News Column

Combine Solicitation - Training & pilot Processing laboratory Facility Services for Food Processing Technology Courses

July 28, 2014



Notice Type: Combine Solicitation

Posted Date: 25-JUL-14

Office Address: Department of Health and Human Services; Food and Drug Administration; Office of Acquisitions and Grants Services; 5630 Fishers Lane, Room 2129 Rockville MD 20857-0001

Subject: Training & pilot Processing laboratory Facility Services for Food Processing Technology Courses

Classification Code: U - Education & training services

Solicitation Number: 14-223-SOL-00100

Contact: Anthony S. Wimbush, Contract Specilaist, Phone 240-402-7628, Email anthony.wimbush@fda.hhs.gov - James G. Whitt, Contracting Officer, Phone 240-402-7627, Email james.whitt@fda.hhs.gov

Setaside: N/AN/A

Place of Performance Country: US

Description: Department of Health and Human Services

Food and Drug Administration

Office of Acquisitions and Grants Services

General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 14-223-SOL-00100 Posted Date: 07-25-2014 Original Response Date: 08-07-2014 Current Response Date: 08-07-2014 Classification Code: http://www.fedbizopps.gov] Set Aside: Unrestricted NAICS Code: 611710 Contracting Office Address 5630 Fishers Lane Room 2182, HFA-500 Rockville, Maryland 20857 Part 1 - Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, "Streamlined Procedures for Evaluation and Solicitation for Commercial Items," as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a Request for Quotations (RFQ) using FAR 12 & 13 procedures, inclusive of Subpart 13.5, Test Program for Certain Commercial Items. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-75.

This is a full and open solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 611710, with a small business size standard of $14.0 Million.

The Food and Drug Administration (FDA) is seeking to acquire Training and Pilot Processing Laboratory Facility Services for Food Processing Technology courses.

All interested prospective quoters/offerors shall provide quotations for the following:

Part 2 - Supplies or Services and Prices/Costs

2.1 Overview The FDA is establishing up to three (3) firm-fixed priced purchase orders to provide Training and Pilot Processing Laboratory Facility Services for Food Processing Technology courses.

2.2 Purchase Order Type Firm-fixed priced purchase orders are anticipated.

2.3 Pricing Schedule Clin Description of Supplies/Services Qty. Unit Price Total Price

Base Period of Performance September 2014 - September 2015

0001 Training and Pilot Processing Laboratory Facility Support for Food Processing & Technology Courses 8

Option 1 Period of Performance September 2015 - September 2016

0002 Training and Pilot Processing Laboratory Facility Support for Food Processing & Technology Courses 8 Option 2 Period of Performance September 2016 - September 2017

0003 Training and Pilot Processing Laboratory Facility Support for Food Processing & Technology Courses 8

Option 3 Period of Performance September 2016 - September 2017

0004 Training and Pilot Processing Laboratory Facility Support for Food Processing & Technology Courses 8 Part 3 - Statement of Work Background

The FDA's Division of Human Resource Development (DHRD) has a Food Processing & Technology Course (FD 152) that is a part of the manufactured food curriculum for training Federal, State, local and tribal investigators/inspectors to conduct these regulatory inspections. Currently, the Food Processing and Technology Course is 4-1/2 days in length and provides an overview of the basic principles in food processing, technology, and awareness of associated equipment used to ensure the safety of manufactured foods. Coursework includes detailed studies of food microbiology, food characteristics and properties, food chemistry, thermal processing and heat transfer, fluid flow, emerging technologies, preservation technologies, fillers and packaging technology. Extensive "hands-on" experience with processing equipment is provided in a pilot laboratory setting. The skills and knowledge obtained by investigators through this course will result in an increased protection of the public health.

DHRD is seeking up to a maximum of three (3) Contractors that will provide a training facility equipped with A/V support (i.e., projector, screen, microphone, etc.) and a pilot processing laboratory facility equipped with a variety of food equipment used in food manufacturing/processing/packaging (i.e., retorts, heat exchange systems, thermal processors, evaporators, dryers and evaporators, freezing equipment, extruders, homogenizers, pumps, and packaging equipment).

Course participants and FDA instructors will be traveling in from around the country. The number of courses offered per year shall be based on training needs as dictated by DHRD and on the availability of funding in the range of 4 to 8 courses per contractor.

The FD152 Food Processing and Technology course currently being delivered has been standardized and is 4-1/2 days long. Annually, a course "content advisory group" (CAG) will be convened to assess the need for course updates based on course evaluations, other relevant factors and the feasibility of blending course content.

Section A. Classroom and Pilot Processing Laboratory Facility

The Contractor shall provide a classroom training facility capable of accommodating a classroom style seating to support up to 40 students, at a minimum of 6 foot tables and no more than 2 students per table, in a minimum 1,200 square foot room, plus a cadre of up to 5 persons comfortably. Additionally, the Contractor shall provide a training facility equipped with the following:

* Easel/Whiteboard * Podium * Projector (LCD preferred) * Document viewer/projector * Projector Screen(s) sized to be viewed from the rear of the room * Instructor laptop connection with internet access * Wireless lavaliere microphone or wireless lecture microphone * Wireless remote with laser pointer * DVD player capable of being connected to AV system * Audio sound system * A/V support staff (for equipment malfunctions) * Ability to turn lights on/off from inside the room * Room temperature control capability * Comfortable seating chairs designed for long periods of sitting * Classroom with unobstructed views * Capability of receiving and storing advance shipment of training materials

The Contractor shall provide access and use of a pilot processing laboratory facility located within or adjacent to the building used for classroom training. The current course design requires students to move between training facility and the pilot processing laboratory frequently during a standard training day. The training facility and the pilot processing laboratory must meet Americans with Disabilities Act (ADA) Accessibility Guidelines for Buildings and Facilities (ADAAG).

The size of pilot processing laboratory equipment shall be at least capable of manufacturing pilot scale batches (generally, one-tenth of a full production scale batch). The Contractor shall provide qualified personnel for logistical support and staffing for equipment set-up, relocation, operation, and demonstrations and serve as a liaison for classroom and A/V support. The equipment must include:

* Water activity meter * pH meter * Viscosity meter * Refractometer * Electro Conductivity Test Equipment * Recording Temperature devices and Thermocouples * Resistance temperature Detectors/devices (RTDs) and Dataloggers * Food processing equipment with hygienic design faults (e.g. stagnant areas or dead spaces)* * Food processing equipment that can be used to demonstrate clean-in-place (CIP) and clean-out-of-place (COP)* * Boiler o Fire Tube o Water Tube

* Examples of food processing equipment that utilize compressed air * Examples of food processing equipment that utilize recirculating process water

* Food processing equipment that can demonstrate the following process controls below: o Manual Control o Automatic Control

o On/Off (Two Position Controller) o Proportional Controller (P-controller) o Proportional Integral (PI) Controller o Proportional Integral Derivative (PID) Controller

* Examples of raw material dry cleaning equipment utilized in food processing (e.g. screens, aspiration, magnetic, electrostatic) * Examples of raw material wet cleaning equipment utilized in food processing (e.g. fruit washing conveyor) * Examples of raw material peeling equipment utilized in food processing (e.g. steam, lye, brine, abrasion peeling, mechanical knives) * Examples of raw material sorting equipment utilized in food processing (e.g. color sorter imagining system) * Examples of raw material blanchers (e.g. water blancher, steam blancher) * Grinder (rotating grater disks)

* Examples of pumps utilized in food processing (cutaway examples for demonstration preferred) o Piston Pump* o Lobe-rotor pump* o Progressive/Eccentric-screw Pump* o High-Pressure Pump (Homogenizer-Cherry-Burrell, APV or similar)* o Peristaltic Pump (Hose Pump)* o Centrifugal Pump* o Aseptic Pump (Fristam or equivalent)

* Examples of valves utilized in food processing (cutaway examples for demonstration preferred) o Flow Diversion valve* o Butterfly valve* o Gate valve* o Globe valve* o Ball valve* o Petcock valve* o Seat valve o Mixproof valve o Plug valve o Check valve* o Diaphragm valve o Control valve o Valve clusters (multiple valves controlled by a PLC) o Back pressure valve o Steam seal

* Examples of conveyors utilized in food processing (cutaway examples for demonstration preferred) o Pneumatic Conveyor o Hydraulic Conveyor o Uniform Belt Conveyor o Segmented belt Conveyor o Roll and skate wheel Conveyor o Chain Conveyor o Screw Conveyor* o Vibratory Conveyor

* Examples of food (in-process) storage utilized in food processing (cutaway examples for demonstration preferred) o Bins and silos o Vats and Vessels o Tanks

* Pressure Filters o Plate-and-frame filter process o Horizontal plate filter o Shell-and-leaf filter o Edge Filter

* Vacuum Filters o Rotary drum vacuum filter o Rotary vacuum disk filter

* Centrifugal Filters (Filtering Centrifugal, Basket Centrifuges) o Batch centrifugal filter o Continuous centrifugal filter

* Liquid-Liquid Centrifugal Separators o Tubular bowl centrifuge o Disk bowl centrifuge

* Solid-Liquid Centrifugal Separators o Solid bowl centrifuge (clarifier) o Nozzel-discharge centrifuge o Self-opening centrifuge o Decanting centrifuge o * Batch Presses o Box and Pot Press o Curb and Cage Press o Bladder Press

* Continuous Press o Screw Press o Roller Press o Belt Press o Juice Reamer

* Fruit Juice Expression o Rack and Frame press o Wilmes Press o Screw Press o Bucher Press o Belt Press o Accordion Press o Screening Centrifuge

* Extraction o Single-Stage Extractor o Multi-stage Extractor o Multistage Moving Bed Extractor * Stemmer/crushers (rotating drum with large holes) * Finisher * De-aerator * De-oiled * Decanters

* Distillation Equipment o Batch Distillation o Continuous Distillation (Fractionating) Columns

* Crystallization Equipment o Cooling Crystallizer o Evaporative Crystallizer * Filtration Sizes o Reverse Osmosis (RO)(hyperfiltration) o Nanofiltration o Ultrafiltration o Microfiltration

* Types of filtration types o Reverse Osmosis Unit* o Nano Filtration Unit o Ultra Filtration Unit o Microfiltration Unit* o Carbon and gravel beds

* Types of filter systems o Plate disc or Multi-disc* o Spiral* o Hollow fiber* o Ceramic o Cartridge* o Plate and Frame or Filter Press

* Types of filter media o Hollow fiber membrane o Cast membrane o Sintered metal o Fibrous o Ceramic membrane o * Ion-Exchange Equipment * Electrodialysis System

* Examples of mixers utilized in food processing (cutaway examples for demonstration preferred) o Paddle Mixer* o Turbine Mixer o Propeller Mixer o Pan (Bowl, Can) Mixers o Kneaders (Dispersers, masticators) o Static Inline Mixers* o Horizontal Screw and Ribbon Mixers* o Vertical Screw Mixers o Tumbling Mixers o Fluidized Bed Mixers o Turbine agitators o Z-blade Mixer o Sonic Mixer

* Examples of homogenizers utilized in food processing (cutaway examples for demonstration preferred) o Pressure Homogenizers o Hydroshear Homogenizers o Membrane Homogenizers o Ultrasonic Homogenizers

* Rolling Mills (Crushing Rolls) * Impact (Percussion) Mills o Hammer mill o Beater Bar Mill o Comminuting Mill o Pin (pin-disk) Mill o Fluid energy (jet) Mill

* Attrition Mills o Buhrstone Mill o Single-disk Attrition Mill o Double-Disk Attrition Mill o The Foos Mill o Colloid Mill

* Tumbling Mills o Ball Mills o Rod Mills

* Extruder o Single Screw o Twin Screw * Transparent tube that can demonstrate laminar flow of products through the tube * Transparent blue tube that can demonstrate turbulent flow of product through the tube

* Steam injection unit (cutaway example for demonstration)*

* Steam Infusion system*

* Plate Heat Exchanger (De-Laval or similar) for heating and cooling (minimum 2-3 sections)* o Extra plates showing different surface flow configurations o * Tubular Heat Exchangers (Stork, Cherry Burrell, Contherm or similar) o Triple Tube Design (cutaway example for demonstration)* o Double Tube Design (cutaway example for demonstration)* o Multi-tube Design * Scrape Surface Heat Exchanger (cutaway example for demonstration)* o Extra blades - carbon, steel, and plastic for hands-on demonstration o * Tube-in-Shell Heat Exchanger * Examples of baking and roasting ovens utilized in food processing * Examples of Fry equipment utilized in food processing o Batch Frying Equipment o Continuous Frying Equipment o Pressure Fryers o Vacuum Fryers o * Examples of kettles utilized in food processing o Steam Kettle* o Agitated Kettle

* HTST Pasteurization equipment * Tunnel (Spray) Pasteurizers * Examples of retort types utilized in food processing: o Vertical or Horizontal Still Steam Retort* o Crateless Retort o Continuous Agitating Retort o Discontinuous Agitating Retort o Steam/Air retort o Water spray/Cascade Retort o Hydrostatic Retort

* Aseptic Processing System * Examples of equipment associated with Microwave processing (e.g. Microwave Sterilizer) * Examples of equipment associated with Dielectic heating Processing * Examples of equipment associated with Ohmic Processing (e.g. Ohmic Processor)

* Examples of equipment associated with the following Irradiation Processing: o Ionizing o Gamma o E-beam o X-ray o Non-Ionizing o UV light (e.g. UV Sterilizer/UV Processing Unit) o Radio frequency (e.g. Radio Frequency Processor)

* Examples of equipment associated with High Pressure Processing (e.g. High Pressure Processor) * Examples of equipment associated with Ozonization Processing (e.g. Ozone Generator)

* Single-Effect Vacuum Evaporators o Vacuum Pans o Short Tube Vacuun Evaporators o Long-Tube Evaporators o Plate Evaporators o Agitated Thin Film Evaporators o Centrifugal Evaporators o Refractance Window Evaporator o Scraped Surface Evaporator (Convap)

* Hot Air Drying of Solid Food Pieces o Cabinet (Tray) Dryer o Tunnel Dryer o Conveyor Belt Dryer o Bin Dryer o Fluidized Bed Dryer o Pneumatic (Flash) Dryer o Rotary Dryer * Drying Solid Foods by contact with Heated Surface o Vacuum Cabinet (Tray or Shelf) Dryer o Double Cone Vacuum Dryer o Freeze Drying Solid o Cabinet (Batch) Freeze Dryer) o Tunnel (Semi-continuous) Freezer Dryer o Continuous-Freeze Dryers o Vacuum Spray Freeze Dryer

* Drying Food Liquids and Slurries in Heated Air o Spray Drying o Drying Liquids and Slurries by Direct contact with a Heated Surface o Drum (Roller, Film) Dryer o Vacuum Band (Belt) Dryer o Refractance Window Drying Systems

* Examples of Cooling equipment utilized in food processing o Cooling of Solids o Hydrocooling o Vacuum-Cooling o Surface contact Cooling o Tunnel Cooling o Cooling of Liquid o Plate Heat exchangers o Scrap Surface Heat Exchangers o Jacketed Vessels o Shell and Coil Equipment o Vacuum Cooling Equipment o Combination Cooling and Mixing

* Plate contact Systems * Gas contact Systems * Immersion and Liquid contact Refrigeration * Cryogenic Freezing

* Examples of Fermentation Systems utilized in food processing

* Temperature controlled chambers

* Form-Fill-Seal Equipment o Vertical form-fill-seal machine for sachets o Vertical form-fill-seal machine for pillow packs o Horizontal form-fill-seal for sachets o Horizontal form-fill-seal machine for pillow packs

* Thermoforming * Blow molding * Injection Molding * Compression Molding * Examples of types of fillers utilized in food processing o Siphon o Vacuum o Pressure o Counter Pressure o Piston o Check Valve Piston o Rotary Valve Piston o Servo Driven Pump o Powder/non-liquid o Net Weight o Auger o Cup/Volumetric/Gravimetric (pocket fillers) o Solbern Tumbler Filler o Aseptic Filler with capability to demonstrating filling of Tetra-Pak, Combibloc, Schlooe or Inpaca containers* o Thermoform cup filling (e.g. Hassia) o Retort pouch filler/sealer

* Tetra-Pak, Combibloc, Hassia, retort pouch sealing equipment that seals by: o Induction o Impulse o Ultrasonic o Heat Bar

* Mechanical Vacuum * Reduced Oxygen packaging/Modified atmosphere packaging system * Single Head Double Seamer* * Bottle capper system

* Examples of Labeling equipment utilized in food processing

* Examples of glass containers o Lug or twist cap glass container* o Press-on Twist-off (PT) cap glass container*

* Examples of glass container Defects o Glass container with crushed lug* o Closed glass container with product over the edge of finish "wicking" o Glass container with titled or cocked cap o Glass container with pinhole in cap*

* Examples of flexible containers o 3-side seal flexible pouch* o 4-side flexible pouch o Semi-rigid Fusion sealed bowl or tray* o Semi-rigid container with double seam metal ends o Semi-rigid paperboard carton* o Semi-rigid erect fill paper carton

* Examples of flexible container defects o Pouch with fracture o Pouch with leaker o Swollen pouch o Pouch with channel leaker* o Pouch with contaminated seal o Pouch with seal wrinkle* o Pouch with blister in seal area* o Pouch with convolution in seal area o Pouch with waffling o Semi-rigid container with cut o Semi-rigid container with incomplete seal o Semi-rigid container with abrasion o Semi-rigid container with uneven impression in seal area o Crushed semi-rigid container o Semi-rigid container with body abrasion o Semi-rigid container with foreign matter inclusion (imbedded) o Semi-rigid paperboard carton with corner leaker o Semi-rigid paperboard carton with pull tab leaker o Crushed semi-rigid paperboard carton o Semi-rigid paperboard carton with loose tab

* Examples of types of metal containers o 2-piece Drawn & Iron (tin free steel bodies & lids)* o 3-piece welded (tin free or tin coated steel)* o 3-piece soldered (tin coated steel; tin solder)*

* Examples of types of metal container defercts o Buckle* o Sweller o Flipper o Springer o Soft Swell o Hard Swell* o False seam o Knocked down end curl* o Veer (Spur)* o Cut over or Fractured seam o Cable Cut (Cut seam) o Deadhead (Skidder) o Incomplete double seam o Severe dent o Rusted can

From the list above, equipment marked with an asterisk (*) is deemed the highest priority for the success of this course.

During the course, the Contractor's classroom and pilot laboratory must be open and available for use Monday through Friday, 7 AM - 6 PM, local time, as the primary training facility and pilot processing laboratory.

Section B. Instructional Services

The Contractor shall provide up to four (4) qualified personnel for instructional services in the design, development and delivery of training modules as identified by FDA/DHRD for the Food Processing and Technology Course (FD152).

Currently, the lecture topics and estimated presentation/lecture times are as follows:

* Introduction to Food Processing and Technology (30 minutes) * Safety in Food processing (90 minutes) * Preservation Technologies (45 minutes) * The Hygienic Design of the Food Processing plant (30 minutes) * Process Controls in Food Processing (45 minutes) * Postharvest Handling and Preparation of Food Processing (45 minutes) * Mechanical transport and Storage (45 minutes) * Separations in Food Processing (45 minutes) * Mixing, Emulsification, and Size Reduction (45 minutes) * Extrusion (30 minutes) * Heat Transfer (90 minutes) * Food Plant Utilities (30 minutes) * Thermal processing (75 minutes) * Non Thermal Processing (45 minutes) * Evaporation & dehydration (90 minutes) * Food Packaging and Food Packaging equipment (105 minutes) The Contractor shall provide qualified support staff to facilitate hands-on presentations and practical exercises as identified by FDA/DHRD for the Food Processing and Technology Course (FD152).

The hands-on demonstration topics, practical exercises and estimated presentation times are as follows:

* Introduction to Food Processing and technology (45 minutes) o Pilot Lab policies and Procedures o Pilot Lab tour

* The Hygienic Design of the Food Processing Plant (60 minutes) o Hygienic Design of equipment exercise

* Process Controls in Food processing (75 minutes) o Hands -on demonstration of equipment process controls

* Mechanical Transport and Storage (120 minutes) o Hands -on demonstration of mechanical transport and storage equipment

* Separations and Mixing (120 minutes) o Hands-on demonstration of separation and mixing equipment

* Heat Transfer (90 minutes) o Hands-on demonstration of heat transfer equipment

* Thermal Processing (120 minutes) o Hands-on demonstration of thermal processing equipment * Extrusion, Non Thermal Processing and Dehydration/Evaporation (90 minutes) o Hands-on demonstration of extrusion, non thermal, dehydration, and evaporation equipment

* Food Packaging and Food packaging equipment (135 minutes) o Hands-on demonstration of food packaging and food packaging equipment o Metal, Glass, Flexible Containers defect Classification

Qualified instructors must have 3-5 years of experience in a food manufacturing setting and have experience in delivering adult education and training, and/or attend an instructor development workshop, or other means of demonstrating effective instruction to adult learners or mutually be agreed upon by both parties, Contractor and FDA/DHRD.

Section C. Air Travel and Lodging Accommodations

The Contractor shall provide logistical support. The Contractor shall identify major airport(s) closest to the Contractor's training venue and ground transportation options between the airport and lodging (the direct cost of airfare and ground transportation expenses for travelers are not borne by the Contractor. The Contractor shall provide logistical support in identifying and coordinating accommodations for participants and cadre attending the FD152 Course. Accommodations must be FEMA approved and listed on the Hotel-Motel National Master List website (http://apps.usfa.fema.gov/hotel/) and meet federal government per diem rates listed on the GSA Per Diem Rates website (http://www.gsa.gov/portal/category/21287). The lodging facilities must be smoke-free, clean, and free of mold and mildew. Lodging accommodations meeting federal travel regulation requirements may be private or a part of the Contractor's organization.

Section D. Transportation between Lodging and Training Venue

Transportation must be available between the lodging and training venue, if not within a reasonable and safe walking distance (i.e., not more than 1/4 mile walk and pedestrian-friendly).

Section E. Quality Assurance and Course Revisions

FDA/DHRD will perform quality assurance and will review course work to ensure quality, accuracy and consistency of the course material and delivery.

A course "content advisory group" (CAG) will be convened to assess the need for course updates based on course evaluations, other relevant factors and the feasibility of blending course content to other means of delivery outside the classroom. FDA/DHRD will then determine who (FDA and/or Contractor) will carry out the specific updates in the course's design and development or other changes. The CAG will consist of FDA/DHRD, FDA subject matter experts (SMEs), Contractor(s) and other identified SMEs. DA/DHRD will determine when and modality of CAG meetings. Currently, FDA is using Microsoft Office 2010 to develop classroom course content and presentations, and the training officer will provide direction as to which software program shall be used.

Section F. Deliverables and Administrative Requirements

The Contractor shall provide the following deliverables:

Base Period

NO. Activity Deliverables Timeframe (Work Day) 1 Course Schedule Set schedule for FY15 course offerings in coordination with the training officer's schedule of courses Within 45 days of effective date of contract 2 Course/Materials Development In coordination with the Training Officer, adjust current standardized curriculum content to align with classroom/ pilot lab facilities, equipment, and instructors provided at each contractor site Within 60 days after effective date of contract 3 Preparation of Training Materials DHRD will provide standardized course material. The contractor(s) may need to provide supplements based on adjustments made to the standardized curriculum based on PWS No. 2. Based on an approved training plan and schedule 4 Delivery of Classroom Training Food Processing & Technology Course (FD152) 90 days after contract award 5 Course Advisory Group Instructional materials/Revisions Scheduled determined by the Training Officer

6 Status Report Status Report, covering: Monthly, by 10th day of the month (for the previous month) * Activities completed during the prior month; * Activities planned for the next month; * Problems/issues; * Recommended solutions

Option Period 1:

NO. Activity Deliverables Timeframe (Work Day) 1 Course Schedule Set schedule for FY16 course offerings in coordination with the training officer's schedule of courses Within 45 days of effective date of option 2 Course/Materials Development In coordination with the Training Officer, adjust current standardized curriculum content to align with classroom/ pilot lab facilities, equipment, and instructors provided at each contractor site Within 60 days after effective date of option. 3 Preparation of Training Materials DHRD will provide standardized course material. The contractor(s) may need to provide supplements based on adjustments made to the standardized curriculum based on PWS No. 2. Based on an approved training plan and schedule 4 Delivery of Classroom Training Food Processing & Technology Course (FD152) 90 days after effective date of option. 5 Course Advisory Group Instructional materials/Revisions Scheduled determined by the Training Officer 6 Status Report Status Report, covering: Monthly, by 10th day of the month (for the previous month) * Activities completed during the prior month; * Activities planned for the next month; * Problems/issues; * Recommended solutions

Option Period 2

NO. Activity Deliverables Timeframe (Work Day) 1 Course Schedule Set schedule for FY17 course offerings in coordination with the training officer's schedule of courses Within 45 days of effective date of option. 2 Course/Materials Development In coordination with the Training Officer, adjust current standardized curriculum content to align with classroom/ pilot lab facilities, equipment, and instructors provided at each contractor site Within 60 days after effective date of option. 3 Preparation of Training Materials DHRD will provide standardized course material. The contractor(s) may need to provide supplements based on adjustments made to the standardized curriculum based on PWS No. 2. Based on an approved training plan and schedule 4 Delivery of Classroom Training Food Processing & Technology Course (FD152) 90 days after effective date of option. 5 Course Advisory Group Instructional materials/Revisions Scheduled determined by the Training Officer 6 Status Report Status Report, covering: Monthly, by 10th day of the month (for the previous month) * Activities completed during the prior month; * Activities planned for the next month; * Problems/issues; * Recommended solutions

Option Period 3:

NO. Activity Deliverables Timeframe (Work Day) 1 Course Schedule Set schedule for FY18 course offerings in coordination with the training officer's schedule of courses Within 45 days of effective date of option. 2 Course/Materials Development In coordination with the Training Officer, adjust current standardized curriculum content to align with classroom/ pilot lab facilities, equipment, and instructors provided at each contractor site Within 60 days after effective date of option. 3 Preparation of Training Materials DHRD will provide standardized course material. The contractor(s) may need to provide supplements based on adjustments made to the standardized curriculum based on PWS No. 2. Based on an approved training plan and schedule 4 Delivery of Classroom Training Food Processing & Technology Course (FD152) 90 days after effective date of option. 5 Course Advisory Group Instructional materials/Revisions Scheduled determined by the Training Officer 6 Status Report Status Report, covering: Monthly, by 10th day of the month (for the previous month) * Activities completed during the prior month; * Activities planned for the next month; * Problems/issues; * Recommended solutions

Period of Performance:

Base Period: Twelve months from contract effective date Option Period 1: Additional Twelve months (If exercised) Option Period 2: Additional Twelve months (If exercised) Option Period 3: Additional Twelve months (If exercised)

Place of Performance: Service shall be performed at the Contractor's facility.

Part 4 - Instruction and Evaluation

The following solicitation provisions apply to this acquisition: * FAR 52.212-1, "Instructions to Offerors-Commercial Items" (Apr 2014) * FAR 52.212-3, "Offeror Representations and Certifications-Commercial Items" (May 2014)

Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, "Offerors Representations and Certifications-Commercial Items." Paragraph (j) of the provision is not applicable.

* FAR 52.217-5 Evaluation of Options (JUL 1990)

The following contract clauses apply to this acquisition: * FAR 52.212-4, "Contract Terms and Conditions-Commercial Items" (May 2014)

* FAR 52.212-5, "Contract Terms and Conditions Required to Implement Statutes or Executive Orders" (Jun 2014)

See full text of Clause FAR 52.212-5 in Addenda 1.

Quotation Preparation Instructions:

Quotations must be submitted no later than 4:30 P.M. Eastern Time on Thursday, August 7, 2014. Quotations shall be submitted electronically via email and CD/DVD. CDs/DVDs shall be hand delivered or shipped to 5630 Fishers Lane, Room 2082, Rockville, Maryland 20857, Telephone 240-402-7628. The subject line shall read: 14-223-SOL-00100: Training and Pilot Processing Laboratory Facility Support for Food Processing & Technology Courses. Please allow for sufficient processing time, as quotations cannot be accepted until they have gone through Security. The FDA will not be held responsible for any delays that may be incurred getting your quotation through security.

Late submissions will NOT be evaluated. Fax submissions are NOT authorized. Requests for information concerning this requirement must be submitted in writing, and must be e-mailed to the above Contract Specialist's e-mail address.

Quoters may submit all questions regarding this RFQ to Anthony S. Wimbush, via email at anthony.wimbush@fda.hhs.gov. The FDA must receive the questions no later than 5:00 PM Eastern Time Wednesday, July 30, 2014. The subject line must read: RFQ No. 14-223-SOL-00100. FDA will not answer questions received after this date and time, and will not answer questions submitted to individuals other than the named contact point (no phone calls, please). It is anticipated that RFQ questions and FDA responses will be posted to the Federal Business Opportunities (FedBizOpps) web site on or about Friday, August 1, 2014. It is the vendor's responsibility to check the FedBizOpps web site for the questions and answers and any other amendments issued for this RFQ.

Quotes must clearly demonstrate the Offeror's understanding of the Statement of Work requirements, as well as convey the Contractor's capability for transforming its understanding into successful performance under any resultant contract/order.

A complete quote must consist of a cover letter; Volume 1 - Technical Quote; Volume 2 - Business/Price Quote; and Volume 3 - Past Performance, as detailed below. Incomplete quotes will be considered non-responsive and will not be further evaluated.

Any assumptions forming the basis of the submittal must be clearly identified in the cover letter submitted with the RFQ.

All quotes will be handled by the Government in accordance with FAR Subpart 3.104.

Information requested by the Government herein must be furnished in writing and be fully and completely in compliance with RFQ instructions. The information requested and the manner of submission is essential to permit prompt evaluation of all quotes on a fair and uniform basis. Simple statements of compliance with the RFQ requirements without a detailed description of how compliance will be accomplished may not be considered sufficient evidence that the Contractor can meet the technical requirements.

Contractor employees responsible for preparing material that may be source selection information must mark each page that the Contractor believes contains source selection information with the legend "Source Selection Information".

As noted above, all Quotes shall consist of a technical volume, a business volume, and a past performance volume. Each volume shall be sent as a separate document. The Technical Quote (Volume 1) and Business/Price Quote (Volume 2) must be kept separate from each other. Kept separate is defined as not including any cost/price information in the Technical Quote (Volume 1) binder. The Technical Quote must not make reference to pricing data in order that the technical evaluation may be made strictly on the basis of technical merit. Each CD or DVD submitted must contain copies of the appropriate proposal volume in two formats: pdf (Adobe Acrobat 7.0 or older) and in the original format (e.g., Word or Excel).

The Quoter must certify that each CD or DVD has been checked using the latest version of virus detection software and is virus free. The Government will accept any valid virus detection software, although McAfee Agent 4.5 and McAfee Virus Scan Enterprise 8.7 are preferred. The certification shall identify the virus detection software, version used, and the date the CDs or DVDs were scanned.

For planning purposes, if your organization intends to submit a quote in response to this solicitation, please inform the Contract Specialist of your intent by sending an email to Anthony S. Wimbush, Contract Specialist, at anthony.wimbush@fda.hhs.gov, by no later than 5:00 PM Eastern Time, Wednesday, July 30, 2014.

The signature of an official authorized to bind the Quoter shall be placed on each volume. Each volume shall be submitted as follows:

I. Technical Volume 1

An electronic copy in PDF format of the the Technical Volume shall be submitted. Quoters must organize the technical quote to follow the technical information requested in this section. The technical quote shall not contain any reference to price. Text color shall be black. Color may be used in graphics or charts for greater clarity at the Quoter's option. Text in graphics and charts shall be no smaller than 9-point.; text in tables shall be no smaller than 9-point Arial. The size and font of headers and footnotes are not dictated. No fonts may be condensed.

The page limitations for the Technical Quote are as follows: 30 pages maximum. Quoters shall use only 8.5 inch by 11 inch (210mm by 297mm) double-sided paper, single-spaced pages, with margins no less than one inch on each border; number each page consecutively; do not use a font size smaller than 9 point.

**FDA will not evaluate information submitted over the page limitation**

Note: A page in the technical quote that contains a table, chart, graph, etc., not otherwise excluded below, is subject to the page limitation.

The following items are not included in the overall 30-page limit:

* Cover Page * Table of Contents * Dividers * Resumes (2 page limit) * Contractor Teaming Arrangement (if applicable) * Skill Matrix/Resumes

All critical information from appendices must be summarized in the technical quote.

An individual authorized to contractually bind the quoter must sign the cover page of the Technical Volume.

Technical Evaluation Factor: Technical Capability

Quoters shall submit a detailed work plan indicating the overall objectives and the specific accomplishments hoped to be achieved, as well as the rationale for the plan and its relation to similar work performed. The quoter shall outline the plan of work, providing a description of how the project will be organized, staffed, and managed. This shall include information demonstrating the Quoter's understanding and management of important tasks, events and discussion of phases. This information must also describe the experience and qualifications of personnel who will be assigned to provide the contract. The quoter shall also describe, in detail, the methodologies that will be used, indicating level of experience, areas of anticipated difficulties and proposed solutions. The quoter shall provide a schedule of completion of the work and delivery of items specified in the SOW. Delivery schedules shall indicate any phases or segments of the program and shall be shown in terms of calendar months.

Quoters shall describe their experience in successfully performing or supporting food processing and technology requirements of similar size, scope, and complexity. Quoters shall identify other organizations with which they have acted (as a subcontractor, teaming partner, etc.) while participating in these prior efforts. Quoters shall include the degree of their involvement in these prior efforts and other information describing their experience.

Quoters shall submit information describing the experience and qualifications of personnel who will be assigned to perform the work. The information must show the composition of the task or work group and must identify any key personnel, including any consultants/subcontractors, that will be assigned to the contract; the information must identify the roles and responsibilities of each. Resumes reflecting educational background, relevant experience, and accomplishments are required for key personnel. Quoters shall also provide brief bio-sketches for the instructors proposed to provide the topical presentations and hands-on demonstrations as identified and listed in Section B, Instructional Services.

Higher consideration will be given to the Contractor(s) that are able to provide more of the equipment items identified and listed in Section A. Classroom and Pilot Processing Laboratory Facility, including equipment considered of highest priority. The equipment itemized in the quotation must be available prior to the initial delivery of the course.

From the lists identified in Section B. Instructional Services, the number of presentations and hands-on demonstrations the Contractor's qualified instructors can deliver is negotiable. However, higher consideration will be given to those Contractor(s) that are able to deliver more of the lecture topics, hands-on presentation topics and practical exercises using up to four (4) instructors. Instructors must be available prior to the initial delivery of the course.

II. Business/Price Volume 2

An electronic copy in both PDF and Excel format of the the Business/Price Volume shall be submitted. The business quote must provide sufficient detail to determine whether the quoted solution represents the best value to FDA. Where pricing data is derived via formula, the Quoter must show formulas that are clearly visible in the individual cells and verifiable. Include any notes or assumptions not described elsewhere in your quote.

Every page of the pricing volume must be numbered. There is no page limit to the pricing volume.

All total dollar amounts provided shall be rounded to the nearest cent.

III. Past Performance Volume 3

The Past Performance Volume shall describe the Quoter's success in performing contracts/orders that are similar in size, scope and complexity to the work described in the SOW. Quoters shall submit a listing of three (3) such contracts/orders completed during the last three (3) years and all contracts/orders currently in process. Contracts/Orders listed may include those with the Federal government, state and local governments, and commercial customers. Quoters with no previous past performance will be evaluated neutrally. Quoters shall submit the following past performance information: 1. name of contracting organization; 2. Contract number; 3. Contract type; 4. Total contract value; 5. Description of requirement; 6. Contracting Oofficer's name; and 7. Program manager's name and contact information. Past Performance information will be used for responsibility determination and as a risk factor against which quoters' relative rankings will be compared to assure the best value to the Government. References other than those identified by the quoter may be contacted by the Government to obtain additional information (e.g., Contractor Performance Assessment Reporting System (CPARS), Department of Defense's Past Performance Information Retrieval System (PPIRs).

Evaluation Criteria and Basis for Award:

Award will be made to the quoters/offeror(s) whose quote(s) offer(s) the best value to the government, considering Technical Capability, Past Performance and Price. The government will evaluate Technical Capability based on how well the proposed solution meets the government's requirement to deliver the services. Past performance will be evaluated as a risk factor based on the offeror's demonstrated history of successfully providing the services.

This is an open-market combined synopsis/solicitation for equipment as defined herein. The government intends to award up to three (3) a purchase orders as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, ALL quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" The Quoter shall list the exception(s) and rationale for the exception(s).

Submission shall be received not later than Thursday, August 7, 2014 , 4:30 PM, Eastern Time. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Tony Wimbush at Anthony.wimbush@fda.hhs.gov.

Addenda 1

Receipt and Acceptance of Supplies/Services:

The supplies and/or services delivered hereunder will be inspected and accepted at destination by the Contracting Officer Representative (COR) specified below. If the supplies or services are acceptable, the COR will promptly forward a report of inspection and acceptance to the payment office. If the supplies and/or services are not acceptable, the COR will document the nonconforming items/services and immediately notify the Contracting Officer.

Project Officer and Contracting Officer's Representative for this order is:

To be determined Questions concerning the pricing or terms of this order should be directed to:

Anthony S. Wimbush Office of Acquisitions and Grants Services 5630 Fishers Lane, Room 2082 Rockville, MD 20857 Tel: (240)402-7628 Fax: (301) 827-7106

Questions concerning invoice payments should be directed to:

The FDA Payment Office at 301-827-3742

The Contractor shall submit one (1) invoice for payment to all addresses in the following manner specified: (I) One original and one copy to the approving official:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services Attention: Anthony S. Wimbush 5630 Fishers lane Room 2082 Rockville, MD 20857 Email: Anthony.wimbush@fda.hhs.gov

(II) One copy to the Contracting Officer's Representative (COR) or other program center/office designee, clearly marked "Courtesy Copy Only."

To be determined

A. Invoices submitted under this task order contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.2321-33 (Payment by Electronic Funds Transfer - Central Contractor Registration) 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: (I) Name and address of the contractor; (II) Invoice date and invoice letter; (III) Purchase Order/Task Order/Award/Number (IV) Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed, including: i. Period of Performance for which costs are claimed; ii. Itemized travel costs, including origin and destination; iii. Any other supporting information necessary to clarify questionable expenditures; (V) Shipping Number and date of shipment, including the 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 (must be the same as that in the purchase order/task 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/task order; (XII) Any other information or documentation required by the purchase order/task order award; (XIII) Contractor _X__ is ____ is not required to attach an invoice log addemdum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: i. List of invoices submitted to date under the subject award, including the following: 1. Invoice number, amount, and date submitted; and 2. corresponding payment amount and date received. ii. total amount of all payments received to date under the subject contract or order, and iii. for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

B. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (I) through (XII) 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.

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

Office of Financial Services Food and Drug Administration 10903 New Hampshire Avenue WO32 -Second Floor MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments 301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

FAR Clauses Full Text

52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor before expiration of call.

52.217-9 - Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires. Any preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed four (4) years.

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 Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es): http://www.arnet.gov 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jun 2014) (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) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)). ____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)). (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 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: [Contracting Officer check as appropriate.] ___ (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 (Apr 2010) (41 U.S.C. 3509). ___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009). ___ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). ___ (5) [Reserved] ___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). ___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). ___ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161). ___ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). ___ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). ___ (13) [Reserved] ___ (14) (i) 52.219-6, Notice of Total Small Business 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. ___ (16) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)). _X_ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637 (d)(4)). ___ (ii) Alternate I (Oct 2001) of 52.219-9. ___ (iii) Alternate II (Oct 2001) of 52.219-9. ___ (iv) Alternate III (July 2010) of 52.219-9. ___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)). ___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). ___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). ___ (21) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). ___ (ii) Alternate I (June 2003) of 52.219-23. ___ (22) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (23) 52.219-26, Small Disadvantaged Business Participation Program-Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f). ___ (25) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). ___ (27) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). _X_ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755). ___ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). _X_ (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _X_ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _X_ (32) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212). _X_ (33) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). _X_ (34) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212). _X_ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X_ (36) 52.222-54, Employment Eligibility Verification (Aug 2013). (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.) ___ (37) (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.) ___ (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.) ___ (38) (i) 52.223-13, Acquisition of EPEAT(R) -Registered Imaging Equipment (Jun 2014) + (E.O.s 13423 and 13514 ___ (ii) Alternate I (Jun 2014) of 52.223-13. ___ (39) (i) 52.223-14, Acquisition of EPEAT(R) -Registered Television (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-14. ___ (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(R) -Registered Personal Computer Products (Jun 2014) (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). ___ (43) 52.225-1, Buy American'upplies (May 2014) (41 U.S.C. chapter 83). ___ (44) (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. ___ (45) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (46) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). ___ (47) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2303 Note). ___ (48) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (49) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). _X_ (50) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (51) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X_ (52) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (53) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (54) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). ___ (55) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (56) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). ___ (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, 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: [Contracting Officer check as appropriate.] ___ (1) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.). ___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67). ___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67). _X_ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). ___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). ___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17. (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). (vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40. (viii) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (x) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.) (xi) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67) (xii) 52.222-54, Employment Eligibility Verification (Aug 2013). (xiii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xiv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xv) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of Clause) HHSA Clauses Full Text 352.202-1 Definitions (January 2006) (a) In accordance with 52.202-1(a)(1), substitute the following as paragraph (a): ''(a) The term ''Secretary'' or ''Head of the Agency'' (also called ''Agency Head'') means the Secretary, Deputy Secretary, or any Assistant Secretary, Administrator or Commissioner of the Department of Health and Human Services; and the term ''his/her duly authorized representative'' means any person, persons, or board authorized to act for the Secretary.''

(b) In accordance with 52.202-1(a)(1), add the following paragraph (h): ''(h) The term ''Project Officer'' means the person who monitors the technical aspects of contract performance. The Project Officer is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. If applicable, the Project Officer is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.''

(End of clause) 352.203-70 Anti-lobbying (January 2006)

Pursuant to the current HHS annual appropriations act, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for (i) publicity or propaganda purposes; (ii) the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself; or (iii) payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (January 2010)

(a) In addition to complying with the clause in FAR 52.222-26, Equal Opportunity, the Contractor shall, in good faith, cooperate with the Department of Health and Human Services (Agency) in investigations of Equal Employment Opportunity (EEO) complaints processed pursuant to 29 C.F.R. Part 1614. For purposes of this clause, the following definitions apply:

(1) "Complaint" means a formal or informal complaint that has been lodged with Agency management, Agency EEO officials, the Equal Employment Opportunity Commission (EEOC), or a court of competent jurisdiction. (2) "Contractor employee" means all current Contractor employees who work or worked under this contract. The term also includes current employees of subcontractors who work or worked under this contract. In the case of Contractor and subcontractor employees, who worked under this contract, but who are no longer employed by the Contractor or subcontractor, or who have been assigned to another entity within the Contractor's or subcontractor's organization, the Contractor shall provide the Agency with that employee's last known mailing address, e-mail address, and telephone number, if that employee has been identified as a witness in an EEO complaint or investigation. (3) "Good faith cooperation" cited in paragraph (a) includes, but is not limited to, making Contractor employees available for: (i) formal and informal interviews by EEO counselors or other Agency officials processing EEO complaints; (ii) formal or informal interviews by EEO investigators charged with investigating complaints of unlawful discrimination filed by federal employees; (iii) reviewing and signing appropriate affidavits or declarations summarizing statements provided by such Contractor employees during the course of EEO investigations; (iv) producing documents requested by EEO counselors, EEO investigators, Agency employees, or the EEOC in connection with a pending EEO complaint; and (v) preparing for and providing testimony in hearings before the EEOC and U.S. District Court. (b) The Contractor shall include the provisions of this clause in all subcontract solicitations and subcontracts awarded at any tier under this contract. (c) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

(End of clause)

352.223-70 Safety and Health (January 2006)

(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies at the federal, State, and local levels.

(1) In addition, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects: (i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by OSHA and included in 29 CFR Part 1910. These regulations are available at http://www.osha.gov/. (ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). The Contractor may obtain copies from the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. (2) The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities: (i) Biosafety in Microbiological and Biomedical Laboratories, CDC. This publication is available at http://www.cdc.gov/biosafety/publications/index.htm. (ii) Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street, NW., Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229- 7). This publication is available at http://www.nap.edu/catalog/4911.html. (b) Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the Contracting Officer's Technical Representative or other appropriate officials, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, the Contracting Officer will make an equitable adjustment in accordance with the applicable ''Changes'' clause set forth in this contract. (c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract and all violations for which the Contractor has been cited by any federal, State or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the federal, State or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action. (d) If the Contractor fails or refuses to comply with the federal, State or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the federal, State or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor. (e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. The Contractor is responsible for the compliance of its subcontractors with the provisions of this clause. (End of clause)

352.227-70 Publications and publicity (January 2006) (a) Unless otherwise specified in this contract, the Government encourages the Contractor to publish the results of its work under this contract. A copy of each article the Contractor submits for publication shall be promptly sent to the Contracting Officer's Technical Representative. The Contractor shall also inform the Contracting Officer's Technical Representative when the article or other publication is published, and furnish a copy of it as finally published. (b) Unless authorized by the Contracting Officer's Technical Representative, the Contractor shall not display the HHS logo on any publications. (End of clause) 352.231-71 Pricing of Adjustments (January 2001) When costs are a factor in determination of a contract price adjustment pursuant to the "Changes" clause or any provision of this contract, the applicable cost principles and procedures set forth below shall form the basis for determining such costs: Cost Principles Types of Organizations Subpart 31.2 of the Federal Acquisition Regulation Commercial Subpart 31.3 of the Federal Acquisition Regulation Educational Subpart 31.6 of the Federal Acquisition Regulation State, local, and federally recognized Indian tribal governments 45 CFR Part 74 Appendix E Hospitals (performing research and development contracts only) Subpart 31.7 of the Federal Acquisition Regulation Other nonprofit organizations (End of clause) 352.242-70 Key Personnel (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

Link/URL: https://www.fbo.gov/spg/HHS/FDA/DCASC/14-223-SOL-00100/listing.html


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