16-223-SOL-1159742.pdf

16-223-SOL-1159742

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PART I

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 SOLICITATION DESCRIPTION

The Contractor shall furnish all necessary facilities, materials, and personnel, and shall perform all non-personal services and program support necessary in a requirement titled, “Counterfeit Detection Device Development Project.”

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-86. The associated North American Industrial Classification System (NAICS) code for this procurement is 541712 Research and Development in the Physical, Engineering, and Life Sciences. The associated small business standard is 1,000 employees. This requirement is for a small business set-aside.

B.2 CONTRACT TYPE

The Government has a requirement for the development of a Counterfeit Detection Device and would like to solicit multiple innovative ideas from industry to fulfill this requirement. Therefore, this contract will be awarded in several stages using a multiple phase approach. The initial contract award will be a firm fixed price contract to several awardees. Following the completion of the fixed price contracts, a delivery order contract will be awarded to a single awardee.

B.3 PRICING

Note: The below pricing table applies to the Phase II: Prototype Development Phase and the delivery of the prototype.

Pricing for the firm fixed price contract is as follows:

Deliverable Price Interim Work Product $ Draft Final Work Product $ Final Work Product $

Total $

Pricing for the delivery order contract that follows the fixed price contract will be established final work product deliverable is submitted.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 BACKGROUND

Global manufacture and distribution of FDA-regulated products provides increased opportunity for counterfeit and falsified pharmaceuticals to enter the global domestic supply chain and reach consumers. In an effort to address and enhance the security of the domestic supply chain, FDA scientists developed the CDx, counterfeit detection device, currently in its version 3 plus (CD3+). This innovative technology provides a low-cost, convenient, and effective tool for FDA to use in protecting consumers from counterfeit or adulterated products.

The FDA has validated and successfully employed the device in the field at International Mail Facilities (IMFs). Consumer Safety Officers (CSOs) from FDA’s Division of Import Operations have been trained and use the CDx to screen incoming packages daily at the IMFs. The CDx has been used successfully in collaborations with other national and international regulatory agencies, to combat the growing problem of counterfeit pharmaceuticals.

There is a need for greater availability of this powerful, low cost device for both domestic and international use in the screening of suspect counterfeit or adulterated pharmaceutical products. The expansion of this reliable, user friendly and accurate CDx device for use in import screening, will improve the FDA’s and other regulatory agencies ability to detect counterfeit or adulterated pharmaceuticals, resulting in a positive impact on national and global public health.

A demonstration of the current device can be seen in Attachment 2. Attachment 2 is a video of an industry day event held by FDA to generate interest in the development of a new version of the device.

C.2 OBJECTIVES

The objective of this contract is to develop a CDx device that is more suitable for field use as well as to provide greater availability of the CDx to the field for the screening incoming packages. The FDA plans to fulfill this requirement by selecting multiple innovative vendors with the capability of developing and designing all aspects of a new and improved counterfeit device. Each of the selected vendors will then develop a prototype for the Counterfeit Detector 5 device (CD5). Both hardware and software applications to run the CD5 hardware off of smartphones are needed. Each prototype will be tested by the government and a single prototype will be selected for future production.

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C.3 STATEMENT OF WORK

Phase I: Technical Understanding

The contractor shall submit capabilities and teaming arrangements to the government in Phase I of the requirement. Submissions must demonstrate a feasible technical approach to fulfilling the government’s need and a description of the prototype testing procedures for the developed device that will be conducted in Phase II. A description of the necessary maintenance for the device as well as any calibration procedures should also be included in this submission. The contractor shall also describe similar experiences in developing other innovative technologies from the prime or teaming partners. The contractor shall demonstrate the capability to develop both hardware and software for a CDx as described in the specifications below. The approach to testing and calibration of the prototype shall be proposed in this phase.

Phase II: Prototype Development

Following the selection of several vendors to participate in this requirement, Phase II will consist of the development of a counterfeit detection device prototype. The selected vendors will begin Phase II with an in-person kickoff meeting to discuss the vision of the prototype, introduction of the team members, a demonstration of the currently used detection device and a discussion of any clarifying questions both parties might have.

Specifically, FDA is interested in a new, user friendly software design with an application to operate on a smartphone with add-on hardware. The add-on hardware should consist of an enclosure that can contain the components of the existing CDx and should include a platform which will accommodate various types of smartphones. The CD5 add-on hardware must be compatible with the to-be designed smartphone application. The CD5 add-on hardware must also be compatible with third party imaging apps native to the smartphone. The to-be designed smartphone application should be downloadable and be used to operate the CD5 hardware, capture images/videos; it will include an algorithm to compare a captured image against images stored in an online location (library) to determine if the captured product image is consistent with an image of the authentic product. The application should be designed to operate on several platforms including Android, iPhone, Blackberry, and Windows operating systems. The application must be user-friendly and require minimal training to operate the CD5 device with the add-on hardware.

Specifications:

The following specifications are what the FDA anticipates will be needed for the device.

However, alternative specifications may be accepted. Alternative specifications must be approved by the Contracting Officers Representative (COR) in advance.

1. Hardware

a. Cameras

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i. 4 imaging sensors (CCD, CMOS, etc.), each with a specific filter attached (e.g. longwave pass, shortwave pass, and/or bandpass)

1. UV/VIS min. 0.05 Lux at Faceplate, 700 TV lines with filter

2. UV/VIS min. 0.05 Lux at Faceplate, 700 TV lines with filter

3. IR at a min. sensitivity of 0.003 Lux at Faceplate, min.

600 TV lines with filter

4. IR at a min. sensitivity of 0.003 Lux at Faceplate, min.

600 TV lines with filter

ii. Auto focus, preferably with zoom capability (digital zoom ok)

iii. Resolution: 1.2MP (720P) minimum; preferably 5MP (1080P)

iv. Touchscreen capture capability with image and video storing;

storage can be on local drive (storage) or if available on micro SD card

v. Modifiable (update capable) imaging firmware preferred

b. CD5 Hardware Housing

vi. Must accommodate all types of smartphones

vii. Must include an internal, rechargeable battery and charging cord capable of four hours of operational use. This battery will run the CD5 hardware independently and is in addition to the smartphone internal battery.

viii. Compact

ix. Light weight (max. 2.5 lbs)

x. Fully portable

xi. Rugged

1. Acceptable dropping distance 3 feet without breakage

2. Rubberized cover

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xii. Integrated environmental light shielding (e.g. dark room environment, NIR blocking) to be used during sample illumination

1. Approximate hardware maximum dimensions including stand and dark room environment:

a. Height = 4in

b. Width = 5in

c. Length = 8in

xiii. Pelican case or protective case for transporting the device

xiv. Additional device requirements

1. Ability to withstand cleaning/decontamination (i.e.

bleach wipe down)

2. Minimum four hours of device use at ~110F and 90% relative humidity

3. Must be sealed to resist moisture and dust

c. LED Illumination with interface digital dimming

i. Only High Power LEDs (HPL); SMD of same power (number of lumen) output accepted

ii. LED wavelength accuracy of +/- 5nm or +/- 2nm depending on the specific wavelength

iii. QC element performance check for system use functionality

iv. Illumination uniformity: Min. of two HPL LEDs for each wavelength – to provide uniform illumination over the sample.

Same wavelength LEDs should be placed opposite of each other encircling the imaging sensors for an even illumination

v. Lambertian angle (min. 125°)

vi. COA for LEDs minimally listing wavelength accuracy and output (Lux)

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vii. LEDs and other electrical components must be of high quality production which should include sharing the purchasing source of these components in order to understand the quality of its production. A measurable stress test should be performed to evaluate the effect of high temperature and long term usage (ex.

Temperature and battery operation during an extended period of use).

viii. Shall have the ability to add up to six additional wavelengths for customization option

ix. LED wavelengths should be easily interchangeable by the manufacturer

x. Illumination overlap: each wavelength shall have a minimum of half of its radiation output overlap at a distance (height) of 3.5” from the surface mount.

1. 2 UV wavelengths each (@min. 700 mA OR 1W output)

2. 3 VIS wavelengths each (@min 700mA, @170lm)

3. 3 IR wavelengths

a. 1 wavelength (min. 75° @min. 700mA, 150mW)

b. 1 wavelength (min. 75° 210mW Infrared Emitters)

c. 1 wavelength (min. 75°, 315mW Infrared Emitters)

2. Software application

i. Scan Options

1. Auto scan (automatically scan product through all wavelength/filter combinations with an illumination time of 4 seconds per wavelength)

2. Manual scan (controlled through touch screen buttons)

3. Customizable scan (selection of wavelength and length of illumination)

ii. Viewing Options

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1. Four quadrant screen viewing – with capability to view all four imaging sensors simultaneously

2. Side-by-side Screen Viewing – Combinations will include:

a. Ability to perform multi-live view mode from any of the live video input signals by user select imaging sensor

b. Split screen displaying a stored image and a live video input view by user selected imaging sensor

c. Ability to view in single screen mode by user selected imaging sensor, allowing the user to swap between all four video input signals in order to compare with stored images

iii. Color System Value

1. L, a, b values (average of x number of pixels based on pointer location)

iv. Built-in Barcode Reader

v. Digital Microscope: Plug and play digital microscope or physical mini microscope with attachment to the specific smartphone being used, with a minimum 65x magnification.

vi. QC Element – a system performance operation check prior to use:

system scan using operational procedures in place in order to assess device performance and propose corrective action if a device problem occurs.

vii. The software / interface design:

1. The software design should require minimal training for the end-user; the end-user should easily be able to see the primary device operations in order to complete a scan.

Upon entering the software, the interface must have primary operation icons visible to the user. Examples of primary operation would be Scan Options, Viewing Options, Color System Value, Barcode reader, Digital Microscope, QC Element, etc.

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2. The software must also include secondary operation icons and these should follow the related primary operations interface. Upon entering a primary operation, the interface must have all its related secondary operation icons visible to the user.

viii. Secured login/encryption of data collected.

ix. Manufactured devices will include a one year warranty starting after inspection and acceptance of the Government.

Note: Inspection and acceptance of the device is expected to be done within a two week timeframe.

Prior to submission of the prototype the contractor shall conduct internal testing of the device to ensure usability and accuracy of the device. Testing procedures and results of the testing shall be documented and submitted to the government with the submission of the prototype.

The device must include a user guide giving step by step instructions for device use. The Government will use the guide to operate the device when testing the functionality of the prototype.

At the conclusion of Phase II each vendor shall submit to FDA a prototype of the counterfeit detection device along with the information described in the Final Work Product deliverable (See Section F.1). The submission will include an in-person demonstration of the device at the Forensic Chemistry Center, an instruction guide/manual for operating the device and a proposed unit price for the production of 450 units of the device. FDA will then begin testing each device submitted.

Phase III: Selection of Prototype for Future Production

Following the testing of each prototype, FDA will then select a single device for production. The selection of a device will be based on the evaluation factors located in section M. It is anticipated that FDA will then issue an IDIQ contract for the manufacturing and maintenance of the newly designed CD5. The scope of the IDIQ contract will be for the issuance of delivery orders for set numbers of units of the device and for the continued maintenance of the device through the issuance of task orders. The IDIQ contract will be in effect for a five (5) year period from the time of issuance.

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SECTION D - PACKAGING AND MARKING

All deliverables under this contract shall be packed and marked in accordance with best commercial practices to ensure safe and timely delivery.

SHIPMENT AND MARKING

Shipment of deliverable items shall be as follows:

Ship to: Food and Drug Administration

6751 Steger Drive Cincinnati, Ohio 45237

Mark for: TBD

The Contractor shall mark each shipment with the company name, the contract number, the item identification, quantity of items, and notice of partial or final delivery.

SECTION E - INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of materials, documents and services to be provided.

For the purpose of this PART, (COR – to be determined upon contract award) is the authorized representative of the Contracting Officer.

SECTION F - DELIVERIES OR PERFORMANCE

All deliverables shall be delivered F.O.B Destination to the COR for acceptance.

52.247-34F.O.B. DESTINATION (NOV 1991)

F.1 DELIVERABLES

Phase II: Prototype Development Deliverables:

Interim Draft Work Product – Due 90 days from the effective date of the contract. The Contractor shall submit to the COR an Interim Draft Work Product. Comments on this report will be provided by FDA within fifteen (15) calendar days after receipt. The interim draft work product shall also include:

• A prototype, example, or draft of the work product. The prototype should include preliminary data validation.

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• An indication of any current problems which may impede performance and proposed corrective action.

• A description of personnel who have contributed work on this phase. Include any current or proposed deviations from the Phase I proposal and a brief explanation as to why this change is in the best interest of the government.

Draft Final Work Product - Due 150 days from the effective date of the contract The Contractor shall submit to the COR a draft final work product, which will be after the completion and approval of FDA’s review of the interim draft work product. The contractor shall also submit, where applicable, draft drawings of the device, list of device functionalities, list of materials, raw data collected from the assessment of the device, and in some instances a final report. Documentation to support all the collected data records (data) which should include explanatory materials such as information about how the data was collected (conditions) and the procedures used, explanation of the presented data, complete list of identified variables, and full details of how the software communicates (coding) to the device and its components, and any classifications used throughout the presented data. The Contractor shall be prepared to present results to FDA at this point. This draft final work product is subject to the review and approval of FDA.

Such approval or disapproval, with any comments, will be provided by FDA within fifteen (15) calendar days after receipt.

Final Work Product - Due 180 days from the effective date of the contract The Contractor shall submit to the COR the developed detection device prototype which incorporates any recommended revisions and other changes from the draft final work product. Documentation will support all the collected data which should include explanatory materials such as information about how the data was collected and the procedures used, explanation of the presented data, a complete list of identified variables, full details of how the software communicates (coding) to the device and its components, and all classifications used throughout the presented data, and data validation.

Additionally, a final data report shall be presented for the device performance validation collection data and procedure information on how the system was evaluated. The final guide shall include tables, graphs, diagrams, curves, sketches, photographs and drawings as necessary and in sufficient detail to comprehensively explain the creation and use of the work product, which can be a database, model, or a written report. This deliverable is inclusive of an in-person demonstration of the prototype along with a user guide for the device.

F.2 PERIOD OF PERFORMANCE

The anticipated period of performance for the Phase II prototype development is six (6) months from the effective date of the contract.

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SECTION G - CONTRACT ADMINISTRATION DATA

G.1 CONTRACTING OFFICERS REPRESENTATIVE (COR) AND

CONTRACTING OFFICER

The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract;

and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in a task order; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

Sean Wybenga 5630 Fishers Lane Rockville, MD 20857 Sean.Wybenga@fda.hhs.gov;

Tel: (301) 827-6761; Fax: (301) 827-7106

G.2 INVOICE SUBMISSION

A. The Contractor shall submit one original copy of each invoice to the address specified below:

Office of Financial Services Food and Drug Administration

W032- Second Floor

MAIL HUB 2145

10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145

Silver Spring MD 20993-0002 mailto:Sean.Wybenga@fda.hhs.gov

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Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@FDA.GOV

B. Invoices submitted under this contract shall comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice shall be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice Date and Invoice Number;

(III) Purchase order/Award Number;

(IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (shall be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice;

(IX) Taxpayer Identification Number (TIN);

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award.

C. Questions regarding invoices shall be directed to the FDA at the telephone number provided above.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 CONTRACTOR PERFORMANCE EVALUATION(S)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

mailto:fdavendorpaymentsteam@FDA.GOV

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FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 15 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 15 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions.

Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.gov/allapps/cpcbtdlf.htm. There is no fee for registration or use of the

CPARS.

H.2 ACOUNTABILITY AND SECURITY

All Contractor and subcontractor employees who will have access to Government information and/or sensitive materials must sign a Confidentiality Agreement. It is the responsibility of the Contractor to assure that such Agreements have been signed before access is permitted. Copies of signed agreements should be provided to the COR.

H.3 508 STANDARD REQUIREMENTS

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194.

Information about Section 508 is available at http://www.section508.gov/. The complete http://www.ppirs.gov/ http://www.cpars.gov/allapps/cpcbtdlf.htm http://www.section508.gov/

Page - 14 - of 32 text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm

The contractor is expected to use the existing FDA environment and tools which are already in compliance with 508 standard requirements.

http://www.access-board.gov/sec508/provisions.htm http://www.access-board.gov/sec508/provisions.htm

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PART II – CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

I.1 HHSAR CLAUSES INCORPORTATED BY REFERENCE

This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:

http://www.hhs.gov/policies/hhsar/subpart301-1.html.

352.203-70, ANTI-LOBBYING (DEC 2015)

352.222-70, CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT

OPPORTUNITY INVESTIGATIONS (DEC 2015)

352.223-70, SAFETY AND HEALTH (DEC 2015)

352.224-70, PRIVACY ACT (DEC 2015)

352.227-70, PUBLICATIONS AND PUBLICITY (DEC 2015)

352.239-73, ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY

NOTICE

I.2 FAR CLAUSES INCORPORATED BY REFERENCE

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the CO will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

https://www.acquisition.gov/far/.

I. FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1)

1. 52.202-1 Definitions (NOV 2013)

2. 52.203-3 Gratuities (APR 1984)

3. 52.203-5 Covenant Against Contingent Fees (MAY 2014)

4. 52.203-6 Restrictions on Subcontractor Sales to the Government (SEP

2006)

5. 52.203-7 Anti-Kickback Procedures (MAY 2014) http://www.hhs.gov/policies/hhsar/subpart301-1.html https://www.acquisition.gov/far/

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6. 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or

Improper Activity (MAY 2014)

7. 52.203-10 Price or Fee Adjustment for Illegal or Improper Activity (MAY 2014)

8. 52.203-12 Limitation on Payment to Influence Certain Federal Transactions

(OCT 2010)

9. 52.204-4 Printed or Copied Double-Sided on Recycled Paper (MAY 2011)

10. 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (OCT 2015)

11. 52.209-6 Protecting the Government's Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment

(OCT 2015)

12. 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations

(MAY 2012)

13. 52.215-2 Audit and Records - Negotiation (OCT 2010)

14. 52.215-8 Order of Precedence - Uniform Contract Format (OCT 1997)

15. 52.215-17 Waiver of Facilities Capital Cost of Money (OCT 1997)

16. 52.219-28 Post-Award Small Business Program Re-representation (JUL

2013)

17. 52.222-1 Notice to the Government of Labor Disputes (FEB 1997)

18. 52.222-2 Payment of Overtime Premiums (JUL 1990)

The use of overtime is authorized under this contract if the overtime premium does not exceed $0.

19. 52.222-3 Convict Labor (JUN 2003)

20. 52.222-21 Prohibition of Segregated Facilities (APR 2015)

21. 52.222-26 Equal Opportunity (APR 2015)

22. 52.222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the

Vietnam Era, and Other Eligible Veterans (OCT 2015)

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23. 52.222-36 Affirmative Action for Workers with Disabilities (JUL 2014)

24. 52.222-37 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (FEB 2016)

25. 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

26. 52.222-50 Combating Trafficking in Persons (MAR 2015)

27. 52.222-54 Employment Eligibility Verification (OCT 2015)

28. 52.223-6 Drug-Free Workplace (MAY 2001)

29. 52.223-18 Encouraging Contractor Policies to Ban Text messaging While

Driving (AUG 2011)

30. 52.225-13 Restrictions on Certain Foreign Purchases (JUNE 2008)

31. 52.225-25 Prohibition on Contracting with Entities Engaging in Certain

Activities or Transactions Relating to Iran—Representation and Certification (Oct 2015)

32. 52.227-1 Authorization and Consent (DEC 2007) – Alternate I (APR 1984)

33. 52.227-2 Notice and Assistance Regarding Patent and Copyright

Infringement (DEC 2007)

34. 52.227-11 Patent Rights—Ownership by the Contractor (MAY 2014)

35. 52.227-16 Additional Data Requirements (JUN 1987)

36. 52.227-17 Rights in Data – Special Works (DEC 2007)

37. 52.232-23 Assignment of Claims (MAY 2014)

38. 52.232-25 Prompt Payment (JUL 2013)

39. 52.232-33 Payment by Electronic Funds Transfer-System for Award

Management (JUL 2013)

40. 52.233-1 Disputes (MAY 2014)

41. 52.233-3 Protest after Award (AUG 1996)

42. 52.233-4 Applicable Law for Breach of Contract Claim (OCT 2004)

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43. 52.242-13 Bankruptcy (JUL 1995)

44. 52.244-2 Subcontracts (OCT 2010) - Alternate I (JUN 2007)

45. 52.244-5 Competition in Subcontracting (DEC 1996)

46. 52.244-6 Subcontracts for Commercial Items (JUL 2013)

47. 52.245-1 Government Property (APR 2012)

48. 52.246-25 Limitation of Liability - Services (FEB 1997)

49. 52.249-2 Termination for Convenience of the Government (Fixed-Price)

(APR 2012)

50. 52.251-1 Government Supply Sources (APR 2012)

51. 52.253-1 Computer Generated Forms (JAN 1991)

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Part III – LIST OF DOCUMETNS, EXHIBITS, AND OTHER ATTACHEMENTS

SECTION J - LIST OF ATTACHMENTS

1. Data Documents

2. Industry Day Video

3. Phase II Testing Method

4. Form 3398

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SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER

STATEMENTS OF OFFERORS OR QUOTERS

52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS

(OCT 2013)

(1) The Offeror certifies, to the best of its knowledge and belief, that --

(i) The Offeror and/or any of its Principals --

(A) Are [_] are not [_] presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;

(B) Have [_] have not [_], within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) contract or subcontract; violation of Federal or State antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property (if offeror checks “have”, the offeror shall also see 52.209-7, if included in this solicitation); and

(C) Are [_] are not [_] presently indicted for, or otherwise criminally or civilly charged by a governmental entity with, commission of any of the offenses enumerated in paragraph (a)(1)(i)(B) of this provision; and

(D) Have [_], have not [_], within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,500 for which the liability remains unsatisfied.

(1) Federal taxes are considered delinquent if both of the following criteria apply:

(i) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.

(ii) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded.

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(2) Examples.

(i) The taxpayer has received a statutory notice of deficiency, under I.R.C. §6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(ii) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. §6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability.

This is not a delinquent tax because it is not a final tax liability.

Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(iii) The taxpayer has entered into an installment agreement pursuant to I.R.C. §6159. The taxpayer is making timely payments and is in full compliance with the agreement terms.

The taxpayer is not delinquent because the taxpayer is not currently required to make full payment.

(iv) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. 362 (the Bankruptcy Code).

(ii) The Offeror has [[_] has not [_], within a three-year period preceding this offer, had one or more contracts terminated for default by any Federal agency.

(2) “Principal,” for the purposes of this certification, means an officer; director; owner; partner; or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

This Certification Concerns a Matter Within the Jurisdiction of an Agency of the United States and the Making of a False, Fictitious, or Fraudulent Certification May Render the Maker Subject to Prosecution Under Section 1001, Title 18, United States Code.

(b) The Offeror shall provide immediate written notice to the Contracting Officer if, at any time prior to contract award, the Offeror learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.

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(c) A certification that any of the items in paragraph (a) of this provision exists will not necessarily result in withholding of an award under this solicitation. However, the certification will be considered in connection with a determination of the Offeror’s responsibility. Failure of the Offeror to furnish a certification or provide such additional information as requested by the Contracting Officer may render the Offeror nonresponsible.

(d) Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render, in good faith, the certification required by paragraph (a) of this provision. The knowledge and information of an Offeror is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings.

(e) The certification in paragraph (a) of this provision is a material representation of fact upon which reliance was placed when making award. If it is later determined that the Offeror knowingly rendered an erroneous certification, in addition to other remedies available to the Government, the Contracting Officer may terminate the contract resulting from this solicitation for default.

(End of Provision)

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS

(JUL 2013)

(a) Definitions. As used in this provision— “Administrative proceeding” means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceeding at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

“Federal contracts and grants with total value greater than $10,000,000” means—

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

“Principal” means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror [_] has [_] does not have current active Federal contracts and grants with total value greater than $10,000,000.

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(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in—

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management database via https://www.acquisition.gov (see 52.204-7).

(End of provision)

52.209-11 REPRESENTATION BY CORPORTATIONS REGARDING

DELINQUENT TAX LIABILITY OR A FELONY CONVICTION

UNDER ANY FEDERAL LAW (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that--

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting https://www.acquisition.gov/

Page - 24 - of 32 the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that—

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

(End of provision)

52.219-1 SMALL BUSINESS PROGRAM REPRESENTATIONS (OCT 2014)

(C) Representations

(1) The offeror represents as part of its offer that it [_] is, [_] is not a small business concern.

(2) [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [_] is, [_] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002.

(3) [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [_] is, [_] is not a women-owned small business concern.

(4) Women-owned small business (WOSB) concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(3) of this provision.] The offeror represents as part of its offer that—

(i) It [_] is, [_] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility;

and

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(ii) It [_] is, [_] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(4)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: _________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(5) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a women-owned small business concern eligible under the WOSB Program in (c)(4) of this provision.] The offeror represents as part of its offer that--

(i) It [_] is, [_] is not an EDWOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility;

and

(ii) It [_] is, [_] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(5)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: _____________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

(6) [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [_] is, [_] is not a veteran-owned small business concern.

(7) [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(6) of this provision.] The offeror represents as part of its offer that is [_] is, [_] is not a service-disabled veteran-owned small business concern.

(8) [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that –

(i) It [_] is, [_] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR part 126; and

(ii) It [_] is, [_] is not a HUBZone joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph (c)(8)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture:

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___________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

Special information

In Phase I the government will evaluate the submission and choose several vendors for participation in Phase II of the requirement. The reason for the selection of multiple vendors as opposed to a single vendor for this project is to receive several creative perspectives for the development of a new counterfeit detection device.

In Phase II no more than four (4) awardees will be awarded firm-fixed-price contracts to develop a counterfeit detection device prototype that meets the minimum specifications as described in the Specifications section of the Statement of Work. Awardees selected for this phase will have six (6) months to develop a counterfeit detection device prototype. Awardees are encouraged to partner and/or enter into teaming arrangements to complete this portion of the requirement.

The vendor selected as a result of Phase II will have the opportunity to receive a five (5) year IDIQ contract for the manufacture of the device. Actual unit amounts for the device may fluctuate. However, it is anticipated that between 400 and 500 units will be needed for field employees. The number of units purchased is also dependent on the final unit price for each device.

L.1 OFFEROR RESPONSE DATES AND TIME

RFP Due Date: All proposals and revisions shall be submitted electronically via email to Sean.Wybenga@fda.hhs.gov before 4:30 Eastern Time on 06 October 2016.

Note: Late proposals will not be evaluated.

352.215-70, LATE PROPOSALS AND REVISIONS (DEC 2015)

52.233-2, SERVICE OF PROTEST (SEP 2006)

Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Sean Wybenga 5630 Fishers Lane

FHSL RM2046

Rockville, MD 20857 mailto:Sean.Wybenga@fda.hhs.gov

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L.2 PROPOSAL INSTRUCTIONS

Note: Pursuant to FAR 52.215-1 (JAN 2004), subparagraph (f)(4), the Government intends to evaluate proposals and make awards without discussion with Offeror’s.

Therefore, the Offeror’s initial proposal should contain the Offeror’s best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if the Contracting Officer determines they are necessary.

Format

Cover Letter The cover letter shall include; a POC (name and telephone number); a statement from the Offeror verifying that they are SAM.GOV Registered under NAICS code 541712 and are a small business for this NAICS. DUNS and TIN number shall be included in the cover letter.

Proposals for Phase I: Technical Understanding shall be submitted in two (2) separate attachments:

Attachment 1 – Volume I Technical and Relevant Past Performance Attachment 2 – Volume II Cost/Price (Note: This price is for the completion of Phase II)

VOLUME I TECHNICAL

The Technical Volume shall be submitted in PDF format.