71348
`
`Federal Register / Vol. 76, No. 222 / Thursday, November 17, 2011 / Notices
`
`Dated: November 9, 2011.
`John Howard,
`Director, National Institute for Occupational
`Safety and Health, Centers for Disease Control
`and Prevention.
`[FR Doc. 2011–29700 Filed 11–16–11; 8:45 am]
`
`BILLING CODE 4163–19–P
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`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`
`[Docket No. FDA–2011–N–0802]
`
`Role of Naloxone in Opioid Overdose
`Fatality Prevention; Public Workshop;
`Request for Comments
`
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice of public workshop;
`request for comments.
`
`The Food and Drug Administration
`(FDA), Center for Drug Evaluation and
`Research (CDER), in collaboration with
`the Office of the Assistant Secretary for
`Health, National Institutes of Drug
`Abuse, and the Centers for Disease
`Control and Prevention, is announcing a
`scientific workshop to initiate a public
`discussion about the potential value of
`making naloxone more widely available
`outside of conventional medical settings
`to reduce the incidence of opioid
`overdose fatalities. Academia,
`government, industry experts, and
`patient advocates will be assembled to
`discuss which populations are at risk for
`opioid overdose and how public health
`groups are working together to curb the
`abuse of opioids. We will also seek to
`identify potential health concerns,
`social concerns, legal concerns,
`regulatory issues, and future research
`needs related to making naloxone more
`widely available.
`Date and Time: The public workshop
`will be held on April 12, 2012, from
`8:30 a.m. to 5:30 p.m.
`Location: The public workshop will
`be held at FDA White Oak Campus,
`10903 New Hampshire Ave., Building
`31 Conference Center, the Great Room
`(rm 1503), Silver Spring, MD 20993–
`0002.
`Contact Person: Mary Gross, Center
`for Drug Evaluation and Research, Food
`and Drug Administration, 10903 New
`Hampshire Ave., Silver Spring, MD
`20993–0002, (301) 796–3519, Mary.
`Gross@fda.hhs.gov; or Matthew
`Petcovic, 10903 New Hampshire Ave.,
`Silver Spring, MD 20993–0002, (301)
`796–5242, Matthew.Petcovik@fda.hhs.
`gov.
`Registration: If you wish to attend the
`public workshop or provide testimony
`
`during the open public hearing, please
`email your registration to CDER_
`Naloxone_Workshop@fda.hhs.gov by
`March 28, 2012. Those without email
`access may register by contacting one of
`the persons listed in the Contact Person
`section of this document. Please provide
`complete contact information for each
`attendee; including name, title,
`affiliation, address, email address, and
`telephone number. Registration is free
`and will be on a first-come, first-served
`basis. Early registration is recommended
`because seating is limited. Registrants
`will receive confirmation once they
`have been accepted for the workshop.
`Onsite registration on the day of the
`public workshop will be based on space
`availability. If registration reaches
`maximum capacity, FDA will post a
`notice closing meeting registration for
`the workshop at: http://www.fda.gov/
`Drugs/NewsEvents/ucm277119.htm.
`An open public hearing will be held
`between 2:45 p.m. and 3:45 p.m. on
`April 12, 2012, during which speaker
`testimony will be accepted. We will try
`to accommodate all persons who wish
`to testify; however, the duration of each
`speaker’s testimony during this open
`public hearing may be limited by time
`constraints. Those wishing to
`participate in the open public hearing
`should limit their remarks to a
`discussion of the advantages and/or
`disadvantages to making naloxone more
`easily accessible to patients outside of
`conventional medical settings.
`Comments: Submit either electronic
`or written comments by June 12, 2012.
`Submit electronic comments to http://
`www.regulations.gov. Submit written
`comments to the Division of Dockets
`Management (HFA 305), Food and Drug
`Administration, 5630 Fishers Lane, rm.
`1061, Rockville, MD 20852. It is
`necessary to send only one set of
`comments. Identify comments with the
`docket number found in brackets in the
`heading of this document. Received
`comments may be seen in the Division
`of Dockets Management between 9 a.m.
`and 4 p.m., Monday through Friday.
`If you need special accommodations
`due to a disability, contact Mary Gross
`or Matt Petcovic (see Contact Person) at
`least 7 days in advance of the meeting.
`SUPPLEMENTARY INFORMATION:
`
`I. Introduction
`The number of prescriptions filled for
`opioid pain relievers has increased
`dramatically in recent years. Nearly 257
`million prescriptions for opioid drugs
`were written in the United States in
`2009 alone and the increased
`availability to prescription opioid drugs
`appear to be contributing significantly
`to abuse and the potential for overdose
`
`in the United States. In the United
`States, mortality rates closely correlate
`with opioid sales. In 2007,
`approximately 36,034 people died from
`unintentional overdoses. At least 14,459
`of these deaths involved prescription
`opioid analgesics. Moreover, according
`to the Substance Abuse and Mental
`Health Services Administration, the
`number of Americans in 2009 aged 12
`and older currently abusing pain
`relievers has increased by 20 percent
`since 2002. Naloxone, a mu-opioid
`antagonist, is an injectable medicine
`that can rapidly reverse the overdose of
`either prescription (e.g., OxyContin) or
`illicit (e.g., heroin) opioids. It is
`currently the standard treatment for
`those who overdose on opioid drugs,
`but is most commonly used only by
`trained medical personnel in emergency
`departments and on ambulances. The
`purpose of this public workshop is to
`discuss the issues around making
`naloxone more widely available. This
`includes work to expand its use through
`the development of novel formulations
`as well as work to potentially support
`its use by individuals other than the
`trained medical personnel currently
`authorized to use it.
`FDA will post the agenda and
`additional workshop background
`material approximately 5 days before
`the workshop at: http://www.fda.gov/
`Drugs/NewsEvents/ucm277119.htm.
`
`II. Transcripts
`
`Please be advised that approximately
`30 days after the public workshop, a
`transcript will be made available. It will
`be accessible at http://www.regulations.
`gov, and may be viewed at the Division
`of Dockets Management (see
`Comments). A transcript will also be
`available in either hardcopy or on CD–
`ROM, after submission of a Freedom of
`Information request. Written requests
`are to be sent to Division of Freedom of
`Information (ELEM–1029), Food and
`Drug Administration, 12420 Parklawn
`Dr., Element Bldg., Rockville MD 20857.
`
`Dated: November 10, 2011.
`Leslie Kux,
`Acting Assistant Commissioner for Policy.
`[FR Doc. 2011–29703 Filed 11–16–11; 8:45 am]
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