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) | |
1http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html
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.
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
Involving Patients Receiving
Dosages of Sodium
Iodide Iodine-131 less than the
Prescribed Dosage Because of
Capsules Remaining in Vials after
Administration
All U.S. Nuclear Regulatory Commission
medical use licensees and NRC Master
Materials Licensees. All Agreement State
Radiation Control Program Directors and
State Liaison Officers.
02/28/07 IN-07-08 Potential Vulnerabilities of Time- reliant Computer-based Systems
Due to Change in Daylight Saving
Time Dates
All U. S. Nuclear Regulatory Commission
licensees and all Agreement State
Radiation Control Program Directors and
State Liaison Officers.
03/13/07 IN-07-10
Sirspheres Impurities
All U.S. Nuclear Regulatory Commission
(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
Evaluate Criticality-related Process
Upsets at Fuel Cycle Facilities
All licensees authorized to possess a
critical mass of special nuclear material.
05/02/07 IN-07-16
Common Violations of the
Increased Controls Requirements
and Related Guidance Documents
All licensees who are implementing the
U.S. Nuclear Regulatory Commission
(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
and Counterfeit Notices
All holders of operating licenses for
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
1301Fire-suppression System from
Incorrect and/or Out-of-date
Procedures
All holders of operating licenses for
nuclear power reactors, except those who
have permanently ended operations and
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
Committee on the Medical Use of
Isotopes For Consideration to
Improve Compliance With Sodium
Iodide I-131 Written Directive
Requirements in 10 CFR 35.40
and Supervision Requirements in
All U.S. Nuclear Regulatory Commission
(NRC) medical-use licensees and NRC
Master Materials Licensees. All
Agreement State Radiation Control
Program Directors and State Liaison
Officers.
08/13/07 IN-07-26
Combustibility of Epoxy Floor
Coatings at Commercial Nuclear
Power Plants
All holders of operating licenses for
nuclear power reactors and fuel cycle
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
Submitted to the U.S. Nuclear
Regulatory Commission
All holders of operating licenses for
nuclear power reactors and holders of and
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
Implementation of NRC Regulatory
Authority for Certain Naturally- occurring and Accelerator- produced Radioactive Material
All NRC materials licensees, Radiation
Control Program Directors, State Liaison
Officers, and NRCs Advisory Committee
on the Medical Uses of Isotopes
04/05/07 RIS-07-07
Clarification of Increased Controls
for Licensees That Possess
Collocated Radioactive Material
During Transportation Activities
All U.S. Nuclear Regulatory Commission
(NRC) licensees issued NRCs Order
Imposing Increased Controls and all
Radiation Control Program Directors and
State Liaison Officers Date
GC No.
Subject
Addressees
05/04/07 RIS-07-09
Examples of Recurring Requests
for Additional Information (RAIs) for
10 CFR Part 71 and 72
Applications
All holders of, and applicants for, a: (1) 10
CFR Part 71 certificate of compliance
(CoC) for a radioactive material
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, Suppl. 1
Availability of NRC 313A Series of
Forms and Guidance for Their
Completion
All U.S. Nuclear Regulatory Commission
(NRC) medical-use licensees and NRC
Master Materials licensees. All Radiation
Control Program Directors and State
Liaison Officers.
05/15/07 RIS-07-10
Subscriptions To New List Server
For Automatic Notifications Of
Medical-Related Generic
Communications, Federal Register
Notices And Newsletters
All U.S. Nuclear Regulatory Commission
(NRC) medical-use licensees and NRC
Master Materials licensees. All Radiation
Control Program Directors and State
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.