I-Limited_Sources_Justification_Redacted.pdf

For information technology (IT) related areas the NCATS Information Technology Resource Branch (ITRB) is responsible for the operating system(s), databases, applications, system architecture, server, and the security infrastructure provided and/or hosted by NCATS, while the contractor will be expected to be knowledgeable about and support these tasks and/or responsibilities in collaboration with ITRB.

b. Project Background: Since 2003, NCATS’ Division of Rare Diseases Research Innovation (DRDRI,) jointly with the National Human Genome Research Institute (NHGRI), has funded the Genetic and Rare Diseases (GARD) information program. The program is meant to foster the generation and maintenance of information for and about research on rare diseases, and to stimulate vibrant partnerships with patient groups and other constituencies in the rare disease community.

Currently, there are over 10,000 known rare diseases that affect people in the United States, yet only a few hundred (less than five percent) have a treatment. A disease is characterized as rare when it affects fewer than 200,000 people in the U.S. While developing treatments for any complex, chronic, and severe disease is challenging, developing treatments for rare diseases presents additional difficulties and has many barriers in the translational development process aimed at treatments.

To this day, accurate, comprehensive, timely, and easy to understand information about a rare disease is difficult to find and is hardly ever available in any one place. It is for these reasons that NCATS supports the GARD information program. DRDRI acts as a convener to bring together the rare diseases community to develop a tools collection such as the NCATS Toolkit for Patient-Focused Therapy Development (“Toolkit”) and the NCATS Rare Diseases Registry (RaDaR) Program. The Toolkit Project brings together, on the GARD website, information on the process of developing a high-quality research program and data collections; and helps shepherd more efficiently and successfully projects through the treatment development process.

This project is a renewal of Task Order Number 75N95021F00084 isssued under GSA FSS Contract Number GS-00F-010CA:

i. Contractor Name: ICF Incorporated, LLC

ii. Period of Performance: July 29, 2021, to July 28, 2024

iii. Total Dollar Amount Obligated to Date: $10,079,403

iv. The Task Order was initially awarded under full and open competition.

3. Description of the Supplies or Services Required to Meet the Agency’s Needs (including the Estimated Value):

a. Project Title: “Management and Research Support for the Genetic & Rare

Diseases (GARD) Information Center & Related Programs”

b. Project Description: The Genetic and Rare Diseases (GARD) Information Center and Its Closely Inter-Related Research Support Activities project requires support services for GARD for the following tasks: project management and planning; inquiry responses; website and social media management, improvement, and maintenance; conferences, workshops, and meetings and resulting product(s); graphic design and production services;

communication; and other considerations.

• Requirement Type:

☒ Support services (non-research & development) ☐ Supplies/equipment ☐ Information technology (IT) ☐ Other (specify)

• Type of Action:

☐ New requirement ☒ Follow-on: Two-month bridge task order ☐ Other (specify):

• Proposed Contract/Order Type:

☐ Firm-fixed-price ☒ Time and materials ☐ Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements) ☐ Other (specify)

• Acquisition Identification Number:

GSA FSS Contract Number GS-00F-010CA

c. Total Estimated Dollar Value and Performance/Delivery Period:

The total estimated dollar value of the acquisition is $564,689, inclusive of options; and the total period of performance will be July 29, 2024, through September 28, 2024.

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) [see FAR 8.405-2] (i.e., fewer than three FSS contractors).

☐ 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 unique qualifications to provide the required supply or service:

• Name and address of the proposed contractor:

ICF Incorporated, LLC 1902 Reston Metro Plz Reston, VA 20190-5231

• Nature of the acquisition and proposed contractor unique qualifications: The Contractor listed above is the incumbent and issuing a two-month, follow-on task order while the Government completes the recompetition of a new task order is in the best interest of the Government. Limiting sources and awarding this task order is justified in accordance with FAR 8.405-6(a)(1)(i)(C); because, in the interest of economy and efficiency this new work is a logical follow-on to Task Order Number 75N95021F00084 under GSA FSS Contract Number GS-00F-010CA.

The proposed contractor’s unique qualifications include:

More than 10 years’ demonstrated experience in administering and improving the existing GARD site and programs; knowledge and experience of the GARD customer base and extensive experience with conference planning and management specifically for the NIH;

possessing a detailed plan and demonstrated capability of providing the Spanish language services needed under this project.

The contractor’s personnel have direct experience with the GARD project. Regarding the project’s call center tasks, the personnel have demonstrated experience managing patient interactions with highly rated feedback from patient community.

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d): The price of the task order will be based upon fixed hourly rates for labor categories priced in the GSA FSS contract. Although GSA has already negotiated fair and reasonable pricing, additional discounts will be sought, obtained, and reflected in the priced rates provided in the task order at the time of award. The Contracting Officer will evaluate the level of effort and the mix of labor proposed to perform the tasks being ordered. The Contracting Officer will also determine the price of the order to be fair and reasonable and that it represents the best value prior to issuance.

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 Subpart 5.2, a synopsis of proposed contract action to award a task order under GSA FSS Contract Number GS-00F- 010CA for the additional work was published July 11, 2024, on SAM.gov with a response date of July 16, 2024. The pre-solicitation notice included a statement that all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

Two (2) responses were received to the notice from the following sources:

• BLKDigitalTech Corp., 2772 Gateway Rd. #200, Carlsbad, CA 92009-

1746. UEI: SDT9S195E931

• Lifestyle Group Inc., 14237 Cherrylawn St., Detroit, MI 48238-2447. UEI:

GCXFL9UCAH41

Both respondents were assessed by the Contracting Officer as not capable of meeting the requirement, because they failed to address the specific requirements in the notice and its Attachment 1 – Statement of Work.

7. Any other facts supporting the justification: The incumbent’s institutional knowledge of the project allows them to immediately begin work on the project without adverse impacts to performance and schedule. The contractor possesses almost 20 years of experience in providing written content to the rare diseases community in patient-friendly language that is easily accessible to the public, and has a proven ability to speak with rare disease patients who have complex conditions and usually little-known and poorly understood rare conditions to provide timely services for these patients.

Institutional knowledge and learning curve efficiencies gained during performance of the current task order, both of which are critical to high quality performance, cannot be transferred to a new contractor without a significant duplication of time, a corresponding duplication of costs, schedule delays, and an interim period of reduced quality of performance. The incumbent’s current personnel performing under the project possess extensive and detailed knowledge about the various GARD related services, applications, and tools and are uniquely positioned to perform and deliver with the highest technical quality.

Given the substantial work already performed under the current task order by the incumbent, utilizing another contractor to provide the additional effort here would adversely impact the economy and efficiency of the project’s current performance.

Executing a sole soure, 2-month bridge task order will be substantially more economical and efficient than conducting a recompete and award now prior to the current task order’s expiration date of July 28, 2024; provide the necessary additional time for a new task order award to be properly recompeted and awarded; and will avoid the risks introduced by the end of these services which would result upon expiration of the current task order on July 28, 2024. These risks include a federally mandated program would cease operation if this project ended abruptly without a new contract in place, because this project currently promotes and encourages a centralized clearinghouse for rare and genetic disease information that provides understandable information about these diseases to the public, medical professionals, patients and families as federally mandated by The Rare Diseases Act of 2002.

A bridge task order (1) avoids duplication of administrative costs and the project startup and transition costs of a new contractor; (2) significantly reduces the award timeframe; (3) avoids the effort and time a new contractor would need to spend in starting up, transitioning in, and achieving learning curve efficiencies for the work under this project; and (4) avoids the above risks resulting from the end of the services.