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FDA Broad Agency Announcement Day Agenda

FDA BAA Day

December 6, 2022, 10:00 a.m. - 3:30 p.m. EST

FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us for the 2022 FDA Broad Agency Announcement Day to learn more about the FY 2023 BAA, and how to apply. Register now to attend. 

Draft agenda

All times are Eastern Standard Time. Please see the event page for additional information. 

Time Agenda item Presenter
10:00 a.m.

Welcome and Opening Remarks

  • FDA regulatory science framework and an overview of the new BAA announcement

 

Dr. Tina Morrison, Director, ORSI
Mr. Leonard D Grant, Director, OAGS

10:30 a.m.

Program Presentations

  • FDA BAA program overview 
  • 2023 BAA updates
  • BAA proposal submission, evaluations and lessons learned

 

Ms. Shaila Shaheed, ORSI

Mr. Ian Weiss, OAGS

Ms. Jessika Alfaro, ORSI

11:30 a.m.

Question and Answer Panel

 

Panel Members: ORSI & OAGS

12:00 p.m. Lunch  
12:30 p.m.

Center for Drug Evaluation and Research (CDER) Presentation 

  • Office of Generic Drugs
  • Office of Pharmaceutical Quality

 

Dr. Sammersingh Raney, OGD

Dr. Neil Stiber & Dr. Thomas O’Connor, OPQ

1:00 p.m.

Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH) Presentation

  • CBER
  • CDRH

 

 

Dr. Emily Braunstein, CBER

Dr. Christina Webber, CDRH

1:30 p.m.

Office of the Commissioner Presentations 

  • Office of Counterterrorism and Emerging Threats 
  • Oncology Center of Excellence 
  • Office of Minority Health and Health Equity 
  • Office of Women’s Health

 

Mr. Robert Orr, OCET

Dr. Julie Schneider, OCE

Dr. Christine Lee, OMHHE                 

Dr. Susan Bersoff-Matcha, OWH

2:30 p.m.

Special Consideration for BAA R&D Contract 

  • Intellectual Property (IP) and Data Rights
  • Human Subject Protection Program Management Staff
  • Paperwork Reduction Act and Privacy 

 

Dr. Alice Welch, TTP

Ms. Bridget Foltz, HSPPMS

Ms. Domini Bean, PRA

3:15 p.m.  Adjourn  

Acronyms

CBER - Center for Biologics Evaluation and Research

CDER - Center for Drug Evaluation and Research

CDRH - Center for Devices and Radiological Health

HSPPMS - Human Subject Protection Program Management Staff

OAGS - Office of Acquisitions and Grants Services

OCE - Oncology Center of Excellence 

OCET - Office of Counterterrorism and Emerging Threats 

OGD - Office of Generic Drugs (CDER)

OMHHE - Office of Minority Health and Health Equity 

OPQ - Office of Pharmaceutical Quality (CDER)

ORSI -  Office of Regulatory Science and Innovation

OWH - Office of Women’s Health

PRA - Paperwork Reduction Act

TTP - Technology Transfer Program

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