ML20028H398
| ML20028H398 | |
| Person / Time | |
|---|---|
| Issue date: | 12/10/1990 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| REF-10CFR9.7 NUDOCS 9101020327 | |
| Download: ML20028H398 (8) | |
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RELEASED TO THE PDR UNITED STATES rT NUCLEAR REGULATORY COMMISSIOBP lbI W ASHIN GT ON, D.C, 20556 O
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OF FICE OF THE
~ SECRETARY December 10 1990 4
MEMORANDUM FOR:
James M. Taylor Executive Director for Operations FROM:
1 J.
Chilk, Secretary
SUBJECT:
SECY-90-356 - SECY-90-117/SECY-89-263 ROTATION OF MEMBERSHIP, ADVISORY COMMITTEE ON-THE-MEDICAL USES OF ISOTOPES (ACMUI)
This is.to advise you-that the Commission (with all Commissioners agreeing) Lhas. approved -. the following actions in response.to the plans outlined in the Subject Paper.
1).
The' Commission L. approves the staf f 's - plans to expand the membership'of-.the ACMUI to improve'the balance'of its advice
.on technical and policy issues.
Staff should' ensure that all individuals ' considered for. membership have the appropriate credentials.and-that.the Committee is kept_to a size that can perform offectively.
The quality of the advice from the committee should not-be compromised for the sake of expanded j
representation.- The 17 member Committee proposed in the paper may makeLiit' difficult to reach =a consensus onfmany issues..
Accordingly, the : staf f should consider tho' possibility of bringing on the. -members -with expertise in hospital-
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administration-and
-monoclonal antibody-
.research
-as replacements for members whose terms will"be. expiring rather-than'appo'inting them'~as additional members. -By seeking-members who. can provide imore than one perspective (e.g.,
nuclear medicine and medicalfresearch) the staff may be able to. balance the representation on the-Committee while i
minimizing the number of.-additional members.
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SECY. NOTE:
This SRM, the subject SECY paper and the vote wheets-
.of Commissionera Curtiss and-Rogers will be made publicly available in 10 working days from the date of this SRM.
i 9101020327 903p39 PDR 10CFR M
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The Commission does not support a 5 year term for ACMUI members at this time.
The Commission has agreed that members shculd be approved for a term of two years.
(The Commission notes that Manual Chapter 4139, Part I,
A.9.C.
requires reappointment of the ACMUI members at the end of the first year of the two year term. )
If the staf f desires to reappoint members to additional two year terms, Commission approval should be sought for each case.
The Commission may be willing to reconsider a longer term at a later date when additional experience has demonstrated that the ACMUI has operated offectively as a group and provides the NRC with consensus views.
3)
The Commission agreed to the attached letters to FDA and PHS and the attached Federal Register Notice.
Attachments:
As stated cc:
Chairman Carr Commissioner Rogers Commissioner Curtiss Commissioner Remick OGC GPA
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vy'o UNITED STATES I
!3 NUCLEAR REGULATORY COMMISSION f
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CHAIRMAN James O.
- Mason, M.D.
Assistant Secretary of Health U.S.
Public Health Service Hubert H. Humphrey Building 200 Independence Avenue, S.W.
Washington, D.C.
20201 Deer Dr. Mason:
I am writing to request your assistance in the Nuclear Regulatory Commission's (NRC's) efforts to expand the membership and enhance the effectiveness of our Advisory Committee on the Medical Uses of Isotopes (ACMUI).
We believe that a member of the U.S.
Public Health Service (USPHS) with broad knowledge of national medical policy issues could make substantial contributions to our-ACMUI as it develops recommendations on NRC regulatory policy and guidance.
Therefore, we invite you to designate an employee of the USPHS to serve as a member of the Advisory Committee.
The ACMUI advises the NRC on policy and technical issues that arise in regulating the medical use of byproduct material (radioisotopes) for diagnosis and therapy.
Responsibilities include providing guidance and comments on changes in NRC rules, regulations, and guides concerning medical use; evaluating certain non-routine uses of byproduct material for medical use; and providing technical assistance in licensing, inspection, and enforcement cases.
The ACMUI will meet approximately twice a year in the Washington metropolitan area.
We recognize that the USPHS employee you may select might only present their individual views based on personal knowledge and experience and not necessarily the views of the USPHS.
You may also wish to designate an alternate, who could vote in place of your. designated representative.
Because members of NRC Advisory Committees are subject to pre-appointment conflict of interest reviews, the designate and alternate you select will be considered members of the ACMUI for this purpose.
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James O.
- Mason, M.D.
-2 I hope you will be able to assist us by designating an USPHS employee to serve on this important advisory committee.
If you
- have any questions, please contact me or Richard E.
Cunningham, Director of the Division of Industrial and Medical Nuclear Safety.
Mr. Cunningham can be reached by telephone at 492-3426.
Sincerely, Kenneth M.
Carr
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UNITED STATES SIm)g NUCLEAR REGULATORY COMMISSION g-4j W ASHING TON, D. C. 20555
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CHAMMAN Mr. James S.
Denson Acting Commissioner of Food and Drugs
'U.S.
Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857
Dear Mr. Benson:
I am writing to request your assistance in the Nuclear Regulatory Commission's (NRC's) efforts to expand the membership and enhance
~
the effectiveness of our Advisory-Committee on the Medical Uses of Isotopes -(ACMUI).
Because both NRC and FDA exercise regulatory _ responsibilities governing the medical use of byproduct material, we believe that a member of the Food and Drug Administration staff could make-substantial contributions to our
'ACMUI-as it develops recommendations on NRC regulatory policy and guidance. _Therefore, we invite-you to designate an FDA employee with experience in biologics, drugs, and medical devices to serve as a member of-the Advisory Committee.
The ACMUI advises-the NRC on policy and technical issues that arise in regulating the medical use of byproduct material for diagnosis and therapy.
Responsibilities-include providing guidance _and_ comments on changes in NRC rules, regulations, and guides concerning medical _use; evaluating cortain non-routine uses of byproduct _ material for-medical use; and providing technical assistance'in-licensing,-inspection, and enforcement The ACMUI will meet approximately twice a year in the c a s e s.--
. Washington metropolitan area.
We recognize-that the FDA employee you may select might only present their individual views based on personal knowledge and
= experience and not necessarily the_ views-of-the FDA.
NRC will continue _to work directly with the FDA to obtain the FDA's
. official position on issues common to both agencies.
We also recognize that FDA has three distinct Centers that handle
' biologics, drugs, and medical devices, and taat_it may.not be practical to have only one-FDA representative.-
Therefore, you may want to. designate a single representative from one of the centers, and alternates from tne other two centers.
The FDA-designated representative should be the primary point of contact with NRC with respect to ACMUI activities and would be a voting member of the ACMUI.
Any alternate that you select could vote in place of the designated representative.
Because members of NRC
Mr. James S.
Denson
-2 advisory com.aittees are subject to pre-appointment conflict of interest reviews, the designate and alternates you select will be considered members of ACMUI for this purpose.
I hope you will be able to assist us by designating an FDA employee to serve on this important advisory committee.
If you have any questions, please contact me or Richard E. Cunningham, Director of the Division of Industrial and Medical Nuclear Safety.
Mr. Cunningham can be reached by telephone at 492-3426.
l sincerely, Kenneth M.
Carr i
[75904) 1 I
NUCLEAR REGULATORY COMMISSION Nominat'ons for New Members of the Advisory Committee on the Medical Uses of Isotopes AGENCY:
Nuclear Regulatory Commission.
ACTION:
Call for Nominations.
SUMMARY
The Nuclear Regulatory Commission (NRC) is increasing membership on its Advisory Committee on the Medical Uses of isotopes (ACMUI) and is inviti nominations of qualified individuals from public interest groups representing patients' rights and care, individuals having expertise in state regulatory programs governing medicine, and individuals having expert qualifications in certain medical specialty fields.
DATES:
Nominations due by
, 1990.
ADDRESS:
Submit nominations to:
Secretary of the Commission, ATTN:
' Advisory Committee Management Officer, Nuclear Regulatory Commission, Washington, DC 20555 FOR FURTHER INFORMATION CONTACT:
Larry Camper, Medical, Academic, and Commercial Use Safety Branch, MS 6-H-3, U.S. Nuclear Regulatory Commission Washington, DC 20555, telepnone (301) 492-3417.
SUPPLEMENTARY INFORMATION: The ACHUI advises the NRC material for diagnosis and therapy.and technical issues that arise in regulat n policy
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guidance and comments on changes in NRC rules, regulationsResponsibilities include concerning medical use; evaluating certain non routine uses, of byproduct and guides material for medical use; and providing technical assistance in licensing, inspection, and enforcement cases.
Committee members possess the medical and technical specialty skills needed to address evolving issues.
The ACMUI currently consists of two physician specialists in therapeutic radiology; four physician specialists in and nuclear cardiology; one nuclear medicine technologis and two specialists in medical physics.
Because NRC is now examining issues such as quality assurance, and training and experience criteria, it is appropriate to expand the ACMUI's experience base to-include new members who not only are technically qualified, but also can represent patients' interests or have experience from the perspective of the States on the regulation of radioactive material for medical use. \\
(7590-1)
NRC is_ soliciting nominations r,f persons to fill the following three openings on the. AMUI; an individual qualified to address patients' rights and care, a person with broad experience ie medical regulation as conducted by the individual States, and a brachi;t.nceapy physician.
Persons who can provide perspectives from organizations on patients' rights and care, or regulatory agencies of States, as well as physicians having expertise in brachytherapy are encouraged to apply.
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Committee members will serve andt 'Mited te+by::r :pp-+ntmentr Nominations must include a resume describing the educational and professional qualifications of the nominee, and provide the nominee's current address and telephone number.
Nominees must be U.S. citizens and be'able to devote approximately 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> per year to committee business.
Members will be compensated and reimbursed for travel (including per diem in lieu of subsistence),
secretarial, and correspondence expenses.
Dated at Washington, DC, this day of 1990.
FOR THE U. S. NUCLEAR REGULATORY COMMISSION John C. Hoyle Advisory Committee Management Officer 2-