RFI - SS for HSP Personnel Management and Support Services - USAMRDC OHARO.pdf

This is a Request for Information (RFI)/Sources Sought for Human Subjects Protection (HSP) Personnel Management and Support Services for the U.S. Army Medical Research and Development Command (USAMRDC), Office of Human and Animal Research Oversight

(OHARO)

1.0 Purpose of this RFI/SS

THIS IS A REQUEST FOR INFORMATION (RFI)/Sources Sought (SS), as well as Industry Feedback ONLY. This RFI/SS is issued solely for information and planning purposes – it does not constitute a solicitation, nor does it restrict the Government as to the ultimate acquisition approach. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. 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 and when one is issued.

This RFI/SS is to gauge interest in the upcoming requirement for support to the USAMRDC, OHARO.

Research protocols funded, conducted, or supported by the USAMRDC must be reviewed for compliance with DoD, federal, state, host national, and local human subjects’ protection regulations and human research ethical standards in accordance with the requirements set forth in the attached draft Performance Work Statement (PWS). When submitting a capability statement response to this draft PWS, please submit a capability statement that describes relevant past performance based upon the size and scope of the outlined requirement. Please do not regurgitate the draft PWS tasks, rather responders shall describe/outline company specific capabilities that match the work outlined in the draft PWS in order for the Government to make a fair capabilities determination. Capability statements will be evaluated to the degree to which they demonstrate: (1) Described relevant past performance based on the size and scope of the outlined requirement; (2) Described company specific capabilities that match the work outlined in the draft PWS. In addition, the Government will review non-capability statement responses to the questions in Appendix A and B in order to determine the most appropriate solicitation (RFP) vehicle.

In addition, the Government requests you respond to the specific questions listed below in order to satisfy this RFI/SS. Any industry feedback regarding the draft PWS is encouraged and welcomed. Please list any feedback accordingly (marked as vendor feedback) following your capability statement and responses to the listed Government questions.

2.0 Attachments

The attachments to the RFI/SS are:

• RFI/SS Attachment 1 - Draft Performance Work Statement (PWS) with PWS Attachment A – Organizational Chart (PWS Attachment’s B, C, and D are not included as part of this RFI/SS.)

3.0 Information

This Commercial Services requirement for Human Subjects Protection (HSP) personnel management and support services will be a Firm Fixed Price with Cost Reimbursement ODC CLINS contract.

The Government requires 27.5 FTEs (See PWS Attachment A) to fulfill the task requirements based on historical and projected workload.

The NAICS Code for this requirement is 541712 - Research and Development in the Physical, Engineering, and Life Sciences.

4.0 How to Respond

a) Provide a capabilities statement of no more than 15 single-sided pages that addresses the questions posed in Appendix A. The formal closing date for this RFI/SS and for the submission of responses is NLT 20 November 2024 at 0900 EST. All responses should be submitted electronically using PDF, MS Word or PowerPoint formats to the POC, Ms. Alana Sowers at the following email address: alana.m.sowers.civ@health.mil.

b) Each response should include the following Business Information:

i) Company name, mailing address, email address, telephone number(s), website address, and the name, telephone number, and email address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

ii) Name, title, telephone number, and email addresses of individuals who can verify the demonstrated capabilities identified in the responses.

iii) UEI number, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Responders also must be registered in System for Award Management (SAM) at www.sam.gov.

Note: Total email file limit size is restricted to 5MB. Files exceeding this threshold shall be submitted over multiple messages, and be identified as “Message #x of #x”.

Appendix A –

1) Describe your organization’s customer base and years of experience in Human Subjects Protection Support Services, or similar/related services to those outlined in the PWS.

2) Describe your organization's specific and relevant experience and expertise to fulfill this requirement.

3) Describe your organization’s relevant past performance for requirements of similar size and scope, and provide examples or references of previously completed deliverables related to this requirement.

Appendix B –

1. Feedback on the attached draft PWS (Attachment 1). Feedback is encourage but not required.

2. Information relating to capabilities, novel ideas, industry best practices, industry capabilities to meet the needs of the Government's requirement as outlined in the draft PWS.

5.0 Summary

THIS IS A REQUEST FOR INFORMATION ONLY to identify sources that can provide Human Subjects Protection Personnel Management and Support Services. The information provided in the RFI/SS is subject http://www.sam.gov/ to change and is not binding on the Government. The Government has not made a commitment to procure any of the services discussed, and release of this RFI/SS should not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. The Government will not entertain questions regarding this Market Research. All submissions become Government property and will not be returned.