Sources Sought Nicotine Dose Discrimination Small Business.docx

Sources Sought Notice: Nicotine Dose Discrimination Study

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to support the Center for Tobacco Products (CTP) requirement for services to assess whether smokers are able to discriminate between two modestly different nicotine doses delivered from two different marketed cigarettes, and to compare smokers’ ability to discriminate nicotine doses in those cigarettes with their ability to discriminate two similar doses of nicotine delivered intravenously.

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 businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition, 541720. 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 that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

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

Scope of Work:

Independently, and not as an agent of the Federal Government, the Contractor shall have the capability to furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described below. The task areas to be supported include:

1. Develop a study protocol for the clinical portion of this project.

2. Develop a laboratory study protocol to chemically characterize the products to be utilized as well as perform stability testing throughout the clinical study.

3. Obtain proper human subject protections approvals.

4. Perform a clinical study.

5. Analyze data to include: clinical study biosamples, pharmacokinetic data, pharmacodynamic data, puff topography, physiological effects, subjective effects and reinforcement data.

6. Develop a clinical and laboratory study report at the conclusion of the project.

Overview of Services Requested

This project will use established laboratory methods to assess whether smokers are able to discriminate between two modestly different nicotine doses delivered from two different marketed cigarettes, and to compare smokers’ ability to discriminate nicotine doses in those cigarettes with their ability to discriminate two similar doses of nicotine delivered intravenously. Smokers’ success in discriminating nicotine doses from two marketed cigarettes and discriminating two doses of intravenous nicotine will be measured. The Contractor shall implement a double-blind, within-subject cross-over study in which current dependent, non-menthol cigarette smokers will complete three experimental study visits. During these visits, each participant will puff two Spectrum brand research cigarettes which differ in nicotine yield, puff two marketed, brand cigarettes which differ in nicotine yield, and will receive intravenous (IV) infusions containing two different doses of nicotine. Visit 1 will serve as a training/screening visit during which eligible participants will receive instructions to puff two Spectrum brand research cigarettes over multiple trials using a prescribed puff regimen. Participants who meet specific requirements after Visit 1 will continue participation on Visits 2 and 3. On Visits 2 and 3, participants will take part in test trials during which they will each puff two marketed cigarettes chosen for their difference in nicotine yield on one visit, and will receive two doses of nicotine delivered intravenously on the other visit. The order of Visits 2 and 3 will be randomized. The Contractor shall use methods recommended by the Government to measure success of nicotine dose discrimination after participants puff the Spectrum cigarettes, after participants puff the marketed cigarettes, and after participants receive the IV infusions. The Contractor shall recommend a puff topography data collection device to control puff volumes/smoke exposure during cigarette use. After each nicotine exposure from cigarettes or infusions, the Contractor shall measure subjective effects (e.g., self-reported urge to smoke, nicotine withdrawal, mood, sensory effects, product reward, product reinforcement). Biological samples (e.g., blood plasma nicotine) shall be collected after each cigarette/IV nicotine exposure to measure pharmacokinetic nicotine exposure, and pharmacodynamic measures (e.g., heart rate, blood pressure) will also be collected.

Two non-menthol marketed cigarettes, with different nicotine yields, will be administered to each participant during the clinical study. Cigarette flavor, full or “light” flavor, will be matched to the flavor of each participant’s usual brand. The Contractor shall perform chemical analyses on the two study marketed cigarettes to assess characteristics such as, but not limited to, nicotine yield, tar, pH, and Carbon Monoxide (CO) in the smoke, verified by the International Organization for Standardization (ISO) and Canadian Intense (CI) smoking regimens, as well as nicotine content, ventilation data, and physical characteristics (e.g. ventilation percentage, rod length, rod weight, rod diameter, filter length, draw resistance, and tobacco filler weight) of the products.

Capability Statements:

Responses to this sources sought shall unequivocally demonstrate the respondent’s capabilities to provide the services above. All interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, DUNS 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.

2. Past Performance information shall include date of services, 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 company (to include DUNS number and size status) if not the respondent.

3. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing.

4. 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 if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

Response Instructions:

Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 3:00 pm Eastern Time on December 19, 2019 to Tara.Hobson@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 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).

Responses to the sources sought shall be no longer than 10 pages.