Sources_Sought.doc

FDA Video in Print Sources Sought Notification This Sources Sought/Request for Information (RFI) is being issued in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration (FDA) or its Centers. The purpose of this RFI is to help the FDA understand the industry best practices and technical solutions capable of providing the full range of requirements described in this RFI. FDA will use this market research information to assess the market's capability to successfully meet the FDA's video in print requirements.

Sources Sought

Another purpose of this Sources Sought Notice/RFI is to determine the availability and capability of qualified small businesses (including Small Business Administration Certified 8(a) companies; firms in Historically Underutilized Business Zones (HUBZone); Service-Disabled Veteran-Owned small businesses; and Women-Owned small businesses).

FDA welcomes responses from all interested parties.

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.

Objective

The objective of this requirement 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 ultimate goal of the required video in print players are 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 possible procurement is just one part of an overall Compliance and Enforcement strategy aimed at reducing the disease and death from tobacco use.

Product Specifications:

The final product must meet the following specifications:

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

2. Integrated memory of at least 256MB

3. Rechargeable Battery with sufficient capacity for 1 hour of continuous play time

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

5. On/Off control

6. Volume Up/Down Controlled by Customer

7. Ability to recharge battery via USB to mini USB cable

8. Screen resolution of a minimum of 400 X 240

9. Ability to play files in MPGE, MOV, or AVI formats

10. Card stock with a minimum A4 size

11. 3,000 Postal boxes to fit product

12. Mechanism in place to drop ship replacements of defective units

13. 3000 USB to mini USB cables with USB wall plug adaptors to support recharging Specific Tasks

1. Kickoff Meeting and Provision of Card Stock Design Materials

Within 30 calendar days after any resulting 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.

2. 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.

3. 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.

4. 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 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 by mail 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.

Deliverables

Each deliverable for this requirement is identified in the table below. All time periods refer to calendar days.

Response Requirements Responses to this notice shall be limited to ten pages (excluding marketing literature and/or technical data sheets) and must include:

1. Organization name, and telephone number and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

2. Name, title, telephone number and e-mail addresses of individuals who can verify the demonstrated technical capabilities identified in the responses, if different from the individual above.

3. Commercial pricing list(s) or other pricing information.

4. Customary practices, including warranties, discounts, and contract type(s) under which commercial sales of the products or services are made.

5. To ascertain if the system is commercially available, deployed and proven; a listing of other organizations (Government and/or private industry) that have implemented the interested party’s item or service described in this notice.

6. Appropriate NAICS code.

7. DUNS number, CAGE code, and company structure (corporation, LLC, partnership, joint venture, etc.).

8. Verification of active registration in the System for Award Management (www.sam.gov).

9. Identification of any available contract vehicles, such as: GSA Federal Supply Schedules (schedule/contract number and appropriate Special Item Numbers) or other GWAC vehicles by agency and contract number.

10. Please provide the size classification of your business. If you are classified as a small business, HUBZone small business, Service Disabled Veteran Owned small business, Woman-owned small business and/or 8(a) certified small business, please provide a detailed capability statement, focusing on your firm's proven ability to provide the range of requirements. Additionally, please demonstrate your firm's capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting.

11. Any comments or suggestions concerning the FDA’s requirements. Specifically:

a. Are any of the FDA’s requirements too restrictive?

b. Are any of the FDA’s requirements inconsistent with standard commercial practices?

c. Does your company have any suggestions the FDA may want to consider regarding this requirement?

12. Please include a description of how you would build your own players or repurpose another manufacturer’s players (if applicable).

13. Please describe your company’s production capacity and how your company can meet the 3,000 player requirement within the timeframes described throughout this notification. If the timeframes are inconsistent with standard commercial practices, please describe the timeframes more consistent with standard commercial practices.

14. Describe your company’s environmental sustainability efforts and practices.

15. Describe how environmentally sustainable products and practices could be integrated in the FDA’s requirement.

Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. However, FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations.

Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation if issued. This announcement is Government market research and may result in revisions in both its requirements and its acquisition strategy based on industry responses.

Any questions regarding this notice must be submitted in writing to Christine Rynkiewicz at christine.rynkiewicz@fda.hhs.gov.

Respondents must submit a capability statement addressing each of the requirements, tasks, and response requirements to Christine Rynkiewicz at christine.rynkiewicz@fda.hhs.gov no later than the specified due date and time indicated on the Government Point of Entry (GPE) for consideration.