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

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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)


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.