[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]
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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.
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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, [email protected]; 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, [email protected].
Registration: If you wish to attend the public meeting or provide
testimony during the open public hearing, please email your
registration to [email protected] 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
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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