FDARFP1195133_Attach_2_TO1.docx

FDA-RFP-1195133

Attachment 2 – Task Order 1 Request for Task Order Proposal

Request for Task Order Proposal: 1195133a IDIQ Contract Number: To Be Awarded Proposal Due Date: 2:00 PM EST, 3 August 2018 Requirement: “Relationship between Wicking Rate and Other ENDS Design Parameters” Company: DUNS:

1. Background The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) has a requirement for the engineering analysis of e-cigarettes. The purpose of this project is to characterize the material composition and design parameter characteristics of e-cigarette atomizers and will include method development and validation.

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 for the analysis of physical design parameter characterization of e-cigarette atomizers, temperature of the heating coil, and chemical composition of e-cigarette aerosols.

1.2 Objectives

CTP has a need to study e-cigarettes to understand how the devices function and the potential impacts of these devices on public health. As e-cigarettes have evolved, new models have increased user control of device settings including a variety of choices in atomizers, atomizer coils, wicks, airflow settings, etc. If the wicking rate is insufficient, all of these parameters combined can cause a “dry puff,” essentially burning of the wick, and cause an increase in carcinogenic carbonyls and other HPHCs. It is therefore important to characterize the design parameters of the variety of atomizers currently on the market in order to understand their effect on aerosol characteristics and how they may have negative impacts on public health. Given the increasing diversity of e-cigarettes, it is imperative that FDA is able to conduct rigorous scientific e-cigarette-related research projects to effectively regulate all tobacco products as defined in the FD&C Act.

PART 2 – SUPPLIES AND SERVICES

2.1 Task Order Type:

The Government anticipates the award of a firm-fixed (FFP) price task order because of this RTOP.

2.2 Pricing Table:

The total firm-fixed price for this project is $_______________.

Upon completion and acceptance of all deliverables under each task the contractor shall submit an invoice for payment.

PART 3 – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

3.1 Scope of Work:

FDA will provide all samples for testing and set specific timelines for the samples to be analyzed. The laboratory is expected to be ISO 17025-accredited and is expected to have advanced, modern day techniques to analyze physical design parameters of state-of-the-art tank atomizers, temperature of the coil, and chemical composition of e-cigarette aerosols.

3.2 Description of Tasks:

1. Develop Test Methods The contractor shall develop and validate methods to:

a. measure all independent design parameters and wicking rate

b. determine the occurrence of dry puff conditions in a non-clinical setting (e.g. quantitatively evaluate chemical constituents of ENDS-produced aerosols to determine if there is a dramatic increase in carbonyls, VOCs, PAHs, etc. during dry puff conditions compared to normal “vaping”; or temperature of the wick may dramatically increase without e-liquid present, indicating the occurrence of a dry puff)

c. measure wicking rate while ENDS devices are in use

d. mix PG, VG, and nicotine to create e-liquid at different PG and VG ratios with 16 mg/ml nicotine.

2. Perform Testing The contractor shall use design of experiments (or similar systematic experimental design) to vary the following design parameters at one time and measure the resulting effect on wicking rate. The contractor shall also identify which of the following combinations of conditions result in a dry puff based on the production of carbonyls and other HPHCs:

a. Type of wicking material, amount, and porosity of wicking material

i. Japanese organic cotton

ii. Ceramic-coated coil

iii. Stainless steel mesh

b. E-liquid compositions and their resulting viscosities (all at 16 mg/ml nicotine):

i. 65/35 PG/VG

ii. 50/50 PG/VG

iii. 35/65 PG/VG

c. Power levels (W)

i. 10

ii. 50

iii. 100

iv. 150 The table below is a matrix of the different conditions that shall be tested in this task order

3. Identify Devices

a. The contractor shall identify one atomizer that can be used with a variety of wicking materials, and with adjustable airflow. Alternatively, the contractor can identify 2-3 different atomizers in order to identify atomizers that use all three wicking materials; however, the atomizers shall minimize the variation in other design parameters such as:

i. Tank volume (ml)

ii. Length of airflow column (mm)

iii. Number of coils

iv. Coil location (top of bottom)

v. Coil mass and wire gauge

vi. Maximum volumetric air flow

b. The power sources shall be capable of providing up to 200 W to the coil consistently and reliably. The power source does not need to be an e-cigarette battery.

4. Final Report The contractor shall provide a final report that includes:

a. Detailed description of methods, including validation data, equipment, and protocols used to test each design parameter including:

i. Any alterations made to the original methods developed in Task 1 and justifications for those alterations (e.g. unforeseen obstacles).

ii. All raw data related to method development and validation

iii. Complete description of design of experiments (or other technique)

iv. A detailed description of all conditions measured including e-liquid composition (viscosity and density of varying concentrations of PG, VG, and water in e-liquid), , volumetric air flow, and wattage.

b. All raw and summary data (including averages and standard deviations)

i. Data shall be provided in excel spreadsheet format.

ii. Data shall include the change in wicking rate due to variation of the design parameters.

3.3 Government Furnished Property:

FDA will provide the contractor with all the tank atomizers to be tested. FDA will provide the contractor with sufficient atomizers for all testing. Any additional consumables (e.g. vegetable glycerin or propylene glycol for e-liquid, coil material (or coil head replacements)) necessary for parameter testing shall be purchased by the contractor. All PG, VG, and nicotine shall be USP grand and shall be purchased by the contractor.

52.245-2 Government Property (April 2012)

PART 4 – INSPECTION AND ACCEPTANCE

The Government shall review all reporting requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the COR. Reporting Requirements/Deliverables shall be submitted to the COR or government designee in accordance to the delivery schedule. The acceptance of deliverables and satisfactory work performance, required herein, shall be based upon the timeliness and accuracy of the deliverables. Draft deliverables and findings will be reviewed by a Technical Advisory Group. Final deliverables will be reviewed by the contracting officer, the project officer, and other designated members of the Contracting Office at the completion of work.

52.246-4 Inspection of Services—Fixed-Price (Aug 1996)

PART 5 - DELIVERIES AND PERFORMANCE

5.1 Deliverables and Milestones

The section 1.2 Objectives and section 3 Scope of Work forms the basis for the following proposed schedule of deliverables. The actual schedule of deliverables may vary based on the final agreed upon work plan. The COR will review all deliverables before final acceptance, and provide comments to the contractor within three to five business days. All documents, plans, diagrams, presentations, etc., are to be submitted solely in electronic form and in the native file format of Microsoft Word 2010, Excel 2010, or Power Point 2010, or later versions. The Contractor shall provide the following, because of specific tasking in performance of the activities in this SOW. All deliverables shall be sent to the COR listed in section 6.3.

Deliverable Schedule

5.2 Progress Reports

The Contractor shall provide a progress report by the 15th of every month starting the first month after contract award. The progress report shall include, but not be limited to, preliminary data analysis, and adverse and unexpected effects, and any event that may affect the schedule or any contract deliverables.

5.3 Period of Performance

The period of performance of this work is seven months (28 weeks) from task award and receipt of the supplies

5.4 Staffing

The contractor shall staff the project with one project manager who shall be responsible for participating in kick-off/closing meetings, ensuring that personnel are making necessary progress in meeting deliverable deadlines, and resolving any performance issues with personnel among other duties.

The contractor shall ensure that all personnel are adequately trained, possess the requisite experience, and are otherwise fully qualified to provide the high level of support required by this SOW prior to being assigned to this task order. In the event that any personnel are found to not be able to perform the tasks listed in the SOW, CTP shall reserve the ability, at any time, to ask the contractor to find adequate replacements within a reasonable timeframe.

PART 6 – SPECIAL CONTRACT REQUIREMENTS

6.1 Security and Privacy

The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval of the Government.

Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation.

Due to the sensitive nature of the information involved, all contractor personnel will be required to sign a non-disclosure agreement before data and information otherwise exempt from public disclosure (e.g. Privacy Act or Data Collected Under an assurance of Confidentiality) may be disclosed to them.

The contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the contract that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change.

Each contractor/subcontractor employee who may have access to non-public Department information under this contract shall complete and submit the FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer or designee prior to performing any work under the contract. The Project officer or designee will inform the contractor of any additional forms and training that are required.

6.2. Place of Performance and Equipment

Work shall be completed at the contractor’s accredited laboratory/site.

Meetings and presentations will take place via teleconference or as determined by the COR.

6.3 Points of Contact

The Contracting Officer for this order is:

Matthew Bucher U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Matthew.Bucher@fda.hhs.gov 240-402-7570

The Contract Specialist for this task order is:

Christine Russman

FDA/OFBA/OAGS/DAP

5630 Fishers Lane Rockville, MD 20851 Christine.Russman@fda.hhs.gov 301-796-7841

Contracting Officer’s Representative (COR): TBD

PART 7 - CONTRACT CLAUSES

52.227-14 Rights in Data—General (Dec 2007)

PART 8 – INSTRUCTIONS TO OFFERORS

8.1 Proprietary Data

The contractor shall provide a descriptive list of the data that is considered confidential, commercial value, and/or trade secret information.

8.2 Response Dates

All quotes shall be submitted via email to Christine Russman, Contract Specialist at Christine.Russman@fda.hhs.gov .

8.3 Proposal Instructions

The Offeror’s proposal shall consist of two (2) separate volumes.

· Volume 1 shall consist of the Technical Approach.

· Volume 2 shall include the Price Proposal.

Volume 1: Technical Proposal:

The page limitation for the technical proposal is 30 pages (resumes and relevant experience are not included in this page limitation). Offerors shall use only 8.5 inch by 11-inch (210mm by 297mm) paper, single-spaced pages with margins no less than one inch on each border; number each page consecutively; do not use a font size smaller than Times New Roman 12. The following items are not included in the page limit:

· Cover Sheet

· Table of Contents

· Resumes

An individual authorized to contractually bind the Offeror shall sign the cover page of the Technical Volume.

Technical Plan/Approach:

Offerors shall demonstrate their understanding of the requirements of this solicitation as they relate to the different tasks described in the SOW by giving a detailed, narrative description of how they would approach the listed tasks. The detailed narrative description should also include how and why certain tasks may differ based on the level of complexity of the e-cigarette being tested. This narrative shall also explain how perceived difficulties and obstacles will be overcome and the risks managed or mitigated.

The offeror shall demonstrate the capacity to provide the services described in the SOW.

Volume 2: Price:

The Offeror is required to submit a price proposal with prices filled into the Part 2 tables along with a total price for the overall project and a proposed pricing schedule.

PART 9 - AWARD DECISION

Award will be made to the party whose proposal offers the best value to the Government based on the evaluation of the criteria above. The Government may award this task order to other than the lowest price technically acceptable proposal. Technical is significantly more important than Price. When these factors are equal, Price becomes the determining factor.