Statement of Work.pdf

Statement of Work (SOW) National Institute of Allergy and Infectious Diseases (NIAID), NIH

Applicant Assistance Program: SBIR/STTR Applicants Training and Advising

1. Introduction and Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), Office of Research Training and Special Programs (ORTSP) requires an Applicant Assistance Program for:

SBIR/STTR applicant training.

Provide support for Small Businesses preparing a Phase II SBIR/STTR application Guide applicants through the application process.

SBIR/STTR Application advice.

NIAID is particularly interested in assisting small businesses that are owned or operated by individuals who are underrepresented in biomedical sciences.

2. Background

The National Institute of Allergy and Infectious Diseases (NIAID) supports the development of biomedical innovations from small businesses through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. The United States Congress requires eligible governmental agencies to set aside a percentage of their extramural budget so that domestic small businesses can engage in R&D activities that have a strong potential for technology commercialization. Federal Agencies are required to allocate 3.2% (FY 2020) of their R&D budget to SBIR Program and 0.45% to STTR Program. NIAID sets aside funds to support small business R&D of products and services that improve public health in areas relevant to NIAID.

Preparing a successful SBIR/STTR application can be a lengthy and challenging process, especially for small businesses underrepresented in extramural biomedical small business programs. The cost for SBIR/STTR application assistance such as consulting services provided by private companies can be prohibitively high for small businesses with limited operating funds. An Applicant Assistance Program lead by NIAID, specifically, Division of Extramural Activities’ (DEA), ORSTP (Office of Research Training and Special Programs), Small Business Program and assisted by a highly experienced Contractor, will improve applicants success in obtaining Phase II funding, enhance customized training, and provide one-on-one assistance for small business applicants in need.

3. Objectives

To enhance the program support and increase success for SBIR/STTR applicants, NIAID Small Business Program proposes to establish an Applicant Assistance Program providing SBIR/STTR applicant training and advising services. These services would include resources and training content creation, customized one on one applicant assessment, training, advising, and post submission support. This program would also provide relevant programmatic support and staff training to enhance NIAID SBIR/STTR program support for applicants and awardees. This program will have an emphasis on engaging and assisting groups underrepresented in extramural biomedical small business programs.

4. Scope

This Applicant Assistance Program shall include applicant assessment, proposal development training and individual SBIR/STTR proposal development assistance to applicants with post submission support for Phase II, Fast-Track, or Direct to Phase II applicants. The Contractor will work with NIAID staff to emphasize engagement of qualifying applicants from underrepresented groups, including both Women-Owned Small Businesses (WOSBs) and Socially and Economically Disadvantaged Businesses (SDBs) to promote their access to the full range of support services provided under this program.

In addition to company support, the proposed program shall provide Phase II AAP related recommendations, assistance, and progress reports to the DEA Small Business Program.

The Contractor shall work closely with the federal Contracting Officer Representative (COR) or the COR designee to implement a task management plan to ensure the timely implementation and operation of the AAP. The scope and the following 6 tasks will be described in detail under Section.

Resources and Training Written Application Summary One-on-one Proposal Preparation Assistance Grants Management Guidance Programmatic Support Task Management

5. Description of the Tasks

The Applicant Assistance Program shall include the program elements described below in the form of individual tasks.

1) Task 1: Resources and Training

The Contractor shall prepare and provide resources and training content for NIAID SBIR/STTR applicants. All content shall be available by website or other methods. The Contractor shall ensure Section 508 compliance for all the content. The topics covered shall be reviewed and approved by the COR prior to creation to ensure the most relevant topics are included to maximize the assistance to applicants. Minimum requirements include:

a. A library of 1 to 1.5 hours recorded webinars that include.

i. NIH SBIR/STTR Phase II basics

ii. Specific sections of an NIH SBIR/STTR Phase II proposal

iii. Webinars are in English

b. Proposal development toolkit. Outlines (including Commercialization Plan document), templates, budget workbooks, registration guides and other tools as needed.

c. Email reminders to small businesses planning to submit Phase II applications to NIH funding opportunity announcements (FOA).

i. Timely reminder emails are required over the course of 4 months for each NIH submission cycle.

ii. Emails to provide specific tips and guidance along with suggested timelines for an on-time submission, as well as tracking the review results of the proposal post-submission by reaching out to the applicants directly.

2) Task 2: Written Application Summary. Contractor shall provide the following:

a. An online SBIR/STTR Application Form for the Applicant Assistance Program shall be designed by the Contractor and it must be reviewed and approved by the COR prior to implementation. The Contractor shall be responsible for collecting completed online submitted SBIR/STTR Application Form from the applicants. The call for application for the Applicant Assistance Program including the COR approved online SBIR/STTR Application Form must be electronically delivered to all eligible NIAID Phase I awardees at least 60 days prior to each SBIR/STTR submission deadline for all three application cycles.

b. The Contractor shall also schedule and conduct follow-up calls (approx. 1 hr.) to gather additional necessary information on the applicants’ needs for assistance based on the application form. The federal COR or other staff shall be included in these follow-up calls, if necessary. The Contractor shall provide a written summary to the NIAID program COR including the information on the application form, minutes of the follow-up calls, and assistance requested by applicants.

c. The Contractor shall work with NIAID staff to emphasize engagement of qualifying applicants from underrepresented groups, including both Women-Owned Small Businesses (WOSBs) and Socially and Economically Disadvantaged Businesses (SDBs) to promote their access to the full range of support services provided under this program. Please note: NIAID shall allow all NIAID Phase I SBIR/STTR awardees eligible to submit a Phase II application to participate in the Program at no cost.

d. The Contractor shall facilitate the NIAID COR with the application process. The application summary for each proposal will be maintained in a secure password-protected web portal that allows access by both the NIAID COR and the Contractor.

3) Task 3: One-on-one Proposal Preparation Assistance

The Contractor shall provide one-on-one proposal preparation assistance to participating applicants. The maximum numbers of participating applicants will be 25/application cycle with 3 application cycles during the performance period. The Contractor shall conduct a kick-off meeting with each applicant and the COR to design a project plan for the one-on-one proposal preparation assistance. A written assistance plan with clear objectives, tasks, and timelines for each applicant shall be prepared by the Contractor after the kick-off meeting. And the federal COR must review and approve aforementioned plan prior to implementation. The one-on-one proposal preparation assistance listed below shall be provided at no cost to the participating applicants. Minimum requirements for one-on-one proposal preparation assistance shall include:

a. Initial company assessment. This initial engagement will provide strategic planning assistance - review of individual project, applicant resources, NIH-specific guidance, proposal development timeline.

b. Proposal editing, advising, and reviewing of project content for consistency with the FOA required sections - iterative critical written/verbal feedback on each component of the proposal detailing areas that need additional revision.

i. Feedback shall be a holistic review process that begins with the development of the Specific Aims with iterative reviews with corrections and notes for improvement provided.

ii. Provide a required timeline for review for each FOA required element, including:

Biosketches Budget Research Strategy Facilities & Resources Letters of support Human subject research Commercialization Plan Forms and submission readiness

c. Administrative assistance: registrations, electronic submission, forms, budgets and other administrative components of a final proposal.

d. Applicant Survey: the Contractor shall design and implement applicant surveys at the end of each applicant assistance project. The survey must be reviewed and approved by the federal COR prior to implementation. The results of the survey shall be analyzed by the Contractor and presented to the COR for program evaluation.

The results will also be used to evaluate the effectiveness of the Program. The Contractor shall conduct and submit the survey results to the COR within 15 days after each SBIR/STTR application cycle. Self-reporting of grants review results will be required for all participating applicants and the Contractor shall inform the applicants and ensure compliance. The Contractor shall collect applicants’ grant review results once available and evaluate the impact of the Program on applicant’s success. The applicants’ grant review outcome metrics are required within 15 days of the release of the review results.

4) Task 4: Grants Management Guidance

The Contractor shall provide post-award grants management assistance to applicants if requested. This service shall be in the form of comprehensive one-on-one consulting including appropriate tools needed based upon the stage of the applicant small business. Awarded small business will receive guidance on accounting system, compliance review, time-and-effort, and other procedure development.

The Contractor shall design and implement applicant surveys at the end of each grants management assistance period. The survey must be reviewed and approved by the federal COR prior to implementation. The results of the survey shall be analyzed by the Contractor. The results will be used to evaluate the effectiveness of the grants management guidance aspect of the program. The federal COR may also use the results and NIH policies to evaluate the Contractor’s performance. The Contractor shall conduct and submit the survey results to the COR within 15 days after each assistance period ends.

The grants management guidance listed below, if requested, shall be provided at no cost to program participants. The minimum requirement for assistance provided by the Contractor shall include the following elements:

a. Understanding what is required for a compliant accounting system.

b. Guidance on NIH policies and procedures.

c. Guidance on development of Time-and-Effort tracking process.

d. Guidance on monitoring of award funds for budget compliance and cost principles.

e. Guidance on preparing NIH required progress reports and close-outs.

5) Task 5: Programmatic Support

The Contractor shall provide the following minimum support to NIAID, DEA Small Business Program to enhance staff training and applicant engagement. The progress reports listed in Task 6 and Table 1 shall require COR review and approval prior to publication. Quarterly progress reports(Table 1, line item 15) that include specific NIAID SBIR/STTR Applicant Assistance Program related topics. The Contractor shall collect appropriate topics and design proper formats for these progress reports. Each progress report shall be reviewed and approved by the COR prior to electronical delivery to NIAID DEA Small Business program staff.

6) Task 6: Task Management

The Contractor shall provide program and project management, project control, and contract administration necessary to ensure that the objectives, scope, deliverables, schedule, as well as roles and responsibilities are defined for all tasks and that cost, schedule and quality requirements are tracked and communicated to the Contracting Officer Representative (COR) or the COR designee.

a. Upon award the Contractor shall work with the program COR to schedule a kick-off meeting to discuss tasks, expectations and projected timelines. The Contractor shall ensure that tasks are performed in a timely manner. The program COR will work with the Contractor to refine and finalize a timeline for deliverables. Sub-task will include the delivery of all required reports to monitor the execution of the tasks and timeliness of the Contractor required for successful delivery.

b. The Contractor’s Project Manager, or an appropriate designee, shall meet on scheduled dates and times, to be determined by the program COR, to discuss work in all active task areas. The COR may include other government staff and contractors as required. NIAID prefers in-person meetings if the Contractors are in the Maryland/Washington D.C./Northern Virginia area. However, these meetings can be held as teleconferences with prior approval of the COR if the Contractors are located outside driving distance of NIAID site or under other special circumstances, such as the current stay-at-home order due to the COVID pandemic. No travel costs are anticipated for these meetings.

c. Application Cycle Progress Report. The Contractor shall write progress reports and organize executive leadership briefings 15 days after the end of each Phase II SBIR/STTR application cycle during the performance period. These task reports shall detail progress made during the prior application cycle, progress expected during the upcoming cycle, resources expended, any significant problems or issues encountered, recommended actions to resolve identified problems, and any variances from the proposed schedule or scope. These items will be discussed during the executive leadership briefings with the COR. Meeting minutes summarizing the discussion and next steps shall be delivered by the Contractor within 7 days after the meetings.

d. Final Program Summary. After discussion with the program COR, the Contractor shall provide a final written report that describes in detail the work accomplished under this SOW. This report should include:

i. A list of resources and training content created with a short description for each item.

ii. A written summary of all the applications received.

iii. A written summary of each one-on-one assistance project conducted, including the work performed and how the work assisted the applicant.

iv. A written summary of each grants management guidance project conducted, including the work performed and how the work assisted the applicant.

v. A written summary of participating applicant survey results and grant review outcome metrics.

vi. A written record of the quarterly progress reports.

vii. Lessons learned during the performance period such as applicant knowledge gaps, unmet needs, recommendations to enhance program support.

e. Final presentation. A final oral presentation with PowerPoint slides highlighting the work conducted for the Applicant Assistance Program (as listed in the final program summary requirements) and future recommendations is required 30 days prior to the end of the performance period.

6. Schedule of Project Deliverables and Reporting

Table 1 presents a tentative schedule of deliverables to support the work required by NIAID in this Statement of Work. The Contractor shall propose a schedule of deliverables based on its proposed technical approach, and will incorporate the final deliverable schedule, as approved by the federal COR, into the Project Work Plan. All deliverables in this SOW will be in digital format only. NIAID does not accept any physical prints of the deliverables.

Table 1. Tentative Program Deliverables and Schedules

No. Task

Deliverables Description Date Due Freque ncy

1 6 Kick-off Meeting Agenda

Formal kick-off meeting agenda outlining tasks, expectations and projected timelines required to start the project

Within 10 days after award of contract

Once

2 6 Project Work Plan (PWP) And Schedule

Formal project overview, outcomes, and schedule of known deliverables for the work covered under this SOW. (May be modified on a regular basis with approval of the COR)

Within 20 business days of contract award

As needed by the

NIAID

COR

3 6 Application Cycle Progress Reports

A written progress report describing the activities and deliverables for the application cycle, anticipated activities and deliverables for the following application cycle, budget status, and risk management.

Within 15 days after each applicatio n submissio n deadline

3 times, once for each NIH

SIBR/ST

TR grant submissi on cycle

4 6 Executive leadership briefing agenda

Formal briefing agenda with topics included in the application cycle progress reports.

Within 15 days after each applicatio n submissio n deadline

3 times, once for each NIH

SIBR/ST

TR grant submissi on cycle

5 1 Work plan for creating resources and training content

Written work plan for creating resources and training content is required. This plan shall include the topics of interest, timelines, Section 508 compliance, and other relevant information requested by the COR

Within the first month of contract award

Once

6 1 Publishing resources and training content

The resources and training content shall be published on website or via other digital methods approved by the COR. A list with brief description of each published document shall be included in the final program summary.

Within the 6 months of contract award

Once

7 2 Written Application Form Meeting

Written application form shall be prepared by the Contractor and sent to the COR prior to this meeting. The Contractor shall revise the form if requested by the COR prior to implementation. The topics of follow-up calls shall also be discussed with the COR during this meeting.

Within the first month of contract award

Once

8 2 Electronical Delivery of Call for Application to NIAID

SBIR/STTR

Phase I Awardees

The call for application for the Applicant Assistance Program including COR approved online SBIR/STTR Application Form must be delivered to all eligible NIAID Phase I awardees at least 60 days prior to each SBIR/STTR submission deadline for all three application cycles.

At least 60 days prior to each

SBIR/STT

R submissio n cycle

Three times, once for each applicatio n cycle

9 2 Written Application Summary

Written application summary including the application forms and minutes of follow-up need assessment calls shall be submitted to the COR as a record for the participating applicants.

Within a month after receiving applicatio n forms at each cycle

3 times, once for each NIH

SIBR/ST

TR grant submissi on cycle

10 3 One-on-one Applicant Assistance Work Plan

The Contractor shall draft a one-on-one applicant assistance work plan indicating the workflow, timeline, methodology, and milestones of the Program for each cycle for all 3 cycles. The Contractor shall revise the work plan if requested by the COR. Final approval by the COR is required prior to implementing the work plan.

Within 15 days after receiving the participati ng applicant lists

3 times, once for each NIH

SIBR/ST

TR grant submissi on cycle

11 3 Design and Implement Applicant Surveys

The Contractor shall design appropriate surveys to measure the satisfaction of the applicants after grant submission. The surveys must be reviewed and approved by the COR prior to implementation. 80% satisfaction rate from applicants is required as government quality assurance.

Within 15 days after each

SBIR/STT

R grant submissio n deadline

3 times, once for each NIH

SIBR/ST

TR grant submissi on cycle

12 3 Collect and Analyze Applicant Outcome Metrics

The Contractor shall implement self-reporting of grants application review outcome as a prerequisite for applicants’ participation in the Program. The Contractor is required to collect and analyze the applicant outcome metrics to demonstrate the effectiveness of the Program.

Within 15 days after each

SBIR/STT

R grant review results are released

3 times, once for each NIH

SIBR/ST

TR grant submissi on cycle

13 4 Grants Management Guidance Work Plan

The Contractor shall draft a grants management guidance work plan indicating the workflow, timeline, methodology, and milestones of the Program for each cycle for all 3 cycles. The Contractor shall revise the work plan if requested by the COR. Final approval by the COR is required prior to implementing the work plan.

Within 15 days after receiving the participati ng applicant lists

3 times, once for each NIH

SIBR/ST

TR grant cycle

14 4 Design and Implement Applicant Surveys for Grants

The Contractor shall design appropriate surveys to measure the satisfaction of the applicants after each project. The surveys must be reviewed and approved by the COR prior to implementation. 80%

Within 15 days after each assistance period ends

3 times, once for each NIH

SIBR/ST

TR grant cycle

Management Guidance satisfaction rate from applicants is required as government quality assurance.

15 5 Draft and Publish Quarterly Progress Reports

A draft of quarterly progress report shall be sent to the COR for review and approval 15 days prior the publication date. The Contractor shall revise the progress report and publish them in a timely manner.

15 days prior to the delivery of each progress report

4 times, once each quarter

16 6 Final Program Summary

A draft of final written program summary shall be sent to the COR for review and approval 30 days prior the end of the performance period.

Requested revisions shall be made by the Contractor. COR approval is required for the final acceptance of this program summary.

30 days prior the end of the performan ce period

Once

17 6 Final presentation

A draft of final presentation summarizing all the work completed by the Applicant Assistance Program shall be sent to the COR for review and approval 30 days prior the end of the performance period. Requested revisions shall be made by the Contractor. COR approval is required for the final acceptance of this presentation. The Contractor is required to give an oral presentation to relevant Program staff before the end of the performance period.

30 days prior the end of the performan ce period

Once

7. Contractor Qualifications and Requirements

The Contractor shall provide personnel with the necessary skills and levels of expertise required to support the tasks to be performed under this SOW.

a. The Contractor must demonstrate the following experiences (experiences shall be addressed in quote):

Demonstrated more than 5 years of experience in assisting applicants to prepare SBIR/STTR grant proposals.

Demonstrated competence in assisting applicants to prepare SBIR/STTR proposals for NIH or other federal agency.

Highly experienced in assisting the preparation of different phases of SBIR/STTR proposals, especially Phase II, Direct to Phase II, and Fast Track proposals.

c. Preferred experiences from the Contractor (experiences shall be addressed in quote):

The Contractor has previous experience working with federal agencies, especially

NIH.

The Contractor has successfully assisted applicants to apply and receive federal SBIR/STTR grants funding, especially from NIH SBIR/STTR program.

The Contractor demonstrated experience working with women-owned and socially-economically disadvantaged-owned small businesses.

d. The Contractor will conform to all NIH and HHS processes for obtaining background checks consistent with requirements related to this effort. The Contractor shall appoint project lead within the Contractor’s organization and other necessary backup personnel to ensure accessibility during normal business hours (Mon-Fri, 9am-5pm).

8. Acceptance Criteria for Deliverables. All deliverables in this SOW will be in digital format only. NIAID does not accept any physical prints of the deliverables.

a. An 80% satisfaction rate from the applicant survey results is required as part of the acceptance criteria. NIAID requires the Program to be helpful and informative for a minimum of 80% of the participating applicants.

b. The COR shall inspect and accept the deliverables listed in the schedule table above. All deliverables shall be sent to the COR and program staff at least 5 business days (unless more time is specified for specific deliverables) prior to the deadline to ensure the quality of the deliverables meets the requirements of this SOW. The quality requirements are listed in Section 6 in the Deliverables Description column.

9. Government Furnished Information (GFI).

GFI is to be provided in conjunction with required performance under this task order as determined by mutual agreement between the Contractor and the NIAID COR at the beginning of the project. GFI for this SOW includes:

a. Current publicly available NIAID SBIR/STTR applicant resources and training content created by NIAID staff. The Contractor shall update this available content and create additional new content independently.

b. Additional information requested by the Contractor that is deemed relevant by the NIAID

COR

10. Section 508: Accessibility of electronic and information technology.

The Contractor shall make sure the resources and training content complies with Section 508 requirement.

11. Period of Performance.

The period of Performance shall be 12 months form the date of the award.

12. Place of Performance.

The tasks outlined in the Statement of Work will be performed at the contractor’s site and no travel cost is anticipated.