Information Notice 2007-31, U.S. Food and Drug Administration Announcement Related to Sleep Disorder Drugs: Difference between revisions

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{{#Wiki_filter:1 http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html
{{#Wiki_filter:UNITED STATES


===UNITED STATES===
NUCLEAR REGULATORY COMMISSION
NUCLEAR REGULATORY COMMISSION


===OFFICE OF NUCLEAR REACTOR REGULATION===
OFFICE OF NUCLEAR REACTOR REGULATION
 
OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS
OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS


WASHINGTON, DC 20555-0001 November 13, 2007NRC INFORMATION NOTICE 2007-31: U.S. FOOD AND DRUG ADMINISTRATION
WASHINGTON, DC 20555-0001 November 13, 2007 NRC INFORMATION NOTICE 2007-31:               U.S. FOOD AND DRUG ADMINISTRATION


===ANNOUNCEMENT RELATED TO CERTAIN===
ANNOUNCEMENT RELATED TO CERTAIN


===SLEEP DISORDER DRUGS===
SLEEP DISORDER DRUGS


==ADDRESSEES==
==ADDRESSEES==
All holders of operating licenses for nuclear power reactors and Category I fuel cycle facilities, except licensees for reactors who have perm
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
 
anently ceased operations and have certified that


fuel has been permanently removed from the reactor vessel.
fuel has been permanently removed from the reactor vessel.
Line 39: Line 37:


provide information regarding a March 14, 2007, U.S. Food and Drug Administration (FDA)
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 related to certain sleep disorder drugs.  The information described in the
announcement could be applicable to a licensees Fitness-for-Duty Program (FFD), Behavioral


announcement could be applicable to a licensee's Fitness-for-Duty Program (FFD), Behavioral
Observation Program (BOP), and Employee Assistance Program (EAP). The NRC expects that
 
Observation Program (BOP), and Employee A
 
ssistance Program (EAP). The NRC expects that


recipients will review this information for applicability to their facilities and consider actions, as
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
appropriate. However, this IN contains no new NRC requirements, and, therefore, no specific


action or written response is required.
action or written response is required.


==DESCRIPTION OF CIRCUMSTANCES==
==DESCRIPTION OF CIRCUMSTANCES==
On March 14, 2007, the FDA1 requested that manufacturers of sleep disorder, or


===On March 14, 2007, the FDA===
sedative-hypnotic drugs strengthen their product labeling to include stronger language
1 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
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
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.
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
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. For example, one drug cited in the FDA announcement had the following


side-effects (taken from the manufacturer's web site): more outgoing or aggressive behavior
side-effects (taken from the manufacturers web site): more outgoing or aggressive behavior


than normal, confusion, strange behavior, agitation, and hallucinations.
than normal, confusion, strange behavior, agitation, and hallucinations.
ML071650373
        1 http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html


==BACKGROUND==
==BACKGROUND==
Title 10 of the
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
 
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
reasonable assurance that nuclear power plant personnel...and personnel of licensees


authorized to possess or use formula quantities of [strategic special nuclear material]
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
SSNM...will perform their tasks in a reliable and trustworthy manner and are not under the


influence of any substance, legal or illegal, or
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.


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
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
personnel after unescorted access has been granted. The BOP looks for behavior that


indicates impairment. The Implementing Guidance for Access Authorization in Current Threat
indicates impairment. The Implementing Guidance for Access Authorization in Current Threat


Environment dated January 7, 2003 (Safeguards Information, EA 02-261, Enclosure 4),
Environment dated January 7, 2003 (Safeguards Information, EA 02-261, Enclosure 4),
provides criteria for determining trustworthiness and reliability related to meeting the
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
requirements of 10 CFR 26.10. EAP staff are required to inform licensee management when a


determination has been made that any individual's condition constitutes a hazard to himself, herself, or others. The behaviors identified (e.g., aggressive behavior) in the FDA
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
announcement and the potential side-effects noted by manufacturers may influence an EAP


provider's determination and subsequent report.
providers determination and subsequent report.


==DISCUSSION==
==DISCUSSION==
There is no regulatory requirement that prohibits licensee personnel from taking the properly
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
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
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
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
satisfying the FFD requirements of 10 CFR Part 26 by looking for behavior that would indicate


impairment by any cause, that would adversely
impairment by any cause, that would adversely affect an individuals ability to safely and
 
affect an individual's ability to safely and


competently perform his or her duties.
competently perform his or her duties.


==CONTACT==
==CONTACT==
This information notice requires no specific action or written response. Please direct any
This information notice requires no specific action or written response. Please direct any


questions about this matter to the technical contact listed below.
questions about this matter to the technical contact listed below.


/RA//RA by TQuay for/Robert C. Pierson, Director   Michael J. Case, DirectorDivision of Fuel Cycle Safety      Division of Policy and Rulemaking
/RA/
                                                    /RA by TQuay for/
Robert C. Pierson, Director                         Michael J. Case, Director


and Safeguards  Office of Nuclear Reactor Regulation
Division of Fuel Cycle Safety                        Division of Policy and Rulemaking


Office of Nuclear Materials Safety
and Safeguards                                    Office of Nuclear Reactor Regulation


and Safeguards
===Office of Nuclear Materials Safety===
  and Safeguards


===Technical Contact:===
===Technical Contact:===


===Amy J. Steen, NSIR===
===Amy J. Steen, NSIR===
301-415-0728
                      301-415-0728 E-mail: axs13@nrc.gov
 
E-mail: axs13@nrc.gov


Enclosure: Recently Issued FSME/NMSS
Enclosure: Recently Issued FSME/NMSS
Line 155: Line 141:


==CONTACT==
==CONTACT==
This information notice requires no specific action or written response. Please direct any
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, DirectorDivision of Fuel Cycle Safety      Division of Policy and Rulemaking
questions about this matter to the technical contact listed below.


and Safeguards  Office of Nuclear Reactor Regulation
/RA/                                                /RA by TQuay for/
Robert C. Pierson, Director                          Michael J. Case, Director


Office of Nuclear Materials Safety
Division of Fuel Cycle Safety                       Division of Policy and Rulemaking


and Safeguards
and Safeguards                                    Office of Nuclear Reactor Regulation
 
===Office of Nuclear Materials Safety===
  and Safeguards


===Technical Contact:===
===Technical Contact:===


===Amy J. Steen, NSIR===
===Amy J. Steen, NSIR===
301-415-0728
                      301-415-0728 E-mail: AXS13@NRC.GOV
 
E-mail: AXS13@NRC.GOV


Enclosure: Recently Issued FSME/NMSS
Enclosure: Recently Issued FSME/NMSS
Line 178: Line 166:
Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under Electronic Reading Room/Document Collections.
Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under Electronic Reading Room/Document Collections.


===DISTRIBUTION===
DISTRIBUTION:
:DSP r/fRIDSNSIRDSORIDSNSIROD      RIDSNSIRDSOLPSB
DSP r/f        RIDSNSIRDSO            RIDSNSIROD        RIDSNSIRDSOLPSB


ADAMS Accession Number: ML071650373OFCNSIR:DSO:LPSBTECH EDITORBC:NSIR:DSO/LPSBDD:NSIR:DDSPD:NSIR:DSOFSME:MSSANAMEDHaseHChangGWestRWay DDorman AMcIntosh
ADAMS Accession Number: ML071650373 OFC    NSIR:DSO:LPSB TECH EDITOR BC:NSIR:DSO/LPSB DD:NSIR:DDSP D:NSIR:DSO              FSME:MSSA


DATE06/21/ 200706/21/2007 06/29/2007 08/17/2007 09/4/2007 09/10/2007 OFCLA:PGCB:DPRPGCB:DPRBC:PGCB:DPRD:DPRNMSS:FCSSNAMECHawes CMHDBeaulieuMMurphyTquay for MCaseRPiersonDATE09 /14/2007 09 /14/2007
NAME DHase            HChang        GWest              RWay            DDorman        AMcIntosh
09/21/2007 11/13/
2007 10/2/2007 OFFICIAL RECORD COPY Recently Issued FSME/NMSS Generic Communications DateGC No.Subject


==Addressees==
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
02/02/07IN-07-03Report


able Medical Events
NAME CHawes CMH      DBeaulieu      MMurphy            Tquay for MCase  RPierson


===Involving Patients Receiving===
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


===Dosages of Sodium===
Date    GC No.                  Subject


Iodide Iodine-131 less than the
==Addressees==
 
02/02/07 IN-07-03    Reportable Medical Events            All U.S. Nuclear Regulatory Commission
===Prescribed Dosage Because of===
 
===Capsules Remaining in Vials after===


AdministrationAll U.S. Nuclear Regulatory Commission
Involving Patients Receiving        medical use licensees and NRC Master


medical use licensees and NRC Master
Dosages of Sodium                    Materials Licensees. All Agreement State


===Materials Licensees. All Agreement State===
Iodide Iodine-131 less than the      Radiation Control Program Directors and


===Radiation Control Program Directors and===
Prescribed Dosage Because of        State Liaison Officers.


State Liaison Officers.02/28/07IN-07-08Potential Vulnerabilities of Time-reliant Computer-based Systems
Capsules Remaining in Vials after


===Due to Change in Daylight Saving===
Administration
Time DatesAll U. S. Nuclear Regulatory Commission


licensees and all Agreement State
02/28/07 IN-07-08    Potential Vulnerabilities of Time-  All U. S. Nuclear Regulatory Commission


===Radiation Control Program Directors and===
reliant Computer-based Systems      licensees and all Agreement State


State Liaison Officers.03/13/07IN-07-10Yttrium-90 Theraspheres
Due to Change in Daylight Saving    Radiation Control Program Directors and


and Sirspheres
Time Dates                          State Liaison Officers.


ImpuritiesAll U.S. Nuclear Regulatory Commission (NRC) Medical Licensees and NRC
03/13/07 IN-07-10    Yttrium-90 Theraspheres and        All U.S. Nuclear Regulatory Commission


===Master Materials Licensees.  All===
Sirspheres Impurities              (NRC) Medical Licensees and NRC


===Agreement State R===
Master Materials Licensees. All
adiation Control


===Program Directors and State Liaison===
Agreement State Radiation Control


Officers.04/04/07IN-07-13Use of As-Found Conditions to
Program Directors and State Liaison


Evaluate Criticality-related ProcessUpsets at Fuel Cycle Facilities
Officers.


===All licensees authorized to possess a===
04/04/07 IN-07-13    Use of As-Found Conditions to        All licensees authorized to possess a
critical mass of special nuclear material.05/02/07IN-07-16Common Violations of the


===Increased Controls Requirements===
Evaluate Criticality-related Process critical mass of special nuclear material.


and Related Guidance DocumentsAll licensees who are implementing theU.S. Nuclear Regulatory Commission
Upsets at Fuel Cycle Facilities


(NRC) Order Imposing Increased Controls
05/02/07 IN-07-16    Common Violations of the            All licensees who are implementing the


(EA-05-090), issued November 14, 2005
Increased Controls Requirements      U.S. Nuclear Regulatory Commission


and December 22, 2005.05/21/07IN-07-19Fire Prot
and Related Guidance Documents      (NRC) Order Imposing Increased Controls


ection Equipment Recalls
(EA-05-090), issued November 14, 2005 and December 22, 2005.


and Counterfeit Notices
05/21/07 IN-07-19    Fire Protection Equipment Recalls    All holders of operating licenses for


All holders of operating licenses fornuclear power reactors and fuel cycle
and Counterfeit Notices              nuclear power reactors and fuel cycle


facilities; except those licensees for
facilities; except those licensees for
Line 259: Line 238:
reactors that have permanently ceased
reactors that have permanently ceased


operations and who hav
operations and who have certified that


e certified thatfuel has been permanently removed from
fuel has been permanently removed from


the reactor vessel; and except those
the reactor vessel; and except those
Line 267: Line 246:
licensees for decommissioned fuel cycle
licensees for decommissioned fuel cycle


facilities.06/11/07IN-07-20Use of Blank AmmunitionAll power reactors, Category I fuel cycle
facilities.
 
06/11/07 IN-07-20    Use of Blank Ammunition              All power reactors, Category I fuel cycle


facilities, independent
facilities, independent spent fuel storage


spent fuel storageinstallations, conversion facility, and
installations, conversion facility, and


gaseous diffusion plants. DateGC No.Subject
gaseous diffusion plants. Date    GC No.                 Subject


==Addressees==
==Addressees==
08/08/07IN-07-23Inadvert
08/08/07 IN-07-23  Inadvertent Discharge of Halon      All holders of operating licenses for


ent Discharge of Halon1301Fire-suppression System from
1301Fire-suppression System from   nuclear power reactors, except those who


Incorrect and/or Out-of-date
Incorrect and/or Out-of-date       have permanently ended operations and


Procedures
Procedures                         have certified that fuel has been
 
All holders of operating licenses fornuclear power reactors, except those who
 
have permanently ended operations and
 
have certified that fuel has been


permanently removed from the reactor
permanently removed from the reactor
Line 294: Line 269:
vessel. All holders of licenses for fuel
vessel. All holders of licenses for fuel


cycle facilities.07/19/07IN-07-25Suggestions from the Advisory
cycle facilities.
 
===Committee on the Medical Use of===
Isotopes For Consideration to


===Improve Compliance With Sodium===
07/19/07 IN-07-25  Suggestions from the Advisory      All U.S. Nuclear Regulatory Commission
Iodide I-131 Written Directive


===Requirements in 10 CFR 35.40===
Committee on the Medical Use of    (NRC) medical-use licensees and NRC


and Supervision Requirements in
Isotopes For Consideration to      Master Materials Licensees. All


10 CFR 35.27All U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC
Improve Compliance With Sodium      Agreement State Radiation Control


===Master Materials Licensees.  All===
Iodide I-131 Written Directive      Program Directors and State Liaison


===Agreement State R===
Requirements in 10 CFR 35.40        Officers.
adiation Control


===Program Directors and State Liaison===
and Supervision Requirements in


Officers.08/13/07IN-07-26Combustibility of Epoxy Floor
10 CFR 35.27
08/13/07 IN-07-26  Combustibility of Epoxy Floor       All holders of operating licenses for


===Coatings at Commercial Nuclear===
Coatings at Commercial Nuclear     nuclear power reactors and fuel cycle
Power Plants


All holders of operating licenses fornuclear power reactors and fuel cycle
Power Plants                        facilities except licensees for reactors that


facilities except licensees for reactors that
have permanently ceased operations and


have permanently ceased operations and
who have certified that fuel has been


who have certified
permanently removed from the reactor


that fuel has beenpermanently removed from the reactor
vessel.


vessel.03/01/07RIS-07-03Ionizing Radiation Warning SymbolAll U.S. Nuclear Regulatory Commission
03/01/07 RIS-07-03 Ionizing Radiation Warning Symbol  All U.S. Nuclear Regulatory Commission


licensees and certificate holders. All
licensees and certificate holders. All


===Radiation Control Program Directors and===
Radiation Control Program Directors and


State Liaison Officers03/09/07RIS-07-04Personally
State Liaison Officers


===Identifiable Information===
03/09/07 RIS-07-04 Personally Identifiable Information All holders of operating licenses for
Submitted to the U.S. Nuclear


===Regulatory Commission===
Submitted to the U.S. Nuclear      nuclear power reactors and holders of and
All holders of operating licenses fornuclear power reactors and holders of and


applicants for certificates for reactor
Regulatory Commission              applicants for certificates for reactor


designs. All licensees, certificate holders, applicants, and other entities subject to
designs. All licensees, certificate holders, applicants, and other entities subject to


regulation by the U.S.
regulation by the U.S. Nuclear Regulatory


Nuclear Regulatory
Commission (NRC) of the use of source, byproduct, and special nuclear material


Commission (NRC) of the use of source, byproduct, and special nuclear material03/20/07RIS-07-05Stat
03/20/07 RIS-07-05 Status and Plans for                All NRC materials licensees, Radiation


us and Plans for
Implementation of NRC Regulatory    Control Program Directors, State Liaison


===Implementation of NRC Regulatory===
Authority for Certain Naturally-   Officers, and NRCs Advisory Committee
Authority for Certain Naturally-


occurring and Accelerator-
occurring and Accelerator-         on the Medical Uses of Isotopes


produced Radioactive Material
produced Radioactive Material


===All NRC materials licensees, Radiation===
04/05/07 RIS-07-07 Clarification of Increased Controls All U.S. Nuclear Regulatory Commission
Control Program Directors, State Liaison


Officers, and NRC's Advisory Committee
for Licensees That Possess          (NRC) licensees issued NRCs Order


on the Medical Uses of Isotopes04/05/07RIS-07-07Clarificati
Collocated Radioactive Material    Imposing Increased Controls and all


on of Increased Controlsfor Licensees That Possess
During Transportation Activities    Radiation Control Program Directors and


===Collocated Radioactive Material===
State Liaison Officers Date      GC No.                     Subject
During Transportation Activities All U.S. Nuclear Regulatory Commission (NRC) licensees issued NRC's Order
 
===Imposing Increased Controls and all===
 
===Radiation Control Program Directors and===
 
===State Liaison Officers DateGC No.Subject===


==Addressees==
==Addressees==
05/04/07RIS-07-09Examples
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


of Recurring Requests
10 CFR Part 71 and 72                (CoC) for a radioactive material


for Additional Information (RAIs) for
Applications                         transportation package; (2) 10 CFR Part
 
10 CFR Part 71 and 72
 
===Applications===
All holders of, and applicants for, a: (1) 10CFR 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
72 CoC for a spent fuel storage cask; and
Line 403: Line 354:
independent spent fuel storage
independent spent fuel storage


installation (ISFSI).06/27/07RIS-06-27, Suppl. 1Availability of NRC 313A Series ofForms and Guidance for Their
installation (ISFSI).


CompletionAll U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC
06/27/07    RIS-06-27,  Availability of NRC 313A Series of    All U.S. Nuclear Regulatory Commission


===Master Materials licensees. All Radiation===
Suppl. 1    Forms and Guidance for Their          (NRC) medical-use licensees and NRC


===Control Program Directors and State===
Completion                            Master Materials licensees. All Radiation


Liaison Officers.05/15/07RIS-07-10Subscriptions To New List Server
Control Program Directors and State


===For Automatic No===
Liaison Officers.
tifications Of


Medical-Related Generic
05/15/07    RIS-07-10    Subscriptions To New List Server      All U.S. Nuclear Regulatory Commission


Communications, Federal RegisterNotices And NewslettersAll U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC
For Automatic Notifications Of        (NRC) medical-use licensees and NRC


===Master Materials licensees. All Radiation===
Medical-Related Generic              Master Materials licensees. All Radiation


===Control Program Directors and State===
Communications, Federal Register      Control Program Directors and State


Liaison Officers.
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.}}
Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under Electronic Reading Room/Document Collections.}}


{{Information notice-Nav}}
{{Information notice-Nav}}

Revision as of 05:21, 23 November 2019

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)
v • d • e


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.

ML071650373

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

10 CFR 35.27

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.


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