82 FR 16044 - Roadmap for Engaging With the Food and Drug Administration's Center for Drug Evaluation and Research; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 61 (March 31, 2017)

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), is announcing the following public workshop entitled ``Roadmap for Engaging with FDA's Center for Drug Evaluation and Research (CDER).'' The purpose of this workshop is to help the public learn how to successfully engage with CDER.

[Federal Register Volume 82, Number 61 (Friday, March 31, 2017)]
[Notices]
[Pages 16044-16045]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Roadmap for Engaging With the Food and Drug Administration's 
Center for Drug Evaluation and Research; 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's) Center for Drug 
Evaluation and Research (CDER), is announcing the following public 
workshop entitled ``Roadmap for Engaging with FDA's Center for Drug 
Evaluation and Research (CDER).'' The purpose of this workshop is to 
help the public learn how to successfully engage with CDER.

DATES: The public workshop will be held on May 12, 2017, from 9 a.m. to 
3 p.m.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20903-0002. 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 Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7381, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop entitled ``Roadmap for Engaging 
with FDA's Center for Drug Evaluation and Research (CDER).'' This 
workshop is intended to help the public learn the most effective ways 
to successfully engage with CDER. There will be presentations on 
learning about the drug approval process, as well as the opportunity 
for questions and answers following each presentation.

II. Participating in the Public Workshop

    Registration: Persons interested in attending this workshop must 
register online at https://www.eventbrite.com/e/fda-public-workshop-roadmap-for-engaging-with-fdas-center-for-drug-evaluation-and-research-cder-tickets-28608664285?utm_source=eb_email&utm_medium=email&utm_campaign=new_event_email&utm_term=viewmyevent_button. 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. Persons interested in attending this public 
workshop must register by May 5, 2016, 6 p.m. EST. Early registration 
is recommended because seating is limited; therefore, FDA may limit the 
number of participants from each organization. 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 workshop.
    If you need special accommodations due to a disability, please 
contact Chris Melton no later than May 1, 2017.

[[Page 16045]]

    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be assessable at https://www.regulations.gov. It may be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. A transcript will also be available in 
either hardcopy 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 https://www.fda.gov.

    Dated: March 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06370 Filed 3-30-17; 8:45 am]
 BILLING CODE 4164-01-P