NIH Applicant Assistance Program

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 and Centers:

  • 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 Disorders and Stroke (NINDS SBIR)
  • The National Institute of Nursing Research (NINR SBIR)
  • The National Institute on Deafness and Other Communication Disorders (NIDCD SBIR)
  • The National Center for Advancing Translational Sciences (NCATS SBIR)
  • The National Institute of Environmental Health Sciences (NIEHS SBIR)
  • The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD SBIR)
  • The National Institute on Alcohol Abuse and Alcoholism (NIAAA SBIR)

TThe application portal will open on November 14th, 2022 and close on December 12th, 2022 5 PM ET. Details on the next cycle and sample long-form questions for the application can be found below.

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, Phase II, or Direct-to-Phase II application. You may be removed from the program if deemed ineligible.

PROGRAM OUTLINE

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:

WEEK 1

  • 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.

WEEK 2

  • 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.

WEEK 3

  • 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.

WEEK 4

  • 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.

WEEK 5

  • 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.

WEEK 6

  • 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.

WEEK 7

  • 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.

WEEK 8

  • Make final corrections to your Research Plan.
  • Write your Project Summary.
  • Write your Project Narrative.
  • Fill out the PHS Assignment Request form.

WEEK 9

  • 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.
  • Prepare Cover letter for grant application

WEEK 10

  • 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, 2023.
  • The research area of interest aligns with the mission of the participating Institutes and Centers (see list above).
  • The company is seeking support for the preparation of a Phase I SBIR or STTR application only. Fast Track, Phase II or 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 2013 may be considered for the AAP.

SAMPLE APPLICATION QUESTIONS

Download sample long form questions by clicking the button below (for review only, not submission)

KEY DATES (April 5, 2023 cohort)

Submission Portal Opens: November 14th, 2022.

Submission Portal Closes: December 12th, 2022, 5:00 pm ET

NIH AAP outreach webinar: Monday, November 14th, 2022, 2:00pm – 3:30 pm ET. Registration link.

NIH AAP Q&A Webinar: Monday, December 5 2022, 2:00pm – 3:30pm ET. Registration link.

Applications Due: December 12th, 2022 at 5 pm ET.

Applicants status notified: January 9th-13, 2023.

Participant letter of acceptance return date to secure program spot: January 12th, 2023

NIH AAP Kick-off Webinar hosted by EGC: January 13th, 2023, 2:00-3:30 pm ET (mandatory for accepted applicants).

NIH AAP Webinar – Tips for a Successful SBIRT/STTR Application hosted by NIH POs: January 23rd, 2023, 2:00-3:00 pm ET (mandatory for accepted applicants)

NIH AAP Developing Entrepreneurial Networks webinar hosted by NIH SEED Office: February 6th, 2023, 3:30-5:00 pm (mandatory for accepted applicants

Applicant Assistance Program: January 17th, 2023 – March 24th, 2023.

SBIR/STTR Submission Deadline: April 5th, 2023.

If you have any questions about the program, please email us at NIH.AAP@evagarland.com.