to obtain source or sources of currently marketed drugs products for FDA research studies.

Sources Sought: Small Business April 17, 2020 This is a Small Business Sources Sought notice. This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small business; HUBZone small businesses; service-disabled veteran owned small businesses; 8(a) or small disadvantaged businesses; women-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North America Industry Classification System (NAICS) code for the proposed acquisition (325412, Pharmaceutical Preparation Manufacturing, Size Standard: 1,250 employees). Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization which is not considered a small business under the applicable NAICS code should not submit a response to this notice. PURPOSE AND OBJECTIVES The purpose and objectives of this potential requirement is to obtain source or sources of currently marketed drugs products for FDA research studies. 3.0 Description of Work The contractor will fulfill orders from the FDA on an as-need basis for drug products currently sold on the US market. The FDA will request both brand name and any available generic products. Requested drug products may include small molecule and peptide therapeutics, drug-device combination products, and contrast agents. An anticipated list of drug products that will be requested for purchase is given in the Attachment 1 – Drug Product List. Other drug products not listed in the attachment may also be requested. The contractor must be able to supply a comprehensive list of pharmaceutical products to the FDA, including but not limited to those products listed in the Attachment 1 – Drug Product List Pricing. The contractor will provide the FDA with the following: Acquisition, management, and distribution of pharmaceuticals. Inventory management services including the calculation of safety stock levels at specific customer service levels. Transportation services to support emergency operations as required. Other supply chain management (including logistics) activities as required. The contractor shall be able to supply overnight delivery on stocked items when necessary. 4.0 Deliverables The contractor(s) shall have a DEA license and an import export license. The Contractor shall be able to arrange direct shipment from their contract vendor warehouses in accordance with the delivery dates below: Location Delivery date Domestic FDA office/laboratory Within 7 business days of order Domestic external research site Within 7 business days of order International external research site Within 14 business days of order Emergency Overnight Delivery The Contractor shall maintain a log of all drug products purchased. The Contractor shall provide all tracking information for all drug product orders to the FDA COR. 5.0 Period of Performance The Period of Performance is for 5 years, 6/01/2020-5/31/2025 6.0 Performance Locations Drug products shall be delivered to various FDA offices or laboratories; academic and industrial external research collaborators located throughout the U.S. and outside the U.S. CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement electronically to Howard Yablon at [email protected] in a commonly used format such as Microsoft Word or pdf. The capability statement shall be no more than five pages long excluding the cover page and table of contents. The FDA will be determining capability based on the ability to supply the above service maintenance as delineated above. Interested eligible small businesses shall also include company information to determine eligibility, including their contact information, DUNS number and size and business type (e.g. 8(a), HUBZONE, etc.). Potential offerors have until 3:00 PM ET, Friday, May 01, 2020 to respond to the FDA. DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of any information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY No propriety, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).