FDA_SOL_1228281.pdf

Solicitation No. FDA_SOL_1228281 Date: June 15, 2020

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020‐06.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION

WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA_SOL_1228281 and is being issued as a Request for Quote (RFQ). The associated North American Industry Classification System (NAICS) Code is 541380 – Testing Laboratories. The Small Business Size Standard is: $16.5 million. The requirement will be awarded as Firm‐Fixed Price and 100% small business set‐aside.

Prospective Offeror’s are responsible for downloading the solicitation and any amendments from Beta.Sam.Gov. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

The Government intends to issue a Purchase Order.

The U. S. Food and Drug Administration (FDA) has a need to procure 158 Severe Combined Immunodeficient (SCID) Mice for Animal Study.

Background and Overview The study “Evaluation of immunogenicity and safety of canine mesenchymal stem cells in mice rendered caninized by transplanting canine hematopoietic or canine leukocytes” requires 158 SCID mice. The 158 mice will be acquired in smaller numbers over a defined period of time as dictated by the study requirements. The study requirements also dictate that these be the strain NOD.Cg‐B2mtm1Unc Prkdcscid H2dlAb1‐Ea Il2rgtm1Wjl/SzJ (Stock No: 030547), also termed NSG‐B2Mnull(IA IE)null mice. The mice need to be females between 8‐9‐weeks of age. The mice need to be homozygous for all four mutations.

The NSG‐B2Mnull(IA IE)null mice were derived from the original NSG strain, but were created to be deficient in the expression of functional MHC Class 1 and MHC Class II proteins. The experimental requirements dictate this mouse strain to significantly delay development of Graft‐Verses‐Host Disease (GVHD). Development of GVDH would impede acquisition of the experimental results needed to accomplish the goals of this project.

Statement of Work

The vendor shall provide exactly 158 Severe Combined Immunodeficient (SCID) Mice meeting the requirements listed below:

Minimum Required Salient Characteristics/Key Specifications:

1) The mice shall be the strain NOD.Cg‐B2mtm1Unc Prkdcscid H2dlAb1‐Ea Il2rgtm1Wjl/SzJ (Stock No:

030547), also termed NSG‐B2Mnull(IA IE)null mice, to significantly delay development of Graft‐ Versus‐Host Disease (GVHD). This specific strain of mice is dictated by an approved study protocol.

2) The mice shall be derived from the original NSG strain and be created to be deficient in the expression of functional MHC Class 1 and MHC Class II proteins and be resistant to the development of Graft‐Verses‐Host Disease (GVHD).

3) The mice shall be supplied in 5 groups, with differing numbers per group delivered per the following quantities and dates (unless modification is required due to current events/pandemic):

a. July 6, 2020 – Quantity 20

b. August 4, 2020 – Quantity 30

c. September 22, 2020 – Quantity 36

d. September 29, 2020 ‐ Quantity 36

e. October 6, 2020 – Quantity 36

4) All mice shall be live females and approximately 8 ‐ 9 weeks old at the time of delivery.

5) Mice shall be free of infectious diseases or congenital conditions at the time of delivery which would prevent them from being used in the research protocol.

Delivery Prior to shipment, the contractor shall provide an electronic copy (via e‐mail) a health status certification to indicate the health status of the animals where they are currently being housed by the vendor. The contractor shall receive an approval from the technical point of contact prior to shipping.

The vendor shall be responsible for proper delivery of the animals to Center for Food Safety and Applied Nutrition (CFSAN’s) animal receiving area, located at the:

CFSAN loading dock 8301 Muirkirk Road Module 1 Laurel, MD 20708

Contractor is to contact the Technical Point of Contact to arrange delivery. Delivery hours are 10AM‐4PM, Monday‐Friday.

Acceptance Criteria Acceptance of the animals will take place at the time of delivery given the contractor provides health certificates and other records with the delivery as required in the statement of work. Center for Veterinary Medicine (CVM) & CFSAN will accept the mice if their respective Attending Veterinarians find no issues with the health certificate and observes no signs of infectious diseases or congenital conditions at the time of delivery which may prevent them from being used in the research protocol.

FOB: Destination Inspection/Acceptance: Destination

Period of Performance

The Period of Performance for this order is 12 months.

Instruction to Offerors Proposals shall include evidence that the facility is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (commonly known as AAALAC International) and also fully compliant with the USDA’s Animal Welfare Act and the Policy on Humane Care and Use of Laboratory Animals issued by the National Institutes of Health’s Office of Laboratory Animal Welfare

****NOTE****

After the solicitation(s) have been received, but prior to awarding the contract, study personnel will conduct a site visit to the potential vendor. The Public Health Service (PHS) Policy requires that the institution evaluate potential vendors for the quality of the animals that they supply. Periodic inspection of animal vendors is mandated by PHS, and is a condition of maintaining our PHS Assurance, under which FDA is allowed to conduct research studies that involve live vertebrates. This visit would include (but is not limited

to) the following: genetic and pathogen status of their colonies or individual animals and relevant clinical history (e.g., vaccination status and anthelminthic administration). In lieu of a site visit, at the Government’s discretion, the health status of the colony will be reviewed by CVM OR Attending Veterinarian using available on‐line, or contractor supplied, health reports from the barrier area and the animal holding rooms for the animal facility providing these mice.

Line Items and Prices

The Contractor shall provide the following deliverables:

NOTE: The Contractor shall complete the pricing table below.

Line Item

Description Qty. Unit Price

Total Price

1 158 Severe Combined Immunodeficient (SCID) Mice 158 EA 1 Shipping and Delivery 1 EA

TOTAL $

Provide a fixed price quote in accordance with the Statement of Work identified above

Instruction to Vendors

1. Responses shall be submitted to the Contract Specialist’s email below.

2. Deadline for questions and answers: Interested offerors shall submit questions electronically to

Heather.Kinsey@fda.hhs.gov and Monifa.Coleman@fda.hhs.gov no later than June 17, 2020, @3PM Eastern Time (ET).

a. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

b. No Phone Calls Please.

3. Quotes Due Date shall be no later than: June 25, 2020 at 3:00 pm ET

a. Quotes shall be in two volumes: Volume I Technical and Volume II Price. The volumes shall be separate and complete, so the evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in Volume Volume I shall discuss offeror plans to accomplish the scope of work and not exceed 15 pages.

4. Quotes shall clearly reference the solicitation, date of offer, organization proposing and point of contact.

5. Quotes shall be valid through September 30, 2020.

Evaluation Method The Government will evaluate quotes received in response to this RFQ on a lowest price, technically acceptable (LPTA) basis. A technically acceptable quote is one that can provide all the items listed above.

General Information Contracting Point of Contact

Heather Kinsey Email: heather.kinsey@fda.hhs.gov mailto:Heather.Kinsey@fda.hhs.gov mailto:Heather.Kinsey@fda.hhs.gov mailto:Monifa.Coleman@fda.hhs.gov mailto:Monifa.Coleman@fda.hhs.gov mailto:heather.kinsey@fda.hhs.gov mailto:heather.kinsey@fda.hhs.gov

Government Holidays

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (6) Labor Day

(2) Martin Luther King's Birthday (7) Columbus Day

(3) President’s Day (8) Veterans' Day

(4) Memorial Day (9) Thanksgiving Day

(5) Independence Day (10) Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around‐the‐clock or emergency operations, Contractor personnel will not be able to perform on‐site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

Provisions and Clauses FAR 52.252‐2 Solicitation Provisions 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): https://www.acquisition.gov/far and https://www.acquisition.gov/hhsar.

The Following Provisions and clauses apply:

HHSAR Clauses 352.222‐70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.223‐70 Safety and Health (Dec 2015)

FAR 52.212‐2 Evaluation‐Commercial Items (OCT 2014) FAR 52.212‐3, Offeror Representations and Certifications‐Commercial Items (Mar 2020) FAR 52.212‐4 Contract Terms and Conditions‐Commercial Items (Oct 2018) https://www.acquisition.gov/far https://www.acquisition.gov/far https://www.acquisition.gov/hhsar https://www.acquisition.gov/hhsar

FAR 52.212‐5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders‐ Commercial Items (Jun 2020)

(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) 52.204‐23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115‐91).

(3) 52.204‐25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115‐232).

(4) 52.209‐10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233‐3, Protest After Award (Aug 1996) (31U.S.C.3553).

(6) 52.233‐4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108‐77 and 108‐78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] ___ (1) 52.203‐6, Restrictions on Subcontractor Sales to the Government (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 (June 2010) (Section 1553 of Pub. L. 111‐5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4) 52.204‐10, Reporting Executive Compensation and First‐Tier Subcontract Awards (Oct 2018) (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).

__ (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 (Oct 2018) (41 U.S.C. 2313).

___ (10) [Reserved].

___ (11) (i) 52.219‐3, Notice of HUBZone Set‐Aside or Sole‐Source Award (Mar 2020) (15 U.S.C.657a).

___ (ii) Alternate I (Mar 2020) of 52.219‐3.

___ (12) (i) 52.219‐4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

___ (ii) Alternate I (Mar 2020) of 52.219‐4.

__ (13) [Reserved] _X_ (14) (i) 52.219‐6, Notice of Total Small Business Set‐Aside (Mar 2020) (15 U.S.C.644).

___ (ii) Alternate I (Mar 2020).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219‐7, Notice of Partial Small Business Set‐Aside (Mar 2020) (15 U.S.C. 644).

___ (ii) Alternate I (Mar 2020) of 52.219‐7.

___ (iii) Alternate II (Mar 2004) of 52.219‐7.

___ (16) 52.219‐8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219‐9, Small Business Subcontracting Plan (Mar 2020) (15 U.S.C. 637(d)(4)) ___ (ii) Alternate I (Jan 2017) of 52.219‐9.

___ (iii) Alternate II (Nov 2016) of 52.219‐9.

___ (iv) Alternate III (Mar 2020) of 52.219‐9.

___ (v) Alternate IV (Aug 2018) of 52.219‐9 ___ (18) 52.219‐13, Notice of Set‐Aside of Orders (Mar 2020) (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 (Mar 2020) (15 U.S.C. 657f).

_X_ (22) 52.219‐28, Post Award Small Business Program Rerepresentation (May 2020) (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 (Mar 2020) (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 (Mar 2020) (15 U.S.C. 637(m)).

___ (25) 52.219‐32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

___ (26) 52.219‐33, Nonmanufacturer Rule (Mar 2020) (15 U.S.C. 637(a)(17)).

_X_ (27) 52.222‐3, Convict Labor (June 2003) (E.O.11755).

_X_ (28) 52.222‐19, Child Labor‐Cooperation with Authorities and Remedies (Jan 2020) (E.O.13126).

_X_ (29) 52.222‐21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (30) (i) 52.222‐26, Equal Opportunity (Sept 2016) (E.O.11246).

___ (ii) Alternate I (Feb 1999) of 52.222‐26.

_X_ (31) (i) 52.222‐35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222‐35.

_X_ (32) (i) 52.222‐36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

___ (ii) Alternate I (July 2014) of 52.222‐36.

___ (33) 52.222‐37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

_X__ (34) 52.222‐40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (35) (i) 52.222‐50, Combating Trafficking in Persons (Jan 2019) (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).

___ (36) 52.222‐54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off‐the‐shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (37) (i) 52.223‐9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off‐ theshelf items.)

___ (ii) Alternate I (May 2008) of 52.223‐9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off‐the‐shelf items.)

___ (38) 52.223‐11, Ozone‐Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

___ (39) 52.223‐12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun2016) (E.O. 13693).

___ (40) (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.

___ (41) (i) 52.223‐14, Acquisition of EPEAT®‐Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223‐14.

___ (42) 52.223‐15, Energy Efficiency in Energy‐Consuming Products (May 2020) (42 U.S.C. 8259b).

___ (43) (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_ (44) 52.223‐18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O.

13513).

___ (45) 52.223‐20, Aerosols (Jun 2016) (E.O. 13693).

___ (46) 52.223‐21, Foams (Jun 2016) (E.O. 13693).

___ (47) (i) 52.224‐3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

___ (ii) Alternate I (Jan 2017) of 52.224‐3.

___ (48) 52.225‐1, Buy American‐Supplies (May 2014) (41 U.S.C. chapter 83).

___ (49) (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.

___ (50) 52.225‐5, Trade Agreements (Oct 2019) (19 U.S.C.2501, et seq., 19 U.S.C. 3301 note).

_X_ (51) 52.225‐13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (52) 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).

___ (53) 52.226‐4, Notice of Disaster or Emergency Area Set‐Aside (Nov 2007) (42 U.S.C. 5150).

___ (54) 52.226‐5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (55) 52.232‐29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).

___ (56) 52.232‐30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

_X_ (57) 52.232‐33, Payment by Electronic Funds Transfer‐System for Award Management (Oct 2018) (31 U.S.C. 3332).

___ (58) 52.232‐34, Payment by Electronic Funds Transfer‐Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

___ (59) 52.232‐36, Payment by Third Party (May 2014) (31 U.S.C.3332).

_X_ (60) 52.232‐40, Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) (DEVIATION APR 2020)(31 U.S.C. 3903 and 10 U.S.C. 2307).

___ (61) 52.239‐1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (62) 52.242‐5, Payments to Small Business Subcontractors (May 2019) (15 U.S.C. 637(d)(13)).

___ (63) (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.

___ (iii) Alternate II (Feb 2006) of 52.247‐64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] ___ (1) 52.222‐17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

___ (2) 52.222‐41, Service Contract Labor Standards (Aug 2018) (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) (Aug 2018) (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).

_X_ (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).

___ (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).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215‐2, Audit and Records‐Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items.

Unless otherwise indicated below, the extent of the flow down shall be as required by the clause‐

(i) 52.203‐13, Contractor Code of Business Ethics and Conduct (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) 52.204‐23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115‐91).

(iv) 52.204‐25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115‐232).

(v) 52.219‐8, Utilization of Small Business Concerns (Oct 2018) (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.

(vi) 52.222‐17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222‐17.

(vii) 52.222‐21, Prohibition of Segregated Facilities (Apr 2015).

(viii) 52.222‐26, Equal Opportunity (Sept 2015) (E.O.11246).

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

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

(xi) 52.222‐37, Employment Reports on Veterans (Feb 2016) (38 U.S.C.4212)

(xii) 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.

(xiii) 52.222‐41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(xiv) (A) 52.222‐50, Combating Trafficking in Persons (Jan 2019) (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 and E.O 13627).

(xv) 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).

(xvi) 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).

(xvii) 52.222‐54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).

(xviii) 52.222‐55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xix) 52.222‐62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(xx) (A) 52.224‐3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224‐3.

(xxi) 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).

(xxii) 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.

(xxiii) 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.

FAR52.217‐8 Option to Extend Services (NOV 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 1 day of the end of POP.

FAR 52.232‐40 Providing Accelerated Payments to Small Business Subcontractors.

FDA Invoice Submission Instructions

FDA Three‐Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 ‐ Second Floor

MAIL HUB 2145

Silver Spring, MD 20993‐0002

(301) 827‐3742 E‐mail: FDAVendorPaymentsTeam@fda.gov *** Acceptable methods of delivery include: E‐mail (preferred) and Standard Mail. Provide a copy marked courtesy to the Technical Point of Contact (TPOC) identified above.

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) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301‐827‐ERIC (3742) or toll‐free 866‐807‐ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call‐in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

***NOTE TO VENDOR***

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212‐3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov.

http://www.sam.gov/ http://www.sam.gov/