Document ID: FDA-2011-N-0802-0001
Agency: fda
Document Type: Notice
Title: Role of Naloxone in OpioidOverdose Fatality Prevention; Workshop; Request for Comments
Posted Date: 2011-11-17T05:00Z

[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Notices]
[Page 71348]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29703]

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-P