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


===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


WASHINGTON, DC 20555-0001 November 13, 2007 NRC INFORMATION NOTICE 2007-31:               U.S. FOOD AND DRUG ADMINISTRATION
===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==
Line 37: Line 41:


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 licensees Fitness-for-Duty Program (FFD), Behavioral


Observation Program (BOP), and Employee Assistance Program (EAP). The NRC expects that
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
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.
Line 54: Line 58:
sedative-hypnotic drugs strengthen their product labeling to include stronger language
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 manufacturers 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==
Line 83: Line 84:
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 individuals 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
Line 101: Line 102:
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
Line 114: Line 115:


==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/
                                                    /RA by TQuay for/
/RA by TQuay for/
Robert C. Pierson, Director                          Michael J. Case, Director
Robert C. Pierson, Director


Division of Fuel Cycle Safety                       Division of Policy and Rulemaking
===Michael J. Case, Director===
Division of Fuel Cycle Safety


and Safeguards                                     Office of Nuclear Reactor Regulation
===Division of Policy and Rulemaking===
  and Safeguards


===Office of Nuclear Materials Safety===
===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 E-mail: axs13@nrc.gov
301-415-0728 E-mail: axs13@nrc.gov


Enclosure: Recently Issued FSME/NMSS
Enclosure: Recently Issued FSME/NMSS
Line 141: Line 146:


==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/
/RA/
Robert C. Pierson, Director                          Michael J. Case, Director
/RA by TQuay for/
Robert C. Pierson, Director


Division of Fuel Cycle Safety                       Division of Policy and Rulemaking
===Michael J. Case, Director===
Division of Fuel Cycle Safety


and Safeguards                                     Office of Nuclear Reactor Regulation
===Division of Policy and Rulemaking===
  and Safeguards


===Office of Nuclear Materials Safety===
===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 E-mail: AXS13@NRC.GOV
301-415-0728 E-mail: AXS13@NRC.GOV


Enclosure: Recently Issued FSME/NMSS
Enclosure: Recently Issued FSME/NMSS
Line 167: Line 177:


DISTRIBUTION:
DISTRIBUTION:
DSP r/f       RIDSNSIRDSO           RIDSNSIROD         RIDSNSIRDSOLPSB
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


ADAMS Accession Number: ML071650373 OFC    NSIR:DSO:LPSB TECH EDITOR BC:NSIR:DSO/LPSB DD:NSIR:DDSP D:NSIR:DSO              FSME:MSSA
DATE


NAME DHase            HChang        GWest              RWay            DDorman        AMcIntosh
06/21/ 2007
06/21/2007
06/29/2007
08/17/2007
09/4/2007
09/10/2007 OFC


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
LA:PGCB:DPR


NAME CHawes CMH      DBeaulieu      MMurphy            Tquay for MCase  RPierson
PGCB:DPR


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
BC:PGCB:DPR


Date   GC No.                   Subject
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==
==Addressees==
02/02/07 IN-07-03   Reportable Medical Events           All U.S. Nuclear Regulatory Commission
02/02/07 IN-07-03
 
===Reportable Medical Events===
Involving Patients Receiving
 
===Dosages of Sodium===
Iodide Iodine-131 less than the


Involving Patients Receiving        medical use licensees and NRC Master
===Prescribed Dosage Because of===
Capsules Remaining in Vials after


Dosages of Sodium                    Materials Licensees. All Agreement State
===Administration===
All U.S. Nuclear Regulatory Commission


Iodide Iodine-131 less than the      Radiation Control Program Directors and
medical use licensees and NRC Master


Prescribed Dosage Because of        State Liaison Officers.
===Materials Licensees. All Agreement State===
Radiation Control Program Directors and


Capsules Remaining in Vials after
State Liaison Officers.


Administration
02/28/07 IN-07-08 Potential Vulnerabilities of Time- reliant Computer-based Systems


02/28/07 IN-07-08    Potential Vulnerabilities of Time-  All U. S. Nuclear Regulatory Commission
===Due to Change in Daylight Saving===
Time Dates


reliant Computer-based Systems      licensees and all Agreement State
All U. S. Nuclear Regulatory Commission


Due to Change in Daylight Saving    Radiation Control Program Directors and
licensees and all Agreement State


Time Dates                          State Liaison Officers.
===Radiation Control Program Directors and===
State Liaison Officers.


03/13/07 IN-07-10   Yttrium-90 Theraspheres and         All U.S. Nuclear Regulatory Commission
03/13/07 IN-07-10
Yttrium-90 Theraspheres and


Sirspheres Impurities               (NRC) Medical Licensees and NRC
===Sirspheres Impurities===
All U.S. Nuclear Regulatory Commission


Master Materials Licensees. All
(NRC) Medical Licensees and NRC


===Master Materials Licensees.  All===
Agreement State Radiation Control
Agreement State Radiation Control


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


Officers.
Evaluate Criticality-related Process
 
===Upsets at Fuel Cycle Facilities===
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.


Evaluate Criticality-related Process critical mass of special nuclear material.
05/02/07 IN-07-16


Upsets at Fuel Cycle Facilities
===Common Violations of the===
Increased Controls Requirements


05/02/07 IN-07-16    Common Violations of the            All licensees who are implementing the
and Related Guidance Documents


Increased Controls Requirements      U.S. Nuclear Regulatory Commission
===All licensees who are implementing the===
U.S. Nuclear Regulatory Commission


and Related Guidance Documents      (NRC) Order Imposing Increased Controls
(NRC) Order Imposing Increased Controls


(EA-05-090), issued November 14, 2005 and December 22, 2005.
(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
05/21/07 IN-07-19


and Counterfeit Notices             nuclear power reactors and fuel cycle
===Fire Protection Equipment Recalls===
and Counterfeit Notices
 
===All holders of operating licenses for===
nuclear power reactors and fuel cycle


facilities; except those licensees for
facilities; except those licensees for
Line 248: Line 338:
facilities.
facilities.


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


facilities, independent spent fuel storage
facilities, independent spent fuel storage
Line 254: Line 347:
installations, conversion facility, and
installations, conversion facility, and


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


==Addressees==
==Addressees==
08/08/07 IN-07-23 Inadvertent Discharge of Halon     All holders of operating licenses for
08/08/07 IN-07-23
 
===Inadvertent Discharge of Halon===
1301Fire-suppression System from
 
Incorrect and/or Out-of-date


1301Fire-suppression System from    nuclear power reactors, except those who
Procedures


Incorrect and/or Out-of-date        have permanently ended operations and
===All holders of operating licenses for===
nuclear power reactors, except those who


Procedures                          have certified that fuel has been
have permanently ended operations and
 
have certified that fuel has been


permanently removed from the reactor
permanently removed from the reactor
Line 271: Line 376:
cycle facilities.
cycle facilities.


07/19/07 IN-07-25 Suggestions from the Advisory      All U.S. Nuclear Regulatory Commission
07/19/07 IN-07-25


Committee on the Medical Use of     (NRC) medical-use licensees and NRC
===Suggestions from the Advisory===
Committee on the Medical Use of


Isotopes For Consideration to       Master Materials Licensees. All
===Isotopes For Consideration to===
Improve Compliance With Sodium


Improve Compliance With Sodium      Agreement State Radiation Control
Iodide I-131 Written Directive


Iodide I-131 Written Directive      Program Directors and State Liaison
===Requirements in 10 CFR 35.40===
and Supervision Requirements in
 
10 CFR 35.27
 
===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.


Requirements in 10 CFR 35.40        Officers.
08/13/07 IN-07-26


and Supervision Requirements in
===Combustibility of Epoxy Floor===
Coatings at Commercial Nuclear


10 CFR 35.27
===Power Plants===
08/13/07 IN-07-26  Combustibility of Epoxy Floor      All holders of operating licenses for
All holders of operating licenses for


Coatings at Commercial Nuclear      nuclear power reactors and fuel cycle
nuclear 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
Line 300: Line 420:
vessel.
vessel.


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


licensees and certificate holders. All
===Ionizing Radiation Warning Symbol===
All U.S. Nuclear Regulatory Commission


Radiation Control Program Directors and
licensees and certificate holders.  All


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


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


Submitted to the U.S. Nuclear      nuclear power reactors and holders of and
nuclear power reactors and holders of and


Regulatory Commission              applicants for certificates for reactor
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. Nuclear Regulatory
regulation by the U.S. Nuclear Regulatory
Line 320: Line 448:
Commission (NRC) of the use of source, byproduct, and special nuclear material
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
03/20/07 RIS-07-05
 
===Status and Plans for===
Implementation of NRC Regulatory
 
Authority for Certain Naturally- occurring and Accelerator- produced Radioactive Material


Implementation of NRC Regulatory    Control Program Directors, State Liaison
===All NRC materials licensees, Radiation===
Control Program Directors, State Liaison


Authority for Certain Naturally-    Officers, and NRCs Advisory Committee
===Officers, and NRCs Advisory Committee===
on the Medical Uses of Isotopes


occurring and Accelerator-         on the Medical Uses of Isotopes
04/05/07 RIS-07-07


produced Radioactive Material
===Clarification of Increased Controls===
for Licensees That Possess


04/05/07 RIS-07-07 Clarification of Increased Controls All U.S. Nuclear Regulatory Commission
===Collocated Radioactive Material===
During Transportation Activities


for Licensees That Possess          (NRC) licensees issued NRCs Order
===All U.S. Nuclear Regulatory Commission===
(NRC) licensees issued NRCs Order


Collocated Radioactive Material    Imposing Increased Controls and all
===Imposing Increased Controls and all===
Radiation Control Program Directors and


During Transportation Activities    Radiation Control Program Directors and
===State Liaison Officers Date===
GC No.


State Liaison Officers Date      GC No.                      Subject
Subject


==Addressees==
==Addressees==
05/04/07   RIS-07-09   Examples of Recurring Requests       All holders of, and applicants for, a: (1) 10
05/04/07 RIS-07-09
                            for Additional Information (RAIs) for CFR Part 71 certificate of compliance
 
===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


10 CFR Part 71 and 72                (CoC) for a radioactive material
===CFR Part 71 certificate of compliance===
(CoC) for a radioactive material


Applications                          transportation package; (2) 10 CFR Part
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 356: Line 504:
installation (ISFSI).
installation (ISFSI).


06/27/07   RIS-06-27,   Availability of NRC 313A Series of   All U.S. Nuclear Regulatory Commission
06/27/07 RIS-06-27, Suppl. 1
 
===Availability of NRC 313A Series of===
Forms and Guidance for Their


Suppl. 1    Forms and Guidance for Their          (NRC) medical-use licensees and NRC
Completion


Completion                            Master Materials licensees. All Radiation
===All U.S. Nuclear Regulatory Commission===
(NRC) medical-use licensees and NRC


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


Liaison Officers.
Liaison Officers.


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


For Automatic Notifications Of        (NRC) medical-use licensees and NRC
===Communications, Federal Register===
Notices And Newsletters


Medical-Related Generic              Master Materials licensees. All Radiation
===All U.S. Nuclear Regulatory Commission===
(NRC) medical-use licensees and NRC


Communications, Federal Register      Control Program Directors and State
===Master Materials licensees. All Radiation===
Control Program Directors and State


Notices And Newsletters              Liaison Officers.
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}}

Latest revision as of 23:15, 14 January 2025

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


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

Yttrium-90 Theraspheres and

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

10 CFR 35.27

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.


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