Request for Information (RFI)/Sources Sought (SS) for Human Subjects Protection (HSP) Personnel Management and Support Services

Request for Information/Sources Sought Human Subjects Protection Scientists Support Services HQ, US Army Medical Research and Materiel Command (HQ USAMRMC), Office of Research Protections (ORP), Fort Detrick, Maryland 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 any is issued. This RFI/SS is to gauge interest in the upcoming requirement for support to the Headquarters United States Army Medical Research Material Command (HQ USAMRMC), Human Research Protection Program (HRPP), specifically for HQ USAMRMC Office of Research Protections (ORP), Human Research Protections Office (HRPO), and Institutional Review Board Office (IRBO) activities. Research protocols funded, conducted or supported by the USAMRMC must be reviewed for compliance with DoD, federal (to include Department of Health and Human Services, Food and Drug Administration, Environmental Protection Agency), state, host national, and local human subjects protection regulations and human research ethical standards in accordance with the requirements set forth in the attached Performance Work Statement (PWS). When submitting a capability statement 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 contractors 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 Appendix A and B questions in order to determine the most appropriate source. 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 PWS is encouraged and welcome. 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: - Performance Work Statement (PWS) Attachment 1 - Outlines Background, Objectives, and Statement of Work - Labor Estimate - Attachment 2 3.0 Human Subjects Protection Scientists Support Services Objectives This Non-Commercial Services requirement will provide Human Subjects Protection Scientist (HSPS) and Human Subjects Protection Administrative Support (HSP AS) support for the HRPO and HSPS support for the IRBO. This requirement will also provide HSPS support for HRPO and IRBO protocol review operations, including workload management and administrative support, operating procedure development, quality assurance, and process improvement initiatives. This requirement will also provide HSPS Subject Matter Expert onsite supervision for personnel that support the HQ USAMRMC ORP. This requirement will be a hybrid Firm Fixed Price, Cost Reimbursement contract. The Government requires 24 (FTE) HSPS Support Personnel (See Attachment 2) shall be needed to fulfill the task requirements based on historical and projected workload (ie. Protocol Reviews and other HSPS support services as outlined in the attached PWS) under NAICS Code 541712 - Research and Development in the Physical, Engineering, and Life Sciences. 4.0 How to Respond a) Please 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 19 March 2019 at 1400 ET. All responses should be submitted electronically using PDF, HTML, MS Word or PowerPoint formats to the POC, Ms. Alana Sowers at the following e-mail address: alana.m.sowers.civ@mail.mil. b) Each response should include the following Business Information: i) Company name, mailing address, e-mail address, telephone and FAX numbers, 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. ii) Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. iii) DUNS number, CAGE Code, Tax Identification Number, 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. *Total e-mail 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) Please describe your organization's customer base and years of experience in Human Subjects Protection Scientists Support Services, or similar/related services. 2) Please describe your organization's specific and relevant experience and expertise to fulfill this requirement. 3) Please describe your relevant past performance for projects of similar size and scope for this requirement. Please provide examples or provide references of previously completed deliverables related to this requirement. Appendix B - 1. Feedback on the attached PWS (Attachment 1) 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 PWS. 3. Provide a summary/description of the the labor categories you would use to fulfill this requirement. 5.0 Summary THIS IS A REQUEST FOR INFORMATION ONLY to identify sources that can provide Human Subjects Protection Scientists Support Services. The information provided in the RFI/SS is subject 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. NOTE: UPON RECEIPT AND EVALUATION OF CAPABILITY STATEMENTS, THE GOVERNMENT WILL MOST LIKELY CONDUCT AN "INDUSTRY DAY" TO ALLOW PROSPECTIVE OFFERORS THE OPPORTUNITY TO MEET WITH ORP STAFF AND RECEIVE A REQUIREMENTS/MISSION BRIEFING.