Sol_Doc_(002).pdf

This is a combined synopsis/solicitation for commercial items prepared in accordance with the

Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

proposals are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures and FAR 13.5

Simplified Procedures for Certain Commercial Items. The solicitation number is 1194677. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2005-97 dated January 24, 2018.

The associated North American Industry Classification System (NAICS) Code is-339999- All

Other Miscellaneous Manufacturing; Small Business Size Standard is 500 employees. This RFQ is issued as a total small business set-aside.

Schedule of Items (Note: No Option Periods for post-warranty preventative and corrective service for the Optional Line items will be exercised past the base contract award to include any exercised Option Periods).

Contract

Line

Item

(CLIN)

Description Quantity Unit Unit Price Extended

Price

Base System. Provide and install a turn-key automatic watering system, inclusive of shipping, delivery, installation and training as specified herein, in the

NCTR Bldg. 53B

Processing Area (Cage

Wash) and Bldg. 53C

Animal Housing Area, Rooms 102, 103, 104, 105, 109, 110, 111, 112, 113, 114, 115, 116, 119, 120, 121, 122, 123, 124, 125, 126, 131, 132, 133)

1 Job $___________ $___________

Option Year 1 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 1 automatic watering system above.

12 Months $___________ $___________

Item

(CLIN)

Description Quantity Unit Unit Price Extended

Price

Option Year 2 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 1 automatic watering system above.

12 Months $___________ $___________

Option Year 3 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 1 automatic watering system above.

12 Months $___________ $___________

Option Year 4 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 1 automatic watering

Optional Item 1 (FAR

52.217-7)

Provide and install a turn-key automatic watering system, inclusive of shipping, delivery, installation and training as specified herein, in NCTR Bldg.

53A Animal Housing

Area, Rooms 102, 103, 104, 105, 106, 110, 111, 112, 113, 114, 115, 116

1 Job $___________ $___________

Option Year 1 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair

Item

(CLIN)

Description Quantity Unit Unit Price Extended

Price service on CLIN 6 automatic watering system above.

Option Year 2 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 6 automatic watering system above.

12 Months $___________ $___________

Option Year 3 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 6 automatic watering system above.

12 Months $___________ $___________

Option Year 4 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 6 automatic watering

Optional Item 2 (FAR

52.217-7)

Provide and install a turn-key automatic watering system, inclusive of shipping, delivery, installation and training as specified herein, in NCTR Bldg.

53B Animal Housing

Area (Rooms 101, 102, 103, 107, 108, 109, 110).

1 Job $___________ $___________

Option Year 1 (FAR

52.217-9): Post-

Warranty preventative

Item

(CLIN)

Description Quantity Unit Unit Price Extended

Price and corrective/remedial maintenance repair service on CLIN 11 automatic watering system above.

Option Year 2 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 11 automatic watering system above.

12 Months $___________ $___________

Option Year 3 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 11 automatic watering system above.

12 Months $___________ $___________

Option Year 4 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 11 automatic watering

Optional Item 3 (FAR

52.217-7)

Provide and install a turn-key automatic watering system, inclusive of shipping, delivery, installation and training as specified herein, in NCTR Bldg.

53D (Rooms 103, 104, 105, 106)

1 Job $___________ $___________

Option Year 1 (FAR

52.217-9): Post-

Item

(CLIN)

Description Quantity Unit Unit Price Extended

Price

Warranty preventative and corrective/remedial maintenance repair service on CLIN 16 automatic watering system above.

Option Year 2 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 16 automatic watering system above.

12 Months $___________ $___________

Option Year 3 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 16 automatic watering system above.

12 Months $___________ $___________

Option Year 4 (FAR

52.217-9): Post-

Warranty preventative and corrective/remedial maintenance repair service on CLIN 16 automatic watering system above.

Grand Total Items 1 through 20 $______________

The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Veterinary Services (DVS) requires a turn-key automatic watering system to supply water to rodents in building 53 at the Jefferson Lab Campus.

The NCTR is the primary research facility within the FDA, and as such, conducts animal studies to support the mission of Center for Biologics Evaluation and Research (CBER), Center for Drug

Evaluation and Research (CDER), Center for Tobacco Products (CTP), National Toxicology

Program (NTP), and Center for Food Safety and Applied Nutrition (CFSAN). The Division of

Veterinary Services at the NCTR supports research projects that conduct animal studies including studies with rodents. The Division of Veterinary Services oversees the care of the rodents, and ensures the appropriate supply of water and food for the animals. Maintaining a proper supply of water for the rodents is a critical veterinary care issue.

The NCTR requires the modification of Building 53 animal facility to provide automated water to the rodents using an automatic watering system in the animal holding rooms. The automated watering system shall include permanent water delivery system, automated computer system for controlling the watering system, and a flush system to flush the cage mounted components at the time of cage sanitation. An option to establish post-warranty preventative and corrective maintenance services after the standard warranty period is also included.

The Contractor shall provide and install a turn-key automatic watering system to supply water to rodents housed in Building 53 at the following locations:

a) Base System, NCTR Bldg. 53B Processing Area (Cage Wash) and Bldg. 53C Animal

Housing Area, Rooms 102, 103, 104, 105, 109, 110, 111, 112, 113, 114, 115, 116, 119, 120, 121, 122, 123, 124, 125, 126, 131, 132, 133);

b) Optional Item 1. NCTR Bldg. 53A Animal Housing Area, Rooms 102, 103, 104, 105, 106, 110, 111, 112, 113, 114, 115, 116;

c) Optional Item 2. NCTR Bldg. 53B Animal Housing Area (Rooms 101, 102, 103, 107, 108, 109, 110); and

d) Optional Item 3. NCTR Bldg. 53D Animal Housing Area (Rooms 103, 104, 105, 106).

See Attachment 1 for floor plans of building 53A and Attachment 2 for floor plans for building

53 B, C, D and E.

Performance requirements

General specifications:

The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration.

Minimum specifications- Brand name or equal

The overall system shall consist of (1) a computer control station to operate the stand-alone controller system , (2) stainless steel piping (compliant with Water NSF ANSI 61 standards) from the water source to pressure reducing stations (if required) outside each housing room, (3) stainless steel piping into the rooms to each housing station, (4) recoil hose to connect the water system to each cage, (5) the ability to periodically flush the system and drain the flushed water, and (6) capability to sanitize the system.

Equipment:

Base System, NCTR Bldg. 53B Processing Area (Cage Wash) and Bldg. 53C Animal Housing

Area, Rooms 102, 103, 104, 105, 109, 110, 111, 112, 113, 114, 115, 116, 119, 120, 121, 122, 123, 124, 125, 126, 131, 132, 133):

Computer Controller Monitoring System shall be a STAND ALONE system that will not connect to the FDA network that will provide real time monitoring and control of the automatic water system to Building 53 and can support all the additional space options

(Optional Items 1-3) included in this Statement of Work.

Required features of the Computer Controller Monitoring System are:

o The automated system shall be a standalone system that monitors and controls pressure reducing stations (if required), monitors water flow through the system, controls room and rack flushing, and sends automated alarms when the system is out of specifications.

o Shall have a user friendly interface.

o Shall be compliant with 21 CFR part 11 electronic record storage requirements

An automated flush system installed in cage wash area (clean side), capable of flushing the water lines on the cage racks.

An automated flush system installed in cage wash area (clean side) capable of flushing the recoil hoses.

A chlorine injection system compatible with the flush systems.

A reverse osmosis system sized large enough to supply the needs for all areas included in this SOW (Base System and Optional Items 1-3).

Automated control panels necessary to support these functions.

Pressure reducing stations (if required) sufficient to serve Bldg. 53C’s 23 animal housing rooms equipped with automated-flush and monitoring, a shut-off valve and an injection port for system sanitization. The cabinet shall be of such durable material to withstand chemical sanitization.

Interconnect stations for Bldg. 53C’s 23 rooms each equipped with a detachable recoil hose with stainless steel quick disconnect couplings. Stainless steel piping (compliant with Water NSF ANSI 61 standards) shall be free of irregular surfaces or glue at the joints which serve as nidus for biofilm creation. Piping shall be mounted using standoff brackets and mounting hardware to allow for sanitation of the walls and ceiling behind the pipes.

Within each room there will be interconnect stations with the following numbers:

maximum of 7 rooms containing 5 racks per room (Bldg. 53C, Rooms 102, 103, 104, 105, 131, 132, 133); and 16 rooms containing 2 racks per rooms (Bldg. 53C, Rooms 109, 110, 111, 112, 113, 114, 115, 116, 119, 120, 121, 122, 123, 124, 125, 126). Piping shall include clean joint (without glue or irregular surfaces) stainless steel (compliant with

Water NSF ANSI 61 standards) complete with standoff brackets and mounting hardware.

Detachable supply hoses for each of the base-requirement 23 housing rooms (number of racks per room listed above) and any required for the flushing stations.

Stainless steel flush valves (compliant with Water NSF ANSI 61 standards) at terminal ends of distribution system with an extension of the stainless-steel piping to a drain within the animal room.

An automated controller panel with power supply to monitor pressure reducing stations

(if required) for high and low pressure, system leak, and control automated flush valves.

A portable sanitation system compatible with the injection ports at the pressure reducing station (if required).

A wall-mounted sanitation system compatible with flushing the rack mounted components during cage sanitation. (Can be contained in a portable system that can flush racks and ports at pressure reducing station (if required).)

A plan to minimize impact of installation to an occupied facility shall be included.

Optional Item 1: NCTR Bldg. 53A - Animal Housing Area, Rooms 102, 103, 104, 105, 106, 110, 111, 112, 113, 114, 115, 116

Equipment

Pressure reducing stations (if required) sufficient to serve twelve (12) animal housing rooms equipped with automated-flush and monitoring, a shut-off valve and an injection port for system sanitization. The cabinet shall be of such durable material to withstand chemical sanitization.

Interconnect stations for the twelve (12) rooms each equipped with a detachable recoil hose with stainless steel quick disconnect couplings. Stainless steel piping (compliant with Water NSF ANSI 61 standards) shall be free of irregular surfaces or glue at the joints which serve as nidus for biofilm creation. Piping shall be mounted using standoff brackets and mounting hardware to allow for sanitation of the walls and ceiling behind the pipes.

Within each room there will be interconnect stations with the following numbers: a maximum of 5 rooms containing 6 racks per room (Rooms 102, 103, 104, 105, 106); and a maximum of 7 rooms containing 9 racks per room (Rooms110, 111, 112, 113, 114, 115, 116). Piping shall include clean joint (without glue or irregular surfaces) stainless steel

(compliant with Water NSF ANSI 61 standards) complete with standoff brackets and mounting hardware.

Detachable supply hoses for each of the twelve (12) housing rooms (number of racks per room listed above) and any required for the flushing stations.

Stainless steel (compliant with Water NSF ANSI 61 standards) flush valves at terminal ends of distribution system with an extension of the stainless-steel piping to a drain within the animal room.

An automated controller panel with power supply to monitor pressure reducing stations

(if required) for high and low pressure, system leak, and control automated flush valves

A portable sanitation system compatible with the injection ports at the pressure reducing station (if required).

A wall-mounted sanitation system compatible with flushing the rack mounted.

components during cage sanitation. (Can be contained in a portable system that can flush

Optional Item 2: NCTR Bldg. 53B – Animal Housing Area (Rooms 101, 102, 103, 107, 108, 109, 110)

Pressure reducing stations (if required) sufficient to serve seven (7) animal housing rooms equipped with automated-flush and monitoring, a shut-off valve and an injection port for system sanitization. The cabinet shall be of such durable material to withstand chemical sanitization.

Interconnect stations for the seven (7) rooms each equipped with a detachable recoil hose with stainless steel quick disconnect couplings. Stainless steel piping (compliant with

Water NSF ANSI 61 standards) shall be free of irregular surfaces or glue at the joints which serve as nidus for biofilm creation. Piping shall be mounted using standoff brackets and mounting hardware to allow for sanitation of the walls and ceiling behind the pipes.

Within each room there will be interconnect stations with the following numbers: a maximum of 5 racks per room (rooms 101, 102, 103, 107, 108, 109, 110) . Piping

(compliant with Water NSF ANSI 61 standards) shall include clean joint (without glue or irregular surfaces) stainless steel complete with standoff brackets and mounting hardware.

Detachable supply hoses for each of the seven (7) housing rooms (number of racks per room listed above) and any required for the flushing stations.

Stainless steel (compliant with Water NSF ANSI 61 standards) flush valves at terminal ends of distribution system with an extension of the stainless-steel piping to a drain within the animal room.

An automated controller panel with power supply to monitor pressure reducing stations

(if required) for high and low pressure, system leak, and control automated flush valves.

A portable sanitation system compatible with the injection ports at the pressure reducing station (if required).

A wall-mounted sanitation system compatible with flushing the rack mounted.

components during cage sanitation. (Can be contained in a portable system that can flush

Optional Item 3: NCTR Bldg. 53D – Animal Housing Area (Rooms 103, 104, 105, 106)53D animal housing area

Pressure reducing stations (if required) sufficient to serve four (4) animal housing rooms equipped with automated-flush and monitoring, a shut-off valve and an injection port for system sanitization. The cabinet shall be of such durable material to withstand chemical sanitization.

Interconnect stations for the four (4) rooms each equipped with a detachable recoil hose with stainless steel quick disconnect couplings. Stainless steel piping (compliant with

Water NSF ANSI 61 standards) shall be free of irregular surfaces or glue at the joints which serve as nidus for biofilm creation. Piping shall be mounted using standoff brackets and mounting hardware to allow for sanitation of the walls and ceiling behind the pipes.

Within each room there will be interconnect stations for a maximum of five racks per room (rooms 103, 104, 105, 106). Piping shall include clean joint (without glue or irregular surfaces) stainless steel (compliant with Water NSF ANSI 61 standards) complete with standoff brackets and mounting hardware.

Detachable supply hoses for each of the four (4) housing rooms (number of racks per room listed above) and any required for the flushing stations.

Stainless steel (compliant with Water NSF ANSI 61 standards) flush valves at terminal ends of distribution system with an extension of the stainless-steel piping to a drain within the animal room.

An automated controller panel with power supply to monitor pressure reducing stations

(if required) for high and low pressure, system leak, and control automated flush valves.

A portable sanitation system compatible with the injection ports at the pressure reducing station (if required).

A wall-mounted sanitation system compatible with flushing the rack mounted components during cage sanitation. (Can be contained in a portable system that can flush

Installation, Training and Additional System Requirements.

The contractor shall provide in-side delivery, installation and operator familiarization training for the system. The contractor shall provide a minimum of one (1) day of on-site training (in addition to installation of the system) to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements.

Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

All personnel that enter FDA/NCTR will be required to submit sufficient information for security screening on this US Government facility. Within 30 calendar days prior to on-site installation or on-site performance the contractor shall provide Full Names, Date of Birth, and

Social Security Numbers for security screening of all personnel who will need US Government facility access. All personnel participating in the installation shall be fit tested to wear a N95 respirator in the animal facility. This will take place at NCTR and performed by Occupational

Health Unit staff.

Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year.

Post-Warranty Preventative and corrective/remedial maintenance repair service on the system shall, at a minimum, include the following

- Minimum of one (1) planned preventative maintenance visit per contract period.

- Unlimited phone and email support during the contractor’s normal operating hours.

- Preventative maintenance shall include all labor, travel, and parts (except consumables).

- Unlimited corrective/remedial maintenance, service and repairs shall include all labor, travel, and parts (except consumables). Provide service response time with quote.

- Pricing shall be inclusive of all labor, travel, replacement parts, components, subassemblies, etc.

- Performance by formally trained and certified technicians/engineers, following Original

Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using

OEM replacement parts, components, subassemblies, etc.

- Access by the FDA Contracting Officer’s Representative (COR), Technical

Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

- System software and firmware updates required for reliability improvements and correction of any defects.

- Service Records and Reports

The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the

Contracting Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

FOB Point Destination. All items shall include shipping, handling, delivery and installation to the destination identified herein. FOB Point of Delivery for Services and Supplies will be the

FDA located at 3900 NCTR Road, Jefferson, AR 72079. Delivery/installation date and system is fully operational is within 215 calendar days after receipt of order (CLIN 1) or option exercise for CLINs 6, 10 and 13.

Period of Performance

Warranty shall commence upon acceptance of the system. Post-warranty Preventative and corrective/remedial maintenance repair service on the system, if exercised, shall commence, upon expiration of the warranty period and continue for a year, which may be extended in annual increments. If/when Option Year 1 of each CLIN is exercised; the period of performance for all options will be formed via bilateral modification. It is anticipated that Optional CLIN 6 may be exercised in Fiscal Year 2019, Optional CLIN 10 may be exercised in Fiscal Year 2020 and

Optional CLIN 13 may be exercised in Fiscal Year 2021.

The period of performance for the option periods in any resultant award will be estimated based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the offered warranty period.

Warranty and preventative maintenance visits shall not be scheduled during Federal Holidays or

Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows:

New Year’s Day

Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Veteran’s Day

Thanksgiving Day

Christmas Day

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum brand name or equal technical requirements.

Contract clauses-

FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at:

https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (JAN 2017), applies to this acquisition. The following addenda apply:

FAR Clause 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform

Employees of Whistleblower Rights (APR 2014)

FAR Clause 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

(MAY 2011)

FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance. (Jul 2016)

FAR Clause 52.211-6 Brand Name or Equal (AUG 1999)

FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the

Schedule as an option item, in the quantity and at the price stated in the Schedule. The

Contracting Officer may exercise the option for one or more of the optional items identified in the schedule by written notice to the Contractor at time of award through

September 30, 2021. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) “… within 1 day of contract expiration; …. at least 15 days before the contract expires...”

(c) “…shall not exceed five years exclusive of the period set forth for delivery, acceptance, training and warranty.”

FAR Clause 52.232-40 Providing Accelerated Payments to Small Business Subcontractors.

(DEC 2013)

http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

HHSAR Clause 352.203-70 Anti-lobbying DEC 2015

HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations DEC 2015

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Technical Representative (TR) specified at award. If the supplies or services are acceptable, the TR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TR shall document the nonconforming items/services and immediately notify the contracting officer.

Contract Administration

a. Contracting Officer/Contract Administrator

Warren Dutter, Contract Specialist

3900 NCTR Road

HFT-320

Jefferson, AR 72079

Phone: 870-543-7577

Email: warren.dutter@fda.hhs.gov

b. Technical Representative (TR) Point of Contact

The following TR will represent the Government for the purpose of this contact:

(To be completed at time of award)

Name:

Phone:

Email:

The TR 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 the statement of work;

(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.

Payments mailto:warren.dutter@fda.hhs.gov

Payment terms Net 30 days after government acceptance of the system (inclusive of delivery, installation and training). Post-warranty service/maintenance services shall be made no more frequently than monthly and will be in arrears. No advance payments will be made.

FDA Three-Way Match Invoice Submission

A. The Contractor shall submit all Invoices to:

U.S. Food and Drug Administration

Attn: Vendor Payments

Office of Financial Services

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Phone: 301-827-3742

An electronic invoice can be emailed to the following address:

FDAVendorPaymentsTeam@fda.gov

B. Invoices submitted under this contract must 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 other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following per FAR 52.212-4 (g):

(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 shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading, if applicable;

(vi) Terms of any discount for prompt payment offered, if applicable;

(vii) Name and address of official to whom payment is to be sent (must 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;

(xii) Company’s DUNS number; and

(xiii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiv) Any other information or documentation required by the purchase order/award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiv) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA payment office at

(301)827-3742 or electronically at FDAVendorPaymentsTeam@fda.gov

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 the CO’s discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

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 https://www.cpars.gov/main/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 14 calendar 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 30 days from date the evaluation was issued by FDA. Any disagreement between the CO and the Contractor will be referred to a contracting official one level above the

CO, 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 (6 years for construction) 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 https://www.cpars.gov/main/cparsmain.htm. There is no fee for registration or use of the CPARS system.

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive

Orders-Commercial Items (JAN 2018)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or

Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further

Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov

2015).

(3) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-

77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the

Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

https://www.cpars.gov/main/cparsmain.htm https://www.cpars.gov/main/cparsmain.htm https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1158787 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1146366 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113344 http://uscode.house.gov/

[Contracting Officer check as appropriate.]

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with

Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C.

3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and

Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards

(Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery

Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility

Matters (Jul 2013) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15

U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business

Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)

(15 U.S.C. 657a).

__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved]

_X_ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C.

644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C.

644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C.

637(d)(2) and (3)).

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__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Nov 2016) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

_X_ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside

(Nov 2011) (15 U.S.C. 657 f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15

U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small

Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15

U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018)

(E.O. 13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

_X_ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

_X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.

793).

_X_ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

_X_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations

Act (Dec 2010) (E.O. 13496).

_X_ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

_X_ (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (Executive Order

12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–

Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential

Hydrofluorocarbons (JUN 2016) (E.O. 13693).

__ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014)

(E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s

13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

_X_ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42

U.S.C. 8259b).

__ (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products

(OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While

Driving (AUG 2011) (E.O. 13513).

__ (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).

__ (45)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

__ (46) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

_X_ (47)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May

2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19

U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-

283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (May 2014) of 52.225-3.

__ (iii) Alternate II (May 2014) of 52.225-3.

__ (iv) Alternate III (May 2014) of 52.225-3.

_X_ (48) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the

Department of the Treasury).

__ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United

States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for

Fiscal Year 2008; 10 U.S.C. 2302 Note).

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