Attachment No. 5 - Additional Questions Answers_.pdf

Attachment No: 5 Questions & Answers

Solicitation No: FDABAA-23-00123 – Amendment # 2

1.

Solicitation Section/Subsection Number: Sol Doc_FDABAA-23-00123

Question:

What is the funding amount for FDABAA-23-00123?

Government Response:

(For Government use only)

We do not have a finalized number at this time, and probably not until 3rd quarter.

2.

Question:

Can offerors submit a single proposal that is responsive to multiple Primary Research Areas?

Government Response:

Offerors required to submit individual proposal of each research area.

3.

Who owns the intellectual property once the research is generated/completed?

Government Response:

Generally the government retains limited use rights, but unlimited rights for the government or a hybrid can be negotiated prior to contract award.

4.

Question:

What time frame is the FDA looking for projects (1, 2, 5, etc.) or is it to the discretion of the applicant?

Government Response:

Timelines are to be proposed by the applicant.

5.

Question:

Based on what I have read, there is no funding limitation specified by the BAA mechanism: however, individual FDA offices are limited by available budgets for research. Do you know what the funding limitation is here or it is the discretion of the applicant to determine.

Government Response:

(For Government use only)

Overall funding is determined by the agency, and the funding at the contract level is determined by the proposal and any negotiations that occur.

6.

How do I find prior recipients of this award?

Prior recipients can find in “Federal Procurement Data System” at the following link.

https://www.fpds.gov/fpdsng_cms/index.php/en/

7.

What is the funding vehicle of this application?

Proposal dependant

8.

Question:

I unfortunately missed the webinar. I am a current participant, and I also intend to submit a couple of white papers this year - would you please share with me the webinar presentation?

Also, was the session recorded? If so, is there a link available to the recorded session?

Government Response:

(For Government use only) https://fda.zoomgov.com/rec/share/I3aM_Gjz7lAb3KVJmJI1lYV8Mqo3aGgL9_oI3jx6fFirkV z8Z9xKvxKWV4Pv5AJr.ubCqbg7TUd7XBSS2?startTime=1670338801000 https://www.fpds.gov/fpdsng_cms/index.php/en/

9.

Question:

We request clarification about the scope of the following research category on page 20 of the FDA BAA solicitation document:

• FDA charge: I. Modernize development and evaluation of FDA-regulated products

• Focus area: I. Approaches to Incorporate Patient and Consumer Input

• Sub-focus area: 2. Devices

• Research category: a. Explore human factors engineering principles in device and combination product design and review

Specifically, does the above research category include any type of medical device, only medications, or both in its scope?

Government Response:

Updated in amendment 00002

10.

Are the cost rules based on internal rates?

Cost is based as proposed.

11.

Where can I can I find clarity on the cost rules as the FDA BAA announcement is not clear on the rates?

https://www.acquisition.gov/far/subpart-16.3

12.

Question:

Are you able to provide guidance on what profit we can add?

Government Response:

Profit must be fair and reasonable as determined by a contracting officer.

13.

Who retains the rights to the models that we create using our software?

Please see question 3.

End of Questions & Answers.