Sources Sought Notice- FDA Office of Clinical Pharmacology (OCP)_Division of Applied Regulatory Science.doc

Sources Sought Notice

FDA Office of Clinical Pharmacology (OCP)/Division of Applied Regulatory Science (DARS) Purchase of Phenomenex High-Pressure Liquid Chromatography (HPLC) Core-Shell Technology Columns and Consumables

1. Sources Sought Number: CDER-OTS-25-C-1691

2. Title: FDA OCP/DARS Purchase of Phenomenex High Pressure Liquid Chromatography (HPLC Core-Shell Technology Columns and Consumables.

3. Product Service Code (PSC): AJ12 General Science and Technology R&D Services; General science and technology; Applied Research

4. North American Classification System Code (NAICS): 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

5. Response Date: 07/01/2025 by 5:00 PM Eastern Standard Time (EST) due via email to the Primary Point of Contact listed in the SAM.gov webpage for this Sources Sought Notice

6. Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. An entity that is not considered a small business under the applicable NAICS code 541715 should not submit a response to this notice. This procurement is for the Purchase of Phenomenex High Pressure Liquid Chromatography (HPLC) Core-Shell Technology Columns and Consumables. The purpose of this notice is to obtain information regarding: (1) the availability of SBA certified HUBZone small businesses; SBA certified service-disabled veteran-owned small businesses (SDVOSBs); SBA certified 8(a) small businesses;; and SBA certified woman-owned small businesses (WOSBs)and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition, CDER-OTS-25-C-1691. This sources sought notice is for HPLC columns and consumables that are Brand Name or Equal to Kinetex HPLC Columns descriptions/part numbers/quantities identified below:

7.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. *Questions will not be entertained as a result of this notice*

8. Capability Statement: Provide a tailored capability statement describing how your organization would meet the requirements listed on the Draft Statement of Work. Include any pertinent information describing your technical qualifications and experience. Responses to the Sources Sought Notice shall not be longer than 10 pages. Information listed beyond the page limitation will not be considered. Capability Statements will not be accepted through US Mail or delivery services. Submit Capability Statements to Brandon Rafus at Brandon.Rafus@fda.hhs.gov with the subject line, “(solicitation number) Sources Sought Submission.” Please include your business size and socioeconomic status and your Unique Entity Identifier (UEI). Lastly, please complete and submit the attached vendor feedback form.

Disclaimer: This announcement constitutes the Sources Sought Notice; Capability Statements are being requested. 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 the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a solicitation may be published in Sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

The Food and Drug Administration intends to issue a Firm-Fixed Price type contract for the following:

PART 3 - CONTRACT ADMINISTRATION DATA

Government Point of Contact

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The Contracting Officer and Contract Specialist for the contract is listed below:

a. Contracting Officer:

Name: Linda Maria Finan Email: Linda.Finan@fda.hhs.gov

b. Contract Specialist:

Name: Brandon Rafus Email: Brandon.Rafus@fda.hhs.gov

c. Contracting Officer’s Representative (COR)

The COR appointed to this contract is identified below. See formal level of appointment for authorized duties/responsibilities.

COR Name: Disclosed at Award COR Telephone:

COR Email Address:

The COR may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification to the Contract. The responsibilities and limitations of the COR are as follows:

(1) The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor. The COR is also responsible for the final inspection and acceptance of all reports, and such other responsibilities as may be specified in the contract.

(2) The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the Contract price, terms or conditions. Any Contractor request for changes shall be referred to the Contracting Officer directly or through the COR. No such changes shall be made without the expressed prior authorization of the Contracting Officer (CO). The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the Contractor.