JA_SSS_HHSN273201600003I_PDF_Final 6.9.26.pdf

Justification for Other than Full and Open Competition "Source Selection Informatio see 2.101 and 3.104"

1. Identi cation of the agency and contracting activity.

a. Federal agency and contracting activity.

Department of Health and Human Services (HHS)/ National Institutes of Health (NIH)/ National Institute of Environmental Health Sciences (NIEHS)

b. Sponsoring organization.

NIEHS/ Division of Intramural Research

c. Project O icer information.

Project O icer: Gitanjali S. Taneja, Ph.D.

Mailing address: 111 T.W. Alexander Drive, Research Triangle Park, NC 27709 E-mail address: tanejagi@mail.nih.gov Telephone number: 984-439-4428

2. Nature and/or description of the action being approved.

c. Acquisition purpose and objectives.

The purpose of this Justification and Approval (J&A) is to obtain approval for the extension of the ordering period of the Support Services for Epidemiology Indefinite Delivery, Indefinite Quantity (IDIQ) Contract (HHSN73201600003I), as well as an increase to the contract maximum amount (ceiling). The contract is in its final period and is scheduled to expire on June 29, 2026. Without approval of this action, there is a risk of interruption to ongoing studies and disruption to mission-critical research activities supported under this contract.

Although planning for the recompete was underway in calendar year 2025, Executive Order 14158 of January 20, 2025 Establishing and Implementing the President’s “Department of Government Efficiency” caused unforeseen circumstances beyond the control of the acquisition office causing significant delays to the acquisition process. Between 2025 and 2026, several delays occurred due to staffing changes, organizational transition and other internal realignments. The ensuing changes to the contracting office impacted the ability to continue efforts to recompete and issue a new contract award by the time that the subject contract ends. Thus, an extension of the ordering period and an increase to the contract ceiling are being requested to maintain continuity of operations and avoid a lapse in services while also allowing the requisite amount of time to conduct the proper recompete of this requirement.

The existing IDIQ contract currently provides comprehensive epidemiology support services through task orders. The proposed modification does not alter the scope of work; rather, it extends the ordering period and increases the contract ceiling to allow for the continued issuance and performance of task orders under the same scope of services. The proposed contract modification will increase the current ceiling from $112,000,000 by $20,000,000 to $132,000,000 and extend the ordering period from June 29, 2026, through June 29, 2028.

The proposed increase of the ceiling is based on the current value of the task orders that are anticipated to be reissued with a 3% inflation escalation applied per year that total the anticipated cost of $16.8M. The additional $3.2M provides a ceiling capacity for several unanticipated follow-on studies and emerging research efforts. Historically, the estimated costs of these projects have ranged from $100,000 to $2,000,000.

Follow-on studies are essential in advancing the science and research findings of NIEHS. Oftentimes, follow-on studies are not established or known until other scientific discoveries or advancements are made. In addition, funding for emerging research efforts is critical to continue to expand the scope of work under NIEHS.

Unfortunately, all efforts made to recompete are out of date and need to be updated and resubmitted for reviews. The current recompetition has not yet begun and requires full two years to ensure proper attention is made to the process to satisfy acquisition rules, regulations and guidelines. The Acquisition document update is almost completed and the milestone plan to award will allow a competitive solicitation and award of a new contract to be completed 14 months from now so that an appropriate amount of transition time (estimated at 10 months) can be provided.

The approval of this J&A will ensure continuity of mission-critical support for ongoing epidemiological studies allowing the continued execution of task orders while the Government completes acquisition planning and prepares for a competitive follow-on procurement.

d. Project background.

Contract Number: HHSN273201600003I Incumbent Contractor: Social & Scientific System, Inc.

Contract Award Value: $112,000,000 ( Q Contract maximum amount) Period of Performance: 06/30/2016 - 06/29/2026 Competition: Full and Open Competition

3. Description of the supplies or services required to meet the agency's needs (including the estimated value). Provide the following information:

a. Project title.

Support Services for Epidemiology IDIQ Contract

b. Project description.

The National Institute of Environment Health Sciences (NIEHS), Division of Intramural Research (DIR), Epidemiology Branch Indefinite Delivery Indefinite Quantity (IDIQ) contract provides epidemiological, scientific, technical, data management, managerial, clerical, and statistical support to Principal Investigators within the Branch. Specifically, this contract provides comprehensive contractor support services to the NIEHS Epidemiology Branch to plan, coordinate, and execute epidemiological studies. Services include regulatory and Institutional Review Board (IRB) support, subject recruitment, enrollment, and follow-up; data collection, processing, and storage of biological, environmental, and clinical specimens; data management, security, and statistical analysis; laboratory and biorepository operations; quality assurance and scientific, technical, programmatic, administrative, technical, and logistical support across domestic and international study sites.

The Epidemiology Branch addresses the mission of NIEHS by carrying out research on the effects of the environment on human health. The research covers a wide range of conditions with potential links to environmental exposures. Studies address health across the lifespan from pregnancy and child development to chronic diseases of aging. The services provided under the Support Services for Epidemiology IDIQ contract are essential to ensure that studies are conducted efficiently, in compliance with applicable federal requirements, and with the scientific rigor necessary to generate reliable data and support dissemination of research findings that advance public health knowledge.

Provide the following information:

• Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify):

• Type of action.

New Requirement

Follow-on o Other (specify):

• Proposed contract/order type.

Firm-fixed-price Other xed-price (specify, e.g., xed-price award-fee, xed-price incentive-fee):

Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): _________ Time and materials

Inde nite delivery (specify whether inde nite quantity, de nite quantity, or requirements): IDIQ

Other Completion Form Term Form

• Acquisition identification number.

Contract Number: HHSN273201600003I

c. Total estimated dollar value and performance/delivery period.

Contract Award Value: $112,000,000 (IDIQ Contract maximum amount) This action estimated value $20,000,000

IDIQ Current Ordering Period: 06/30/2016 - 6/29/2026 This action ordering period: 06/30/2026 - 06/29/2028

The IDIQ ordering period will be extended by two years through 06/29/2028. The total IDIQ ceiling will increase from $112,000,000 by $20,000,000 to $132,000,000. The contract is structured such that task orders are initiated immediately following the end of the period of performance of the current task orders, preventing any lapse in coverage and ensuring continuity of operations.

4. Identi cation of the statutory authority permitting other than full and open competition. This acquisition is conducted under the authority of 41 U.S.C.

3304(a)(1)

RFO 6.103-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

RFO 6.103-2 Unusual and compelling urgency.

RFO 6.103-3 Industrial mobilization; engineering, developmental, or research capability; or expert services.

RFO 6.103-4 International agreement.

RFO 6.103-5 Authorized or required by statute.

RFO 6.103-6 National security.

RFO 6.103-7 Public interest

5. Demonstration that the proposed contractor(s) unique quali cations or the nature of the acquisition requires the use of the authority cited.

a. Name and address of the proposed contractor.

Social & Scientific Systems Inc.

875 Georgia Ave Silver Spring, MD 20910

b. Nature of the acquisition and proposed unique quali cations of the contractor(s).

This acquisition supports the continuation of critical non-severable epidemiological research studies and support services for the NIEHS requiring continuity and consistency of highly specialized mission-critical support involving longitudinal studies, complex data collection and analysis, and sustained participant engagement.

The Government would be harmed if this contract were allowed to expire on the current date of June 29, 2026 as non-severable studies are not yet complete. If these studies are interrupted or stopped before final results are delivered, many years of funded effort and data will be lost. Therefore, it is essential that the current contractor, SSS, continue the work while the acquisition is appropriately re-competed, as they provide specialized facilities, capabilities, and critical expertise necessary to meet programmatic, scientific, and public health needs.

The contractor's unique, experience-based understanding of cohort-specific procedures, informed consent frameworks, and data handling practices further distinguishes its ability to perform this work without disruption or increased risk to ongoing activities. SSS possesses unique qualifications, including institutional knowledge, and established infrastructure with operational systems, and experienced teams that are not reasonably available from any other source within the required timeframe.

Over more than three decades of performance supporting NIEHS, SSS has developed extensive familiarity with ongoing study protocols, data collection methodologies, regulatory requirements and operational processes associated with the Government's epidemiological programs. In addition, SSS has established relationships with study participants, community partners, clinical sites, and stakeholders. These relationships are critical to successful participant recruitment, engagement, and retention, particularly for longitudinal studies involving diverse and hard-to-reach populations. The contractor's unique, experience-based understanding of cohort-specific procedures, informed consent frameworks, and data handling practices further distinguishes its ability to perform this work without disruption or increased risk to ongoing activities.

Consequently, transitioning these services to a new contractor at this stage would require significant time and resources to replicate the level of operational readiness, technical understanding, and stakeholder trust. It is NIEHS’ estimation that the time involved to train and transition to another contractor is months. The costs associated with transition are estimated at approximately $9 Million. Moreover, a transition would introduce substantial risks to ongoing studies, including potential loss of participants, disruption to data collection, and impacts to the continuity and integrity of longitudinal datasets. An extension of the current IDIQ ordering period for an additional 24 months, along with an increase to the contract ceiling by $20M, is necessary to ensure continuity of mission-critical epidemiological studies and to support and accommodate any emerging and evolving epidemiological research activities while the Government conducts a full and open competition and completes an orderly transition in the event an entity other than the incumbent receives the award. The scope and complexity of the work necessitate an extension period of this duration; a shorter period would create an unacceptable risk of disruption to active longitudinal studies, data collection efforts, and time-sensitive research milestones.

The anticipated two-year period of performance for the contract is necessary to ensure continuity of mission-critical activities and to allow sufficient time for full execution of ongoing and planned efforts. A transition period of no more than 10 months is considered in the event the incumbent is not awarded the new contract to ensure continuity of operations and an orderly transfer of responsibilities. Potential transition costs will be covered by Task Order funds and the transition tasks will take place during the final 10 months of the active Task Order. Rates for services will remain the same as the active Task Order. This transition timeframe provides sufficient overlap to support the acquisition planning and development of the acquisition strategy for this complex R&D requirement, as well as the full acquisition lifecycle, including solicitation development, proposal preparation, a technical evaluation process consistent with NIH peer review requirements, source selection, and award of the follow-on contract. This approach ensures sufficient time for thorough review of proposals commensurate with the complexity of the requirement, while allowing the new contractor to be fully in place without interruption to operations.

6. A description of e orts made to ensure that o ers are solicited from as many potential sources as possible, including whether a notice was or will be publicized as required by RFO part 5 and, if not, which exception under part 5 applies.

On February 17, 2026, a Presolicitation Notice was posted to SAM.gov for 15 days under Contract Opportunity Number HHSN2732016000031. The notice informed industry of the Government's intent to extend the ordering period and increase the contract ceiling of the existing IDIQ contract on a sole source basis under the authority of 41 U.S.C. § 3304(a)(1 ), as implemented by RFO 6.103-1, and the notice invited responsible sources to submit capability statements demonstrating their ability to meet the Government's requirement.

While the Government issued public notice to maximize industry awareness, the ability to expand competition is constrained by the requirement for uninterrupted execution of ongoing clinical research studies and interventional trials, which depend on established operational infrastructure and continuity of performance.

The presolicitation required that any responses or inquiries must demonstrate clear and convincing evidence that competition would be advantageous to the Government. No capability statements were received by the deadline of March 4, 2026, 4:00 pm. As a result, it is in the Government's best interest to proceed with a sole source modification to SSS.

For the re-compete requirement, a full and open competition is planned, and efforts for the acquisition of Support Services for Epidemiology are underway. The current contract extension is intended to ensure continuity of services during and after the re-competition. The IDIQ contract extension and ceiling increase will provide for adequate time to publicize the Support Services for Epidemiology requirement and subsequently increase competition. To remove the barriers that led to the use of other than full and open competition, further market research will be conducted by the Contracting Officer Representative in collaboration with the Contracting Officer to determine qualified vendors to meet the requirements of the Statement of Work for this initiative and to promote full and open competition to the maximum extent practicable. This extension and increase in ceiling is a one-time action, interim solution to prevent a lapse in critical services while the agency completes the competitive acquisition process.

Determination by the Contracting O icer that the anticipated cost/price to the Government will be fair and reasonable.

The Contracting Officer will ensure that the cost/price of each task order issued under the IDIQ contract is fair and reasonable in accordance with RFO Part 15 prior to award. The increase to the IDIQ ceiling does not itself establish pricing; rather, it enables continued issuance of task orders, each of which will be evaluated individually for price reasonableness.

Cost or pricing information: At the task order level, the Contracting Officer will request cost or pricing information appropriate to the circumstances in accordance with RFO 15.403. Obtaining cost or pricing data. This may include historical pricing data, labor rates, indirect rates, and other supporting cost information. Certified cost or pricing data will be required when applicable in accordance with RFO 15.403-3 Certified cost or pricing data and RFO 15.406 Data to support proposal analysis, unless an exception applies under RFO15.403-2 (e.g., adequate price competition, commercial item acquisition, or other exceptions). The determination of whether certified cost or pricing data is required will be made at the time of each task order award based on the value of the order and applicable RFO criteria.

o

Description of the market research conducted (see Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted to determine whether other qualified sources could meet the Government's requirement without interrupting ongoing studies and causing lapse in mission critical services. NIH contract databases were queried, inquiries from industry were researched, and the current contractor's performance was assessed. It was determined that no other contractor has the capacity nor capability to stand up the services, studies, and facilities in the necessary time frame before June 29th, 2026.

On February 17, 2026, a Presolicitation was posted to SAM.gov under Contract Opportunity Number HHSN2732016000031. The notice informed industry of the Government's intent to extend the ordering period and increase the contract ceiling of the existing IDIQ contract on a sole source basis under the authority of 41 U.S.C. § 3304(a)(1), as implemented by RFO 6.103(a) and invited responsible sources to submit capability statements demonstrating their ability to meet the Government's requirement for a transition of the research services.

The Presolicitation notice required that any responses or inquiries must have demonstrated clear and convincing evidence that competition would be advantageous to the Government.

No capability statements were received by the deadline of March 4, 2026, 4:00 pm. As a result, it is in the Government's best interest to proceed with a sole source modification to

SSS.

Any other facts supporting the use of other than full and open competition.

The two-year extension is essential to ensure su icient time is allocated for the recompetition of this complex acquisition. A summary of the milestones is below.

1. Requirements Development and Market Research (approximately 3 months)

2. Acquisition Plan and Strategy Review and Approval (approximately 3 months)

3. Solicitation Development and Internal Review (approximately 1 months)

4. Solicitation Release and Receipt of Proposals (approximately 2 months)

5. Evaluation, Discussions, and Negotiations (approximately 5 months)

6. Award and Transition Planning (approximately 10 months)

Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest in writing in the proposed acquisition.

Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The recompete acquisition will be solicited under full and open conditions on a competitive basis. To promote future competition, the Epidemiology Branch, in coordination with the NIH Office of Acquisitions, will use the extended ordering period to complete acquisition planning activities for the Support Services for Epidemiology recompete. These activities will include updated requirements development, market research, acquisition strategy refinement consistent with any revised NIH procurement guidance, and solicitation preparation. The extended ordering period is intended to provide adequate time to conduct a full and open competition on the subsequent acquisition prior to the conclusion of the extended ordering period set to expire June 29, 2028. Public postings, including a Sources Sought Notice, Presolicitation Notice and Solicitation, etc., will not be posted during the holidays to ensure all qualified vendors are aware of the requirement and that it is competed to the maximum extent possible.

Program office certification.

This is to certify that the portions of this justi cation that have been developed by the undersigned program o ice personnel, including supporting information and/or data verifying the Government's minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

FOR

TIFFANY D.

CHADWICK -S

Digitally signed by

TIFFANY D. CHADWICK

-S Date: 2026.06.05 11:35:39 -04'00'

FOR

KATHRYN M.

PARTIN -S

Digitally signed by

KATHRYN M. PARTIN -S

Date: 2026.06.09 15:32:42 -04'00'