[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6098-6100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1570]


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NUCLEAR REGULATORY COMMISSION

[EA 05-110]


In the Matter of Alfred C. Burris, Senior, M.D.; Confirmatory 
Order (Effective Immediately)

    Alfred C. Burris, Senior, M.D. (Dr. Burris) is a self-employed 
cardiologist, who is licensed to practice medicine in the State of 
Maryland and the District of Columbia. Dr. Burris submitted an 
application for an NRC license dated February 2, 2004, to authorize use 
of byproduct material for diagnostic nuclear medicine.
    An investigation was initiated by the NRC Office of Investigations 
(OI) on May 24, 2004, (OI Case No. 1-2004-028) to determine if Dr. 
Burris submitted inaccurate and/or misleading information to the NRC in 
his NRC application to be the sole authorized user (AU) as well as the 
Radiation Safety Officer (RSO) on a license for use of byproduct 
material for medical imaging and diagnostic purposes. During the course 
of this investigation, OI identified that an NRC licensee, a mobile 
cardiac imaging company, may have provided the same inaccurate 
information in support of their amendment request to add Dr. Burris and 
another physician to its NRC materials license as Authorized Users. On 
August 6, 2004, OI initiated a separate investigation (OI Case No. 1-
2004-034) to determine if Dr. Burris submitted false information to an 
NRC

[[Page 6099]]

licensee to become an AU on their existing NRC license. Based on the 
evidence developed during its investigations, OI concluded that Dr. 
Burris deliberately submitted false and/or inaccurate information (1) 
to the NRC as an applicant for an NRC license and (2) to an NRC 
licensee with the purpose to become an AU on their existing NRC 
license. The results of the two investigations were completed by OI on 
April 15, 2005 and June 15, 2005, and were sent to Dr. Burris in two 
letters dated September 15, 2005.
    Subsequent to becoming aware of the details of the apparent 
violation, Dr. Burris took several prompt actions to assure that these 
events would not recur. These actions included: (a) Correcting 
inaccurate information for the record in a letter dated July 26, 2004; 
(b) providing details of the violation to associates in the process of 
getting character references; (c) supplementing his work experience in 
May 2004, when he began working with the nuclear medicine technologists 
at Greater Southeast Community Hospital; and (d) undertaking efforts to 
better understand regulatory requirements through self study and review 
of his consultant's letter of May 4, 2004.
    In response to the NRC's September 15, 2005 letters, Dr. Burris 
requested the use of Alternative Dispute Resolution (ADR) to resolve 
this apparent violation and pending enforcement action. ADR is a 
process in which a neutral mediator, with no decision-making authority, 
assists the NRC and the individual to resolve any disagreements on 
whether a violation occurred, the appropriate enforcement action, and 
the appropriate corrective actions. An ADR session was held between Dr. 
Burris and the NRC in Rockville, MD, on December 1, 2005, and was 
mediated by a professional mediator, arranged through Cornell 
University's Institute of Conflict Management. During that ADR session, 
a settlement agreement was reached. The elements of the settlement 
agreement consisted of the following:
    1. Dr. Burris agreed that he was in violation of NRC requirements 
when, in an application for a new NRC license, dated February 2, 2004, 
Dr. Burris submitted inaccurate information contrary to 10 CFR 30.9(a). 
Specifically, his application indicated that Dr. Burris was listed as 
an authorized user (AU) on the Greater Southeast Community Hospital 
license, when he was not. In addition, the preceptor statement, 
prepared by a radiologist and attached to his application, inaccurately 
described required supervised work experience in handling nuclear 
materials.
    2. While NRC and Dr. Burris agreed the violation was not 
deliberate, NRC maintained that it was in careless disregard of NRC's 
regulation.
    3. Dr. Burris, subsequent to becoming aware of the details of the 
violation, took prompt actions to assure that he learned from this 
violation and provided the NRC with assurance that it would not recur. 
These actions included: (a) Correcting inaccurate information for the 
record in a letter dated July 26, 2004; (b) providing details of the 
violation to associates in the process of getting character references; 
(c) supplementing his work experience in May 2004, when Dr. Burris 
began working with the nuclear medicine technologists at Greater 
Southeast Community Hospital; and (d) undertaking efforts to better 
understand regulatory requirements through self study and review of his 
consultant's letter of May 4, 2004.
    4. During the ADR mediation session, Dr. Burris recognized an 
opportunity for other potential Authorized Users/Radiation Safety 
Officers in the industry to learn from his participation in the NRC 
enforcement process and his experiences regarding the necessity to 
provide complete and accurate information to the NRC. Therefore, Dr. 
Burris agreed to take the following future corrective actions: (a) 
Submit an article for consideration to an appropriate medical journal 
that reaches an audience of cardiologists; (b) offer to speak at a 
training session at a meeting of the American Society of Nuclear 
Cardiology, a similar society, or at a Nuclear Cardiology symposium; 
and (c) write a letter to local cardiologists describing his 
experiences. In addition, Dr. Burris agreed to meet with a hospital RSO 
who has a knowledge of imaging and localization studies in order to 
review NRC requirements.
    5. Dr. Burris agreed to complete the additional actions in Item 4 
within 12 months of the date of the Order, and send a letter to the NRC 
informing the NRC that these actions are completed. Dr. Burris agreed 
to send this letter to the NRC within 30 days of completion of all 
actions.
    6. In light of the actions Dr. Burris took as described in Item 3, 
those actions Dr. Burris has committed to take as described in Item 4, 
and his cooperation in providing information during the ADR session, 
the NRC agreed to issue a Severity Level III Notice of Violation (10 
CFR 30.9) to Dr. Burris with no civil penalty. This action will be 
publicly available in ADAMS, will appear on the NRC ``Significant 
Enforcement Actions--Individuals'' Web site for a period of 1 year, and 
will be discussed in a press release announcing the ADR agreement 
between Dr. Burris and the NRC.
    7. Any license application received from Dr. Burris will be 
reviewed without prejudice.
    8. Dr. Burris agreed to issuance of a Confirmatory Order confirming 
this agreement.
    In light of the actions Dr. Burris has taken and agreed to take to 
correct the violation and prevent recurrence, as set forth in Section 
III above, the NRC has concluded that its concerns regarding the 
violation can be resolved through the NRC's confirmation of the 
commitments as outlined in this Confirmatory Order.
    I find that Dr. Burris' commitments as set forth in Section III 
above are acceptable. However, in view of the foregoing, I have 
determined that these commitments shall be confirmed by this 
Confirmatory Order. Based on the above, and Dr. Burris' consent, this 
Confirmatory Order is immediately effective upon issuance.
    Accordingly, pursuant to Sections 103, 161b, 161i, 161o, 182, and 
186 of the Atomic Energy Act of 1954, as amended, and the Commission's 
regulations in 10 CFR 2.202 and 10 CFR part 30 and 35, it is hereby 
ordered, that:
    1. Dr. Burris will (a) submit an article for consideration to an 
appropriate medical journal that reaches an audience of cardiologists; 
(b) offer to speak at a training session at a meeting of the American 
Society of Nuclear Cardiology, a similar society, or at a Nuclear 
Cardiology symposium; and (c) write a letter to local cardiologists 
describing his experiences. In addition, Dr. Burris agreed to meet with 
a hospital RSO who has a knowledge of imaging and localization studies 
in order to review NRC requirements.
    2. Dr. Burris will complete the actions in Section V.1 within 12 
months of the date of this Order, and send a letter to the NRC 
informing the NRC that these actions are completed within 30 days of 
completion of all actions.
    The Director, Office of Enforcement, may relax or rescind, in 
writing, any of the above conditions upon a showing by Dr. Burris of 
good cause.
    Any person adversely affected by this Confirmatory Order, other 
than Dr. Burris, may request a hearing within 20 days of its issuance. 
Where good cause is shown, consideration will be given to extending the 
time to request a hearing. A request for extension of time must be made 
in writing to the Director, Office of Enforcement, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555, and must include a 
statement of good cause for the extension. Any request for

[[Page 6100]]

a hearing shall be submitted to the Secretary, U.S. Nuclear Regulatory 
Commission, ATTN: Chief, Rulemaking and Adjudications Staff, 
Washington, DC 20555. Copies of the hearing request shall also be sent 
to the Director, Office of Enforcement, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555, to the Assistant General Counsel for 
Materials Litigation and Enforcement, and to the Director of the 
Division of Regulatory Improvement Programs at the same address. 
Because of continuing disruptions in delivery of mail to United States 
Government offices, it is requested that answers and requests for 
hearing be transmitted to the Secretary of the Commission either by 
means of facsimile transmission to 301-415-1101 or by e-mail to 
[email protected] and also to the Office of the General Counsel by 
means of facsimile transmission to 301-415-3725 or e-mail to 
[email protected]. If such a person requests a hearing, that person 
shall set forth with particularity the manner in which his interest is 
adversely affected by this Order and shall address the criteria set 
forth in 10 CFR Sec.  2.309(d) and (f).
    If a hearing is requested by a person whose interest is adversely 
affected, the Commission will issue an Order designating the time and 
place of any hearing. If a hearing is held, the issue to be considered 
at such hearing shall be whether this Confirmatory Order shall be 
sustained. An answer or a request for a hearing shall not stay the 
effectiveness date of this order.

    Dated this 27th day of January, 2006.

    For the Nuclear Regulatory Commission.
Michael Johnson,
Director, Office of Enforcement.
[FR Doc. E6-1570 Filed 2-3-06; 8:45 am]
BILLING CODE 7590-01-P