75N91019Q00128_Attachment_J.1._SOW_Base.pdf

ATTACHMENT J.1

STATEMENT OF WORK (SOW)

75N91019Q00128

1. GENERAL

Title: Support for the NIH SBIR/STTR Applicant Assistance Program (AAP)

2. BACKGROUND

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are U.S. Government programs. In these programs, federal agencies set aside a percentage of their funding for competitions that are limited to small businesses for R&D activities appropriate for technology development. Small businesses that win awards under these programs keep the rights to any technology developed and are highly encouraged to commercialize them. Each year, the National Institutes of Health (NIH) issue three investigator-initiated SBIR/STTR Funding Opportunity Announcements (FOAs), termed the Omnibus Solicitation. The Omnibus Solicitation invites small businesses to apply for Phase I or Phase II SBIR and STTR grants within any of the Agency’s Institutes. To compete for an SBIR/STTR grant, small businesses must create a grant application and submit it to the Agency for peer review. More information regarding the SBIR/STTR research programs at participating institutes can be found on the following websites:

• NIH: https://SBIR.nih.gov/

• NCI: https://SBIR.cancer.gov/

• NINDS: https://www.ninds.nih.gov/Funding/Small-Business-Grants

• NHLBI: https://sbir.nih.gov/nhlbi

• NIA: https://www.nia.nih.gov/nia-small-business-programs-sbir-sttr

SBIR/STTR Applicant Assistance Program (AAP) One of the challenges that many small businesses face is a lack of understanding of how to prepare and submit NIH-funded grant applications. In particular, nationally underrepresented groups, and businesses operating in regions underrepresented in governmental NIH funding (defined below), lack of access to advice and support on eligibility, grant proposal writing, budget development, applicant registration, and submission of a proposal package that is deemed to be responsive and complete.

In view of these challenges the Government established a pilot project, the “Applicant Assistance Program” (AAP) which is an educational program to provide training on how to prepare and submit a Phase I SBIR/STTR grant application.

https://sbir.nih.gov/ https://sbir.nih.gov/ https://sbir.cancer.gov/ https://sbir.cancer.gov/ https://www.ninds.nih.gov/Funding/Small-Business-Grants https://www.ninds.nih.gov/Funding/Small-Business-Grants https://sbir.nih.gov/nhlbi https://sbir.nih.gov/nhlbi https://www.nia.nih.gov/nia-small-business-programs-sbir-sttr https://www.nia.nih.gov/nia-small-business-programs-sbir-sttr

The AAP assists applicants in utilizing existing resources and tools by offering mentorship and coaching to small businesses that (1) have a technology that fits within the mission of the NIH Institutes participating in the AAP, and (2) are either new to the SBIR/STTR programs, or were unsuccessful in competing for NIH SBIR/STTR funding during the last ten years. The AAP services, including learning material, are free to the small businesses who are accepted into the program.

The AAP DOES NOT offer grant writing or submission services, the responsibility to write and submit the grant application including all required documentation remains with the applicants.

Support for Fast Track or Phase II applications is also excluded.

Goals of the Applicant Assistance Program The AAP’s major goals are:

a. Enhance the understanding of the application process amongst the target audiences defined below.

b. Ensure the submission of NIH SBIR/STTR applications that are free of errors or omissions and are deemed complete, compliant and responsive to the funding announcement criteria for review.

c. Measurably increase NIH SBIR/STTR applications from underrepresented small business applicants that have not previously won an award from this program in the past ten years.

Target Audiences of the Applicant Assistance Program The AAP’s target audiences are:

a. Businesses owned or founded by individuals from nationally underrepresented groups (as defined in the NIH Notice of Interest in Diversity, NOT-OD-18-210) and individuals meeting the Small Business Administration (SBA) definition of socially and economically disadvantaged individuals (https://www.sba.gov/blogs/sbas-8a-certification-program-explained).

b. Businesses operating in regions underrepresented in terms of NIH funding as defined by the NIH Institutional Development Award (IDeA) program.

There are three classes of underrepresented small businesses:

(1) Socially and Economically Disadvantaged Businesses. A socially and economically disadvantaged individual is a member of any of the following groups: African Americans, Hispanic Americans, Native Americans, Asian-Pacific Americans, Subcontinent Asian Americans, other groups designated from time to time by the Small Business Administration (SBA) to be socially disadvantaged, or any other individual found to be socially and economically disadvantaged by SBA pursuant to section 8(a) of the Small Business Act, 15 U.S.C. 637(a).

(2) Women-Owned Small Businesses. Women-owned small business concern means a small business concern (a) which is at least 51 percent owned by one or more women; or, in the case of any publicly-owned business, at least 51 percent of the stock of which is https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-210.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-210.html https://www.sba.gov/blogs/sbas-8a-certification-program-explained https://www.sba.gov/blogs/sbas-8a-certification-program-explained https://www.sba.gov/blogs/sbas-8a-certification-program-explained https://www.sba.gov/blogs/sbas-8a-certification-program-explained owned by one or more women; and (b) whose management and daily business operations are controlled by one or more women. The Federal Acquisition Regulations defines a women-owned small business concern in Part 19.001 Definitions.

(3) Small Businesses Operating in NIH-designated IDeA Regions. IDeA states are those which have historically been underrepresented in both applicants and awards in the NIH SBIR/STTR programs; including Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming.

Marketing and Outreach The Government shall conduct outreach and recruitment of the above target groups for the AAP.

AAP Application Procedure and Selection of Participants Small businesses who are interested in receiving assistance from the AAP submit electronic applications to the Contractor. One application may be submitted per participant/company for each round of the AAP.

The applications include:

• General and small-business-specific information about the candidate in short free-text paragraphs and answers to structured questions.

• A project abstract and a one-page high-level description on the nature and current state of the technology for which funding would be applied for.

• A CV or biosketch for the person who will serve as principal investigator The Contractor shall perform a high-level analysis to determine if the proposed project appears to be feasible within the scope and budget of a Phase I award, and whether it fits within the mission of the participating NIH institute(s).The Contractor then shares all applications and observations with the Government in a format that allows the Government to conduct in-depth analyses about the type of participant applying, and on their eligibility to enroll in the AAP. At the time that the Contractor shares all of the applications, the Contractor must also provide an excel workbook containing all of data collected during the application process on all applicants.

After the Government has selected the successful candidates, the Contractor shall arrange for their notification and subsequent enrollment in the program.

AAP Coaching Procedure SBIR/STTR grant applications for NIH have three submission deadlines per year; April 5th, September 5th, and January 5th. Therefore, the AAP offers three structured coaching rounds per year leading up to the application submission deadlines. Over a 10-week period, AAP coaches provide structured training and customized assistance to the AAP participants to receive guidance and feedback on registration procedures, timelines, grant writing techniques, budget calculation, and other items to enable participants to ultimately submit NIH SBIR/STTR proposals that are deemed complete, compliant, competitive, and responsive to all review criteria at the end of the AAP.

3. SCOPE

The Contractor shall furnish all of the necessary personnel, materials, services, facilities, (except as otherwise specified herein), and otherwise do all the things necessary for or incident to the performance of the work as set forth below.

The services provided under this purchase order shall include the continuation and expansion of an existing AAP pilot program to improve the support of underrepresented small businesses, as well as businesses operating in regions underrepresented in terms of NIH funding. The Contractor shall leverage existing tools and resources beyond the current pilot program as needed, such as helping participants decide to leverage regional programs like the FAST program, etc. The AAP program shall provide structured coaching rounds for three submission deadlines per year (April 5th, September 5th, and January 5th) for NCI, NHLBI, NINDS and NIA;

enable up to 80 AAP participants per round; and ensure high level of training quality by an appropriate ratio between the number of participants and qualified coaches with in-depth knowledge of the NIH SBIR/STTR grant process and of what makes a NIH SBIR/STTR proposal competitive in the peer review. Marketing and outreach activities are not included in the scope of work. The tasks to be completed under this purchase order are as follows:

1. Develop a project plan to describe the development and implementation of the requirements under this purchase order.

2. Develop a quality control plan to describe the measurements taken to further improve the AAP during the course of the purchase order.

3. Collect AAP applications electronically and provide an AAP application receipt system.

Based on previous experience, it is anticipated that approximately 250 applications will be submitted for each coaching round in total.

4. Pre-examine AAP applications on a high level on eligibility criteria defined by the Government within a reasonable time frame and provide recommendations; in particular if the proposed project fits within the mission of the participating NIH institutions. The Government will ultimately be the responsible party for selecting participants.

5. Share AAP applications with the Government in a secure, electronic format.

6. Provide training and coaching to AAP participants. The Contractor shall enroll a minimum of 40 small businesses per coaching round. If required, the Contractor shall have the ability to enroll up to 80 small businesses per coaching round.

7. Develop a “Best Practices” guideline to help identify particular areas in which the target small businesses are in need of assistance, which can help improve the program over time.

4. PURCHASE ORDER REQUIREMENTS / TASKS

The Contractor shall:

1. Develop and Execute a Project Management and Quality Control Plan (PMQC-Plan).

The Contractor shall develop a PMQC-Plan for the scope of the project.

1. The PMQC-Plan shall describe the development and implementation of the requirements under this purchase order.

2. The PMQC-Plan shall outline the timing of the key operations and the associated resources in sufficient amount of detail.

3. The PMQC-Plan shall include a description on how quality control will be achieved:

i. how and when AAP participant feedback will be collected;

ii. how cause analysis and process analysis will be conducted;

iii. how and when results will be incorporated to improve all processes related to the scope under this purchase order.

4. The Contractor shall be required to share an outline of the PMQC-Plan with the Contracting Officer’s Representative (COR). The finished PMQC-Plan shall be submitted to the COR for approval.

2. Participate in a Mandatory SBIR Program Overview Training.

All coaches of the selected Contractor must complete mandatory trainings and Q&A session on the SBIR program and institute-specific details. Coaches shall participate in a 2-hour training session conducted by SBIR Program Directors which shall take place via WebEx one (1) time during each 12-month period of performance. Any new coaches that join the program mid-year must complete the training before they begin work with any assigned AAP participants.

3. Collect AAP Applications.

The Contractor shall collect electronic applications for participation in the AAP.

1. Data collection. The Contractor shall provide a structured method for collecting electronic data and PDF-files from the AAP candidates.

2. Receipt system. The Contractor shall provide receipts to the applicants for successful submission and notify the COR and Institute POCs of each submission.

3. Data access. The Contractor shall provide secure, password-protected electronic access to the applicant pool, which can be accessed by the Contractor, by the COR, and by NIH staff selected by the COR.

4. Process AAP Applications.

1. Pre-examine AAP applications. The Contractor shall conduct a cursory review of AAP applications to determine (a) if the proposed technology fits within the mission of the participating NIH Institutes, (b) on the readiness of the technology to receive NIH SBIR/STTR funding, and (c) on the needs of the small business grant applicants.

2. Share pre-examined AAP applications with the NIH in a secure, electronic format.

The Contractor shall share the applications together with the high-level observations with

NIH staff in an electronic format approved by the COR within 7 business days after the application deadline.

i. The format shall allow the compilation of all components of an individual application in a single file.

ii. The format shall allow the NIH to bulk analyze the answers to the structured questions.

iii. The format shall allow the tagging of such files to be assigned to individual NIH institutes.

iv. The format shall allow the export of all data from the AAP application into Excel.

v. Provide a concatenated document for each participating NIH institute containing each application with all associated documentation that is assigned to that institute.

3. Notify AAP candidates and enroll participants. The Contractor shall inform the candidates if their application to enroll into the AAP has been successful and provide instructions to the participants on time and in sufficient detail.

5. Administer Coaching and Training to AAP Participants.

1. Provide Training on Technical Writing Specifically Tailored to NIH SBIR/STTR

Applications. The Contractor shall provide structured training to the AAP participants on how to develop and write all components of a phase I NIH SBIR/STTR application, included but not limited to (1) technical research plan with specific aims and a reasonable scope, (2) defined commercial potential as appropriate for a phase I NIH SBIR/STTR application, (3) budget and cost proposal, (4) biographical sketches. The training must be built around the 5 NIH review criteria, and the training shall aim to produce competitive proposals. The training shall capture the existing nuances between the participating NIH institutes. Any virtual trainings offered as part of the AAP shall allow AAP participants to directly interact with the lecturer during the training session, and information shall be made accessible to the participants after the session is completed, including associated training material.

2. Provide Project Management Support Related to SBIR/STTR Applications. The Contractor shall provide AAP participants with an SBIR/STTR grant submission timeline and action items checklist that AAP participants can use as they go through the training program to ensure they meet all critical milestones and deadlines to submit a NIH SBIR/STTR grant proposal that is deemed complete, compliant and responsive to all review criteria, and tailored for the specific NIH institute.

3. Provide Qualified Coaches to AAP Participants. The Contractor shall provide coaches with in-depth expertise on NIH SBIR/STTR grant writing, and NIH SBIR/STTR peer review. The coaches shall assist all AAP participants for regular support and to contact with questions about the proposal preparation and submission process. The coaches shall support AAP participants during the application process, included but not limited to (1) identifying opportunities to apply to, (2) registration in the SBIR database, (3) filing of the required certifications for an NIH SBIR/STTR application, (4) identification of befitted Scientific Review Groups, and (5) submitting applications.

a. The coaches shall provide AAP participants with assistance defining the commercial potential as needed to support participants in writing competitive phase I NIH SBIR/STTR proposals. This task does not require a full market report for each participant.

b. The coaches shall provide professional feedback on all aspects in technical writing.

c. The coaches shall assist AAP participants in communications with their Technical Points of Contact at the NIH.

d. The coaches shall maintain contact with the AAP participants on at least a weekly basis by phone and within 1 business day by email after being contacted by the participant to ensure continuous support.

e. Changes in coaching staff must be approved by the COR.

f. The Contractor shall give the participants the opportunity to provide direct feedback to the COR if requested by the participants.

6. Prepare Post-Cycle “Lessons Learned”.

Included in the monthly reports after the end of each AAP cycle, i.e. the monthly reports in September, January, and April, the Contractor shall assess the most recent AAP cycle and deliver a “lessons learned” section in the appropriate monthly report.

1. The “lessons learned” section shall include a brief statement describing the significant outcomes and successes against AAP objectives, expectations, and critical milestones.

2. The “lessons learned” section shall contain detailed statistics on the type of participants, course completion rates, and grant submission rates of the AAP participants in the most recent cycle.

3. The “lessons learned” section shall list different variables that affected the success rates of the participants, identify the most critical challenges the participants faced, and summarize the most critical areas of need among the AAP participants. The needs assessment must include a baseline comparison of the knowledge that the applicants had in the beginning vs end.

4. The “lessons learned” section shall include detailed listings for each AAP participant, including tracking and trend data and identifying the NIH institute for which the service was provided.

7. Prepare AAP Improvement.

The Contractor shall discuss the “lessons learned” section of the September, January, and April monthly reports within 2 weeks of supplying the report. During this teleconference, specific process improvements based on lessons learned will be agreed upon between the Contractor and the Government to be implemented in the subsequent AAP cycle. A list of the Improvements shall be supplied to the COR within 2 business days after the “lessons learned” discussion in electronic format.

8. Develop and Continuously Update a “Best Practices” Guideline.

The Contractor shall develop a “Best Practices” (BP) guideline.

1. The BP guideline shall be based on the PMQC-Plan.

2. The Contractor shall incorporate the “lessons learned” as feasible, applicable, and in accordance with the COR, continuously into the BP guideline.

3. The final version of the BP guideline shall be submitted to the COR at the end of the project, together with the final project report.

9. Provide Reporting Related to This Acquisition.

The following reports are required under this purchase order:

1. Certification of NIH training completion. Report certifying all coaches participated in the mandatory SBIR/STTR overview training session.

2. Bi-weekly teleconferences. This reporting to the COR shall include a status update on the program from the Contractor, current status of participants in the program, and any issues with participants or gaps in understanding about the NIH SBIR/STTR program by coaches. The Contractor shall prepare bullet point meeting minutes after each teleconference and to send these to the COR.

3. Monthly Progress Reports. The Monthly Progress Reports shall summarize the activities of the preceding month. Each Monthly Progress Report shall identify the events and fully describe the accomplishments of the previous month including all services delivered and federal funding expended and invoiced, including for what purpose and activity, training, materials, meetings, or other significant small business briefings or instruction, identifying the agency for which the service was provided.

Reporting shall include the number of applicants, applicant underrepresented profiles from their application, participant number, participant profiles, the number of NIH SBIR/STTR applications submitted, the number of NIH SBIR/STTR application accepted by the agency, which applicants completed the program, and which applicants did not complete the program with a reason for the departure.

4. Final Report. The Final Report shall summarize all of the application assistance provided during the full purchase order period, identifying services provided to each agency. Special emphasis shall be made regarding any significant successes and recommendations for improvements to the AAP. A brief summary on the status of each participant shall be provided as a baseline for future programs.