[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Page 2219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00694]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Navigating the Center for Drug Evaluation and Research: What You
Should Know for Effective Engagement; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administrations (FDA) Center for Drug
Evaluation and Research (CDER), is sponsoring a public workshop
entitled ``Navigating CDER: What You Should Know for Effective
Engagement.'' The purpose of this public workshop is to help the public
and patient advocacy groups gain a better understanding of how to
effectively engage CDER.
DATES: The public workshop will be held on March 31, 2016, from 8:30
a.m. to 5 p.m.
ADDRESSES: The public workshop will be held at FDA's White Oak campus,
10903 New Hampshire Ave., Building 31 (The Great Room A, B, and C),
Silver Spring, MD 20993. Entrance for the public workshop participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Shawn Brooks, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6509, email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop entitled
``Navigating CDER: What You Should Know for Effective Engagement.''
This public workshop is intended to enhance the public and advocacy
groups' ability to effectively engage FDA's CDER. The presentations are
intended to provide information on how best to interact with CDER.
There will be an opportunity for questions and answers following each
presentation.
Registration: There is no registration fee to attend the public
workshop. Early registration is recommended because seating is limited,
and registration will be on a first-come, first-served basis. There
will be no onsite registration. Persons interested in attending this
workshop must register online at http://www.fda.gov/Drugs/NewsEvents/ucm472604.htm before March 24, 2016. For those without Internet access,
please contact Shawn Brooks (see FOR FURTHER INFORMATION CONTACT) to
register.
If you need special accommodations due to a disability, please
contact Shawn Brooks (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.
Transcripts: A transcript of the workshop will be available for
review at the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and
on the Internet at http://www.regulations.gov approximately 30 days
after the workshop. Transcripts will also be available in either hard
copy or on CD-ROM, after submission of a Freedom of Information
request. The Freedom of Information office address is available on the
Agency's Web site at http://www.fda.gov.
Dated: January 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00694 Filed 1-14-16; 8:45 am]
BILLING CODE 4164-01-P