National Institutes of Health Ask The Experts: SBIR/STTR Grant Application Submissions Webinar November 25, 2008

3:00-3:45Meeting Kick-Off  Introductions to the Experts  General SBIR/STTR FAQs (Jo Anne Goodnight / Kay Etzler, SBIR/STTR Office)  E-submission Hints (Sheri Cummins, eRA Customer Relationship Manager)  Receipt/Referral and Submission Reminders (Dr. Suzanne Fisher, CSR, Director Receipt and Referral)  Grants.gov Find/Apply/Succeed Tips (Michael Pellegrino, Grants.gov, OS) 3:45-5:00Ask The Experts  Questions and Answers (Meeting Participants, U.S.A.) SBIR/STTR Webinar Agenda Presentations will be posted on the NIH SBIR/STTR Web site: grants.nih.gov/grants/funding/sbir.htm

FAQs (1) Q. What is the difference between the “Parent” FOA and a specific FOA? The Parent FOA (PA [ [SBIR] or PA [STTR]) is sponsored by all 23 Institutes/Centers (ICs), and can be used for any topic area, investigator-initiated ideas, or “unsolicited” ideas within the mission of the NIH.PA http://grants.nih.gov/grants/guide/pa-files/PA html A specific FOA is one that has been issued by one or more ICs and has a more specific focus, but still permits investigator-initiated ideas within that program area. Q.Have the page limits changed for Phase I and Phase II? Not yet….Shorter (12 page research plan) for R01 applications (with other activity codes scaled appropriately) will be restructured to align with review criteria for January 2010 receipt dates. Following are the current page limits: Phase I: Items 2-5: 15 pages maxPhase II: Items 2-5: 25 pages max (2. Specific Aims, 3. Background and Significance, 4. Prelim Studies/Progress Report, 5. Research Design & Methods) Q. On a resubmission, are the page limits for a Phase I different that for a Phase II? Phase I : one page maximum Phase II and Fast-Track Applications: 3 pages maximum (Introduction is excluded from page limitations of the Ph I, Ph II or Fast-Track application.) (I-26)

FAQs (2) Q.I’m submitting a Phase II. Is this a New, Renewal, Continuation, or ?? It is a Renewal. Q. Must the Principal Investigator be a U.S. citizen? No, the PI, the individual who is responsible for the scientific and technical direction of the project, is not required to have US citizenship BUT the PI must be here legally in the United States and must be available to perform the research proposed for the duration of the project. Q. Do I need to identify an Institute or Center to submit the application to? No. We have an entire office, the Center for Scientific Review/Receipt and Referral Office, that refers applications to the appropriate Institute/Center (IC). If you know that your proposed research overlaps with several ICs, then include a cover letter and request that your application be assigned to those ICs. CSR makes the final call as to assignments. (I-104)

FAQs (3) Q. I will be subcontracting ALL of the Human Subjects work to a University, so do I still need to address the points delineated in the Research Plan? YES.YES. YES. Be sure to review the “Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan” on page II-1 of the SF424 (R&R) Guide (II-1) Q. I will be using Human Subjects in my research but do not have approval by an Institutional Review Board yet. Is this required at the time of submission? No. Your company will be required to obtain an Assurance (typically a Single Project Assurance) by the time an award is made. Our NIH staff will initiate that process if you do not have an assurance, and you will work closely with your Program director and OHRP staff to negotiate such an assurance. (II-1) Q. I will be using vertebrate animals in my research. Do I need to have an IACUC approval at the time of submission or within 60 days of submission? This is also done prior to award. NIH no longer requires Institutional Animal Care and Use Committee (IACUC) approval of the proposed research before NIH peer review of an application. But you must address the points under the Vertebrate Animal section of the Research Plan. (III-19)

Q. Is it permissible to submit a budget that deviates from the time and dollars normally awarded to Phase I or Phase II? Yes. Deviations from the guidelines are permissible, but must be well justified. We recognize that not all types of biomedical/behavioral research can be conducted under the prescribed amounts of time and dollars. You are encouraged to discuss budgetary deviations with NIH Program Staff prior to submission of the application. (I-97) Q. How do I know what the estimated start date of my project is? To select an appropriate beginning date for a new application, consult the following schedule: (I-35) SBIR and STTR Due Dates Phase I and Phase II E STIMATED Award Date April 5December August 5April December 5July FAQs (4)

FAQs (5) Q. What’s the difference between a “resubmission” and a “revision?” Resubmissions are applications that were previously submitted and reviewed but not selected for an award and are being resubmitted for evaluation again. These applications include an introduction addressing the comments of the previous reviewers. (I-27) Revisions are competing supplemental applications to request support for a significant expansion of a project’s scope or research protocol. (I-28) Q. Are subcontractors on an SBIR or STTR application required to provide a letter of support. Yes. Each individual and/or collaborating organization must include a letter confirming their role on the proposed project. For STTR, a letter from the collaborating institution must be included. (I-124) Q. May multiple PD/PIs be included on SBIR and STTR applications? Yes. Multiple PD/PIs are acceptable on those SBIR and STTR projects requiring a team approach. Each PD/PI must have a PD/PI role and a leadership plan is required. (I-51)

FAQs (6) Q. My company does not have a negotiated F&A (overhead) rate with NIH. What am I permitted to charge? SBIR and STTR Phase I Applicants: If your organization does not have a currently effective negotiated F&A cost rate with a Federal agency, then propose estimated F&A costs at a rate not to exceed 40% of the total direct costs. If awarded at a rate of 40% or less of total direct costs the rate used to charge actual F&A costs to projects cannot exceed the awarded rate. NIH will not negotiate F&A rates for Phase I awards. SBIR and STTR Phase II Applicants: If the requested F&A rate is 25 percent or less (of total direct costs), F&A costs will be awarded at the requested rate. If the requested F&A rate is greater than 25 percent of total direct costs, additional information will be required prior to award to justify the requested rate. If awarded at a rate of 25% or less of total direct costs, the rate used to charge actual F&A costs to projects cannot exceed the awarded rate. (I-96)

Contact: Jo Anne Goodnight Or Kay Etzler

E-Submission Hints Next Topic: E-Submission Survival Tips from the eRA Lens

Questions from audience: Indicate “expert” or office General SBIR/STTR FAQs Jo Anne Goodnight/Kay Etzler, SBIR/STTR Office E-submission Hints Sheri Cummins, Customer Relationship Manager, eRA Receipt/Referral and Submission Reminders Dr. Suzanne Fisher, Director Division Receipt and Referral, CSR Grants.gov Find/Apply/Succeed Tips Michael Pellegrino, Outreach Director, Grants.gov

Multiple PD/PI Leadership: How long and how detailed? NIH SBIR Web site: