FY2014 Contract Topics – Frequently Asked Questions

Please click here to view the solicitation amendment and for answers to general questions about contracts.

General Questions

1. Can I do electronic submission?
2. Who should I contact with questions on technical matters or contract administration?
3. I know the SBIR Program Manager (Contracting Officer Representative) that is in charge of a specific topic. Why can't I call them directly with my questions?
4. Advice: Always reference the topic number and solicitation when submitting questions!
5. Can I submit the same project as a proposal for a contract and as a grant?
6. How do I know if you received the proposal?
7. How do I find out about the status of my proposal and the date my proposal will be reviewed?
8. How will I know who else has submitted a proposal under my topic?
9. I didn’t find out about the solicitation until recently and it will take time to put the proposal together. Can I submit my proposal late?
10. I am doing research on X. Is there a topic on X? Do you fund X? Can we submit a proposal in response to this contract solicitation PHS-2014-1?
11. There is no topic in the current solicitation that is in my business’s area. Should I wait for the next solicitation? What can I do?
12. Can you recommend us for SBIR/STTR Phase 1 grant application submission?
13. Are the slides available from the October 30, 2013 NCI SBIR Contracts Funding Webinar event?

Proposal Structure and Logistics

14. Can I propose a greater budget than is listed on the topic?
15. Are all the milestones expected to be met, or would achieving one or two of them be sufficient?
16. Can funds be used to participate in training programs to evaluate your market potential?
17. I want to use a foreign subcontractor, may I?
18. How much preliminary data is required?
19. What is the proposal structure? What are the page limits and required sections?
20. Can you send me a sample proposal? Sample budget pages?
21. Specifically what do we need to do to respond to this solicitation?
22. How do we describe commercial potential? What is the difference in the commercialization sections in contract proposals compared to grant applications?
23. May I submit a proposal for a Phase II only project under this solicitation?
24. What are the pros and cons of a Fast Track submission compared to delaying a Phase II submission for a contract proposal? If a Fast Track contract is funded only for Phase I, what is the timeline for a Phase II proposal submission?
25. Can a Phase I contract awardee apply for a Phase II grant?
26. Can a Phase I grant awardee apply for a Phase II contract?

Review

27. How many proposals do you expect to receive for each topic?
28. What are the historic funding rates (percentage of proposals) for NCI SBIR contracts?
29. Do reviewers of grants and contracts have similar backgrounds (e.g. academia vs. industry)?
30. What is a promising score in the likelihood of being funded for a contract?

Topic 327

31. Does the formulation technology have to be innovative or is a novel and innovative drug formulated with a sophisticated but established formulation technology sufficient?
32. Can you provide the list of available failed chemotherapeutic drugs and why it failed?

Topic 332

33. Is it necessary to have preliminary in vivo tox studies showing that the radiomodulator is not sensitized to healthy cells?

General Questions

1. Can I do electronic submission?

   No. The NIH and CDC do not currently accept electronic proposals. Paper copies and the original proposal must be submitted at the address specified for the appropriate HHS Component or Topic indicated in Section 10 of the solicitation. See section 7.3 How To Submit Proposals.

2. Who should I contact with questions on technical matters or contract administration?

   For any questions related to contracts, please contact:
   Ms. Elizabeth Shanahan
   Phone: (240) 276-5432
   Fax: (240) 276-5431
   E-mail: eshanahan@mail.nih.gov

3. I know the SBIR Program Manager (Contracting Officer Representative) that is in charge of a specific topic. Why can't I call them directly with my questions?

   Once the solicitation is released, all contacts concerning the acquisition must be directed through the Contracting Officer who will facilitate technical discussions. Once contract awards are made contractors are free to interact with the Contracting Officer Representative. For NCI, the Contracting Officer is Ms. Elizabeth Shanahan, eshanahan@mail.nih.gov.

4. Advice: Always reference the topic number and solicitation when submitting questions!

5. Can I submit the same project as a proposal for a contract and as a grant?

   No, you may not submit both a contract proposal and a grant application for essentially the same project to the same or different awarding component(s) of the NIH/CDC. The only exception is after a contract proposal has been evaluated and is no longer being considered for award, you may submit a grant application. See Section 4.18 Prior, Current, or Pending Support of Similar Proposals or Awards in the solicitation.

6. How do I know if you received the proposal?

   There is no acknowledgement of receipt. It is advised that you save tracking information from the mailing.

7. How do I find out about the status of my proposal and the date my proposal will be reviewed?

   We do not currently have a portal through which you can track your proposal through the award process. The NCI does not utilize eRA Commons for tracking contract proposals, so this information will not be available in eRA Commons as it is with grant applications. Please contact Elizabeth Shanahan, eshanahan@mail.nih.gov, for an update on your proposal.

8. How will I know who else has submitted a proposal under my topic?

   This acquisition is governed by Federal Acquisition Regulations. Accordingly, offerors are not entitled to information concerning the names or proposal details of competitors. Information about who has been awarded contracts can be found on the NIH RePORTER site that contains information about grant and contract awards: http://projectreporter.nih.gov.

9. I didn’t find out about the solicitation until recently and it will take time to put the proposal together. Can I submit my proposal late?

   The NCI will not accept late proposals.

10. I am doing research on X. Is there a topic on X? Do you fund X? Can we submit a proposal in response to this contract solicitation PHS-2014-1?

    Before your inquiry can be addressed, you need to identify which technical topic you would be responding to under PHS-2014-1. We are only soliciting contract proposals under specific topics. Please review Section 12 of the solicitation COMPONENT INSTRUCTIONS AND TOPIC DESCRIPTIONS to determine if your project would fall within one of the topics outlined, and if you feel your project could fulfill the requirements specified.

    If you feel that your project could address the requirements outlined in one of the technical topics you may e-mail a two paragraph summary of your project to the Contracting Officer designated as the point of contact in Section 10 CONTRACTING OFFICERS AND ADDRESSES FOR DELIVERY OF CONTRACT PROPOSALS of the solicitation. A response will be coordinated with the program staff. The program staff will review your summary and indicate if they feel your project would be responsive to the topic you have identified. You may not interact with the program staff directly as this is a competitive acquisition.

11. There is no topic in the current solicitation that is in my business’s area. Should I wait for the next solicitation? What can I do?

    There are a number of funding opportunities available through the NCI SBIR/STTR programs. If there is no contract topic being solicited, please check available grant funding opportunities here: http://sbir.cancer.gov/funding/opportunities/omnibussolicitation. In general, if you are working on a research project within the mission of the NCI, advancing cancer research, prevention, diagnosis, or treatment, then you may apply through the Omnibus solicitation, the NIH investigator-initiated funding opportunity. Learn more about the Omnibus here: http://sbir.cancer.gov/funding/opportunities/omnibussolicitation.

12. Can you recommend us for SBIR/STTR Phase 1 grant application submission?

    In general we cannot recommend opportunities. Please review the NIH SBIR website. All current and open Request for Grant Applications, as well as this Request for Contract Proposals can be found. You must read and review the descriptions of these opportunities to determine if they are of interest to your organization. Each opportunity lists a point of contact if you have specific questions.

13. Are the slides available from the October 30, 2013 NCI SBIR Contracts Funding Webinar event?

    Yes, here: http://sbir.cancer.gov/pdfs/2013-10-30_nci_sbir_contracts_webinar.pdf

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Proposal Structure and Logistics

14. Can I propose a greater budget than is listed on the topic?

    While you are allowed to propose a greater budget than is listed, this is a competitive process, and it is strongly advised that proposals adhere to the budget amounts and project periods. Proposals with budgets exceeding the specified amounts and project periods may not be funded. Section 12 has a description of each topic with a dollar value specified.

15. Are all the milestones expected to be met, or would achieving one or two of them be sufficient?

    It is generally expected that all the milestones would be met, though this may depend on the particular topic. If you have a question regarding the milestones of a specific topic, please submit your question, referring to PHS2014-1 and the contract topic number, to Elizabeth Shanahan, eshanahan@mail.nih.gov.

16. Can funds be used to participate in training programs to evaluate your market potential?

    SBIR funding is intended for use in research and development activities, and thus excludes use for market analysis or training. However, you may include a request for technical assistance funds of up to $5000. If you wish to request technical assistance funds, you are required to include these costs in your budget and provide a detailed budget justification. Refer to Section 8.1 for how to include this in your Pricing Proposal. Refer to Section 4.20 for a description of the eligible types of technical assistance services.

    If the amount of $5000 is included in your cost proposal and is determined to be appropriate and allowable for technical assistance, this will be in addition to the amount negotiated per award, and as specified in the topic description.

    Please note, if funds are requested to utilized your own technical assistance vendor and an award is made, the awardee is not eligible to apply for the NIH-provided technical assistance program for the phase of their award.

17. I want to use a foreign subcontractor, may I?

    No.

18. How much preliminary data is required?

    There is no requirement for preliminary data for Phase I proposals. However, competitive applications almost always include a substantial amount of preliminary data, as this is a competitive funding environment. Consider including preliminary data to establish a foundation for your project proposal to make it competitive.

19. What is the proposal structure? What are the page limits and required sections?

    See Sections 7 and 8 in the solicitation. SBIR Phase I technical proposals shall not exceed 50 pages. SBIR Phase II technical proposals shall not exceed 150 pages. Pages in excess of the page limitation will be removed from the proposal and will not be read, considered, or evaluated. Section 8 details proposal preparation and instruction, including all required sections.

20. Can you send me a sample proposal? Sample budget pages?

    We do not provide sample documents. For detailed instructions on how to fill out budget pages and definitions, please refer to the solicitation, section 8, http://grants.nih.gov/grants/funding/SBIRContract/PHS2014-1.pdf.

21. Specifically what do we need to do to respond to this solicitation?

    You must read the solicitation and determine if your organization is eligible to compete, if your project would be address the technical topic requirements, and follow the directions for submitting your proposal as detailed in sections 7 PROPOSAL SUBMISSION and 8 PROPOSAL PREPARATION AND INSTRUCTIONS of the solicitation.

22. How do we describe commercial potential? What is the difference in the commercialization sections in contract proposals compared to grant applications?

    It depends on the technology. For some technologies, such as drug development, it is appreciated that there will be large capital requirements and long time-frames for ultimate marketing and regulatory approval for a new therapeutic. In this scenario, commercial potential involves determining whether there is a reasonable plan in place to secure regulatory advice, a preclinical plan in place to achieve critical milestones and hit key inflection points to bring additional investors to fund the next stages of development. For research tools with no regulatory path, the plan may be more specific, including manufacturing, talking to key customers, specifying your competitive advantages with a comparison of competing technologies.

    For Phase I contract proposals, review criteria includes an evaluation of the commercial potential and commercial applications, so more emphasis is placed on commercial potential in the Phase I contract proposal than in a Phase I grant application. The commercialization sections would be similar for Phase II contract proposals and grant applications.

23. May I submit a proposal for a Phase II only project under this solicitation?

    No. Specific topic descriptions will indicate if a Fast Track proposal will be accepted. Fast Track is for NIH projects only and a proposal for Phase I and Phase II work must be submitted simultaneously when Fast Track proposals will be accepted.

24. What are the pros and cons of a Fast Track submission compared to delaying a Phase II submission for a contract proposal? If a Fast Track contract is funded only for Phase I, what is the timeline for a Phase II proposal submission?

    For a Fast Track contract proposal, the Phase I proposal and Phase II proposal are reviewed and scored independently, unlike with a grant Fast Track application, which is reviewed as a single application. One implication is that if the Phase I contract proposal scores well, but the Phase II proposal does not, the NCI has the option to decide only to fund the Phase I portion of the proposal.

    The biggest consideration on whether to submit a Fast Track is how much preliminary data you have to suggest a relatively low level of technical risk for the Phase I portion of the study. Put yourself in the mind of a reviewer; if there’s too much risk and too many questions based on the Phase I work, it would be difficult being comfortable going forward with the full project without getting the early Phase I data.

    For the timeline, historically, it can take about 1 year between the end of the Phase I contract and being awarded a Phase II contract.

25. Can a Phase I contract awardee apply for a Phase II grant?

    Yes, a Phase I contract awardee can apply for a Phase II grant.

26. Can a Phase I grant awardee apply for a Phase II contract?

    No, you must be a successful recipient of a Phase I contract award and perform that effort in order to be eligible to compete for a Phase II contract.

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Review

27. How many proposals do you expect to receive for each topic?

    We do not know how many proposals we will receive for each topic, as it varies from topic to topic and from year to year. In the past, some topics have received 0 – 2 proposals, while others have received 15 – 20 proposals.

28. What are the historic funding rates (percentage of proposals) for NCI SBIR contracts?

    Identifying a historical percentage is not useful for contracts, because each topic differs from each other, and changes from year to year. In section 12, each topic specifies an anticipated number of awards.

29. Do reviewers of grants and contracts have similar backgrounds (e.g. academia vs. industry)?

    Yes. In SBIR study sections and review panels, mix of reviewers with industry backgrounds and academic backgrounds. For contract topics, reviews are very focused, in finding reviewers well-suited for particular topics. Cover the science, as well as the business space.

30. What is a promising score in the likelihood of being funded for a contract?

    Contract proposals are scored from 0 – 1000, with 1000 being the best score. For a score to be considered competitive, it depends on the contract topic. Generally, 800-900 would likely be competitive. Sometimes a score of 600-700 could be competitive, sometimes not. In addition to the score of a particular proposal, whether a contract is selected for award depends on a number of factors, including: the distribution of scores, the amount of funding available for a particular topic, the distribution of types of technologies proposed in a particular round, and the interests and priorities of the NCI.

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Topic 327

31. Does the formulation technology have to be innovative or is a novel and innovative drug formulated with a sophisticated but established formulation technology sufficient?

    In order to be responsive to topic 327, it is not necessarily a requirement that the platform is novel. The focus of the announcement is on reformulation of the drug, not necessarily developing new formulation strategies; therefore, reformulation using a sophisticated but established technology would be considered responsive. Please note, however, that one of the factors used for evaluating Phase I proposals is: “The potential of the proposed research for technological innovation.” If you have a specific question about your project, you should submit the question to Elizabeth Shanahan, eshanahan@mail.nih.gov.

32. Can you provide the list of available failed chemotherapeutic drugs and why it failed?

    The NCI is not providing a list of failed chemotherapeutic drugs for development under this topic. The offeror is responsible for identifying and selecting an appropriate small-molecule chemotherapeutic drug (i.e., the active pharmaceutical ingredient [API]) proposed for reformulation.

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Topic 332

33. Is it necessary to have preliminary in vivo tox studies showing that the radiomodulator is not sensitized to healthy cells?

    It is not necessary to have preliminary data prior to submission of the proposal. But it is a good idea to include a plan for getting that data during the course of your Phase I. If for some reason, you believe you do not need to do those experiments, include a valid rationale to support your belief.

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