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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 14, 2018 FBO #5927
SOURCES SOUGHT

B -- Dissolution of Smokeless Tobacco Products

Notice Date
2/12/2018
 
Notice Type
Sources Sought
 
NAICS
541380 — Testing Laboratories
 
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
20857-0001
 
Solicitation Number
FDA-SS-1194857
 
Archive Date
3/20/2018
 
Point of Contact
Christine L. Russman, Phone: 3017967841
 
E-Mail Address
Christine.Russman@fda.hhs.gov
(Christine.Russman@fda.hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
Dissolution of Smokeless Tobacco Products Document Type: Sources Sought Solicitation Number: FDA-SS-1194857 Posted Date: 12 February 2018 Response Date: 5 March 2018 NAICS Code: 541380 Testing Laboratories, Small Size Standard is $15 M dollars. Part 1 - Description This is a Sources Sought Notice only. This is not a request for proposal, but a survey to locate potential sources. This Sources Sought does not constitute an Invitation for Bids, Request for Proposals or a Request for Quotations, and is not to be construed as a commitment by the Government to issue an order or otherwise pay for the information solicited, nor is it a guarantee of a forthcoming solicitation or contract. It is for market research purposes only. Respondents will not be notified of the results of the evaluation. The purpose of this Sources Sought Notice is to gain knowledge of interest, capabilities, and qualifications of various members of industry, to include the Small Business Community: Small Business, Section 8(a), Historically Underutilized Business Zones (HUB-Zone), Service-Disabled Veteran-Owned Small Business (SDVOSB), Women-Owned Small Business (WOSB), and Economically Disadvantaged Women-Owned Small Business (EDWOSB). The Government must ensure there is adequate competition among the potential pool of responsible contractors. Small business, Section 8(a), HUBZone, SDVOSB, WOSB, & EDWOSB businesses are highly encouraged to participate. Part 2 - Description/Specifications Purpose The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) requires a contractor to develop one selective dissolution procedure for each subcategory of smokeless tobacco products: loose moist snuff and snus, portioned moist snuff and snus, dry snuff, chewing tobacco, and dissolvables. The purpose is to measure the nicotine release profile of available market products in the USA in order to create a baseline for comparison of products and to investigate the effects of tobacco blend changes, formulation and pH changes, and physical parameters differences. The contractor shall develop and validate an analytical procedure (or adapt an existing procedure) to measure nicotine in the selected dissolution medium. The contractor shall also analyze the nicotine release profiles of marketed smokeless tobacco products. Statement of Work Capability Requirements: 1) Ability to purchase the required tobacco products 2) Ability to conduct a dissolution study 3) Access to a USP Apparatus 4-Flow-Through-Call Dissolution apparatus 4) Access to an appropriate chewing gum machine (e.g. Erweka DRT Chewing Gum Tester) apparatus Specific Tasks: Independently and not as an agent of the government, the Contractor shall furnish the necessary personnel and services required for, or incident to, the performance of the work as described to overall include: a) Samples - The contractor shall purchase the smokeless tobacco products per list to be provided in the USA, preferably within the Mid-Atlantic region (DE, MD, DC, VA, WV and PA), no later than 7 days after award. b) Analytical Test Method 1. The contractor shall have, or have access to, an appropriate USP Apparatus 4 - Flow-through-call dissolution apparatus and an appropriate chewing gum machine (suitable instruments are available from Erweka Gmbh) if not available in their current laboratory. 2. The contractor shall develop a recommended single dissolution procedure that can differentiate the nicotine release profile of Comparator A and Comparator B for each subcategory (moist loose snuff and snus, portioned moist snuff and snus, dry snuff, chewing tobacco, and dissolvables) of smokeless tobacco product. The analytical method used for nicotine release rate determination shall at a minimum include the following information: i. pH of dissolution media (pH gradient may be considered as necessary) ii. Dissolution media components (i.e. artificial saliva, artificial saliva with enzymes, pH 6.8 buffer, water, etc.) iii. Temperature of the dissolution media iv. Sampling times (at least 3 points in the initial release zone and at least 2 approaching steady state) v. Determination of t∞ time point (time at which all extractable nicotine as been released) vi. Media flow rate 3. The contractor shall adjust the dissolution conditions described in (2) above to ensure that the nicotine release profiles of Comparator A and B are significantly different. In theory, all the products included in the study should produce dissolution profiles that are significantly different and this should be the goal of the dissolution protocol development efforts. c) Testing 1. The contractor shall procure the smokeless tobacco products. The number of individual containers (cans, pouches, packs, etc.) of each product will be provided. This number indicates a minimum number of containers; additional containers may be procured at the contractor's discretion. [Note: where a product is unavailable, alternatives shall be proposed to CTP prior to procurement] 2. The contractor shall measure 12 replicate portions per container and 6 to 10 containers per tobacco product designated as Comparator A or B. All tobacco products without a special designation shall require at least 30 portions, (twelve portions from a single container, the remainder from additional containers) preferably from the same lot of material. 3. The contractor shall develop an analytical procedure for the measurement of nicotine in the dissolution medium. The analytical procedure shall be validated in accordance with ICH Q2(R). Alternatively, the contractor may adapt an existing validated nicotine assay procedure for this application. If the procedure has been previously validated, then the contractor shall demonstrate that the precision and accuracy of the procedure are unchanged by the dissolution medium and that the LOQ is sufficient to measure early dissolution time points. 4. The contractor shall consult with CTP to determine whether all the products within the same subcategory contain sufficient differences. If the products are sufficiently different, the evaluation of the balance of the products may be completed. In the case where the contractor has determined that subsequent adjustments to the dissolution procedure are necessary to achieve differentiation, the adjustment shall be reported to CTP prior to implementing the change. At the completion of the dissolution method development of each subcategory of smokeless tobacco product, the contractor shall prepare a report describing the proposed dissolution protocol, the analytical procedure, and the dissolution profiles of Comparators A and B. The contractor shall schedule a meeting with CTP within 1 month of the conclusion of the nicotine release method development and shall prepare and submit an interim report to CTP 3 months after completion of data collection for products with special designation. 5. The contractor shall determine the nicotine release profiles of each of the products in accordance with the parameters list in (b) above. 6. The contractor shall prepare and submit a final report 3 months after the final data collection for undesignated products (e). Part 3 - Instructions for Response Responses: All interested parties should notify this office in writing by mail or e-mail within the posted date. Responses shall include: (I) Capability statement that demonstrates minimum requirements outlined in the Statement of Work. Capability statement is limited to 10 pages. (II) Provide the following Business Information: - Company Name - Company Address - Company Point of Contact, name, phone number, and e-mail address - Type of business (i.e. commercial, academia), as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. any potential government contractor must be registered on SAM located at http://www.sam.gov/index.asp. - Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.) - DUNS Number - Classified as a large or small business based on size standard that accompanies NAICS code 541720. If a small business, you must also list any small disadvantaged status you hold [HUBZone, 8(a), Service Disabled Veteran Owned Small Business (SDVOSB), Women Owned Small Business (WOSB), Economically Disadvantaged Women-Owned Small Business (EDWOSB), etc.]. - Current GSA Schedules appropriate to this Sources Sought - Current Government Wide Agency Contracts (GWACs) (III) Past experience/ performance through the description of completed projects. (IV) Questions are due no later than 2:00 PM Eastern time 26 February 2108 and may be directed to Christine Russman, Contract Specialist, Christine.Russman@fda.hhs.gov. Responses to this sources sought are due no later than 2:00 PM Eastern time 5 March 2018. Submissions should be emailed to Christine Russman, Contract Specialist, at Christine.Russman@fda.hhs.gov Please be advised that.zip and.exe files cannot be accepted. The contact information for the Contract Specialist is the following: Christine Russman U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Christine.Russman@fda.hhs.gov;
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1194857/listing.html)
 
Record
SN04819749-W 20180214/180212231311-a31c4b5cd4c3f81033c6b9989bc753f0 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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