THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this source sought. Any responses received will not be used as a proposal. Statement of Work The Food and Drug Administration’s (FDA), Statement of Work (SOW) Background: The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is testing various small and large molecule drug products to determine if cytokine release syndrome can be predicted using a ‘humanized’ mouse animal model. This assay requires that we evaluate up to 10 cytokines simultaneously in 96-well format using very small sample volumes. We have completed method discovery and development on the Meso Scale Discovery (MSD) multiplex platform which uses a proprietary MSD analyzer. In order to ensure comparability and validity of data, we need to continue using the MSD platform. This requisition seeks to have MSD create custom plates to assay the cytokines we have validated in a single sample well which are GM-CSF, IFN-γ, IL-2, IL-6, IL-8, IL-10, IL-12/IL-23/p40, IL-13, IL-17A and TNF-α. Requirements: GM-CSF, IFN-γ, IL-2, IL-6, IL-8, IL-10, IL-12/IL-23/p40, IL-13, IL-17A and TNF-α., Quantity of 15, Multi-Spot® 10-plex cytokine plates with human analytes using serum or plasma. Analytes shall include GM-CSF, IFN-γ, IL-2, IL-6, IL-8, IL-10, IL-12/IL-23/p40, IL-13, IL-17A and TNF-α.,,Sufficient reagents included with the custom plates to run samples on all plates ordered and will include detection antibodies and calibrator beads for each analyte, Read Buffer T (4x), Diluent 43, and Diluent 3, Availability of positive control samples, such as provided in Proinflammatory Control Pack (catalog #C4049-1) and Cytokine Panel 1 (catalog #C4050-1), but containing positive samples for custom kit., Completion of a functional QC test prior to release, Step-by-step instructions on completion of the custom assay. Deliverables: Description: Proinflammatory Control Pack Product C4049-1 1 quantity, Cytokine Panel 1 Control Pack C4050-1 quantity 1, Multi-spot 10-spot Special Order Human 10-plex; N05JA-1 quantity 10. ***************************************************************************** Companies are encouraged to respond if they have the capability and capacity to provide the identified supplies. Interested small business potential Offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 15 pages, and must include: 1. 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. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 334516 with size limitation standards of 1000 employees, and status, if qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the System for Award Management (SAM) at www.sam.gov to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation, such as letters or certificates to indicate the firm's status (see item #3 above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement shall also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. SUBMISSIONS ARE DUE no later than 10:00am, Eastern Time, July 8, 2020 . The capabilities response shall be e-mailed to:
[email protected]. All information received in response to this notice that is marked Proprietary will be handled accordingly. Responses to the notice will not be returned, nor will there be any ensuing discussions or debriefings of any responses. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process. This notice is part of Government Market Research, a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for or award a competitive contract. The FDA will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, the content of any responses to this notice may be reflected in subsequent solicitation. FDA reserves the right to contact any respondent to this notice for the sole purpose of enhancing FDA's understanding of the notice submission. This announcement is Government market research and may result in revisions in both its requirements and its acquisition strategy based on industry responses. It is emphasized that this is a notice for planning and information purposes only and is not be construed as a commitment by the Government to enter into a contractual agreement, nor will the Government pay for information solicited