ML20211A880

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Responds to SRM on SECY-97-012 Re Pros & Cons of Having ACMUI Recommendations Provided Directly to Commission, Concurrent W/Such Provision to Staff
ML20211A880
Person / Time
Issue date: 08/05/1997
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
ML20211A766 List:
References
NACMUI, NUDOCS 9709240431
Download: ML20211A880 (3)


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NUCLEAR REGULATORY COMMISSION

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..... August 5, 1997 MEMORANDUM TO: Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan FROM: ,

L. Joseph Callan Executive Director fofDperations

SUBJECT:

RESPONSE TO STAFF REQUIREMENTS MEMORANDUM SECY-97-012 - PROS AND CONS OF HAVING ADVISORY COMMllTEE ON THE MEDICAL USE OF ISOTOPJS RECOMMENDATIONS PROVIDED DIRECTLY TO THE COMMISSION, CONCURRENT WITH SUCH PROVISION To i THE STAFF Staff Requirements Memorandum - SECY 97-012, ' Appointments of a Physician Practicing Nuclear Cardiology, a Patients' Rights and Care Advocate, and an Individual with State or O Local Govemment Perspective to the Advisory Committee on the Medical Use of Isotopes *

(ACMUI), directed the staff to ' report back to the Commission on the pros and cons of having ACMUl's recommendations provided directly to the Commission, concurrent with such provision to the staff" (Attachment 1) Staffs understanding of the Commission's request focuses on whether or not ACMUI should communicate with the Commission following the same process as that used by the ACRS and ACNW. The ACRS and ACNW are

' Commission level Committees with dedicated stdf to accommodate the technical and administrative issues associated with conducting the affairs of those Committees including providing their recommendations to the Commission. In contrast, ACMUI functions are supported by staff within the Division of Industrial and Medical Nuclear Safety, The current process for providing ACMUI comments is based on direction from the Commission on April 16,1993, in COMSECY 93 013, ' Guidelines on the role, procedures, size, and composition of the Advisory Committee on the Medical Use of Isotopes' I (Attachment 2). This guidance was developed in response to a review of all govemment '

advisory committees in accordance with President's general directions on the use of advisory committees, At that time, the Commission explored the role of all NRC Advisory Committees including the ACMUI and provided specific direction to staff. Some of the key points of the Commission direction were: ACMUI should provide an annual briefing to the Commission, develop bylaws goveming communication between the Committee and the Commission similar to ACRS, and "the Committee shou'd continue to interact with staff to provide such smport as the staff may deem warranted to help accomplish its regulatory missions."

CONTACT: Robert L. Ayres, NMSS/IMNS (301) 415 5746

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9709240431 970923 PDR ADVCM NACMUI PDR ,

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2 As a result of this direction, substantial changes were made in the conduct of ACMUI affairs I

including the development of bylaws for the Committee. ACMUI now provides minutes to the Commission containing the Committees' recommendations, including dissenting opinions which was not done previously, in providing this direction, the Commission appears to have l explored ACMUI as a Commission level Advisory Committee but chose to continue with the l q Committee as a staff level advisory Committee but " encouraged the Committee to adopt l

bylaws goveming communications between the Committee and the Commission along the l lines of the bylaws that have been adopted by the ACRS."

j Recently, ACMUI raised concems as to how its recommendations are considered with respect to the ultimate outcome of regulation and guidance development. Staff has in response, initiated two significant changes in this regard which were discussed with the ACMUI during its last meeting. First, the staff will include a line item in the Statennnts of Consideration for all medical use rulemakings that would address the outcome of ACMUI

recommendations. Secondly, the staff now provides feedback to ACMUl, during subsequent i meetings on the outcome of all Committee recommendations other than rulemaking.

The staff believes the current process is adequate tc, deliver ACMUl recommendations and

opinions to the Commission in timely manner. Currently, the minutes are prepared by the staff in close coordination with the Chairman of the ACMUl, then reviewed and signed by the Chairman. Staff believes further movement toward an ACRS and ACNW process would add further inefficiencies and unnecessary complexity.

, in light of the above, the staff does not recommend any change to the current procedures or process.

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Attachments: 1. SRM - SECY-97-012 l 2. COMSECY-93-013 4

4 cc: SECY OGC

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CFO ClO QISTRIBUTION- EDO 9700032/NMSS 9700072
IMAB r4 NRc Fine Center NMSS r# PTressier HThompson

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JCallan CEstep EDOr4 CPoland NMSS Dir. Off. rn GMmss0072 wbm c=aoormu.sv 4 w To recerve a copy of this document. Indicate in the box: "C* = Copy without attachment *E" = Copy with attachment "N" = No copy OFFICE IMAB E IMAB' l iMAB l Tecn Edmor* l D IMNS* l

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NAME , T DWhne for CHaney LCamper EKraus DACool DATE 6/2997 6/26/97 7/01/97 6/1G97 07/01/97 m m m m  :=- - :-- : m NAME JL w ches CJPaperiello 4 HThompson UCanan DATE 8/V97 8/ 1/97 8/ /97 8/i/97 see previous concur I

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2 As a result of this direction, substantial changes were made in the conduct of ACMUI affairs V including the development of bylaws for the Committee. ACMUI now provides minutes to the Commission containing the Committees' recommendations, including dissenting opinions which was not done previously, in providing this direction, the Commission appears to have explored ACMUI as a Commission level Advisory Committee but chose to continue with the Committee as a staff level advisory Committee but " encouraged the Committee to adopt bylaws goveming communications between the Committee and the Commission along the lines of the bylaws that have been adopted by the ACRS."

l Recently, ACMUI raised concoms as to how its recommendations are considered with i respect to the uttimate outcome of regulation and guidance development. Staff has in

response, initiated two significant changes in this regard which were discussed with the ACMUI during its last meeting. First, the staff willinclude a line item in the Statements of Consideration for all medical use rulemakings that would address the outcome of ACMUI recommendations. Secondly, the staff now provides feedback to ACMUI, during subsequent meetings on the outcome of all Committee recommendations other than rulemaking.

The staff believes the current process is adequate to deliver ACMUI recommendations and opinions to the Commission in timely manner. Currently, the minutes are prepared by the staff in close coordination with the Chairman of the ACMUI, then reviewed and signed by the Chairman. Staff believes further movement toward an ACRS and ACNW process would add further inefficiencies and unnecessary complexity, p

4 I In light of the above, the staff does not recommend any change to the current procedures or process.

V Attachments: 1. SRM - SECY 97-012

2. COMSECY 93-013 cc: SECY OGC OCA OPA CFO ClO

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