SOLICITATION NOTICE
66 -- Slide Imaging System
- Notice Date
- 5/11/2015
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1146518
- Archive Date
- 6/4/2015
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6 as authorized in Subpart 13.5, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement under Simplified Acquisition Procedures. The solicitation number is 1146518 and this solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-82 effective May 7, 2015. The associated North American Industry Classification System (NAICS) Code is 334516 ‐ Analytical Laboratory Instrument Manufacturing. FSC Code is 6640. Small Business Size Standard is 500 employees. Acquisition is unrestricted. Contract Type: Commercial Item-Firm Fixed Price. REQUIREMENTS: Statement of Need: The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) has a requirement for one (1) automated slide scanning system to include shipping, installation, set-up, testing, on-site operator training and up to four (4) 1- year option periods for post-warranty maintenance, for a high number of cell and tissue (fluorescence and histological) slide image acquisitions and evaluations in high magnification at one time to obtain the details of morphological changes. The system will be used by multiple researchers for broad molecular imaging. CBER analyzes the host-pathogen (e.g. virus, bacteria, parasites) interaction using cultured cell and tissue in immunological responses and vaccine related studies. Additionally, the system will be used to visualize and evaluate slides in 3-Dimension (3D) using optical sectioning in z- axis (z-stack) for thick tissue or cell samples from a variety of experiments targeted towards understanding the cellular consequences, to evaluate the vaccine or drug candidates, and evaluate efficacy of agents to viruses or bacteria in a variety of species and cell types. The research requires scanning thick tissue samples and Induced Pluripotent Stem cells (iPS cell) colonies which can be difficult to autofocus because of the thickness of samples. Currently, CBER has a manual microscope that takes several hours to capture the Bright-Field (BF) or fluorescent images. This is due to the focusing, optics and determination of the Region Of Interest (ROI) to capture. Researchers have to tile the images to have full view of a section of each specimen. Moreover, normal fluorescent images risk bleaching under emission excitation light if exposed for several hours. CBER requires a whole slide scanner, be able to accomplish the following: (a) High resolution slide imaging with fast scanning speed of 35 seconds or less for 15mmx15mm area at 20x and 45 seconds or less for 15mmx15mm area at 40x in BF mode. (b) Hold a minimum of 320 slides for batch processing with fully automated mode to handle multi-user samples simultaneously. (c) Obtain high quality line scanned images at high speed for less bleaching and reduce stitching time for reconstruction. (d) Capability of multi-user's fluorescence imaging to scan for cover emission filters wavelengths of following colors, 4',6-diamidino-2-phenylindole (DAPI) or Hoeschst dyes, Cerulean Fluorescent Protein (CFP), Green Fluorescent Protein (GFP), Alexa Fluor 488 dye, Yellow Fluorescent Protein (YFP), Alexa Fuor 555 dye, Alexa Fluor 568 dye, Alexa Fluor 594 dye, Cyanine 3 dye, Cyanine 5 dye, and Alexa Fluor 647 dye with appropriate, minimum of three (3) dichroic filter positions to generate multi-color fluorescence image with good color separation and minimize cross talk of fluorescence. (e) Dynamic Pre-focusing and Auto-focusing capabilities for handling /focusing thick and uneven tissue specimen. (f) Z-stack scanning capability for 3D image data acquisition for thick tissue and cell samples. Optical sectioning capability is important to make Z-stack scanning for making 3D imaging and obtain the right focusing and reconstruction of these thick samples. (g) Automatic system calibration function for brightness control and white balance where slides can remain in the slide cassette and provide periodical recalibrate to ensure the best image quality in daily operations. (h) Acquired images will be saved to a dedicated server for sharing / discussion on line as well as data archiving. Minimum Specifications: The automated slide imaging system shall be delivered with all necessary supplies, equipment, components, adapters, software, accessories, slides, cameras, objectives/lenses, filters/filter wheels, cassettes, etc. required to seamlessly install, set-up, test and train; Contractor is responsible for a turnkey solution. The components and equipment shall be a newly manufactured, not be used, refurbished, or previously used for demonstration. The entire system shall be warranted for parts and labor for a minimum of 1 year from date of acceptance. All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system. In addition to the functions listed in the above minimum requirements and in the Statement of Need section, the system shall: • Have high resolution, high speed, high content imaging with efficient multicolor image acquisition for fluorescently labeled cells and /or BF tissue samples on standard slides format. • Not show any stitching lines in the final large stitched slide scanned images or image intensity unevenness for further intensity measurement /analysis purposes. • Be able to save fluorescent images for individual channels as well as merged images automatically. • Able to hold a minimum of 320 slides for batch processing for scanning with fully automated or semi-automated mode for both light and fluorescently samples. Due to the multi-user facility purposes, the system shall be able to receive both BF imaging and fluorescence imaging within same batch processing. The slides can be either histological samples, fluorescently labeled cell or tissue samples or both for same run. • Be able to handle and scan vast amount of slides with fast mode and reconstruct fast by using one (1) dimensional reconstruction for image stitching. Mimimum scanning speed of less than 35seconds for 15mm by 15mm area at 20x and 45 seconds in 40x in BF mode. • Be able to scan the slide without post image color adjustment. • Have an auto calibration function inside to reproduce precise image acquisition for each time. • Be able to save acquired images on a dedicated server for sharing / discussion on line as well as for data archiving. • Be able to fully control the exposure time of excitation light to minimize bleaching of fluorescence slides. • Be flexible to select the scanning area of ROI by fully automated or manual selection depending on the user's needs. • Be capable of saving image data for suitable imaging analysis and exporting functionality for user's desired ROIs, easy to compare multiple images side by side. • Have easy access holder to place minimum of 320 slides per batch run for multi-user facility. • Be able to handle scan thick and uneven tissue specimens. • Have z-stack scanning capability for 3D image data acquisition for difficult thick sample scanning or large neuronal cell imaging in both fluorescence and BF. • Be able to handle a minimum of 320 slides for overnight run without attending. • Be able to scan the slide tab information to identify each image data information and the acquired image data shall have automatically according image position information on each slide • Have automated focus check function, in case of failure of out of focus data, system shall be able to rescan to recollect the data. • Be able to select the focus point either manually by user or full automatic focus point selection. For manual focusing, shall be able to place an unlimited number of focus points. • Be able to scan DAPI/Hoechst, CFP, GFP, alexa 488, YFP, mOrange, TRITC, Texas Red, alexa 568, alexa 594, alexa 647 and Cy5 for multi-user needs. • Have industry standard long life mercury and halogen lamp for fluorescence and BF imaging. • Be equipped with anti-vibration table, or other mechanism, to minimize vibration from the environment. Minimum Installation, Set-Up, Testing and Training Requirements The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for at least four (4) attendees. Such familiarization shall include system operations, calibration, optimization, trouble-shooting and basic operational maintenance procedures. Minimum Post-Warranty Annual Service Requirements covering both the main system and fluorescence components: • Shall include at least one (1) planned, onsite preventative maintenance visit per contract year. • Shall include unlimited technical support (e.g., telephone-based, email-based, website-based, etc.) and unlimited corrective/remedial maintenance visits, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Central Standard Time (CST). • Shall include unlimited software and firmware updates. • All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc. • All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. • The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Location: Delivery Address (FOB Destination) if loading dock required: US Food and Drug Administration Bldg. 52 10903 New Hampshire Ave. Silver Spring, MD 20993 Installation, set-up, on-site training and post-warranty maintenance shall be conducted at: US Food and Drug Administration Bldg. 52/72, Room 1233 10903 New Hampshire Ave. Silver Spring, MD 20993 Delivery shall be coordinated with: Point of Contact info to be provided with award. Period of Performance Delivery, to include installation, set-up, testing and on-site training, required within 90 days of award with up to four (4) 1-year option periods for post-warranty maintenance. Schedule of Items: 0001 -Slide Scanning System - 1 each, in accordance with specifications above to include all components, shipping, inside delivery, installation, set-up, testing, and on-site training $____________ 0002 - Option Period 1, Post-Warranty Maintenance $____________ 0003 - Option Period 2, Post-Warranty Maintenance $____________ 0004 - Option Period 3, Post-Warranty Maintenance $____________ 0005 - Option Period 4, Post-Warranty Maintenance $____________ Total $____________ FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: http://www.acquisition.gov/far/ http://farsite.hill.af.mil/vfhhsara.htm The provision at FAR 52.212-1, Instructions to Offerors- Commercial Items (Apr 2014), applies to this solicitation. Addenda to this provision are as follows: Site Visit Offerors are afforded the opportunity to inspect the site for installation of the equipment prior to solicitation response date by contacting the Contract Specialist, Crystal G. McCoskey, crystal.mccoskey@fda.hhs.gov, phone: 870-543-7267, to schedule an appointment no later than 15 May 2015, 9:00 AM CST. Failure to inspect the installation location will not relieve the successful Offeror from fully meeting the requirements of the resulting contract at the price offered. Offer Submission Instructions The government is not responsible for locating or securing any information, which is not identified in the offer. To ensure information is available, offerors shall furnish as part of their quote all descriptive material necessary for the government to unequivocally determine the equipment offered meets or exceeds the technical requirements, and the system will absolutely support FDA's stated need. The quote shall provide information on any turn-key solutions to meet the intended application, inclusive of all necessary accessories, software, components, hardware, drivers, adapters, cables, computer, monitors, plates, objectives, filters, lasers, stages, slides, workstations, control and display panels, lenses, clamps and holders, etc, etc. All proprietary information shall be clearly marked. Offeror shall include a price breakout for all components within Item No. 0001's extended total, to include detailed description, catalog/part number, quantity, and unit price of each accessory or ancillary item to the system. Any items offered on GSA Contract shall be indicated on offer as such. The post-warranty maintenance periods will not be funded at point of equipment purchase. If exercised, funding will be obligated individually each year for the option period exercised via contract modification; the option periods shall be priced accordingly. The period of performance for the option periods in any resultant award will be estimated based on the date of award, estimated ultimate delivery of Item No. 0001, and applicable warranty period. If/when Option Period 1 is exercised, the periods of performance for all options will be firmed via modification. Prices provided shall be valid through September 30, 2015. Award subject to availability of funds. Price quotes shall be F.O.B. destination inclusive of shipping & handling expenses. Evaluation Approach The Government will award an order resulting from this solicitation to the lowest priced technically acceptable responsible offeror. Offers will be evaluated on their ability to meet the minimum technical requirements. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options does not obligate the Government to exercise the option(s). The lowest priced quote will be evaluated first. If the lowest priced quote is not technically acceptable, the next lowest priced quote will be evaluated and so on until a technically acceptable quote is determined. Service Contract Act Exemption This solicitation is being issued under the premise that the Contractor will certify that the post-warranty maintenance services are exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If this is the case and the Contractor certifies that is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination No. 2005-2103 (Rev 15): http://www.wdol.gov/wdol/scafiles/std/05-2103.txt?v=13 FAR 52.222-48 - Exemption From Application Of The Service Contract to Contracts For Maintenance, Calibration, Or Repair Of Certain Equipment - Certification (May 2014) (a) The offeror shall check the following certification: CERTIFICATION The offeror [ ] does [ ] does not certify that- (1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations; (2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment. (i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public. (ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and (3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. (b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Act- (1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or (2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis. (c) If the offeror does not certify to the conditions in paragraph (a) of this provision- (1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements, will not be included in any resultant contract awarded to this offeror; and (2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation. (d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision. (End of provision) The following provisions are incorporated by reference: • FAR 52.233-2, Service of Protest (Sep 2006), (a)"...Jerry Martin, 3900 NCTR Rd, HFT-320, Bldg. 50, Room 434, Jefferson, AR 72079." The provision at FAR 52.212-3, Offeror's Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015), applies to this acquisition. Addenda to this clause are as follows: Inspection and Acceptance The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. 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 or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. Contractor Performance Assessment Rating System (CPARS): (a) Pursuant to FAR 42.1502, this contract is subject to Contractor Performance Assessment System (CPARS). CPARS is an automated centralized information system accessible via the Internet that maintains reports of contractor performance for each contract. CPARS is located at https://www.cpars.gov/. (b) Under CPARS, the Government will conduct annual evaluations of the contractor's performance. The contractor has thirty (30) days after the Government's evaluation is completed to comment on the evaluation. The contractor may request a meeting to discuss the CPAR at any time during the reporting period. (d) The CPARS system requires the Government to assign the contractor a UserID and password in order to view and comment on the evaluation. Provide the name of one individual who will be assigned as your Contractor Representative for CPARS below: Name: Phone: E-mail Address: Invoice Submission The Contractor shall submit an invoice once the equipment is installed, inspected and accepted and in quarterly arrears during the option periods for maintenance in accordance with the following instructions: A. An original and two (2) copies shall be submitted to the attention of the designated Contract Specialist at the following address: Department of Health and Human Services Food and Drug Administration National Center for Toxicological Research Attention: Crystal G. McCoskey, Contract Specialist Office of Acquisitions & Grants Services, HFT-320 3900 NCTR Road, Bldg 50, Rm 426 Jefferson, AR 72079-9502 B. One copy to the COR clearly marked "courtesy copy only".(To be identified in award) C. Invoices submitted under this contract must comply with the requirements set forth in FAR clauses 52.212-4 (i)(2)(Prompt Payment), FAR 52.232-33 (Payment by Electronic Funds Transfer -System for Award Management), and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Contract number; (iv) Description, quantity, unit of measure, unit price and extended price supplies delivered or services performed; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading; (vi) Terms of any discount for prompt payment offered; (vii) Name and address of official to whom payment is to be sent (must be the same as that in the Contract 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. (xi) Name and telephone number of the FDA COR referenced on the contract; (xii) An itemization of the amounts requested, related to the various elements of work required by the contract covered by the payment requested. (xiii) A listing of the amount included for work performed by each subcontractor under the contract. (xiv) A listing of the total amount of each subcontract under the contract. (xv) A listing of the amounts previously paid to each such subcontractor under the contract. (xvi) Additional supporting data in a form and detail required by the CO; and (xvii) Any other information or documentation required by the Contract. D. Questions regarding invoice payments should be directed to the FDA payment office at: Food and Drug Administration Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th floor suite 616 Jefferson, AR 72079 Fax 870-543-7224 nctrinvoices@fda.hhs.gov E. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in C. (i) through (xvii) of this clause must be included in the electronic invoice. The following clauses are incorporated by reference: • FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000), (a) "...by written notice to the Contractor within one (1) day of contract expiration;...preliminary written notice of its intent to extend at least 30 days before the contract expires." (b) "...shall not exceed four (4) years beyond the warranty expiration." • FAR Clauses: 52.203-3, Gratuities (Apr 1984); 52.203-12, Limitations on Payments to Influence Certain Federal Transactions (Oct 2010); 52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (Apr 2014); 52.204-4, Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011); 52.223-6, Drug-Free Workplace (May 2001); 52.225-8, Duty-Free Entry (Oct 2010); 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013); 52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013); 52.242-13, Bankruptcy (Jul 1995) • HHSAR Clauses: 352.202-70, Definitions (Jan 2006); 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010); 352.231-71, Pricing of Adjustments (Jan 2001); 352.239-70, Standard Security Configurations (Jan 2010); 352.242-71, Tobacco-Free Facilities (Jan 2006) FAR 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (May 2015) (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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014) (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: _X__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). ___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). ___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009). _X__ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). ___ (5) [Reserved] ___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). ___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). _X__ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note). ___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). ___ (10) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161). ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). ___ (ii) Alternate I (Nov 2011) of 52.219-3. _X__ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). ___ (ii) Alternate I (Jan 2011) of 52.219-4. ___ (13) [Reserved] ___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644). ___ (ii) Alternate I (Nov 2011). ___ (iii) Alternate II (Nov 2011). ___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). ___ (ii) Alternate I (Oct 1995) of 52.219-7. ___ (iii) Alternate II (Mar 2004) of 52.219-7. ___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)). ___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (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 (Oct 2014) of 52.219-9. ___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)). ___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). ___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). ___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f). _X__ (22) 52.219-28,Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). ___ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). _X__ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _X__ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). _X__ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 1999). _X__ (28) 52.222-26, Equal Opportunity (Apr 2007) (E.O. 11246). _X__ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). _X__ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). _X__ (31) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). _X__ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X__ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627). ___ (34) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) ___ (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) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-13. ___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-14. ___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). ___ (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-16. _X__ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513). ___ (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83). _X__ (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43). ___ (ii) Alternate I (May 2014) of 52.225-3. ___ (iii) Alternate II (May 2014) of 52.225-3. ___ (iv) Alternate III (May 2014) of 52.225-3. ___ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X__ (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). ___ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). ___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X__ (50) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (51) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). ___ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (54) (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: ___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495) ___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.). ___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67). ___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). _X__ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658). ___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). ___ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17. (iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). (v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). (vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). (vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (viii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). (ix) 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. (x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627). (xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.) (xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67) (xiv) 52.222-54, Employment Eligibility Verification (Aug 2013). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658). (xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of Clause) Additional Information It is the offeror's responsibility to monitor the internet site for the release of any information related to this combined synopsis/solicitation. Offerors are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete offer and any additional documents before 2:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on May 20, 2015 to crystal.mccoskey@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Crystal G. McCoskey, 3900 NCTR Road, Building 50, Room 426 Jefferson, AR 72079-9502. For information regarding this solicitation and to schedule a site visit, please contact Crystal G. McCoskey by e-mail at crystal.mccoskey@fda.hhs.gov. Questions and site visits requests regarding this solicitation will be accepted only via email and shall be submitted no later than 09:00 AM CST on May 15, 2015. Please reference Solicitation Number 1146518, Slide Scanning System in subject line of all correspondence. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the Place of Performance section above.
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- Place of Performance
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- Zip Code: 20993
- Zip Code: 20993
- Record
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