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          FDA BAA Questions & AnswersScience & Research FDA BAA Questions & Answers
  
  					FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation.
	
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    PrintThis page includes responses to questions asked at FDA BAA Day on December 6, 2022. For consideration in FY 2023, white papers are due by **5:00 p.m. EST, January 23, 2023**.

Key links on SAM.gov:

**BAA announcement:** FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
	Full FY 23 BAA PDF (788 KB)BAA Q&A

**What is a BAA?**

FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) solicitation for research and development to support regulatory science and innovation. The FDA BAA is open to all responsible sources, and small businesses are strongly encouraged to respond. Offerors may include single entities or teams from private sector organizations, Federally Funded Research and Development Centers (FFRDCs), and academic institutions.

**Will presentations from the FDA BAA Day event be shared?**

Yes. Presentations are available on the event web page, under Event Materials. A recording of the full event (4 hours, 12 minutes), including closed captioning and an audio transcript, is also available. See the agendafor recording start times for each presenter.

**How will we know about BAAs when they are posted?**

The BAA announcement can be found both on the FDA website and on the SAM.gov website. Any updates will be posted directly to the solicitation on SAM.gov. Once awards are made, the award announcements will also be posted on SAM.gov, linked from the original announcement.

**Are BAAs posted at the same time each year?**

FDA’s fiscal year ends September 30. Each October, we work with FDA centers to define their priorities for the next fiscal year and identify areas of interest. Then, we work with OAGS to open the announcement. We target posting the FDA BAA solicitation for each fiscal year in November on SAM.gov.

**Can you please describe the BAA stage I white paper and quad chart requirements and templates, if any?**

This information can be found in the BAA announcement.

**What is the average budget and duration of projects awarded under the BAA? Are there guidelines for how much FDA can award for a typical BAA each year?**

In general, BAA awards are all between the simplified acquisition threshold ($250,000) to about $2 million. However, there is not a minimum or maximum and it is just based on what is put forth in the proposal and if it is determined to be fair and reasonable by the government. Duration is maximum 5 years.

**Is there a maximum dollar limit for the award? Is this amount different for oncology?**

There is not a minimum or maximum amount for a BAA award. It all depends on the proposal, what the work entails, and if the government finds the amount and level of effort fair and reasonable.

**Are there limits on indirect cost rates?**

No, there is no limit on indirect cost rates. However, the indirect rates will need to be determined fair and reasonable by the federal government. If the entity has already negotiated their indirect rates with HHS or another federal government agency, we will request a copy of the negotiated rate agreement.

**Will proposals that can only be priced using FFP (firm fixed price) be negatively weighted?**

No, not at all. While there is a preference for the cost reimbursement contract type, if the research that is being proposed lends itself to a firm fixed price contract type and that can be properly articulated, that is acceptable.

**Can you post the link to the list of past awards through the BAA mechanism?**

You can find previous awards on SAM.gov by searching the corresponding BAA announcement number. Information about past awards will be listed in a PDF document. The FY 22 FDA BAA awards list is posted at SAM.gov (PDF, 199 KB).

FDA centers and offices may share additional information on their web pages. See, for example:

Extramural Research (Medical Countermeasures Initiative)
	Extramural Research (Office of Minority Health and Health Equity)
	CBER Advanced Technologies Program Extramural Research Funding
	CDER Office of Infectious Diseases Research Activities
	OCE Scientific Collaborative (Oncology Center of Excellence)**At FDA BAA Day, it was mentioned that the FARS report is available online. Are there similar reports from years past on topics selected and awarded by BAA by the different centers?**

The FDA Focus Areas of Regulatory Science report is available on the FDA website. The FY 22 FDA BAA awards list is posted at SAM.gov (PDF, 199 KB).

**Are there any publicly available examples of prior white papers submitted?**

No, these procurement-sensitive documents are not shared publicly.

**Are there any publicly available examples of prior white papers submitted?**

No, these procurement-sensitive documents are not shared publicly.

**Do proposers have the ability to interact with FDA scientific SMEs in advance of submission?**

The research areas of interest are listed in the BAA as the announcement is crafted after consultations with the FDA centers/offices on what their needs are with regard to the research areas.

**What is the timeframe for decisions for each stage? This seems like a tight timeline.**

Please refer to Ms. Shaheed’s presentation (PDF, 558 KB). The BAA is an open solicitation. We are reviewing new white papers as they are received. For FY 23, once we receive the white papers, they are initially triaged and then we follow through with stage I evaluation.

In approximately mid-May, notification letters will go out to the applicants. For stage II, in mid-July, approximately, notification letters will be sent to applicants, but it may vary from proposal to proposal.

The timeline is based on the whole two-stage BAA process. Timelines are put into place in order for the FDA to be able to make awards in the corresponding fiscal year. We do accept white papers on a rolling basis—they just might not be reviewed/evaluated in the present fiscal year.

**The 30-day timeline for developing the full proposal is a very tight turnaround for academic institutions. Would FDA consider a longer turnaround for the stage II proposals?**

You may request additional time if needed via the Contracting Officer. We will consider your request if feasible.

**What academic areas of research might qualify?**

The research areas of interest are outlined in the BAA announcement. You may also reference the FDA BAA Day recording and materials to view presentations from some of the FDA centers/offices outlining their research areas of interest.

**Can I propose a multi-year project/contract?**

Yes, you can propose a multi-year project timeline as long as the timeline is reasonable for the research being proposed.

**What is the average duration of these awards? Do you have any recommendations for proposing a 1-year vs. 3-year vs. 5-year project, for example?**

The duration of the contract depends on the timeline proposed and if that timeline is reasonable considering the research and deliverables being proposed. There is no recommended timeline, but BAA contract duration maximum is 5 years.

**Does the BAA program fund clinical trials?**

It depends on the proposed topic. As noted within the BAA solicitation, we have a topic area, complex innovation of clinical trials, which we receive a lot of submissions for. The short answer is, yes, the BAA program can fund clinical trials depending on the research topic area.

**The instructions between FY 22 and FY 23 look inherently the same with regard to the stage I proposal submission. What is the difference in the specification of a free-standing quad chart and free-standing white paper for FY 23, compared to FY 22?**

Please refer to page 1 of the FY 23 BAA PDF (788 KB ). White paper alignment is different for FY 23.

**If the team includes a large academic institution and a small business, does the small business need to be the lead organization in order to qualify as a small business submission?**

If the large institution is the prime and the small institution is the subcontractor, then no, this would not qualify as a small business submission. However, it depends on the relationship between the two institutions.

**We have existing relationships with academic institutions and pharmaceutical companies. Part of the proposal would involve collaborative work with these companies/institutions, but we may not be able to finalize contractual agreements for work specific to the FDA BAA before the stage I or even stage II proposals are due. Can we submit the proposals listing potential partnerships in progress and highlight prior work done with these institutions?**

Partnerships are fine. They will fall under subcontracting, and applicable Federal Acquisition Regulation (FAR) subcontracting rules will apply.

**SAM.gov registration is required for the lead institution. What about foreign subs for BAA with a U.S. lead institution? Is State Department permission needed?**

No, State Department permission is not needed, but SAM.gov registration is required.

**How do I get feedback on my white paper?**

Once the evaluation is complete, you will receive an email notification that will include technical feedback, if permitted. The feedback may be limited depending on the reasons it was not chosen to move on to Stage II, if applicable.

**Who are the reviewers for BAA applications? Are they from academia, industry, or FDA? Does each office have their own evaluation panel?**

All voting panel members are subject matter experts and most are FDA employees. We can recruit reviewers from other agencies if needed.

**Is the technical evaluation panel the same for stage I and stage II?**

Yes, it usually is. However, if additional subject matter experts are needed for stage II evaluation, which is a lot more robust and involved, we do recruit additional members, or if they are unable to participate, we recruit additional reviewers. But this very rare.

**Will the services and products be sourced directly, or will there be RFIs/RFPs in the future?**

If the results from the individual awards are a defined product or service and FDA has a continuing need for that product or service, then that would be put out for public competition via a Request for Information or Request for Proposals.

**Are clinical instructors who are on NIH instructional K grants eligible to apply?**

If the individual is applying through an entity that is registered in SAM.gov, they can submit a white paper for consideration. Please note that the offeror’s capability is an evaluation factor as well.

**Some of the solutions may be applicable to many organizations in FDA. Do we need to solicit individually to these organization? For cross cutting areas, does the proposer need to decide which office the application should go to?**

Please review the BAA announcement. It includes specific instructions about how to submit a white paper and quad chart, including the charge and topic area alignment. Details are listed within the BAA announcement. All proposals for BAA should be submitted through the FDA BAA inbox (FDABAA@fda.hhs.gov), listed in the BAA announcement. We will direct them to the appropriate centers/offices.

**If we apply for CERSI and BAA with a similar topic in parallel, should we point that out in the proposals?**

Yes, it is highly recommended.

**What will be the role of the *in silico*(computing modelling & simulation) technologies in this new framework?**

In the BAA solicitation, see Charge Area I: Modernize development and evaluation of FDA-regulated products; Regulatory Science Topic Area of Interest C: Analytical and Computational Methods.

**In the context of a tool development proposal, who would own the resulting intellectual property at the end of the contract period?**

It depends on the individual requirements and the contract.

**If a software prototype is developed under contract. and later after contract is completed and full software is developed from the prototype with substantial difference, will the government still have license rights to the full software?**

It depends, and this would be negotiated prior to award.

**Is existing real-world data collected by other entities before contract but used in the contract considered data property under contract?**

Not typically, but this may be negotiated if relevant.

**Does the license to IP include all government agencies?**

Generally yes, but this could be negotiated.

**I have a question not answered above.**

Please contact FDABAA@fda.hhs.gov with additional questions.

                                                                                  Content current as of:
      01/05/2023Science & Research

          
                        


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