FDA Broad Agency Announcement: Frequently Asked Questions for Oncology Researchers
Background Information
Where can I find the BAA announcement?
The FY24 BAA announcement is posted on www.sam.gov. Scientific interest areas in the BAA announcement are usually updated on an annual basis. Applicants should periodically search www.sam.gov to find the updated BAA announcement.
Who is eligible to apply?
As indicated in the BAA announcement, the BAA is open to all responsible sources, which includes single entities or teams from private sector institutions, academic and nonprofit institutions. Historically black colleges and universities and other minority institutions are encouraged to apply or join teams that submit applications. There are no specific educational or experience requirements for Principal Investigators, but capabilities and experience are considered evaluation criteria in the review process (Refer to Part IV of BAA Solicitation Notice for additional details).
Can international institutions submit proposals?
Yes, but institutions must be registered on www.sam.gov in time to receive funding if an application is successful. International applicants should ensure sufficient time to complete the sam.gov registration process, as FDA cannot make awards unless this registration is complete. FDA does not have authority over the sam.gov registration process.
Does the BAA result in a contract or a grant? What reporting is required once a BAA is awarded?
The BAA results in a research and development (R&D) contract. There are regular reporting requirements to the FDA Contracting Office that are different to those typically required for grants. Reporting requirements are described in detail in the BAA announcement (Refer to Part II of BAA Solicitation Notice for additional details).
What is the maximum length for a project supported by the BAA?
The BAA mechanism can support projects for up to five years.
Does the FDA Oncology Center of Excellence (OCE) limit the amount of funding provided for an individual project?
There is no funding limitation specified by the BAA mechanism; however, individual FDA offices (including OCE) are limited by available budgets for research. It is most important for applicants to propose a cost that is reasonable to complete the research.
Does OCE support basic and applied research under the BAA?
The BAA mechanism can fund both basic and applied research, but work funded under the BAA should have a direct impact to FDA. OCE prefers to fund applied research studies. OCE is most interested to support applied research that focuses on solving a specific, practical problem encountered in the review of oncology products rather than expanding general knowledge.
How can I find out about previously awarded BAAs?
You may find a summary of active OCE-funded BAAs on the OCE-Funded Active Extramural Research Projects web page and a summary of all FDA-funded BAAs on the FDA.gov BAA web page. The awards are also posted on sam.gov under the solicitation for which awards are made.
Communicating with OCE staff about potential submissions
How can I communicate with OCE staff about my research idea?
Prior to submission of an Optional Early Concept Paper or Stage 1 package (includes Concept Paper and Full Proposal), you may contact individual OCE staff to seek clarification about the scientific interest areas described in the BAA Solicitation Notice. Please note that FDA staff can only discuss information in the BAA announcement. If you do not have a specific OCE contact, you may request input by email to: FDAOncology@fda.hhs.gov.
After an Optional Early Concept Paper or Stage 1 package has been submitted to FDA, all communications about the research proposal must go through the FDA Contracting Office at FDABAA@fda.hhs.gov.
Can OCE staff comment on draft specific aims for a potential project?
No. OCE staff cannot comment on specific aims for a potential project or be involved in drafting or commenting on a research proposal.
Can OCE staff stay involved in the research if a project is funded through the BAA?
Yes. OCE staff may provide regulatory perspectives about the research project and may co- publish with BAA-funded investigators.
Who can I contact about questions, details, and logistics regarding submission of an application?
FDA contracting office representatives are the experts about the details of submitting applications. You can find specific contact names in the “Contact Information” section of the BAA announcement and/or may use the general BAA email inbox: FDABAA@fda.hhs.gov.
Can I propose to analyze data submitted to FDA using the BAA mechanism?
Yes, because the BAA mechanism results in a research contract (rather than a grant), it is possible for Offerors to analyze data submitted to FDA. All FDA contractors (including funded BAA Offerors) are bound by Federal Acquisition Regulation rules about protecting commercial confidential information and can access data submitted to FDA on FDA-issued laptops.
Application and review
When is the application deadline?
FDA accepts BAA submissions on a rolling basis but posts a deadline to apply for consideration for funding in a specific fiscal year. The Optional Early Concept Paper due date is November 6, 2023. Stage I submission packages are due February 19, 2024, to be considered for funding in FY24. Details related to the Concept Paper and full proposal are described in the BAA Solicitation Notice (Part III).
What is an Offeror?
In the Federal Acquisition Regulations, an "offer" means a response to a contract solicitation. For the BAA, an Offeror is the institution/ applicant who submits the research proposal to FDA for consideration.
How are BAA submissions reviewed?
For Optional Early Concept Paper submissions, FDA may provide recommendations with optional feedback to Offeror on whether to submit a Stage 1 package. For Stage 1 packages, FDA will conduct a high-level review of the Concept Paper to determine potential program relevance. If the submission is determined to have the potential to align with an Agency Program, the Full Proposal will receive a full Stage I Evaluation/ Review by FDA internal scientific experts who consider the following factors: (1) scientific and technical merit; (2) program relevance; and (3) offeror capability and experience. Past performance and costs are also analyzed. More details can be found in the BAA Solicitation Notice (Part IV).
How frequently are the scientific interest areas in the BAA updated?
FDA updates the scientific interest areas annually, with a new BAA announcement typically being issued each year. Applicants should periodically search beta.sam.gov to look for the updated BAA announcement.
OCE submits specific scientific interest areas in the BAA solicitation notice (further described on the OCE Scientific Collaborative web page) but is also open to proposals in other areas relevant to oncology regulatory science research.