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

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)

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, 2007NRC INFORMATION NOTICE 2007-31: U.S. FOOD AND DRUG ADMINISTRATION

ADDRESSEES

All holders of operating licenses for nuclear power reactors and Category I fuel cycle facilities, except licensees for reactors who have perm

anently 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 A

ssistance 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 FDA

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

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.

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.

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, DirectorDivision of Fuel Cycle Safety Division of Policy and Rulemaking

and Safeguards Office of Nuclear Reactor Regulation

Office of Nuclear Materials Safety

and Safeguards

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, DirectorDivision of Fuel Cycle Safety Division of Policy and Rulemaking

and Safeguards Office of Nuclear Reactor Regulation

Office of Nuclear Materials Safety

and Safeguards

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/fRIDSNSIRDSORIDSNSIROD RIDSNSIRDSOLPSB

ADAMS Accession Number: ML071650373OFCNSIR:DSO:LPSBTECH EDITORBC:NSIR:DSO/LPSBDD:NSIR:DDSPD:NSIR:DSOFSME:MSSANAMEDHaseHChangGWestRWay DDorman AMcIntosh

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

09/21/2007 11/13/

2007 10/2/2007 OFFICIAL RECORD COPY Recently Issued FSME/NMSS Generic Communications DateGC No.Subject

Addressees

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able Medical Events

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Iodide Iodine-131 less than the

Capsules Remaining in Vials after

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medical use licensees and NRC Master

Radiation Control Program Directors and

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and Sirspheres

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adiation Control

Program Directors and State Liaison

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All licensees authorized to possess a

critical mass of special nuclear material.05/02/07IN-07-16Common Violations of the

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ection Equipment Recalls

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All holders of operating licenses fornuclear power reactors and fuel cycle

facilities; except those licensees for

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e certified thatfuel has been permanently removed from

the reactor vessel; and except those

licensees for decommissioned fuel cycle

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facilities, independent

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ent Discharge of Halon1301Fire-suppression System from

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All holders of operating licenses fornuclear power reactors, except those who

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All holders of operating licenses fornuclear power reactors and holders of and

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Control Program Directors and State

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