Document ID: FDA-2011-N-0802-0039
Agency: fda
Document Type: Notice
Title: Exploring Naloxone Uptake and Use; Public Meeting; Request for Comments
Posted Date: 2015-05-19T04:00Z

[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28621-28622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12061]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0802]

Exploring Naloxone Uptake and Use; Public Meeting; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

    The Food and Drug Administration (FDA), Center for Drug Evaluation 
and Research, in collaboration with the National Institutes on Drug 
Abuse, the Centers for Disease Control and Prevention, the Substance 
Abuse and Mental Health Services Administration, and the Health 
Resources and Services Administration, will hold a public meeting to 
discuss increasing the use of naloxone to reduce the incidence of 
opioid drug overdose fatalities. During the meeting, academic and 
government experts, industry representatives, and patient advocates 
will discuss which populations are at-risk for opioid drug overdose and 
how we can work together to encourage the use of naloxone to reduce the 
risk of overdose from opioid drugs.
    Date and Time: The public meeting will be held on July 1, 2015, 
from 8 a.m. to 5 p.m. and on July 2, 2015, from 8 a.m. to 3 p.m. The 
open public hearing will be held between 1 p.m. and 2 p.m. on July 1, 
2015, and between 1 p.m. and 2 p.m. on July 2, 2015, 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 may be limited by time constraints. Those wishing to 
participate in the open public hearing should limit their remarks to 
issues related to the uptake of naloxone both in conventional medical 
settings and outside of those settings to reduce the incidence of 
opioid drug overdose fatalities.
    Location: The public meeting will be held at the 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 
Georgiann Ienzi, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-3515, Georgiann.Ienzi@fda.hhs.gov.
    Registration: If you wish to attend the public meeting or provide 
testimony during the open public hearing, please email your 
registration to NaloxoneWorkshop@fda.hhs.gov by June 22, 2015. Those 
without email access may register by contacting one of the contact 
persons (see Contact Persons). When registering, 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 public 
meeting. Onsite registration on the day of the public meeting will be 
permitted based on space availability. If registration reaches maximum 
capacity, FDA will post a notice closing registration for the public 
meeting at: http://www.fda.gov/Drugs/NewsEvents/ucm442236.htm.
    Comments: Submit either electronic or written comments by September 
1, 2015. 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 only necessary to send 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, 
and will be posted to the docket at http://www.regulations.gov. If you 
need special accommodations due to a disability, contact Mary Gross or 
Georgiann Ienzi (see Contact Persons) at least 7 days in advance of the 
meeting.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The number of prescriptions filled for opioid drugs has increased 
drastically in recent years. In 2009 nearly 257 million prescriptions 
were written for opioid drugs in the United States. This number rose to 
nearly 260 million in 2012. The increased availability of opioid drugs 
appears to be contributing significantly to abuse and overdose in the 
United States. In 2013 there were approximately 16,235 deaths from 
overdose involving opioid drugs. That same year, there were 8,257 
deaths from overdose involving heroin.
    Naloxone, a mu-opioid antagonist, is a medication that can rapidly 
reverse the overdose of both prescription opioid

[[Page 28622]]

drugs (e.g., OxyContin) and illicit opioid drugs (e.g., heroin). It is 
currently the standard treatment for those experiencing overdose and is 
commonly used by trained medical personnel in emergency departments and 
on ambulances. Its use among nonmedical personnel has also increased in 
recent years. The purpose of the public meeting is to explore issues 
surrounding the uptake of naloxone to treat opioid drug overdose. The 
meeting agenda will include topics on the clinical, regulatory, and 
legal implications of making naloxone more widely available. FDA will 
post the agenda and additional public meeting material approximately 2 
days before the workshop at: http://www.fda.gov/Drugs/NewsEvents/ucm442236.htm.

II. Transcripts

    A transcript will be made available approximately 45 days after the 
public meeting. 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: May 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12061 Filed 5-18-15; 8:45 am]
 BILLING CODE 4164-01-P