JA--ICorp -.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Acquisition Title:

Agency:

Acquisition Year (FY):

Author and Title:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

https://www.acquisition.gov/far/part-8#FAR_Subpart_8_4 https://www.acquisition.gov/far/part-13 https://www.acquisition.gov/far/part-16#FAR_16_505 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-6#FAR_6_303_1

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or s ervices.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or servic es will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)

If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)

Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Other (See FAR Subpart 6.3 for additional authority)

Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

https://www.acquisition.gov/far/part-6#FAR_6_302_1 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-11#FAR_11_105 https://www.acquisition.gov/far/part-6#FAR_6_302_2 https://www.acquisition.gov/far/part-6#FAR_6_302_5

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones f or the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start -up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quant ity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If ac tion is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

9. Procurement History:

Purchase order or contract number:

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202 https://www.acquisition.gov/far/part-10#FAR_10_002

10.Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this

J&A is accurate and complete.

Program Manager

Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager)

Name:

Position Title:

Email address:

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name: Phone:

Signature: Date:

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_403_4

14. Legal Review:

All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million (value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name:

Phone:

Signature:

Date:

All J&As greater than $68 million must have a review from the Office of Small & Disadvantaged Business Utilization (OSDBU) prior to sending it to the Department. The OSDBU at their discretion may review any J&A.

16. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $68 million (value calculated including all options)):

Concur:

Non-Concur:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million (value calculated including all options)):

18. Department Competition Advocate (Required for contracts exceeding $68 million (value calculated including all options)):

Concur:

Non-Concur:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

This will be a 12-month base period under a firm-fixed price contract type.

Innovation Corps at NIH (I-Corps) provides vital support to researchers and innovators through its experiential training program’s rigorous process of customer discovery and business model development. This approach has provided an effective process to assess the commercial potential of scientific research and discoveries, providing an initial path to the creation of new ventures and strong economic development. Since 2014, NIH has worked with VentureWell as the key partner in the implementation and evaluation of the I-Corps program and in the growth of the national biomedical innovation ecosystem.

The Small Business Education and Entrepreneurial Development (SEED) office supports the NIH innovator community in their efforts to validate the potential health impacts of promising scientific discoveries and advance them into healthcare products that improve patient care and enhance health. Developing products across the biomedical spectrum requires NIH’s collaboration with universities and research institutions, small businesses, trade associations and societies, angel investors, venture capitalists, and strategic partners. SEED leads initiatives that develop these relationships and build opportunities for NIH innovators to further their product development efforts.

SEED’s core business objectives are to provide services that enable investigators to convert scientific discoveries into impactful healthcare solutions, coordinate early-stage product development activities across the NIH, inspire and support a diverse entrepreneurial workforce, and demonstrate NIH’s role in improving patient care and driving economic growth.

Please refer to the SOW for a more in-depth description of this requirement.

Text70:

A search was conducted on AbilityOne and Unicor, but neither can meet the essential need of this requirement.

In addition to the Sources Sought Notification posted onto GSA and SAM.gov. GSA eLibrary was reviewed under the NAICS 541611. There were 2,683 contractors ranging from small to large businesses.

By the end of the Sources Sought Notification, nine (9) vendors expressed an interest in the requirement and provided capability statements. The Program Office’s point-of-contact, Deanna Pastore, was provided the documents so that the technical expert could conduct their review.

Upon completion of the technical review, it was determined that none of the responding vendors were nonresponsive or not capable of fulfilling the essential needs of the requirement.

To further confirm the market, another Sources Sought Notification was posted on July 24, 2024, to SAM.gov and GSA. This notice included all sizes of businesses. As a result of the posting, there were a total of nine (9) responses (three (3) from GSA and six (6) from SAM.gov). Out of the nine (9) submissions, there were seven (7) small business and two (2) large businesses (one (1) who is considered a large business in relation to the utilized NAICS). This information was provided to the COR, Deanna Pastore, to have the Program Office’s technical expert review the provided information.

The technical expert determined that none of the responding vendors were responsive or not capable of fulfilling the essential needs of the requirement.

Historical Information of a similar requirement:

A Sources Sought Notification was posted for a similar requirement on July 20, 2023 onto SAM.gov and GSA. By the end of the posting, 15 vendors expressed an interest, but after review of capability statements, they were determined not to be able to fulfill the essential needs of the requirement.

Based on the program’s high risk elements, the lack of reasonable expectation of receiving two (2) or more small businesses, and the administrative costs to continuously seek a vendor with the minimal experience to not exacerbate potential risks, an approved sole source justification to VentureWell was approved by the Contracting Officer, Daniel Johnson.

The package was then submitted for a Small Business – 653 review via SBCX. The package and approach were concurred by OSDBU’s, Jonathan Ferguson on August 29, 2023.

As a result of the information, on September 14, 2023, the Contracting Officer, Daniel Johnson, issued a Purchase Order to National Collegiate Inventors & Innovators Alliance (VentureWell) for a contract value of $540,000.00.

To conclude, due to the high risk nature of the requirement, a more stringent oversight is required. The independent government cost estimate (IGCE) comes to an estimated value of $444,960.00. To continuously proceed seeking vendors that can fulfill the essential elements of the requirement will greatly increase administrative costs and the risk in the timeliness in the start of the program I-Corp program. As for experience, VentureWell has been the only vendor that demonstrated their capability, experience, and historical background in handling/managing the requirement.

By the end of the Sources Sought Notification, nine (9) vendors expressed an interest in the requirement and provided capability statements. The Program Office’s point-of-contact, Deanna Pastore, was provided the documents so that the technical expert could conduct their review.

Upon completion of the technical review, it was determined that none of the responding vendors were nonresponsive or not capable of fulfilling the essential needs of the requirement.

To further confirm the market, another Sources Sought Notification was posted on July 24, 2024, to SAM.gov and GSA. This notice included all sizes of businesses. As a result of the posting, there were a total of nine (9) responses (three (3) from GSA and six (6) from SAM.gov). Out of the nine (9) submissions, there were seven (7) small business and two (2) large businesses (one (1) who is considered a large business in relation to the utilized NAICS). This information was provided to the COR, Deanna Pastore, to have the Program Office’s technical expert review the provided information.

The technical expert determined that none of the responding vendors were responsive or not capable of fulfilling the essential needs of the requirement.

This program is considered high risk and to provide a contract with an untested vendor would further exacerbate any risks, be more costly, and cause an unnecessary delay. To remedy the situation and mitigate the risk, issuing a contract to VentureWell, who has previous experience and the understanding of OER/SEED's operation, would be the most advantageous to both the requirement and taxpayer.

By the end of the Sources Sought Notification, nine (9) vendors expressed an interest in the requirement and provided capability statements. The Program Office’s point-of-contact, Deanna Pastore, was provided the documents so that the technical expert could conduct their review.

Upon completion of the technical review, it was determined that none of the responding vendors were nonresponsive or not capable of fulfilling the essential needs of the requirement.

To further confirm the market, another Sources Sought Notification was posted on July 24, 2024, to SAM.gov and GSA. This notice included all sizes of businesses. As a result of the posting, there were a total of nine (9) responses (three (3) from GSA and six (6) from SAM.gov). Out of the nine (9) submissions, there were seven (7) small business and two (2) large businesses (one (1) who is considered a large business in relation to the utilized NAICS). This information was provided to the COR, Deanna Pastore, to have the Program Office’s technical expert review the provided information.

The technical expert determined that none of the responding vendors were responsive or not capable of fulfilling the essential needs of the requirement.

A search was conducted on the Interagency Contract Directory (contractdirectory.gov) for the following keywords:

Consulting The keyword, ‘consulting,’ had 100 contracts that ranged from small to large businesses.

In addition to the Sources Sought Notification posted onto GSA and SAM.gov. GSA eLibrary was reviewed under the NAICS 541611. There were 2,683 contractors ranging from small to large businesses.

By the end of the Sources Sought Notification, nine (9) vendors expressed an interest in the requirement and provided capability statements. The Program Office’s point-of-contact, Deanna Pastore, was provided the documents so that the technical expert could conduct their review.

Upon completion of the technical review, it was determined that none of the responding vendors were nonresponsive or not capable of fulfilling the essential needs of the requirement.

To further confirm the market, another Sources Sought Notification was posted on July 24, 2024, to SAM.gov and GSA. This notice included all sizes of businesses. As a result of the posting, there were a total of nine (9) responses (three (3) from GSA and six (6) from SAM.gov). Out of the nine (9) submissions, there were seven (7) small business and two (2) large businesses (one (1) who is considered a large business in relation to the utilized NAICS). This information was provided to the COR, Deanna Pastore, to have the Program Office’s technical expert review the provided information.

The technical expert determined that none of the responding vendors were responsive or not capable of fulfilling the essential needs of the requirement.

Historically, after reviewing information on a similar requirement, on July 20, 2023, a Sources Sought Notification was posted onto SAM.gov and GSA. This posting was structured to seek potential small businesses. By the completion of the notice, there were 15 vendors who provided written responses. Seven (7) of those vendors are in possession of a federal contract.

As stated previously, VentureWell has experience to support based on their I-Corps exposer, entrepreneurship training, online class support, etc. The vendors who responded did not: 1) only provided information based on the technical business and assistance programs and not addressing the commercialization enhancement programs, such as I-Corps, or didn't even provide this information; 2) had limited to no SBIR/STTR experience; 3) have entrepreneurship training experience; 4) did not provide information in the manner to which it sufficiently fulfilled the outcome of the Sources Sought Notification; and 5) any combination of the previously listed deficiencies.

VentureWell has the experience to work with the I-Corps program, the instructional material which is based on the Lean Launch Pad customer discovery process. This vendor also has experience in supporting entrepreneur training and support with courses via an online environment.

This program is considered high risk and to provide a contract with an untested vendor would further exacerbate any risks, be more costly, and cause an unnecessary delay. To remedy the situation and mitigate the risk, issuing a contract to VentureWell, who has previous experience and the understanding of OER/SEED's operation, would be the most advantageous to both the requirement and taxpayer.

Based on the program’s high risk elements, the administrative costs, and no reasonable expectation of receiving two (2) or more quotes, to continuously seek a vendor with the minimal experience to not exacerbate potential risks, an approved sole source justification to VentureWell was approved by the Contracting Officer, Daniel Johnson.

The package was then submitted for a Small Business – 653 review via SBCX. The package and approach were concurred by OSDBU’s, Jonathan Ferguson on August 29, 2023.