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) is issuing this source sought announcement on behalf of the National Center for Toxicological Research (NCTR), Division of Biochemical Toxicology, in order to determine if there are existing small business sources capable of providing the items described herein. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 541380 - Testing Laboratories and services with a Small Business Size Standard is $19 Million and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to [email protected].

Background:  

The National Center for Toxicological Research (NCTR), Division of Biochemical Toxicology has a requirement for a Contractor to conduct Pig-a mutation frequency assays for in vivo rodent studies investigating low level exposure to ethyl methansulfonate (EMS). 

The Division of Biochemical Toxicology is investigating the genotoxic effects of EMS in an approved protocol entitled ‘Dose- and time-dependent formation of DNA adducts from ethyl methanesulfonate’ to investigate the shape of the dose response curve for the formation of DNA adducts and Pig-a mutation frequency from low levels of EMS.

Results of this study will help the FDA define safe limits of EMS exposure in pursuit of their overall mission to protect public health.

Objectives:

The objective of this study is to examine the shape of the dose-response curve for Pig-a mutation frequency after repeated administration of EMS at low levels.

Scope:

Due to the highly sensitive and technical nature of the Pig-a gene mutation assay, 180 rat samples collected at defined times over a 56-day exposure period will be shipped to the Contractor.  After the samples are received by the Contractor, the Contractor shall conduct the analysis of 180 samples and provide a final report.

Pig-a mutation Assay Minimum Technical Requirements:

1. Contractor shall provide In Vivo Rat Blood Freezing kit, which shall allow the user to collect, freeze, store and ship rat blood samples for analysis of Pig-a gene mutation.
2. The contractor shall conduct In Vivo analysis of rat blood samples that have been prepared and shipped by the FDA in a Freezing Solution.
3. The contractor shall provide raw data for all samples at the conclusion of the analysis to the Technical Point of Contact (TPOC).

Deliverables:

1. Within 30 calendar days of award the Contractor shall provide In Vivo Rat Blood Freezing kits to the FDA for collection of 180 samples. 
2. Within 180 calendar days after award, the FDA shall provide the Contractor with the 180 samples; samples shall be shipped on dry ice overnight via UPS or FedEx to the contractor POC designated at time of award. 
3. Within 90 calendar days after receipt of 180 samples, the Contractor shall perform a complete analysis of the 180 samples as specified above and deliver all data to the TPOC via email. 
4. Within 10 calendar days after the FDA’s receipt of data, the TPOC shall work FDA subject matter experts (SME) to verify sample data received as acceptable. 

Place of Performance:

FOB Point Destination. All items shall include shipping, handling and inside delivery and to the destination identified herein.

FDA/NCTR

Building 53B/203A

3900 NCTR Rd.

Jefferson, AR 72079

Period of Performance:

Total Period of Performance is 280 days.

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. 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 identification (UEI) 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.

• Provide Past Performance information of the same or substantially similar verifiable experience in providing Mutation assay by flow cytometer 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 UEI number and size status) if not the respondent.

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

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

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

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance 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.

• Informational pricing is desired.

• 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 due by email to the point of contact listed below on or before May 28, 2024 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email [email protected]. Reference: FDA-SSN-123427.

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 and solicitation may be published in sam.gov. 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.