Ceiling Value

Total Obligated to date: $27,429,977.47

Total IDIQ Maximum: $174,470,000.00

Total Remaining Ceiling: $147,040,022.53

3. Description of Supplies and/or Services:

This is a multiple-award, Indefinite Delivery/Indefinite Quantity (IDIQ) contract administered and funded through individual Task Orders (TO). Task Orders, for severable and non-severable research and development services, are awarded on a cost-reimbursement and/or fixed-price basis to support the research activities for the NIH BPN.

The IDIQ contractor holders compete for individual pharmacology and toxicology study requirements as they arise. The Contractor performs work only as directed under awarded task orders. Task orders are awarded under two performance areas:

• Performance Area 1: Management and Operations Support

• Performance Area 2: Pharmacology and Toxicology Studies

Task orders for individual pharmacology and toxicology studies of investigational agents/therapeutics are competed among the IDIQ holders through a Task Order Request for Proposal (TORFP) process under Performance Area 2. These task orders are issued as cost-reimbursement, completion and/or level-of-effort type orders. A task order under Performance Area 1 is awarded only to those contractors that have also received a task order award under Performance Area 2.

The goal of the PTTP contract is to assess the pharmacokinetics, toxicology and safety of promising drug candidates to support their eventual use as therapeutics. NIH-approved samples are submitted from a variety of sources including NIH-funded research programs, pharmaceutical companies, biotechnology companies, or other sources. The pharmacology, toxicology and safety data generated under this program are used by investigators in support of Investigational New Drug (IND) applications.

Studies to be performed may include, but are not limited to:

• Development and validation of the analytical methods for quantitating drug/biologic concentrations in dosing solutions, biological fluids, and tissues, as required

• In vivo pharmacokinetic studies through various routes of administration

• Preclinical acute toxicity evaluations on lead compounds or therapeutics

• Subacute, sub-chronic, and/or long-term toxicity evaluations in rodents and non-rodent species

• Safety Pharmacology Studies in rodent and non-rodent species (e.g., cardiovascular, pulmonary, CNS)

• Genotoxicity assessments using a battery of appropriate assays and carcinogenicity assessments

• In vitro predictive ADMET assays, including metabolic stability studies, hepatotoxicity, permeability studies, cytochrome P450 assays, plasma protein binding, and cytotoxicity assays

4. Statutory Authority Cited and Rationale:

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

Nature of the Unusual and Compelling Urgency: SRI International, Southern Research (SR), IIT Research Institute (IITRI), and the University of Illinois Chicago Toxicology Research Laboratory (TRL) are the only sources able to immediately continue providing critical Preclinical Toxicology Testing Program (PTTP) services to BPN while the recompete process is completed and new IDIQ contracts are awarded in FY2027. These four (4) contractors are the sole holders of the current PTTP IDIQ and possess the technical expertise, staffing plans, and infrastructure required to perform GLP-IND-enabling toxicology work during the period needed to define, recompete, and award the follow-on requirement.

Each incumbent was competitively awarded its position under the PTTP IDIQ and has been evaluated and approved to perform pharmacokinetic, non-GLP, and GLP-IND-enabling toxicology studies. Some currently hold active task orders involving study-specific protocols, validated analytical methods, and test articles subject to defined GLP toxicology batch expiration windows. Allowing these IDIQ contracts to lapse and potentially transitioning this in-progress work to different contractors would require re-validation of methods and protocols and, in some cases, synthesis of a new test article batch — resulting in duplicative costs and delay.

Using conventional competitive procurement procedures at this time would result in an unacceptable delay in providing these mission-critical services. Although the government has initiated the follow-on competitive acquisition, the remaining time before expiration of the current contracts is insufficient to finalize requirements, issue the solicitation, evaluate proposals, make award, and accomplish an orderly transition to the successor contractor(s).

The timeline for the follow-on competitive acquisition was significantly and unavoidably affected by external government-wide actions beyond the Agency’s control. Specifically, Executive Order 14210, Implementing the President’s “Department of Government Efficiency” Workforce Optimization Initiative (Feb. 11,2025), directed federal agencies, including the Department of Health and Human Services (HHS), to prepare for large-scale reductions in force (RIFs) and organizational restructuring. Implementation of these government-wide workforce initiatives and related Executive Branch directives required agencies to realign organizational structures, reassign personnel, and modify internal review and approval processes. These actions disrupted established acquisition workflows, extended legal and management review timelines, and delayed completion of critical procurement milestones necessary to award the follow-on competitive acquisition. Despite the government’s continued efforts to advance the acquisition, these external circumstances made it not feasible to complete the competitive procurement before expiration of the current contracts.

5. Special Considerations for Certain Contract Extensions or Bridge Contracts:

The proposed action is a one-year extension of the current multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contracts to assess the pharmacokinetics, toxicology, and safety of promising drug candidates to support their eventual use as therapeutics.

The four (4) PTTP IDIQ contracts were originally awarded through full and open competitive procedures under FAR Part 15, with an ordering period scheduled to expire on September 12, 2026. Since award, these contractors have been eligible to compete for and receive task orders supporting pharmacokinetic, non-GLP, and GLP-IND-enabling toxicology studies for BPN and other NINDS-supported development programs. No prior extensions or ceiling increases were issued. Some contractors currently hold active task orders under this arrangement; others do not currently hold active task orders but remain available and qualified to be tasked as new requirements arise.

Task orders may be issued through September 12, 2027, the end of the extended ordering period. In accordance with FAR/RFO 52.216-22, Indefinite Quantity, task orders issued before the expiration of the ordering period may continue through their established periods of performance until completion of the required work, even if performance extends beyond the expiration of the ordering period.

The government's objective remains to competitively award the follow-on contract(s) by September 2027 using the procedures of RFO/FAR 15. Despite the government's diligent efforts, circumstances outside of its control affected the acquisition schedule and prevented completion of the competitive procurement within the required timeframe, necessitating this bridge action.

Additionally, for the contractors currently performing active task orders on other NINDS Division of Translational Research (DTR) IDIQs, transitioning the work they have completed and that will be used as testing materials for the planned task orders to new contractor(s) would require re-validation of analytical methods, re-establishment of study protocols, and, in some cases, synthesis of a new GLP toxicology batch of the test article, resulting in duplicative costs already incurred and delays to FDA IND submission timelines. Delays from the lapse of these IDIQ contracts would place Investments in the amount of $9-10 million at risk in related grants in contracts that are integral to the therapeutic development process, from the initial idea of the therapeutic to the final IND application with the FDA. Additionally, if the GLP toxicology batch of the test article expires before use, a new batch would need to be synthesized, resulting in increased costs and delays to IND filings, clinical trial initiation, and the timely provision of therapies to patients. For the remaining contractors, while no work is currently in progress, each has been competitively qualified under the PTTP IDIQ and maintains the facilities, accreditations, and staffing necessary to perform GLP-IND-enabling studies on short notice; qualifying a new contractor in their place during the two-year bridge period would instead require a facility and quality-system audit, SOP review, and a phase-in period. In both cases, it is neither cost-effective nor realistic to transition this requirement to a new contractor during the interim bridge period.

This action extends the ordering period of the four (4) existing IDIQ contracts by one (1) year only, from September 13, 2026, through September 12, 2027, solely to permit issuance of task orders necessary to complete ongoing and near-term pharmacology and toxicology studies while the follow-on requirement is competitively re-competed. No increase to contract ceiling value, scope, or performance areas is included in this action, and the extension reflects the minimum time necessary to bridge to award of the follow-on IDIQ contract based on the acquisition lead-time estimates above.

Milestones: It is anticipated to release a solicitation for the PTTP re-competition in December 2026. Contract awards are expected in August/September 2027.

6. Actions to Increase Competition:

a. A Notice Was Published:

A notice for the proposed contract action will not be published. This acquisition is being conducted pursuant to FAR/RFO 6.103-2, Unusual and Compelling Urgency, and the exception to synopsis requirements at FAR/RFO 5.101 (b)(2) applies because of publication of such a notice would unnecessarily delay the acquisition and the government’s need is such an unusual and compelling urgency that the government would be seriously injured if the Agency complied with the normal synopsis requirements.

b. Responses Received:

Not applicable. Because a notice will not be published for the proposed contract action, no responses to a synopsis are anticipated.

c. Sources Expressing Interest:

No additional sources have expressed written interest in the proposed contract action.

Should any source express interest prior to award, the government will evaluate the information provided and consider whether the source demonstrates the capability to meet the government’s requirements within the required timeframe.

d. Actions to Foster Competition for Future, Similar Requirements:

This bridge action is a temporary measure intended solely to ensure continuity of mission-critical services while the government completes the follow-on acquisition. NIH has already initiated acquisition planning for the successor requirement. As part of this effort, the government has conducted updated market research, reviewed current industry capabilities, and evaluated the existing acquisition strategy to maximize competition to the greatest extent practicable. The follow-on acquisition will include the publication of the appropriate pre-solicitation and solicitation notices in accordance with applicable FAR/RFO requirements, providing all eligible sources with the opportunity to compete. The government will continue to monitor industry capabilities, engage with potential offerors as appropriate during acquisition planning, and consider any new responsible sources identified through market research or other outreach activities.

The acquisition planning process for the re-competition has already begun. This requirement was previously competed using full and open competitive procedures under FAR Part 15, and the re-compete will follow the same approach. As part of acquisition planning, the Contracting Officer (CO) and Contracting Officer's Representative (COR) will conduct market research to identify marketplace capabilities and determine additional ways to remove barriers to competition. This extension is intended solely to bridge the gap between expiration of the current ordering period and completion of a properly planned, full and open re-competition — not to circumvent competition on a long-term basis.

For the successor procurement, the government intends to use the procedures of RFO/FAR Part 15 to foster full and open competition. The program office and contracting office will undertake advance acquisition planning, conduct updated market research, review the requirement to eliminate unnecessarily restrictive provisions, and allow sufficient lead time to support a competitive follow-on procurement. This non-competitive action is not intended to circumvent competition, but rather to maintain essential services until the follow-on requirement can be solicited and awarded through a competitive process.

7. Market Research:

Market research supporting this extension is based on the government’s ongoing assessment of industry capability and availability throughout performance of the current contracts. The Contracting Officer’s Representative (COR) maintains ongoing awareness of industry capabilities through routine oversight of contractor performance and direct engagement with industry, as well as general market research, including online searches for changes in the marketplace. This continuous market surveillance has not identified any additional responsible sources capable of providing the full range of required services and infrastructure to meet the government’s immediate requirements.

NINDS also conducted market research using SAM.gov, online searches, reviews of publicly available contractor capability information, and video conference calls and emails with industry representatives to identify sources capable of meeting the PTTP requirements. This research

This determination will be made using the following: ☐ cost analysis ☒ price analysis ☐ cost realism ☒ market pricing ☒ historical pricing ☒ other:

No funds will be obligated, and no additional funds will be added to the IDIQ contracts as a result of this contract action. Funds will be obligated at the individual task-order level, subject to the availability of funds, when specific requirements are competed and awarded among the eligible PTTP IDIQ contractors.

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.

Certified cost or pricing data are not anticipated to be required when the task-order prices are based on adequate price competition. If adequate price competition is not obtained, the Contracting Officer will obtain and analyze the data necessary to determine that the proposed prices are fair and reasonable and will address certified cost or pricing data requirements, as applicable.

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

OALM/OD.

Title: Contracting Officer, OALM/NIH

Signature & Date:

ELEVATED REVIEWS & APPROVALS

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

Title: Associate Director, OALM/NIH Chief of the Contracting Office

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.]

Title: Director, OALM/NIH Head of the Contracting Activity

15. NIH Advocate for Competition (AfC) Review and Approval: I reviewed this justification and find that it adequately supports other than full and open competition.

Title: Director, Deputy Director, Office of Extramural Research, NIH