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Tender Details
- Country: USA
- Summary: Notice of Intent to Sole Source - Human Subjects Protection Personnel Management and Support Services for USAMRDC OHARO
- UST Ref No: 118953149
- Deadline: 26 May 2025
- Competition: ICB
- Financier: Self Financed
- Purchaser Ownership: Public
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.:
- Purchaser's Detail :
- Description :
- Description
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 protec... - Documents :
Purchaser : DEPT OF DEFENSE | DEFENSE HEALTH AGENCY (DHA)
Office: Notice of Intent to Sole Source - Human Subjects Protection Personnel Management and Support Services for USAMRDC OHARO
Primary Point of Contact: Alana M. Sowers, alana.m.sowers.civ@health.mil
Email :alana.m.sowers.civ@health.mil
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