FBSNENGNEG12619720Q0013finalNN.DOC

Fetal Bovine Serum BVDV nucleic acid negative

INSTRUCTIONS CONDITIONS AND NOTICES TO INTERESTED PARTIES OR RESPONDENTS

In order to have a complete package, as a minimum, the return package must contain the following items. Offers submitted without completion of items listed here shall not be considered and ineligible for award.

· Submit quote on company letterhead.

· Completed Price Schedule of Items

· DUNS NUMBER - Anyone interested in doing business with the USDA must first obtain a Dunn and Bradstreet number. If your company does not have a DUNS number, you may contact Dun and Bradstreet directly to obtain one by calling 1- 866-705- 5711or via the following website:

http://fedgov.dnb.com/webform

· Online Registration of Government System for Award Management (SAM) at http://sam.gov Anyone interested in doing business with the USDA must also be listed in the government’s System for Award Management known as SAM. You may register on line with http://sam.gov A prospective awardee shall be registered and active in the SAM database to submit a quote, prior to award, during performance and through final payment of any contract resulting from this solicitation.

Interested Parties may obtain information on registration and annual confirmation requirements via the SAM database accessed through http://sam.gov or by calling 1-866-606-8220

***REGISTRATION IS FREE***

· Completion of 52.212-3 - Offeror Representations and Certifications - Commercial Items. The Quoter shall complete only paragraphs (b) of this provision if the Quoter 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) through (u) of this provision (See pages 25-43)

· Completion of FAR Provision 52.209-5 -- Certification Regarding Responsibility Matters. (page 43 - 45)

· Completion of FAR Provision 52.209-7 – Information Regarding Responsibility Matters. Item (b), Page ( 46)

· 52.209-4 - First Article Approval -- Government Testing. ***To be completed upon notification request from Contracting Officer

First Article Test items and shipping costs are to be submitted at the vendor’s expense.

Interested vendors please submit quotes to the Contracting Officer’s Email, by notice due date to sarah.c.schauf@usda.gov Sarah Schauf

Contracting Officer Sol# 12619720Q0013 Sarah.c.schauf@usda.gov. Electronic quotes are the only format to submit quotes.

Quote must be valid for 90 days

INCLUDE DOUCMENTS TO SUPPORT EVALUATION FACTORS

NOTES TO QUOTER:

1. This solicitation is for a 12 month with 2 additional ordering periods of 12 months each. A Firm Fixed price Indefinite Delivery Indefinite Quantity (IDIQ) type contract is contemplated. Quoted price shall include all costs necessary to produce and deliver the product FOB destination to the address in the SOW.

2. ANY QUESTIONS PERTAINING TO THIS Request for Quotes (RFQ) SHALL BE DIRECTED TO SARAH SCHAUF, BY EMAIL TO SARAH.C.SCHAUF@USDA.GOV

3. CONTRACTOR MUST BE REGISTERED IN THE SYSTEM FOR AWARD MANAGEMENT (SAM) PRIOR TO SUBMITTING A QUOTE and CONTRACT AWARD. Please make sure that your registration is current.

4. YOU MAY EMAIL YOUR QUOTE DIRECTLY TO Sarah Schauf before the time specified on the solicitation. Send quotes to: SARAH SCHAUF, BY EMAIL TO SARAH.C.SCHAUF@USDA.GOV

1.0 Pricing Schedule

The quantities in the schedule are estimates only and are not guaranteed. The minimum guaranteed amount under this contract will be ordered at time of award. Prices shall include all costs necessary to produce and deliver the product FOB Destination to the delivery address in the SOW.

2.0 STATEMENT OF WORK

Fetal Bovine Serum

Commercial off the shelf: BVDV nucleic acid and antibody negative

Background The National Centers for Animal Health (NCAH) is seeking pre-existing, off-the-shelf lots of Fetal Bovine Serum (FBS). NCAH wants to purchase up to 200 liters of US origin, 100% FBS that meets specified testing requirements. This must be unadulterated, 100% fetal bovine serum that has not been gamma irradiated.

Fetal bovine serum (FBS) is used as a media additive in cell culture for growth promotion. Cell cultures are used for testing associated with infectious viral agents as well as reagent production. These activities are conducted as part of diagnosing animal diseases, performing agricultural research, and regulation of veterinary biologics.

FBS from fetal calves is often contaminated with viral material or antibodies that interfere with testing for certain viruses. Specifically, FBS contaminated with Bovine Viral Diarrhea virus (BVDV) or BVDV antibody will interfere with testing for bovine diseases. Infectious virus, non-infectious viral particles, and antibody can all negatively affect testing. Infectious BVDV in FBS can infect cell cultures leading to false positive results in virus isolation testing as well as contaminate reagents which could be sent to external consumers. Non-infectious BVDV RNA will lead to false positives on PCR testing. Extraneous antibodies in the serum will interfere with virus neutralization tests, virus isolation tests, and reagent production (stock virus, antiserum, conjugate, and antigen). These antibodies may neutralize potentially infectious viruses, resulting in false negative results.

SOW Format: Scope The NCAH expects to purchase up to 200 liters of US origin FBS that meets our testing requirements from pre-existing lots of FBS. In particular, this FBS needs to be BVDV nucleic acid negative and BVDV antibody negative.

SOW Format: Objectives The FBS must be free of extraneous infectious viruses, antibodies against certain microorganisms, and the presence of particular non-infectious RNA. See provided list. The FBS must be unadulterated, 100% fetal bovine serum that has not been gamma irradiated. This FBS will be used in testing required for diagnosing animal diseases, agricultural research, and regulation of veterinary biologics.

SOW Format: Tasks 1.

The contractor shall provide NCAH with samples from pre-existing, off-the-shelf lots of FBS they expect are likely to meet the listed testing specifications. The volume of each sample must be at least 250 ml. The NCAH will test these samples for extraneous infectious viruses, antibodies against certain microorganisms, and the presence of particular non-infectious RNA. See provided list. In addition to the extraneous viruses and antibodies, the lots must also be free of bacteria, fungi, and mycoplasma. The hemoglobin level must be lower than 20 mg/dL and the endotoxin level must be lower than 2.5 EU/ml.

2.

The NCAH will select lots of FBS that are free of the antibodies, viruses, and RNA listed. Following acquisition of the FBS, additional testing may be conducted on the delivered product to verify the absence of infectious virus, viral RNA, and antibodies from the list. Any confirmed positive results for the following can cause rejection of the FBS. If rejected, shipment will be returned and re-performance will be necessary at no cost to the government.

3.

The contractor shall work with NCAH to arrange gamma irradiation of accepted lots of FBS before those lots are delivered to NCAH. The material would need to be irradiated while frozen with a minimum dose of 25 kGy and a maximum dose of 40 kGy.

SOW Format: Delivery The contractor shall provide the NCAH with samples of FBS for testing from pre-existing, off-the-shelf lots. The sample from each lot of FBS to be tested must be at least 250 ml in volume.

Once testing requirements have been met and a lot has been accepted, the contractor shall arrange for gamma irradiation of that lot and then ship the irradiated FBS from the selected lot(s) to the NCAH where a final round of testing may occur.

SOW Format: Place of Performance Ames IA SOW Format: Period of Performance 30 days after receipt of order Testing to be performed by USDA labs

FBS can be rejected for the presence of any of the following:

Extraneous infectious virus:

· Bovine viral diarrhea and Hobi-like viruses

· Border disease virus

· Bluetongue virus

· Bovine adenovirus

· Infectious bovine rhinotracheitis virus (bovine herpesvirus 1)

· Parainfluenza-3 virus

· Bovine respiratory syncytial virus

· Reovirus

· Rabies virus

· Senecavirus A

Non-infectious RNA

· Bovine viral diarrhea and Hobi-like viruses

· Border disease virus

· Senecavirus A

Extraneous antibody:

· Reovirus

· Rabies virus

· Bovine viral diarrhea and Hobi-like viruses

· Border disease virus

· Bluetongue virus

· Bovine adenovirus

· Infectious bovine rhinotracheitis virus (bovine herpesvirus 1)

· Bovine herpes mammilitis virus (bovine herpesvirus 2)

· Bovine herpesvirus 4

· Parainfluenza-3 virus

· Bovine respiratory syncytial virus

· Bovine rotavirus

· Malignant catarrhal fever viruses

· Vesicular stomatitis virus

· Bovine papular stomatitis virus

· Pseudocowpox virus

· Bovine parvovirus

· Bovine coronavirus

· Bovine enteroviruses (types 1-7)

· Epizootic hemorrhagic disease virus

· Orf virus

· Coxiella burnetii

· Hemagglutinating encephalomyelitis virus

· Porcine parvovirus

· Pseudorabies virus (suid herpesvirus 1)

· Swine adenovirus

· Transmissible gastroenteritis virus

· Canine adenovirus 1 and 2

· Canine coronavirus

· Canine distemper virus

· Canine herpesvirus

· Canine parainfluenza virus

· Canine parvovirus

· Feline calicivirus

· Feline infectious peritonitis virus

· Feline panleukopenia virus

· Feline viral rhinotracheitis

SPECIAL CONTRACT REQUIREMENTS

PACKAGING AND MARKING

1. PACKING FOR DOMESTIC SHIPMENT

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with the Interstate Commerce regulations, Uniform Freight Classification Rules, or regulations of other carriers as applicable to the mode of transportation.

2. PACKING SLIP

Each shipment shall include a packing slip enclosed in a protective pouch and attached to the outside of one box and a packing slip placed inside one of the shipment boxes.

The packing slip shall identify the following: Delivery Order and Contract Number

Required Delivery Date:

Quantity Shipped Invoice Number

Quality Control Inspection of Traps:

During the production the Contracting Officer’s Representative (COR) or representative authorized by her/him may elect to inspect and monitor production of the traps at the production facility.

Additionally, testing may be conducted to ensure FBS meet specifications.

First Article Test Procedures:

The USDA may require first article testing (at no additional cost to the government) in two phases after the award of the contract.

Phase 1:

After receiving approval/notification from Contracting Officer (CO) the contractor will first submit a sample of at least 250 mL from the prospective lots of FBS thought to meet the testing specifications

USDA APHIS

Attention: Rachel Tell

1920 Dayton Ave

Ames, IA 50010

Testing will be conducted to determine if the standards have been met. Within 35 working days after the Government receives the first article, the CO will notify the contractor, in writing, of the conditional approval or disapproval for the sample of FBS. The notice of conditional approval or disapproval shall not relieve the Contractor from complying with all requirements in the specifications and all other terms and conditions of this contract. A notice of conditional approval or disapproval shall state any further action required of the Contractor.

Phase 2:

Within 3 months after the Contractor receives notice of approved or conditionally approved FBS samples that met the first article phase 1 testing, the Contractor shall then work with the Government to arrange gamma irradiation of accepted lots of FBS before those lots are delivered to the Government. The FBS would need to be irradiated while frozen with a minimum dose of 25 kGy and a maximum dose of 40 kGy. The Contractor will then ship the irradiated FBS from the selected lot(s) to the Government where a final round of testing may occur.

Within 35 working days after the Government receives the phase 2 first article, the CO will notify the Contractor, in writing, of the approval or disapproval of the first article. The notice of conditional approval or approval shall not relieve the Contractor from complying with all requirements for the specifications and all other terms and conditions of this contract. A notice of conditional approval shall state any further action required of the Contractor.

Quality Assurance and Quality Assurance Surveillance:

The contractor may be asked to provide a written copy of its quality control program utilized in the manufacturing process to ensure compliance with the specifications.

Delivery Points of Contact

The USDA designated local Contracting Officer’s Representative (COR) to coordinate the work to be completed under this contract is Teresa Sigafoose.

The USDA designated local Technical Points of Contact (TPOCs) under this contract are Rachel Tell

Phone 515-337-7873 Email: Rachel.M.Tell@usda.gov Alethea Fry

Phone 515-337-7460 Email: Alethea.M.Fry@usda.gov The USDA/APHIS/ Contract Administrator under this contract is Sarah Schauf. Contact information is listed below:

Contracting Officer

USDA/ APHIS

1920 Dayton Ave

Ames, IA 50010

515-337-7572

Sarah.C.Schauf@usda.gov Contract Delivery Order Instructions:

USDA/APHIS will begin issuing Delivery Orders shortly after award of the basic contract. The Delivery Order contains the actual funding for the supplies ordered. Any warranted USDA APHIS Ames Contracting Officer may place delivery orders.

Upon delivery/performance and acceptance of the products/or services for any Delivery Order, the vendor will be responsible for submitting the invoice for payment against the Delivery Order Contract number, referencing the individual Delivery Order number in the IPP system at https://www.ipp.gov.

The Contractor shall submit an original invoice (or electronic invoice, if authorized,) to the address designated in the contract to receive invoices (https://www.ipp.gov).

Invoice Processing and Payment.

Payment is 30 days After Receipt of Supplies or Services and upon acceptance of proper invoicing in accordance with Prompt Payment Act (31 U.S.C. 3903)

USDA uses the Invoice Processing Platform (IPP) for electronic submission and tracking of purchase orders, invoices, and payment information to its suppliers of goods and services: Enroll at https://ipp.gov. The IPP is a government-wide secure web-based invoice processing service offered free of charge to government agencies and their suppliers by the U.S. Department of Treasury’s Financial Management Service (FMS).

Upon contract award, you will receive a notification of your one-time enrollment requirement in an automatic invoice payment notification system available through IPP. This one-time enrollment in IPP means that you will receive a series of e-mails from Treasury services.

Contractors must submit invoices and attach all supporting documentation as required within 5 business days of completion of services provided. Supporting documentation include, for example; maintenance inspection checklist, timecard for labor, travel receipts etc. The COTR will review the supporting documents before approving invoices in IPP, if supporting documentation is not provided the invoice will be rejected. IPP will issue a notification to contractor that they must submit supporting documentation and resubmit the invoice.

Please see https://www.ipp.gov/vendors/enrollment-vendors.htm and Submit invoices through the Invoice Processing Platform (IPP)

Enroll at https://www.ipp.gov/ IPP is a secure, web-based system that manages government invoicing

The U.S. Department of Agriculture is a tax exempt agency. (Exempt from state and Federal tax) Tax ID Number: 41-0696271.

Clause Addendum

52.252-2 Clauses Incorporated by Reference. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://farsite.hill.af.mil/vmfara.htm https://www.dm.usda.gov/procurement/policy/agar_x/agar02/subchaph.html 52.212-4 Contract Terms and Conditions—Commercial Items. (Jan 2017) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (DEC 2013) 52.204-18 Commercial and Government Entity Code Maintenance. (Jul 2016)

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:

[Contracting Officer check as appropriate.]

(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]

(14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

(ii) Alternate I (Nov 2011).

(iii) Alternate II (Nov 2011).

(15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

(ii) Alternate I (Oct 1995) of 52.219-7.

(iii) Alternate II (Mar 2004) of 52.219-7.

X (16) 52.219-8, Utilization of Small Business Concerns (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 Rerepresentation (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.

X (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)).

(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.

(4) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 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)).

(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iv) 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.

(v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vi) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

(vii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(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) (E. O. 12989).

(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(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 (Oct 2016) (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.

(5) 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)

Clauses in Full Text:

52.204-21 – Basic Safeguarding of Covered Contractor Information Systems. (Jun 2016)

(a) Definitions. As used in this clause-- “Covered contractor information system” means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

“Federal contract information” means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public Web sites) or simple transactional information, such as necessary to process payments.

“Information” means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

“Information system” means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).

“Safeguarding” means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial items, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of clause)

52.209-4 - First Article Approval -- Government Testing. (Sep 1989) Phase 1:

(a) After receiving approval/notification from Contracting Officer (CO ) or Contract Administrator (CA) of the Contractor will first submit a sample of at least 250 mL from a pre-existing lot of FBS, at no cost to the government, within 15 working days of notification to:

USDA APHIS

Attention: Rachel Tell

1920 Dayton Ave

Ames, IA 50010.

Testing will be conducted to determine if the standards have been met. Within 35 working days after the Government receives the first article, the CO or CA shall notify the contractor, in writing, of the conditional approval or disapproval for the submitted FBS. The notice of conditional approval or disapproval shall not relieve the Contractor from complying with all requirements in the specifications and all other terms and conditions of this contract. A notice of conditional approval or disapproval shall state any further action required of the Contractor.

Phase 2:

(b) Within 3 months after the Contractor receives notice of approved or conditionally approved FBS samples that met the first article phase 1 testing, the Contractor shall then work with the Government to arrange gamma irradiation of accepted lots of FBS before those lots are delivered to the Government. The FBS would need to be irradiated while frozen with a minimum dose of 25 kGy and a maximum dose of 40 kGy. The Contractor will then ship the irradiated FBS from the selected lot(s) to the Government where a final round of testing may occur. Shipping documentation shall contain the government procurement number and the item identification. The characteristics that the first article must meet and the testing requirements are specified elsewhere in this contract. Samples should be submitted to:

USDA APHIS

Attention: Rachel Tell

1920 Dayton Ave

Ames, IA 50010.

Within 35 working days after the Government receives the phase 2 first article, the CO will notify the Contractor, in writing, of the approval or disapproval of the first article. The notice of conditional approval or approval shall not relieve the Contractor from complying with all requirements for the specifications and all other terms and conditions of this contract. A notice of conditional approval shall state any further action required of the Contractor.

(c) If the first article is disapproved, the Contractor, upon Government request, shall submit an additional first article for testing. After each request, the Contractor shall make any necessary changes, modifications, or repairs to the first article or select another first article for testing. All costs related to these tests are to be borne by the Contractor, including any and all costs for additional tests following a disapproval. The Contractor shall furnish any additional first article to the Government under the terms and conditions and within the time specified by the Government. The Government shall act on this first article within the time limit specified in paragraph (b) of this clause. The Government reserves the right to require an equitable adjustment of the contract price for any extension of the delivery schedule or for any additional costs to the Government related to these tests.

(d) If the Contractor fails to deliver any first article on time, or the Contracting Officer disapproves any first article, the Contractor shall be deemed to have failed to make delivery within the meaning of the Default clause of this contract.

(e) Unless otherwise provided in the contract, the Contractor --

(1) May deliver the approved first article as a part of the contract quantity, provided it meets all contract requirements for acceptance and was not consumed or destroyed in testing; and

(2) Shall remove and dispose of any first article from the Government test facility at the Contractor’s expense.

(f) If the Government does not act within the time specified in paragraph (b) or (c) of this clause, the Contracting Officer shall, upon timely written request from the Contractor, equitably adjust under the Changes clause of this contract the delivery or performance dates and/or the contract price, and any other contractual term affected by the delay.

(g) The Contractor is responsible for providing operating and maintenance instructions, spare parts support, and repair of the first article during any first article test.

(h) Before first article approval, the acquisition of materials or components for, or the commencement of production of, the balance of the contract quantity is at the sole risk of the Contractor. Before first article approval, the costs thereof shall not be allocable to this contract for

(1) progress payments, or

(2) Termination settlements if the contract is terminated for the convenience of the Government.

(i) The Government may waive the requirement for first article approval test where supplies identical or similar to those called for in the schedule have been previously furnished by the Offeror/Contractor and have been accepted by the Government. The Offeror/Contractor may request a waiver.

(End of Clause)

52.216-18 – Ordering. (Oct 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from Date of Award through 36 months.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

52.216-19 -- Order Limitations. (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 50 liters the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor --

(1) Any order for a single item in excess of 200 liters;

(2) Any order for a combination of items in excess of 200 liters; or

(3) A series of orders from the same ordering office within 7 days that together call for quantities exceeding the limitation in subparagraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph

(b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 5 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

52.216-22 - Indefinite Quantity. (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after 36 months.

(End of Clause)

452.216-73 Minimum and Maximum Contract Amounts. (FEB 1988)

During the period specified in FAR clause 52.216-18, ORDERING, the Government shall place orders totaling a minimum of 50 liters, but not in excess of 200 liters .

(End of Clause)

452.211-74 Period of Performance. (FEB 1988)

The period of performance of this contract is from date if award for 36 Months (End of Clause)

3.0Provisions

52.252-1 - Solicitation Provisions Incorporated by Reference. (Feb 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

http://farsite.hill.af.mil/vmfara.htm https://www.dm.usda.gov/procurement/policy/agar_x/agar02/subchaph.html (End of Provision)

52.204-16 Commercial and Government Entity Code Reporting. (Jul 2016) 52.204-7 System for Award Management (Oct 2016)

52.212‐1 Instructions to Offerors – Commercial Items, is replaced in its entirety by this addendum.

(a) North American Industry Classification System (NAICS) code is 325413 and small business size standard of 1250 Emp.

(b) Submission of Quotes. Submit quotes to Sarah Schauf @sarah.c.schauf@usda.gov See “Notes to Quoters” on this attachment

(c) Submission deadline. Quotes must be received by the date and time specified in this solicitation. A late quote will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late quote would not unduly delay the acquisition. In the case of an emergency or unanticipated event that delays Government operations so that quotes cannot be received, the deadline will be extended by one working day.

(d) Terms of and content. Quotes must be based on the terms of this solicitation. The Government may reject any quote that is not based on these terms in every respect. Quotes must contain all of the information required by the solicitation.

(e) Contract award. The Government intends to evaluate quotes and award a contract without discussions. Therefore, a quote should contain the quoter’s best terms from a price and technical standpoint. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in quotes received. Quoters are responsible for ensuring completeness of quotes. The Government may evaluate solely on the information provided with the initial quotation.

(f) System for Award Management. Unless exempted by an addendum to this solicitation, by submission of a quote, the quoter acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance and through final payment of any contract resulting from this solicitation. If the quoter does not become registered in the SAM database by the response date specified in the solicitation, the Contracting Officer will proceed to award to the next otherwise successful registered quoter. Quoters may obtain information on registration and annual confirmation requirements via the SAM database accessed through https://www.acquisition.gov.

(g) Requests for information. The contracting officer will not notify unsuccessful quoters that responded to this solicitation. Quoters may request information on award(s) resulting from this solicitation from the contracting officer.

(End of Provision)

52.212-3 Offeror Representations and Certifications-Commercial Items.

As prescribed in 12.301(b)(2), insert the following provision:

Offeror Representations and Certifications-Commercial Items (Mar 2020)

The Offeror shall complete only paragraph (b) of this…