ML20248B439
| ML20248B439 | |
| Person / Time | |
|---|---|
| Issue date: | 05/21/1998 |
| From: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Diaz N, Dicus G, Shirley Ann Jackson, Mcgaffigan E, The Chairman NRC COMMISSION (OCM) |
| Shared Package | |
| ML20248B443 | List: |
| References | |
| NACMUI, NUDOCS 9806010299 | |
| Download: ML20248B439 (5) | |
Text
May 21, 1998 MEMORANDUM TO:
Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan FROM:
L. Joseph Callan M
L.h D Executive Director for Operations
SUBJECT:
ACMUI RESPONSE TO STAFF REQUIREMENTS MEMORANDUM DATED JUNE 5,-1997 - MEETING WITH ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (M970508)
In the above cited Staff Requirements Memorandum addressed to Judith Stitt, M.D., Chairman of the Advisory Committee for the Medical Uses of isotopes (ACMUI) (Attachment 1), the Commissioners requested that the ACMUI take a focused look at revisions to 10 CFR Part 35,
" Medical Use of Byproduct Material." In addition, the Commission directed the ACMUI, when providing its recommendations, to address the questions posed by the Commissioners during the May 1997 meeting.
The ACMUI discussed the SRM at the September 1997 and March 1998 meetings. Subsequent to the May meeting, Chairman Stitt submitted to the staff a formal response to the questions.
J The ACMUI response is forwarded for your information (Attachment 2).
Attachments:
- 1. SRM dtd 6/5/97
- 2. Letter dtd 5/18/98 to Dr. Cool cc:
SECY, OGC, OPA, OCA, CIO, CFO CONTACT: Patricia Vacherlon, NMSS/IMNS (301) 415-6376 Distribution: NMSS 9700316/EDO 9700229 NRC File Center NMSS Dir Off r/f IMNS Central File IMAB rf CEstep CPoland MBridgers EDO r/f LJCallan 1
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DATE 5/
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.a4 ERC F!LF BEilFiEB CDPW 9006010299 980521 PDR ADVCM NACMUI PDR L__.__
_... _. _ _ _. _ ______._._____._____._________.___._____._.___._____________._._.__________._______i
. MEMORANDUM TO:
Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan FROM:
L. Joseph Callan Executive Director for Operations
SUBJECT:
ACMUI RESPONSE TO STAFF REQUIREMENTS MEMORANDUM DATED JUNE 5,1997/ MEETING WITH ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (M970508)
In the above cited Staff Requirements Memorandum addres/
sed to Judith Stitt, M.D., Chairman of the Advisory Committee for the Medical Uses of Isotop5s (ACMUI) (Attachment 1), the Commissioners requested that the ACMUI take a focused look at revisions to 10 CFR Part 35,
" Medical Use of Byproduct Material." In addition, the ommission directed the ACMUI, when providing its recommendations, to address the qu ions posed by the Commissioners during the May 1997 meeting.
/
The ACMUI discussed the SRM at the Septep1 er 1997 and March 1998 meetings. Subsequent to the May meeting, Chairman Stitt submitt9d, to Dr. Cool, a formal response to the questions.
The ACMUI response is forwarded for you/information (Attachment 2).
Attachments:
- 1. SRM dtd 6/5/97
- 2. Letter dtd 5/18/98 to Dr. Cool cc:
SECY, OGC, OPA, OC, CIO, CFO CONTACT: Patricia Vacherip'n, NMSS/IMNS (301) 415-6376'
/
NRC File Center NMSSo)6/EDO 9700229 Distribution: NMSS 97003 ir Off r/f IMNS Central File IMAB rf CEstep CPoland MBridgers EDO /f LJCallan Release to the PDR: J_Yes No A:\\M970508.wpd CP/PRCOFED/MAY 19,1998 OFC lidAB*
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IMAB*
IMNs*
NAME Vacherton EKraus JPiccone DCool DATE
[ 5/14 /98 5/14/98 5/18 /98 5/18 /98 oFC
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- DEDR, EDO NAME aperiello HLTh pson LJCallan 5/ b/98 DATE 5/t /98 5/
/98 OFFICIAL RECORD COPY:
MEMORANDUM TO: Chairm:n Jackson' Commission:r Dicus Commissioner Diaz Commissioner McGaffigan FROM:
L. Joseph Callan Executive Director for Operations
SUBJECT:
ACMUI RESPONSE TO STAFF REQUIRE ENTS MEMORANDUM DATED JUNE 5,1997 - MEETING WITH DVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (AC l} - M970508 In the above cited Staff Requirements Memorandum addr sed to Judith Stitt, M.D., Chairman of the Advisory Committee for the Medical Uses of isoto s (ACMUI)(Attachment 1), the Commissioners requested that the ACMUI take a focu look at revisions to 10 CFR Part 35,
" Medical Use of Byproduct Material." In addition, the ommission directed the ACMUI, when providing its recommendations, to address the que ions posed by the Commissioners during the May 1997 meeting.
The ACMUI discussed the SRM at the Septe r 1997 and March 1998 meetings. Subsequent to the May meeting, Chairman Stitt submitte, to Dr. Cool, a formal response to the questions.
The ACMul response is forwarded for your nformation (Attachment 2).
Attachments:
1.
SRM dated 6/5/97 2.
Letter dated 5/18/98 to Dr. Cool cc:
SECY-OGC OPA OCA CONTACT: Patricia Vacheri n, NMSS (301) 415-637 Distribution: This closes NM, Off r/f IMNS Central File IMAB rf S 9700316.
NRC File Center NMSS Qr CEStep CPoland MBridgers EDO r/f LJCallan File name: A:\\M970508.wpd Release to the PDR: _ _ Yes No X
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HLThompson LJCallan DATE 5/
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198 5/
/98 OFFICIAL RECORD COPY:
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IN RESPONSE, PLEASE REFER TO: M970508 June 5,1997 MEMORANDUM TO:
Judith A. Stitt, Chairman Advisory Committee on Medical Uses of Isotopes l
Karen D. Cyr General Counsel FROM:
John C. Hoyle, Secretary /s/
SUBJECT:
STAFF REQUIREMENTS - MEETING WITH ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI),9:00 A.M., THURSDAY, MAY 8,1997, COMMISSIONERS' CONFERENCE ROOM, ONE WHITE FLINT NORTH, ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE)
The Commission was briefed by the Advisory Committee on Medical Uses of Isotopes (ACMUI) on the Committees' discussions on DSI-7 and the revision of 10 CFR Part 35.
The Commission requested the ACMUI to take a focused look at revisions to Part 35, including test cases, as the Commission moves toward a more risk-informed, performance-based regulatory program. In providing recommendations, the Committee should address the questions posed by the Commissioners during the meeting, which include the following:
1.
How should the NRC determine which industry standards, including voluntary ones, are adequate to meet the NRC's regulatory responsibility for patient, worker, and public safety? To what extent should NRC allow the licensee flexibility in interpreting or selecting an industry standard? How should the concept of " quality improvement" be incorporated into reliance on industry standards and an accreditation-type of approach to licensing and inspection?
'l 2.
What are the necessary transition steps the NRC should take in order to implement a more positive enforcement program that, in effect, encourages or rewards good performance while addressing the outlyers. What metrics should the NRC use to decide whether the approach is working?
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3.
In considering various events (e.g., misadministration, equipment failures, or procedural errors), what criteria should the NRC use to determine that a particular event is isolated, rather than having program implications for that licensee or generic implications for other medicallicensees? What is the best process for the reporting of events to ensure that the NRC is aware of potential generic issues?
4.
In evaluating errors, should a threshold be established beneath which corrective action is not required? How would such a threshold be set, and how would it be implemented?
The Commission requested OGC to provide an analysis of whether the Atomic Energy Act supports ACMUI's proposal that NRC regulation should tolerate a level of risk in radiation medicine comparable to the level of risk associated with other practices of medicine.
(OGC)
(SECY Suspense:
8/22/97) cc:
Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Diaz Commissioner McGaffigan EDO CFO CIO OCA OlG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)