Document ID: FDA-2017-N-0001-0008
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Center for Drug Evaluation and Research
Small Business and Industry Assistance Regulatory Education for
Industry Generic Drugs Forum; Public Conference
Posted Date: 2017-03-22T04:00Z

[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Notices]
[Page 14734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05602]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Food and Drug Administration Center for Drug Evaluation and 
Research Small Business and Industry Assistance Regulatory Education 
for Industry Generic Drugs Forum; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA) Center for Drug 
Evaluation and Research (CDER) is sponsoring a 2-day public conference 
entitled ``FDA CDER Small Business and Industry Assistance (SBIA) 
Regulatory Education for Industry (REdI) Generic Drugs Forum.'' The 
goal of this public conference is to provide direct, relevant, and 
helpful information on the key aspects of the generic drug development 
process. Our primary audience is that of small manufacturers within the 
generic drug industry. However, anyone involved in the pharmaceutical 
industry may attend.

DATES: The public conference will be held April 4-5, 2017, from 8:30 
a.m. to 4:30 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration information.

ADDRESSES: The public conference will be held in the Pinnacle Ballroom 
located on the 2nd floor of DoubleTree by Hilton Hotel, 8727 Colesville 
Rd., Silver Spring, MD 20910.

FOR FURTHER INFORMATION CONTACT: Brenda Stodart, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6707, email: 
cdersbia@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public conference entitled ``FDA CDER Small 
Business and Industry Assistance Regulatory Education for Industry 
Generic Drugs Forum.'' This public conference is intended to increase 
the generic drug industry's awareness of applicable FDA regulations.

II. Topics for Discussion at the Public Conference

    This 2-day, FDA-led forum offers the opportunity to interact with 
FDA subject matter experts from across CDER involved in the Generic 
Drug Review Program. It will provide up-to-date information on program 
progress and current initiatives and present a high-level regulatory 
overview of the complete ANDA review pathway.

III. Participating in the Public Conference

    Registration: There is no fee to attend the public conference. 
Space is limited, and registration will be on a first-come, first-
served basis. To register, please complete registration online at: 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm540969.htm?utm_source=FRN&utm_campaign=GDF2017. Early registration 
is recommended. Registrants will receive email confirmation when they 
have been accepted, and reminder emails will be sent to registrants 2 
days before the conference. If time and space permit, onsite 
registration will be available beginning at 7:30 a.m. on each day of 
the public conference.
    If you need special accommodations due to disability, please 
contact info@sbiaevents.com at least 7 days in advance.
    Streaming Webcast of the Public Conference: This public conference 
will also be webcast. Persons interested in viewing the webcast must 
register to receive a confirmation email with the webcast link.
    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 Web site addresses in this document, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.
    Transcripts: Transcripts will not be available.

    Dated: March 16, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05602 Filed 3-21-17; 8:45 am]
 BILLING CODE 4164-01-P