use regulations. This document briefly 
summarizes the proposed amendments.

DATES: The first public workshop is planned for June 20-21, 2011, and 
the second public workshop is planned for August 2011. See 
SUPPLEMENTARY INFORMATION section for public meeting information.

ADDRESSES: The first public workshop is scheduled to be held at the 
Flatotel Hotel, http://www.flatotel.com/loction_apartment_hotels.shtml 135 West 52nd Street, New York, NY 10019. The second 
public meeting is scheduled to be held in Houston, TX (specific 
location and dates to be determined).

FOR FURTHER INFORMATION CONTACT: Varughese Kurian, telephone: 301-415-
7426, e-mail: [email protected] or Michael Fuller, telephone: 
301-415-0520, e-mail: [email protected] of the U.S. Nuclear 
Regulatory Commission, Office of Federal and State Materials and 
Environmental Management Programs, Division of Materials Safety and 
State Agreements, Mail Stop T-8 F5, 11545 Rockville Pike, Rockville, 
Maryland 20852-0001.

SUPPLEMENTARY INFORMATION: 

I. Background Information

    In SRM-SECY-10-0062, dated August 10, 2010, the Commission directed 
the staff to work closely with the NRC's Advisory Committee for the 
Medical Uses of Isotopes (ACMUI) and the broader medical and 
stakeholder community to develop event definitions that will protect 
the interests of patients and allow physicians the flexibility to take 
actions that they deem medically necessary, while continuing to enable 
the agency to detect failures in process, procedure, and training, as 
well as any misapplication of byproduct materials by authorized users. 
Additionally, the staff was directed to hold a series of stakeholder 
workshops to discuss methods for defining MEs which continue to ensure 
the safe use of radioactive materials while providing flexibility to 
account for medically necessary adjustments and the terms and 
thresholds for reporting medical events to the NRC and patients.

II. Purpose of the Public Workshops

    In selecting the dates for these public workshops, the staff has 
taken into consideration and has made efforts to accommodate, as much 
as possible, the schedules of the major professional society meetings. 
It is the goal of the NRC staff to organize and execute a facilitated 
discussion through which comments and suggestions can be obtained from 
the participants and attendees on the topics and issues identified in 
this document. The information obtained will help the NRC to better 
understand the views of the medical community and broader stakeholder 
community on these issues as proposed rulemaking language is developed 
to amend certain sections of 10 CFR part 35.
    Each workshop is planned for 2 days; from 8:30 a.m. to 5 p.m. The 
NRC has developed a designated Web site for the purposes of these 
meetings and will update it as information becomes available. The Web 
address is http://www.blsmeetings.net/NRCMedicalRulemakingWorkshop/. 
The final agenda for the workshops will be available on the NRC Public 
Meeting Schedule Web site at http://www.nrc.gov/public-involve/public-meetings/index.cfm at least ten days prior to the meeting. Those 
members of the public unable to travel to the workshop location but 
still wishing to participate may do so via Web-broadcast via Internet 
connection, or by telephone via a conference bridgeline. Information 
about how to participate via Web cast or telephone is available at 
http://www.blsmeetings.net/NRCMedicalRulemakingWorkshop/, or by 
contacting the NRC as noted in this document.
    Prior to the meeting, attendees are required to register with the 
meeting organizer to ensure sufficient accommodations can be made for 
their participation. Please let the contact know if special services 
are needed (hearing impaired, etc.) as well as your planned method for 
attendance (i.e., in person, via telephone, or via Web cast).

III. Topics of Discussion

    The following format is used in the presentation of the issues that 
follow. Each topic is assigned a number, a short title, and questions 
for discussion. These topics and questions are not meant to be a 
complete or final list, but are intended to initiate discussion. 
Interested stakeholders are welcome to recommend additions, deletions, 
or modifications of these general ideas for NRC's consideration. These 
topics and questions will serve as the basis for discussion at the 
public meetings. Meeting participants, and those wishing to make 
comments, can find additional background information on each of these 
topics through the designated workshop Web site.

Topic 1. Medical Event Reporting Requirements for Permanent Implant 
Brachytherapy

    The current regulations in 10 CFR part 35 related to MEs associated 
with permanent implant brachytherapy are recognized by the NRC, ACMUI, 
and the broader medical and stakeholder community to be inadequate. 
There are many areas that need to be addressed including written 
directive (WD) requirements, training issues, and the basis for 
defining an ME. The NRC

[[Page 29172]]

needs the ability to detect failures in process, procedure, and 
training, as well as any misapplication of byproduct materials by 
authorized users (AU), without impeding on the practice of medicine. A 
proposed rule published on August 6, 2008 (73 FR 45635), was an attempt 
to balance the goal of achieving the NRC's needs with the medical 
community's desire to change the basis for defining an ME (dose-base 
vs. activity-base). A significant number of MEs reported in 2008 gave 
the NRC a larger data set to analyze, which led to the staff's 
initiative to re-propose the rule. However, the Commission disapproved, 
and instead directed the staff to hold public workshops to discuss 
further methods for defining MEs.
Questions for Discussion
    The NRC staff has developed the following questions to provide 
context for discussion during the public meeting:
     Should the regulations have a specific section for 
prostate implant brachytherapy rather than combined with all other 
permanent implant brachytherapy?
     Should the criterion for defining an ME for permanent 
implant brachytherapy be activity-based only?
     Should the criterion for defining an ME for permanent 
implant brachytherapy be dose-based only?
     Should the criteria for defining an ME for permanent 
implant brachytherapy be a combination activity- and dose-based 
criterion?
     Should the NRC require training on how to identify MEs?
     Many professional organizations have recommended standards 
for when a dose to the treatment site for permanent prostate implants 
is assessed. The NRC staff is considering adding a time requirement to 
the regulations for this purpose. What is the appropriate time frame?
    Members of the public may have different or additional questions 
that should be considered, and are encouraged to raise them during the 
public workshop. Members of the public are also encouraged to provide 
for consideration comments that they believe are important.

Topic 2. Amending Preceptor Attestation Requirements

    Currently, 10 CFR part 35 provides three pathways for individuals 
to satisfy training and experience (T&E) requirements to be approved as 
a Radiation Safety Officer (RSO), authorized medical physicist (AMP), 
authorized nuclear pharmacist (ANP), or authorized user (AU). These 
pathways are: (1) Approval of an individual who is certified by a 
specialty board whose certification process has been recognized by the 
NRC or an Agreement State; (2) approval based on an evaluation of an 
individual's training and experience; or (3) identification of an 
individual's name on an existing NRC or Agreement State license. (For 
this discussion, pathway (1) will be referred to as the certification 
pathway, and pathway (2) as the alternate pathway.)
    Under the certification and alternate pathways, the individual 
seeking authorization must obtain written attestation signed by a 
preceptor with the same authorization. The attestation must state that 
the individual has satisfactorily completed the necessary T&E 
requirements and has achieved a level of competency sufficient to 
function independently in the position for which authorization is 
sought. Prior to the 2002 major revision of 10 CFR part 35, there was 
no requirement for a board certified individual (except nuclear 
pharmacists) to provide a preceptor attestation in order to be 
authorized on an NRC or Agreement State license.
    The ACMUI briefed the Commission in April 2008, and recommended 
that the attestation requirements in 10 CFR part 35 be modified. Based 
on ACMUI recommendations, NRC staff in SECY-08-0179, ``Recommendations 
on Amending Preceptor Attestation Requirements in 10 CFR part 35, 
Medical Use of Byproduct Material'' made the following recommendations:
    a. Eliminate the attestation requirement for individuals seeking 
authorized status via the board certification pathway.
    b. Retain the attestation requirement for individuals seeking 
authorized status via the alternate pathway, and modify the text 
stating that the attestation demonstrates that the individual ``has 
achieved a level of competency to function independently.''
    c. Accept attestations from residency program directors, 
representing consensus of residency program faculties.
    In SRM-SECY-08-0179, dated January 16, 2009, the Commission 
approved these recommendations and directed the staff to develop the 
proposed rule language for the alternate pathway attestation 
requirements.
Questions for Discussion
    The NRC staff has developed the following questions to provide 
context for discussion during the public meeting:
     Should the NRC eliminate the attestation requirement for 
individuals seeking authorized status via the board certification 
pathways?
     Should the NRC eliminate the attestation requirement for 
boards whose processes have been recognized by the NRC or Agreement 
States?
     Should the NRC eliminate the attestation requirement for 
individuals ``grandfathered'' under 10 CFR 35.57?
     Should the NRC eliminate the attestation requirements for 
all boards?
     For the alternate pathway, should the NRC amend the 
language for attestation requirements from the current text that states 
the individual ``has achieved a level of competency to function 
independently'' with alternative text such as ``has demonstrated the 
ability to function independently to fulfill the radiation-safety-
related duties required by the license, or has received the requisite 
training and experience in order to fulfill the radiation safety duties 
required by the licensee?''
     If the attestation is retained for the alternate pathway, 
who should be allowed to provide the attestations? Should it be the 
residency program directors representing consensus of residency program 
faculties, and/or medical institution administrators familiar with the 
applicant?
    Members of the public may have different or additional questions 
that should be considered, and are encouraged to raise them during the 
public workshop. Members of the public are also encouraged to provide 
comments that they believe are important to consider.

Topic 3. Extending Grandfathering to Certified Individuals

    The NRC received a petition for rulemaking dated September 10, 
2006, filed by E. Russell Ritenour, PhD on behalf of the American 
Association of Physicists in Medicine. The petitioner requested that 10 
CFR 35.57, ``Training for experienced Radiation Safety Officer, 
teletherapy or medical physicist, authorized medical physicist, 
authorized user, nuclear pharmacist, and authorized nuclear 
pharmacist'' be revised to recognize medical physicists certified by 
either the American Board of Radiology (ABR) or the American Board of 
Medical Physics (ABMP) on or before October 24, 2005, as 
``grandfathered'' for the modalities that they practiced as of October 
24, 2005.
    In its review and resolution of the petition, the NRC concluded 
that revisions made to the regulations in 2005 may have inadvertently 
affected a group of board certified professionals

[[Page 29173]]

who were not listed on an NRC or Agreement State license as October 24, 
2005. The NRC concluded that the issues raised in the petition would be 
considered in the rulemaking process, provided a technical basis could 
be developed. The NRC staff surveyed the certification boards and based 
upon their responses has concluded that pursuing a rulemaking is 
warranted.
    Issue No. 1: Individuals certified by boards that had been listed 
in the NRC's former regulations found in 10 CFR part 35, Subpart J, who 
had not been named on an NRC or Agreement State license or permit prior 
to October 25, 2005, were not grandfathered under 10 CFR 35.57, and 
cannot use their board issued certifications to qualify them as AMPs or 
RSOs.
Questions for Discussion
    The NRC staff has developed the following questions to provide 
context for discussion during the public meeting:
     Should only AMPs and RSOs be grandfathered per the 
petition request?
     Should the NRC recognize all individuals certified by 
boards that had been listed in NRC's regulations, and who had not been 
named on an NRC or Agreement State license or permit prior to October 
25, 2005?
    Members of the public may have different or additional questions 
that should be considered, and are encouraged to raise them during the 
public workshop. Members of the public are also encouraged to provide 
comments that they believe are important to consider.
    Issue No. 2: In support of the petition, the petitioner stated that 
for the RSO preceptor attestations would be provided with the board 
certification for listing on an NRC or Agreement State license. 
Additionally, the petitioner requested that medical physicists 
certified by the ABR or ABMP on or before October 24, 2005, be 
grandfathered for the modalities they practiced as of that date.
    The NRC, in resolving the petition, noted that the rationale for 
grandfathering individuals under Sec.  35.57 was that their credentials 
had been reviewed and accepted during the licensing process and that 
they had been functioning in their positions and had established an 
acceptable record of performance. For individuals to be grandfathered 
under 10 CFR 35.57, an attestation would serve as an acceptable record 
of performance.
    The NRC agreed with the petitioner for requiring an attestation for 
an individual applying to be named as an RSO on a license. 
Additionally, in expanding the petitioners request for grandfathering 
medical physicists to include all individuals certified by boards that 
had been listed in the NRC's regulations, the NRC considered an 
attestation to be a necessary requirement.
Questions for Discussion
    The NRC staff has developed the following questions to provide 
context for discussion during the public meeting:
     Should the NRC require preceptor attestations for 
grandfathering under 10 CFR 35.57 for only RSOs per the petition 
request?
     Should the NRC require an attestation for all individuals 
to be grandfathered under 10 CFR 35.57?
     Should the NRC require no attestations for individuals to 
be grandfathered under 10 CFR 35.57?
     Should the NRC require some other means other than an 
attestation to establish an acceptable record of performance?
     If the NRC adopts the ACMUI recommendation to remove 
attestation requirements for all board certified individuals, how 
should the NRC proceed with the grandfathering under the Ritenour 
petition?
    Members of the public may have different or additional questions 
that should be considered, and are encouraged to raise them during the 
public workshop. Members of the public are also encouraged to provide 
comments that they believe are important to consider.

Topic 4. Revise Part 35 To Allow Assistant/Associate RSOs on a License

    Currently, regulations in 10 CFR part 35 do not allow licensees to 
have more than one permanent RSO. Section 35.24(c) allows licensees to 
simultaneously appoint more than one temporary RSO, if necessary, to 
make sure that the licensee has an individual that is qualified to be 
an RSO for each of the different types and uses of byproduct material 
permitted by the licensee.
    The NRC is considering amending the regulations to add assistant/
associate RSOs on a license. The intent of this proposed change to the 
regulations would be to allow licensees to appoint qualified 
individuals with expertise in certain uses of byproduct material to 
serve as assistant/associate RSOs who would be assigned duties and 
tasks while reporting to the primary RSO. The primary RSO would 
continue to be the individual named on the license that is responsible 
for the day-to-day oversight of the entire radiation safety program. 
Licensees with multiple operating locations could have a qualified 
assistant/associate RSO at each location of byproduct use.
Questions for Discussion
    The NRC staff has developed the following questions to provide 
context for discussion during the public meeting:
     What should the qualifications be for an Assistant/
Assistant RSO? Should they be the same as the RSO?
     Should there be a limitation on the number of Assistant/
Associate RSOs on a License?
     Should the RSO continue to be the one person that the 
regulations hold responsible for the day-to-day oversight of the 
licensee's radiation safety program, or should the regulations be 
changed to allow for Assistant/Associate RSO to have some 
accountability?
     Should the title of the additional named supporting RSOs 
be Assistant RSO, or Associate RSO? Does the title matter?
    Members of the public may have different or additional questions 
that should be considered, and are encouraged to raise them during the 
public workshop. Members of the public are also encouraged to provide 
comments that they believe are important to consider.

Topic 5. Require Molybdenum Breakthrough Tests After Each Elution and 
Require Reporting of Failed Molybdenum Breakthrough Tests

    Currently, 10 CFR 35.204(b) requires that a licensee that uses 
molybdenum-99/technetium-99m generators for preparing a technetium-99m 
radiopharmaceutical must measure the molybdenum-99 concentration of 
only the first eluate. Prior to 2002, 10 CFR 35.204 required the 
licensee to measure the molybdenum-99 concentration of each eluate. In 
the April 2002 revision, the NRC decided to require this test to be 
made only for the first eluate because the frequency of molybdenum 
breakthrough was considered to be rare by the medical and 
pharmaceutical industries.
    During October 2006 through February 2007, and again in January 
2008, medical licensees reported generators that failed the molybdenum-
99 breakthrough tests. Some licensees were reporting the failures 
detected from measuring the first elution, and others were reporting a 
normal first elution with subsequent elutions.
    Generator manufacturers have always recommended testing each 
elution prior to use in humans. In addition, while Sec.  35.204(d) 
requires that a licensee

[[Page 29174]]

retain a record of each molybdenum-99 concentration measurement and 
retain the record for three years, there is no requirement that an 
elution that exceeds the regulatory limit of 0.15 microCuries of 
molybdenum-99 per milliCurie of technetium-99m must be reported.
Questions for Discussion
    The NRC staff has developed the following questions to provide 
context for discussion during the public meeting.
     Should the NRC require licensees perform the test for each 
eluate as recommended by the generator manufacturers?
     Should the NRC require reporting of a failed test? If so, 
how soon should after the failed test is discovered, should the 
licensee be required to make a report?
    Members of the public may have different or additional questions 
that should be considered, and are encouraged to raise them during the 
public workshop. Members of the public are also encouraged to provide 
comments that they believe are important to consider.

Topic 6. Additional Items Under Consideration for Rulemaking

    The NRC is also considering amending the regulations to address the 
following 18 items. Members of the public may have questions or 
comments about these additional items, and are encouraged to raise them 
during the public workshop.
    The following section under consideration relates to the authorized 
medical physicist issues.
    1. Section to be amended: 10 CFR 35.433(a).
    Issue: 10 CFR 35.433 requires an authorized medical physicist to 
perform the task described in this section, i.e., calculate the 
activity of each strontium-90 source that is used to determine the 
treatment times for ophthalmic treatments. The Sr-90 eye applicators 
are typically used in geographic locations that may not have access to 
an authorized medical physicist and further description of the tasks 
required of a physicist during the eye applicator use would make it 
easier to permit other physicists to perform the tasks.
    Revising 10 CFR 35.433 to add a description of the tasks required 
and to permit a medical physicist with training and experience in these 
specific tasks to perform the tasks in Sec.  35.433 would provide 
relief to licensees in remote areas.
    (Reviewed with ACMUI during its May 23, 2006 meeting).
    The following sections under consideration relate to training and 
experience issues.
    2. Section to be amended: 10 CFR 35.51(a)(2)(i).
    Issue: One of the conditions for recognition of board certification 
in Sec.  35.51(a)(2)(i) is that all candidates have 2 years of full-
time practical training and/or supervised experience in medical 
physics--under the supervision of a medical physicist who is certified 
in medical physics by a specialty board recognized by the Commission or 
an Agreement State. This has been interpreted to mean that a diagnostic 
medical physicist certified by a board recognized in Sec.  35.50 can 
serve as the supervising medical physicist under Sec.  35.51. NRC staff 
believes that a therapy medical physicist should receive supervised 
experience under a therapy medical physicist.
    (Reviewed with ACMUI during its May 23, 2006 meeting).
    3. Section to be amended: 10 CFR 35.50(c)(2).
    Issue: 10 CFR 35.50(c)(2) permits an AU, AMP, or ANP identified on 
the licensee's license and with experience with the radiation safety 
aspects of similar types of use of byproduct material for which the 
individual has RSO responsibilities to be an RSO. This restricts the 
licensee from naming a qualified AU, AMP, or ANP identified on another 
licensee's license as an RSO. It also prohibits an individual who meets 
the requirements to be an AU, AMP, or ANP that has not been listed on a 
license to be an RSO.
    (Reviewed with ACMUI during its April 26, 2006 meeting).
    4. Section to be amended: 10 CFR 35.290(b)(ii)(G).
    Issue: 10 CFR 35.290(b)(ii) requires the supervised work experience 
to be under the supervision of an AU. Most facilities that provide the 
supervised work experience training required in 10 CFR 35.290(b)(ii)(G) 
for generator elution do not have generators available or prepare kits. 
The effect is that these facilities usually make arrangements with a 
nuclear pharmacy to obtain this hands-on training and experience from 
an ANP. Although the supervising AU can make an arrangement for the ANP 
to provide the training under the AU's supervision, it would be simpler 
if the ANP providing the training could be recognized as the 
supervising individual.
    (The ACMUI approved the change during its October 22, 2007 
meeting).
    5. Section to be amended: 10 CFR 35.390(b)(1).
    Issue: The NRC currently recognizes the residency program approved 
by the Royal college of Physicians and Surgeons of Canada for 
physicians seeking authorized user status under Sec. Sec.  35.390, 
35.490, and 35.690. But in each case, the NRC's regulations require 
supervised work experience under an authorized user. The Canadian 
residency program does not appear to meet this criterion. The challenge 
is to determine how to assure physicians going through the Canadian 
residency programs receive training and supervised work experience in 
the radiation safety issues unique to the U.S. regulations for medical 
uses.
    6. Section to be amended: 10 CFR 35.390(b)(1)(ii)(G).
    Issue: Work experience for parenteral administration of alpha 
emitters: Based upon the interpretation of the regulations, the staff 
has determined that the current language of 10 CFR 35.390(b)(1)(ii)(G) 
is insufficient. Contrary to what had been intended, the current 
language in category 4 does not allow the category to encompass any 
byproduct material, since the NRC staff has determined that no pure 
alpha emitter exists. The staff is proposing a change to the regulation 
to reflect the original intent of placing the parenteral administration 
of alpha emitters into a separate category from the parenteral 
administration of beta emitting and low energy photon-emitting 
byproduct material. References to that section in 10 CFR 35.396(d)(2) 
and (d)(2)(vi) would also be amended.
    7. Section to be amended: 10 CFR 35.490(b)(1)(ii).
    Issue: Change site requirements for AU work experience. The 
amendment would allow supervised work experience to be obtained at 
places other than medical institutions, i.e. clinics.
    (Reviewed with the ACMUI at the October 19, 2009 meeting).
    8. Section to be amended: 10 CFR 35.491(b)(3).
    Issue: There is an error in 10 CFR 35.491(b)(3). Section 35.491 
states the AU of strontium-90 for ophthalmic radiotherapy is a 
physician who meets the requirements in paragraph (a) or (b). However 
the attestation statement in 10 CFR 35.491(b)(3) requires the preceptor 
AU to attest that the individual meets the requirements in paragraphs 
(a) and (b). The effect is that paragraph (b)(3) requires an 
attestation statement for the individual that is already an AU under 
the requirements of 10 CFR 35.490. The statements of consideration (67 
FR 20310) state that physicians who meet the requirements in 10 CFR 
35.490 automatically meet the requirements to

[[Page 29175]]

become an AU under 10 CFR 35.491 which means an attestation is not 
required under the paragraph (a) pathway. To support this 
interpretation, the regulations that are structured similar to 10 CFR 
35.491(a) (e.g., Sec. Sec.  35.190(b), 35.290(b), 35.392(b), and 
35.394(b)) that require a physician to be a specific AU do not refer to 
the section requiring an attestation and the corresponding attestation 
paragraph does not reference the authorized user paragraphs.
    (Not reviewed by ACMUI).
    9. Section to be amended: 10 CFR 35.610(d).
    Issue: It is recommended that Sec.  35.610(d) be revised to include 
a new section on vendor training and distinguish this training from 
licensee provided ``initial'' training. The differentiation should be 
based upon the licensee experience with the unit, i.e., new units and 
units with significant manufacturer upgrades. The vendor training needs 
to be provided before first patient treatment using the unit. The 
vendor training needs to be provided by the device manufacturer or by 
individuals certified by the device manufacturer.
    (Reviewed with the ACMUI during its March 1-2, 2004 meeting).
    10. Section to be amended: 10 CFR 35.690(b)(1).
    Issue: Change site requirements for AU work experience. The 
amendment would allow supervised work experience to be obtained at 
places other than medical institutions, i.e. clinics.
    (Reviewed with the ACMUI at the October 19, 2009 meeting).
    The following sections under consideration relate to the Sealed 
Sources/Device issues.
    11. Section to be amended: 10 CFR 35.13.
    Issue: 10 CFR 30.32 requires that an application for a specific 
license to use byproduct material in the form of a sealed source or in 
a device that contains the sealed source either (1) identify the source 
or device by manufacturer and model number as registered with the 
Commission under Sec.  32.210 or with an Agreement State; or (2) 
contain the information identified in Sec.  32.210(c). Therefore, an 
amendment is needed every time the licensee changes the manufacturer or 
model of a bracytherapy source.
    NRC staff is also considering revising Sec.  35.14, 
``Notifications,'' to permit medical use licensees to notify the NRC 
within 30 days of when the licensee obtains sealed sources from a new 
manufacturer or new model of sealed sources from a manufacturer listed 
on the license for a use already authorized in the license.
    (Reviewed with the ACMUI at the November 12-13, 2003 meeting).
    12. Section to be amended: 10 CFR 35.14.
    Issue: Conforming changes for Sec.  35.13.
    13. Section to be amended: 10 CFR 35.65(a) through (d).
    Issue: 10 CFR 35.65 authorizes a medical use licensee to possess 
certain calibration, transmission and reference sources if each sealed 
source or individual amounts of other forms of byproduct material do 
not exceed a specific activity. A manufacturer of attenuation sources 
used for SPEC or PET scanners believes this authorization includes its 
array of 28 sources, since each does not exceed the individual limits 
specified. The requirement needs to be clarified to exclude bundling or 
aggregating the sources for one device.
    (Reviewed with ACMUI during its April 26, 2006 meeting).
    14. Section to be amended: 10 CFR 35.65(a)-(d).
    Issue: Move transmission sources that are used on patients or human 
research subjects to Subpart G.
    15. Sections to be amended: 10 CFR 35.400, 35.500, and 35.600.
    Issue: 10 CFR 35.400, 35.500, and 35.600 require licensees to only 
use the sealed sources and devices in these sections as approved in the 
Sealed Source and Device Registry (SSDR). Some of the SSDR certificates 
include specific medical procedures or treatment of specific diseases 
or treatment areas listed by the manufacturer. If ``only as approved in 
the SSDR'' means only for the treatments described in the SSDR, other 
accepted uses under the practice of medicine would be either for 
research or not permitted by the regulations. The staff is considering 
more flexible wording to ensure uses under the practice of medicine are 
included.
    (The ACMUI approved the change during its October 22, 2007 
meeting).
    16. Section to be amended: 10 CFR 35.655(a).
    Issue: 10 CFR 35.655(a) requires a licensee to have each 
teletherapy unit and gamma stereotactic radiosurgery unit fully 
inspected and serviced during source replacement or at intervals not to 
exceed 5 years, whichever comes first, to assure proper functioning of 
the source exposure mechanism. This regulation requires a gamma 
stereotactic radiosurgery unit to be fully inspected and serviced at 5 
years if the source replacement is delayed. However, the type of 
inspection and full servicing expected can only be done during source 
replacement for the gamma stereotactic radiosurgery unit.
    (Reviewed with the ACMUI during its November 12-13, 2003 meeting).)
    In addition, the following sections are also under consideration 
for amendments.
    17. Section to be amended: 10 CFR 35.12(c).
    Issue 1: 10 CFR 35.12(d) requires an applicant for a license or 
amendment for a Sec.  35.1000 medical use to meet the requirements in 
Sec.  35.12(b) and (c). 10 CFR 35.12(b) requires an applicant for a 
license for medical use of byproduct material as described in Sec.  
35.1000 to file an original and one copy of NRC Form 313, ``Application 
for Material License,'' that includes the facility diagram, equipment, 
and training and experience qualifications of the RSO, AU(s), AMP(s), 
and ANP(s). 10 CFR 35.12(c) requires an applicant for a license 
amendment or renewal to submit an original and one copy of either NRC 
Form 313 or a letter requesting the amendment or renewal but is silent 
on the need to submit the facility diagram or the training and 
experience of the RSO, AU(s), AMP(s), and ANP(s). It is unclear whether 
the information specified in Sec.  35.12(b) is included in Sec.  
35.12(c).
    (Reviewed with ACMUI during its April 26, 2006 meeting).)
    Issue 2: 10 CFR 35.12(c)(1) indicates that the application will be 
either on NRC Form 313 or in a letter but does not indicate that the 
information submitted in the letter must be equivalent to the 
information submitted on the NRC Form 313. By adding ``or equivalent'' 
the burden associated with the letter submission is captured in the 
information collection and recordkeeping burden of the NRC Form 313. 
This will also capture the burden on the NRC Form 313 for completing 
the NRC Form 313A series or letters containing equivalent information 
to that in the NRC Form 313A series.
    (The ACMUI approved the change during its June 13, 2007 meeting).)
    18. Section to be amended: 10 CFR 35.12(d).
    Issue 1: 10 CFR 35.12(d) does not address all the radiation safety 
aspects for medical use of byproduct material as described in Sec.  
35.1000 and, as written, may imply that only the radiation safety 
aspects in Subparts A through C apply to Sec.  35.1000 medical uses.
    (Reviewed with the ACMUI during its March 1-2, 2004 meeting).)
    Issue 2: 10 CFR 35.12(d) and 10 CFR 35.12(d)(1) are confusing 
because there are radiation safety aspects that are neither addressed 
in Subparts A through C of this part nor included in the list

[[Page 29176]]

that the Supplemental Information section for Sec.  35.12(d)(1) 
considers to be all the information NRC needs to approve a Sec.  
35.1000 medical use.
    (Reviewed with the ACMUI during its March 1-2, 2004 meeting).)
    During the two-day workshops, the NRC will be available to discuss 
preliminary draft rule language under consideration for new and amended 
sections of 10 CFR part 35. The preliminary draft rule language, and 
any public comments on that language, can be found at http://www.regulations.gov by searching on Docket ID NRC-2008-0175.

    Dated at Rockville, Maryland, this 5th day of May 2011.

    For the Nuclear Regulatory Commission.
Michael Fuller,
Acting Branch Chief, Radioactive Materials Safety Branch, Division of 
Materials Safety and State Agreements, Office of Federal and State 
Materials and Environmental Management Program.
[FR Doc. 2011-12048 Filed 5-19-11; 8:45 am]
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