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This document includes a solicitation for a Needs Assessment Program for Department of Health and Human Services and National Institutes of Health Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awardees. The selected contractor will provide customized Needs Assessment Reports for selected SBIR/STTR Phase I and Phase II awardees covering ten commercialization areas from a life science industry perspective, including target market attractiveness, technology's ability to address market need, regulatory path, business model profitability, competition and intellectual property, sales and marketing strategy, management team, strategic partners, funding status and financial plan, and potential exit plan. The Reports will analyze the company and product, identify strengths and weaknesses in each commercialization area, summarize highest priority areas to address, and identify appropriate resources. The statutory limit per Needs Assessment Report is $6,500.

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RFP-NIH-NICHD-OER-2020-10 Questions and Answers Amendment 2

Offerors must acknowledge receipt of this Amendment in their Business Proposal.

1. Can you please clarify if Needs Assessment Reports will be provided to SBIR/STTR Phase I awardees, Phase II awardees, or both??

Answer: Needs Assessments will primarily be requested for Phase I awardees, however it is possible that Phase II companies will also be included in requests.

2. Will each awardee, whether Phase I or Phase II, receive the same templated report with all ten commercialization areas?

Answer: Yes, with the understanding that beyond the information collected from the company, it is anticipated that potential offerors will have the appropriate subject matter expertise and resources to do the significant research required to generate a Needs Assessment.

3. Do you foresee customizing the commercialization areas covered for an individual company for conditions specific to that company (i.e. stage of development, experience with SBIR/STTR Programs, regional location or other specific special characteristics)?

Answer: Needs Assessments will be customized to each company based on the research done by the contractor. Each Needs Assessment will cover the same commercialization areas, however, the content of each Assessment will be specific to the company receiving the Needs Assessment.

4. In reference to Attachment 8 ADDITIONAL TECHNICAL AND BUSINESS PROPOSAL INSTRUCTIONS, Section 2. Sample Assessments— “The offeror must submit a number of sample assessments sufficient to provide two (2) examples”… “Four (4) assessments are necessary to cover each commercialization area. The offeror shall submit four (4) summaries [one for each assessment]” These appear to be conflicting instructions. Can you please clarify if you would like the offeror to provide two (2) sample assessment reports, or four (4)?

Answer: The offeror must provide 2 examples of each of the 10 commercialization areas through sample assessments. The minimum that could take would be 2 samples, however, if you need to provide additional samples to ensure that each commercialization area is covered twice, that is allowable. Therefore, you might have a situation where you provide 4 samples to cover each area twice.

5. On page 47 of the Solicitation continuing onto page 48, number 4 TECHNICAL EVALUATION FACTORS, Factor 1: Sample Assessments in the paragraph after the list of commercialization areas, it states “… Offerors should provide sample assessments that collectively cover all of the commercialization areas listed above for at least two (2) example life science technologies from two separate companies. Offerors should provide enough sample assessments to provide two

(2) examples for each of the commercialization areas listed. …” Does this mean that there must be at least two example technologies for each commercialization area? If so, then there may be more than 2 sample reports necessary for this requirement. Is there a limit on the number of reports that can be submitted to satisfy the requirement of 2 sample technologies for each commercialization area?

Answer: There is no limit on the number of sample Needs Assessments to be provided.

However, offerors must be mindful of the page limitations for Needs Assessments included in the Additional Proposal Instructions.

6. On page 36, continuing on to pare 37 of the Solicitation, TECHNICAL PROPOSAL INSTRUCTIONS, #1 Technical Discussions, a. Statement of Work, 1) Objectives, it is written to “State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relation to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it.” This requirement seems to be more relevant to a research project than to a service contract. Please clarify what information is being requested here?

Answer: The offeror should provide information as to their understanding of the objective of the requirements and its specific accomplishments it expects to meet.

7. Shall Past Performance be included in the Technical Proposal or the Business Proposal? (There is conflicting information on pg. 35 of the RFP which states it should be in the Business Proposal, while pg. 13 of the SOW lists Past Performance as part of the Technical Proposal Instructions.)

Answer: Please include the Past Performance examples in the Business Proposal.

8. On page 41 continuing onto page 42 of the Solicitation, #5 Total Compensation Plan, b.

Evaluation, 1, it is stated that “Proposals offering total compensation levels less than currently being paid by the predecessor Contractor for the same work will be evaluated, in addition to the above, on the basis of maintaining program continuity, uninterrupted work of high quality, and availability of required competent employees.” Can you please provide a reference to the program administered by the predecessor Contractor and any publicly available information on the program and how to interpret “uninterrupted work of high quality”?

Answer: Information about a predecessor contract was included in error. There is no predecessor contract, as this is a new program.

9. Do you have a maximum budget per Assessment that you may share?

Answer: The statutory limit per Needs Assessment is $6,500. The Government expects that competitive pricing for these assessments would be lower than the statutory maximum.

10. How will participants of the Needs Assessment Program be recruited and/or selected?

Answer: Companies request a Needs Assessment through a standard application form. NIH will verify eligibility of the request and that the application is complete. If the program is oversubscribed, NIH may prioritize utilizing information in the application and other factors (i.e.

first-time awardees).

11. What flexibility is there to deviate from the format or approach of the needs assessments prescribed in the RFP, if the respondent believes there is a better approach?

Answer: It is expected that potential offerors will utilize the format and approach in the RFP.

12. In reference to pg. 37 of the RFP— “Offerors should assure that the Principal Investigator and all other personnel proposed shall not be committed on federal grants and contracts more than a total of 100% of their time.” Does this request require a PI be assigned even though this is not a research proposal? If so, who should be considered the “Principal Investigator” on this contract?

Answer: For this contract, a Principal Investigator is not necessary, however, special attention should be paid to Key Personnel.

13. In reference to pg. 3 of the SOW, Section 2) SCOPE— Can you please confirm whether this contract will include management of the SEED program contract?

Answer: The management of this Needs Assessment contract would be included in the scope of work. The management of the SEED program, which is larger than this contract alone, is not within the scope of work of the anticipated award.

14. In reference to pg. 3 of the SOW, Section 3 a)— What is the criteria for “Performing background research about selected HHS-supported small businesses”? Please clarify what this means.

Answer: Beyond the information collected from the company, it is anticipated that potential offerors will have the appropriate subject matter expertise and resources to do the significant research required to generate a Needs Assessment.

15. In reference to pg. 3-4 of the SOW, Section 1.1 Contract Management— Can you please clarify if the Contractor will be managing the SBIR/STTR SEED Program contract/ subcontracts (i.e.

reviewing proposals, assigning funds, tracking award funds, etc.)? OR more simply managing the contract for the Needs Assessment Program?

Answer: The contractor will only be managing the contract for the Needs Assessment program.

16. Attachments 9 and 11 require PI contact information. Does this RFP require a PI be assigned even though this is not a research proposal?

Answer: A PI is not required.

17. Does Attachment 7 “HHS Guide to Completing the Section 508 Evaluation Template” apply to this RFP?

Answer: Yes. Please follow the guidance found on that page.

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