Omnibus IV Presolicitation Notice Amendment 01.docx

Pre-solicitation Notice: On-Ramp for the Department of Defense OMNIBUS IV Multiple-Award Contract Notice ID: HT942626R0002

Amendment 01: The first amendment to this pre-solicitation notice is to extend the anticipated posting of the solicitation. Guidance pertaining to the Revolutionary FAR Overhaul was recently issued for the Department of Defense (DoD) to be adopted starting 01 February 2026. Additional time is needed to ensure the solicitation remains in compliance with the FAR Overhaul guidance.

This is a pre-solicitation notice to synopsize the intention of the Defense Health Agency Contracting Activity (DHACA) to issue a Request for Proposal (RFP) for an on-ramp to the OMNIBUS IV Multiple Award, Indefinite Delivery, Indefinite Quantity (IDIQ) contract vehicle covering military medical research and development services. This notice is not a request for proposals and does not commit the Government to any contractual agreement.

The OMNIBUS IV contract vehicle was awarded under full and open competition in June 2022 with a base ordering period of 20 June 2022 through 19 June 2027 and an Option Ordering Period of 20 June 2027 – 19 June 2032.

The cumulative ceiling of this existing IDIQ contract vehicle is $10 billion. To date, the accumulated awarded task order value is over $600 million across 51 task orders (including future unexercised option periods). Task Orders have been issued by a growing number of end users including DHACA, the U.S. Army Medical Research Acquisition Activity (now integrated into DHACA), the Naval Supply Systems Command, and the Uniformed Services University of the Health Sciences. When excluding the task orders simply providing a minimum guarantee to the existing Contract Holders, 51 task orders have been issued off this contract vehicle with 8 task orders being set aside for the 8(a) Program and 9 task orders being awarded to an 8(a) Participant. 33 task orders have been awarded so far to small businesses under this contract vehicle. Of the 51 task orders, 94% were awarded during the Government's Fiscal Years 2024 - 2026, and the amount of competitive task orders has grown each fiscal year.

This on-ramp is intended to expand the pool of eligible contractors to support the ongoing and future needs of the Department of Defense’s (DoD) medical research and development programs. Task orders set aside for the 8(a) Program under this contract vehicle are required to be competitive. The FAR Overhaul removes the requirement for Contract Holders under an unrestricted contract vehicle to recertify their size and status for task order requirements set aside for small businesses. As a result, Contract Holders can rely on their size/status representation at the IDIQ level when proposing for task order requirements set aside for small business concerns even if they have graduated out of the 8(a) Program or have grown out of being a small business since their most recent size/status representation at the IDIQ level. Contract Holders will still be held to the requirement to recertify their size/status at the IDIQ level within 60 – 120 days prior to the end of the fifth year in accordance with FAR 19.301-2(b)(1)(iii)(A). Starting in August 2026Between 19 February 2027 and 20 April 2027 (60 – 120 days prior to the end of the fifth year), only one existing Contract Holder is anticipated to still have representation of the 8(a) Program. be registered within the 8(a) Program. In accordance with FAR 19.301-2(b)(2)(i), Contractors who represented its status as any of the small business concerns before award of an unrestricted multiple-award contract are required to re-represent their size and status for orders set aside exclusively for a small business concern.

The scope of the OMNIBUS IV contract vehicle is broad and covers a wide range of health-related research and development and support services. These services are divided into four market segments:

· Market Segment 1: Research and Development- Research aligning to prioritized requirements and capability gaps to ensure successful research efforts transition into medical materiel products or into clinical practice as knowledge products. Proficiency Areas include, but are not limited to -

· Collaborations in DoD Medical Research

· Transitioning of Programs through Funding Continuum

· Maintenance of Quality, Safety, Security, and Surety Standards

· Success in Research Deliverables and Outcomes applying all federal (e.g. Department of Health and Human Services and Food and Drug Administration (FDA)) and DoD Rules and Regulations

· Market Segment 2: Research and Development Support Services- Support for research activities, including laboratory and technical support. Proficiency Areas include, but are not limited to –

· Administrative Support Services

· Information Technology Support Services

· Scientific and Technical Support Services

· Facilities Support Services

· Medical Non-Personal Services Support for Clinical and Research Protocols

· Supplies and Equipment

· Logistical Support Services

· Task Order Administrative, Technical, and Other Support

· Market Segment 3: Regulatory Processes- Support and expertise in comprehensive regulations protecting the welfare and rights of humans and animals in medical research. Proficiency Areas include, but are not limited to –

· Animal Use Programs and Vivaria

· Research Involving Human Subjects

· DoD Use of Investigational Products

· Code of Federal Regulations Title 21 (FDA), Investigational New Drug Application

· Federal and DoD Privacy

· Technology Transfer

· Market Segment 4- Translational Science Support and Services: Support for the transition of new technologies from the laboratory to clinical practice. Proficiency Areas include, but are not limited to –

· Pre-Transition Support

· Transition Support

· Evidence-based Solution Development

· Dissemination Strategies, Processes, and Evidence-based Practices

· Implementation Strategies, Processes, and Evidence-based Practices

· Evaluation Strategies, Plans, and Execution Task Order requirements are solicited among the Market Segment(s) applicable to the required services. There may be overlap between Market Segments allowing task orders to be solicited between more than one Market Segment.

Program Areas broadly define health-related research and development activities and do not align precisely with individual Market Segments and their Proficiency Areas. Services under the Market Segments may apply to, but are not limited to, the following Program Areas:

· Medical Simulation Technologies

· Infectious Diseases

· Military Health, Performance and Recovery

· Joint Battlefield Healthcare

· Radiation Health Effects

· Clinical and Rehabilitative Medicine

· Chemical and Biological Readiness

· Clinical Investigations, Graduate Health Science Education, and Military Health System Research

· Genomics and Omics-Based

· Emerging Science and Technology

2. Anticipated Solicitation The Government anticipates releasing the formal RFP for the OMNIBUS IV on-ramp on SAM.gov around late January February 2026 (at least 15 calendar days from the posting of this notice. The due date for proposals will be specified in the RFP. The RFP and its amendments will be posted to the Solicitation module in the Procurement Integrated Enterprise Environment (PIEE, https://cac.piee.eb.mil/). This module automatically posts a notice to SAM.gov whenever the solicitation and its amendments are issued. All interested parties are responsible for monitoring SAM.gov and/or the Solicitation module for the release of the solicitation and any amendments. Any proposals in response to the RFP are to be submitted through the Solicitation module. The posting in the Solicitation module will be viewable to the public; however, proposals can only be submitted through an individual’s account that has been granted the appropriate roles to submit a proposal on behalf of a Contractor registered in SAM.gov. Instructions to register for roles in PIEE are attached to this notice and will be attached to the solicitation.

3. Eligibility This solicitation will be set-aside for small businesses certified under the Small Business Administration’s 8(a) Program. The Government anticipates making multiple new awards under this on-ramp, and all new awards will align with the existing unrestricted contract vehicle. New awardees will be eligible to propose on task orders solicited under fair opportunity or an exception to fair opportunity (such as set-asides for small businesses or applicable small business socioeconomic categories). No solicitations will be mailed. All proposals shall be submitted in accordance with the instructions set forth in the solicitation. Instructions for questions regarding this requirement will be outlined in the solicitation. No phone calls or faxes will be accepted. The Government reserves the right to change information included in this notice.

4. Point of Contact All inquiries regarding this pre-solicitation notice should be directed to the Contracting Officer at the email address to be provided in the forthcoming solicitation.

5. Disclaimer This notice is for informational purposes only and is not a request for proposals. The Government is not obligated to issue a solicitation as a result of this notice. No reimbursement will be made for any costs associated with providing information in response to this notice or for any follow-up information requests.