83 FR 8280 - Center for Drug Evaluation and Research and You: Keys to Effective Engagement; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 38 (February 26, 2018)

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the following public workshop entitled ``CDER and You: Keys to Effective Engagement.'' The purpose of the public workshop is to build upon previous efforts to help advocates understand how they can engage with FDA to enhance drug development and safety. This marks the third annual CDER public workshop for patient advocacy groups.

[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Pages 8280-8281]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03805]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Center for Drug Evaluation and Research and You: Keys to 
Effective Engagement; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research (CDER) is announcing the following public 
workshop entitled ``CDER and You: Keys to Effective Engagement.'' The 
purpose of the public workshop is to build upon previous efforts to 
help advocates understand how they can engage with FDA to enhance drug 
development and safety. This marks the third annual CDER public 
workshop for patient advocacy groups.

DATES: The public workshop will be held on April 3, 2018, from 8 a.m. 
to 3 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Silver Spring, MD 20903. 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 https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Chris Melton, Center for Drug 
Evaluation and Research, Food and

[[Page 8281]]

Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-7381, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA's CDER is announcing a public workshop entitled, ``CDER and 
You: Keys to Effective Engagement.'' This workshop is intended to help 
the public learn effective ways for engaging with CDER. There will be 
educational presentations about the drug approval process, an 
interactive panel featuring patient advocates who will offer engagement 
guidance, as well as an opportunity for questions and answers following 
many of the presentations. Finally, presenters will highlight 
innovative new procedures for requesting a meeting with CDER staff.

II. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online at https://www.fda.gov/Drugs/NewsEvents/ucm592902.htm by 6 p.m. Eastern Time, Tuesday, March 20, 2018. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. 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 time and space permit, onsite registration on 
the day of the public workshop will be provided beginning at 8 a.m. We 
will let registrants know if registration closes before the day of the 
public meeting/public workshop.
    If you need special accommodations due to a disability, please 
contact Chris Melton no later than March 26, 2018 (See FOR FURTHER 
INFORMATION CONTACT.)
    Streaming webcast of the public workshop: This public workshop will 
also be available via webcast at https://collaboration.fda.gov/cdereffectiveengagement/.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. 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.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, approximately 30 days after the workshop. A link 
to the transcript will also be available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm472604.htm.

    Dated: February 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03805 Filed 2-23-18; 8:45 am]
 BILLING CODE 4164-01-P