81 FR 2219 - Navigating the Center for Drug Evaluation and Research: What You Should Know for Effective Engagement; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 10 (January 15, 2016)

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.

[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Page 2219]
From the Federal Register Online  [www.thefederalregister.org]
[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