F Combined_synopsis.pdf

COMBINED SYNOPSIS / SOLICITATION

COMPETITIVE

Title: Early Markers of Alzheimer’s Disease: PET Radiotracer Acquisition in the Baltimore Longitudinal Study of Aging (BLSA)

(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. This acquisition is conducted under the authority of 42 U.S.C. 287(a).

(ii) The solicitation number is 75N95023Q00150 and the solicitation is issued as a request for quote (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-01 dated December 30, 2022.

(iv) The associated NAICS code is 325412 - Pharmaceutical Preparation Manufacturing, and the small business size standard is 1,250 employees. This requirement utilizes full and open competition.

(v) Project Background:

Advances in molecular imaging with positron emission tomography (PET) have allowed a window into the hallmark pathologies of AD in living humans. The ability to image amyloid plaques and tau tangles in vivo is impacting the conduct of clinical trials, including verifying target engagement, informing patient selection, and advancing therapeutic monitoring and outcomes. Importantly, PET molecular imaging tools also are now widely applied in research studies of individuals without cognitive impairment to identify the earliest stages of AD and elucidate the temporal sequence of events leading to cognitive impairment and AD. Information on biomarker status also provides the opportunity to study age-related cognitive changes in individuals without (as well as with) AD pathology.

The National Institute on Aging (NIA) initiated amyloid PET imaging with Pittsburgh compound B (PiB) in the Baltimore Longitudinal Study of Aging (BLSA) in 2005 and tau PET imaging with AV-1451 (T-807) in 2016. Consistent with autopsy data from BLSA and other studies, approximately 30% of cognitively normal individuals have detectable amyloid deposition in the brain on amyloid PET imaging. Individuals with higher levels of β-amyloid are older, more likely to carry the Apolipoprotein E ε4 allele, have greater longitudinal decline in memory and other cognitive functions, and are more likely to accumulate amyloid and show tau progression over time. In addition, through the BLSA autopsy program, we have shown the correspondence between in vivo imaging and post-mortem values of amyloid burden. Work by our group has been central to defining the relationship between amyloid burden and memory change, to characterizing the magnitude and spatial pattern of progression of amyloid burden and its relation to tau progression, to highlighting the importance of individuals with intermediate amyloid levels that would be considered PiB negative in many binary classification schemes, and to identifying modifiers of amyloid burden. The NIA has also developed an approach for estimating age at onset of amyloid accumulation, providing an individualized index that can be used as a dependent outcome to assess factors that may modify age at onset of amyloid accumulation. This approach was applied to demonstrate that Apolipoprotein E ε4 genotype is associated with earlier age of onset of amyloid accumulation in the BLSA sample.

The BLSA was initiated in 1958 and is a multi-disciplinary study of physiologic and psychologic aspects of normal aging in community-dwelling men and women. Since 1994, the NIA has been conducting a longitudinal brain imaging study of selected older adults in the BLSA to characterize individual differences in longitudinal brain changes, to investigate the extent to which these brain changes underlie individual differences in cognitive aging, to identify brain changes that may be predictors of cognitive decline and Alzheimer’s disease (AD), and to assess the impact of potential modulators of brain and cognitive aging. More recently, the NIA has been using PET scanning to acquire in vivo measures of brain amyloid and tau, the hallmark pathologies of AD.

This is anticipated to be an indefinite delivery/indefinite quantity contract with an ordering period of five years.

(vi) Project Requirements:

This is anticipated to be an indefinite delivery/indefinite quantity contract using primarily fixed-price delivery orders. The contractor shall furnish FDA-approved amyloid (Henceforth “amyloid”) PET radioligand doses and second generation tau (Henceforth “tau”) PET imaging radioligand doses in amounts specified by NIA. As NIA cannot predict exactly how many doses will be needed, a range will be provided. Quotes should provide pricing per dose.

The IDIQ minimum is 40 amyloid doses and 40 tau doses, and the maximum is 500 amyloid doses and 500 tau doses. The estimated amount that NIA plans to order per year are below:

• Year 1: Estimated MINIMUM: 40 amyloid doses and 40 tau doses. Estimated MAXIMUM: 75 amyloid doses and 75 tau doses).

• Year 2: Estimated MINIMUM: 40 amyloid doses and 40 tau doses. Estimated MAXIMUM: 75 amyloid doses and 75 tau doses).

• Year 3: Estimated MINIMUM: 50 amyloid doses and 50 tau doses. Estimated MAXIMUM: 95 amyloid doses and 95 tau doses).

• Year 4: Estimated MINIMUM: 50 amyloid doses and 50 tau doses. Estimated MAXIMUM: 95 amyloid doses and 95 tau doses).

• Year 5: Estimated MINIMUM: 50 amyloid doses and 50 tau doses. Estimated MAXIMUM: 95 amyloid doses and 95 tau doses).The estimated amounts per year are as follows:

The Contractor must have the capability to deliver both amyloid and tau radioligands to an imaging facility within 15 miles of the NIA Clinical Research Program at Harbor Hospital, Baltimore, MD. Radioligands shall meet quality control standards for human use and shall be prepared and delivered as individual doses timed to specific image acquisition times, accounting for expected radioactivity decay.

The Contractor must also provide all information and assistance required for regulatory documents, including materials to meet Institutional Review Board, FDA, and radiation safety regulatory requirements.

(vii) Delivery will be made to an imaging facility within 15 miles of the NIA Clinical Research

Program at Harbor Hospital, Baltimore, MD. Additional delivery details will be provided upon award of a resultant contract. Delivery terms are FOB destination.

The estimated ordering period will be from April 15, 2023 through April 14, 2028.

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

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Products and Commercial Services, applies to this acquisition.

(a) The award resulting from this solicitation will be made to the responsible offeror whose proposal is most advantageous to the Government, Technical Capability, Past Peformance and other factors considered.

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

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

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 2018) 52.204-16, Commercial and Entity Code Reporting (Aug 2020) 52.204-18, Commercial and Entity Code Maintenance (Aug 2020) 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services of Equipment (Nov 2021) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015).

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

52.225-6, Trade Agreements Certificate

(xii) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xiii) The offeror must complete and return FAR 52.204-24 and FAR 52.204-26 with its offer.

(xiv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance;

trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

The Unique Entity Identifier (UEI), 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 March 21, 2023, 5:00 pm, Eastern Standard Time and reference number 75N95023Q00150. Responses shall be submitted electronically to Kevin Alvarez, Contracting Officer, kevin.alvarez@nih.gov. Quotes must be submitted in the English language and in US Dollars.

http://www.sam.gov/ mailto:kevin.alvarez@nih.gov

Fax responses will not be accepted.

Attachments:

1. 52.216-18 - Ordering

2. 52.216-19 – Order Limitations

3. 52.216-22 – Indefinite Quantity

4. 52.212-5, Contract Terms and Conditions Required to Implement Statutes or

Executive Orders–Commercial Items

5. NIH Invoice and Payment Instructions

52.216-18 Ordering (AUG 2020)

(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 March 15, 2023 through March 14, 2028.

(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) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor 's fax number;

or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor 's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(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 (TBD), 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 (TBD);

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

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (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.

https://www.acquisition.gov/far/part-52#FAR_52_216_21

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 March 13, 2029.

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

—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

[Contracting officer check as appropriate.] https://www.acquisition.gov/far/52.203-6 https://www.acquisition.gov/far/52.203-13 https://www.acquisition.gov/far/52.203-15 https://www.acquisition.gov/far/52.204-10 https://www.acquisition.gov/far/52.204-14 https://www.acquisition.gov/far/52.204-15 https://www.acquisition.gov/far/52.209-6 https://www.acquisition.gov/far/52.209-9 https://www.acquisition.gov/far/52.219-3 https://www.acquisition.gov/far/52.219-4 https://www.acquisition.gov/far/52.219-6 https://www.acquisition.gov/far/52.219-7 https://www.acquisition.gov/far/52.219-8 https://www.acquisition.gov/far/52.219-9 https://www.acquisition.gov/far/52.219-13 https://www.acquisition.gov/far/52.219-14 https://www.acquisition.gov/far/52.219-16 https://www.acquisition.gov/far/52.219-27 https://www.acquisition.gov/far/52.219-28 https://www.acquisition.gov/far/52.219-29 https://www.acquisition.gov/far/52.219-30 https://www.acquisition.gov/far/52.219-32 https://www.acquisition.gov/far/52.219-33 https://www.acquisition.gov/far/52.222-3 https://www.acquisition.gov/far/52.222-21 https://www.acquisition.gov/far/52.222-26 https://www.acquisition.gov/far/52.222-35 https://www.acquisition.gov/far/52.222-36 https://www.acquisition.gov/far/52.222-37 https://www.acquisition.gov/far/52.222-40 https://www.acquisition.gov/far/52.222-50 https://www.acquisition.gov/far/52.222-54 https://www.acquisition.gov/far/52.223-9 https://www.acquisition.gov/far/52.223-11 https://www.acquisition.gov/far/52.223-12 https://www.acquisition.gov/far/52.223-13 https://www.acquisition.gov/far/52.223-14 https://www.acquisition.gov/far/52.223-15 https://www.acquisition.gov/far/52.223-16 https://www.acquisition.gov/far/52.223-18 https://www.acquisition.gov/far/52.223-20 https://www.acquisition.gov/far/52.222-19 https://www.acquisition.gov/far/52.223-21 https://www.acquisition.gov/far/52.224-3 https://www.acquisition.gov/far/52.225-1 https://www.acquisition.gov/far/52.225-3 https://www.acquisition.gov/far/52.225-5 https://www.acquisition.gov/far/52.225-13 https://www.acquisition.gov/far/52.225-26 https://www.acquisition.gov/far/52.226-4 https://www.acquisition.gov/far/52.226-5 https://www.acquisition.gov/far/52.232-29 https://www.acquisition.gov/far/52.232-30 https://www.acquisition.gov/far/52.232-33 https://www.acquisition.gov/far/52.232-34 https://www.acquisition.gov/far/52.232-36 https://www.acquisition.gov/far/52.239-1 https://www.acquisition.gov/far/52.242-5 https://www.acquisition.gov/far/52.247-64 https://www.acquisition.gov/far/52.229-12 https://www.acquisition.gov/far/52.222-41 https://www.acquisition.gov/far/52.222-42 https://www.acquisition.gov/far/52.222-43 https://www.acquisition.gov/far/52.222-44 https://www.acquisition.gov/far/52.222-51 https://www.acquisition.gov/far/52.222-53 https://www.acquisition.gov/far/52.222-55 https://www.acquisition.gov/far/52.222-62 https://www.acquisition.gov/far/52.226-6

FAC 52.212-5 as of FAC 2023-01 (12/30/2022) Edited 01/03/2023

Updated on April 21, 2022

Invoice and Payment Provisions (Vendor has Transitioned to

IPP)

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) 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 considered in the computation of any interest penalty owed the Contractor.

1. Vendor/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 vendor 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. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI 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.*

ATTACHMENT 5

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.

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.

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing

Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the Approving Official (Contracting Officer) and Technical Point of Contact or Contracting Officer’s Representative.

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 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.

https://www.ipp.gov/

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (November 2021)

(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, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of Clause)

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of Clause) http://www.ipp.gov/

(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 (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (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)).

(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.

212-5(e) text: (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 products or commercial services. 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 (NOV 2021) (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 (NOV 2021) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2022) (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 the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(vii) 52.222-26, Equal Opportunity (SEP 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

(xi) 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.

(xii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (NOV 2021) (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).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May2014) (41 U.S.C. chapter 67).

(xv) 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).

(xvi) 52.222-54, Employment Eligibility Verification (MAY 2022) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (JAN 2022).

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

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

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

(xx) 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. Subtitle A, Part V, Subpart G Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) (46 U.S.C. 55305 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 products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8 G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial products or commercial services, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and

(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(A) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C. 3509).

(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5).

(C) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(D) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(E) 52.219-8, Utilization of Small Business Concerns (OCT 2022) (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 the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(F) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(G) 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246).

(H) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(I) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(J) 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.

(K) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

(L) ___ (1) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O 13627).

___ (2) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(M) 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).

(N) 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).

(O) 52.222-54, Employment Eligibility Verification (NOV 2021) (Executive Order 12989).

(P) 52.222-55, Minimum Wages Under Executive Order 13658 (JAN 2022).

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

(R) (1) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

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

(S) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as…