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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 A REQUEST FOR QUOTE (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 purpose of this notice is to obtain information regarding the availability and capability of qualified sources and their business size status.

North American Industry Classification System (NAICS):

The North American Industry Classification System (NAICS) code for the proposed requirement is: 541990.

Business Status:

Please provide your business size status (e.g., small business, 8(a), HUBZone, etc) and Unique Entity Identification (UEI) number.

Capabilities and Technical Experience:

Provide a capability statement describing how your company would meet the requirements described within this source sought announcement. Responses to the sources sought shall be no longer than 10 pages.

Capability statements are to be submitted by email only to Pamela Lee (Contract Specialist) at Pamela.Lee@fda.hhs.gov. Reference: FDA2023116537.

Responses to this Sources Sought shall demonstrate that the respondent is regularly engaged in the sale of same or substantially similar 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.gov) 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 services.

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

• 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 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.

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

**QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE**

Background

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law (Public Law 111-31). The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted the FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The FDA has authority over cigarettes, smokeless tobacco, and roll-your-own tobacco. The FDA has also obtained deem jurisdiction over other tobacco products, including e-cigarettes, on August 8, 2016.

Use of tobacco products expose the consumer to a variety of harmful and potentially harmful constituents (HPHCs) and other toxic chemicals that commonly result in the occurrence of adverse health outcomes. These HPHCs and other toxic chemicals may interact with each other in ways that enhance their toxic effects. There is a significant research knowledge gap in understanding the mechanisms and magnitude of these interactions between HPHCs and other toxic chemicals and if these interactions result in observable increases in toxic effects. These interactions and resulting enhanced toxicity may partially explain the observed discordance between predicted lifetime cancer risk associated with use of tobacco products and reported epidemiological data.

FDA seeks more information on the occurrence of interactions between HPHCs and other toxic chemicals present in tobacco products, and how these interactions may result in enhanced toxic effects.

Objectives

The objectives of this contract are to develop an aerosol co-exposure system for use with a human relevant in vitro air-liquid interface (ALI) airway tissue model, to characterize the occurrence of cytotoxic and genotoxic responses following exposure to single and combined aldehydes, and to assess the occurrence of enhanced cytotoxic and genotoxic responses following co-exposure to this aldehyde mixture to identify if toxic interactions between these HPHCs occur. The human relevant in vitro ALI airway tissue model will consist of differentiated normal human primary tracheobronchial epithelial cells collected from a single donor. This aerosol co-exposure system will utilize model aldehyde HPHCs (i.e., formaldehyde and acrolein) that likely undergo toxicologically relevant interactions and have complementary mechanisms of toxicity.

The findings of this study will assist FDA in understanding the occurrence of toxicological interactions between mixtures of HPHCs produced from tobacco products and their effect on the development of toxicity following exposure. These findings will also provide a platform to analyze if these interactions between HPHCs may affect the calculated lifetime cancer and non-cancer risk of tobacco products.

Scope

Under this contract, FDA expects the development of an aldehyde HPHC aerosol co-exposure system, using model aldehyde HPHCs (i.e., formaldehyde and acrolein), paired with a human relevant in vitro ALI airway tissue model consisting of differentiated normal human primary tracheobronchial epithelial cells collected from a single donor. FDA expects that this aerosol exposure system and human relevant in vitro model will be used to evaluate the occurrence of toxic responses following exposure to single aldehyde HPHCs and a mixture of aldehyde HPHCs. The toxicity data produced from this work will be used to evaluate the occurrence of toxicologically relevant interactions (i.e., additive, antagonistic, synergistic) between these aldehyde HPHCs.

Tasks

• Meetings (Kick-off, Bi-weekly, and etc.)


• Monthly Reports


• Study Protocol Review and Study Experiments


• Data Analysis Plan


• Study Report

Other Unique Requirements

FDA considers the sharing of FDA-funded research, including digital data, an important means to enhance its value and support future research. When the findings associated with research developed with FDA funds are published, they are required to be made readily available to the public. In addition, investigators seeking FDA funding, in whole or in part, via a contract, grant, or assistance agreement must have an FDA-approved Data Management Plan – a plan for digital data management and sharing – prior to commencing any related services or work. FDA will retain ownership of the data produced during performance of its contracts and retains sole responsibility to draft, prepare, review, and submit any subsequent manuscripts using this data for publication in any format.

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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

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.

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