Amendment 1 - Questions and Answers.pdf

AMENDMENT ONE (1)

Solicitation Number: 75N91025R00005 Date of Solicitation Issuance: 05/16/2025 Date of Amendment No. 1 Issuance: 07/08/2025 Number of Pages: 5 Point of Contact: Tanya Renwick, Contract Analyst [C] E-mail: ncioasbir@nih.gov Issuing OƯice: National Cancer Institute (NCI)

PURPOSE OF SOLICITATION AMENDMENT

The purpose of this amendment is to provide the recording of the pre-proposal conference, as well as to provide key questions and answers from that session in written format (see below).

A recording of the pre-proposal conference and associated materials have been posted on the NCI SBIR webpage (https://sbir.cancer.gov/small-business-funding/contracts/innovative-concept-award) and are also made available below. Visit the link to: (1) watch the recording, (2) access the transcript, and (3) access the slides.

The hour and date specified for receipt of oƯers remains unchanged. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full eƯect.

QUESTIONS AND RESPONSES

Question 1: Is there an opportunity to apply for an STTR award based on this solicitation?

Answer 1: No, this solicitation is limited to SBIR awards only.

Question 2: Who is eligible to receive an award under this solicitation?

Answer 2: Applicant must be a small business concern, defined as having 500 or less employees including aƯiliates, must be organized for profit, and located in the U.S. and with at least 50% U.S.

ownership.

Question 3: Why would someone seek SBIR funding?

Answer 3: Funding provided is not a loan (no repayment is required) and IP rights are retained by the small business. Further, awards provide recognition and visibility, as well as attracting additional funding and support.

Question 4: What is the diƯerence between an academic grant and a SBIR award?

Answer 4: Academic awards are focused on advancing science and the resulting output can be an intangible answer to a basic science research question, while an SBIR award has to be focused on taking a technology and driving it towards a commercial product. All SBIR aims and objectives should be focused on product development.

Question 5: What are some key diƯerences between a grant and a contract award?

Answer 5: This solicitation is for a contract award. Unlike a grant, contracts require that:

(1) The output has to be consistent with a NCI-identified priority focus area;

(2) OƯerors may only contact the Contracting OƯicer assigned pre-award and not the Program OƯicer;

(3) There is only one proposal receipt date defined in the solicitation annually;

(4) There are multiple reporting requirements structured into the contract award;

(5) Award decisions are based on: (i) Technical Evaluation (see Solicitation Section 6.3); Areas of high programmatic relevance; Programmatic balance (i.e., balance among areas of research);

Availability of funds; Cost/price reasonableness; and Security risk as assessed by the HHS Due Diligence Program; and (6) funds are received when work is completed with quarterly invoicing anticipated.

Question 6: How does the Concept Award program fit into NCI’s SBIR funding phases?

Answer 6: Concept Awards are Phase I awards, but they are the earliest Phase I awards NCI oƯers where the earliest stages of development are funded. The NCI is interested in really high risk, high reward projects with limited or no preliminary data available. Phase I awards typically require preliminary data related to feasibility and proof-of-concept.

Question 7: How do you define “innovation” for the purpose of this solicitation?

Answer 7: The solicitation defines "innovation" as something new or improved, having marketable potential, that includes the development of new technology, the refinement of existing technology, or the development of new applications for existing technology.

Question 8: What is the diƯerence between the White Paper review and the review of the full proposal?

Answer 8: The white paper process is internal to NIH staƯ, but the peer review process is an independent review comprised of experts from outside the Federal Government, in accordance with 42 CFR 52h.

Question 9: What does “rare cancer” mean for the purpose of the solicitation?

Answer 9: The list of "rare" cancers for the purposes of this solicitation can be found at https://rarediseases.info.nih.gov/search-result?category=Cancer). You can type in your indication and see if it’s on the list. Some cancers on the list are not typically considered “rare,” such as pancreatic cancer, so please check the list to see if your cancer is included.

Question 10: Can you apply for a Concept Award if you are waiting for an award under another NIH funding mechanism?

Answer 10: You cannot receive SBIR funding for "essentially equivalent work" funded by the Government, as stated in Section 8.9 of the solicitation. However, you can receive SBIR awards for projects that are not already funded even if you have other Government contract awards or grants.

Question 11: What is the White Paper and what should be included?

Answer 11: White Papers are 2-3 page summaries of your technology that can be submitted for NCI review prior to the proposal due date for feedback and suggestions. It is recommended that you identify the rare or pediatric cancer unmet need focus, highlight innovation and disruptive impact, discuss the development stage, summarize derisking research aims and objectives, and include quantitative milestones. NCI will provide bulleted feedback and recommend whether you should submit a full proposal. However, the decision to submit a proposal is still entirely with the oƯeror.

White papers are due July 11, 2025 at 5:00PM EDT to ncioasbir@mail.nih.gov. See Solicitation Section 7.1 for more details.

Question 12: What is “innovative” for the purposes of this solicitation?

Answer 12: Innovation, for the purposes of this award, means the development of groundbreaking new products, technologies, or tools. NCI is seeking disruptive innovation rather than incremental innovation. We are particularly interested in transformative technologies with the potential to change clinical care. Innovation is not therapeutics targeting known pathways with FDA-approved agents, technologies in clinical stage or already far down the development pathway, or continuation of already funded SBIR/STTR projects. OƯerors should clearly highlight what’s innovative about the proposed work.

Question 13: How do I submit a proposal?

Answer 13: OƯerors should carefully review the solicitation requirements for details on submitting a proposal. OƯerors should submit their proposals using solicitation Attachment 1 – Technical Proposal Form.

Question 14: What is the proposal review process?

Answer 14: The Concept Award proposals are evaluated in the same manner as all other NCI R&D contracts. OƯerors are encouraged to review solicitation Section 6.1 Evaluation Process to learn more about the proposal evaluation process.

Question 15: Is there a preference for brand new companies or established companies that have received previous awards?

Answer 15: No, there is no preference. However, we are seeing a high number of awards going to companies that have not received previous awards. We also see previous awardees who have a new and innovative project receiving awards.

Question 16: Can companies with preliminary data apply?

Answer 16: Yes, they can apply. The information is limited to a one-page maximum in the proposal.

This data is not required, but it will be reviewed if included.

Question 17: Can you be competitive for an award if they don’t already have a full team on staƯ?

Answer 17: Yes. Small businesses are allowed to leverage consultants, and you can add an employee to the proposal without hiring them in anticipation of hiring them upon award. You can also utilize iCorps for to supplement staƯing.

Question 18: Can companies apply that have preliminary data for non-cancer indications apply?

Answer 18: Yes, they can apply if they have a new indication related to a covered cancer.

Question 19: Can the PI be employed at another organization at the time of application?

Answer 19: Yes, as long as the PI will be primarily employed at the company at the time of award.

This is also true for physical space.

Question 20: Is a clinical or academic partner required?

Answer 20: It is acceptable to have a university or clinical collaborator. OƯerors should address any weaknesses in staƯing. A multi-PI leadership plan can be completed (see Solicitation Section 4.4).

The PI can also be the main scientific expert as well, but there will likely be additional expertise required for some elements of the award.

Question 21: What about platform technologies?

Answer 21: These technologies are acceptable. It is recommended to focus on a single indication.

Question 22: Can you submit multiple white papers?

Answer 22: It is recommended not to submit multiple white papers, but any papers submitted that include all required elements will receive a response.

Question 23: Can you explain the criteria for human subjects?

Answer 23: Non-exempt Human subjects research is not allowed under this solicitation. See Solicitation Sections 7.4 and 8.8 for more information about human subjects requirements.

Question 24: Can an oƯeror propose a PI who is not a PhD? What if the only person working over 50% of the time for the company is a non-scientist?

Answer 24: Yes, the PI should have expertise and that should be explained in the proposal, but no specific degree is required. The proposal should provide detail on the relevant technical expertise available to complete the project.

Question 25: Are there any specific topics for this solicitation?

Answer 25: This solicitation is focused on rare and pediatric cancers. Solicitation Section 11 defines the two topics as:

Topic 1: Development of therapeutic or preventative technologies for treatment or prevention of Pediatric Cancers and/or Rare Cancers.

Topic 2: Development of devices, diagnostic technologies, or digital health tools for treatment, detection, and diagnosis of Pediatric Cancers and/or Rare Cancers.

Question 26: Can I get specific feedback on my project?

Answer 26: The best way to receive specific feedback on your project is to submit a White Paper.

Question 27: Do you have sample White Papers?

Answer 27: Unfortunately, no.

Question 28: If I receive a Concept Award, will I be eligible for future SBIR contract or grant awards?

Answer 28: Yes. Depending on how far you get with your project, you may be eligible for a Phase II grant award after the Concept Award contract is complete. The NCI also anticipates that Concept Awardees will be invited to submit a proposal for a Transition to Phase II contract solicitation when their Concept Award contract is complete.