Approved LSJ-NLM Operations Maintenance and Modernization Support for ClinicalTrials.gov.pdf

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“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS.

Department of Health and Human Services (HHS) National Institutes of Health (NIH)

b. Sponsoring organization.

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

c. Project Officer information.

• Project Officer name: Anna M. Fine, PharmD, MS Acting Program Head, ClinicalTrials.gov

• Mailing address:

National Center for Biotechnology Information National Library of Medicine 8600 Rockville Pike, Bldg., 38A, B1 Rm. B1N30F Bethesda, MD 20894

• E-mail address: anna.fine@nih.gov

• Telephone number: 301-443-5063

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

a. Acquisition purpose and objectives.

The purpose of this requirement is for the acquisition of operations, maintenance, and modernization of ClinicalTrials.gov. Services include complex professional specialized expertise, some of which is Information Technology (IT) services. NLM is responsible for the legislatively mandated ClinicalTrials.gov information resource which, in part, is supported by this effort.

The objective of this effort is to establish a new task order to ensure continuity of mission critical services and support diverse tasks aligned with new and expanding Congressional mandates, changing policies and information technologies, expanding NIH research programs, and NLM's role in the NIH community until the modernization of the ClinicalTrials.gov is complete.

b. Project background As the world’s largest biomedical library, the NLM maintains and makes available a vast print collection and produces electronic information resources on a wide range of medical and biological research topics that are searched billions of times each year by millions of people around the globe. It also supports and conducts research, development, and training in biomedical informatics, computational biology, and health information technology. The NLM's goal is to educate the current and next generation of innovators in biomedical informatics and data science, and, in addition to creating and disseminating databases covering a wide range of

Limited Source Justification mailto:anna.fine@nih.gov

pg. 2 the biomedical bibliographic and genomic sequence space, its researchers develop gene analysis techniques, devise creative ways to search and analyze medical images, and apply advanced analytics to decode clinical narratives. In essence, the NLM looks to apply advanced analytics to addressing public health and basic genomic research needs.

ClinicalTrials.gov was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). It was created to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications. The law also requires the submission of results for certain trials. This led to the development of the ClinicalTrials.gov results database which is administered by NCBI.

ClinicalTrials.gov is an important NIH enterprise system, maintained by the NCBI, that serves a critical role in providing the NIH, researchers, the public, and others with up-to- date clinical research information. Such information has been reinforced during the COVID-19 pandemic.

Congress mandated in 1997 that NIH create and maintain ClinicalTrials.gov. It reemphasized the importance of the system in 2007 by expanding NIH’s mandate to accept information from a broader set of clinical trials and include summary trial results information, and by empowering the Food and Drug Administration (FDA) to enforce compliance with data submission requirements. Public expectations and support related to clinical trial transparency have led to passage of other laws, regulations, and policies requiring registration and results reporting in ClinicalTrials.gov. These include regulatory requirements issued in 2016 and an NIH policy issued in the same year that establishes an expectation that all NIH-funded clinical trials be registered and have results reported to ClinicalTrials.gov. This NIH policy is one component of NIH’s broader efforts to enhance stewardship of NIH-funded clinical trials and to improve both accountability and transparency.

ClinicalTrials.gov 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. As of December 2022, ClinicalTrials.gov has over 430,000 registered clinical studies sponsored by the NIH, other Federal agencies, non-profit organizations and private industry. More studies are added daily and an average of 850-1,200 studies are added per week. Studies listed in the database are conducted in all 50 states and in over 220 countries. ClinicalTrials.gov also includes a results database with results information for completed studies. The web site lists over 56,000 studies with results and 350 – 400 new results submissions are added per week. ClinicalTrials.gov receives over 160 million-page views per month and hosts approximately 200,000 visitors daily.

The requirement for the operations, maintenance, and modernization of ClinicalTrials.gov is commercially available. The proposed Task Order is a combination of Firm-Fixed-Price (FFP) and Time-and-Materials (T&M) structured as the following:

• Task 1 – Task Order Management (Non-IT Services) (FFP)

• Task 2 – Support, Operations and Maintenance (Non-IT Services) (T&M)

• Task 3 – Ongoing Technical Support (IT Services) (T&M)

• Task 4 – Modernization Support (IT Services) (T&M)

• Task 5 – Subject Matter Expert and Research Support (IT Services) (T&M)

• Task 6 – Transition Plan (Non-IT Services) (T&M)

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title: Operations, Maintenance, and Modernization Support for ClinicalTrials.gov

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b. Project description: The scope of this requirement is to acquire complex professional specialized expertise to support the operations, maintenance, and modernization of ClinicalTrials.gov. Statement of Work is attached.

• Requirement type.

Support services (non-research & development)

❑ Supplies/equipment

Information technology (IT)

❑ Other (specify):

• Type of action.

❑ New requirement

Follow-on

Other (specify):

• Proposed contract/order type.

❑ Firm-fixed-price ❑ Time and materials ❑ Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements):

Other (specify): Combination of FFP & T&M

• Acquisition identification number.

N/A

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

The anticipated period of performance consists of a 12-month Base Period with one six- month option period for a total not-to-exceed of 18 months. The total estimated dollar value for this requirement is $26,691,861.00, inclusive of the option period.

• Base Period: September 27, 2023 through September 26, 2024

• Option Period One: September 27, 2024 through March 26, 2025

4. Identification of the justification rationale [see 8.405-6(a) and (b)] and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition authority.

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 (FAR) 8.405-6(a)(1)(i)(B), “Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

❑ This acquisition is conducted under the authority of the Multiple Award Schedule Program.

Consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer as provided in FAR 8.405-6(a)(2).

b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

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• Name and address of the proposed contractor(s).

ICF Incorporated 9300 Lee Highway, Room 876 Fairfax, VA 22031

• Nature of the acquisition and proposed contractor(s) unique qualifications. Current Task Order 75N97020A00019/75N97020F00002, awarded to ICF Incorporated, was procured using competitive procedures under GSA FSS for a period of performance of 09- 29-20 through 09-28-2023. ICF Incorporated began supporting Operations & Maintenance and Modernization in 2020 and is currently working on upgrading user-focused designs and deploying a modularized submission system with optimized workflow management.

Ongoing pilots and usability testing performed by the contractor still need to be implemented.

Given the importance of ClinicalTrials.gov, NLM will have to maintain and sustain the existing ClinicalTrials.gov while modernization is finalized. ICF Incorporated currently perform both Operations & Maintenance (non-IT) and Modernization (IT). Although significant progress has been made over the period of performance, it is estimated the completion of the modernization portion will take another 12-18 months. Both components, Operations & Maintenance and Modernization, must be performed by the same contractor and it is vital the modernization portion is completed by ICF Incorporated since this contractor started the project and cannot be transferred to another contractor. If this requirement were to be procured competitively and if another contractor were to take on the modernization, it is estimated it would take an additional 6-12 months of onboarding and knowledge transfer which would result in significant delays, service disruptions to millions of users, and unacceptable cost. ClinicalTrials.gov is a Congressionally mandated project, NCBI could not accept a break in service or degradation of performance.

This requirement is complex and technical in nature, and several of the services, as part of the modernization phase, are under evaluation and/or undergoing modernization planning.

ICF Incorporated provides key personnel that are essential to the work of ClinicalTrials.gov and these personnel have been heavily involved for many years. Utilizing another contractor to take over the modernization process would take an inordinate amount of time and expense.

Any lapse of service would create serious consequences for the FDA and NIH since critical information from the registration and results of clinical trials would not be available to the medical community as well as the public. Additionally, other resources that provide information for emergency managers and public health professionals via the disaster health information resources and services, to communicate with non-English speakers via HealthReach and MedlinePlus, and potential health concerns to communities would not be maintained or would not be available should a lapse occur. Approving this Limited Source Justification will not only help NLM achieve its mission to provide information about new, ongoing, and completed research protocols, but also will help the NIH fulfill the Congressional mandate.

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

Per FAR 8.404(d), GSA has already determined the prices of fixed-price services, and rates for services offered at hourly rates, under schedule contracts to be fair and reasonable; however, the Contracting Officer, will seek additional discounts before an award is made. Furthermore, the current

pg. 5 task order was awarded using competitive procedures under GSA FSS. Contract prices for the base period and the option periods were determined to be fair and reasonable based on adequate competition among the proposals received and a review of GSA contract pricing.

6. Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

In accordance with FAR Part 10, NCBI and Office of Acquisition (OA) conducted market research using the techniques provided at FAR 10.002 (b)(2).The market research techniques used by NCBI included (1) contacting knowledgeable sources to identify existing companies that could demonstrate the ability to successfully deliver the full range of complex specialized professional services specified in the Statement of Work (SOW); (2) reviewing generally available information on the Internet; and (3) reviewing source lists to determine what commercial businesses are available in the open market and/or contract vehicles (e.g., NITAAC and GSA FSS).

Based on the information available at the beginning of the procurement process, NCBI anticipated a competitive acquisition for this requirement with adequate competition; however, based on the market research described below and the additional feedback from the ClinicalTrials staff, it was determined that only IFC Incorporated is capable of meeting our requirements. Program staff concluded that due to the current stage of the modernization, the introduction of any new vendor (large or small) would result in the inability to deliver on NIH deadlines.

NLM, Office of Acquisitions released a Small Business Sources Sought notice RFQ1623723 in GSA e-Buy on April 27, 2023 with closing date of May 11, 2023. The purpose of posting the notice was to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service- disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to NAICS Code 541511 that is applicable to this requirement. The notice resulted in the receipt of 28 capability statements.

The review of the capability statements focused on the two main components of the ClinicalTrials.gov: (1) Operations & Maintenance (non-IT) and (2) Modernization (IT). As a result of his review of the capability statements received in response to the small business sources sought notice, the Contracting Officer's Representative (COR) determined that no vendors were identified as fully capable of meeting the requirements for both components.

Further review of the requirements and status of the ongoing modernization portion determined that procuring through ICF Incorporated is in the Government’s best interest in order to avoid disruption of service, unnecessary delays, and unacceptable cost. For this reason, the Contracting Officer did not release an unrestricted Sources Sought notice. Therefore, this requirement will be procured under the authority of Federal Acquisition Regulation (FAR) Subpart 8.405-6(a)(1)(i)(B), “Only one source is capable of providing the supplies or services required at the level of quality required because the services are unique or highly specialized."

7. Any other facts supporting the justification.

High-profile stakeholder engagement activities, and webinars have led to high stakeholder engagement and high public expectations. Any interruption in service, delays, or unnecessary cost would put NIH at risk of not meeting these expectations. For instance, there is proposed draft language in section 203 of the Cure 2.0 Act to make ClinicalTrials.gov more user friendly; at the moment, the modernization efforts are fulfilling this initiative; however, if modernization efforts do

pg. 6 not move at the current pace or faster, these highly invested stakeholders could resort to other actions including legislative processes to achieve their goals by other means necessary. Taking this into account, ICF incorporated plays a key role in the modernization initiative for ensuring completion of critical infrastructure upgrades to a new cloud platform and deployment of a modern, robust, user-centered system informed by stakeholder input.

8. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

a. Removal of barriers to competition.

As discussed before, this requirement entails two main components: Operations & Maintenance (non-IT) and Modernization (IT). Once the Modernization portion is completed, the majority of the requirements will become non-IT Operations & Maintenance with very minor IT requirements. The main barrier for competition right now is the completion of the modernization phase; once this phase is done, the barrier for competition is removed. Actions are underway to complete a follow-on procurement when modernization is done. For instance, the new task order will include a transition plan and transition period to ensure the quality and integrity of the work is not impacted.

Also, It is anticipated that based on the changes over the next year, the new follow-on statement of work will be significantly different than the existing one. The next iteration of this requirement will be competed using full and open competitive procedures, potentially even set-aside for small businesses, if warranted, based on the results of market research.

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

None.

9. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs or requirements, or other rationale for limited sources, are accurate and complete.

Official Name & Title Signature Date

Project Officer Anna M. Fine, PharmD, MS Acting Program Head, ClinicalTrials.gov

Anna M. Digitally signed by Anna M. Fine -S

Fine -S Date: 2023.09.14 07:45:28 -04'00'

9/14/23

Project Officer’s Immediate Supervisor

Kim Pruitt, Branch Chief, IEB, NCBI Kim D. Digitally signed by

Kim D. Pruitt -S

Pruitt -S Date: 2023.09.14 08:58:09 -04'00'

9/14/2023

Head of the Sponsoring Program Office

Stephen Sherry, Ph.D., Director, NCBI

Stephen T. Digitally signed by

Stephen T. Sherry -S

Sherry -S Date: 2023.09.14 09:54:59 -04'00'

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10. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Iris Farrell, Supervisory Contract Specialist, Office of Acquisitions, NLM

11. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the Contracting Office

Daniel J. Hartinger, Director, Office of Acquisitions, NLM

Head of the Contracting Activity for Diane J. Frasier, Director, OALM and Head of Contracting Activity

12. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

Dr. Kathryn Partin, Director of Research Integrity, AIRIO, NIH

13. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement Executive

N/A