Research and Development Biomedical Solutions Provider

General Services Administration Federal Acquisition Service Region 7 AAS SOURCES SOUGHT NOTICE (SSN)/ REQUEST FOR INFORMATION (RFI) SSN/RFI Number: ID0720BMRD Title: Research and Development Biomedical Solutions Provider 1. Market Research Notice This SSN/RFI is for planning and information purposes only and shall not be construed as a commitment or a promise of a contract by the Government. This is not a solicitation. This notice does not constitute an Invitation for Bid (IFB), Request for Quote (RFQ) or Request for Proposal (RFP), nor does it restrict the Government as to the ultimate acquisition approach. The Government will not reimburse respondents for any costs incurred in preparation of a response to this notice. For the purpose of this acquisition, the Government anticipates the use of one of the NAICS codes listed within this document and contemplates the use of single award Cost Reimbursement type contract. Information received in response to this notice will be used to further define the Government's requirement. We encourage all interested, large and small businesses in all socio-economic categories (including 8(a) Business Development Program, Small Disadvantaged Business, Historically under-utilized Business (HUB) Zone, Veteran-Owned Business, Service Disabled Veteran-Owned Business, and Woman-Owned Business concerns) capable of satisfying any portion of the listed requirement to identify their capabilities and provide their feedback. Information received as a result of this RFI will be used solely for market research purposes. The Government shall use this market research in determining the best method of procurement, which is part of the acquisition planning process. This RFI is for information purposes only and no award will result from the RFI. 2. Background and Anticipated Scope Background. The anticipated scope of this requirement has not been finalized and is subject to change. This is Phase one of a multi-phased market research approach to better understand the industry, capabilities, and factors impacting this anticipated requirement. Subsequent phases of this market research approach include teleconferences, comment on a draft PWS, and exchanges with industry. Anticipated Scope. The Government has a need for contract services to conduct translational research and development in the areas of emergency medical care, combat casualty care, force health protection, restorative medicine, clinical and rehabilitative medicine all with multiple centers of excellence (i.e., diabetes, eye, hearing, advanced molecular detection), and specialty centers (i.e., burn management and transport, cardio-vascular, extracorporeal life support and critical care transport, maternal and neonatal intensive care, pain management). This program continues to facilitate development of innovations for advancing the care and rehabilitation of the combat wounded and support for Food and Drug Administration (FDA) regulated trials supporting activities Enterprise-Wide. The potential awardee will need to be prepared to provide staffing for multiple labor categories and be able to provide highly technical research support and research solutions. Additionally, the potential awardee will need to be develop multiple approaches to potentially develop a cost effective solution for various research projects. Anticipated NAICS codes. 541714: Research and Development in biotechnology 541990: All Other Professional Scientific and Technical Services 3. Submission Requirements for RFI RESPONSE TO THIS RFI: In order to be considered responsive to this RFI, please provide a concise response to the items and questions posed in sections 4 - 6 along with any kind of capabilities brief you feel would help to inform the Government regarding your firm's experience, capabilities, or strategic sourcing partners. This RFI shall be open from December 17, 2019 through January 7th, 2020. Both large and small businesses are encouraged to participate in this phase of Market Research. A draft copy of the scope of work has been provided for reference. All responses are due not later than 10:00 PM Eastern, January 7th, 2020. All responses shall be submitted via email correspondence. Please send responses to david.kilbourne@gsa.gov 4. Firm Name and Admin Data a) Please provide Name of the firm, point of contact, phone number, email address, DUNS number, CAGE code, a statement regarding small business status, if applicable, (including small business type(s)/certifications(s) such as SDB, 8(a), HUBZone, SDVOSB, WOSB, etc.) and the corresponding NAICS codes. b) Please indicate if your firm would be interested in participating in an industry wide group teleconference call led by GSA Federal Acquisition Services (FAS) Region 7 (R7). If you would be interested in participating in this event, respond and provide point of contact information so the Government may contact your firm. Event dates and times to be determined after this SSN/RFI closes. 5. Previous Experience / Capabilities Statement a) Please provide a short statement addressing previous experience for similar requirements. Statement should address the following: Identify if you were a prime contractor or subcontractor, size, scope, complexity, and timeframe, whether the services provided were commercial or non-commercial, experience of conducting research and development in a biomedical setting, and any other similar types of information. The narrative shall draw direct correlations and relate directly to the requirement described herein, and shall directly demonstrate the interested contractor's capabilities to perform the effort herein through the examples of past experience provided. Failure to provide the information as requested may result in the Government's continuance of the acquisition planning phase, without giving consideration to the capabilities of the contractors who do not respond timely. 6. Questions Regarding Industry Specific Market Trends and Conditions. Special Notice: All information provided in response to this notice will be kept confidential and will be used for internal Governmental purposes only to help inform how we develop and solicit our anticipated requirement. a) Have you ever been the Prime for a Cost Reimbursement contract with the Government? b) What strategies or methods should the Government use to help control costs for this type of requirement? c) When working on a Research and Development project how do you determine the correct labor mix? d) Is it common for private firms and companies to partner with universities and research institutions in the biomedical R&D field? e) Are you able to partner with universities or research institutions to obtain skilled expertise and labor at a reduced rate? f) What controls or countermeasures does your company have in place to control costs and mitigate cost overrun on your projects? g) What criteria do you look for when you determine whether or not you will submit a proposal? h) How long does it take you to find and onboard new employees from the time you receive notification that you need a new employee, until they start the job? i) Do you have an approved accounting system to qualify for a Government Cost Reimbursement type contract? j) How many employees does your company currently employ? k) What unique characteristics should the Government look for in a contractor to be successful in the R&D biomedical industry? l) What potential hazards or concerns should the Government be aware of when hiring a contractor in the R&D biomedical industry? m) How is profit structured or determined for a private firm in the biomedical R&D industry? n) Is there a labor shortage in the biomedical R&D industry? o) What private firms should the Government be aware of that are leading the biomedical R&D field? p) Do highly skilled personnel in this field frequently change employment with companies in order to seek higher pay raises? q) What does your company do to create stability with your staffing and help retain highly skilled employees? r) Do highly skilled personnel in this field prefer long term employment or do they prefer to have short term employment? s) Do the employees you hire prefer part time or full time employment? t) How do you gain access to new employees with specialized skillsets? u) What credentials and certifications do you feel a successful and competent private firm would need to perform on a Government Biomedical R&D contract? v) Has your company ever performed work to gain approval from the Federal Drug Administration (FDA) for a drug, product, or medical device? w) Please provide any experience your company has with obtaining approval from the FDA for a drug, product, or medical device. x) Please identify any current Industry trends taking place that the Government would need to understand or be aware of for this requirement. Thank you in advance for your time and consideration in responding to this Sources Sought Notice / Request for Information.