D.6170569 Combined_synopsis-noncomp with Attachments.pdf

NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Compounding of 10% Polysorbate-80 to dilute TPM-001 Investigational Drug for treatment of Peritoneal Cancer

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the 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.

(ii) The solicitation number is 75N95022Q00007 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS

SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT

PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), NIDA Office of Acquisitions – NCATS

Section, on behalf of the National Center for Advancing Translational Sciences

(NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Pine Pharmaceuticals, LLC, 355 Riverwalk

Pkwy,Tonawanda, NY 14150 for compounding of 10% polysorbate-80 to dilute TPM-001 invesigational drug for peritoneal cancer. The anticipated award date is 11/15/2021.

This acquisition is non-competitive due to the urgency of this requirement to meet deadlines associated with initiation of clinical studies. See FAR 13.106(b).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-07 dated 9/10/2021.

(iv) The associated NAICS code is 325412 and the small business size standard is 1250 employees. No set-aside restriction is applicable.

(v) Line 0001: the contractor shall manufacture and deliver 10% polysorbate-80l, 150 vials, in accordance with the attached Statemen of Work dated 11/8/2021.

(vi) Except as specified in the Statement of Work, delivery shall be to:

The National Center for Advancing Translational Sciences (NCATS)

9800 Medical Center Drive

Rockville, MD 20850

Delivery shall be with 9 months after receipt of order.

(vii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items applies to this acquisition.

(viii) The award resulting from this solicitation will be made to the responsible offeror whose proposal is most advantageous to the Government, price and other factors considered.

The following factors shall be used to evaluate quotations: Technical Capability, Past

Performance, and Price.

(ix) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with offers.

(x) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

The following FAR clause is incorporated in full text and it attached.

52.223-99, Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors

The following FAR provisions or clauses are incorporated by reference:

52.204-7, System for Award Management (Oct 2018)

52.204-13, System for Award Management Maintenance (Oct 2020)

52.204-16, Commercial and Entity Code Reporting (Aug 2020)

52.204-18, Commercial and Entity Code Maintenance (Aug 2020)

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015).

HHSAR 352.239-73, Electronic Information and Technology Accessiblity Notice.

52.212-4(g), Invoice, is supplemented by the NIH Invoice and Payment Instructions, attached.

Offerors must complete and return the FAR representation 52.204-24 Representation

Regarding Certain Telecommunications and Video Surveillance Services or

Equipment (Oct 2020), attached.

(xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition.

(xii) This synopsis is not a request for competitive proposals. All responsible sources may submit a bid, proposal or quotation which shall be considered by the agency.

(xvi) In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number

(TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by 11:00 am on 11/15/2021 Eastern time and reference solicitation no. 75N95022Q00007. Responses must be submitted by email to Stuart

Kern, Contracting Officer, stuart.kern@nih.gov, tel. 301-402-3334.

Attachments:

- Statement of Work dated 11/8/2021

- FAR 52.204-24 Representation Regarding Certain Telecommunications and Video

Surveillance Services or Equipment (Oct 2020)

- FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or

Executive Orders–Commercial Items

- FAR 52.223-99, Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors

- NIH Invoice and Payment Instructions http://www.sam.gov/ mailto:stuart.kern@nih.gov

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Compounding of 10% Polysorbate-80 to dilute TPM-001 Investigational Drug for treatment of Peritoneal Cancer Statement of Need and Purpose:

This is to compound/manufacture 10% Polysorbate-80 in vials to dilute the IND cleared investigational drug TPM-001by FDA to support the clinical study by providing the diluent to the clinic where the clinical trial will be performed.

Background Information and Objective:

Peritoneal cancers are major health concerns in the US. There are over 230,000 new cases of cancers arising from organs in the peritoneal cavity. BrIDGs’ collaborator had developed tumor-penetrating microparticles (TPM), a first-in-class delivery system tailored to the unique anatomical properties in the peritoneal cavity. After several years of effort of NCATS BrIDGs team, the collaborator was able to receive Investigational New Drug (IND) approval from FDA to begin the clinical study with TPM-001 investigational drug. However, the collaborator didn’t acknowledge the issue of making a diluent which is 10% of Polysorbate-80 until FDA requested the sterility data and endotoxin level of the diluent before mixing the investigational drug. Commercial Polysorbate-80 is very popular chemical, however there is no commercial supply as sterile. Therefore compounding of this diluent has to be sterile and limited endotoxin level to meet the FDA comment.

Manufacturing 10% Polysorbate-80 can be done by a compounding pharmacies or GMP drug product manufacturers. Since the IND is cleared and clinical site is reviewing the Institutional Review Board (IRB) to begin the study, this task has to be performed soon so that TPM-001 can be used for the patients in the study.

Period of Performance:

To be completed within 9 months after agreement.

SCOPE OF WORK

General Requirements:

The contractor will (1) manufacture 150 vials of 10% Polysorbate-80l to deliver 50 vials to NCATS for the clinical study (2) release the compounded vials for appearance, pH, particulate matter, sterility, endotoxin, container closure including validation;. And (3) Conduct stability testing up to 6 months.

Specific Requirements:

The contractor will provide all of the manufacturing related documents including certificate of analysis of each ingredients.

The contractor will provide a master batch record before compounding The contractor will perform the manufacturing the vials under cGMP condition with 503B guideline.

NCATS has contracted separately with SGS Health Science (“SGS”), 201 Route 17 North, Rutherford, NJ 07070 for method development and validation, and release and stability testing.

At NCATS direction, the Contractor shall ship samples to SGS. The Contractor shall coordinate with NCATS and SGS regarding shipping details. The price of shipping shall be included in the Contractor’s quote.

The contractor will provide the certificate of analysis including the assay result from SGS.

The contractor will execute batch record after the manufacturing.

The contractor will perform the stability study at 3 months and 6 months after manufacturing.

Shipment Timeline:

Month 0: Purchase orders awarded. Manufacturing begins.

Months 1 to 3: Ships sample of manufactured vials to SGS for release assay. When SGS finishes the first assay of samples, the Contractor shall issue CoA and release drug product. The Contractor shall ship released drug product and COA to NIH collaborator at the clinic site.

Months 3 to 9: Ships sample of manufactured vials to SGS for stability assay on Month 1, 3 and

6. When SGS provides assay report for stability to the Contractor, the Contractor shall provide the stability report to NIH.

Month 3: ship 50 vials for the clinical study to NCATS or NCATS’ designee.

GOVERNMENT RESPONSIBILITIES

NIH/NCATS will provide the formulation of 10% Polysorbate-80.

DELIVERY OR DELIVERABLES and REPORTING REQUIREMENTS The compounding of 150 vials and batch record are due 90 business days after the completion of the release. The stability study up to 6 months shall be delivered to NCATS 9 months after receipt of the purchase order. The 50 vials for the clinical study shall be released and delivered 3 months after receipt of the purchase order.

Data Rights:

This purchase order will include FAR 52.227-14, Rights in Data – General. Use, release, reproduction, distribution, and publication of data will be prohibited in accordance with paragraph 52.227-14(d).

Publications and Publicity:

The contractor will not write or publish articles using or based on data produced as a result of this compounding.

Confidentiality of Information:

The following elements of this study are considered to be confidential: the compounding procedure, compounding components, and all the reports related to this performance. This contract will include HHSAR 352.224-71, Confidential Information, and state that this information is considered to be trade secrets or commercial information that is confidential or privileged under the Freedom of Information Act.

52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.

As prescribed in 4.2105(a), insert the following provision:

REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE

SERVICES OR EQUIPMENT (OCT 2020)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or https://www.acquisition.gov/far/part-4#FAR_4_2105 https://www.acquisition.gov/far/part-52#FAR_52_204_26 https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-52#FAR_52_204_26 https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-52#FAR_52_204_25

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(d) Representation. The Offeror represents that—

(1) It will, will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It does, does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

https://www.sam.gov/

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained:

Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained:

Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

CERTIFICATION:

Name of Authorized Individual Signature of Authorized Individual Date

Title Name of Organization

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

ITEMS ( )

(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 2020) (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) (31 U.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:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

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(10)

(11)

52.203-6

52.203-13

52.203-15

52.204-10

52.204-14

52.204-15

52.209-6

52.209-9

52.219-3

Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509)).

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.)

Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L.

109-282) (31 U.S.C. 6101 note).

[Reserved].

Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L.

111-117, section 743 of Div. C).

Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note).

Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.

2313).

[Reserved].

Notice of HUBZone Set-Aside or Sole-Source Award (Sep 2021) (15 U.S.C.657a).

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(12)

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52.219-4

52.219-6

52.219-7

52.219-8

52.219-9

52.219-13

52.219-14

52.219-16

52.219-27

52.219-28

52.219-29

52.219-30

52.219-32

52.219-33

(i), Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Sep 2021) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[Reserved].

(i) Notice of Total Small Business Set-Aside (Nov 2020) of 52.219-6 (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-6.

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

(ii) Alternate I (Mar 2020) of 52.219-7.

Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

(i), Small Business Subcontracting Plan (Sep 2021) (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 (Jun 2020) of 52.219-9.

(v) Alternate IV (Sep 2021) of 52.219-9.

(i) Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

Limitations on Subcontracting (Sep 2021) (15 U.S.C. 637(a)(14)).

Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Sep 2021) (15 U.S.C. 657 f).

Post Award Small Business Program Rerepresentation (Sep 2021) (15 U.S.C. 632(a)(2)). May require contractor completion.

(ii) Alternate I (Mar 2020) of 52.219-28.

Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Sep 2021) (15 U.S.C. 637(m)).

Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Sep 2021) (15 U.S.C. 637(m)).

Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

Nonmanufacturer Rule (Sep 2021)(15 U.S.C. 637(a)(17)).

(ii) Alternate I (Mar 2020) of 52.219-13.

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52.222-3

52.222-21

52.222-26

52.222-35

52.222-36

52.222-37

52.222-40

52.222-50

52.222-54

52.223-9

52.223-11

52.223-12

52.223-13

52.223-14

52.223-15

52.223-16

52.223-18

52.223-20

Convict Labor (June 2003) (E.O. 11755).

Child Labor—Cooperation with Authorities and Remedies (Jan 2020) (E.O. 13126).

Prohibition of Segregated Facilities (Apr 2015).

(i) Equal Opportunity (Sept 2016) (E.O. 11246).

(ii) Alternate I (Feb 1999) of 52.222-26. If this is checked, some terms have been waived.

(i) Equal Opportunity for Veterans (Jun 2020)(38 U.S.C. 4212).

(ii) Alternate I (July 2014) of 52.222-35. If this box is checked, some terms have been waived.

(i) Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(ii) Alternate I (July 2014) of 52.222-36. If this box is checked, some terms have been waived.

Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

(i) Combating Trafficking in Persons (Oct 2020) (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). Alt I requires CO completion.

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.)

(i) 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.) Requires CO completion.

(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.) Alt I requires contractor certification.

Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693). Requires contractor completion.

Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

(i), Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Oct 2015) of 52.223-13.

(i) Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-14.

Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

(i), Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-16.

Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

Aerosols (JUN 2016) (E.O. 13693).

52.222-19

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52.223-21

52.224-3

52.225-1

52.225-3

52.225-5

52.225-13

52.225-26

52.226-4

52.226-5

52.232-29

52.232-30

52.232-33

52.232-34

52.232-36

52.239-1

52.242-5

52.247-64

Foams (JUN 2016) (E.O. 13693).

(i), Privacy Training (JAN 2017) (5 U.S.C. 552a).

(ii) Alternate I (JAN 2017) of 52.224-3.

Buy American—Supplies (Jan 2021) (41 U.S.C. chapter 83).

(i), Buy American—Free Trade Agreements—Israeli Trade Act (Jan 2021) (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 (Jan 2021) of 52.225-3.

(iii) Alternate II (Jan 2021) of 52.225-3.

(iv) Alternate III (Jan 2021) of 52.225-3.

Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

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).

Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). Requires CO completion.

Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C.

3332).

Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). Requires CO completition.

Payment by Third Party (May 2014) (31 U.S.C. 3332).

Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

(i), Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. 55305 and 10 U.S.C. 2631).

(ii) Alternate I (Apr 2003) of 52.247-64.

(iii) Alternate II (FEB 2006) of 52.247-64.

Tax on Certain Foreign Procurements—Notice and Representation (Feb 2021)(55) 52.229-12

[Contracting Officer check as appropriate.]

52.222-41 Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67). (1)

52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). Requires CO completion.

(2)

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).

(3)

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).

(4)

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).

(5)

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).

(6)

52.222-55 Minimum Wages Under Executive Order 13658 (Nov 2020). (7)

52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). (8)

52.226-6 Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). (9)

FAR Deviation Clause

Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal

Contractors

September 30, 2021

PART 52—SOLICITATION PROVISIONS AND CONTRACT CLAUSES

Subpart 52.2—Text of Provisions and Clauses

[52.223-99 Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors.

ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR FEDERAL

CONTRACTORS (OCT 2021) (DEVIATION)

(a) Definition. As used in this clause -

United States or its outlying areas means—

(1) The fifty States;

(2) The District of Columbia;

(3) The commonwealths of Puerto Rico and the Northern Mariana Islands;

(4) The territories of American Samoa, Guam, and the United States Virgin

Islands; and

(5) The minor outlying islands of Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Islands, Navassa Island, Palmyra Atoll, and Wake Atoll.

(b) Authority. This clause implements Executive Order 14042, Ensuring Adequate

COVID Safety Protocols for Federal Contractors, dated September 9, 2021 (published in the Federal Register on September 14, 2021, 86 FR 50985).

(c) Compliance. The Contractor shall comply with all guidance, including guidance conveyed through Frequently Asked Questions, as amended during the performance of this contract, for contractor or subcontractor workplace locations published by the

Safer Federal Workforce Task Force (Task Force Guidance) at https:/www.saferfederalworkforce.gov/contractors/.

(d) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (d), in subcontracts at any tier that exceed the simplified acquisition threshold, as defined in Federal Acquisition Regulation 2.101 on the date of subcontract award, and are for services, including construction, performed in whole or in part within the United States or its outlying areas.

Revised: February 10, 2021

Invoice and Payment Provisions

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase

Agreement (BPA) Orders/Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per contractor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract Number;

Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

* NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

C. The Contractor shall submit invoice to the National Institutes of Health/Office of Financial Management (NIH/OFM) via email at invoicing@nih.gov with a copy to Contracting Officer, Contracting Officer’s Representative, and Program point of contact, as directed. The invoices must be emailed in accordance with instructions below. Do not submit supporting documentation (e.g., receipts, time sheets, invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email.

Please Note: NIH/OFM will not accept invoices postmarked and/or delivered in-person on/after December 1, 2020.

For inquiries regarding the status of invoices such as receipt of invoices, due date, request for payment of invoices, etc., contact NIH/OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods see the NIH/OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

The NIH/OFM Customer Service is open Eastern Standard Time Monday – Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

In order to facilitate the prompt payment of invoices, it is recommended that the contractor submit a photocopy of the invoice to the “Consignee” designated for the acquisition in blocks 6A – 6E of the OF-347 of the Order/Award document.

II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and https://ofm.od.nih.gov/Pages/Home.aspx mailto:invoicing@nih.gov https://ofm.od.nih.gov/Pages/Home.aspx https://ofm.od.nih.gov/Pages/Customer-Service.aspx mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

To: All National Institutes of Health (NIH) Contractors

Date: November 4, 2020

Subject: NIH Will No Longer Accept Hard Copy Invoices Effective December 1, 2020

Dear NIH Contractors, On April 1, 2020, in response to the COVID-19 pandemic, the National Institutes of Health (NIH)/Office of Financial Management (OFM) implemented an electronic invoice submission solution, which allows contractors to submit their invoices electronically via email. The electronic invoice submission solution also allows OFM accounts payable representatives to process invoices for payment securely and in a timely manner. The new electronic invoice submission solution has streamlined the invoicing process resulting in faster processing times by OFM staff and faster payments to our contractors. Currently, OFM is receiving approximately 80% of invoices via the new electronic invoice submission solution.

This email is to notify you that effective December 1, 2020, OFM will no longer accept hard copy contractor invoices sent to the OFM billing office via any shipping services (i.e., USPS, FedEx, UPS, DHL, etc.) or those delivered by any in-person drop off. OFM is requiring that all contractors submit their invoices for payment processing using the electronic invoice submission solution via email at invoicing@nih.gov. For your convenience, attached are step-by-step instructions, which must be followed, to ensure your invoices are submitted using the correct format to facilitate accurate and timely payments. OFM will not accept any invoices postmarked and/or delivered in-person on/after December 1, 2020.

The new electronic invoice submission solution is preparing NIH/OFM for the implementation of Treasury’s Invoice Processing Platform (IPP) (eInvoicing), scheduled to be rolled-out throughout the Department of Health and Human Services (HHS) in December 2021.

OFM’s Customer Service Office is here to help. Please do not hesitate to contact us at ofm_customer_service@incontactemail.com or call us at 301-496-6088 if you have any questions or concerns regarding the electronic invoice submission process. The Customer Service Office is open Monday – Friday from 8:30 a.m. to 5:00 p.m. Eastern Standard Time and is closed daily between 12:00 p.m. to 1:00 p.m. Eastern Standard Time.

Thank you, OFM Commercial Accounts Team mailto:invoicing@nih.gov mailto:ofm_customer_service@incontactemail.com

Instructions for Submitting Electronic Invoices via Email to the NIH Office of Financial

Management (OFM) Effective April 23, 2020 (Updated October 30, 2020)

4 Steps to Create the Invoice Submission Email

PLEASE READ THE BELOW INSTRUCTIONS THOROUGLY BEFORE SUBMITTING YOUR INVOICE

ELECTRONICALLY.

*Note: The key words (Vendor, PO, and Invoice), Colon (:) character following the keywords and the PIPE (|) character must be present to identify the information. The pipe (|) character is entered by pressing and holding the shift key and the backslash (\) key at the same time. The term “PO” is being used as a generic term to identify the award number

Step 3:

Attach the invoice to the email as either a PDF or

Word document.

See Reminders below

Step 4:

In the body of the email, type

“Correspondence

Email:” followed by your email address.

Step 1:

Send invoices to the following email address:

invoicing@nih.gov

Step 2:

Subject line must follow this format for the invoice you are submitting

(see note* below) mailto:invoicing@nih.gov

[purchase order, contract, Blanket Purchase Agreement (BPA) call, task or delivery order] and must be used in the subject line, regardless of the specific type of your award.

How to Properly Format the Subject Line of Your Email

EXAMPLE 1 – If Your Contract Includes a Contract Number AND an Order Number or Call Number:

Vendor: Name of the Contractor or Vendor|PO:Contract Number/Order Number or Call Number|Invoice:9999999

EXAMPLE 2 – If Your Contract ONLY Includes a Contract Number:

Vendor: Name of the Contractor or Vendor|PO:Contract Number|Invoice:9999999

EXAMPLE 3 – If Your Contract ONLY Includes an Order Number:

Vendor: Name of the Contract or Vendor|Order Number|Invoice:99999999

Screenshot of How to Locate the Contract Number and Order Number on Your SF 1449

(SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS Form)

The screenshot below shows where the Contract Number and Order Number are located on the SF 1449. The SF 1449 is provided to you by the NIH Contracting Officer upon awarding the contract. Please use the information on your SF 1449 to populate the correct Contract Number and Order Number in the subject line of your email invoice submission.

The Contract Number is required in order to process all invoices. The Contract Number is the same as the “PO” on the invoice email subject line. The Order Number is only applicable for certain contracts and can be found in field number 4, on the SF 1449 form. If your SF 1449 does not include an Order Number, then follow EXAMPLE 2 above to ensure the

Subject line of your email is properly formatted.

Screenshot of How to Locate the Contract Number on Your SF 1447 (SOLICITATION/CONTRACT Form)

The screenshot below shows where the Contract Number is located on the SF 1447. The SF 1447 is provided to you by the

NIH Contracting Officer upon awarding the contract. Please use the information on your SF 1447 to populate the correct

Contract Number in the subject line of your email invoice submission.

The Contract Number is required in order to process all invoices. The Contract Number is the same as the “PO” on the invoice email subject line.

Screenshot of How to Locate the Contract Number and Release Number on Your OF 347 (ORDER FOR SUPPLIES OR

SERVICES Form)

The screenshot below shows where the Contract Number and Order Number are located on the OF 347. The OF 347 is provided to you by the NIH Contracting Officer upon awarding the contract. Please use the information on your OF 347 to populate the correct Contract Number (if any) and Order Number in the subject line of your email invoice submission.

The Order Number is required in order to process all invoices. If there is no Contract Number, the Order number is the same as the “PO” on the invoice email subject line. The Contract Number is only applicable for certain contracts and can be found in field number 2, Contract Number, on the OF 347 form. If your OF 347 does not include a Contract Number, then follow EXAMPLE 3 on page 2 to ensure the Subject line of your email is properly formatted.

Subject Line Examples

For your reference, below is a chart listing examples of the correct and incorrect subject lines. Note: These are just examples, you must enter the applicable information for the invoice you are submitting.

Subject Line Correct Incorrect

Vendor: XYZ Corp|PO:HHSN299202000053J/75X98019S00848|Invoice:XYASAD

XYZ Corp|PO # HHSN299202000053J \75X98019S00848|Invoice # XYASAD

XYZ Corp| HHSN299202000053J \75X98019S00848|Invoice # XYASAD

XYZ Corp| HHSN299202000053J \75X98019S00848| XYASAD

Vendor: XYZ Corp,PO: HHSN299202000053J \75X98019S00848,Invoice:XYASAD

Vendor: XYZ Corp|PO:HHSN299202000053J|Invoice:XYASAD

Vendor: XYZ Corp|PO:HHSN311201600011U|Invoice:XYASAD

Reminders

• Effective December 1, 2020, OFM will no longer accept hard copy vendor invoices sent to the OFM billing office via any shipping services (i.e., USPS, FedEx, UPS, DHL, etc.) or those delivered by any in-person drop off. OFM will not accept any invoices postmarked and/or delivered in-person on/after December 1, 2020. Please follow the electronic submission instructions on page 1. Failure to follow the above electronic submission instructions will result in invoice processing delays.

• Only invoices should be sent to the following mailbox: invoicing@nih.gov. Please do not send emails to this mailbox requesting a status of your invoice(s) and do not include the invoicing@nih.gov email address in your correspondence with NIH Institutes/Centers.

• You must submit only one invoice per email.

• Follow the system size limits that apply to the email and each invoice: individual email attachments cannot exceed

5 megabytes each; and the email plus all attachments cannot exceed a total of 30 megabytes.

• Clearly identify a valid and complete contract number on each invoice.

• Clearly identify an accurate DUNS number on each invoice.

• DO NOT include confidential information such as Social Security Numbers (do not include TIN if it is a Social

Security Number).

The invoice attached to the email must be in a PDF or Word format. The date/time that a valid invoice is submitted electronically to the email box (invoicing@nih.gov) will be the same date/time logged as the invoice is received by NIH.

Questions?

Please direct inquiries regarding the status of invoices such as receipt of invoices, due date, or payment of invoices to the

OFM Commercial Accounts Branch, Customer Service Office. The OFM Customer Service contact information and of methods to contact are available at the following OFM website https://ofm.od.nih.gov/Pages/Customer-Service.aspx and below.

The Customer Service Office is open Monday – Friday from 8:30 am to 5:00 pm (Eastern Standard Time) and is closed daily between 12:00 pm to 1:00 pm (Eastern Standard Time). The Customer Service Office phone number is 301-496-

6088.

Instructions for Contractor Courtesy Copy Electronic Invoice Submission to the Contracting Officer (CO): The Contractor shall send a cc: copy to the NIH Contracting Officer and the NIH Contracting Officer’s Representative (COR) stated in the award and the NIH Program point of contact when submitting the invoice to NIH/OFM for payment.

mailto:invoicing@nih.gov mailto:invoicing@nih.gov mailto:invoicing@nih.gov https://ofm.od.nih.gov/Pages/Customer-Service.aspx