SSN 75F40124SSN123430.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY

COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS

ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable providing 100ML bottles of Sigma Aldrich, or equal, laboratory Nicotine Free Base: 98-100% purity.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 325998 – All Other Miscellaneous Chemical Product and Preparation Manufacturing (Electronic cigarette vapor liquids, including closed refills, manufacturing); with a Small Business Size Standard of 650 employees, and you believe that your firm would be able to provide the FDA with the products described herein, please submit an email with a capability statement to suzanne.martella@fda.hhs.gov.

As well, if your firm is an “Other than small business” and you may be able to supply this product, you are encouraged to submit a capability statement that provides company information, as well as information demonstrating that your firm can meet the minimum requirements included herein.

If your firm is any sized business who can supply a domestic product, please provide a capability statement which includes information on the proposed product and include the country of manufacture of the product offered.

Background and Requirement: The CTP/NCTR Inhalation Toxicology Facility is a collaborative research facility between CTP and NCTR for conducting inhalation toxicology studies invivo in support of CTP regulatory decisions. To support the ongoing nicotine inhalation study, a bulk purchase of Sigma Aldrich nicotine, or equal, is needed to complete the study while also maintaining the integrity of the research. The high purity of this nicotine is critical for the continuation of DBT’s nicotine inhalation toxicology studies. NCTR’s Chemistry Analytical Group analyzed the Sigma nicotine and reported “High Performance Liquid Chromatography Samples of the two test articles were also evaluated using a reverse phase HPLC column (Gemini C18) and an acetonitrile/water mobile phase and detection by an Evaporative light Scattering Detector (ELSD). One major peak was observed for both lots of the test article, with a purity estimate of 99.7 to 100%.”

In addition, the nicotine that CTP-NCTR InhaleCore used in the previous study: “A 5-Day Pilot mailto:suzanne.martella@fda.hhs.gov

Study of Nose-Only Inhalation Toxicity of Nicotine in Sprague-Dawley Rats (E07782.01 and E07782.11)” was manufactured by Sigma. Based on the results of this study, CTP has requested the CTP-NCTR InhaleCore conduct two follow-up studies to test toxicity of additional nicotine concentrations of inhaled tobacco-derived nicotine aerosol.

Because these two studies are continuation of the previous 5-day pilot study, it is critical to use the same nicotine manufacturer in this research.

This requirement is for a Brand Name or Equal solution. Proposed equal needs to meet all of the Minimum Specifications listed below to be deemed technically acceptable.

Minimum Specifications: The Nicotine shall:

1) Include a quantity of 148, 100ml containers; Millipore Sigma catalogue number: N3876-100ML, or equal

2) Must come standard with certified purity standard

3) Be colorless to yellow/orange

4) Be in liquid form

5) Be ≥ 99 % pure

6) Maintain specific rotation (20/D) of -177 to -162 Degrees

Delivery: Expected delivery is within 120 days of contract award.

Place of Delivery

The product shall be delivered to the National Center for Toxicological Research (NCTR) at the following address:

US FDA/NCTR

3900 NCTR Rd.

Bldg 50, Room 624 Jefferson AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, Unique Entity ID (SAM) number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include Unique Entity ID (SAM) number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the service the responding firm is regularly engaged in manufacturing or selling.

• How the proposed product will maintain integrity/consistency in nicotine from previous studies.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above.

• The offeror’s estimated historical on-site response time for the brand name and model of product in this requirement.

• If applicable, identification of the firm’s GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture of this product and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes.

The Government is not responsible for locating or securing any information not identified in the response.

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 2:00 pm (Central Time in Jefferson AR) on May 16, 2024 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40124SSN123430.

mailto:suzanne.martella@fda.hhs.gov

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 the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre‐solicitation synopsis or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

No proprietary, 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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.