beta_SAM_Post_JA_Attachment_Redacted.pdf

Sole Source Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Department of Health and Human Services (HHS) / U.S. Food and Drug Administration (FDA) / Office of Acquisition and Grants Services (OAGS)

b. Sponsoring organization.

Department of Health and Human Services (HHS) / U.S. Food and Drug Administration (FDA) / Center for Devices and Radiological Health (CDRH) / Office of Science and Engineering Laboratories (OSEL)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Todd Johnston (COR) / Michael Caiola (Technical SME/Program Manager) / Meijun Ye (Technical SME/Program Manager)

ii. Mailing address: 10903 New Hampshire Avenue, Silver Spring, MD 20993

iii. E-mail address: Todd.Johnston@fda.hhs.gov / Michael.Caiola@fda.hhs.gov /

Meijun.ye@fda.hhs.gov

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

a. Acquisition purpose and objectives.

The objective of this procurement is to recruit human patient subjects with mild traumatic brain injury to evaluate the performance of novel digital technologies in the diagnosis or monitoring the progress of the injury.

b. Project background.

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

The Office of Science and Engineering Laboratories (OSEL) supports the CDRH’s mission of protecting and promoting public health. The OSEL undertakes the highest quality science to provide their customers with the best methods, tools and expertise to:

Ensure readiness for emerging and innovative medical technologies Develop appropriate evaluation strategies and testing standards Create accessible and understandable public health information and Deliver timely and accurate decisions for products across their life cycle.

Under OSEL, the Division of Biomedical Physics (DBP) participates in the Center's mission of protecting and promoting public health by identifying and investigating the biophysical interactions between medical devices and the human body. The division accomplishes this through activities supporting the OSEL mission.

DBP investigates gender-based differences in cardiac resynchronization therapy for pacemakers, development of phantoms (physical models) to assess the measurement of eye disease by optical imaging systems, evaluation and improvement of electrode reliability in neural prosthetics used to control artificial limbs, and computational modeling of active and passive implants to determine if unsafe levels of heating arise during a patient’s exposure to magnetic resonance imaging (MRI) systems. These serve the Center’s mission of advancing regulatory science, facilitating consistent and efficient regulatory pathways, and assuring continued access to safe, effective, and high-quality medical devices.

Specifically, DBP focuses on device issues that involve:

Biomedical and tissue optics Biophysics and electrophysiology Electrical engineering Functional device performance and human factors, and Wireless communication and electromagnetic interference and compatibility

One of CDRH’s Office of Science and Engineering Laboratories’ (OSEL) research programs, the Neurological Devices Program conducts regulatory science research to help ensure patient access to innovative neurology devices that are safe and effective.

Neurological disorders and injuries are the leading cause of disability and second leading cause of death worldwide. Early detection is critical to prevent neurological disorders from progressing to a disabling or lethal level. With conventional imaging methods reaching their technical limit, alternative tools are under intense investigation. Novel imaging modalities, physiological sensors and algorithms, and wearables are some examples. However, the distributions of the derived metric in the clinical and normal populations have not been established, and sensitivity and specificity of a metric needs to be validated to strengthen the confidence in a given measure.

With the improvement of public health as the mission, OSEL’s Neurological Devices Program focuses research on developing and validating markers derived from these emerging technologies as diagnostic and monitoring tools, and as outcome measures for the development of therapeutics.

With the recognition of the importance of early detection and medical intervention in the management of neurological disorders and injuries, FDA has been updating regulatory guidelines for therapeutic and diagnostic development. To efficiently implement these guidelines, well-validated biomarkers are needed for early diagnosis and for evaluating efficacy of novel therapeutics. The primary regulatory barrier hindering clinical translation of these innovative technologies is that there is no clear regulatory strategy for demonstrating performance of these devices.

In collaboration with OSEL, the DBP seeks to recruit human patient subjects with mild to moderate traumatic brain injury to evaluate the performance of novel digital technologies in the diagnosis or monitoring the progress of the injury. This project is being pursued in part to further the OSEL Neurological Devices Sub-program’s interest in developing biomarkers of neurological disorders and injuries.

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

a. Project title.

Patient Recruitment VR-TB

b. Project Description.

This procurement calls for the following tasks to be completed:

Task Management o Kick Off Meeting o Monthly Status Reports o Project Work Plan

Institutional Review Board (IRB) Preparation and Approval Patient Recruitment Patient Data Collection Location Perform Current Standard Clinical Evaluation Clinical Oversight and Expertise Summary Report

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:

Type of action.

New requirement Follow-on Other:

Proposed contract/order type.

Firm-fixed-price Other fixed-price:

Cost-plus-fixed-fee Other cost reimbursement:

Time and materials Indefinite delivery:

Other:

Completion Form Term Form

Acquisition identification number.

CIN: CDRH-OSEL-23-C-1392, Requisition: 1266955

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

The total estimated dollar value of the acquisition is $72,973.91. The anticipated period of performance is one (1) twelve-month base year and one (1) twelve-month option year.

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

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

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

Mark Scarboro Senior Director, Research Operations and Compliance Shock, Trauma and Anesthesiology Research (STAR)-Organized Research Center University of Maryland, School of Medicine 110 S. Paca Street, 03-144 Baltimore, MD 21201-1642 Phone #410-328-8713 Email: mscarboro@som.umaryland.edu

SAM UEI: Z9CRZKD42ZT1

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

This highly complex service request requires cooperation of multiple parties within the contractor’s organization and involves strategic planning and preliminary data analysis.

Therefore, the process of engaging interest and preliminary commitment is lengthy. This particular arrangement has been in the planning stages for the past 8 months.

This acquisition requires the contractor to have a highly specific capacity of the targeted patient population within a limited geographic area and specific time-window, which limits the number of possible capable contractors. The contractor needs to be easily reachable from the FDA White Oak Campus as FDA employees will be frequently visiting the contractor’s site to perform the associated study. The targeted disorder also requires quick identification and recruitment of patients in order to be enrolled in the study, making only one contractor suitable for this task.

CDRH/OSEL has been working with other medical institutions for similar services. However, due to the limited capacity of the other medical institutions, none of these contractors are able to meet the requirement for the number of patients with reasonable time commitment.

The University of Maryland’s (UMD) Shock, Trauma and Anesthesiology Research (STAR) Organized Research Center is a world-class, multi-disciplinary research and educational center focusing on critical care and organ support, resuscitation, surgical outcomes, patient safety and injury prevention. It is the first research center in the nation dedicated exclusively to the study of trauma, its complications, and its prevention. CDRH/OSEL has determined their team and plan to be the only capable contractor to continue the ongoing study. CDRH/OSEL has not been able to identify any other contractors who can meet the need for both the number of patients and budget because no other contractor has access to CDRH/OSEL’s targeted patient population in suitable numbers, delivery time, and cost within the limited geographic area and time-window.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

In accordance with FAR Subpart 5.2, a notice will be publicized on SAM.gov.

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

Upon receipt of a proposal from the contractor, a cost/price analysis will be conducted to ensure a fair and reasonable price, including the conducting of negotiations with the contractor, if necessary.

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

Market research was conducted by working with other medical institutions for similar services;

however, due to the limited capacity of the other medical institutions, none of these contractors were determined to be able to meet the requirements of this procurement. Additional market research was conducted by locating contractors within the limited geographic area of the FDA White Oak Campus that has the capability to quicky identify and recruit targeted patient population in suitable numbers and continue the ongoing study within the limited budget and time period. UMD’s Shock, Trauma and Anesthesiology Research (STAR) Organized Research Center was determined to be the only contractor capable to meet the needs of this requirement based on this market research.

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

None.

10. 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.

11. 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.

CDRH/OSEL is expecting to expand the study by recruiting more patients from different resources when appropriate. Due to the highly complex nature of this type of service, it is anticipated that it will take an extended period of time to engage interest and preliminary commitment from additional contractors. To overcome barriers to competition for the future acquisitions, CDRH/OSEL will actively present the study in relevant scientific communities and communicating with clinical institutions for their capability and interest and will continue to survey the marketplace for these resources in the event similar services are required.

12. 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, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:

Todd Johnston

COR/Requiring Activity POC

Signature:

Piya Sawhney

COR/POC Team Leader

Signature:

Sara Sadaie

Head of the Sponsoring Program Office

13. 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.

Signature:

Gary Klaff

Contracting Officer