SAM Op Mgt and IT Support of ClinicalTrials.gov-SSJ.pdf

Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES National Institutes of Health

Specialized Scientific Information Technology Division (SSIT) Office of Logistics and Acquisition Operations (OLAO) Office of Acquisitions & Logistics Management (OALM)

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY.

a. Federal agency and contracting activity.

Department of Health and Human Services (HHS) | National Institutes of Health (NIH) | Office of Acquisition and Logistics Management (OALM) | Office of Logistics and Acquisition Operations (OLAO) | Specialized & Scientific Information Technology Division (SIT)

b. Sponsoring Organization.

The National Library of Medicine (NLM) | National Center for Biotechnology Information (NCBI)

c. Project Officer Information

Project Officer Name: Anna Fine Mailing Address: 8600 Rockville Pike, Bldg. 38A, Bethesda, MD 20894 Email Address: anna.fine@nih.gov Telephone Number: (301) 443-5063

2. NATURE AND/OR DESCRIPTION OF THE ACTION BEING APPROVED.

The NCBI program requests a task order (bridge) for ClinicalTrials.gov, to prevent a lapse in service, once task order 75N98022D00019/75N98025F00008 expires on August 26, 2026. This acquisition will be conducted under FAR Part 8 via the Federal Supply Schedule (FSS) program, using the ordering procedures established by the General Services Administration found in the General Services Acquisition Manual/Regulation (GSAM/R) at subpart 538.71.

The Government projects award for the Base Period in August 2026 using fiscal year 2026 Appropriated funds.

Contractor: Black Canyon Consulting, LLC, 4490 Market Commons Dr, Unit 307 Fairfax, VA 22033 GSA MAS Contract Number: 47QTCA18D00JA PoP Dates/Duration Unit Price/CLIN Total Base Period 12 months

(August 27, 2026 – August 26, 2027) $15,017,534.00 $15,017,534.00

Estimated Total Dollar Value: $15,017,534.00

Sole Source Justification (SSJ) FAR 8.401 & GSAM/R 538.7104-3(b)(1)(i)

National Library of Medicine (NLM) | National Center for Biotechnology Information (NCBI)

Operations, Maintenance, and IT Support for ClinicalTrials.gov Program Management Support

3. DESCRIPTION OF SUPPLIES AND/OR SERVICES.

The scope of this requirement is to continue the acquisition of complex scientific professional specialized expertise to support the regulatory requirements, operations, and maintenance of ClinicalTrials.gov. Additionally, the Task Order supports expert curation of data quality control and related processes to ensure that submitted data meet quality standards for posting on ClinicalTrials.gov. It is essential to NLM that all of these activities be performed with a high degree of scientific accuracy.

NIH created and maintains ClinicalTrials.gov and provides patients, family members, health care professionals, researchers, and other members of the public with convenient access to information on clinical studies for a wide range of diseases and conditions. The Food and Drug Administration Modernization Act of 1997 (FDAMA) requires trial registration on ClinicalTrials.gov while Section 113 of FDAMA (FDAMA 113) required the National Institutes of Health (NIH) to create a public information resource on certain clinical trials regulated by the FDA. Specifically, FDAMA 113 required that the registry include information about federally or privately funded clinical trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for patients with serious or life-threatening diseases or conditions. Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) expanded the statutory requirements to more trials and results reporting for the aforementioned trials. Additionally, ClinicalTrials.gov advances the transparency goals of Executive Order 14303, Restoring Gold Standard Science by requiring prospective trial registration and structured, standardized reporting of results. For trials that are federally funded or regulated under FDAAA 801, this includes negative and null findings alongside positive ones—ensuring the scientific record reflects what was actually found, not just what proved publishable elsewhere.

A lapse of any one service in the ClinicalTrials.gov requirement would create serious consequences for the Food and Drug Administration (FDA) and NIH as outlined below. Approving this Sole Source Justification for a 12-month period will not only help NLM achieve its mission to provide information about new, ongoing, and completed research protocols, but also will help the NIH fulfil its Congressional mandate.

4. AUTHORITY CITED AND RATIONALE:

Under the Authority at GSAM/R 538.7104-3(b)(1)(iii), the order should be issued on a sole source basis in the interest of economy and efficiency because it is a logical follow-on to an FSS order already issued on a competitive basis. This acquisition is conducted under the authority of the Multiple Award Schedule Program.

Consideration of schedule contractors will be restricted to fewer than the number required by Federal Acquisition Regulation.

Continuing this acquisition in the interest of efficiency and economy will ensure continuation of program objectives without delays; specifically, publications of clinical trial results and information technology (IT) support for the modernized systems used to register and publish them. Task Order services include procuring highly specialized staff who possess the appropriate scientific, medical, and clinical trials knowledge as well as expertise in data abstraction, data entry, data validation, needed to review and publish clinical trials. Deliverables include publications of clinical trial results and support for the modernized systems used to register and publish them. As of July 2026, ClinicalTrials.gov has over 595,000 registered clinical studies sponsored by the NIH, other federal agencies, non-profit organizations and private industry and is responsible for the registration, review, and publishing of 850-1200 clinical studies per week. The current results team receives over 650 submissions per week, which require highly skilled scientific reviewers, who review, on average, 455 new records per week, and 155 modified records per week. Protocol record reviews are conducted within 2 to 5 business days of submission, per CTG operational practices. Results record reviews are conducted within 30 calendar days of submission, as required by federal regulation. If this contract were to transition to a new vendor without adequate transition time, the timely publication of clinical trials would be impacted which represents an unmitigated risk to program operations. NLM cannot risk interruption of clinical trial registration and results reporting as mandated by Congress.

Continuing this acquisition in the interest of efficiency and economy will also continue uninterrupted specialized IT support for the newly modernized systems used to register and publish clinical trials. Through a five-year effort, NIH has made major investment in the ClinicalTrials.gov modernization effort enhancing the system’s information infrastructure. Continuation of this Task Order will enable the support needed to maintain recently modernized systems funded at the NIH level. A lapse in contract services will represent a loss of considerable investment in infrastructure if the modernized systems are not maintained. And through our modernized Application Programming Interface (API), ClinicalTrials.gov received over 202 million calls on our data from Artificial Intelligence (AI) services who rely on this data. Any interruption in service, delays, or unnecessary cost would put NIH at risk of not meeting these expectations to support a variety of users. Awarding to a new vendor without adequate transition time would duplicate costs and cause delays in service as staff is transitioned.

Additionally, current contract staff are responsible for ensuring a smooth user transition to the updated platform in accordance with all regulations and requirements and for maintaining the modern system operational. Without adequate transition time, ClinicalTrials.gov risks losing competent staff not only in the areas of IT support/security, but also stakeholder engagement and user support. A bridge contract remains the best option to control costs and maintain efficient stakeholder support until a follow-on is awarded.

5. MARKET RESEARCH.

Market research for this vehicle was conducted in accordance with Federal Acquisition Regulation (FAR) Part 10, including industry outreach, review of public sources, Acquisition Gateway, GSA e-Library, and publication on SAM.gov.

The market research efforts used by the NIH included (1) reviewing industry partner capability statements to identify existing companies that could demonstrate the ability to successfully deliver the complex specialized services described above; (2) reviewing generally available information on the Internet; (3) reviewing source lists to determine what commercial sources are available in the open market and/or strategic sourcing vehicles (e.g., GSA MAS); and (4) consulting Subject Matter Experts (SME)s to leverage comprehensive understanding of the ClinicalTrials.gov technical and operational requirements, enabling identification of vendors demonstrably capable of successfully performing all tasks outlined in the Statement of Work (SOW).

Market research regarding the Subject Matter Expert (SME) support for non-IT based ClinicalTrials.gov requirements is highly focused on determining vendor capability in the area of clinical trials and the federally mandated registration and results review process, both of which are critical non-IT aspects of the Task Order.

Very few vendors have worked in areas with ever-changing government regulations which guide decision-making on operational requirements, particularly in the clinical trials space. NLM determined four (4) vendors to be capable in supporting this work due to direct experience in the areas of scientific, medical, and clinical trials knowledge. These four vendors are also capable of meeting IT requirements. Transition time is optimal, hence the need to issue a bridge order until a follow-on award is in place. Issuing a logical follow-on on a sole source basis in the interest of economy and efficiency would enable the NLM to engage these vendors and others in an acquisition plan of fuller scope. For example, the acquisition of SMEs to support the clinical trial review and/or results process has been well documented to involve up to 6 months of training.

Adequate transition time is needed to reduce duplicative cost by ensuring experienced contract staff are given the opportunity to remain and/or participate in knowledge transfer to a new vendor.

Vendor capability in the area of science-based IT support is interrelated with services for other NLM products given the Institute/Center’s (IC’s) focus on stability, security, and interoperability of NLM products. This complex interrelated work, much of which is scientific information or science-based IT work, on NLM portfolio products necessitates a larger acquisition strategy which will serve the Institute/Center (IC) at large and deliver best value. As described in greater detail below, under Section 7. Actions to Foster Competition for Future, Similar Requirements, the NLM intends to procure its own BPA for acquiring non-Research and Development (non-R&D) specialized portfolio management and strategic support services.

6. PROCUREMENT HISTORY.

Operations, Maintenance, and IT Support for ClinicalTrials.gov Program Management Support was procured through specialized project, program, and portfolio (P3) management support services for the NIH Intramural Research Program (IRP), a Blanket Purchase Agreement (BPA) through the NIH Office of Intramural Research (OIR), Office of the Director (OD), NIH. This award was made for a 12 month period of performance.

a. Incumbent Contractor: Black Canyon Consulting, LLC

Contract or Order Number: 75N98022D00019_75N98025F00008 Award Date and Period of Performance: 08/27/2025-08/26/2026 Value (including all options): $14,992,074.81 Competitive Status: Awarded under competitive procedures.

Authority formerly relied upon if Not Competed: N/A

7. ACTIONS TO FOSTER COMPETITION FOR FUTURE, SIMILAR REQUIREMENTS:

The NLM intends on procuring a multi-award Blanket Purchase Agreement (BPA) for acquiring non- Research and Development (non-R&D) specialized portfolio management and strategic support services which will assist the National Library of Medicine (NLM) in executing and overseeing complex, evolving mission priorities and initiatives. This approach will foster competition for future, similar requirements and will enable vendors to provide capability statements and/or provide proposals on a multi-vendor award. With full backing from NLM leadership, the initiative will feature a Sources Sought notice and other market research efforts to connect with vendors. The BPA will be a strategic sourcing vehicle for highly specialized NLM portfolio products, including ClinicalTrials.gov, Division of Intramural Research (DIR) portfolio products, and more. A Statement of Work has been drafted, and NIH intends on posting a Sources Sought Notice on December 04, 2026 after engaging with NLM stakeholders and conducting preliminary market research. An Acquisition Plan (AP) will be finalized by March 01, 2027, with the Request for Proposals (RFP) posted by March 08, 2027. Our intent is to award this vehicle by May 25, 2027.

Due to unforeseen delays, NLM has been unable to engage industry and intends on doing so during the contemplated Sole Source task order to ensure the Government is taking advantage of the best possible options and is procuring the talent it needs for complex, interrelated portfolio services. Delays in market research include the following factors: (1) The National Library of Medicine (NLM) experienced workforce reorganizations through workforce optimization, voluntary departures, and retirements, impacting the staff’s ability to prioritize this urgent contract action. A lapse of appropriations from October 2025 – November 2025 for 43 days further impacted staff ability to prioritize market research and refine the acquisition strategy. This lapse in appropriations also impacted ClinicialTrials.Gov program staff and operations by redirecting program resources. (3) EO 14275 — Restoring Common Sense to Federal Procurement (April 15, 2025) and the "Revolutionary FAR Overhaul" (RFO) involved the need to reassess contracts in progress, and confirm alignment with the newest guidance, which involved the redirection of a follow-on contract action in the service of pursuing a BPA for this task order and others within the NLM portfolio. (4) Funded contract priorities were re-evaluated and re-aligned by the NLM in consideration of EO 14303 “Restoring Gold Standard Science” which commits to ensuring federally funded research is transparent, rigorous, and impactful, and that federal decisions are informed by the most credible, reliable, and impartial scientific evidence available. EO 14303 sets reproducibility and transparency requirements that agencies with major biomedical and bibliographic infrastructure are implementing in ways that touch their databases and platforms, since poorly-documented, or siloed systems make it hard to prove work is reproducible and traceable. (5) Reassessing funding proprieties to ensure alignment with other Executive Orders (EO 14212 – “Establishing the President’s Make America Healthy Again Commission”) required the redirection to pursuing a Blanket Purchase Agreement (BPA) in support of ClinicalTrails.gov and other work within the broader NLM portfolio which implement EO 14212.

NLM will reach out to vendors interested in this BPA at the earliest possible time and pending all NIH/HHS approvals needed to start the BPA.

This BPA has received considerable market interest, receives the full support of IC leadership, and will include the operations and maintenance of ClinicalTrials.gov in addition to including other products within the NLM portfolio. Formal, informal, and ongoing market research further suggests deep interest in a BPA for NLM product portfolio services, including interest in both this requirement (ClinicialTrails.gov) and other services on a wide range of NLM biomedical and bibliographic projects.

8. ADDITIONAL INFORMATION OR OTHER FACTS:

None.

Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES National Institutes of Health

Specialized Scientific Information Technology Division (SSIT) Office of Logistics and Acquisition Operations (OLAO)

Office of Acquisitions & Logistics Management (OALM)

9. 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.

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Viatcheslav Gorelenkov Technical Program Manager, ClinicalTrials.gov Signing on behalf of

Anna M. Fine, PharmD, MS Director, ClinicalTrials.gov Signature

& Date:

10. Best Value Determination: As the contracting officer, I hereby determine that the anticipated price to the Government for this contract action represents the best value for the Government.

Consistent with GSA ordering procedures in GSAR subpart 538.71, the ordering activity Contracting Officer has determined that this order represents the best value to the Government. This determination is based on a balanced consideration of price and discriminating non-price factors relevant to NIH's immediate requirement for uninterrupted operations support, including continuity of operations, transition risk, administrative burden, and the contractor's ability to continue performance without disruption during the bridge period. Because the Federal Supply Schedule program is a pre-competed vehicle under which basic price reasonableness has already been established, the Government's analysis focused on the comparative benefits of available approaches and the rationale for selecting the solution that provides the greatest overall benefit to the Government. In this case, continued performance by the incumbent through the Schedule contract vehicle avoids duplication of transition, onboarding, security processing, access provisioning, and related operational turnover costs that would otherwise be incurred if performance were shifted to another contractor at this time.

11. Contracting Officer (CO) Certification and Approval: I hereby certify that this justification is accurate and complete to the best of my knowledge.

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Courtney Warren Contracting Officer Signature &

Date:

12. NIH OALM Specialized Scientific Information Technology (SSIT) Division Director: I reviewed this justification and find that it adequately supports a sole source acquisition.

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Jeremy White Director, SSIT Division Signature &

Date:

ELEVATED REVIEWS & APPROVALS

13. NIH Advocate for Competition Review and Approval: I reviewed this justification and find that it adequately supports a sole source acquisition.

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Dr. Kathryn Partin Director of Research Integrity, NIH Signature &

Date:

FINAL APPROVAL

14. NIH Head of the Contracting Activity (HCA) Review and Approval: I reviewed this justification and find that it adequately supports a sole source acquisition.

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For Olga M. Acosta Head of the Contracting Activity Signature &

Date: