Orthopedic Surgical and Research Services_JOFOC_Revised_Mod P00002_Redacted.pdf

NIAMS’ research and ongoing clinical protocols. The current contract widely distributes the benefits of orthopedic surgery outcomes, innovations, and techniques, as well as other research findings.

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

a. Project title. Orthopedic Surgical and Research Services

b. Project description. Please reference Statement of Work.

• 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 (specify): ____________________

• Type of action.

❑ New requirement ❑ Follow-on

Other (specify): Modification to increase tasks on existing contract, 75N92021P00084

• Proposed contract/order type.

Firm-fixed-price ❑ Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ ❑ Cost-plus-fixed-fee ❑ Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ ❑ Time and materials ❑ Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

❑ Other (specify): ___________

❑ Completion Form ❑ Term form

• Acquisition identification number. Requisition 6232054/Purchase Order# 75N92021P00084

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

Current Contract Dollar Value:

Base Period. March 30, 2021 – March 29, 2022: $50,400.00

Option Period One. March 30, 2022 – March 29, 2023: $51,660.00

Option Period Two. March 30, 2023 – March 29, 2024: $52,951.50

Option Period Three. March 30, 2024 – March 29, 2025: $54,275.29

Option Period Four. March 30, 2024 – March 29, 2026: $55,632.17

Modification to Increase/New Contract Dollar Value:

Option Period One. March 30, 2022 – March 29, 2023: $78,120.00

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

❑ This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

❑ This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

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).

Dr. Timothy Bhattacharyya/Spartina Medical

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). The uninterrupted continuation of protocol requires the guidance and expertise of a board-certified 15-AR-0165 orthopedic surgeon/investigator. The Contractor currently involved in the care and evaluation of NIAMS patient cohort, has been involved in this protocol since its inception. The Contractor has the appropriate training and experience in orthopedics and rare bone diseases, essential to provide ongoing patient care and to establish continuity for protocol-driven research. Since 2016, the Contractor has been responsible for clinical evaluation, gathering of patient information, and formulating a management plan for these patients. The evolution of research has led to the study of rare bone diseases such as melorheostosis. With it, comes the need to complement and explain clinical observations through the expansion of laboratory resources to develop animal and cellular models and the establishment of a new laboratory to oversee in-vitro experiments. For this reason, the Government is increasing the tasks under this contract, which includes: developing a growing program of advanced laboratory research related to rare bone diseases such as melorheostosis, and expanding the ongoing research with other NIH investigators to animal and cellular models of orthopedic diseases and rare bone diseases such as melorheostosis.

The current Contractor is unique to oversee the continuation of these trials because he has contributed to protocol amendments, continuing renewals, created case report forms (CRFs), formulated data points and clinimetrics to be captured in the study and is an expert in melorheostosis. Furthermore, the Contractor has experience in the understanding and navigating of clinical protocols at the NIH Clinical Center and is already credentialed by the NIH Medical Executive Committee (MEC).

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. This action will be publicized on Contract Opportunities/System for Award Management (SAM), per FAR 5.201(b)(1)(ii).

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. There is no reason to believe that the price provided by the Contractor will not be fair and reasonable to the Government. A final fair and reasonable price determination by the Contracting Officer will be conducted prior to the award of this contract.

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 via GSA elibrary and SAM.gov generated no results for a physician/orthopedic surgeon/researchers with expertise in bone diseases such as melorheostosis. A review of eight (8) BPA sources revealed labor categories for physicians with Internal Medicine and/or Rheumatology expertise with five (5)