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B -- Sources Sought: Assessment of Tobacco Product Pharmacology/Toxicology and Human Behaviors in Tobacco Users - FDA-17-223-SS-1178035

Notice Date
Notice Type
Sources Sought
541690 — Other Scientific and Technical Consulting Services
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
ZIP Code
Solicitation Number
Archive Date
Point of Contact
Christopher R. McGucken, Phone: (240) 402-7566
E-Mail Address
Small Business Set-Aside
Sources Sought Notice: 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 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, and pharmacology/toxicology, inclusive of clinical pharmacokinetics and pharmacodynamics. This is a Sources Sought notice to determine the availability of Small 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 set-aside is possible. 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. Input and development of scientific protocols and methodologies for clinical pharmacology and behavioral studies. 2. Selection of an appropriate clinical research facility. 3. Development and/or validation of assessments (including biological assays), measurement techniques, study protocols, and statistical analysis plans. 4. Documentation and other assistance necessary for package submission to the FDA RIHSC (Research in Human Subjects Committee), including comprehensive human subjects’ protection plans, consent forms, data safety and monitoring plan, and security plan for sensitive data. 5. Obtain Investigational Tobacco Product (ITP) clearance, if necessary. 6. Provide approval from an FWA-certified IRB. 7. Documentation and other information needed for submission of a packet to OMB (Office of Management and Budget) including Information Collection Requests ( http://www.hhs.gov/ocio/policy/collection/infocolsub.html ). 8. Develop sampling and retention plans, including power analyses and expected drop out rates. 9. 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), harm perception, and other possible 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. Development of a comprehensive quality assurance plans. 14. Perform and document safety and quality assurance testing. 15. Conduct scientific literature reviews. Capability Statements: Responses to this sources sought 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, 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 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 March 16th, 2017 to Christopher.mcgucken@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).
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SN04406212-W 20170218/170216235506-64b2904ecf2f680c1c77958667f023dd (fbodaily.com)
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