26-006897 - JOFOC Leptin.docx

Justification for Other than Full and Open Competition (JOFOC) RFO - FAR 6.103- (Insert applicable FAR authority/citation)

1. Acquisition Title: Leptin for in vivo studies.

Division: NIH – CC - CCMD.

Contracting Activity: Identify the contracting activity responsible for this action.

Author: Gabriela A Ferreyra, Senior technical Laboratory Manager.

Basis for approval under RFO - FAR 6.104(c): Individual Basis.

2. Nature and/or Description of the Action being Approved: The Critical Care Medicine Department requests a firm-fixed-price purchase with the contractor listed in the table below. The Government projects award for 2026 using fiscal year 2026 funds.

Contractor: Bio-Techne 614 McKinley Place NE Minneapolis, MN 55413, USA

Estimated Total Dollar Value:

$34,272.85

Original Contract Value:

New Contract Value:

3. Description of Supplies and/or Services: recombinant product as below:

Qty : 10 vials of Recombinant Rat Leptin Protein, CF Size: 80 MG Endotoxin: 0.00314 Eu/ug State: Lyo Formulation: STD Buffer: PBS, pH 7.4 Lot Selection (Bulk): AQP33

Qty 5 Vials of of Recombinant Rat Leptin Protein, CF Size: 1 MG Endotoxin: 0.00314 Eu/ug State: Lyo Formulation: STD Buffer: PBS, pH 7.4 Lot Selection (Bulk): AQP33

This product is a sole source item as it’s manufactured by the supplier. This material will be use on in vivo experiment under ORWH Innovation Awards SEX- AND OBESITY-ASSOCIATED MECHANISMS AND THERAPEUTIC TARGETS IN PULMONARY ARTERIAL HYPERTENSION. Biological material for animal treatments can’t be changed as we will incur in additional testing, additional testing subjects and validation and in vivo results can’t be compared.

4. Statutory Authority Cited and Rationale: Include the applicable statutory authority (listed in black print and underlined below) that permits other than full and open competition. Make sure the selection matches the FAR citation listed in the title of this JOFOC. Delete the sub-section identifier (e.g., a, b, c, etc.).

For any statutory authority selected, demonstrate how the proposed contractor’s unique qualifications or the nature of the acquisition requires using the authority cited. Add additional supporting narratives per the instructions specific to the option selected. Then, delete the remaining options.

a. RFO - FAR 6.103-1, Only one responsible source and no other supplies or services will satisfy agency requirements. Authority: 41 U.S.C. 3304(a)(1). Per RFO - HHSAR 306.103-1, for acquisitions covered by 42 U.S.C. 247d-6a(b)(2)(A), “available from only one responsible source” must be deemed to mean “available from only one responsible source or only from a limited number of responsible sources.”

Identify the appropriate authority selection within RFO - FAR 6.103-1(c).

Explain why the intended contractor is the only responsible source that can provide the required supplies or services. Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or services 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 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 specific feature, do not meet, or cannot be modified to meet Division needs in accordance with RFO - FAR part 11. If the action is a follow-on contract for continued development or production of highly specialized equipment, detail any significant duplication of cost or unacceptable delay being avoided.

When there is a non-competitive follow-on to a previous non-competitive award for the same supply or service, include a copy of the previous justification to assist the approval authority in determining whether the planned actions to remove any barriers that led to the restricted consideration cited on the previous justification were completed.

b. RFO - FAR 6.103-2, Unusual and compelling urgency. Authority: 41 U.S.C. 3304(a)(2).

Justifications citing RFO - FAR 6.103-2 must explain how the agency’s need for the supplies or services is of such an unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. Include a discussion of the required delivery schedule and lead-time involved. Describe the unusual or compelling urgency and provide an explanation of how Government use of conventional procurement procedures would result in an unacceptable delay to the Government. Provide data, estimated cost, or other rationale as to the extent and nature of harm to the Government that would result from following competitive procedures.

Explain the Period of Performance (PoP) requested and why that PoP is needed to support the Urgent and Compelling requirement, as well as what the agency is doing to secure a competitive action by the end of the urgent need and PoP stated.

Contract actions citing RFO - FAR 6.103-2 as the authority for issuing non-competitive work may not exceed one year, including all options, unless the SPE [or the SPE’s designee] determines that exceptional circumstances apply and makes this recommendation to, and is approved by, the head of the agency.

c. RFO - FAR 6.103-3, Industrial mobilization; engineering, developmental, or research capability; or expert services. Authority: 41 U.S.C. 3304(a)(3).

Identify the appropriate authority selection within RFO – FAR 6.103-3(b).

Explain why the Division finds it necessary to pursue other than full and open competition and how the authority selected is applicable.

d. RFO - FAR 6.103-4, International Agreement. Authority: 41 U.S.C. 3304(a)(4).

Identify the appropriate authority selection within RFO – FAR 6.103-4(b).

Explain why the Division finds it necessary to pursue other than full and open competition and how the authority selected is applicable.

Two examples of when this authority may be used include situations where (1) a contemplated acquisition is to be reimbursed by a foreign country that requires the product be obtained from a particular firm, as specified in an official written direction (e.g., a Letter of Offer and Acceptance (LOA), in which case the applicable LOA must identify the designated source), or (2) when a contemplated acquisition is for services to be performed, or supplies to be used, in the sovereign territory of another country and the terms of a treaty or agreement specify or limit the sources to be solicited.

e. RFO - FAR 6.103-5, Authorized or Required by Statute. Authority: 41 U.S.C. 3304(a)(5).

Identify the appropriate authority selection within RFO – FAR 6.103-5(b).

Explain why the Division finds it necessary to pursue other than full and open competition and how the authority selected is applicable.

f. RFO - FAR 6.103-6, National Security. Authority: 41 U.S.C. 3304(a)(6).

This authority may be used when the disclosure of the Government’s needs would compromise national security (e.g., would violate security requirements): not merely because the acquisition is classified, or because access to a classified matter will be necessary to submit a proposal or to perform under the prospective award.

g. RFO - FAR 6.103-7, Public Interest. Authority: 41 U.S.C. 3304(a)(7).

Full and open competition need not be provided for when the agency head determines that it is not in the public’s best interests. This authority may be used when none of the other authorities in RFO - FAR 6.103 apply. Use of this justification authority requires a Determination and Findings (D&F) in accordance with RFO - FAR subpart 1.5. The D&F must be signed by the HHS Secretary (non-delegable). Additionally, Congress must be notified in writing of such determination NLT 30 days before award.

5. Special Considerations for Certain Contract Extensions or Bridge Contracts: For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize the history of the current contract and explain the reasons for any delays in the acquisition. Include a discussion of the milestones for the follow-on action. Discuss why it would be neither cost effective nor realistic to have another contractor meet Division needs during the interim period. Provide all pertinent details, such as start-up costs, phase-in, transfer of government furnished property, recruitment and staffing, etc. If the action arose due to protest, provide a brief summary of the protest, including date, grounds, status, and any other pertinent information. Explain how the action will meet only minimum needs in terms of quantity and length of time. If this section is not applicable, indicate “Not applicable.”

Note: This section is required for explanatory purposes only and is not included as an authority for an exception to full and open competition.

6. Actions to Increase Competition:

a. A Notice Was / Was Not Published: Indicate whether a notice was or will be published, as required by RFO - FAR 5.201(a); or identify which exemption under RFO - FAR 5.201(b) applies.

b. Responses Were / Were Not Received: If a notice was published, discuss the number of written responses to the synopsis and the results of the assessment of the written responses.

c. Sources Expressing Interest: 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 must be considered.

d. Actions to Foster Competition for Future, Similar Requirements: 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, will be made to compete it to the maximum extent possible. If the action is non-competitive because of proprietary data or licensing rights and there may 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/licensing costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain any planned actions to compete the follow-on. If the action is an urgent, new requirement and a competitive follow-on is anticipated, address any efforts underway to facilitate a full and open competition.

7. 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, which may 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 other types of inquiries. Research must be meaningful (i.e., demonstrating a reasonable attempt to discover relevant information about market capabilities and common commercial practices). The CO may use market research conducted within 18 months of prospective award if the information is still current, accurate, and relevant. Lack of 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.

Reference and attach the standalone Market Research Report, as necessary and appropriate; however, general reliance upon its contents in lieu of formulating this section is unacceptable.

8. Procurement History: (Add as many prior awards as necessary to provide a thorough understanding of the procurement history.)

Contractor:

Contract or Order Number:

Award Date and Period of Performance:

Value (including all options):

Competitive Status:

Authority formerly relied upon if Not Competed: (If the action was not competed, state the cited authority from any previous justification, summarize the rationale, describe the actions taken to increase competition and the results thereof.)

9. Additional Information or Other Facts: List any other relevant information or facts supporting the use of other than full and open competition. See RFO - FAR 6.104-1(a)(9).

10. Technical or Requirements Program Management Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief. [Always required.] (Only the Program or Project Manager or higher-level program official with specific knowledge of the individual requirement may sign the technical and requirements certifications.)

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11. Fair and Reasonable Price Determination: As the contracting officer, I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable.

Select the applicable squares to mark the techniques used:

This determination will be made using the following: ☐ cost analysis ☐ price analysis ☐ cost realism ☐ market pricing ☐ historical pricing ☐ other: Describe the methodology or combination of methodologies that will be used. See RFO - FAR subpart 15.2 for proposal analysis guidance.

As a part of this basis, certified cost, or pricing data (see RFO - FAR 15.403)— ☐ will be required. ☐ will not be required and the following FAR part 15 exception applies:

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☐ A commercial item is being acquired.

☐ A waiver has been granted by the HCA in accordance with RFO - FAR 15.403-2(c)(4).

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☐ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

12. Contracting Officer (CO) Certification and Determination: I hereby certify that this justification is accurate and complete to the best of my knowledge and belief. And, based upon the foregoing, I also determine that using a sole-source contract is in the best interest of (insert Division). [Always required; CO approval authority is limited to $900 thousand.]

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(The following Reviews and Approvals will ordinarily be provided on a separate page at the end of the justification to allow for minor, administrative changes to be made during the review process; delete any individual reviews/approvals not applicable.)

ELEVATED REVIEWS & APPROVALS

13. Insert Division Division Director: I reviewed this justification find that it adequately supports other than full and open competition.

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14. NIH Head of the Contracting Activity (HCA) Review and Approval: I reviewed this justification and find that it adequately supports other than full and open competition. [Division HCA approval authority is limited to $90 million.]

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15. NIH Advocate for Competition (AfC) Review and Approval: I reviewed this justification find that it adequately supports other than full and open competition. [Division AfC approval authority is limited to $20 million.]

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16. HHS Office of General Counsel Review and Concurrence: I reviewed this justification and concur that it adequately supports other than full and open competition. [Mandatory when SPE approval is required, unless otherwise waived in writing by the SPE.]

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17. HHS Advocate for Competition (AfC) Review and Concurrence: I reviewed this justification and concur that it adequately supports other than full and open competition. [Mandatory when SPE approval is required.]

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FINAL APPROVAL

18. HHS Senior Procurement Executive: Based on the foregoing, I hereby approve this justification for other than full and open competition pursuant to the authority of 41 U.S.C. 3304(a)(1) and in accordance with RFO - FAR 6.103. [Required if the total action value, including all options and FAR 52.217-8 value, exceeds $90 million.]

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