Amended RFQ 01242023 Food Processing Training.pdf

RFQ 01242023 Food Processing and Technology Course

Food and Drug Administration (FDA)

Amendment 1 Request for Quote #: RFQ 01242023 Food

Processing and Technology Course

Amendment 1:

The purpose of this amendment is to alter the due date for proposals from February 3rd to February 17th.

PART I – THE SCHEDULE

B - Supplies or Services and Prices/Costs

Contract Type: The Government intends to issue a Firm-Fixed-Price (FFP) contract resulting from this solicitation.

Pricing Table:

Base Year: March 24, 2023 – March 23, 2024

Description (Three to Eight Classes Total) Cost per Class

In Person Class $

Virtual Class $

Option Year I: March 24, 2024 – March 23, 2025

Option Year II: March 24, 2025 – March 23, 2026

Option Year III: March 24, 2026 – March 23, 2027

Option Year IV: March 24, 2027 – March 23, 2028

C - Description/Specifications/Work Statement

1.0 Background

The FDA Office of Training Education and Development (OTED) 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 ½ days in length for in-person instruction and 5 days in length for virtual instruction. The course provides an overview of the basic principles in food processing, technology, awareness of associated equipment used to ensure the safety of manufactured foods. The 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.

OTED is seeking four (4) contractors in the United States that will provide a training facility equipped with, qualified instructors, A/V support i.e. projector, screen, microphone etc. OTED is also seeking a pilot processing laboratory facility equipped with facilitators and 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. The course delivery will be conducted in- person or virtually as need dictates.

Course participants and FDA instructors will be attending the training from around the country.

The number of courses offered per year shall be based on training needs as dictated by OTED and on the availability of funding in the range of 3 to 8 courses per year per contractor. For virtual delivered courses, delivery will be set in the Eastern (EST) time zone, with at least one selected virtual offering per Contractor) to be scheduled in the Pacific (PST) time zone.

The FD152 Food Processing and Technology course currently being delivered has been standardized and is 4 ½ days long in-person and 5 days long virtually. 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. OTED would like the contractor to provide access to Instructional Systems Developers (ISDs) and Subject Matter Experts (SMEs) to assist the CAG with the design, development, and implementation of course updates.

2.0 Objective

The FDA Office of Training Education and Development (OTED) has a Food Processing &Technology Course (FD 152) as part of the manufactured food curriculum for training Federal, State, local and tribal investigators/inspectors to conduct inspections. Currently, the in-person course is 4 ½ days in length (5 days virtually) and provides an overview of the principles in food processing technology, and “hands-on” experience with equipment used to ensure the safe production of manufactured foods. OTED is seeking one (1) contractor that will provide a training facility equipped with A/V support i.e. projector, screen, microphone etc. and an equipped pilot processing laboratory.

Develop/utilize a virtual delivery training mechanism to promote continual learning by providing instructor-prompted learning activities the participants can use to reinforce the material learned during formal training and webinars.

3.0 Scope

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 ft tables and no more than 2 students per table in a minimum 1,200 sq.ft. room, plus a cadre of 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

• Capability to access the facility no less than a day in advance of the course to set-up or the contractor agrees to set up the course no less than a day in advance

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 should 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 demonstration the following process controls below:

o Manual Control o Automatic Control

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

Proportional Integral Derivative (PID) Controller o Programmable Logic Controller (PLC)

• 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 press 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 Nozzle-discharge centrifuge o Self-opening centrifuge o Decanting centrifuge

• Batch Presses o Box and Pot Press o Curb and Cage Press o Bladder Press

• Continuous Presses 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

• Ion-Exchange Equipment

• Electro dialysis 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 Hydro shear Homogenizers o Membrane Homogenizers o Ultrasonic Homogenizers

• Roller 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 Burrstone mill o Single-disk attribution mill o Double-disk attrition mill o The Foo’s 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 product through the tube

• Transparent 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

• 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

• Scraped Surface Heat Exchanger (cutaway example for demonstration) * o Extra blades - carbon, steel, and plastic for hands-on demonstration

• 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

• 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 Craterless Retort o Still Water Immersion 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 Dialectic Heating Processing

• Examples of equipment associated with Ohmic Heating Processing (e.g. Ohmic

Processor)

• Examples of equipment associated with the following Irradiation Processing:

o Ionizing Gamma E-beam X-ray o Non-ionizing UV light (e.g. UV Sterilizer/ UV Processing Unit) 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 Vacuum 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 a 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) Freeze 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 System

• Examples of Cooling equipment utilized in food processing o Cooling of Solids

• Hydrocooling

• Vacuum-Cooling

• Surface Contact Cooling

• Tunnel Cooling o Cooling of Liquid

• Plate Heat Exchangers

• Scrape Surface Heat Exchangers

• Jacketed Vessels

• Shell and Coil Equipment

• Vacuum Cooling Equipment

• Combination Cooling with Mixing

• Plate Contact Systems

• Gas Contact Refrigerators

• Immersion and Liquid Contact Refrigeration

• Cryogenic Freezing

• Examples of Fermentation Systems utilized in 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 machine 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

• Check Valve Piston

• Rotary Valve Piston o Servo Driven Pump o Powder/ non-liquid

• Net Weight

• Auger

• Cup/Volumetric/Gravimetric (pocket fillers) o Solbern Tumbler Filler o Aseptic Filler with capability to demonstrating filling of Tetra-Pak, Comb bloc, Scholle 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* o Continuous Thread Closure (CTC) 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 seal 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 channel leaker o Semi-rigid container with contaminated 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 defects o Buckle* o Sweller

• Flipper

• Springer

• Soft Swell

• 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. Highest consideration will be given to the Contractor that will provide most the above equipment, including equipment considered of highest priority. The equipment itemized in the quote must be available prior to the initial delivery of the course. Failure to have such will be grounds for immediate termination of the contract.

During the course, the contractor’(s) classroom and pilot laboratory shall be open and available for use Monday through Friday, 7 AM – 6 PM as the primary facility and pilot processing laboratory.

D - Packaging and Marking

a. All non-electronically submitted deliverables required under this contract shall be packaged, marked and shipped. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

b. Reports not submitted electronically shall be delivered F.O.B. Destination, as set forth in FAR Clause 52.247-35, F.o.b. Destination, Within Consignee’s Premises (APR 1984), as specified in the delivery schedule.

c. Unless otherwise specified herein, deliveries shall be made to the COR on Mondays through Fridays (excluding Federal Holidays and Executive Orders).

E - Inspection and Acceptance

CLAUSES INCORPORATED BY REFERENCE – FAR 52.252-2 (FEB 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

Also, the full text of a clause may be accessed electronically at this address:

FAR - https://www.acquisition.gov/?q=browsefar HHSAR - https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FEDERAL

NUMBER

ACQUISITION REGULATION (48 CFR CHAPTER

TITLE

1) CLAUSE:

DATE

52.246-4 INSPECTION OF SERVICES-FIXED-PRICE AUG

The COR or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

Acceptance may be presumed within 10 days of receipt, unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative COR.

F - Deliveries or Performance

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

FAR - https://www.acquisition.gov/?q=browsefar HHSAR - https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

NUMBER

52.242-15

TITLE

STOP-WORK ORDER

DATE

AUG

https://www.acquisition.gov/?q=browsefar https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/?q=browsefar https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.242-17 GOVERNMENT DELAY OF WORK APR

Period of Performance The period of performance shall consist of a twelve (12) month Base Period and four (4) twelve

(12) month Options.

• Base year: March 24, 2023 – March 23, 2024

• Option Year 1: March 24, 2024 – March 23, 2025

• Option Year 2: March 24, 2025 – March 23, 2026

• Option Year 3: March 24, 2026 – March 23, 2027

• Option Year 3: March 24, 2027 – March 23, 2028

Place of Performance

TBD. This is based on the contract award. The location will be in the state of Contractor/University location

DELIVERIES

Satisfactory performance of this contract shall be deemed to occur upon performance of the work and upon delivery and acceptance by the COR or the duly authorized representative.

a. Deliveries required by the Contractor shall be made F.o.b. Destination, as set forth in

FAR Clause 52.247-35, F.o.b. Destination, Within Consignees Premises (APR 1984), and any specification stated in SECTION D. PACKAGING AND MARKING.

b. Unless otherwise specified, deliveries shall be made to the COR on Mondays through

Fridays (excluding Federal Holidays and Executive Order), between the hours of 8:00 a.m. and 5:00 p.m., Eastern Time, only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

Observance of Federal Holidays: The workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

New Year’s Day Labor Day

Martin Luther King, Jr. Day Columbus Day

President’s Day Veterans Day

Memorial Day Thanksgiving Day

Juneteenth National Independence Day Christmas Day

Independence Day

Inclement Weather – The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

The Contractor may not bill the Government for any hours that Contractor employees did not work due to any Government closure under this contract.

G - Contract Administration Data

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) Unless specified otherwise, the Government will not furnish any equipment or facilities for contractor use during this contract. Unless there is a mutual agreement in writing, the contractor shall provide the necessary hardware, software, personnel, materials, and facilities to perform the tasks specified in this SOW.

Travel Air Travel and Lodging Accommodations

Identify major airport(s) closest to the Contractor’s training venue and ground transportation options between the airport and lodging (airfare and ground transportation expenses are not borne by the Contractor). The Contractor shall provide 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 shall be smoke-free, clean, and free of mold and mildew. Lodging accommodations meeting federal travel regulation requirements may be private or apart of the Contractor’s organization. The cost, availability, and feasibility of air travel, ground transportation and lodging are relevant factors for vendor consideration only.

Transportation between Lodging and Training Venue

Transportation must be provided by the contractor between the lodging and training venue, if not within a reasonable and safe walking distance (i.e. not more than ¼ mile walk and pedestrian friendly). The cost, feasibility and transportation time are relevant factors for vendor consideration only.

Contracting Officer (CO) James Jenrette James.JenretteIII@fda.hhs.gov

Contract Specialist (CS) Matthew Tran Matthew.tran@fda.hhs.gov

Contracting Officer Representative (COR)

TBD

Contracting Officer’s Authority The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor effects any changes to this contract at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO is the only Government Official authorized to change term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

Contracting Officer Representative (COR) The COR will be responsible for the following:

• Receiving the Monthly Report;

• Tracking compliance with Limitations on Subcontracting clause;

• Perform required annual performance evaluations in CPARS; and

• Reviewing changes to staffingmatrix.

http://apps.usfa.fema.gov/hotel/) http://www.gsa.gov/portal/category/21287 mailto:James.JenretteIII@fda.hhs.gov mailto:Matthew.tran@fda.hhs.gov

The COR may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification to the Contract.

The responsibilities and limitations of the COR are as follows:

The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor. The COR is also responsible for the final inspection and acceptance of all reports, and such other responsibilities as may be specified in the contract.

The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the Contract price, terms or conditions. Any Contractor request for changes shall be referred to the Contracting Officer directly or through the COR. No such changes shall be made without the expressed prior authorization of the Contracting Officer (CO). The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the Contractor.

H - Special Contract Requirements

REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS- TIPS (1- 800-447-8477), 8:00 am – 5:30 pm Eastern Time, Monday –Friday. Fax 1-800-223-

8164, TTY

1-800-377-4950. All telephone calls will be handled confidentially. The e-mail address is hhstips@oig.hhs.gov and the mailing address is:

HHS TIPS Hotline

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026 mailto:hhstips@oig.hhs.gov

DISCLOSURE OF INFORMATION

Contractors are reminded that information furnished under this solicitation and resulting contract may be subject to disclosure under the Freedom of Information Act (FOIA). Therefore, all items that are confidential to business, or contain trade secrets, proprietary, or personnel information must be clearly marked. Marking of items will not necessarily preclude disclosure when the U.S.

Office of Personnel Management (OPM or The Government) determines disclosure is warranted by FOIA. However, if such items are not marked, all information contained within the submitted documents will be deemed to be releasable.

Any information made available to the Contractor by the Government must be used only for the purpose of carrying out the provisions of this contract and must not be divulged or made known in any manner to any person except as may be necessary in the performance of the contract.

In performance of this contract, the Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its subcontractors shall be under the supervision of the Contractor or the Contractor's responsible employees.

Each officer or employee of the Contractor or any of its subcontractors to whom any Government record may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for a purpose and to the extent authorized herein, and that further disclosure of any such information, by any means, for a purpose or to an extent unauthorized herein, may subject the offender to criminal sanctions imposed by 19 U.S.C. § 641. That section provides, in pertinent part, that whoever knowingly converts to their use or the use of another, or without authority, sells, conveys, or disposes of any record of the United States or whoever receives the same with intent to convert it to their use or gain, knowing it to have been converted, shall be guilty of a crime punishable by a fine of up to $10,000, or imprisoned up to ten years, or both.

1 FDA IT Security and Privacy

A. Baseline Security Requirements

Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

• Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

Protect government information and information systems in order to ensure:

Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

Availability, which means ensuring timely and reliable access to and use of information.

Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information securityincident.

Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P),by contacting the CO/COR or emailing your ISSO.

Comply with the Privacy Act requirements and tailor FAR clauses as needed.

Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf the three factors (Confidentiality, Integrity, and Availability) of the information or information system arethe following:

Confidentiality: [ x ] Low [ ] Moderate [ ] High Integrity: [ x ] Low [ ] Moderate [ ] High Availability: [ x ] Low [ ] Moderate [ ] High Overall Risk Level: [ x ] Low [ ] Moderate [ ] High

Based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[ x ] No PII [ ] Yes PII

Personally Identifiable Information (PII). Per the OMB Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following:

Social Security number, date and place of birth, mother’s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [X ] Low [ ] Moderate [ ] High

Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI.

32 C.F.R. 2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re- using, and disposing of the information.” 81 Fed. Reg. 63323.

All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

marked appropriately;

disclosed to authorized personnel on a Need-To-Know basis;

protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled

Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization and the FDA IS2P Appendix T: Sanitization of Computer-Related StorageMedia.

Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validatedsolution.

Confidentiality and Nondisclosure of Information. Any information provided to the Contractor (and/or any subcontractor) by FDA or collected by the Contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS/FDA sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP.

For internal-facing websites, the HTTPS is not required, but it is highly recommended.

Contract Documentation. The Contractor shall use FDA-provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

Standard for Encryption. The Contractor (and/or any subcontractor) shall:

Comply with the HHS Standard for Encryption of Computing Devices and

Information to prevent unauthorized access to government information.

Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non-public FDA information should utilize FDA-provided or FDA information security authorized devices that meet HHS and FDA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

Verify that the encryption solutions in use are compliant with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR.

Use the Key Management system on the HHS Personal Identification Verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys.

Encryption keys (PIV card) shall be provided to the COR upon request and at the conclusion of the contract. Upon completion of contract, Contractor ensures that COR is able to access and read any encrypted data.

Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the FDA non-disclosure agreement (3398 Form), as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E- Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

B. Training

Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable FDA Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete FDA Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS and FDA training policies.

Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy and FDA Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Standard Operating Procedures (SOP).

Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS and FDA policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

C. Rules of Behavior

The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

All Contractor employees performing on the contract must read and adhere to the Rules of Behavior (ROB) before accessing HHS and FDA data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual FDA Information Security Awareness Training. If the training is provided by the Contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines.

D. Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA SMC /Incident Response Team (IRT) teams within 24 hours, whether the response is positive or negative.

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.” The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by FISMA as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract to avoid a secondary sensitive information incident with FIPS 140-2 validatedencryption.

NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so, instructed by the Contracting Officer or representative, the Contractor shall send FDA approved notifications to affected individuals as directed by FDA’sSOP.

Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, and other stakeholders, (Recommend adding the FDA Senior Official for Privacy with contact information and either defining or deleting “other stakeholders.”) including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour of discovery/detection, and consistent with the applicable FDA and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

• Cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

• Not include any sensitive information in the subject or body of any reporting e-mail; and

• Encrypt sensitive information in attachments to email, media, etc.

Comply with OMB M-17-12, Preparing for and Responding to a Breach of

Personally Identifiable Information and HHS and FDA incident response policies when handling PII breaches.

Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to Contractor facilities during a breach/incident investigation demand.

E. Position Sensitivity Designations

All…