82 FR 19066 - Food and Drug Administration Small Business and Industry Assistance Regulatory Education for Industry Spring Conference; Public Conference

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), together with the Center for Devices and Radiological Health (CDRH), is sponsoring a 2-day public conference entitled ``FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Spring Conference.'' The goal of this public conference is to provide direct, relevant, and helpful information on the key aspects of drug and medical device regulations in order to increase regulatory certainty and predictability for pharmaceutical and/or medical device industry. Our primary audience is that of small manufacturers of drug and/or medical devices who want to learn about how FDA approaches the regulation of drugs and medical devices and for whom increased certainty and predictability will help to decrease the regulatory burdens that can be associated with a lack of understanding of, or familiarity with, FDA's drug and medical device regulations. However, anyone involved in the pharmaceutical and/or medical device industry may attend.

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19066-19067]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Food and Drug Administration Small Business and Industry 
Assistance Regulatory Education for Industry Spring Conference; 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), together with the Center for Devices 
and Radiological Health (CDRH), is sponsoring a 2-day public conference 
entitled ``FDA Small Business and Industry Assistance Regulatory 
Education for Industry (REdI) Spring Conference.'' The goal of this 
public conference is to provide direct, relevant, and helpful 
information on the key aspects of drug and medical device regulations 
in order to increase regulatory certainty and predictability for 
pharmaceutical and/or medical device industry. Our primary audience is 
that of small manufacturers of drug and/or medical devices who want to 
learn about how FDA approaches the regulation of drugs and medical 
devices and for whom increased certainty and predictability will help 
to decrease the regulatory burdens that can be associated with a lack 
of understanding of, or familiarity with, FDA's drug and medical device 
regulations. However, anyone involved in the pharmaceutical and/or 
medical device industry may attend.

DATES: The public conference will be held May 9 and 10, 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 High Ballroom, 
located on the Lobby Level of the Renaissance Atlanta Midtown Hotel, 
866 W. Peachtree St. NW., Atlanta, GA 30308. The hotel's phone number 
is 678-412-2400.

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: 
[email protected]; or Elias Mallis, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-7100, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing a public conference entitled ``FDA Small Business 
and Industry Assistance Regulatory Education for Industry Spring 
Conference.'' This public conference is intended to increase the drug 
and medical device industry's awareness of applicable FDA regulations. 
There will be an opportunity for questions and answers following each 
presentation.

II. Topics for Discussion at the Conference

    This 2-day, FDA-led forum offers the opportunity to interact with 
FDA subject matter experts from across CDER and CDRH. The following 
information will be discussed:

 CDER Investigational New Drug Application (IND) Review 
Process: Types of IND; Content and Format of an IND; Chemistry 
Manufacturing and Controls; Pharmacology/Toxicology; Drug Inspections
 CDRH: 510(k); Biocompatibility in Premarket Submissions; Non-
Conforming Product; Device Inspections

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/ucm545309.htm. 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 [email protected] 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

[[Page 19067]]

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: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08308 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P