1

http://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 licensee’s 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 manufacturer’s web site): more outgoing or aggressive behavior

than normal, confusion, strange behavior, agitation, and hallucinations.

ML071650373
IN 2007-31

Page 2 of 3

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 individual’s 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

provider’s 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 individual’s ability to safely and

competently perform his or her duties. 
IN 2007-31

Page 3 of 3

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.
IN 2007-31

Page 3 of 3

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
Enclosure

IN 2007-31

Page 1 of 3

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 Timereliant 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.
Enclosure

IN 2007-31

Page 2 of 3

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 Naturallyoccurring and Acceleratorproduced Radioactive Material

All NRC materials licensees, Radiation

Control Program Directors, State Liaison

Officers, and NRC’s 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 NRC’s Order

Imposing Increased Controls and all

Radiation Control Program Directors and

State Liaison Officers
Enclosure

IN 2007-31

Page 3 of 3

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.