USAMRDC FDA regulatory Compliance Training RFI-Sources Sought.doc

U.S. Army Medical Research and Development Command (USAMRDC) Office of Regulated Activities (ORA) THIS IS A REQUEST FOR INFORMATION (RFI)/Sources Sought (SS). This RFI/SS does not constitute a solicitation, nor does it restrict the Government as to the ultimate acquisition approach. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI/SS will be solely at the interested vendor's expense. Not responding to this RFI/SS does not preclude participation in any future Request for Proposal (RFP), if issued. The information provided in the RFI/SS is subject to change and is not binding on the Government. This RFI/SS is issued solely for information and planning purposes to determine the number and socioeconomic size of sources capable of meeting the upcoming requirement for the U.S. Army Medical Research and Development Command (USAMRDC), Office of Regulated Activities (ORA).

The overall scope of this requirement provides for competency training for personnel involved in FDA regulated research activities. The USAMRDC requires FDA regulated training in the areas Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) and Quality Systems Regulations (QSR) to comply with U.S FDA and all other applicable DoD and Army regulations, directives, and guidance. Any resulting contract will provide expertise in the development of applicable courseware/training materials and the conduct of classes to increase technical and regulatory knowledge.

The Period of Performance of this requirement is estimated to be a 1-year Base Period with four 1-year Option Periods.

How to Respond:

Submit a Capability Statement that describes relevant experience, expertise, and capabilities based upon the size and scope of this requirement stated above and detailed in the draft PWS. Interested vendors must also specify if the training will be provided directly by the prime vendor or by a subcontractor/teaming partner.

Each response should also include the following business information and must not be more than five (5) pages in length:

a) Company name, mailing address, e-mail address, telephone, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

b) Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses.

c) Unique Entity ID number, CAGE Code, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in System for Award Management (SAM, at www.sam.gov) to be considered as potential sources.

d) Description of business size (Large Business, Small Business, 8(a), HUBzone Business, etc.).

e) Any and all Government IDIQ Contracts (e.g. Federal Supply Schedule, OASIS, etc.) you currently hold (to include the vehicle and your contract number) that could be used to fulfill this requirement.

The formal closing date for this RFI/SS and for the submission of all responses is NLT 05 February 2025 at 4:00 ET. All responses shall be submitted electronically using PDF or MS Word formats to the POC, Mr. Matthew Gembe at matthew.w.gembe.civ@health.mil. The Government will not entertain questions regarding this RFI/SS/Market Research.

Attachment: FDA Compliance Training_ Performance Work Statement