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  • #305

    What questions do you have about the Dept. of Health and Human Services (HHS) and/or the National Institutes of Health (NIH)?

    #644
    huawang0
    Participant

    Are there time requirements (e.g., PI needs to spend at least 50% of time) for sub-award PI, Co-Is, and consultants?

    When do you need a sub-award PI?

    Do I need letters of support for consultants?

    #645
    Lu@EGC
    Moderator

    To answer your questions:

    1. For NIH Phase I and Phase II SBIR projects, the contact PI/PD needs to spend at least 50% of the time in the small business at the time of award and during the conduct of the proposed project. Deviations from this requirement are rare and must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.
    For Phase I and Phase II STTR projects, the PD/PI is not required to be employed by the small business. However, the Contact PD/PI, the first PD/PI listed, must have a formal appointment with, or commitment to, the small business, which must be in the form of an official relationship between the parties, but need not include a salary or other form of remuneration. Each PD/PI on a multiple PD/PI award must commit a minimum of 1.2 calendar months (10% effort) to the project.
    There is no time effort requirement for consultants.

    2. When the small business cannot finish the proposed work by itself and need collaboration and intellectual input from other institutions, subawardee is usually needed. All subawards will need subaward PIs.

    3. Yes, you do need letters of support from consultants to show their commitment to the small business.

    Feel free to reach out again for additional questions!

    #687
    huawang0
    Participant

    Thanks! Another question – in addition to letters of support from consultants (technical people who will build the technology), do I need to provide letters of support from investigators (scientists and professors)?

    #688
    Lu@EGC
    Moderator

    Hua, consultants provide letters to show their commitments to the project. They are usually giving guidance and advice and usually do not perform the work. Each PD/PI must have a PD/PI role and a leadership plan is required.

    #689
    huawang0
    Participant

    Do I need bio sketches for consultants as well? The bio sketches will include access to facilities (computers, labs, etc), research interests, publications, employment and awards. I assume the leadership plan is detailing the PIs’ roles, areas of responsibility, org chart, and dispute resolution. What else do I need to include in the leadership plan for the PIs?

    Can we work with a company that has offices in US and abroad, as long as the people doing the work is physically in the US? Do they need to be US citizens (or is US permanent residents OK)?

    #690
    Lu@EGC
    Moderator

    Hua,

    You will need biosketches for consultants. Here is the instruction and template from NIH:
    https://grants.nih.gov/grants/forms/biosketch.htm
    The facility and resource information is usually placed in an individual section, named as “Facilities and Resouces” and you will be able to upload this during submission.

    Regarding the leadership plan, here is an example for you from NIH:
    https://grants.nih.gov/grants/multi_pi/sample_leadership_plans.pdf
    You will need to talk about roles/areas of responsibility of the PIs, including
    • Fiscal and management coordination
    • Process for making decisions on scientific direction and allocation of resources
    • Data sharing and communication among investigators
    • Publication and intellectual property (if needed) policies
    • Procedures for resolving conflicts

    Yes, you can work with such a company. They do not need to be US citizens. Permanent residents and people with legal working visas will be fine too.

    #697
    huawang0
    Participant

    To confirm, a PI does not need to provide a letter of support? It seems that way from the discussion above, but one of our PIs wants us to draft a letter of support for her to review and sign.

    #699
    lindsay@EGC
    Moderator

    Hello, Hua!

    The PI for your small business would not need to provide a letter of support. However, if you have a subaward, the subaward PI would provide a letter of support describing their willingness to participate and their role in your project. Here is a helpful “refresher” on subawards from the NIH NIAID that may be helpful: https://www.niaid.nih.gov/grants-contracts/refresher-subawar

    I hope this helps! Let us know if you have additional questions.

    #701
    huawang0
    Participant

    I am working on my biosketch. I am a former lawyer and strategy consultant, and not a BS/PhD/MD/engineer, etc (we have other PIs who have these scientific/technical backgrounds). I thus have limited experience to add in the “contributions to science” section of the biosketch. Should I elaborate on whatever “scientific” contributions I have (e.g., I-Corps program, hackathon prize), or not include this section in my biosketch?

    #702
    Stacey@EGC
    Moderator

    Hi Hua,

    In addition to the contributions to science that a researcher may list, you can also list a product that resulted from your work. Products can include publications; patents; audio or video products; conference proceedings such as meeting abstracts, posters, or other presentations; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware.

    I-Corps is a training program, so it should not be listed as a Contribution to Science. If the hackathon resulted in a product, I would recommend you add that.

    #787
    huawang0
    Participant

    Should I be adding references to academic papers as part of my SBIR Phase I proposal?

    #789
    Wout@EGC
    Moderator

    Hi Hua,

    Yes, including references throughout your text is strongly encouraged for SBIR proposals. It is best to provide a reference whenever you make a claim in your proposal, and references to peer-reviewed journals are preferred over websites or “personal communication” references. Using references helps you support statements in your Research Strategy and will show reviewers that you are up to date on the science in the field you propose to work in, and references can highlight your Key Personnel accomplishments and strengths in their biosketches. In fact, a bibliography (compiling all references used throughout your Research Plan) is a required document for a complete submission.

    Some additional guidance for NIH (NIAID in this case) can be found here: https://www.niaid.nih.gov/grants-contracts/add-bibliography-appendix

    Any other questions, let us know!

    Best,
    Wout

    #794
    rashimsingh
    Participant

    Does NIH usually give phase I SBIR award money all at the same time or in installments?

    #796
    nitesh@EGC
    Moderator

    Hi Rashim,

    The NIH makes the payments as cost-reimbursements. You may draw funds in advance, but no more than 3 days before the funds are needed. See the NIH Grants Policy on Payments here: https://grants.nih.gov/grants/policy/nihgps/html5/section_6/6_payment.htm

    I hope that helps! Let us know if you have further questions.

    Best,
    Nitesh.

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