[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32881-32882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]


Scientific Conference: Opioid and Nicotine Use, Dependence, and 
Recovery--Influences of Sex and Gender; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Office of 
Women's Health, Center for Drug Evaluation and Research, and Center for 
Tobacco Products are announcing the following conference entitled 
``Scientific Conference: Opioid and Nicotine Use, Dependence, and 
Recovery--Influences of Sex and Gender.'' The purpose of the conference 
is to discuss the biological (sex) and sociological (gender) influences 
on misuse, abuse, and cessation of opioids and tobacco. Researchers, 
educators, and clinicians may benefit from attending this 
multidisciplinary review and update on opioid and tobacco.

DATES: The two-day conference will be held on September 27, 2018 (8:30 
a.m.-4:00 p.m.) and September 28, 2018 (8:30 a.m.-4:00 p.m.). See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The conference will be held at FDA's White Oak Campus, 10903 
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 
1503-A), Silver Spring, MD 20993. Entrance for the conference 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Gwendolyn Jones, Food and Drug 
Administration, Bldg. 32, Rm. 2333, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, [email protected], 301-796-9940.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is responsible for protecting the public health by assuring the 
safety and efficacy of FDA-regulated products. This conference will 
provide the Agency with further insight into the devastating public 
health crises caused by pervasive opioid and tobacco use. Drug overdose 
deaths and opioid-involved deaths continue to increase in the United 
States. Many of the drug overdose deaths (more than 6 out of 10) 
involve an opioid. Since 1999, the number of overdose deaths involving 
opioids (including prescription opioids and heroin) quadrupled. Drug 
overdose deaths and opioid-involved deaths continue to increase in the 
United States. Of the 63,632 drug overdose deaths in 2016, 66.4 percent 
(42,249) involved opioids, with increases across age groups, racial/
ethnic groups, urbanization levels, and multiple states. Combustible 
cigarettes have been identified as the dominant cause of tobacco-
related disease and are responsible for more than 20 million premature 
deaths since the first Surgeon General's report in 1964. Together, 
opioid and tobacco use are the leading causes of preventable disease 
and death in the United States, and women are increasingly affected. 
Sex and gender differences may influence susceptibility to substance 
abuse, which could have implications for optimal prevention and 
treatment. Gender influencers also impact public health from a familial 
and environmental perspective. Researchers, educators, and clinicians 
must be able to recognize and consider both sex and gender differences 
to identify and treat women most at risk.

II. Topics for Discussion at the Conference

    The conference will include presentations and panel discussions by 
experts in the field of opioid and tobacco research, professional 
education, and clinical care on the biological (sex) and sociological 
(gender) influences on misuse, abuse, and cessation of opioids and 
tobacco. Each panel discussion will have a Q&A session to respond to 
questions from in-person attendees.

III. Participating in the Conference

    Registration: To register for the Scientific Conference: Opioid and 
Nicotine Use, Dependence, and Recovery--Influences of Sex and Gender, 
please visit the following website: https://www.eventbrite.com/e/scientific-conference-opioid-and-nicotine-use-dependence-and-recovery-influences-of-sex-and-gender-tickets-47087275308.
    Registration is free and in-person seating is limited. The 
conference will also be available for viewing via webcast. Persons 
interested in attending or viewing this conference must register online 
by September 24, 2018, 5:00 p.m. Eastern Time. Early registration is 
recommended because seating is limited; therefore, FDA may limit the 
number of participants from each organization. Registrants will receive 
confirmation when they have been accepted. If you need special 
accommodations due to a disability, please email Gwendolyn Jones at 
[email protected] (See FOR FURTHER INFORMATION CONTACT) no 
later than September 24, 2018.
    Streaming Webcast of the public meeting: This public meeting will 
also be webcast and can only be viewed if registered. To register, 
please go to

[[Page 32882]]

https://www.eventbrite.com/e/scientific-conference-opioid-and-nicotine-use-dependence-and-recovery-influences-of-sex-and-gender-tickets-47087275308. Registrants will receive confirmation and information 
about accessing the webcast when they have been accepted. FDA has 
verified the website addresses in this document, as of the date this 
document publishes in the Federal Register, but websites are subject to 
change over time.

    Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15096 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P