Combine Solicitation – Microbial Air Sampler

Notice Type: Combine Solicitation

Posted Date: 04-SEP-14

Office Address: 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 AR 72079

Subject: Microbial Air Sampler

Classification Code: 66 - Instruments & laboratory equipment

Solicitation Number: FDA-14-1135501

Contact: Tammy L. Wright, Contract Specialist, Phone 2404027587, Email [email protected]

Setaside: N/AN/A

Place of Performance (address): 60 8th Street NEAtlanta, GA

Place of Performance (zipcode): 30309

Place of Performance Country: US

Description: Department of Health and Human Services

Food and Drug Administration

Office of Acquisitions and Grants Services

PART 1: COMBINED SYNOPSIS/SOLICITATION This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This solicitation is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures, as applicable.

The solicitation number is FDA-14-1135501 which is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-76, dated July 25, 2014.

The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business size standard is 500 employees. This procurement is pursued as a full and open competition.

PART 2: SUPPLIES/SERVICES AND PRICES/COSTS

2.1 Supplies/Services

The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price (FFP) purchase order for procurement and delivery of one (1) Microbial Air Sampler - Monitoring System.

2.2 Pricing: See document attachment for pricing breakdown. PART 3: DESCRIPTION/STATEMENT OF WORK

Background:

The Southeast Regional Laboratory (SRL) is a full service facility capable of performing a broad spectrum of analyses. The Microbiological Sciences Branch is the largest of the three branches that comprise SRL and is one of FDA's largest microbiological testing labs. SRL's sterility testing isolator is in need of an active air monitoring system to test for presence of viable air contaminants, which may include a wide range of microorganisms. Airborne contaminants may settle into reagents or onto equipment within the isolator and potentially contaminate the results of costly and lengthy regulatory procedures. Currently SRL is only capable of passively monitoring for viable air contaminants within the isolator during sample analysis with the use of settle plates. Actively measuring for pollutants with a Microbial Air Sampler would further ensure quality while preventing the unnecessary loss of regulatory findings or contamination of a regulatory sample.

3.1 Statement of Work

<p>3.1.1 General New instrument: The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration.

The Contractor shall warranty all systems for parts and labor for a minimum of 12 months from date of Government's formal acceptance.

The Contractor shall provide in-side delivery, installation, and shall provide on-site training on the installed system. Installation: The vendor shall demonstrate upon installation that the item meets all performance specifications. The instrument shall not be accepted until those performance specifications have been met. The system shall be delivered with all necessary supplies and accessories required for installation and start-up. 3.2 Requirement

3.2.1 Equipment

The contractor shall provide, deliver, and install one (1) wall mountable Microbial Air Sampler - Monitoring System that meets the following salient characteristics:

* Capable of integration of the mass air flow sampler into one (1) Isotech Isophere ST Isolator * System and all components shall be capable of withstanding the Isolator's in-line vaporized hydrogen peroxide (VHP) sterilization cycles * Nominal Air Flow of at least 100 liters per minute; with an allowance of +/- 2.5% * Capable air sampling volumes ranging from one (1) liter to 2000 liters * Sampling head compatibility with agar plates that are 90 - 100 millimeters in diameter * Sampling head shall be removable and autoclavable * Sampling head shall be stainless steel, type 316L * Weigh no more than eight (8) kilograms * Footprint no larger than 17 x 29 x 24 (length/height/width) centimeters * Internal rechargeable battery and charging system compatible with 110-240 volt (V) Alternating Current (A/C), 1.5 Amp, 50/60 Hertz (Hz) * Compact disc (CD) documentation for the installation protocol (IQ), operating protocol (OQ), and validation protocol; along with one (1) hard copy of the documentation, printed on 8 1/2 x 11 paper, and bound in a three ring binder * Provide ten (10) feet of 3/4" inch diameter stainless steel tubing and one (1) tri-connector for installation. * One (1) year warranty inclusive of labor, travel, replacement parts, tools, components, subassemblies required to repair the system * One (1) year of technical support via either online, email, or telephone

3.2.1.2 Installation

The contractor shall install the equipment, and demonstrate that the equipment meets all of the manufacturer's performance specifications. The contractor shall execute the initial validation protocol to ensure proper calibration of the system. The equipment shall not be accepted until those performance specifications have been met.

3.2.1.3 Onsite Training

The contractor shall provide on-site training for the Microbial Air Sampler - Monitoring System for up to seven (7) participants. The training shall be no longer than four (4) hours in duration and shall cover all aspects of operation and general use of the Microbial Air Sampler - Monitoring System. The Specific date and time for the training will be coordinated with the COR within two (2) weeks after contract award.

3.3 Delivery 3.3.1 Delivery shall be during regular business hours, 8:00 am - 4:00 pm, of the local time zone, Monday -Friday. PART 4: PERFORMANCE

4.1 Place of Performance

The contractor shall deliver one (1) of the above detailed Clean Air Benches to each of the following locations:

* FDA Atlanta (ATL-DO) 60 8th Street Northeast, Atlanta, GA 30309 - attn. xxxxxxxx, (404) xxx-xxxx

4.2 Period of Performance

Delivery and installation shall be no later than ninety (90) days after receipt of order (ARO).

Deliveries shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or as identified on www.opm.gov.

PART 5. CONTRACT ADMINISTRATION

5.1 Contracting Officer Representative

The COR names will be provided at the time of award.

The supplies delivered hereunder shall be inspected and accepted by the Contracting Officer Representatives (CORs) specified at the time of award. If the supplies are not acceptable the COR shall document the nonconforming items and immediately notify the Contracting Officer (CO).

The CORs are responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance

5.2 Contracting Officer

The Contracting Officer (CO) for this procurement is:

Name: Jamie Whitt Email address: [email protected] Phone number: 240-402-7627

The CO is the only person with authority to act as an agent of the Government under this contract. Only the CO has the authority to:

(1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract

5.3 Contracting Specialist

The Contracting Specialist for this procurement is:

Name: Tammy Wright Email address: [email protected] Phone number: 240-402-7587

5.4 Invoicing Instructions

FDA TWO-WAY-Matching Invoice Clause

A. The contractor shall submit all invoices to all addressees in the manner specified below:

(i) One (1) original and one (1) copy to the approving official:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services ATTN: Tammy Wright, Contract Specialist 5630 Fishers Lane Room 2079, HFA-500 Rockville, Maryland 20857 E-mail: [email protected]

*** Acceptable methods of delivery include: mail, hand delivery, and e-mail

(ii) One (1) copy to the contracting officer representative (COR) clearly marked "courtesy copy only": U.S. Food and Drug Administration Office of Program Operations ATTN: [INSERT NAME], COR 10903 New Hampshire Ave Silver Spring, MD 20993 E-mail: [email protected]

*** Acceptable methods of delivery include: mail, hand delivery, or e-mail

B. Invoices submitted under this contract must comply with the requirements set forth in far clauses 52.232-25 (prompt payment) and 52.232-33 (payment by electronic funds transfer - 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 number; (iii) purchase order/award number; (iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; (c) any other supporting information necessary to clarify questionable expenditures; (v) shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading; (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/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's representative (COR) or other program center/office point of contact, as referenced on the purchase order; (xii) any other information or documentation required by the purchase order/award. (xiii) contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (a) list of all invoices submitted to date under the subject award, including the following: (1) invoice number, amount, & date submitted (2) corresponding payment amount & date received (b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance

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

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments 301.827.3742 or 866.807.3742 [email protected]

PART 6: CONTRACT PROVISIONS/CLAUSES

6.1 CONTRACT PROVISIONS

1.The provision of FAR 52.212-1 Instructions to Offerors - Commercial Items (APR 2014) applies to this solicitation.

2. The provision of FAR 52.212-2 Evaluation-Commercial Items (JAN 1999) is applicable to this solicitation and is modified as follows:

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

(i) technical capability of the item offered to meet the Government requirement; and (ii) price

Technical is significantly more important when compared to price.

Technical capability will be determined by review of information submitted by the offeror which shall provide sufficient technical information necessary for the Government to conclusively determine that the offered products and/or services meets the technical requirement identified above. It is highly recommended that offerors provide technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror.

The price proposed shall be detailed and represent the offeror's response to the schedule of supplies above. Understanding the possibility that only one vendor might respond with a quote, absent competitive pricing, offerors are encouraged to include a commercial price list with their quote.

The Government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Include the firms DUNS number with quote.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

The government reserves the right to make an award without discussions.

3. The provision of FAR 52.212-3 Offeror Representations and Certifications-Commercial Items (NOV 2013) applies to this solicitation. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via https://www.sam.gov/portal/SAM/#1.

6.2 CONTRACT CLAUSES

CLAUSES INCORPORATED BY REFERENCE

FAR 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 www.acquisition.gov/far/index.html

The following clauses are incorporated by reference:

FAR 52.204-7 System for Award Management (JUL 2013) FAR 52.212-4 Contract Terms and Conditions-Commercial Items (FEB 2012) FAR 52.216-24 Limitation of Government Liability (APR 1984) FAR 52.232-18 Availability of Funds (APR 1984) FAR 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (DEC 2013) FAR 52.233-2 Service of Protest (SEP 2006) FAR 52.246-4 Inspection of Services-Fixed Price Clause (AUG 1996)

FAR CLAUSES INCORPORATED BY FULL TEXT

The following clauses are incorporated by full text:

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jul 2014) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)). _x_ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)). (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: _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) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). _x_ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). ___ (13) [Reserved] _x_ (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. _x_ (16) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)). ___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637 (d)(4)). ___ (ii) Alternate I (Oct 2001) of 52.219-9. ___ (iii) Alternate II (Oct 2001) of 52.219-9. ___ (iv) Alternate III (July 2010) of 52.219-9. ___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)). ___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). ___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). ___ (21) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). ___ (ii) Alternate I (June 2003) of 52.219-23. ___ (22) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (23) 52.219-26, Small Disadvantaged Business Participation Program-Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f). _x_ (25) 52.219-28, Post Award Small Business Program Re-representation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). ___ (27) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). _x_ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _x_ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). _x_ (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _x_ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _x_ (32) 52.222-35, Equal Opportunity for Veteran (Jul 2014) (38 U.S.C. 4212). _x_ (33) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). _x_ (34) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). _x_ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). ___ (36) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) ___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) ___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) ___ (38) (i) 52.223-13, Acquisition of EPEAT(R) -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Jun 2014) of 52.223-13. ___ (39) (i) 52.223-14, Acquisition of EPEAT(R) -Registered Television (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-14. ___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). ___ (41) (i) 52.223-16, Acquisition of EPEAT(R) -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-16. _x_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011). _x_ (43) 52.225-1, Buy American'upplies (May 2014) (41 U.S.C. chapter 83). ___ (44) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43). ___ (ii) Alternate I (May 2014) of 52.225-3. ___ (iii) Alternate II (May 2014) of 52.225-3. ___ (iv) Alternate III (May 2014) of 52.225-3. ___ (45) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _x_ (46) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). ___ (47) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2303 Note). ___ (48) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (49) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (50) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (51) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _x_ (52) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (53) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (54) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). ___ (55) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (56) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). ___ (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items: ___ (1) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.). ___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67). ___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). ___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). ___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17. (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). (vi) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (vii) 52.222-17, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). (viii) 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. (ix) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (x) 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)). (xi) 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.) (xii) 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) (xiii) 52.222-54, Employment Eligibility Verification (Aug 2013). (xiv) 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). (xv) 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. (xvi) 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. 52.217-9 Option to Extend the Term of the Contract (Mar 2000) (a) The Government may extend the term of this contract by written notice to the Contractor any time prior to the end of the warranty period; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least thirty (30) days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed three (3) years beyond the warranty expiration of the requirement of CLIN 0001.

FAR 52.246-17 Warranty of Supplies of a Noncomplex Nature. (June 2003)

(a) Definitions. As used in this clause- "Acceptance" means the act of an authorized representative of the Government by which the Government assumes for itself, or as an agent of another, ownership of existing supplies, or approves specific services as partial or complete performance of the contract. "Supplies" means the end items furnished by the Contractor and related services required under this contract. The word does not include "data." (b) Contractor's obligations. (1) Notwithstanding inspection and acceptance by the Government of supplies furnished under this contract, or any condition of this contract concerning the conclusiveness thereof, the Contractor warrants that for one (1) year after delivery - (i) All supplies furnished under this contract will be free from defects in material or workmanship and will conform with all requirements of this contract; and (ii) The preservation, packaging, packing, and marking, and the preparation for, and method of, shipment of such supplies will conform with the requirements of this contract. (2) When return, correction, or replacement is required, transportation charges and responsibility for the supplies while in transit shall be borne by the Contractor. However, the Contractor's liability for the transportation charges shall not exceed an amount equal to the cost of transportation by the usual commercial method of shipment between the place of delivery specified in this contract and the Contractor's plant, and return. (3) Any supplies or parts thereof, corrected or furnished in replacement under this clause, shall also be subject to the terms of this clause to the same extent as supplies initially delivered. The warranty, with respect to supplies or parts thereof, shall be equal in duration to that in paragraph (b)(1) of this clause and shall run from the date of delivery of the corrected or replaced supplies. (4) All implied warranties of merchantability and "fitness for a particular purpose" are excluded from any obligation contained in this contract. (c) Remedies available to the Government. (1) The Contracting Officer shall give written notice to the Contractor of any breach of warranties in paragraph (b)(1) of this clause within forty-five (45) days after discovery of the defect. (2) Within a reasonable time after the notice, the Contracting Officer may either- (i) Require, by written notice, the prompt correction or replacement of any supplies or parts thereof (including preservation, packaging, packing, and marking) that do not conform with the requirements of this contract within the meaning of paragraph (b)(1) of this clause; or (ii) Retain such supplies and reduce the contract price by an amount equitable under the circumstances. (3)(i) If the contract provides for inspection of supplies by sampling procedures, conformance of supplies or components subject to warranty action shall be determined by the applicable sampling procedures in the contract. The Contracting Officer- (A) May, for sampling purposes, group any supplies delivered under this contract; (B) Shall require the size of the sample to be that required by sampling procedures specified in the contract for the quantity of supplies on which warranty action is proposed; (C) May project warranty sampling results over supplies in the same shipment or other supplies contained in other shipments even though all of such supplies are not present at the point of reinspection; provided, that the supplies remaining are reasonably representative of the quantity on which warranty action is proposed; and (D) Need not use the same lot size as on original inspection or reconstitute the original inspection lots. (ii) Within a reasonable time after notice of any breach of the warranties specified in paragraph (b)(1) of this clause, the Contracting Officer may exercise one or more of the following options: (A) Require an equitable adjustment in the contract price for any group of supplies. (B) Screen the supplies grouped for warranty action under this clause at the Contractor's expense and return all nonconforming supplies to the Contractor for correction or replacement. (C) Require the Contractor to screen the supplies at locations designated by the Government within the contiguous United States and to correct or replace all nonconforming supplies. (D) Return the supplies grouped for warranty action under this clause to the Contractor (irrespective of the f.o.b. point or the point of acceptance) for screening and correction or replacement. (4)(i) The Contracting Officer may, by contract or otherwise, correct or replace the nonconforming supplies with similar supplies from another source and charge to the Contractor the cost occasioned to the Government thereby if the Contractor- (A) Fails to make redelivery of the corrected or replaced supplies within the time established for their return; or (B) Fails either to accept return of the nonconforming supplies or fails to make progress after their return to correct or replace them so as to endanger performance of the delivery schedule, and in either of these circumstances does not cure such failure within a period of 10 days (or such longer period as the Contracting Officer may authorize in writing) after receipt of notice from the Contracting Officer specifying such failure. (ii) Instead of correction or replacement by the Government, the Contracting Officer may require an equitable adjustment of the contract price. In addition, if the Contractor fails to furnish timely disposition instructions, the Contracting Officer may dispose of the nonconforming supplies for the Contractor's account in a reasonable manner. The Government is entitled to reimbursement from the Contractor, or from the proceeds of such disposal, for the reasonable expenses of the care and disposition of the nonconforming supplies, as well as for excess costs incurred or to be incurred. (5) The rights and remedies of the Government provided in this clause are in addition to and do not limit any rights afforded to the Government by any other clause of this contract. 6.3 HHSAR Clauses Incorporated by Reference

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, 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: http://farsite.hill.af.mil/VFHHSARA.HTM.

HHSAR Clause Description Date 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.231-71 Pricing of Adjustments (Jan 2001) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences, and (Jan 2001) seminars to persons with disabilities

The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice.

It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-14-1135501. The quotes are due in person, by postal mail or email to the point of contact listed below on or before September 11, 2014, by 2:00 PM Eastern Time at the Food and Drug Administration, OA/OAGS, Attn: Tammy Wright, 5630 Fishers Lane, Room 2079, HFA-500, Rockville, Maryland 20857. Offeror's shall ensure the RFQ number is visible in the subject line of the email. Faxed quotes shall not be accepted.

For information regarding this solicitation, please contact Tammy Wright by phone at (240) 402-7587, or email: [email protected].

Link/URL: https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-14-1135501/listing.html