SOL_FDA-14-223-1139152_-_IOPQ_ISO_17025_Services.pdf

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-14-223-1139152. This solicitation is issued as a Request for Quote (RFQ).

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

The associated North American Industry Classification System (NAICS) Code is - 811219 – Other Electronic and Precision Equipment Repair and Maintenance; Small Business Size Standard is $19.0 in millions of dollars. The solicitation is set-aside 100% for small businesses.

The US Food & Drug Administration (FDA) intends to issue a Commercial Item UFirm Fixed-Price U purchase order that meets the specifications of this solicitation.

SUPPLIES OR SERVICES AND PRICES/COSTS

CLIN Item Description Qty U/I Unit

Price Extended Price

0001 Installation, Operation, Qualification (IOQ) Protocol Development and Quality Documentation Review (Biological Safety Cabinet (BSC) Model: SG603A-HE, S/N: 108819)

1 Ea $ $

0002 IOQ Duplicate Protocol Development and Quality Documentation Review for the following BSCs:

Model: SG403A-HE, S/N: 108758 Model: SG403A-HE, S/N: 108767 Model: SG403A-HE, S/N: 108786 Model: SG403A-HE, S/N: 108789 Model: SG403A-HE, S/N: 108772 Model: SG403A-HE, S/N: 108765 Model: SG403A-HE, S/N: 108790 Model: SG603A-HE, S/N: 108766 Model: SG603A-HE, S/N: 108925 Model: SG403A-HE, S/N: 108815 Model: SG603A-HE, S/N: 108804 Model: SG603A-HE, S/N: 108800 Model: SG603A-HE, S/N: 108799 Model: SG403A-HE, S/N: 108817 Model: SG603A-HE, S/N: 108806 Model: SG603A-HE, S/N: 108824 Model: SG603A-HE, S/N: 108986 Model: SG603A-HE, S/N: 109011 Model: SG603A-HE, S/N: 108990

19 Ea $ $

CLIN Item Description Qty U/I Unit Price

Extended Price

0003 Installation, Operation, Performance Qualification (IOPQ) of BSCs

20 Ea $ $

0004 ISO 17025 Test and Certification of Class II BSCs

20 Ea $ $

0005 Fuel Surcharge (if applicable) 1 Ea $ $

TOTAL $

Background:

The Division of Biological Standards and Quality Control (DBSQC) is an International Standards Organization (ISO) 17025 accredited biological product testing laboratory of the Center for Biologics Evaluation and Research (CBER)/Office of Compliance and Biologics Quality (OCBQ). DBSQC is currently relocating to the White Oak Campus. New BSCs were acquired and installed in the new laboratories.

The use of BSCs is critical for the transfer of samples, standards, and reagents under sterile conditions in support of testing of Sponsor-submitted products and reagents for the evaluation of Biologics License Application (BLA) submissions, lot release, and other regulatory decisions in support of CBER’s mission. The qualification of the equipment prior to use is mandated by DBSQC Standard Operating Procedures (SOPs) on equipment, Current Good Manufacturing Practices (cGMP), and ISO 17025 accreditation guidelines. The American Association for Laboratory Accreditation (A2LA) is an ISO 17025 accreditation agency, who has audited and accredited DBSQC. One of the conditions of the A2LA to maintain accreditation status is to use services from a vendor who has current ISO 17025 accreditation for the performance of calibrations. Therefore, all respondents to this RFQ must clearly demonstrate they are an ISO 17025 accredited.

For more information on cGMP and ISO 17025, please link to the following websites:

• cGMP:

http://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm 169105.htm

• ISO 17025: http://en.wikipedia.org/wiki/ISO/IEC_17025

• A2LA: https://www.a2la.org/

Statement of Work:

An ISO 17025 accredited service provider shall provide the following on-site IOPQ certification services, at a minimum, in support of 20 BSCs currently in use at

DBSQC:

• IOPQ OF BSC

o IOPQ PROTOCOL EXECUTION

Execution of Validation Document Quality Review Executive Summary and Final Sign-Off http://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm http://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm http://en.wikipedia.org/wiki/ISO/IEC_17025 https://www.a2la.org/ o TEST AND CERTIFICATION - CLASS II BSC

1) INSTALLATION QUALIFICATION

• Shall consist of verifying the unit is installed according to the manufacturer

2) OPERATIONAL QUALIFICATION

• Consists of testing all of control functions

• Air Flow Analysis

• HEPA Filter Leak Test

3) PERFORMANCE QUALIFICATION

• Air Flow Smoke Pattern Test

• Particle Counts

• Noise Level Measurement

• Fluorescent Light Intensity Measurement

• ISO 17025 TEST AND CERTIFICATION

Place of Performance:

On-site services shall be provided at the following address:

HHS/FDA/CBER/OCBQ/DBSQC, White Oak Facility, 10903 New Hampshire Drive, Building 52/72, Silver Spring, MD 20993.

Period of Performance:

Within 40 calendar days after receipt of order.

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (MAY 2014), applies to this acquisition. The following addenda have been attached to the clause.

The following FAR and HHSAR clauses, incorporated by reference, and apply to this acquisition. FAR clauses and provisions can be obtained at HUhttps://acquisition.gov/far/index.htmlU H.

52.204-7, System for Award Management (JUL 2013) FAR 52.232-18, Availability of Funds (APR 1984) FAR 52.232-40, Providing Accelerated Payment to Small Business Subcontractors

(DEC 2013)

The following HHSAR clauses apply and can be obtained at the following website: HUhttp://farsite.hill.af.mil/VFHHSAR1.htmU

352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010) 352.223-70 Safety and Health (Jan 2006) 352.231-71, Pricing of Adjustments (JAN 2001) 352.242-71 Tobacco-Free Facilitates (JAN 2006)

Service Records and Reports: The Contractor shall, commensurate with the completion of each calibration service, provide the end-user of the equipment with a copy of a service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and https://acquisition.gov/far/index.html http://farsite.hill.af.mil/VFHHSAR1.htm detailing the reason for the action—to include a brief 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. In addition, the Contractor shall provide monthly reports to the FDA COR and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities for the previous month; negative reports are required.

The supplies and/or services delivered hereunder shall be inspected and accepted by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

The COR name will be provided at time of award.

The COR is 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.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (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.

Invoice Submission

The contractor shall submit one (1) original copy of the invoice to the addresses specified below:

FDA/OC/OA/OFO/OFS

Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th Floor, Suite 616 Jefferson, AR 72079

An electronic invoice can be emailed to the following address:

nctrinvoices@fda.hhs.gov.

One copy to the Contracting Officer Representative (COR) or other program center/office designee clearly marked "courtesy copy only: (To be provided at time of award).

Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042.

nctrinvoices@fda.hhs.gov.

mailto:nctrinvoices@fda.hhs.gov mailto:nctrinvoices@fda.hhs.gov

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)).

___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:

_X_ (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.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Feb 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).

_X_ (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]

_X_ (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.

__ (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 Subcontracting 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).

_X_ (23) 52.219-28, Post Award Small Business Program Representation (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).

_X_ (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).

__ (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).

__ (32) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

__ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

__ (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).

_X_ (40)(i) 52.225-3, Buy American Act Free Trade Agreements Israeli Trade Act (May 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, and 112-42).

_X_ (ii) Alternate I (Mar 2012) of 52.225-3.

__ (iii) Alternate II (Mar 2012) of 52.225-3.

__ (iv) Alternate III (Mar 2012) of 52.225-3.

__ (41) 52.225-5, Trade Agreements (May 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).

__ (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:

__ (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.).

_X_ (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.).

__ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247).

__ (8) 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) [Reserved]

(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.

(End of clause)

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

Addendum to Paragraph (b)(8) Representations and Certifications - This solicitation is being issued under the premise that the Contractor will certify that the combination of equipment/service it will propose to fulfill this requirement is 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 the company 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 WD 05-2035 (Rev.-14):

http://www.wdol.gov/sca.aspx.

Accordingly, in addition to completing the representations and certifications at FAR 52.212-3(b), the Contractor's proposal shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48 which follows:

52.222-48 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification. (Feb 2009)

(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.

https://www.acquisition.gov/far/current/html/52_222.html#wp1152427 https://www.acquisition.gov/far/current/html/Subpart%2022_10.html#wp1105165 https://www.acquisition.gov/far/current/html/52_222.html#wp1152427 https://www.acquisition.gov/far/current/html/52_222.html#wp1155380 https://www.acquisition.gov/far/current/html/52_222.html#wp1160021 https://www.acquisition.gov/far/current/html/52_222.html#wp1148260 http://www.wdol.gov/sca.aspx

(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.

The provision at FAR 52.212-2 Evaluation-Commercial Items (JAN 1999) is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

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

(i) Technical capability of the items/services offered to meet or exceed the Government’s requirement.

(ii) Price.

Technical is significantly more important when compared to price in determining the best value to the government.

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/services above. Understanding the possibility that only one vendor might respond with a quote, absent competitive pricing, Uofferors are encouraged to include a commercial price list with their quoteU.

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.

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.

The Provision at FAR 52.212-3, Offeror Representations and Certifications- Commercial Items (MAY 2014), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at:

https://www.sam.gov/portal/public/SAM/#1.

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-14-223-1139152.

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 1200 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OA/OAGS/DAP, Attn:

James “Scott” Rawls, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502.

For information regarding this solicitation, please contact James “Scott” Rawls at

(870) 543-7540, fax (870) 543-7990 or email: HUjames.rawls@fda.hhs.govUH.

https://www.sam.gov/portal/public/SAM/#1 mailto:james.rawls@fda.hhs.gov