Information Notice 2007-31, U.S. Food and Drug Administration Announcement Related to Sleep Disorder Drugs
| ML071650373 | |
| Person / Time | |
|---|---|
| Issue date: | 11/13/2007 |
| From: | NRC/NMSS/FCSS, NRC/NRR/ADRO/DPR |
| To: | |
| Amy Steen, NSIR/DSP/DDRS/RSLPB | |
| References | |
| IN-07-031 | |
| Download: ML071650373 (7) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR REACTOR REGULATION
OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS
WASHINGTON, DC 20555-0001 November 13, 2007 NRC INFORMATION NOTICE 2007-31: U.S. FOOD AND DRUG ADMINISTRATION
ANNOUNCEMENT RELATED TO CERTAIN
SLEEP DISORDER DRUGS
ADDRESSEES
All holders of operating licenses for nuclear power reactors and Category I fuel cycle facilities, except licensees for reactors who have permanently ceased operations and have certified that
fuel has been permanently removed from the reactor vessel.
PURPOSE
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to
provide information regarding a March 14, 2007, U.S. Food and Drug Administration (FDA)
announcement related to certain sleep disorder drugs. The information described in the
announcement could be applicable to a licensees Fitness-for-Duty Program (FFD), Behavioral
Observation Program (BOP), and Employee Assistance Program (EAP). The NRC expects that
recipients will review this information for applicability to their facilities and consider actions, as
appropriate. However, this IN contains no new NRC requirements, and, therefore, no specific
action or written response is required.
DESCRIPTION OF CIRCUMSTANCES
On March 14, 2007, the FDA1 requested that manufacturers of sleep disorder, or
sedative-hypnotic drugs strengthen their product labeling to include stronger language
concerning potential risks. These risks included complex sleep-related behaviors, which may
include sleep-driving. The FDA announcement listed the name of the drugs and
manufacturers. This class of drugs is widely advertised in both television and print media.
In addition to the complex sleep-related behaviors noted above, there are other potential
side-effects. For example, one drug cited in the FDA announcement had the following
side-effects (taken from the manufacturers web site): more outgoing or aggressive behavior
than normal, confusion, strange behavior, agitation, and hallucinations.
1 http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html
BACKGROUND
Title 10 of the Code of Federal Regulations (10 CFR) Part 26, Fitness for Duty Programs, Section 26.10, General Performance Objectives, states that FFD programs must provide
reasonable assurance that nuclear power plant personnel...and personnel of licensees
authorized to possess or use formula quantities of [strategic special nuclear material]
SSNM...will perform their tasks in a reliable and trustworthy manner and are not under the
influence of any substance, legal or illegal, or mentally or physically impaired from any cause, which in any way adversely affects their ability to safely and competently perform their duties.
The BOP is the primary method of ensuring the continued trustworthiness and reliability of
personnel after unescorted access has been granted. The BOP looks for behavior that
indicates impairment. The Implementing Guidance for Access Authorization in Current Threat
Environment dated January 7, 2003 (Safeguards Information, EA 02-261, Enclosure 4),
provides criteria for determining trustworthiness and reliability related to meeting the
requirements of 10 CFR 26.10. EAP staff are required to inform licensee management when a
determination has been made that any individuals condition constitutes a hazard to himself, herself, or others. The behaviors identified (e.g., aggressive behavior) in the FDA
announcement and the potential side-effects noted by manufacturers may influence an EAP
providers determination and subsequent report.
DISCUSSION
There is no regulatory requirement that prohibits licensee personnel from taking the properly
prescribed sleep disorder drugs listed in the March 14, 2007, FDA announcement. This IN
serves to make licensees aware of the FDA announcement that describes potential side-effects
of these commonly prescribed sleep disorder drugs. The BOP plays an important part in
satisfying the FFD requirements of 10 CFR Part 26 by looking for behavior that would indicate
impairment by any cause, that would adversely affect an individuals ability to safely and
competently perform his or her duties.
CONTACT
This information notice requires no specific action or written response. Please direct any
questions about this matter to the technical contact listed below.
/RA/
/RA by TQuay for/
Robert C. Pierson, Director Michael J. Case, Director
Division of Fuel Cycle Safety Division of Policy and Rulemaking
and Safeguards Office of Nuclear Reactor Regulation
Office of Nuclear Materials Safety
and Safeguards
Technical Contact:
Amy J. Steen, NSIR
301-415-0728 E-mail: axs13@nrc.gov
Enclosure: Recently Issued FSME/NMSS
Generic Communications
Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under Electronic Reading Room/Document Collections.
CONTACT
This information notice requires no specific action or written response. Please direct any
questions about this matter to the technical contact listed below.
/RA/ /RA by TQuay for/
Robert C. Pierson, Director Michael J. Case, Director
Division of Fuel Cycle Safety Division of Policy and Rulemaking
and Safeguards Office of Nuclear Reactor Regulation
Office of Nuclear Materials Safety
and Safeguards
Technical Contact:
Amy J. Steen, NSIR
301-415-0728 E-mail: AXS13@NRC.GOV
Enclosure: Recently Issued FSME/NMSS
Generic Communications
Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under Electronic Reading Room/Document Collections.
DISTRIBUTION:
DSP r/f RIDSNSIRDSO RIDSNSIROD RIDSNSIRDSOLPSB
ADAMS Accession Number: ML071650373 OFC NSIR:DSO:LPSB TECH EDITOR BC:NSIR:DSO/LPSB DD:NSIR:DDSP D:NSIR:DSO FSME:MSSA
NAME DHase HChang GWest RWay DDorman AMcIntosh
DATE 06/21/ 2007 06/21/2007 06/29/2007 08/17/2007 09/4/2007 09/10/2007 OFC LA:PGCB:DPR PGCB:DPR BC:PGCB:DPR D:DPR NMSS:FCSS
NAME CHawes CMH DBeaulieu MMurphy Tquay for MCase RPierson
DATE 09 /14/2007 09 /14/2007 09/21/2007 11/13/2007 10/2/2007 OFFICIAL RECORD COPY Recently Issued FSME/NMSS Generic Communications
Date GC No. Subject
Addressees
02/02/07 IN-07-03 Reportable Medical Events All U.S. Nuclear Regulatory Commission
Involving Patients Receiving medical use licensees and NRC Master
Dosages of Sodium Materials Licensees. All Agreement State
Iodide Iodine-131 less than the Radiation Control Program Directors and
Prescribed Dosage Because of State Liaison Officers.
Capsules Remaining in Vials after
Administration
02/28/07 IN-07-08 Potential Vulnerabilities of Time- All U. S. Nuclear Regulatory Commission
reliant Computer-based Systems licensees and all Agreement State
Due to Change in Daylight Saving Radiation Control Program Directors and
Time Dates State Liaison Officers.
03/13/07 IN-07-10 Yttrium-90 Theraspheres and All U.S. Nuclear Regulatory Commission
Sirspheres Impurities (NRC) Medical Licensees and NRC
Master Materials Licensees. All
Agreement State Radiation Control
Program Directors and State Liaison
Officers.
04/04/07 IN-07-13 Use of As-Found Conditions to All licensees authorized to possess a
Evaluate Criticality-related Process critical mass of special nuclear material.
Upsets at Fuel Cycle Facilities
05/02/07 IN-07-16 Common Violations of the All licensees who are implementing the
Increased Controls Requirements U.S. Nuclear Regulatory Commission
and Related Guidance Documents (NRC) Order Imposing Increased Controls
(EA-05-090), issued November 14, 2005 and December 22, 2005.
05/21/07 IN-07-19 Fire Protection Equipment Recalls All holders of operating licenses for
and Counterfeit Notices nuclear power reactors and fuel cycle
facilities; except those licensees for
reactors that have permanently ceased
operations and who have certified that
fuel has been permanently removed from
the reactor vessel; and except those
licensees for decommissioned fuel cycle
facilities.
06/11/07 IN-07-20 Use of Blank Ammunition All power reactors, Category I fuel cycle
facilities, independent spent fuel storage
installations, conversion facility, and
gaseous diffusion plants. Date GC No. Subject
Addressees
08/08/07 IN-07-23 Inadvertent Discharge of Halon All holders of operating licenses for
1301Fire-suppression System from nuclear power reactors, except those who
Incorrect and/or Out-of-date have permanently ended operations and
Procedures have certified that fuel has been
permanently removed from the reactor
vessel. All holders of licenses for fuel
cycle facilities.
07/19/07 IN-07-25 Suggestions from the Advisory All U.S. Nuclear Regulatory Commission
Committee on the Medical Use of (NRC) medical-use licensees and NRC
Isotopes For Consideration to Master Materials Licensees. All
Improve Compliance With Sodium Agreement State Radiation Control
Iodide I-131 Written Directive Program Directors and State Liaison
Requirements in 10 CFR 35.40 Officers.
and Supervision Requirements in
08/13/07 IN-07-26 Combustibility of Epoxy Floor All holders of operating licenses for
Coatings at Commercial Nuclear nuclear power reactors and fuel cycle
Power Plants facilities except licensees for reactors that
have permanently ceased operations and
who have certified that fuel has been
permanently removed from the reactor
vessel.
03/01/07 RIS-07-03 Ionizing Radiation Warning Symbol All U.S. Nuclear Regulatory Commission
licensees and certificate holders. All
Radiation Control Program Directors and
State Liaison Officers
03/09/07 RIS-07-04 Personally Identifiable Information All holders of operating licenses for
Submitted to the U.S. Nuclear nuclear power reactors and holders of and
Regulatory Commission applicants for certificates for reactor
designs. All licensees, certificate holders, applicants, and other entities subject to
regulation by the U.S. Nuclear Regulatory
Commission (NRC) of the use of source, byproduct, and special nuclear material
03/20/07 RIS-07-05 Status and Plans for All NRC materials licensees, Radiation
Implementation of NRC Regulatory Control Program Directors, State Liaison
Authority for Certain Naturally- Officers, and NRCs Advisory Committee
occurring and Accelerator- on the Medical Uses of Isotopes
produced Radioactive Material
04/05/07 RIS-07-07 Clarification of Increased Controls All U.S. Nuclear Regulatory Commission
for Licensees That Possess (NRC) licensees issued NRCs Order
Collocated Radioactive Material Imposing Increased Controls and all
During Transportation Activities Radiation Control Program Directors and
State Liaison Officers Date GC No. Subject
Addressees
05/04/07 RIS-07-09 Examples of Recurring Requests All holders of, and applicants for, a: (1) 10
for Additional Information (RAIs) for CFR Part 71 certificate of compliance
10 CFR Part 71 and 72 (CoC) for a radioactive material
Applications transportation package; (2) 10 CFR Part
72 CoC for a spent fuel storage cask; and
(3) 10 CFR Part 72 specific license for an
independent spent fuel storage
installation (ISFSI).
06/27/07 RIS-06-27, Availability of NRC 313A Series of All U.S. Nuclear Regulatory Commission
Suppl. 1 Forms and Guidance for Their (NRC) medical-use licensees and NRC
Completion Master Materials licensees. All Radiation
Control Program Directors and State
Liaison Officers.
05/15/07 RIS-07-10 Subscriptions To New List Server All U.S. Nuclear Regulatory Commission
For Automatic Notifications Of (NRC) medical-use licensees and NRC
Medical-Related Generic Master Materials licensees. All Radiation
Communications, Federal Register Control Program Directors and State
Notices And Newsletters Liaison Officers.
Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under Electronic Reading Room/Document Collections.