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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 17, 2016 FBO #5350
SOLICITATION NOTICE

B -- Chemical Analysis of Cigarette Butts - FDA-RFQ-1169382

Notice Date

7/15/2016
 

Notice Type

Combined Synopsis/Solicitation
 

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 - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-RFQ-1169382
 

Archive Date

8/24/2016
 

Point of Contact

Lisa K. Yaw, Phone: 2404024018
 

E-Mail Address

lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

FDA/CTP has a requirement for a study to support characterization and quantification of specific chemical constituents and HPHCs in leachate from cigarette butts. THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is being issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-88-1. The associated North American Industrial Classification System (NAICS) code for this procurement is 541712. Its associated Small Business size standard is 500 employees. The Government intends to award this purchase to a small business. Part 2 - Supplies or Services and Prices/Costs Purchase Order Type: Firm-Fixed Price Base Year TaskDescriptionPrice 1Cigarette Butt Collection, Identification of Test Methods, and Analysis Plan Development 2Preparation of Leachate 3Analysis of Leachate 4Draft Final Report 5Final Report 6Final Briefing Total Part 3 - Description/Specifications 3.1 Background A major existing environmental consequence of cigarette use is the waste disposal of discarded cigarette filters, as an estimated 4.5 trillion cigarette butts are thrown away every year worldwide and 1.69 billion pounds of cigarette butts are disposed of as toxic trash each year., In addition, research has shown cigarette butt leachate to be toxic to fish. The National Environmental Policy Act requires an impact analysis on the environment, as well as scenarios that could lead to human health impact, for federal actions, such as tobacco product marketing authorizations. Information about the identities and amounts of constituents that leach from cigarette butts is limited and is necessary to characterize the hazard and model the fate and transport of the constituents in the environment. A preliminary study to identify leachable constituents, including Harmful/Potentially Harmful Constituents (HPHCs), from cigarette butts will provide information to design focused, high value, cost effective fate and effects studies when needed in the future. 3.2 Statement of Work The objectives of this study are to: •conduct laboratory analysis of three replicates from a single cigarette butt leachate; and •characterize and quantify the different chemical constituents and HPHCs from the lab analysis for the leachate Under the contract, the FDA is interested in conducting a study to support characterization and quantification of specific chemical constituents and HPHCs in leachate from cigarette butts. Tasks/Requirements The Contractor shall: •determine appropriate "off the shelf" analytical methodologies (e.g. - EPA Methods 8270 and 8310 for organics and EPA Method 200 series for metals) for the constituents of concern identified in Task 2; •collect cigarette butts for analysis; •prepare cigarette butt leachate; •measure the amounts of each chemical constituent and HPHCs in the leachate; •identify unknown constituents that have a mass greater than 10% of the total injected mass; •monitor, manage, and maintain data collected during the contract period; and •submit a final report that includes the following sections: executive summary, methods, results, discussion, and conclusions. The Contractor shall follow all federal, state, and local environmental, health, sanitation and emissions regulations. In addition, the Contractor shall follow all applicable Environmental Protection Agency (EPA) and Occupational Safety & Health Administration (OSHA) regulations. Disposal of cigarette butts, leachates and laboratory waste must follow the above environmental, health and safety regulations. Task 1: Cigarette Butt Collection, Identification of Test Methods, and Analysis Plan Development The Contractor shall identify the project timeline, develop and implement a cigarette butt collection plan, and develop an analytical methods plan for conducting the leachate tests. Additionally, the Contractor shall conceptualize how the analysis shall be performed based on the list of chemical constituents in Task 3. The Contractor must verify that the selected test methods have been validated to achieve the study's objectives. The methods must be determined to be fit for purpose, which includes consideration of, but not limited to, the following method characteristics: accuracy, precision, robustness, limit of detection, limit of quantification, range, and specificity. The Contractor, with concurrence from the COR, may perform multiple tasks at one time for efficiency. The Contractor shall submit a cigarette butt collection plan, test methods for conducting leachate tests, and an analysis plan to the COR for concurrence and feedback. The Contractor shall collect cigarette butts to use for preparing the leachate. This study is not a human subject study. This study is not a research activity involving human subjects for study recruitment. It does not involve obtaining information about living individuals. There will be no interaction or intervention with individuals. No individuals will be interviewed nor their individually identifiable information obtained. The study does not involve videotaping, recording, or surveying individuals. The Contractor shall collect only cigarette butts and will not interact with humans from whom cigarette butts are obtained. Task 2: Preparation of Leachate The Contractor shall prepare a leachate by placing cigarette butts in distilled or deionized water for 24 hours, making note of cigarette butt weights, number of butts used and water volume. The Contractor shall determine the appropriate volume of water and number of butts to use in order to minimize the need for, or number of, extraction and concentration steps. Task 3: Analysis of Leachate Using the validated analytical methods proposed in Task 4, the Contractor shall analyze three replicates of the leachate to quantify levels of each chemical constituent and HPHC. The Contractor shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions. For sample mass, the Contractor shall report the data to at least three decimal points, as well as the accuracy of the analytical balance and the date of last calibration. The Contractor shall quantify the chemical constituents and HPHCs listed below: 1,3-ButadieneAcroleinCrotonaldehydePAHs (total)Chromium (Cr) 1-AminonaphthaleneAcrylonitrileFormaldehydePhenol and catecholLead (Pb) 2-AminonaphthaleneAldehydes (total)Isoprenem-, p-, and o-cresolMercury (Hg) 4-AminobiphenylBenzeneNicotine (total and free)Arsenic (As)pH AcetaldehydeBenzo[a]pyreneNNK and NNNCadmium (Cd)Glycerol, propylene glycol ethylene glycol, and diethylene glycol In addition to the above list, the Contractor shall identify any constituents not on the list (i.e. - unknown) that have a mass greater than 10% of the injected mass. Analytical results will be reported in mg/L, mg/cigarette butt and mg/kg of cigarette butts. Task 4: Draft Final Report The Contractor shall submit a draft of the final report within 3 months of contract award. The Contractor shall prepare a detailed final report including: 1) an executive summary; 2) identification of the laboratory used and methods describing how the data was collected and analyzed; 3) results of the analysis; 4) discussion, including problems encountered during the study and their solutions; and 5) conclusions; and 6) related appendices. As a part of the final report, the Contractor shall submit analytical procedures (including details regarding extraction procedures and/or any other procedures used during sample preparation), validation reports, system suitability, and any other pertinent information for measuring the analytes indicated in Task 3. Task 5: Final Report The Contractor shall submit a Final Report within 4 months that presents the objectives, methods, results of the analyses, and summarizes the findings and conclusions of the project. The Final Report shall include the required elements outlined for the draft report (Task 4) and shall incorporate any revisions based on comments received from the FDA. The Contractor shall provide the Final Report to the COR in the following manner: 1.An electronic version of the final report. 2.The final report delivered on a CD Rom. Task 6: Final Briefing Within 4 months of the award, the Contractor shall conduct a final briefing to FDA personnel via web conference. This briefing shall consist of a 30- to 40-minute presentation of the project and shall include a background on the problem, descriptions of methods used, the results of the tasks, and a brief discussion of the results and problems encountered during the study. The Contractor shall be prepared with appropriate briefing materials and shall send their presentation materials to the COR for review within two days prior to the presentation date. Key Personnel The Contractor shall provide the names and resumes of the key personnel assigned to this contract. The individuals cited below are key personnel •Principal Investigator/Project Manager •Lead Scientist •Technician Part 4 Performance and Deliverables 4.1 Place of Performance The work for this project will take place at the Contractor's laboratory facility and contractor site. All deliverables shall be sent to the COR electronically at the following address: COR / Point of Contact: Food and Drug Administration Center for Tobacco Products Division of Regulatory Project Management, Branch I 10903 New Hampshire Avenue White Oak Campus, Bldg. 32, Rm 4144 Silver Spring, MD 20993 ATTN: TBD 4.2 Deliverables TaskDescriptionEstimated Completion Date 1Kickoff Meeting/ Initial BriefingWithin 2 weeks after award 1Develop a cigarette butt collection plan, test methods, and an analysis planWithin 2 weeks after award 1Collect cigarette butts to use for preparing the leachateWithin 1 month after award 2Prepare leachate Within 1 ½ months after award 3Analyze replicates of the leachate Within 2 months after award 4Summarize findings in draft reportWithin 3 months after award 5Summarize findings for Final ReportWithin 4 months after award 6Prepare briefing materials2 days prior to final briefing 6Conduct Final BriefingWithin 4 months after award 4.3 Reporting The COR may request conference calls to discuss status of deliverables and any other issues which may arise with the contract. The COR will coordinate a schedule with the Contractor to determine when the conference calls will occur on an as needed basis. Monthly Progress Reports The Contractor shall furnish one electronic copy to the FDA COR by the 1st of each month. At a minimum, the progress report shall include a narrative description of the following items: 1.Accomplishments made during the reporting period. 2.Plans for accomplishments in the next reporting period. 3.Interim results, conclusions, trends or other items of information that the Contractor believes are of interest to the FDA. 4.Problems or delays that the Contactor has experienced in the performance of his/her services, as well as any quality assurance and control measures taken during the reporting period 5.Specific action(s) that the Contactor would like the FDA to undertake to alleviate a problem. 6.Due dates for upcoming deliverables. 4.4 Period of Performance The period of performance is four (4) months or September 1, 2016 to January 5, 2017. See attachment for full RFQ.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFQ-1169382/listing.html)
 

Place of Performance

Address: 10903 New Hampshire Avenue, White Oak Campus, Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN04184306-W 20160717/160715234328-eef21c1dd1496793c7751cb948bd3dd7 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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