SOURCES SOUGHT
B -- E-Cigarette Engineering Analysis Laboratory Services
- Notice Date
- 7/20/2016
- 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-16-1162252
- Archive Date
- 8/18/2016
- Point of Contact
- Mekeba Barrett, Phone: 2404027563
- E-Mail Address
-
mekeba.barrett@fda.hhs.gov
(mekeba.barrett@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A REQUEST FOR QUOTE OR PROPOSAL AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED IN REFERENCE TO THIS NOTICE. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE. Background : Section 906 of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) provides FDA with the authority to enter into contracts for research, testing, and demonstrations respecting tobacco products and may obtain products for research, testing, and demonstration purposes. Based on this authority, FDA is seeking services by testing laboratories that may include analysis of the engineering of e-cigarettes, the composition of e-liquids and e-cigarette aerosols, method validation studies, or other projects that FDA needs to effectively regulate e-cigarettes and e-liquids. Description : FDA will provide all samples for testing and specify storage conditions and set specific timelines for the samples to be analyzed. The laboratory is expected to be ISO 17025-accredited and have advanced, modern day techniques to modify and analyze e-cigarette engineering characteristics. The laboratory will encounter issues for which there are no existing solutions specific to e-cigarette applications. It should have the engineering knowledge and capabilities to quickly and easily solve these issues, including manipulation of e-cigarette design. Instruments needed in this research may include infrared temperature sensors, thermocouple and DAQ readers, nanometer aerosol samplers, scanning mobility particle sizers, electrical, low pressure impactors, butanol-based condensation particle counters, airflow meters, pressure gauges, viscometers, battery failure assessment capabilities, and puff topography recorders. In addition, to analyze the impact of e-cigarette engineering, the laboratory may need inductively coupled plasma-mass spectrometry (ICP-MS), gas chromatography-mass spectrometry (GC-MS), high pressure liquid chromatography-mass spectrometry (HPLC-MS), high pressure liquid chromatography-diode array detector (HPLC-DAD), proton transfer reaction quantitative mass spectroscopy (PTR-QMS), aerosol-generating machine adapted for testing e-cigarettes, and an atomic absorption spectrometer. The laboratory should also be capable of performing engineering and chemical testing on multiple types of e-cigarettes including open and closed e-cigarettes, as well as the aerosols produced by these e-cigarettes. These projects will be limited to e-cigarette engineering manipulation and characterization and e-liquid and aerosol composition and as such will not include any in vitro or animal toxicological or human clinical studies. The laboratory must have extensive experience in e-cigarette engineering and compositional analysis as well as battery failure analysis and provide evidence for it. In addition, the laboratory must have the capability of conducting both the engineering and compositional analysis studies at the same location, so that e-liquid and/or aerosol composition is not altered due to transportation issues (e.g., leakage from packaging, lack of adequate refrigeration, extended time in storage) that could result in changes in aerosol or e-liquid composition. Technical Requirements : • The Contractor shall provide complete method procedure and method validation data to FDA for each measurement as well as means and standard deviations for each sample. A non-disclosure agreement (NDA) will be signed by FDA to protect any proprietary methods developed under this IDIQ. • The Contractor shall perform the necessary engineering, compositional, and battery testing analyses stated in each task order on a variety of e-cigarettes, identified by FDA, at appropriate and acceptable levels of quantitation, precision, and accuracy. • The Contractor shall perform acceptable quality control analyses while performing e-cigarette engineering and compositional analyses. Examples of acceptable quality control analyses may include, but need not be limited to, analysis of blanks and check standards. • The Contractor shall contact FDA immediately when quality control measures indicate that data generated by the Contractor may not be accurate. • The Contractor shall provide reports as described in each task order. • The Contractor shall ship all unused samples to FDA at the end of the study using an FDA FedEx or UPS account, at no additional cost to the Contractor. • The contractor must sign a confidentiality agreement. Interested vendors must submit a capability statement. Responses to this sources sought shall unequivocally demonstrate that the respondent is regularly engaged in the performance of the same or substantially similar services and possesses the required equipment, licensing and/or certifications/accreditation required. Though the target audience is small business, all interested parties may respond. At a minimum, responses shall include the following: • 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. • Past Performance information for the manufacturer and/or sale of same or substantially similar service to include date of sale, 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 the manufacturer (to include DUNS number and size status) if not the respondent. • Descriptive literature, brochures, marketing material, etc. detailing the nature of the service the responding firm is regularly engaged in manufacturing and/or selling. • 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. 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 t information received or provide feedback to respondents with respect to any information submit. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on FedBizOpps. 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). Notice of Intent : Responses to this Sources Sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. SUBMISSION INSTRUCTIONS : Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email. Please note the Government reserves the right to schedule interviews and /or product demonstrations with vendors. Responses shall be limited to 15 pages. Responses must be received in writing, no later than Wednesday, August 3, 2016 5:00 PM, Eastern Time. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Mekeba Barrett at mekeba.barrett@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-16-1162252/listing.html)
- Record
- SN04189368-W 20160722/160720234618-18602e21ac22efb895ab4193f297289b (fbodaily.com)
- Source
-
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