ML18099A220: Difference between revisions

From kanterella
Jump to navigation Jump to search
(Created page by program invented by StriderTol)
 
(Created page by program invented by StriderTol)
 
Line 15: Line 15:


=Text=
=Text=
{{#Wiki_filter:2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE 1NRC staff should issue an (IN), which describes errors previously made and provides examples of best practices with regards units of AKS vs.
{{#Wiki_filter:2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM                                    DATE          STATUS 1
apparent activity (mCi) for brachytherapy sources. The IN should be done in collaboration with the American Association of Physicists in Medicine (AAPM) and coordinated with Agreement States.6/12/07Accepted Closed 9/9/09 2NRC staff should remove the attestation requirement for board certified individuals and rewrite the attestation requirement for individuals seeking authorization under the alternate pathway. The rewritten attestation should not include the word "competency" but should instead read "has met the training and experience requirements."6/12/07Accepted Closed 3/7/18 3NRC staff should revise the regulations so that board certified individuals, who were certified prior to the effective date of recognition or were certified by previously recognized boards listed in Subpart J of the previous editions of Part 35, are grandfathered.6/12/07Accepted Closed 3/7/18 4NRC staff should reduce the 200-hour radiation safety training requirement to 120 hours for individuals seeking authorization under the  
NRC staff should issue an (IN), which describes errors previously made and provides examples of best practices with regards units of AKS vs.
Closed apparent activity (mCi) for brachytherapy sources. The IN should be done     6/12/07  Accepted 9/9/09 in collaboration with the American Association of Physicists in Medicine (AAPM) and coordinated with Agreement States.
2 NRC staff should remove the attestation requirement for board certified individuals and rewrite the attestation requirement for individuals seeking Closed authorization under the alternate pathway. The rewritten attestation         6/12/07  Accepted 3/7/18 should not include the word competency but should instead read has met the training and experience requirements.
3 NRC staff should revise the regulations so that board certified individuals, who were certified prior to the effective date of recognition or were                             Closed 6/12/07  Accepted certified by previously recognized boards listed in Subpart J of the                             3/7/18 previous editions of Part 35, are grandfathered.
4 NRC staff should reduce the 200-hour radiation safety training requirement to 120 hours for individuals seeking authorization under the     6/12/07 Not accepted Closed alternate pathway in 10 CFR 35.390.
5 NRC staff should not change the current definition for a RSO.                6/13/07  Accepted    Closed 6
NRC staff should add the words or equivalent so it is clear that Closed information included in a letter is the same as that which would have been 6/13/07    Accepted 3/7/18 submitted in NRC Form 313A (35.12(c))
1


alternate pathwa y in 10 CFR 35.390.6/12/07Not acceptedClosed 5NRC staff should not change the current definition for a RSO.6/13/07AcceptedClosed 6NRC staff should add the words "or equivalent" so it is clear that information included in a letter is the same as that which would have been
2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM                                  DATE          STATUS 7
NRC staff should revise 10 CFR 35.50(c)(2) to include AUs, AMPs, or ANPs identified on any license or permit that authorizes similar types of Closed use of byproduct material. Additionally, the AU, AMP, or ANP must have    6/13/07  Accepted 3/7/18 experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking RSO authorization.
8 NRC staff should remove the attestation requirement from 10 CFR 35.50(d) for AUs, AMPs, and ANPs seeking RSO status, if the AU, AMP,                            Closed 6/13/07  Accepted or ANP seeking RSO status will have responsibilities for similar types of                        3/7/18 uses for which the individual is authorized.
9 ACMUI tabled the following issue until the next full ACMUI meeting:              Moved to Oct 6/13/07              Closed 35.57(a), 35.75, 35.491(b)(2), 35.400, 35.500, and 35.600.                          Agenda 10 a) NRC staff should allow more than one RSO on a license with a designation of one RSO as the individual in charge. b) NRC should create                      a) Closed a) Accepted a Regulatory Issue Summary (RIS) to inform the regulated community of    6/13/07                3/7/18 b) Accepted NRCs interpretation. The RIS should be sent to ACMUI and the                                 b) Closed Agreement States for review and comment.
2


submitted in NRC Form 313A (35.12(c))6/13/07Accepted Closed 3/7/18STATUS 1 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 7NRC staff should revise 10 CFR 35.50(c)(2) to include AUs, AMPs, or ANPs identified on any license or permit that authorizes similar types of use of byproduct material. Additionally, the AU, AMP, or ANP must have experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking RSO authorization.6/13/07Accepted Closed 3/7/18 8NRC staff should remove the attestation requirement from 10 CFR 35.50(d) for AUs, AMPs, and ANPs seeking RSO status, if the AU, AMP, or ANP seeking RSO status will have responsibilities for similar types of uses for which the individual is authorized.6/13/07Accepted Closed 3/7/18 9ACMUI tabled the following issue until the next full ACMUI meeting:
2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM                                    DATE            STATUS 11 NRC staff should include the three-case work experience requirement for individuals seeking authorization for Y-90 microsphere use; however, the             Partially three cases do not have to be with the particular type of microsphere for           accepted, which the individual is seeking authorization. Furthermore, ACMUI                    Revised 6/13/07                Closed recommends the training and experience does not have to be performed                guidance under the supervision of an AU, and NRC staff should replace the                    published proposed supervision paragraph with the existing language from 10 CFR                 09/07 35.690(c).
12                                                                                    Accepted, NRC staff should delete the attestation requirement for Y-90 Revised microspheres users and incorporate a requirement in the second 6/13/07  guidance      Closed paragraph of the guidance for individuals seeking authorization to provide published and retain documentation of the completion of training.
09/07 13                                                                                    Accepted, NRC staff should incorporate the proposed wording for the team Revised approach section of the Y-90 microspheres guidance with one exception:
6/13/07  guidance      Closed ACMUI recommends the word oncology be replaced by cancer published management.
09/07 14                                                                                    Moved to For 10 CFR 35.1000 guidance documents, NRC staff should incorporate 10/07 the proposed wording that notification under 10 CFR 35.14 does not apply 6/13/07                  Closed agenda for for specific medical use licensees.
clairification 15                                                                                    Moved to ACMUI tabled the absorbed dose vs. activity issue for Y-90 microspheres 6/13/07    10/07      Closed until the next full ACMUI meeting.
agenda 3


35.57(a), 35.75, 35.491(b)(2), 35.400, 35.500, and 35.600.
2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM                                    DATE          STATUS 16 NRC staff should revise the current guidance to conclude that the surgical Closed removal of the sentinel lymph node is an independent procedure and        6/13/07  Accepted 1/9/09 should not be regulated by NRC.
6/13/07Moved to Oct Agenda Closed 10a)NRC staff should allow more than one RSO on a license wi th a designation of one RSO as the indiv i dual in charge. b) NRC should create a Regulatory Issue Summary (RIS) to inform the regulated community of NRC's interpretation. The RIS should be sent to ACMU I and the Agreement States for review and comment.
17                                                                                    Completed, NRC staff committed to consult legal counsel to determine the feasibility added to of discussing PRM 35-20 (Ritenour/AAPM petition) with ACMUI members        6/13/07              Closed 10/07 in a closed executive session.
6/13/07a)Accepted b)Accepteda)Closed 3/7/18b)Closed 2 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 11NRC staff should include the three-case work experience requirement for individuals seeking authorization for Y-90 microsphere use; however, the three cases do not have to be with the particular type of microsphere for which the individual is seeking authorization. Furthermore, ACMUI recommends the training and experience does not have to be performed under the supervision of an AU, and NRC staff should replace the proposed supervision paragraph with the existing language from 10 CFR
agenda 18                                                                                    Completed, NRC staff should arrange a briefing for ACMUI members regarding the 6/13/07    8/15/07  Closed Increased Controls Orders to be issued later this year for fingerprinting.
meeting 19                                                                                    Not directed by NRC staff should engage ACMUI in a discussion regarding the review of Commission; operational events and data and work towards a goal of minimizing          6/13/07                N/A NRC may therapeutic medical events, if directed by the Commission to do so.
request in future 20 NRC staff should provide detailed background information for the current Accepted,on and future presentations on the subject of potential changes to 10 CFR    6/13/07                N/A going Part 35.
21 NRC staff should email the ACMUI members a copy of the memo                        Accepted, 6/13/07                N/A summarizing action items and motions made during the meeting.                       ongoing 22 Not ACMUI supports grandfathering for individuals who had previously been              accepted, 8/15/07              Closed determined to be trustworthy and reliable and granted unescorted access.              Orders mailed 10/07 4


35.690 (c).6/13/07Partially accepted, Revised guidance published 09/07 Closed 12NRC staff should delete the attestation requirement for Y-90 microspheres users and incorporate a requirement in the second paragraph of the guidance for individuals seeking authorization to provide and retain documentation of the completion of training.
2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM                                    DATE          STATUS 23 Not ACMUI agrees to assist the NRC, if requested, to determine those levels requested, and types of material that could be of such significance to public health      8/15/07               Closed Orders and safety to warrant fingerprinting and background checks.
6/13/07 Accepted, Revised guidance published 09/07 Closed 13NRC staff should incorporate the proposed wording for the team approach section of the Y-90 microspheres guidance with one exception:
mailed 10/07 24 NRC staff should revise the current regulations to include Canadian                                Closed on 8/16/07   Accepted trained individuals who have passed the ABNM certification exam.                                      3/7/18 25 NRC staff should maintain Compatibility B for training and experience requirements to ensure that authorized individuals may cross state            8/16/07   Accepted   Closed borders and practice throughout the U.S.
ACMUI recommends the word "oncology" be replaced by "cancer management."
26 NRC staff should accept a preceptor statement from another AU for a non-                Accepted, board certified individual if the AU who supervised the training and work      9/20/07 current NRC  Closed experience is not available as a preceptor.                                              practice 27 NRC staff should add increased complexity vs. additional benefit as an                Moved to agenda item for the October ACMUI meeting, so that ACMUI may                  9/20/07  October    Closed continue the discussion on this topic.                                                2007 agenda 28 The AU should be required to place a signature on orders for radioactive                Motion did 10/22/07               Closed material before the supplier can legally ship the material to an institution.            not pass 29 The Elekta Perfexion should be regulated under 10 CFR 35.1000 until Open 10 CFR 35.600 is modified to be performance-based, which would allow          10/22/07   Accepted Delayed the Perfexion to be regulated under 10 CFR 35.600.
6/13/07 Accepted, Revised guidance published 09/07 Closed 14 For 10 CFR 35.1000 guidance documents, NRC staff should incorporate the proposed wording that notification under 10 CFR 35.14 does not apply for specific medical use licensees.
30 NRC staff should require experienced RSOs and AMPs to receive Closed additional training, if the individual is seeking authorization or            10/22/07  Accepted 3/7/18 responsibility for new uses.
6/13/07Moved to 10/07 agenda for clairification Closed 15ACMUI tabled the absorbed dose vs. activity issue for Y-90 microspheres until the next full ACMUI meeting.
5
6/13/07Moved to 10/07 a g enda Closed 3 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 16NRC staff should revise the current guidance to conclude that the surgical removal of the sentinel lymph node is an independent procedure and should not be regulated by NRC.6/13/07Accepted Closed 1/9/09 17 NRC staff committed to consult legal counsel to determine the feasibility of discussing PRM 35-20 (Ritenour/AAPM petition) with ACMUI members in a closed executive session.
6/13/07Completed, added to 10/07 a g enda Closed 18NRC staff should arrange a briefing for ACMUI members regarding the Increased Controls Orders to be issued later this year for fingerprinting.
6/13/07Completed, 8/15/07 meetin g Closed 19NRC staff should engage ACMUI in a discussion regarding the review of operational events and data and work towards a goal of minimizing therapeutic medical events, if directed by the Commission to do so.
6/13/07 Not directed by Commission; NRC may request in future N/A 20NRC staff should provide detailed background information for the current and future presentations on the subject of potential changes to 10 CFR


Part 35.6/13/07 Accepted,on going N/A 21NRC staff should email the ACMUI members a copy of the memo summarizin g action items and motions made durin g the meetin g.6/13/07 Accepted, on g oin g N/A 22ACMUI supports grandfathering for individuals who had previously been determined to be trustworthy and reliable and granted unescorted access.
2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM                                      DATE          STATUS 31 NRC staff should not require experienced RSOs to obtain written                                    Closed 10/22/07  Accepted attestation to become authorized or have responsibility for new uses.                               3/7/18 32 NRC staff should not revise 10 CFR 35.75 to read 5 mSv/year (0.5 10/23/07 Not accepted  Closed rem/year).
8/15/07 Not accepted, Orders mailed 10/07 Closed 4 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 23ACMUI agrees to assist the NRC, if requested, to determine those levels and types of material that could be of such significance to public health and safety to warrant fingerprinting and background checks.
33 NRC staff should modify 10 CFR 35.491(b)(2) to specify 'superficial Open ophthalmic treatments. Additionally, NRC staff should change the title of   10/22/07  Accepted Delayed 10 CFR 35.491 to specify superficial ophthalmic treatments.
8/15/07 Not requested, Orders mailed 10/07 Closed 24NRC staff should revise the current regulations to include Canadian trained individuals who have passed the ABNM certification exam.8/16/07Accepted Closed on 3/7/18 25NRC staff should maintain Compatibility B for training and experience requirements to ensure that authorized individuals may cross state
34 NRC staff should not revise 10 CFR 35.491 (intended for ophthalmologists) to include training and experience for the new                       Partially  Open 10/22/07 intraocular device. Instead, NRC staff should regulate the new intraocular             Accepted    Delayed device under 10 CFR 35.490.
 
35 NRC staff should not require medical licensees regulated under 10 CFR Closed 35.400, 500, or 600, as applicable, to only use the sealed sources and       10/22/07  Accepted 3/7/18 devices for the principle use as approved in the SSDR.
borders and p ractice throu g hout the U.S.8/16/07AcceptedClosed 26 NRC staff should accept a preceptor statement from another AU for a non
36 NRC staff should revise 10 CFR 35.290 to allow physicians to receive Closed training and experience in the elution of generators and preparation of kits 10/22/07  Accepted 3/7/18 under the supervision of an ANP.
-board certified individual if the AU who supervised the training and work ex perience is not available as a p rece p tor.9/20/07 Accepted, current NRC p ractice Closed 27NRC staff should add 'increased complexity vs. additional benefit' as an agenda item for the October ACMUI meeting, so that ACMUI may
6}}
 
continue the discussion on this topic.
9/20/07Moved to October 2007 agenda Closed 28The AU should be required to place a signature on orders for radioactive material before the supplier can legally ship the material to an institution.
10/22/07Motion did not pass Closed 29The Elekta Perfexion should be regulated under 10 CFR 35.1000 until 10 CFR 35.600 is modified to be performance-based, which would allow the Perfexion to be regulated under 10 CFR 35.600.10/22/07Accepted    Open Delayed 30NRC staff should require experienced RSOs and AMPs to receive additional training, if the individual is seeking authorization or responsibility for new uses.10/22/07Accepted Closed 3/7/18 5 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 31NRC staff should not require experienced RSOs to obtain written attestation to become authorized or have responsibility for new uses.10/22/07Accepted Closed 3/7/18 32 NRC staff should not revise 10 CFR 35.75 to read "5 mSv/year (0.5 rem/year)."10/23/07Not acceptedClosed 33NRC staff should modify 10 CFR 35.491(b)(2) to specify 'superficial' ophthalmic treatments. Additionally, NRC staff should change the title of 10 CFR 35.491 to specify 'superficial' ophthalmic treatments.10/22/07Accepted    Open Delayed 34NRC staff should not revise 10 CFR 35.491 (intended for ophthalmologists) to include training and experience for the new intraocular device. Instead, NRC staff should regulate the new intraocular device under 10 CFR 35.490.
10/22/07Partially AcceptedOpen Delayed 35 NRC staff should not require medical licensees regulated under 10 CFR 35.400, 500, or 600, as applicable, to only use the sealed sources and devices for the principle use as approved in the SSDR.10/22/07Accepted Closed 3/7/18 36NRC staff should revise 10 CFR 35.290 to allow physicians to receive training and experience in the elution of generators and preparation of kits under the supervision of an ANP.10/22/07Accepted Closed 3/7/18 6}}

Latest revision as of 09:54, 21 October 2019

Advisory Committee on the Medical Uses of Isotopes (ACMUI) 2007 Recommendations and Actions Chart - April 2018
ML18099A220
Person / Time
Issue date: 04/09/2018
From:
Advisory Committee on the Medical Uses of Isotopes
To:
Holiday, Sophie
References
Download: ML18099A220 (6)
v • d • e


Text

2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 1

NRC staff should issue an (IN), which describes errors previously made and provides examples of best practices with regards units of AKS vs.

Closed apparent activity (mCi) for brachytherapy sources. The IN should be done 6/12/07 Accepted 9/9/09 in collaboration with the American Association of Physicists in Medicine (AAPM) and coordinated with Agreement States.

2 NRC staff should remove the attestation requirement for board certified individuals and rewrite the attestation requirement for individuals seeking Closed authorization under the alternate pathway. The rewritten attestation 6/12/07 Accepted 3/7/18 should not include the word competency but should instead read has met the training and experience requirements.

3 NRC staff should revise the regulations so that board certified individuals, who were certified prior to the effective date of recognition or were Closed 6/12/07 Accepted certified by previously recognized boards listed in Subpart J of the 3/7/18 previous editions of Part 35, are grandfathered.

4 NRC staff should reduce the 200-hour radiation safety training requirement to 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> for individuals seeking authorization under the 6/12/07 Not accepted Closed alternate pathway in 10 CFR 35.390.

5 NRC staff should not change the current definition for a RSO. 6/13/07 Accepted Closed 6

NRC staff should add the words or equivalent so it is clear that Closed information included in a letter is the same as that which would have been 6/13/07 Accepted 3/7/18 submitted in NRC Form 313A (35.12(c))

1

2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 7

NRC staff should revise 10 CFR 35.50(c)(2) to include AUs, AMPs, or ANPs identified on any license or permit that authorizes similar types of Closed use of byproduct material. Additionally, the AU, AMP, or ANP must have 6/13/07 Accepted 3/7/18 experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking RSO authorization.

8 NRC staff should remove the attestation requirement from 10 CFR 35.50(d) for AUs, AMPs, and ANPs seeking RSO status, if the AU, AMP, Closed 6/13/07 Accepted or ANP seeking RSO status will have responsibilities for similar types of 3/7/18 uses for which the individual is authorized.

9 ACMUI tabled the following issue until the next full ACMUI meeting: Moved to Oct 6/13/07 Closed 35.57(a), 35.75, 35.491(b)(2), 35.400, 35.500, and 35.600. Agenda 10 a) NRC staff should allow more than one RSO on a license with a designation of one RSO as the individual in charge. b) NRC should create a) Closed a) Accepted a Regulatory Issue Summary (RIS) to inform the regulated community of 6/13/07 3/7/18 b) Accepted NRCs interpretation. The RIS should be sent to ACMUI and the b) Closed Agreement States for review and comment.

2

2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 11 NRC staff should include the three-case work experience requirement for individuals seeking authorization for Y-90 microsphere use; however, the Partially three cases do not have to be with the particular type of microsphere for accepted, which the individual is seeking authorization. Furthermore, ACMUI Revised 6/13/07 Closed recommends the training and experience does not have to be performed guidance under the supervision of an AU, and NRC staff should replace the published proposed supervision paragraph with the existing language from 10 CFR 09/07 35.690(c).

12 Accepted, NRC staff should delete the attestation requirement for Y-90 Revised microspheres users and incorporate a requirement in the second 6/13/07 guidance Closed paragraph of the guidance for individuals seeking authorization to provide published and retain documentation of the completion of training.

09/07 13 Accepted, NRC staff should incorporate the proposed wording for the team Revised approach section of the Y-90 microspheres guidance with one exception:

6/13/07 guidance Closed ACMUI recommends the word oncology be replaced by cancer published management.

09/07 14 Moved to For 10 CFR 35.1000 guidance documents, NRC staff should incorporate 10/07 the proposed wording that notification under 10 CFR 35.14 does not apply 6/13/07 Closed agenda for for specific medical use licensees.

clairification 15 Moved to ACMUI tabled the absorbed dose vs. activity issue for Y-90 microspheres 6/13/07 10/07 Closed until the next full ACMUI meeting.

agenda 3

2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 16 NRC staff should revise the current guidance to conclude that the surgical Closed removal of the sentinel lymph node is an independent procedure and 6/13/07 Accepted 1/9/09 should not be regulated by NRC.

17 Completed, NRC staff committed to consult legal counsel to determine the feasibility added to of discussing PRM 35-20 (Ritenour/AAPM petition) with ACMUI members 6/13/07 Closed 10/07 in a closed executive session.

agenda 18 Completed, NRC staff should arrange a briefing for ACMUI members regarding the 6/13/07 8/15/07 Closed Increased Controls Orders to be issued later this year for fingerprinting.

meeting 19 Not directed by NRC staff should engage ACMUI in a discussion regarding the review of Commission; operational events and data and work towards a goal of minimizing 6/13/07 N/A NRC may therapeutic medical events, if directed by the Commission to do so.

request in future 20 NRC staff should provide detailed background information for the current Accepted,on and future presentations on the subject of potential changes to 10 CFR 6/13/07 N/A going Part 35.

21 NRC staff should email the ACMUI members a copy of the memo Accepted, 6/13/07 N/A summarizing action items and motions made during the meeting. ongoing 22 Not ACMUI supports grandfathering for individuals who had previously been accepted, 8/15/07 Closed determined to be trustworthy and reliable and granted unescorted access. Orders mailed 10/07 4

2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 23 Not ACMUI agrees to assist the NRC, if requested, to determine those levels requested, and types of material that could be of such significance to public health 8/15/07 Closed Orders and safety to warrant fingerprinting and background checks.

mailed 10/07 24 NRC staff should revise the current regulations to include Canadian Closed on 8/16/07 Accepted trained individuals who have passed the ABNM certification exam. 3/7/18 25 NRC staff should maintain Compatibility B for training and experience requirements to ensure that authorized individuals may cross state 8/16/07 Accepted Closed borders and practice throughout the U.S.

26 NRC staff should accept a preceptor statement from another AU for a non- Accepted, board certified individual if the AU who supervised the training and work 9/20/07 current NRC Closed experience is not available as a preceptor. practice 27 NRC staff should add increased complexity vs. additional benefit as an Moved to agenda item for the October ACMUI meeting, so that ACMUI may 9/20/07 October Closed continue the discussion on this topic. 2007 agenda 28 The AU should be required to place a signature on orders for radioactive Motion did 10/22/07 Closed material before the supplier can legally ship the material to an institution. not pass 29 The Elekta Perfexion should be regulated under 10 CFR 35.1000 until Open 10 CFR 35.600 is modified to be performance-based, which would allow 10/22/07 Accepted Delayed the Perfexion to be regulated under 10 CFR 35.600.

30 NRC staff should require experienced RSOs and AMPs to receive Closed additional training, if the individual is seeking authorization or 10/22/07 Accepted 3/7/18 responsibility for new uses.

5

2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 31 NRC staff should not require experienced RSOs to obtain written Closed 10/22/07 Accepted attestation to become authorized or have responsibility for new uses. 3/7/18 32 NRC staff should not revise 10 CFR 35.75 to read 5 mSv/year (0.5 10/23/07 Not accepted Closed rem/year).

33 NRC staff should modify 10 CFR 35.491(b)(2) to specify 'superficial Open ophthalmic treatments. Additionally, NRC staff should change the title of 10/22/07 Accepted Delayed 10 CFR 35.491 to specify superficial ophthalmic treatments.

34 NRC staff should not revise 10 CFR 35.491 (intended for ophthalmologists) to include training and experience for the new Partially Open 10/22/07 intraocular device. Instead, NRC staff should regulate the new intraocular Accepted Delayed device under 10 CFR 35.490.

35 NRC staff should not require medical licensees regulated under 10 CFR Closed 35.400, 500, or 600, as applicable, to only use the sealed sources and 10/22/07 Accepted 3/7/18 devices for the principle use as approved in the SSDR.

36 NRC staff should revise 10 CFR 35.290 to allow physicians to receive Closed training and experience in the elution of generators and preparation of kits 10/22/07 Accepted 3/7/18 under the supervision of an ANP.

6

Retrieved from "https://kanterella.com/w/index.php?title=ML18099A220&oldid=1939292"