POLICY ISSUE

NOTATION VOTE

August 26, 2003 SECY-03-0149

FOR: The Commissioners

FROM: William D. Travers

Executive Director for Operations

SUBJECT: PROPOSED AMENDMENT TO THE CHARTER OF THE

ADVISORY COMMITTEE ON THE MEDICAL USES OF

ISOTOPES

PURPOSE:

This memorandum requests Commission approval of the staff’s proposed amendment to the

charter of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) so that staff may

utilize the ACMUI as consultants on medical related matters.

BACKGROUND:

The ACMUI advises U.S. Nuclear Regulatory Commission on technical issues that arise

regarding the medical uses of byproduct material. The Committee provides information to the

NRC concerning the potential impact of regulations on the medical community and regulatory

matters that may affect the treatment of patients.

Periodically, the staff encounters issues related to the medical use of byproduct material for

which it would be useful to have timely input from a consultant with relevant expertise. For

example, the staff occasionally receives licensee requests for exemption from the training and

experience requirements in 10 CFR Part 35 that the licensee normally must meet in order to be 

CONTACT: Angela R. Williamson, NMSS/IMNS

301-415-5030
The Commissioners 2

granted recognition as an Authorized Medical Physicist. Because of the complexity of issues

that are encountered while reviewing these applications, the staff may require timely expert

advice on resolving these issues, to maintain safety while not impeding necessary health 

care delivery.

DISCUSSION:

During its May 20-21, 2003, public meeting, the ACMUI expressed a desire to assist the staff in

resolving matters related to the medical use of byproduct material. The Committee reiterated

its willingness to assist the staff during the Commission briefing on May 28, 2003. Since the

ACMUI is comprised of professional clinicians, who routinely apply the medical regulations in 

10 CFR Part 35 to their professional activities, the staff believes that the ACMUI can provide

valuable advice and insights as consultants on medical issues.

The ACMUI’s charter currently restricts its role to that of advisors to the staff regarding the

application of 10 CFR Part 35 to the regulated medical community. The staff believes it is

necessary to amend the charter to enable ACMUI members to serve as consultants, to assist in

resolving issues, when the staff determines such assistance is necessary. Attached is a copy

of the revised charter and a redline-strike out version showing the proposed changes.

In addition to amending the charter so that ACMUI’s scope of service is expanded, other small

editing updates are necessary. For example, the name of the Director, Industrial and Medical

Nuclear Safety, was updated to reflect the current Director, Charles L. Miller, PhD.

COORDINATION:

The Office of the General Counsel has no legal objection.

RECOMMENDATION: 

The staff recommends Commission approval of the proposed modification of the ACMUI

charter as indicated in the attachment, to allow for the use of ACMUI members as consultants

on an as-needed basis.

 /RA/

William D. Travers

Executive Director

 for Operations

Attachments: 

1. Amended ACMUI Charter

2. Redline-Strike Out Version
UNITED STATES NUCLEAR REGULATORY COMMISSION 

CHARTER FOR THE ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES

(Pursuant to Section 9 of Public Law 92-463)

1. Committee’s Official Designation:

Advisory Committee on the Medical Uses of Isotopes

2. Committee’s objectives, scope of activities and duties are as follows:

The Committee provides advice, as requested by the Director, Division of Industrial and

Medical Nuclear Safety, Office of Nuclear Materials Safety and Safeguards, on policy

and technical issues that arise in regulating the medical use of byproduct material for

diagnostic and therapeutic nuclear medicine. The Committee may provide consulting

services as requested by the Director, IMNS

3. Time period (duration of this Committee):

From March 20, 2002, to March 20, 2004

4. Official to whom this Committee reports:

Charles L. Miller, Director

Division of Industrial and Medical Nuclear Safety

Office of Nuclear Material Safety and Safeguards

U.S. Nuclear Regulatory Commission

Washington, DC 20555

5. Agency responsible for providing necessary support to this Committee:

U.S. Nuclear Regulatory Commission

6. The duties of the Committee are set forth in Item 2 above.

7. Estimated annual direct cost of this Committee:

a. $160,000.00 (includes travel, per diem, and compensation)

b. Total staff-year of support: 1.5 Full Time Equivalent

8. Estimated number of meetings per year:

Three meetings per year, except when active rulemaking is conducted, then five

meetings per year.
Charter, ACMUI

9. The Committee’s termination date.

April 4, 2004

10. Filing date: 

March 20, 2002

 

Andrew L. Bates

Advisory Committee Management

Officer

Office of the Secretary of the 

Commission
UNITED STATES NUCLEAR REGULATORY COMMISSION 

CHARTER FOR THE ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES

(Pursuant to Section 9 of Public Law 92-463)

1. Committee’s Official Designation:

Advisory Committee on the Medical Uses of Isotopes

2. Committee’s objectives, scope of activities and duties are as follows:

The Committee provides advice, as requested by the Director, Division of Industrial and

Medical Nuclear Safety, Office of Nuclear Materials Safety and Safeguards, on policy

and technical issues that arise in regulating the medical use of byproduct material for

diagnostic and therapy. The Committee may provide consulting services as requested

by the Director, IMNS.

3. Time period (duration of this Committee):

From March 20, 2002, to March 20, 2004

4. Official to whom this Committee reports:

Donald A. Cool Charles L. Miller, Director

Division of Industrial and Medical Nuclear Safety

Office of Nuclear Material Safety and Safeguards

U.S. Nuclear Regulatory Commission

Washington, DC 20555

5. Agency responsible for providing necessary support to this Committee:

U.S. Nuclear Regulatory Commission

6. The duties of the Committee are set forth in Item 2 above.

7. Estimated annual direct cost of this Committee:

a. $160,000.00 (includes travel, per diem, and compensation)

b. Total staff-year of support: 1.5 FTE Full Time Equivalent

8. Estimated number of meetings per year:

Three meetings per year, except when active rulemaking is conducted, then five

meetings per year.
Charter, ACMUI

9. The Committee’s termination date.

April 4, 2004

10. Filing date: 

March 20, 2002

 

Andrew L. Bates

Advisory Committee Management

Officer

Office of the Secretary of the 

Commission
The Commissioners

granted recognition as an Authorized Medical Physicist. Because of the complexity of issues

that are encountered while reviewing these applications, the staff may require timely expert

advice on resolving these issues, to maintain safety while not impeding necessary health 

care delivery.

DISCUSSION:

During its May 20-21, 2003, public meeting, the ACMUI expressed a desire to assist the staff in

resolving matters related to the medical use of byproduct material. The Committee reiterated

its willingness to assist the staff during the Commission briefing on May 28, 2003. Since the

ACMUI is comprised of professional clinicians, who routinely apply the medical regulations in 

10 CFR Part 35 to their professional activities, the staff believes that the ACMUI can provide

valuable advice and insights as consultants on medical issues.

The ACMUI’s charter currently restricts its role to that of advisors to the staff regarding the

application of 10 CFR Part 35 to the regulated medical community. The staff believes it is

necessary to amend the charter to enable ACMUI members to serve as consultants, to assist in

resolving issues, when the staff determines such assistance is necessary. Attached is a copy

of the revised charter and a redline-strike out version showing the proposed changes.

In addition to amending the charter so that ACMUI’s scope of service is expanded, other small

editing updates are necessary. For example, the name of the Director, Industrial and Medical

Nuclear Safety, was updated to reflect the current Director, Charles L. Miller, PhD.

COORDINATION:

The Office of the General Counsel has no legal objection.

RECOMMENDATION: 

The staff recommends Commission approval of the proposed modification of the ACMUI

charter as indicated in the attachment, to allow for the use of ACMUI members as consultants

on an as-needed basis.

 /RA/

William D. Travers

Executive Director

 for Operations

Attachments: 

1. Amended ACMUI Charter

2. Redline-Strike Out Version

ML031920082 *See previous concurrence

OFC IMNS Editor IMNS IMNS IMNS NMSS

NAME AWilliamson* EKraus 

(by fax)*

MMarkley* TEssig*

(MBailey for)

CMiller* MVirgilio

DATE 7/14/03 7/10/03 7/23/03 7/23/03 8 /11 /03 8/14/03

OFC OGC DEDMRS EDO

NAME STreby* CPaperiello WTravers

DATE 8 /03 /03 08/25/03 08/26/03

OFFICIAL RECORD COPY