ABOUT THE PROGRAM
The National Institutes of Health (NIH) Applicant Assistance Program (AAP) is designed to assist small businesses with an interest in preparing and submitting a Small Business Innovation Research or Small Business Technology Transfer (SBIR/STTR) application to any of the following Institutes:
- The National Cancer Institute (NCI SBIR)
- The National Institute on Aging (NIA SBIR)
- The National Heart, Lung, and Blood Institute (NHLBI SBIR)
- The National Institute of Neurological Disease and Stroke (NINDS SBIR)
- The National Center for Complementary and Integrative Health (NCCIH SBIR)
- The National Center for Advancing Translational Sciences (NCATS SBIR)
- The National Institute of Environmental Health Sciences (NIEHS SBIR)
- The National Institute of Nursing Research (NINR SBIR)
Application portal is now open. A Q&A webinar by the NIH will be held on Wednesday, December 9, 2020 at 2:00 PM ET. Please register here.
The goal of this program is to increase the number of applications submitted by underrepresented small businesses and to increase the number of these applications that are free of errors or omissions and are deemed complete, compliant and responsive to the review criteria.
Please note that a for-profit company must be established prior to applying for AAP. The AAP is NOT available to companies who have a current SBIR/STTR application under review with the same scope of work or to support preparation of a Fast Track or Phase II application. You may be removed from the program if deemed ineligible.
AAP services are FREE to the small businesses who are accepted into the program. Each AAP participant will be assigned to a coach from Eva Garland Consulting who has expertise in preparing NIH SBIR/STTR applications. Over a 10-week period, the coach will provide customized assistance to the AAP participant, using the book Winning SBIR/STTR Grants: A Ten Week Plan for Preparing Your NIH Phase I Application 3rd Edition as a guide. One free copy of the book will be provided to each participating company.
The following topics will be covered each week:
- Develop a project scope and Specific Aims that are appropriate for a NIH Phase I SBIR/STTR application.
- Contact your Program Officer (PO) to schedule a call during Week 4 to discuss your Specific Aims.
- Download the Application Guide.
- Initiate all registrations.
- Compose project title.
- Write or revise the Specific Aims section of your Research Plan.
- Prepare an initial outline of your budget, and identify all work that will be done at outside institutions.
- Identify expertise needed for team.
- Request letters of support from consultants, key opinion leaders and/or potential customers.
- For STTR proposals, arrange for a letter from the partnering research institution.
- If a resubmission, plan your response to reviewers’ comments.
- Finalize your Specific Aims and share with PO 1 week prior to call.
- Review the available Scientific Review Groups (SRG) to discuss with PO.
- Begin preparing Biographical Sketches.
- Review the competitive landscape for your project.
- Assess whether you will be required to include information for Vertebrate Animals and/or Human Subjects.
- Create a list of questions to ask the PO.
- Identify references to include in your Significance and Innovation sections.
- Identify references to include in your Approach section.
- Discuss your Specific Aims with your PO.
- Write the Significance section of your Research Strategy.
- Write the Innovation section of your Research Strategy.
- Follow up on quotations, Biographical Sketches and letters of support.
- Write the Approach section of your Research Strategy.
- Edit the Specific Aims section of your Research Plan.
- Familiarize yourself with ASSIST and begin filling out the administrative sections of the application.
- Identify the Protection of Human Subjects/Clinical Trial information that will be required to support your approach.
- Identify the Vertebrate Animals information that will be required to support your approach.
- Solicit an independent review of your proposal.
- Confirm that you received all materials requested from external sources.
- Write your Facilities and Equipment sections.
- Prepare your Budget.
- Complete each of the following sections as needed for your proposal: Vertebrate Animals, Human Subjects, Authentication of Key Resources, Select Agents, Resource Sharing Plan, and Multiple PD/PI Leadership Plans.
- Make final corrections to your Research Plan.
- Write your Project Summary.
- Write your Project Narrative.
- Fill out the PHS Assignment Request form.
- Verify that your required registrations are in place for submission.
- Collect and complete any outstanding items from previous weeks.
- Assemble and systematically review your final application.
- Submit your proposal.
- Review your submitted application in the eRA Commons.
WHO IS ELIGIBLE
You must meet the following eligibility criteria:
- The company has not received an NIH SBIR/STTR award.*
- The company does not have a current NIH SBIR/STTR application under review with the same scope of work.
- The company intends to submit a Phase I NIH SBIR/STTR application for April 5, 2021.
- The research area of interest aligns with the mission of the participating Institutes (see list above).
- The company is seeking support for the preparation of a Phase I SBIR or STTR application only. Fast Track and Direct-to-Phase II applicants are not eligible.
- The company must be established in the US prior to applying for AAP.
- Each company may submit only one application to the AAP.
* Companies who received their most recent SBIR/STTR award prior to 2010 may be considered for the AAP.
KEY DATES (April 5, 2021 cohort)
Submission Portal Opens: November 12, 2020
NIH AAP outreach webinar: November 12, 2020 at 2:00 PM ET. Please register here.
NIH AAP Q&A webinar: December 9, 2020 at 2:00 PM ET. Please register here.
Applications Due: December 10, 2020 at 5:00 PM ET.
Applicants status notified: January 11-14, 2021.
Participant letter of acceptance return date to secure program spot: January 15, 2021.
NIH AAP Kick-off Webinar: January 15, 2021 (mandatory for accepted applicants).
NIH AAP Describing Technology Fitness and Unmet Need Webinar: date TBD (mandatory for accepted applicants).
Applicant Assistance Program: January 15, 2021 – March 29, 2021.
SBIR/STTR Submission Deadline: April 5, 2021.
If you have any questions or would like to receive information about the program, please email us at NIHAAP@evagarland.com.