SOURCES SOUGHT
A -- Research and Analysis of Clinical Pharmacology of Dissolvable Tobacco Products
- Notice Date
- 10/11/2011
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- RFI10112011
- Point of Contact
- Ann G. Argaman, Phone: 3018276758, Dawn Rabunsky, Phone: 301-827-7062
- E-Mail Address
-
Ann.Argaman@fda.hhs.gov, Dawn.Rabunsky@fda.hhs.gov
(Ann.Argaman@fda.hhs.gov, Dawn.Rabunsky@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- RESEARCH AND ANALYSIS OF CLINICAL PHARMACOLOGY OF DISSOLVABLE TOBACCO PRODUCTS This is a Request for Information (RFI) to identify the capabilities of the marketplace of all interested parties, including individuals, academic institutions, businesses, or other public or private agencies. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. Mission and Objectives: FDA anticipates the need to initiate a series of clinical studies of the dissolvable tobacco products (DTP). The clinical and clinical pharmacology information for DTPs is very sparse. In fact, none of the clinical studies of the pharmacokinetics and pharmacodynamics of DTPs described in the literature was prospectively designed (i.e. used an appropriate population of people; adequate sample size; assessed several meaningful biomarkers of exposure and response during the adequate length of time post-dose). There is no clear picture of the absorption, distribution and elimination of nicotine, its pharmacologically active derivatives after the administration of the dissolvable tobacco lozenges, pellets, and/or strips. Moreover, the pharmacokinetics and harmful effect of toxic compounds found in tobacco, such as nitrosamines, polyunsaturated and/or fluorinated hydrocarbons, heavy metals and volatile compounds in human biologic fluids, are not properly characterized for DTPs. The relationship between the biomarkers of exposure and response are not established for DTPs. The dissolvable tobacco lozenges are composed from the milled tobacco leafs and several ingredients with the functions of binding, protection of degradation, coating, taste making and flavoring. Together with the other flavors (cinnamon, vanilla, etc.) some products contain menthol as a direct addition as well as a part of the natural products (i.e. peppermint) extracts. Since it is well known that menthol in general influences the buccal absorption, it is important to evaluate the effect of menthol on absorption of nicotine and other components of the dissolvable tobacco products, including nitrosamines. The Office of Science of the FDA Center for Tobacco Products, therefore, plans to initiate a series of clinical studies of the dissolvable tobacco products. The information acquired in these studies will fill the gap of knowledge of clinical pharmacology of these products. The main objective of these studies are to evaluate the pharmacokinetics and pharmacodynamics of nicotine, its metabolites, as well as tobacco specific toxic compounds after the buccal administration of orally dissolvable tobacco products; to compare the bioavailability of nicotine after oral administration of the dissolvable tobacco product (4 mg nicotine lozenge) and to evaluate effect of menthol (mentholated and non-mentholated lozenges) on the nicotine pharmacokinetics. RFI Instructions: Please complete Part A, Specification Questionnaire, describing your company's capabilities; Part B, Size of Business and Part C, Estimated Dollar Value Range. Responses shall be:  identified with the RFI number ;  no more than five (5) pages in length;  not submit published or unpublished completed analyses;  Submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Part A. Technical Capability Specification Questionnaire: 1. Do you or your company have an ability to perform a clinical pharmacology study. Please describe the types of studies you have completed including the examples of their synopses. 2. Does your company have the expertise to utilize the clinical study methodology, establishment and validation of assay of chemicals in the human biologic fluids and interpretation of results (e.g. clinicians, nurses, laboratory technicians, data managers, pharmacokineticists, statisticians)? Please describe the staff expertise in this area. 3. Does your company have the ability to perform pharmacokinetic data analyses and provide a comprehensive written report, including tables, graphs, output arrays, etc? Please describe your experience with similar projects and the expertise of the staff utilized to perform that work. 4. What restrictions, if any, does your company place on sharing analyses with other government agencies or non-governmental organizations? Please describe the nature of any restriction (e.g., proprietary restrictions). Part B. Size of Business State whether your company is a large business, small business (and also state your socioeconomic status), College/University, or is a non-profit organization. Part C. Estimated Dollar Value Range Based on the government's mission and objectives, what dollar value range would you determine to be the most accurate rough estimate for the performance of such studies. Under $50,000.00 Over $50,000.00 and Under $200,000.00 Over $200,000.00 and Under $500,000.00 Over $500,000.00 and Under $1,000,000.00 More than $1,000,000.00
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/RFI10112011/listing.html)
- Record
- SN02605626-W 20111013/111011234708-e0fd92c70154668ba5f7f05d95bfc8da (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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