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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 12, 2015 FBO #5010
SOLICITATION NOTICE

66 -- Development for Runinant Material Porcine Heparin - Package #1

Notice Date

8/10/2015
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
 

ZIP Code

20857-0001
 

Solicitation Number

FDASOL1148575
 

Point of Contact

Telisha Wilson, Phone: 2404027572
 

E-Mail Address

telisha.wilson@fda.hhs.gov
(telisha.wilson@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Development for Runinant Material Porcine Heparin Subject: Establishing test to assure the quality of the heparin supply chain; Identification of ruminant contamination in porcine heparin PART 1 - DESCRIPTION The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has a need for a laboratory analysis of crude heparin using a specific method. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-74. The North American Industry Classification System (NAICS) code for the proposed acquisition is 621511, Medical Laboratories. Background The FDA is exploring the re-introduction of heparin sourced from bovine tissues to the US market. Thus, the FDA Office of Testing and Research, Division of Pharmaceutical Analysis (DPA) is currently performing heparin analyses on procine and bovine sourced heparin products. The major goal of the work is to establish test methods to enable detection of ruminant material in porcine heparin at the crude stage of manufacturing and/or in heparin APIs. The impact of this work will be to establish tests to assure the quality of porcine heparin or bovine heparin sourced products. By have a robust test for ruminant heparin, cross-contaminated material can be prevented from reaching the active pharmaceutical ingredient manufacturing processes which are often performed under GMP in US based plants. Because the supply chain for heparin is complex and a global one, controlling the quality of this widely used drug, its intermediates and starting materials (at least as early as the crude heparin warehouse) solely through cGMP inspection is insufficient and often impractical, in part, due to the limited resources that the FDA has. Thus there is a critical need to develop strong analytics and appropriate specifications for crude heparin to ensure the consistent high quality of the final heparin drug substance. For this reason, the proposed work will help assure the quality of generic heparin and LMWH drug product by improving the quality of the entire global heparin supply chain. The purpose of this acquisition is to develop test methods to detect ruminant material in porcine products. Perform needed experiments on DPA-supplied crude heparin samples. Task • The contractor shall develop a method for 1D-1H-NMR analysis of crude heparin samples and 2D-NMR monosaccharide and disaccharide composition analysis of crude heparin • The contractor shall collect data for Multivariate statistical analyses to compare, contrast and classify heparin sample types • The contract shall provide a Technical Report or a Peer Reviewed Publication of the findings Deliverables Deliverable Schedule Method Development Due within 1 month Data Collection Due within 6 months Technical Reports to FDA or Peer Reviewed Publication(s) Due within 12 months Contract Administration Contracting Officer's Representative (COR) The following COR will represent the Government for the purpose of this order: [TBD] The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order. The contact information for the Contracting Officer is the following:[TBD] The contact information for the Contract Specialist is the following: Telisha Wilson U.S. Food and Drug Administration Office of Acquisitions and Grants Services Rockville, MD 20857 Telisha.Wilson@fda.hhs.gov Telephone: (240) 402-7572 The contact information for the Contractor is the following: [TBD] PAYMENT The Government will pay the Contractor only each respective deliverable's firm-fixed-price delineated in the table in Subpart 3.3 above, upon successful completion, as determined by the COR, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below. Payment Schedule Deliverable Amount Due within 1 month Method Development $ Due within 6 months Data Collection $ Due within 12 months Technical Reports to FDA or Peer Reviewed Publication(s) $ Total $ INVOICE INSTRUCTIONS The Contractor shall submit all invoices in the manner specified below: The Contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration 10903 New Hampshire Avenue W032-Second Floor Bldg. 32, Rm. 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments Phone: (301) 827-3742 or (866) 807-3742 Email: fdavendorpaymentsteam@fda.gov Invoices submitted under this order must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer - Central Contractor Registration) and the 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 of supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, 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 a 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 COR or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. Questions regarding invoices shall be directed to the FDA at the telephone numbers provided above. Payment will only be made on a firm-fixed-price basis. 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (JUL 2014) (IAW FAR 12.301(b)(4)) (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)(Public Laws 108-77 and 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: [Contracting Officer check as appropriate.] __ __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sep 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). __ __ 108) 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). __ __ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011)(15 U.S.C. 657a). __ __ (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] __ __ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011)(15 U.S.C. 644). __ __ (14) (ii) Alternate I (Nov 2011). __ __ (14) (iii) Alternate II (Nov 2011). __ __ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003)(15 U.S.C. 644). __ __ (15) (ii) Alternate I (Oct 1995) of 52.219-7. __ __ (15) (iii) Alternate II (Mar 2004) of 52.219-7. __ __ (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)). (In accordance with DDP Memo dated 9 Sep 2013, DAR Tracking Number 2013-O0014, Class Deviation-Summary Subcontract Report Submission, this clause is replaced with DFARS Deviation dated Aug 2013. Effective until incorporated into the FAR or DFARS or until rescinded.) __ __ (17) (ii) Alternate I (Oct 2001) of 52.219-9. __ __ (17) (iii) Alternate II (Oct 2001) of 52.219-9. __ __ (17) (iv) Alternate III (Jul 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). (In accordance with DDP Memo dated 12 Mar 2010, DAR Tracking Number 2010-O0006, Immediate Cessation of the Use of Price Evaluation Adjustment for Small Disadvantaged Businesses, this clause is suspended in DoD. Effective until incorporated into the FAR or DFARS or until rescinded.) __ __ (21) (ii) Alternate I (June 2003) of 52.219-23. (In accordance with DDP Memo dated 12 Mar 2010, DAR Tracking Number 2010-O0006, Immediate Cessation of the Use of Price Evaluation Adjustment for Small Disadvantaged Businesses, this clause is suspended in DoD. Effective until incorporated into the FAR or DFARS or until rescinded.) __ __ (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 Total Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011)(15 U.S.C. 657 f). __X __ (25) 52.219-28, Post Award Small Business Program Rerepresentation (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) (1 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)). __ __ (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 Veterans (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). __ __ (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.) __ _ (37) (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®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514). ____ (38) (ii) Alternate I (Jun 2014) of 52.223-13. ____ (39) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514). ____ (39) (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®-Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514). __ _ (41) (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). __ __ (43) 52.225-1, Buy American--Supplies (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). __ _ (44) (ii) Alternate I (May 2014) of 52.225-3. __ _ (44) (iii) Alternate II (May 2014) of 52.225-3. __ _ (44) (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, Restriction on Certain Foreign Purchases (Jun 2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of 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. 2302 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)). __ __ (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). __ _ (56) (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] __ __ (1) 52.222-41, Service Contract 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 paragraphs (e)(1) of this paragraph 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 (l) of FAR clause 52.222-17. (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Veterans (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) 52.222-37, 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 paragraphs (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.ADDENDUM TO CLAUSE 52.212-4 352.201-70 PAPERWORK REDUCTION ACT (JAN 2006) (IAW HHSARFARS 301.106(c)) 52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS (MAY 2014) (IAW FAR 12.301(b)(3)) THE FOLLOWING IS FILL-IN DATA FOR CLAUSE 52.212-5 PARA (b)(25): 52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JUL 2013) (g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed: The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code _____________ assigned to contract number ______________________________. [Contractor to sign and date and insert authorized signer's name and title]. 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS (JAN 2010) (IAW HHSARFARS 322.810(h)) 352.227-70 PUBLICATIONS AND PUBLICITY (JAN 2006) (IAW HHSARFARS 327.404-70) 52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013) (IAW FAR 32.706-3) 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) (IAW FAR 32.009-2) SOLICITATION PROVISIONS REPRESENTATIONS, INSTRUCTIONS AND EVALUATIONS 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (MAY 2014) (IAW FAR 12.301(b)(2)) An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision. (a) Definitions. As used in this provision- "Economically disadvantage women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program. "Forced or indentured child labor " means all work or service-- (1) Extracted from any person under the age of 18 under the menace of penalty for its nonperformance and for which the worker does not offer himself voluntarily; or (2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties. "Inverted domestic corporation," as used in this section, means a foreign incorporated entity which is treated as an inverted domestic corporation under 6 U.S.C. 395(b), i.e., a corporation that used to be incorporated in the United States, or used to be a partnership in the United States, but now is incorporated in a foreign country, or is a subsidiary whose parent corporation is incorporated in a foreign country, that meets the criteria specified in 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c). An inverted domestic corporation as herein defined does not meet the definition of an inverted domestic corporation as defined by the Internal Revenue Code at 26 U.S.C. 7874. "Manufactured end product" means any end product in Federal Supply Classes (FSC) 1000-9999, except- (1) FSC 5510, Lumber and Related Basic Wood Materials; (2) Federal Supply Group (FSG) 87, Agricultural Supplies; (3) FSG 88, Live Animals; (4) FSG 89, Food and Related Consumables; (5) FSC 9410, Crude Grades of Plant Materials; (6) FSC 9430, Miscellaneous Crude Animal Products, Inedible; (7) FSC 9440, Miscellaneous Crude Agricultural and Forestry Products; (8) FSC 9610, Ores; (9) FSC 9620, Minerals, Natural and Synthetic; and (10) FSC 9630, Additive Metal Materials. "Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture. "Restricted business operations" means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate- (1) Are conducted under contract directly and exclusively with the regional government of southern Sudan; (2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization; (3) Consist of providing goods or services to marginalized populations of Sudan; (4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization; (5) Consist of providing goods or services that are used only to promote health or education; or (6) Have been voluntarily suspended. "Sensitive technology"- (1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically-- (i) To restrict the free flow of unbiased information in Iran; or (ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and (2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)). "Service-disabled veteran-owned small business concern"-- (1) Means a small business concern-- (i) Not less than 51 percent of which is owned by one or more service--disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and (ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran. (2) "Service-disabled veteran" means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16). "Small business concern" means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation. "Subsidiary" means an entity in which more than 50 percent of the entity is owned- (1) Directly by a parent corporation; or (2) Through another subsidiary of a parent corporation. "Veteran-owned small business concern" means a small business concern-- (1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and (2) The management and daily business operations of which are controlled by one or more veterans. "Women-owned business concern" means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women. "Women-owned small business concern" means a small business concern-- (1) That is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and (2) Whose management and daily business operations are controlled by one or more women. "Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127)," means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States. (b)(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website. (2) The offeror has completed the annual representations and certification electronically via the SAM website accessed through http://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representation and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ____________. [Offeror to identify the applicable paragraphs at (c) through (o) of this provision that the offeror has completed for the purposes of this solicitation only, if any. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.] (c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply. (1) Small business concern. The offeror represents as part of its offer that it [ ] is, [ ] is not a small business concern. (2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a veteran-owned small business concern. (3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a service-disabled veteran-owned small business concern. (4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, for general statistical purposes, that it [ ] is, [ ] is not a small disadvantaged business concern as defined in 13 CFR 124.1002. (5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is, [ ] is not a women-owned small business concern. Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold. (6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that- (i) It [ ] is, [ ] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and (ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: ______________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation. (7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that- (i) It [ ] is, [ ] is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and (ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: ______________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation. (8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is a women-owned business concern. (9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price: ______________________________________________________ (10) [Complete only if the solicitation contains the clause at FAR 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, or FAR 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting, and the offeror desires a benefit based on its disadvantaged status.] (i) General. The offeror represents that either-- (A) It [ ] is, [ ] is not certified by the Small Business Administration as a small disadvantaged business concern and identified on the date of this representation, as a certified small disadvantaged business concern in the SAM Dynamic Small Business Search database maintained by the Small Business Administration, and that no material change in disadvantaged ownership and control has occurred since its certification, and, where the concern is owned by one or more individuals claiming disadvantaged status, the net worth or each individual upon whom the certification is based does not exceed $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); or (B) It [ ] has, [ ] has not submitted a completed application to the Small Business Administration or a Private Certifier to be certified as a small disadvantaged business concern in accordance with 13 CFR 124, Subpart B, and a decision on that application is pending, and that no material change in disadvantaged ownership and control has occurred since its application was submitted. (ii) Joint Ventures under the Price Evaluation Adjustment for Small Disadvantaged Business Concerns. The offeror represents, as a part of its offer, that it is a joint venture that complies with the requirements in 13 CFR 124.1002(f) and that the representation in paragraph (c)(10)(i) of this provision is accurate for the small disadvantaged business concern that is participating in the joint venture: [The offeror shall enter the name of the small disadvantaged business concern that is participating in the joint venture: _______________________________________.] (11) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that- (i) It [ ] is, [ ] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR part 126; and (ii) It [ ] is, [ ] is not a HUBZone joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph (c)(11)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: ____________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation. (d) Representations required to implement provisions of Executive Order 11246-- (1) Previous Contracts and Compliance. The offeror represents that-- (i) It [ ] has, [ ] has not participated in a previous contract or subcontract subject either to the Equal Opportunity clause of this solicitation; and (ii) It [ ] has, [ ] has not filed all required compliance reports. (2) Affirmative Action Compliance. The offeror represents that-- (i) It [ ] has developed and has on file, [ ] has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR parts 60-1 and 60-2), or (ii) It [ ] has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor. (e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352). (Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payment of reasonable compensation were made. (f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American--Supplies, is included in this solicitation.) (1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of "domestic end product," The terms "commercially available off-the-shelf (COTS) item," "component," "domestic end product," "end product," "foreign end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Supplies." (2) Foreign End Products: Line Item No. Country Of Origin _______________ __________________ _______________ __________________ [List as necessary] (3) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. (g) (1) Buy American--Free Trade Agreements-Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act, is included in this solicitation.) (i) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms "Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product," "commercially available off-the-shelf (COTS) item," "component," "domestic end product," "end product," "foreign end product," "Free Trade Agreement country," "Free Trade Agreement country end product," "Israeli end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act." (ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American--Free Trade Agreements--Israeli Trade Act": Free Trade Agreement Country End Products (Other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products: Line Item No. Country Of Origin _______________ __________________ _______________ __________________ [List as necessary] (iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) of this provision) as defined in the clause of this solicitation entitled "Buy American--Free Trade Agreements--Israeli Trade Act." The offeror shall list as other foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of "domestic end product." Other Foreign End Products: Line Item No. Country Of Origin _______________ __________________ _______________ __________________ [List as necessary] (iv) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. (2) Buy American--Free Trade Agreements--Israeli Trade Act Certificate, Alternate I. If Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g) (1) (ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled "Buy American--Free Trade Agreements--Israeli Trade Act": (ii) Canadian End Products: Line Item No. _______________ _______________ [List as necessary] (3) Buy American--Free Trade Agreements--Israeli Trade Act Certificate, Alternate II. If Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g) (1) (ii) The offeror certifies that the following supplies are Canadian end products or Israeli end products as defined in the clause of this solicitation entitled "Buy American--Free Trade Agreements--Israeli Trade Act": Canadian or Israeli End Products: Line Item No. Country Of Origin _______________ __________________ _______________ __________________ [List as necessary] (4) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate III. If Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g) (1) (ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American--Free Trade Agreements--Israeli Trade Act": Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products: Line Item No. Country Of Origin _______________ __________________ _______________ __________________ [List as necessary] (5) Trade Agreements Certificate. (Applies only if the clause at FAR 52.225-5, Trade Agreements, is included in this solicitation.) (i) The offeror certifies that each end product, except those listed in paragraph (g)(5)(ii) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled "Trade Agreements." (ii) The offeror shall list as other end products those end products that are not U.S.-made or designated country end products. Other End Products: Line Item No. Country Of Origin _______________ __________________ _______________ __________________ [List as necessary] (iii) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for such products are insufficient to fulfill the requirements of the solicitation. (h) Certification Regarding Responsibility Matters (Executive Order 12689). (Applies only if the contract value is expected to exceed the simplified acquisition threshold.) The offeror certifies, to the best of its knowledge and belief, that the offeror and/or any of its principals- (1) [ ] Are, [ ] are not presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency; (2) [ ] Have, [ ] have not, within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: Commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a Federal, state or local government contract or subcontract; violation of Federal or state antitrust statutes relating to the submission of offers; or Commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating criminal tax laws, or receiving stolen property; (3) [ ] Are, [ ] are not presently indicted for, or otherwise criminally or civilly charged by a Government entity with, commission of any of these offenses enumerated in paragraph (h)(2) of this clause; and (4) [ ] Have, [ ] have not, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,000 for which the liability remains unsatisfied. (i) Taxes are considered delinquent if both of the following criteria apply: (A) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted. (B) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded. (ii) Examples. (A) The taxpayer has received a statutory notice of deficiency, under I.R.C. section 6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appear rights. (B) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. section 6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals Contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights. (C) The taxpayer has entered into an installment agreement pursuant to I.R.C. section 6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment. (D) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. section 362 (the Bankruptcy Code). (i) Certification Regarding Knowledge of Child Labor for Listed End Products (Executive Order 13126). [The Contracting Officer must list in paragraph (j)(1) any end products being acquired under this solicitation that are included in the List of Products Requiring Contractor Certification as to Forced or Indentured Child Labor; unless excluded at 22.1503(b).] (1) Listed End Products. Listed End Product Listed Countries of Origin _______________ __________________ _______________ __________________ (2) Certification. [If the Contracting Officer has identified end products and countries of origin in paragraph (j)(1) of this provision, then the offeror must certify to either (j)(2)(i) or (j)(2)(ii) by checking the appropriate block.] [ ] (i) The offeror will not supply any end product listed in paragraph (j)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. [ ] (ii) The offeror may supply an end product listed in paragraph (j)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. The offeror certifies that is has made a good faith effort to determine whether forced or indentured child labor was used to mine, produce, or manufacture any such end product furnished under this contract. On the basis of those efforts, the offeror certifies that it is not aware of any such use of child labor. (j) Place of Manufacture. (Does not apply unless the solicitation is predominantly for the acquisition of manufactured end products.) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly- (1) [ ] In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or (2) [ ] Outside the United States. (k) Certificates regarding exemptions from the application of the Service Contract Labor Standards. (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.) (1) [ ] Maintenance, calibration, or repair of certain equipment as described in FAR 22.1003-4(c)(1). The offeror [ ] does [ ] does not certify that- (i) The items of equipment to be serviced under this contract are used regularly for other than Governmental purposes and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontract) in substantial quantities to the general public in the course of normal business operations; (ii) The services will be furnished at prices which are, or are based on, established catalog or market prices (see FAR 22.1003-4(c)(2)(ii)) for the maintenance, calibration, or repair of such equipment; and (iii) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract will be the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. (2) [ ] Certain services as described in FAR 22.1003-4(d)(1). The offeror [ ] does [ ] does not certify that- (i) The services under the contract are offered and sold regularly to non-Governmental customers, and are provided by the offeror (or subcontractor in the case of an exempt subcontract) to the general public in substantial quantities in the course of normal business operations; (ii) The contract services will be furnished at prices that are, or are based on, established catalog or market prices (see FAR 22.1003-4(d)(2)(iii)); (iii) Each service employee who will perform the services under the contract will spend only a small portion of his or her time (a monthly average of less than 20 percent of the available hours on an annualized basis, or less than 20 percent of available hours during the contract period if the contract period is less than a month) servicing the Government contract; and (iv) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract is the same as that used for these employees and equivalent employees servicing commercial customers. (3) If paragraph (k)(1) or (k)(2) of this clause applies- (i) If the offeror does not certify to the conditions in paragraph (k)(1) or (k)(2) and the Contracting Officer did not attach a Service Contract Labor Standards wage determination to the solicitation, the offeror shall notify the Contracting Officer as soon as possible; and (ii) The Contracting Officer may not make an award to the offeror if the offeror fails to execute the certification in paragraph (k)(1) or (k)(2) of this clause or to contact the Contracting Officer as required in paragraph (k)(3)(i) of this clause. (l) Taxpayer Identification Number (TIN) (26 U.S.C. 6109, 31 U.S.C. 7701). (Not applicable if the offeror is required to provide this information to the SAM database to be eligible for award.) (1) All offerors must submit the information required in paragraphs (l)(3) through (l)(5) of this provision to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the Internal Revenue Service (IRS). (2) The TIN may be used by the Government to collect and report on any delinquent amounts arising out of the offeror's relationship with the Government (31 U.S.C. 7701(c)(3)). If the resulting contract is subject to the payment reporting requirements described in FAR 4.904, the TIN provided hereunder may be matched with IRS records to verify the accuracy of the offeror's TIN. (3) Taxpayer Identification Number (TIN). [ ] TIN:_________________________________________ [ ] TIN has been applied for. [ ] TIN is not required because: [ ] Offeror is a nonresident alien, foreign corporation, or foreign partnership that does not have income effectively connected with the conduct of a trade or business in the United States and does not have an office or place of business or a fiscal paying agent in the United States; [ ] Offeror is an agency or instrumentality of a foreign government; [ ] Offeror is an agency or instrumentality of the Federal Government. (4) Type of organization. [ ] Sole proprietorship; [ ] Partnership; [ ] Corporate entity (not tax-exempt); [ ] Corporate entity (tax-exempt); [ ] Government entity (Federal, State, or Local); [ ] Foreign government; [ ] International organization per 26 CFR 1.6049-4; [ ] Other________________________________________ (5) Common parent. [ ] Offeror is not owned or controlled by a common parent; [ ] Name and TIN of common parent: Name___________________________________________ TIN_____________________________________________ (m) Restricted business operations in Sudan. By submission of its offer, the offeror certifies that the offeror does not conduct any restricted business operations in Sudan. (n) Prohibition on Contracting with Inverted Domestic Corporations- (1) Relation to Internal Revenue Code. An inverted domestic corporation as herein defined does not meet the definition of an inverted domestic corporation as defined by the Internal Revenue Code 25 U.S.C. 7874. (2) Representation. By submission of its offer, the offeror represents that- (i) It is not an inverted domestic corporation; and (ii) It is not a subsidiary of an inverted domestic corporation. (o) Prohibition on contracting with entities engaging in certain activities or transactions relating to Iran. (1) The offeror shall email questions concerning sensitive technology to the Department of State at CISADA106@state.gov. (2) Representation and Certification. Unless a waiver is granted or an exception applies as provided in paragraph (o)(3) of this provision, by submission of its offer, the offeror- (i) Represents, to the best of its knowledge and belief, that the offeror does not export any sensitive technology to the government of Iran or any entities or individuals owned or controlled by, or acting on behalf or at the direction of, the government of Iran; (ii) Certifies that the offeror, or any person owned or controlled by the offeror, does not engage in any activities for which sanctions may be imposed under section 5 of the Iran Sanctions Act; and (iii) Certifies that the offeror, and any person owned or controlled by the offeror, does not knowingly engage in any transaction that exceeds $3,000 with Iran's Revolutionary Guard Corps or any of its officials, agents, or affiliates, the property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (50(U.S.C. 1701 et seq.) (see OFAC's Specially Designated Nationals and Blocked Persons List at http://www.treasury.gov/ofac/downloads/t11sdn.pdf ). (3) The representation and certification requirements of paragraph (o)(2) of this provision do not apply if- (i) This solicitation includes a trade agreements certification (e.g., 52.212-3(g) or a comparable agency provision); and (ii) The offeror has certified that all the offered products to be supplied are designated country end products. 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS -- ALTERNATE I (MAY 2014) (IAW FAR 12.301(b)(2)) As prescribed in 12.301(b)(2), add the following paragraph (c)(12) to the basic provision: (c)(12) (Complete if the offeror has represented itself as disadvantaged in paragraph (c)(4) or (c)(8) of this provision.) [The offeror shall check the category in which its ownership falls]: Black American. Hispanic American. Native American (American Indians, Eskimos, Aleuts, or Native Hawaiians). Asian-Pacific American (persons with origins from Burma, Thailand, Malaysia, Indonesia, Singapore, Brunei, Japan, China, Taiwan, Laos, Cambodia (Kampuchea), Vietnam, Korea, The Philippines, Republic of Palau, Republic of the Marshall Islands, Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, Guam, Samoa, Macao, Hong Kong, Fiji, Tonga, Kiribati, Tuvalu, or Nauru). Subcontinent Asian (Asian-Indian) American (persons with origins form India, Pakistan, Bangladesh, Sri Lanka, Bhutan, the Maldives Islands, or Nepal). Individual/concern, other than one of the preceding. ADDENDUM TO PROVISION 52.212-1 52.207-4 ECONOMIC PURCHASE QUANTITY--SUPPLIES (AUG 1987) (IAW FAR 7.203) (a) Offerors are invited to state an opinion on whether the quantity(ies) of supplies on which bids, proposals or quotes are requested in this solicitation is (are) economically advantageous to the Government. (b) Each offeror who believes that acquisitions in different quantities would be more advantageous is invited to recommend an economic purchase quantity. If different quantities are recommended, a total and a unit price must be quoted for applicable items. An economic purchase quantity is that quantity at which a significant price break occurs. If there are significant price breaks at different quantity points, this information is desired as well. OFFEROR RECOMMENDATIONS ITEM QUANTITY QUOTATION PRICE TOTAL (c) The information requested in this provision is being solicited to avoid acquisitions in disadvantageous quantities and to assist the Government in developing a data base for future acquisitions of these items. However, the Government reserves the right to amend or cancel the solicitation and re-solicit with respect to any individual item in the event quotations received and the Government's requirements indicate that different quantities should be acquired. 52.225-18 PLACE OF MANUFACTURE (SEP 2006) (IAW FAR 25.1101(f)) (a) Definitions. As used in this clause- "Manufactured end product" means any end product in Federal Supply Classes (FSC) 1000-9999, except- (1) FSC 5510, Lumber and Related Basic Wood Materials; (2) Federal Supply Group (FSG) 87, Agricultural Supplies; (3) FSG 88, Live Animals; (4) FSG 89, Food and Related Consumables; (5) FSC 9410, Crude Grades of Plant Materials; (6) FSC 9430, Miscellaneous Crude Animal Products, Inedible; (7) FSC 9440, Miscellaneous Crude Agricultural and Forestry Products; (8) FSC 9610, Ores; (9) FSC 9620, Minerals, Natural and Synthetic; and (10) FSC 9630, Additive Metal Materials. "Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture. (b) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly- (1) [ ] In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or (2) [ ] Outside the United States. 52.225-25 PROHIBITION ON CONTRACTING WITH ENTITIES ENGAGING IN CERTAIN ACTIVITIES OR TRANSACTIONS RELATING TO IRAN--REPRESENTATION AND CERTIFICATIONS (DEC 2012) (IAW FAR 25.1103(e)) CONFLICTS OF INTEREST The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, it does not have any actual, potential, or apparent conflict of interests pertaining to the subject order, as defined in FAR Subpart 9.5 and HHS and FDA policies, for its organization, employees, or subcontractors working or proposed to be working under this order. The Contractor agrees that, if after award, it discovers a conflict of interest with respect to this order, it shall make an immediate and full disclosure in writing to the FDA Contracting Officer for this order. The Government reserves the right to exercise any remedy available at law or equity, including termination of the order for cause or convenience, should the Government determine remedial action is necessary to address any actual, potential, or apparent conflict of interest. INSTRUCTIONS TO OFFERORS Cover Page Offerors shall include a cover page which shall include a point of contact (name, telephone number, and email address), proposed firm-fixed-prices (i.e. complete the pricing table in Subpart 2.2), estimated delivery date, business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.), Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current. Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote. Faxed quotes will not be accepted. Quotes must be valid through September 30, 2015. Offerors Response Date and Time All quotes and revisions shall be submitted via email to Telisha Wilson@fda.hhs.gov by or before 9:00 AM Eastern Time on August 19, 2015. Award shall be made to the lowest priced technically acceptable offer
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDASOL1148575/listing.html)
 

Record

SN03831164-W 20150812/150810235433-b5dccf32bfa38a0a074c3372d601529e (fbodaily.com)
 

Source

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