FDA-SSN-1223623.pdf

FDA-SSN-1223623

Establishment and Operation of a Center of Excellence for Engagement with Compounding Outsourcing

Facilities

Document Type: Sources Sought Notice Solicitation Number: FDA-SSN-1223623 Posted Date: April 17, 2020 Response Date: April 30, 2020 NAICS Code: 325412 (Pharmaceutical Preparation

Manufacturing)

Part 1 – Description

The U.S. Food and Drug Administration (FDA) is issuing this Request for Information (RFI)/Sources Sought notice to identify possible small business sources with capability to support the FDA Center for Drug Evaluation and Research’s (CDER) upcoming requirement for the Establishment and Operation of a Center of Excellence for Engagement with Compounding Outsourcing Facilities.

The intent of this Sources Sought Notice is to obtain market information in accordance with FAR 15.201(e) for planning purposes and to determine appropriate strategies to meet the Agency's requirements. The FDA may release a Requests for Proposal (RFP) for this requirement in the near future. However, this RFI is issued solely for information and planning purposes and does not constitute a Request for Proposal (RFP) or a commitment to an RFP in the future. Responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. Responders are advised that the Government will not pay for any information or administrative cost incurred in response to this announcement and information submitted in response to this RFI will not be returned.

This RFI is issued to assess and evaluate interest, capabilities, and qualifications of various members of industry, specifically the Small Business Community: Small Business, Section 8(a), Historically Underutilized Business Zones (HUB-Zone), Service-Disabled Veteran-Owned Small Business (SDVOSB), Women-Owned Small Business (WOSB), and Economically Disadvantaged Women-Owned Small Business (EDWOSB). All of these socio-economic entity classifications are highly encouraged to respond to this RFI.

Part 2 – Draft Statement of Work (SOW)*

*See Attachment 1 (DRAFT SOW) to this RFI.

Part 3 – Instructions for Response Responses: All interested parties should notify the FDA point of contact named herein via email in accordance with the instructions below.

Responses shall include:

(I) Capability statement that demonstrates that the entity can meet all minimum requirements outlined in the SOW. Capability statements shall be limited to not more than ten (10) pages.

(II) Provide the following Business Information:

• Company Name

• Company Address

• Company Point of Contact, name, phone number, and e-mail address

• Type of business (i.e. commercial, academia), as validated via the System for Award

Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. any potential government contractor must be registered on SAM located at http://www.sam.gov/index.asp.

• Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.)

• DUNS Number

• Classification as a large or small business based on size standard that accompanies NAICS code 325412. If a small business, you must also list any small disadvantaged status you hold [HUBZone, 8(a), Service Disabled Veteran Owned Small Business (SDVOSB), Women Owned Small Business (WOSB), Economically Disadvantaged Women-Owned Small Business (EDWOSB), etc.].

• Current GSA Schedules appropriate to this Sources Sought

• Current Government Wide Agency Contracts (GWACs) appropriate to this Sources

Sought.

• Indicate if your company can provide the professional services needed to fulfill requirements in all areas of the DRAFT SOW. If your company cannot provide services in all areas, please identify which areas can be supported and identify which areas could be covered through one or more Governmentwide Contract Vehicle.

• Identify any existing or anticipated teaming arrangements that would provide full coverage of all DRAFT SOW Task Areas indicating whether this coverage could be provided via one or more of the Government Contract vehicles (GSA Schedules, GWAC, etc.).

• Include a statement indicating if the Company has an approved Federal audited account system. If so, provide certification that the accounting system was deemed adequate (e.g. name of audit agency and audit number).

• Indicate if Company has a rate agreement that has been audited. If so, provide a copy.

(III) Relevant past experience/performance through the description of completed projects.

Questions related to this Request for Information/Source Sought notice are due no later than 14:00 Eastern time April 23, 2020.

Responses to this Request for Information/Source Sought notice are due no later than 14:00 Eastern time April 30, 2020.

http://www.sba.gov/ http://www.sam.gov/index.asp http://www.sam.gov/index.asp

Questions and Responses are to be e-mailed to Benjamin Golway, Contract Specialist, at Benjamin.Golway@fda.hhs.gov. All emails related to this notice must contain “FDA-SSN-1223623” in the subject line.

NOTE: Emails sent to the FDA contact stated in this notice shall not exceed 15 MBs (Megabytes) each.

Please also be advised that .zip and .exe files shall not be accepted. Responses must be received by the by the closing date and time stated above in order to be considered timely. Receipt of emails by FDA at the specified email address by the specified closing date and time is the sole responsibility of the responder.

The FDA shall not be responsible for late or non-delivery of emails due to IT problems, server or other technical issues.

FDA Contract Specialist point of contact for this notice:

Benjamin Golway Contract Specialist U.S. Food and Drug Administration Office of Acquisitions and Grants Services Benjamin.Golway@fda.hhs.gov mailto:Benjamin.Golway@fda.hhs.gov mailto:Benjamin.Golway@fda.hhs.gov mailto:Benjamin.Golway@fda.hhs.gov