General SBIRSTTR FAQs (Goodnight and Etzler, NIH SBIRSTTR Office)

							National Institutes of Health


                                     Ask The Experts:
                                SBIR/STTR Grant Application
                                       Submissions
                                             Webinar
                                         November 25, 2008
                             SBIR/STTR Webinar Agenda
3:00-3:45 Meeting 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)

3:45-5:00 Ask The Experts
               Questions and Answers
                (Meeting Participants, U.S.A.)

      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-08-050 [http://grants.nih.gov/grants/guide/pa-files/PA-08-050.html]
   [SBIR] or PA-08-051 [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.
   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 max                Phase 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)
                                                                          FAQs (4)
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        ESTIMATED
    Phase I and Phase II           Award Date
               April 5                     December

              August 5                       April

             December 5                      July
                                                                        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
jg128w@nih.gov

Or

Kay Etzler
Etzlerk@od.nih.gov
                   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?
http://grants.nih.gov/grants/multi_pi/sample_leadership_plans.pdf




NIH SBIR Web site:

http://grants.nih.gov/grants/funding/sbir.htm