sources sought Human Pharmacology.pdf

Sources Sought Notice: Assessment of Tobacco Product Pharmacology/Toxicology and Human Behaviors in Tobacco Users.

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

This is a Sources Sought Notice to determine the availability of businesses capable of supplying the required supply item/services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government will award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a small business set-aside is possible.

Background

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 evaluate the impact of tobacco products on human behavior, switching behaviors, topography, pharmacology and toxicology outcomes.

On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (FSPTCA) was signed into law. The Tobacco Control Act granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health. Because tobacco products are not regulated as drugs, their effects on human behavior and pharmacology have not been fully evaluated by FDA. The Contractor will provide scientific support necessary to assist in the implementation of this law. The primary objectives of future contracts is to evaluate the impact of tobacco products (e.g., smokeless tobacco, cigarettes, cigars, electronic nicotine delivery systems (ENDS), hookah, gels, etc.) on human behavior, switching behaviors, topography, pharmacology, toxicology and biomarkers, including clinical pharmacokinetics, pharmacodynamics and subjective effects.

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 are as follows:

1. Develop scientific protocols and methodologies for clinical pharmacology and behavioral studies to evaluate switching behaviors, topography, pharmacology and toxicology outcomes.

2. Develop and/or validate laboratory assessments (including biological assays), measurement techniques, study protocols, and statistical analysis plans. Additional considerations are subject to specific study design and may include the manufacturing, manipulation, or procurement of study product as well as product characterization and stability.

3. Provide documentation for protocol package submission to the FDA Institutional Review Board

(IRB) and an external IRB, including comprehensive human subjects’ protection plans, consent forms, data safety and monitoring plan, and security plan for sensitive data.

4. Receive review and approval from an FWA-certified IRB.

5. Obtain Investigational Tobacco Product (ITP) clearance, if necessary.

6. Provide documentation and other information needed for submission of a packet to the Office of Management and Budget (OMB) including Information Collection Requests (http://www.hhs.gov/ocio/policy/collection/infocolsub.html).

7. Select an appropriate clinical research facility. Additional considerations are subject to specific study design and may include in-patient overnight and weekend visits.

8. Develop sampling and retention plans, including power analyses and expected drop out rates.

9. Provide recruitment, screening, and selection of participants based on inclusion and exclusion criteria.

10. Administer tobacco products to participants and provide appropriate medical monitoring.

11. Collect behavioral, biological and pharmacological/toxicological data, including data on use behavior and topography, switching behaviors, subjective effects, pharmacokinetic and pharmacodynamic analyses of tobacco and tobacco smoke constituents (e.g., nicotine, cotinine, CO, TSNAs) biomarkers. Additional outcomes are subject to specific study design but may include harm perception, sensory effects and acute health effects.

12. Deliver tabulated interim raw data as well as the results of all data analyses in SAS transport

(.xpt), Microsoft Excel, or other appropriate formats.

13. Develop a comprehensive quality assurance plan.

14. Develop laboratory and clinical final reports including up to date scientific literature reviews.

Capability Statements

Responses to this sources sought notice shall unequivocally demonstrate the respondent’s capabilities to provide the services above. Though the target audience is small business, 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, clinical recruitment challenges and solutions.

3. 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.

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

5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and http://www.hhs.gov/ocio/policy/collection/infocolsub.html

Schedule Item Numbers (SIN)s that are applicable to this potential requirement are also requested. If a large business, clarify 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 May 20, 2022 to lisa.jackson@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).

mailto:lisa.jackson@fda.hhs.gov