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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. 

Recording

Recording of the full event (4 hours, 12 minutes), including closed captioning and an audio transcript. Times for each speaker are noted in parentheses below, under each speaker's name. Available slides are posted on the event page

BAA Q&A

Responses to questions asked at the FDA BAA Day event are now available.

Agenda

All times are Eastern Standard Time. Please see the event page for additional information. Also see: FDA BAA Day Speaker Bios (PDF, 287 KB).

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
(00:00:01 – 00:03:11)
(00:16:24 – 00:35:40)

Mr. Leonard D Grant, Director, OAGS
(00:03:27 – 00:15:47)

10:30 a.m.

Program Presentations

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

 

Ms. Shaila Shaheed, ORSI
(00:35:47 – 00:51:56)

Mr. Ian Weiss, OAGS
(00:52:03 – 01:05:55)

Ms. Jessika Alfaro, ORSI
(01:06:03 – 01:17:47)

11:30 a.m.

Question and Answer Panel

  • Review of questions submitted via webinar Q&A pod, and in advance to FDABAA@fda.hhs.gov

 

Panel Members: ORSI & OAGS
(01:18:24 – 01:52:50)

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
(01:53:08 – 02:04:16)

Dr. Neil Stiber & Dr. Thomas O’Connor, OPQ
(02:04:35 – 02:19:04)

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
(02:19:37 – 02:27:32)

Dr. Christina Webber, CDRH
(02:27:41 – 02:43:33)

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
(02:43:41 – 03:01:44)

Dr. Julie Schneider, OCE
(03:02:57 – 03:15:04)

Dr. Christine Lee, OMHHE
(03:15:33 – 03:21:06)                   

Dr. Susan Bersoff-Matcha, OWH
(03:21:50 – 03:33:16)   

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
(03:34:24 – 03:51:36)

Ms. Bridget Foltz, HSPPMS
(03:51:54 – 03:59:49)

Ms. Domini Bean, PRA
(03:59:51 – 04:11:19)

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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