Animal Feed and Bedding
Added: May 30, 2018 3:09 pm 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. It is the Government's intent to issue a Firm Fixed Priced Purchase Order in accordance with FAR Part 13.The solicitation number is FDA- 1198638. This solicitation is issued as a Request for Quote (RFQ).The solicitation document and incorporated provisions and clauses in effect tough the Federal Acquisition Circular 2005-97 dated January 24, 2018.The appropriate NAICS code for the acquisition is 311119 -- Other Animal Food Manufacturing; Small Business Size standards - 500 employees. This requirement is being competed total small business set-aside.Schedule of Supplies or Services and Prices/Costs0001 Prolab RMH 3000 - 25 lb. bag, LabDiet, Part #5P76 or equal in accordance with the below requirements.Quantity: 2550 EachUnit Price: ____________________________Extended Price: ____________________________GSA Contract Number (if applicable): ____________________________0002 Laboratory Guinea Pig Diet 50 lb. bag, LabDiet, Part #5025 or equal in accordance with the below requirements.Quantity: 200 EachUnit Price: ____________________________Extended Price: ____________________________GSA Contract Number (if applicable): ____________________________0003 Laboratory Rabbit Diet, LabDiet - 50 lb. bag, Part #5321 or equal in accordance with the below requirements.Quantity: 200 EachUnit Price: ____________________________Extended Price: ____________________________GSA Contract Number (if applicable): ____________________________0004 Ferret Diet - 33 lb., LabDiet, Part #5L14 or equal in accordance with the below requirements.Quantity: 30 EachUnit Price: ____________________________Extended Price: ____________________________GSA Contract Number (if applicable): ____________________________0005 Soft bedding - 35 lb. bag, PaperChip, Part # Papsoft or equal in accordance with the below requirements.Quantity: 3960 EachUnit Price: ____________________________Extended Price: ____________________________GSA Contract Number (if applicable): ____________________________Background:The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) Division of Veterinary Services is responsible for support of all aspects of FDA's White Oak Consolidated Animal Program (WOC AP) located in Silver Spring, Maryland. CBER/DVS administers a comprehensive set of animal-related services and provides humane care and health of multiple species of animals that are being utilized for research, which are critical to FDA's overall mission. Currently, WOC AP facilities are using the following animal feed and bedding for the research animals. FDA/CBER requires continued use of the controlled feed and bedding listed below as to prevent any introduction of variables on on-going research.Minimum Technical Specification:ITEM #1: Prolab RMH 3000 5P76 1. The diet shall be irradiated to reduce the microbial content and eliminate the need for autoclaving. It shall support ideal development and effective generation execution of rats, hamsters and mice.2. Shall have high quality of animal protein added to make a prevalent parity of amino acids for ideal execution. 3. Shall be formulated to feed rats, hamsters and various mice strains. 4. Shall feature Constant nutrition where ingredients are assayed to help minimize nutritional variables. 5. The shape shall be an oval pellet that measures 3/8"x5/8"x1"6. The guaranteed Analysis shall be as follow:a. Crude Protein not less than 22%b. Crude fat not less than 5%c. Crude fiber not more than 5%d. Ash not more than 9%e. Moisture not more than 12%7. Shall contain the following ingredients: a. Whole wheat, dehulled soybean meal, wheat middlings, ground corn, fish meal, porcineanimal fat preserved with BHA and citric acid, dehydrated alfalfa meal, calcium carbonate, soybean oil, brewers dried yeast, dicalcium phosphate, salt, DL-methionine, L-lysine, choline chloride, menadionedimethylpyrimidinol bisulfite (source of Vitamin K), magnesium oxide, ferrous sulfate, pyridoxine hydrochloride, cholecalciferol, vitamin A acetate, biotin, dl-alpha tocopheryl acetate (form of Vitamin E), vitamin B12 supplement, riboflavin supplement, thiamine mononitrate, zinc oxide, calcium pantothenate, folic acid, nicotinic acid, manganous oxide, ferrous carbonate, copper sulfate, zinc sulfate, calcium iodate, cobalt carbonate, sodium selenite.ITEM #2: 5025 Laboratory Guinea Pig Diet 1. The diet shall be formulated using managed formulation delivered from Constant Nutrition. 2. Shall contain the proper amount of stabilized vitamin C as determined by PMI Nutrition International research. 3. Shall eliminate the need for supplements; minimize stillbirths, tissue calcification, and pregnancy toxemia.4. The shape shall be a pellet that measures 4mm diameter x 10mm length5. The guaranteed Analysis shall be as follow:a. Crude Protein not less than 18%b. Crude fat not less than 4%c. Crude fiber not more than 16%d. Ash not more than 9%e. Moisture not more than 12%6. Shall contain the following ingredients: a. Dehydrated alfalfa meal, dehulled soybean meal, ground soybean hulls, ground corn, ground oats, wheat middlings, porcine animal fat preserved with BHA and citric acid, cane molasses, dicalcium phosphate, whole wheat, whey, calcium carbonate, salt, magnesium oxide, l-ascorbyl-2-polyphosphate (stabilized vitamin C), DL-methionine, menadione dimethylpyrimidinol bisulfite (source of vitamin K), choline chloride, vitamin A acetate, cholecalciferol, folic acid, pyridoxine hydrochloride, dl-alpha tocopheryl acetate (form of vitamin E), calcium pantothenate, thiamine mononitrate, nicotinic acid, vitamin B12 supplement, riboflavin supplement, cobalt carbonate, manganous oxide, zinc oxide, ferrous carbonate, copper sulfate, zinc sulfate, calcium iodate, sodium selenite.ITEM #3: 5321 Laboratory Rabbit Diet 1. The diet shall be formulated using managed formulation delivered from Constant Nutrition.2. Shall be drug-free and synthetic estrogen-free diet to help minimize research variables. 3. The shape shall be a pellet that measures 5/32"diameter x 3/8" length4. The guaranteed Analysis shall be as follow:a. Crude Protein not less than 16%b. Crude fat not less than 2.5%c. Crude fiber not more than 14%d. Ash not more than 8%e. Crude fiber not more than 18%f. Moisture not more than 12%g. Calcium not less than 0.70%h. Calcium not more than 1.20%i. Phosphorus not less than 0.50%j. Salt not less than 0.25%k. Vitamin A not less than 9000 IU/lbl. Vitamin E not less than 10 IU/lb5. Shall contain the following ingredients: a. Dehydrated alfalfa meal, ground corn, wheat middlings, dehulled soybean meal, ground oats, ground soybean hulls, cane molasses, calcium carbonate, salt, dicalcium phosphate, soybean oil, DL-methionine, choline chloride, folic acid, vitamin A acetate, cholecalciferol, pyridoxine hydrochloride, calcium pantothenate, dl-alpha tocopheryl acetate (form of vitamin E), nicotinic acid, vitamin B12 supplement, magnesium oxide, riboflavin supplement, manganous oxide, zinc oxide, ferrous carbonate, copper sulfate, zinc sulfate, calcium iodate, cobalt carbonate, sodium seleniteITEM #4: 5L14- Ferret Lab Diet 1. The diet shall be formulated using managed formulation delivered from Constant Nutrition. 2. Shall contain urine acidifiers and high nutrient content.3. The guaranteed Analysis shall be as follow:a. Crude Protein not less than 38%b. Crude fat not less than 20.5%c. Crude fiber not more than 4%d. Moisture not more than 12%4. Shall contain the following ingredients: a. Poultry by-product meal, porcine animal fat preserved with BHA, ground corn, dehulled soybean meal, corn gluten meal, poultry digest, poultry fat perserved with ethoxyquin, dried beet pulp, soy-bean oil, phosphoric acid, salt, brewers dried yeast, fish oil, fish meal, taurine, choline chloride, calcium propionate (a preservative), pyridoxine hydrochloride, DL-methionine, menadione dimethylpyrimidinol bisulfite, thiamine mononitrate, vitamin A acetate, dl-alpha tocopheryl acetate, cholecalciferol, biotin, folic acid, ethoxyquin (a preservative), zinc oxide, vitamin B12 supplement, calcium pantothenate, riboflavin, nicotinic acid, ferrous sulfate, copper sulfate, manganous oxide, ferrous carbonate, zinc sulfate, calcium iodate, calcium carbonate, cobalt carbonate, sodium selenite.ITEM #5: PAPERCHIP® soft bedding1. The bedding shall absorb ammonia odors, be dust-free, absorb moisture to keep animals dry, must be autoclavable, and made from recycled newspaper.2. The texture shall be soft and is a crumbled pellet for use as contact bedding for small rodents. 3. Shall be lab tested and controlled and proves to be longer lasting. 4. Paper comprises shall be approximately 75% of the product. Oak sawdust comprises approximately 25% of the product. 5. Moisture content shall be 9 - 13%. Pelleted paperchip shall have a diameter of approximately 0.20" (5mm) and the length shall vary from approximately 0.25" (7mm) to approximately 0.75" (20mm).6. Shall contain no clay or diatomaceous earth absorbents of crystalline silica. 7. Shall contain no sodium aluminosilicate or Propionic Acid for odor or mold control. 8. Product shall be sanitized by heating above 180 Degrees F for at least tee minutes. 9. Product shall absorb at between tee to four times its weight in moisture. 10. Product shall be packaged in autoclavable 35 pound paper bags.11. The guaranteed Analysis shall be as follow:BI Bismuth <2.50ppmMGF Magnesium 313.9ppmHG Mercury by Thermal Decomposition <0.025ppmICPHM Heavy Metals via ICP-MS: Arsenic 0.106ppmSelenium 0.0504ppmCadmium <0.0500ppmLead 0.843ppmZNF Zinc 15.8ppmPest Organiphosphates and Chlorinated Pest ic.:Diazinon <0.0200ppmDisulfoton <0.0200ppmEthion <0.0200ppmLalathion <0.0200ppmMethyl Parathion <0.0200ppmThimet <0.0200ppmThiodan <0.0200ppmTrithion <0.0200ppm1-leptach lor epoxide <0.0200ppmHeptach lor <0.0200ppm DDE <0.0200ppmLindane <0.0200ppmEndrin <0.0200ppmMirex <0.0200ppmAlpha-BHC <0.0200ppmDelta BHC <0.0200ppmAldrin <0.0200ppmDieldrin <0.0200ppmDDT <0.0200ppm Chlordane <0.0200ppmMethoxych lor <0.0200ppmBeta-BHC <0.0200ppmHCB <0.0200ppmPCB <0.0200ppmContract Type: Commercial: Firm Fixed PricedPlace of Performance/Ship to Address (FOB Destination):US Food and Drug Administration - CBERATTN: To be provided upon contract award10903 New Hampshire Ave.Silver Spring, MD 20993Delivery/Period of Performance: The first delivery 30 days ARO and must be coordinated in advance with the Technical Point of Contact (TPOC); after which, the remaining deliveries will be monthly (12 month period) as need.Deliveries shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows:New Year's Day Martin Luther King, Jr. Washington's Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran's Day Thanksgiving Day Cistmas DayContract Clauses:The clause at 52.212-4, Contract Terms and Conditions-Commercial Items Jan 2017), applies to this acquisition. The following addenda apply:The following FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained at https://www.acquisition.gov/far/ and http://farsite.hill.af.mil/VFHHSAR1.htm.FAR Clause:52.211-6 Brand Name or Equal (AUG 1999)52.232-40 Providing Accelerated Payment to Small Business Subcontractors (DEC 2013)HHSAR Clause:352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010)Inspection/Acceptance:The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the Contracting Officer.The TPOC 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.The following Technical Point of Contact (TPOC) will represent the Government for the purpose of this contract (To be provided upon contract award):Name:Email address:Phone:The contact information for the Contract Specialist:Name: Jennifer L. Johnson Email Address: jennifer.johnson3@fda.hhs.gov Phone: (870) 543-7830Payments:Payment Schedule: Payment terms net 30 days after government acceptance of the supplies/service.Payment will be made by:Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments 301.827.3742 or 866.807.3742fdavendorpaymentsteam@fda.govInvoice Submission:A. The contractor shall submit all invoices to:Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments 301.827.3742 or 866.807.3742fdavendorpaymentsteam@fda.gov*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:(i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination;(c) any other supporting information necessary to clarify questionable expenditures;(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30); (vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)(viii) Name, title, and phone number of person to notify in event of defective invoice; (ix) Taxpayer Identification Number (TIN);(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award; (xii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:(a) list of all invoices submitted to date under the subject award, including the following:(1) invoice number, amount, & date submitted(2) corresponding payment amount & date received(b) total amount of all payments received to date under the subject contract or order(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;(xiii) Any other information or documentation required by the award.C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) tough (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address provided above in Section A.52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jan 2018)(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)(3) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (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 (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).___ (5) [Reserved]___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (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 (Oct 2015) (31 U.S.C. 6101 note). ___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).___ (10) [Reserved]___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).___ (ii) Alternate I (Nov 2011) of 52.219-3.___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).___ (ii) Alternate I (Jan 2011) of 52.219-4.___ (13) [Reserved]_X__ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).___ (ii) Alternate I (Nov 2011).___ (iii) Alternate II (Nov 2011).___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).___ (ii) Alternate I (Oct 1995) of 52.219-7.___ (iii) Alternate II (Mar 2004) of 52.219-7.___ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637 (d)(4)).___ (ii) Alternate I (Nov 2016) of 52.219-9.___ (iii) Alternate II (Nov 2016) of 52.219-9.___ (iv) Alternate III (Nov 2016) of 52.219-9.___ (v) Alternate IV (Nov 2016) 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 (Jan 2017) (15 U.S.C. 637(a)(14)).___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f)._X__ (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)).___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m))._X__ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755)._X__ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126)._X__ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015)._X__ (28) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246)._X__ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212)._X__ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793)._X__ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496)._X__ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 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) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).___ (38) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514___ (ii) Alternate I (Oct 2015) of 52.223-13.___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).___ (ii) Alternate I (Jun 2014) of 52.223-14.___ (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 (Oct 2015) (E.O.s 13423 and 13514).___ (ii) Alternate I (Jun 2014) of 52.223-16._X__ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).___ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13696).___ (45) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).___ (ii) Alternate I (Jan 2017) of 52.224-3.___ (46) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).___ (47) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).___ (ii) Alternate I (May 2014) of 52.225-3.___ (iii) Alternate II (May 2014) of 52.225-3.___ (iv) Alternate III (May 2014) of 52.225-3.___ (48) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note)._X__ (49) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).___ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).___ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).___ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).___ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).___ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f))._X__ (55) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332).___ (56) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).___ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).___ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).___ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).___ (60) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).___ (ii) Alternate I (Apr 2003) of 52.247-64.(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).___ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).___ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).___ (11) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (DEVIATION 2013-O0019) (NOV 2017)(a) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (a) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition teshold, 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.(b) (1) Notwithstanding the requirements of any other clause in this contract, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (b)(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 (Oct 2015) (41 U.S.C. 3509).(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).(v) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).(vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).(viii) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).(ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).(x) 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.(xi) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).(xii) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).(xiii) 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.)(xiv) 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)(xv) 52.222-54, Employment Eligibility Verification (Oct 2015).(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).(xvii) 52.222-62, Paid sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).(xviii) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).(B) Alternate I (Jan 2017) of 52.224-3.(xix) 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).(xx) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.(xxi) 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)Solicitation Provisions:The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (Jan 2017) applies to this solicitation. The following addenda apply:All questions shall be received via email to jennifer.johnson3@fda.hhs.gov before 12:00 P.M. (Central Time) on June 4, 2018.It is the offeror's responsibility to monitor FedBizOpps for information relevant to this solicitation, e.g., questions and answers, amendments, etc.An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.Offerors shall provide sufficient technical information necessary for the government to conclusively determine that the offered services meet all of the technical requirements herein, to include descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror.Proprietary information shall be clearly marked.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.The provision at 52.212-2 Evaluation-Commercial Items (Oct 2014) is applicable to this solicitation. The following addenda apply:The Government will award a contract resulting from this solicitation to the lowest priced technically acceptable responsible offeror. Offers will be evaluated on their ability to meet the minimum requirements provided herein. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined.Technical acceptability will be determined by review of information submitted by the Offeror which must provide a description in sufficient detail to show that the product and/or service quoted meets the Government's requirement and demonstrate successful performance of the product/service requested as stated herein.Price proposed must be detailed and represent the offeror's response to the schedule of items.The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2017)The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site located at http://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) tough (u) of this provision.(a) Definitions. As used in this provision--"Economically disadvantaged 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-(6) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or(7) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties."Highest-level owner" means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner."Immediate owner" means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees. "Inverted domestic corporation," means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c)."Manufactured end product" means any end product in product and service codes (PSCs) 1000-9999, except-(1) PSC 5510, Lumber and Related Basic Wood Materials;(2) Product or Service Group (PSG) 87, Agricultural Supplies;(3) PSG 88, Live Animals;(4) PSG 89, Subsistence;(5) PSC 9410, Crude Grades of Plant Materials;(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;(8) PSC 9610, Ores;(9) PSC 9620, Minerals, Natural and Synthetic; and(10) PSC 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."Predecessor" means an entity that is replaced by a successor and includes any predecessors of the predecessor."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."Small disadvantaged business concern, consistent with 13 CFR 124.1002," means a small business concern under the size standard applicable to the acquisition, that--(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by--(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition."Subsidiary" means an entity in which more than 50 percent of the entity is owned-(1) Directly by a parent corporation; or(2) Tough another subsidiary of a parent corporation."Successor" means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often tough acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances."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 the 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 SAMwebsite.(2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed tough https://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) tough (u) 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 is to 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 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 teshold.(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) 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)(10)(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 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 payments 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 "Baainian, 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 Baainian, 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 Baainian, 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) or 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":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 Baainian, 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 Baainian, 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 ProductsLine 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 teshold.) 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 tee-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 Federal criminal tax laws, or receiving stolen property; and(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 tee-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,500 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. §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. §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. §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. §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 (i)(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 ProductListed End Product: Listed Countries of Origin:(2) Certification. [If the Contracting Officer has identified end products and countries of origin in paragraph (i)(1) of this provision, then the offeror must certify to either (i)(2)(i) or (i)(2)(ii) by checking the appropriate block.][_] (i) The offeror will not supply any end product listed in paragraph (i)(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 (i)(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.) [The contracting officer is to check a box to indicate if paragraph (k)(1) or (k)(2) applies.](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) tough (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) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4.(2) Representation. The offeror represents that-(i) It [ ] is, [ ] is not an inverted domestic corporation; and(ii) It [ ] is, [ ] 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 $3,500 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.(p) Ownership or Control of Offeror. (Applies in all solicitations when there is a requirement to be registered in SAM or a requirement to have a unique entity identifier in the solicitation.(1) The Offeror represents that it [ ] has or [ ] does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (2) and if applicable, paragraph (3) of this provision for each participant in the joint venture.(2) If the Offeror indicates "has" in paragraph (p)(1) of this provision, enter the following information:Immediate owner CAGE code:_____________________________________________Immediate owner legal name:______________________________________________(Do not use a "doing business as" name)Is the immediate owner owned or controlled by another entity:[ ] Yes or [ ] No.(3) If the Offeror indicates "yes" in paragraph (p)(2) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information:Highest level owner CAGE code:_____________________________________________Highest level owner legal name:______________________________________________(Do not use a "doing business as" name)(q) Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law.(1) As required by section 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that-(i) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless and agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or(ii) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.(2) The Offeror represents that--(i) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and (ii) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.(r) Predecessor of Offeror. (Applies in all solicitations that include the provision at 52.204-16, Commercial and Government Entity Code Reporting.)(1) The Offeror represents that it [ ] is or [ ] is not a successor to a predecessor that held a Federal contract or grant within the last tee years.(2) If the Offeror has indicated "is" in paragraph (r)(1) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last tee years (if more than one predecessor, list in reverse conological order):Predecessor CAGE code ______(or mark "Unknown).Predecessor legal name: _________________________. (Do not use a "doing business as" name).(s) Reserved.(t) Public Disclosure of Greenhouse Gas Emissions and Reduction Goals. Applies in all solicitations that require offerors to register in SAM (52.212-1(k)).(1) This representation shall be completed if the Offeror received $7.5 million or more in contract awards in the prior Federal fiscal year. The representation is optional if the Offeror received less than $7.5 million in Federal contract awards in the prior Federal fiscal year.(2) Representation. [Offeror to check applicable block(s) in paragraph (t)(2)(i) and (ii)]. (i) The Offeror (itself or tough its immediate owner or highest-level owner) [ ] does, [ ] does not publicly disclose greenhouse gas emissions, i.e., makes available on a publicly accessible Web site the results of a greenhouse gas inventory, performed in accordance with an accounting standard with publicly available and consistently applied criteria, such as the Greenhouse Gas Protocol Corporate Standard.(ii) The Offeror (itself or tough its immediate owner or highest-level owner) [ ] does, [ ] does not publicly disclose a quantitative greenhouse gas emissions reduction goal, i.e., make available on a publicly accessible Web site a target to reduce absolute emissions or emissions intensity by a specific quantity or percentage.(iii) A publicly accessible Web site includes the Offeror's own Web site or a recognized, third-party greenhouse gas emissions reporting program.(3) If the Offeror checked ``does'' in paragraphs (t)(2)(i) or (t)(2)(ii) of this provision, respectively, the Offeror shall provide the publicly accessible Web site(s) where greenhouse gas emissions and/or reduction goals are reported:_____.(u)(1) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions), Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.(2) The prohibition in paragraph (u)(1) of this provision does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.(3) Representation. By submission of its offer, the Offeror represents that it will not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).(End of Provision)All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-1198638. The quotes are due in person, by postal mail or email to the point of contact listed below on or before June 11, 2018, by 12:00 pm (CST) at the Food and Drug Administration; OO/OFBA/OAGS/DAP/FOB; Attn: Jennifer L. Johnson; 3900 NCTR Road, HFT-320; Bldg. 50, Rm. 429; Jefferson, AR 72079.For information regarding this solicitation, please contact Jennifer Johnson at (870) 543-7830, fax (870) 543-7990 or email: jennifer.johnson3@fda.hhs.gov.
FDA-1198638 Department of Health and Human Services Food and Drug Administration
5/30/18, 3:09 PM