SOW.docx

U.S. Food and Drug Administration Center for Tobacco Products Statement of Work Custom Designed Video in Print Players

1. Background

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the U.S. Food and Drug Administration (FDA) with the authority to regulate the manufacture, distribution, and marketing of tobacco products to address public health issues, including use of tobacco by young people and dependence on tobacco. FDA recognizes that federal tobacco laws are relatively new to our stakeholders and since the enactment of the Tobacco Control Act and the inception of the Center for Tobacco Products (CTP), CTP has provided resources to those who need to understand the law and the regulations.

CTP’s Office of Compliance and Enforcement (OCE) aims to ensure that regulated industry complies with the laws. OCE uses a three pronged approach to help industry move towards this goal by: 1) developing and providing compliance training and education, 2) monitoring compliance with the law through surveillance, inspections, and investigations, and 3) taking advisory and enforcement actions such as issuing Warning Letters and Civil Money Penalties against noncompliant industry as appropriate.

Among other things, OCE intends to utilize the video in print players procured under this contract to provide targeted compliance training and education to tobacco retailers and other regulated industry on violations frequently observed during inspections in an attempt to achieve prompt, voluntary compliance with the law and regulations. OCE is committed to working with industry to ensure that they know, understand, and comply with the law. This procurement is just one part of an overall Compliance and Enforcement strategy aimed at reducing the disease and death from tobacco use.

2. Objectives & Scope of Work

The objective of this acquisition is to obtain the design, production, and delivery to CTP of 3,000 brochure style video cards uploaded with FDA supplied audio and video content that can be viewed by the end recipient. The Contractor shall provide design services that incorporate FDA provided text, logos, and images onto the cardstock; manufacture and deliver to CTP the required number of units by the delivery timelines; and meet all other requirements specified within this Statement of Work.

3. Product Specifications

The Contractor shall create and deliver a final product that meets the following specifications:

· LCD Screen size of 3.5 to 4.3 inches (measured diagonally)

· Integrated memory of at least 256MB

· Rechargeable battery with sufficient capacity for 1 hour of continuous play time

· A minimum of three dedicated control buttons to directly launch individual videos

· On/Off control

· Volume Up/Down controlled by Customer

· Ability to recharge battery via USB to mini USB cable

· Screen resolution of a minimum of 400 X 240

· Ability to play files in MPGE, MOV, or AVI formats

· Card stock with a minimum A4 size

· 3,000 Postal boxes to fit product

· Mechanism in place to drop ship replacements of defective units

· 3000 USB to mini USB cables with USB wall plug adaptors to support recharging

4. Specific Tasks

a. Kickoff Meeting and Provision of Card Stock Design Materials Within 30 calendar days after award, the Contractor shall meet with the Government via teleconference to discuss the project and any outstanding questions. Prior to that meeting, the Government will provide by electronic means the text, logos and colors to be used for the designing of the card stock

b. Creation and Submission of Draft Designs for Government Consideration The Contractor shall utilize the text, logos, and colors provided by the Government, create two draft designs for the cardstock, and submit them for Government consideration within 30 calendar days after the kickoff meeting. Within 30 calendar days after receiving the draft designs, the government will provide feedback regarding the selected draft design and any required alterations. The contractor shall implement the required modifications and submit a final draft for Government approval within 10 days of receiving feedback.

c. Provision of Video Content and Submission of Prototype Subsequent to final design approval, the Government shall provide the Contractor with the video content that will be uploaded to the final product. The Contractor shall utilize the approved design and video content to create and deliver to the COR for approval one prototype unit of the final product, in accordance with the specifications in section C.3., within 30 calendar days of receiving FDA’s video content.

Should the Contractor’s prototype fail to meet the contract specifications, or otherwise receive approval from the COR, the COR will provide feedback regarding the required changes, and the Contractor shall create and submit a new prototype incorporating those changes for approval.

d. Production and Delivery of Final Product

Upon receiving prototype approval from the COR, the Contractor shall, after incorporating the COR’s requested changes, create the integrated video player within the custom-designed CTP card. The Contractor shall ensure the units meet the minimum requirements specified in section C.3. above and shall upload the cards with the FDA provided video content. The Contractor shall deliver the 3,000 video cards, charging cables, and postal boxes to the COR at the address listed in section G.1.2. below, and according to the instructions specified in section D within 90 calendar days of receiving prototype approval.

The Contractor shall have a mechanism in place to drop ship replacements of defective units within 14 calendar days after receiving the defective units from the Government. The Contractor shall be financially responsible for all activities and materials involved with the shipping and replacement for all defective units.

e. Quality Control Plan

The Contractor shall implement, and maintain a written copy of, a Quality Control Plan (QCP) demonstrating how they will effectively monitor all aspects of the work they will provide for the Government. The QCP shall be specific to the work described within this SOW and describe a continuous process that monitors work that is being performed for CTP and the specific procedures for corrective actions to be taken when quality measures are not being met.

The QCP shall include realistic and comprehensive measures to identify and document problems, determine corrective actions, and determine improvement based upon corrective actions. The QCP shall also include the Offeror’s procedures for ensuring the functionality and contract specifications adherence of the video in print player; and for the convenient, rapid, and otherwise minimally burdensome procedures to allow for the return and shipment of replacement units for defective product units.

5. Period of Performance

The period of performance shall be 12 months from the date of award.

6. Deliverables

All deliverables required by this Contract shall be delivered to the COR at the physical address listed, except where indicated that the Contracting Officer (CO), Contract Specialist (CS), and the COR receive copies. The description of each deliverable is identified in the table below. All deliverables shall be subject to the inspection and acceptance of the COR. All time periods refer to calendar days.

Table 1. Deliverables

7. Inspection and Acceptance

The Government shall review all requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the Contracting Officer Technical Representative (COR). Requirements/deliverables shall be submitted to the COR or government designee in accordance with the delivery schedule. The acceptance of deliverables and satisfactory work performance, required herein, shall be based upon the timeliness and accuracy of the deliverables.

Acceptance may not be presumed under this order. The COR, or the duly authorized representative shall inspect and provide the contractor with requested changes or acceptance within 30 business days of receipt of deliverables.

The Contractor shall implement necessary changes within 10 business days, or a mutually agreed upon period of time, from the day of change notification.

The COR or the duly authorized representative shall perform inspection and acceptance of materials and services.

Inspection and acceptance shall be performed at: TBD.

8. Contracting Officer’s Technical Representative (COR)

The COR assigned to this acquisition is:

TBD

Performance of work under this Contract must be subject to the technical direction of the COR identified above, or a representative designated in writing. The term “technical direction” includes, without limitation, direction to the Contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

Technical direction must be within the scope of the specification(s)/work statement.

The COR does not have authority to issue technical direction that:

· Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

· Constitutes a change as defined in the clause entitled “Changes”;

· In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

· Changes any of the terms, conditions, or specification(s)/work statement of the Contract;

· Interferes with the Contractor's right to perform under the terms and conditions of the Contract; or

· Directs, supervises or otherwise controls the actions of the Contractor's employees.

Technical direction may be oral or in writing. The COR shall confirm oral direction in writing within five (5) business days, with a copy to the Contracting Officer. The Contractor shall proceed promptly with performance resulting from the technical direction issued by the COR. If, in the opinion of the Contractor, any direction of the COR, or his/her designee, falls within the limitations in Section (b) above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government business day. Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the Contract shall be subject to the terms of the FAR Clause 52.233-1, Disputes. The type of actions within the purview of the COR’s authority is to assure that the Contractor performs the technical requirements of the Contract, and to notify both the Contractor and the Contracting Officer of any deficiencies observed.

9. Place of Performance and Travel

No travel shall be conducted under this purchase order. The contractor is expected to perform the scope of this order off-site at the contractor’s facilities.

10. Government Information – Furnished

The Government will be responsible for submitting to the contractor the video content.