Sole Source Justification .pdf

07/18

Sole-Single Source (including brand-name) Justification

1. Requesting Organization.

a. Name of the Institute or Center

National Institutes of Arthritis Musculoskeletal and Skin Diseases (NIAMS)

b. Name of the Office / Division / Branch / Program Office

Pediatric Clinical Trials Unit, Office of Clinical Director, IRP

c. Project Officer Information.

2. Project Description.

a. Project Title.

Medical Specialist (Rheumatologist) with training in Spondyloarthritis

b. Acquisition purpose and objectives.

The purpose on this acquisition is to acquire the services of a Medical Specialist- Pediatric Rheumatologist with experience in Spondyloarthritis to assist on research under clinical protocol 11-AR-0223, “Studies of the Natural History and Pathogenesis of Spondyloarthritis”, and be responsible in part for clinical evaluation, gathering data, and formulating management plan for these patients. The objective of this protocol is to accelerate and establish a treatment for Spondyloarthritis to help patients that suffer from this disease.

c. Project background.

The Pediatric Clinical Trials Unit, Office of the Clinical Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH) conducts patient-based investigation in the areas of rheumatic, skin, muscular and inflammatory diseases, and train the next generation of physician-scientists and clinician-investigators in these areas. As part of the NIH intramural research program, the program is uniquely positioned to perform clinical and translational studies in the NIH Clinical Center, the world’s largest hospital and outpatient facility devoted exclusively to clinical investigation.

The goal the of clinical investigation is to bridge information gained from laboratory research with that afforded by clinical experience. The carefully designed observational and interventional studies provide opportunities to verify basic biological understanding of disease.

The NIAMS clinical research program, in partnership with Children National Center, is currently working on Protocol 11-AR-0223, “Studies of the Natural History and Pathogenesis of Spondyloarthritis” to follow Spondyloarthritis patients longitudinally to determine predictors of axial disease (spine involvement) to accelerate and establish a treatment protocol for Spondyloarthritis patients.

Spondyloarthritis (SpA) is a group of bone and joint disorders that may cause back and joint pain and stiffness. In some cases, SpA can lead to abnormal bone growth affecting the joints and spine. Some patients have SpA without ever developing these growths, while others develop them after only a few years. As part of the institute’s objectives, NIAMS investigators are interested in studying people with SpA and their relatives to determine which people are more likely to develop more severe conditions.

To achieve the above-mentioned objective, NIAMS has collaborated with Children's National Medical Center Hospital on Protocol 11-AR-0223.

During this time, Children's National Medical Center has served as a referral base for patients and, its faculty has been providing the clinical examinations and evaluations for the program.

The NIAMS’ Pediatric Clinical Trials Unit has a need for a Pediatric Rheumatologist with an expertise in caring for pediatric and juvenile patients with Spondyloarthritis to assist in numerous clinical related activities on the Protocol 11-AR-0223. The Medical Specialist will be responsible in part for clinical evaluation, gathering data, and formulating management plan for patients under the protocol.

d. Period of Performance.

Base year: September 13, 2022 – September 12, 2023 Option Year 1: September 13, 2023 – September 12, 2024 Option Year 2: September 13, 2024 – September 12, 2025 Option Year 3: September 13, 2025 – September 12, 2026 Option Year 4: September 13, 2026 – September 12, 2027 e.

3. Acquisition Authority. This acquisition is conducted under the authority of the

Federal Acquisition Regulations (FAR) Subpart 13.106-1. A(b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization).

4. Market Research.

5. Justification Rationale.

To be able to provide the ongoing patient care and have protocol continuity, it is necessary that the candidate for this position is familiar with the patients participating in the study and have the appropriate training and experience to continue evaluating and managing plans for patient participants. Dr. Hemalatha Srinivasalu is uniquely qualified to provide the required services.

Dr. Srinivasalu is the board-certified rheumatologist that is presently overseeing the Spondyloarthritis Protocol 11-AR-0223 for Children’s National Medical Center and NIAMS. She is familiar with the patients participating in the study and has the appropriate training and experience in this required field of the study. She has been involved in this protocol since its inception, and has contributed to protocol amendments, continuing renewals, helped create case report forms (CRFs), and formulated data points and clinimetrics to be captured in the study.

During the seven (7) years this protocol has been active, Dr. Srinivasalu has been responsible for clinical evaluation, gathering of patient information, and formulating a management plan for these patients. Furthermore, she helped create an electronic database for the clinical data and analyzed cross-sectional and longitudinal data from this protocol. As an expert in the field, Dr. Srinivasalu has presented abstracts at the American College of Rheumatology and other relevant scientific meetings.

Dr. Srinivasalu is also author on a manuscript from this collaboration published in Rheumatic Disease Clinics of North America in 2013. The unique collaboration established to administer this clinical research protocol restricts the selection of this requirement; it can only be fulfilled by an employee of Children’s National Medical Center.

6. Any other facts supporting the justification. Not applicable.

7. Project Officer Certification. The Project Officer, Technical or Requirements Personnel certifies that any data or information provided in support of this justification for the proposed acquisition has been reviewed and that to the best of our knowledge and belief is accurate and complete and the below signature recommends approval.

Project Officer Date

8. Contracting Officer Certification. The Contracting Officer 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 and the below signature denotes approval.

Contracting Officer Date

Project Officer