Notice of Intent to Sole Source - Human Subjects Protection Personnel Management and Support Services for USAMRDC OHARO

This notice announces the intent by the United States Army Medical Research Acquisition Activity (USAMRAA), in support of the United States Army Medical Research and Development Command (USAMRDC), Office of Human and Animal Research Oversight (OHARO), to issue a new contract on a sole source basis, as prescribed by the procedures in FAR 13.5 in accordance with 41 USC 1901, to General Dynamics Information Technology (GDIT).  This is not a request for proposals.

Human subjects research funded, conducted, or supported by the USAMRDC is governed by DoD Instruction (DoDI) 3216.02; 32 Code of Federal Regulations (CFR) 219; 45 CFR 46 Subparts B, C, D, and E; 45 CFR 160; and 45 CFR 164. The USAMRDC also adheres to the Food and Drug Administration (FDA) Regulations 21 CFR 11 (Electronic Records; electronic signatures), 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), 312 (Investigational New Drug Application), 314 (Applications for FDA Approval to Market a New Drug or Antibiotic Drug), 601 (Licensing), 812 (Investigational Device Exemptions), and 814 (Pre-Market Approval of Medical Devices) for research involving investigational drugs or devices. FDA “Guidance for Industry” publications provide additional directions in the research, development, test, and evaluation of regulated products. All research involving cadaver specimens must comply with the Department of Army (DA) policy, “Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education or Training.” All research conducted outside of the continental United States (OCONUS) must comply with host nation laws and regulatory requirements. The OHARO provides component-level oversight of the USAMRDC and subordinate institutions’ Human Research Protection Programs and serves as the proponent for implementation and oversight of the Army Cadaver Policy.

The USAMRDC OHARO requires human subjects protection personnel management and support services. As such, the Government intends to award a sole source contract to General Dynamics Information Technology for a period of approximately eight (8) months, inclusive of all options (3- month base, and a 5-month option). General Dynamics Information Technology is the only contractor poised to provide the necessary support services in accordance with the Performance Work Statement until a competitive recompete is fully executed (currently in source selection).  Award of this contract to any other contractor would result in duplicative costs and unacceptable delays, including a lengthy lapse in service.

The North American Industry Classification System (NAICS) for this requirement is 541715 (Research and Development in the Physical, Engineering, and Life Sciences except Nanotechnology and Biotechnology) and the size standard is 1,000 employees.

This announcement fulfills the synopsis requirements under FAR 5.101(a) and 5.203(a). This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purposes of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects seventeen (17) days after the publication of this notice, the Government intends to issue an award directly to General Dynamics Information Technology without further remark. All questions and responses concerning this notice shall be emailed to Ms. Alana M. Sowers at alana.m.sowers.civ@health.mil.  This notice is provided solely as information to the marketplace. Interested concerns must identify their capability in writing to the above email address no later than 11:59 am EDT, Monday, 26 May 2025.