SOLICITATION NOTICE
U -- Training and Pilot Processing Laboratory Facility Services for Food Processing Technology Courses
- Notice Date
- 9/9/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 611710
— Educational Support Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 13-223-SOL-00217
- Archive Date
- 3/9/2014
- Point of Contact
- Anthony S. Wimbush, Phone: 3018270305, James G. Whitt, Phone: 301-827-1022
- E-Mail Address
-
anthony.wimbush@fda.hhs.gov, james.whitt@fda.hhs.gov
(anthony.wimbush@fda.hhs.gov, james.whitt@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 13-223-SOL-00217 Posted Date: 09-09-2013 Original Response Date: 09-16-2013 Current Response Date: 09-16-2013 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. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-69. 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 U.S. Food and Drug Administration is establishing a firm-fixed priced purchase order to provide training and Pilot Processing Laboratory Facility Services for Food Processing Technology courses. 2.2 Purchase Order Type A firm-fixed priced purchase order is anticipated.   2.3 Pricing Schedule Clin Description of Supplies/Services Qty. Unit Price Total Price 0001 Training and Pilot Processing Laboratory Facility Support for Food Processing & Technology Courses 12 Part 3 - Statement of Work Background The FDA Division of Human Resource Development (DHRD) has a Food Processing & Technology Course (FD 152) the third in a three part series of courses for 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 and provides an overview of the basic principles in food processing, technology, 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 a Contractor 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 will include up to 12 courses. The FD152 Food Processing and Technology course currently being delivered has been standardized and is 4 ½ days long. 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 ft tables and no more than 2 students per table in a minimum 1,200 sq.ft. 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 should include: • 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 • Various 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 • Continuous Pasteurizer • Batch Pasteurizer • Boiler o Fire Tube o Water tube • Various pumps (cutaway examples for demonstration) o Centrifugal Pump* o Lobe-rotor pump* o Progressive/Eccentric-screw Pump* o Piston Pump* o High-Pressure Pump (Homogenizer- Cherry-Burrell, APV or similar)* o Peristaltic Pump (Hose Pump)* o Aseptic Pump (Fristam or equivalent) o Magnetic Flow Meter* • Shaft Seal of a pump • Various valves (cutaway examples for demonstration) o Seat valve o Mixproof valve o Flow Diversion valve* o Butterfly valve* o Plug valve o Check valve* o Gate valve* o Globe valve* o Ball valve* o Diaphragm valve o Control valve o Petcock valve* • Various retorts o Vertical Still Steam Retort o Horizontal Still Steam Retort o Continuous Agitating Retort (FMC Steritort)* • Various filter systems o Plate disc or Multi-disc* o Spiral* o Hollow fiber* o Ceramic o Cartridge* o Plate and frame or filter press • Various filter media o Cast membrane o Sintered metal o Fibrous structures o Ceramic membrane o Hollow fiber membrane • Various filtration types o Reverse Osmosis Unit* o Nano Filtration Unit o Ultra Filtration Unit o Microfiltration Unit* o Carbon and gravel beds • Various evaporators (with the ability to view various parts inside of equipment) o Batch Pan o Rising film (forced recirculation) o Circulation o Falling film o Plate evaporator • Various preheaters o spiral-tube preheater* o straight-tube preheater (shell & tube) (cutaway example for demonstration)* o duplex preheating system • Various dryers (with the ability to view various parts inside of equipment) o Roller or drum drying o Box spray dryer o Cyclone spray dryer (Niro Atomizer or similar)* o Fluid Bed Dryer • Extruder o Single Screw o Twin Screw • Freeze Dryer* • Various freezers o Spiral freezer o Immersion freezer o Tunnel freezer o Chill - Freeze Fluidized bed • Various Fillers 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, Combibloc, 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 • Microwave Sterilizer • UV Sterilizer • Modified atmosphere packaging system • Various types of kettles o Steam Kettle* o Agitated Kettle • Various types of industrial ovens • Single Head Double Seamer* • Bottle capper system • Water activity meter • pH meter • Viscosity meter • Refractometer • Electro conductivity Test Equipment • Recording Temperature Devices and Thermocouples • Resistance Temperature Detectors/Devices (RTDs) and Dataloggers • Dye Test Equipment • Under Water Bubble Test Equipment • Double seam tear down equipment • Transparent tube that can demonstrate laminar flow of product through the tube • Transparent tube that can demonstrate turbulent flow of product through the tube • 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. 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 training facility and pilot processing laboratory. Section B. Instructional Services The Contractor shall provide 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: • History of Process Technology (45 minutes) • Concepts of D-, Z-, & F-Values (45 minutes) • Basic Heat Treatments Employed for Microbial Destruction (60 minutes) • Heat Transfer and Effects of Food Properties and Preparation on Heating Rates (60 minutes) • Factors That Affect Microbial Growth And Control (45 minutes) • Microorganisms of Concern in Processed Foods (60 minutes) • Basic Principles of Fluid Mechanics (45 minutes) • Heat Processing Technology (60 minutes) • Support Equipment (90 minutes) • Basic Overview of Retort Technology (45 minutes) • Retort Technology & Equipment (90 minutes) • Fluid Treatment Technology & Equipment (60 minutes) • Drying Application & Equipment (45 minutes) • Preservation Technology (45 minutes) • Fillers & Packaging Systems (45 minutes) • Package Application for Food Safety & Preservation: o Metal (60 minutes) o Flexible Packaging (60 minutes) o Glass (60 minutes) • Extrusion Technology (30 minutes) • Freeze Drying Technology (30 minutes) • Emerging Food Processing Technologies (30 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: • Hands-On Demonstration: Heat Exchange Systems (90 minutes) o Plate Heat Exchangers o Tubular Heat Exchangers o Scrape-Surface Heat Exchangers o Steam Injection/Infusion Systems • Hands-On Demonstration: Support Equipment (105 minutes) o Pumps o Valves • Hands-On Demonstration: Retort Technology (60 minutes) o Horizontal / Vertical Still Steam o Continuous Agitating • Hands-On Demonstration: Drying Application Equipment (30 minutes) o Dehydration o Freeze Dehydration o Evaporators o Dryers • Hands-On Demonstration: Filler and Packaging Equipment (20 minutes) o Filler • Hands-On Demonstration of Container Defects (60 minutes) o Metal Cans o Flexible Packaging o Glass • Practical Exercise: Container Defects (90 minutes) o Metal Cans o Flexible Packaging o Glass • Practical Exercise: Support Equipment Assessment (equipment identification) (30 minutes) From the lists above, the number of presentations and hands-on demonstrations, the Contractor'(s) qualified instructors can deliver is negotiable. The Contractor shall provide qualified instructors that 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. From the topical presentations and hands-on demonstrations above, the Contractor shall provide the instructor(s) and their brief bio sketch(s). Instructors shall be available prior to the initial delivery of the course. 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 Contractor shall also 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 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 direct cost of airfare, ground transportation, and travel accommodation are not borne by the Contractor. 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 ¼ mile walk and pedestrian friendly). Section E. Quality Assurance and Course Revisions FDA/DHRD shall 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(s)) 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. The CAG meeting may be up to a two day face to face meeting or equivalent meeting time (up to 16 hours) spread out over conference calls or webinars. FDA/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(s) shall provide the following deliverables: NO. Activity Deliverables Timeframe (Work Day) 1 Course Schedule Set schedule for FY13 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 may need to provide supplements based on adjustments made to the standardized curriculum based on Course/Materials Development activity. 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 Period of Performance: 12 months after date of award. Place of Performance: Service shall be performed at the Contractor's facility site. Part 4 - Instruction and Evaluation The following solicitation provisions apply to this acquisition: • FAR 52.212-1, "Instructions to Offerors-Commercial Items" (Jan 2013) • FAR 52.212-3, "Offerors Representations and Certifications-Commercial Items" (Aug 2013) 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. The following contract clauses apply to this acquisition: • FAR 52.212-4, "Contract Terms and Conditions-Commercial Items" (Jul 2013) • FAR 52.212-5, "Contract Terms and Conditions Required to Implement Statutes or Executive Orders" (Sep 2013) For applicable clauses see Clause 52.212-5 attached with Addenda 1 Quotation Instructions: Technical Quote Instructions: Technical Evaluation Factor 1: Technical Capability - Quoters shall submit a detailed work plan indicating the overall objectives and the specific accomplishments hoped to be achieved, as well as rationale for plan and relation to comparable work elsewhere. The quoter shall outline the plan of work providing a description of how the project is to be organized, staffed, and managed. This shall include information demonstrating understanding and management of important task and events and discussion of phases. This information shall also describe the experience and qualifications of personnel who will be assigned to provide the services. The quoter shall also describe in detail the methodologies that will be used, indicating level of experience, areas of anticipated difficulties, and any anticipate unusual. The quoter shall provide a schedule of completion of the work and delivery of items specified on the SOW. Delivery schedules shall indicate any phases or segments of the program and shall be shown in terms of calendar months. Technical Evaluation Factor 2: Past Performance - Quoters shall submit a listing of three (3) contracts/orders completed during the last five (5) years and all contracts/orders in process that is similar in nature to the solicitation work scope. Contracts/Orders listed may include those with Federal government, state and local government, and commercial customers. Quoters with no previous past performance will be neutrally evaluated. 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 officer's name; and 7. Program manager's name and contact information. The quoter will be evaluated on its performance under existing and prior contracts for similar services. Performance information will be used for responsibility determination as an evaluation factor against which quoter's relative ranking 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. Personnel: Quoters shall sumbit information describing the experience and qualifications of personnel who will be assigned to provide the work. The information shall show the composition of the task or work group and shall identify any key personnel including any consultants/subcontractors that will be assigned. The information shall identify the roles and responsibilities of each. Resumes reflecting education background, recent experience, and accomplishments are required for key personnel. Business/Price Quote Instructions: Quoters shall provide a breakdown of associated price/costs. All quoters shall submit one (1) electronic quote to anthony.wimbush@fda.hhs.gov. Evaluation: Award shall be made to the offeror whose quote offers the best value to the government, considering Technical Capability, Past Performance, and Price. The government will evaluate information based on the following evaluation criteria: 1. Technical Capability - meeting or exceeding the requirement to deliver the services through objectives, approach, methodology, and schedule; 2. Past Performance; and; 3. Price. Technical Capability when combined with Past Performance is significantly important than price. As quotes become more technically equal, then price becomes more important. This is an open-market combined synopsis/solicitation for equipment as defined herein. The government intends to award a purchase order 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 shall 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:" Quoter shall list exception(s) and rationale for the exception(s). Electronic submissions shall be received not later than Friday, September 13, 2013. 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 shall be inspected and accepted at destination by the Contracting Officer Representative (COR) specified below. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies and/or services are not acceptable, the COR shall 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 Rockville, MD 20857 Tel: (301) 827-0305 Fax: (301) 827-7106 Questions concerning invoice payment 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 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. As prescribed in 12.301(b)(4), insert the following clause: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (JAN 2013) (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) (Pub. L. 108-77, 108-78). (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. 253g and 10 U.S.C. 2402). __ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). __ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) __ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Aug 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note). __ (5) 52.204-11, American Recovery and Reinvestment Act-Reporting Requirements (Jul 2010) (Pub. L. 111-5). __ (6) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Dec 2010) (31 U.S.C. 6101 note). __ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Feb 2012) (41 U.S.C. 2313). __ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 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). __ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). __ (10) 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). __ (11) [Reserved] __ (12)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644). __ (ii) Alternate I (Nov 2011). __ (iii) Alternate II (Nov 2011). __ (13)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). __ (ii) Alternate I (Oct 1995) of 52.219-7. __ (iii) Alternate II (Mar 2004) of 52.219-7. _X_ (14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)). __ (15)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (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 (Jul 2010) of 52.219-9. __ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)). __ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). __ (18) 52.219-16, Liquidated Damages-Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (19)(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. __ (20) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (21) 52.219-26, Small Disadvantaged Business Participation Program- Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f). __ (23) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2012) (15 U.S.C. 632(a)(2)). __ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Apr 2012) (15 U.S.C. 637(m)). __ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Apr 2012) (15 U.S.C. 637(m)). _X_ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755). __ (27) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Mar 2012) (E.O. 13126). _X_ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _X_ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _X_ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212). _X_ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). _X_ (32) 52.222-37, Employment Reports on Veterans (SEP 2010) (38 U.S.C. 4212). _X_ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X_ (34) 52.222-54, Employment Eligibility Verification (JUL 2012). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) __ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (36) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). __ (37)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (DEC 2007) (E.O. 13423). __ (ii) Alternate I (DEC 2007) of 52.223-16. _X_ (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513). __ (39) 52.225-1, Buy American Act-Supplies (Feb 2009) (41 U.S.C. 10a-10d). __ (40)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (Nov 2012) (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 (Mar 2012) of 52.225-3. __ (iii) Alternate II (Mar 2012) of 52.225-3. __ (iv) Alternate III (Nov 2012) of 52.225-3. __ (41) 52.225-5, Trade Agreements (NOV 2012) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (42) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). __ (43) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (44) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). _X_ (45) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). __ (46) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). _X_ (47) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). __ (48) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332). __ (49) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332). __ (50) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (51)(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 Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). __ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 351, et seq.). __ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). _X_ (7) 52.222-17, Nondisplacement of Qualified Workers (JAN 2013) (E.O.13495). __ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). __ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 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) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). (ii) 52.219-8, Utilization of Small Business Concerns (Dec 2010) (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 (JAN 2013) (E.O. 13495). Flow down required in accordance with paragraph (l) 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 Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (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 Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). (xii) 52.222-54, Employment Eligibility Verification (JUL 2012). (xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xiv) 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.
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