SOLICITATION 8 30 2022.pdf

75F40122R00082

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information in this notice. Proposals are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a hybrid firm-fixed-price and labor-hour contract resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-06 dated May 26, 2022.

The associated North American Industrial Classification System (NAICS) code for this procurement is 518210 - Data Processing, Hosting, and Related Services. The competition for this requirement is full and open.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: The Government intends to issue a hybrid-price contract (firm-fixed-price plus labor-hour) resulting from this solicitation.

Pricing Table:

Contract Line Item # Description Period of Performance Price 1 Base Year: US

Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

90 users

9/29/2022-9/28/2023, 12 units/year

Firm Fixed Price:

2 Base Year: US Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product Customization (Note 1)

9/29/2022-9/28/2023 200 Labor Hours: Not to exceed

3 Base Year – Option Quantity: US Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

10 additional users

9/29/2022-9/28/2023, 12 units/year

Firm Fixed Price:

4 Base Year: US Pharmaceutical Market Data – Retail/Non-retail:

Access to quarterly updates and three add on modules, SMART, Project Management and Technical Support (unlimited access license) 4 users

9/29/2022-9/28/2023, 12 units/per year

Firm Fixed Price:

5 Base Year: International Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product Customization (Note 1)

9/29/2022-9/28/2023 200 Labor Hours: Not to exceed

6 Base Year – Option Quantity: International Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

1 user

9/29/2022-9/28/2023, 12 units/year

Firm Fixed Price:

Total Base Year

7 Option Year 1: US

Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

90 users, 9/29/2023-9/28/2024, 12 units/year

8 Option Year 1: US Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product (Note 1)

9/29/2023-9/28/2024 200 Labor Hours: Not to exceed:

9 Option Year 1 – Option Quantity: US Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

additional 10 users

9/29/2023-9/28/2024, 12 units/year

Firm Fixed Price:

10 Option Year 1: US Pharmaceutical Market Data – Retail/Non-retail:

Access to quarterly updates and three add on modules, SMART, Project Management and Technical Support (unlimited access license) 4 users

9/29/2023-9/28/2024, 12 units/year

Firm Fixed Price:

11 Option Year 1:

International Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product Customization (Note 1)

9/29/2023-9/28/2024 200 Labor Hours: Not to exceed:

12 Option Year 1 – Option Quantity: International

9/29/2023-9/28/2024, Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

1 user

Total Option Year 1

13 Option Year 2: US

Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

90 users

9/29/2024-9/28/2025, 12 units/year

Firm Fixed Price:

14 Option Year 2: US Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product (Note 1)

9/29/2024-9/28/2025 200 Labor Hours: Not to exceed:

15 Option Year 2 – Option Quantity: US Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

additional 10 users

9/29/2024-9/28/2025, 12 units/year

Firm Fixed Price:

16 Option Year 2: US Pharmaceutical Market Data – Retail/Non-retail:

Access to quarterly updates and three add on modules, SMART, Project Management and Technical Support (unlimited access license) 4 users

9/29/2024-9/28/2025, 12 units/year

Firm Fixed Price:

17 Option Year 2:

International Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product Customization (Note 1)

9/29/2024-9/28/2025 200 Labor Hours: Not to exceed:

18 Option Year 2 – Quantity Option: International Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

additional 1 user

9/29/2024-9/28/2025, 12 units/year

Firm Fixed Price:

Total Option Year 2

19 Option Year 3: US

Pharmaceutical Market 9/29/2025-9/28/2026, Data – Retail/Non-retail, unlimited access licensing:

90 users

20 Option Year 3: US Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product (Note 1)

9/29/2025-9/28/2026 200 Labor Hours: Not to exceed:

21 Option Year 3 – Quantity Option: US Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

additional 10 users

9/29/2025-9/28/2026, 12 units/year

Firm Fixed Price:

22 Option Year 3: US Pharmaceutical Market Data – Retail/Non-retail:

Access to quarterly updates and three add on modules, SMART, Project Management and Technical Support (unlimited access license) 4 users

9/29/2025-9/28/2026, 12 units/year

Firm Fixed Price:

23 Option Year 3: US Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product Customization (Note 1)

9/29/2025-9/28/2026 200 Labor Hours: Not to exceed:

24 Option Year 3 – Quantity Option: International Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

additional 1 user

9/29/2025-9/28/2026, 12 units/year

Firm Fixed Price:

Total Option Year 3

25 Option Year 4: US

Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

90 users

9/29/2026-9/28/2027, 12 units/year

Firm Fixed Price:

26 Option Year 4 US Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product (Note 1)

9/29/2026-9/28/2027 200 Labor Hours: Not to exceed:

27 Option Year 4 – Quantity Option: US Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

additional 10 users

9/29/2026-9/28/2027, 12 units/year

Firm Fixed Price:

28 Option Year 4: US Pharmaceutical Market Data – Retail/Non-retail:

Access to quarterly updates and three add on modules, SMART, Project Management and Technical Support (unlimited access license) 4 users

9/29/2026-9/28/2027, 12 units/year

Firm Fixed Price:

29 Option Year 4: US Pharmaceutical Market Data – Retail/Non-retail:

Ad-hoc Analyses: Custom Reporting and Product Customization (Note 1)

9/29/2026-9/28/2027 200 Labor Hours: Not to exceed:

30 Option Year 4 – Quantity Option: International Pharmaceutical Market Data – Retail/Non-retail, unlimited access licensing:

additional 1 user

9/29/2026-9/28/2027, 12 units/year

Firm Fixed Price:

Total Option Year 4 Total Contract Value

Note 1: AD-HOC ANALYSIS: CUSTOM REPORTING AND PRODUCT CUSTOMIZATION:

During the contract period(s) of performance, the FDA may encounter additional Ad-hoc analysis work for the following labor categories.

Project Manager/Research Director Sr. Computer Systems Analysis Application Programmer Statistician Pharmacist Survey Scientist Sr. Training Specialist.

(See Attachment 8 for labor category descriptions.)

The contractor shall state the labor rates for these labor categories for US Sales and International Sales for the base year and all option years (Rates will be based on 200 hours/year.)

(See Attachment 1 Statement of Work for details.)

Year Labor Category Labor Hourly Rate Base Year Project Manager/Research

Director

Sr. Computer Systems Analysis

Application Programmer

Statistician

Pharmacist

Survey Scientist

Sr. Training Specialist.

Option Year 1 Project Manager/Research

Option Year 2 Project Manager/Research

Option Year 3 Project Manager/Research

Option Year 4 Project Manager/Research

PART 3: DESCRIPTION OF REQUIREMENT

3.1 Background

A vital part of FDA and The Center for Drug Evaluation and Research’s (CDER) mission is to promote and protect the public health. Offices within CDER take a variety of approaches to meet these broad goals. For example, the Office of Surveillance and Epidemiology (OSE) evaluates drug risks and promotes the safe use of drugs by the American people. The Drug Shortage Staff (DSS) aims to minimize the impact of shortages of drug products, by working to avoid such shortages or to mitigate the effects when shortage is unavoidable. Finally, the Office of Program and Strategic Analysis (OPSA) conducts economic and quantitative analyses of proposed and existing policies.

To fulfill these missions and other program functions, CDER requires access to national-level pharmaceutical sales data to estimate and forecast trends in pharmaceutical sales, pricing, and volume of distribution throughout various settings of care. Continued access to these data allows the FDA to respond expeditiously to questions relating to drug safety, the impact of regulatory policies, and to potential drug shortage situations, helping the Agency to make more informed decisions about matters that affect the health of Americans.

Several prior efforts have supported CDER’s interest in obtaining access to pharmaceutical sales data. In early 2005, FDA commissioned the Institute of Medicine (IOM) to conduct a study to examine the U.S. drug safety system. In September 2006, the IOM report entitled, “The Future of Drug Safety: Promoting and Protecting the Health of the Public” was released and outlined numerous ongoing and future activities designed to continue to strengthen the FDA’s drug safety program.

In response to reports from the Institute of Medicine (IOM), FDA is authorized by the FDA Amendments (2007) Act to expand database resources for providing advanced analyses of drug safety data to improve the quality of post-market risk/benefit analyses and enhance the ability of FDA to make timely assessments of drug safety data. OSE contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. Specific recommendations in the IOM report addressed modernizing the drug safety program including activities for the expansion of database resources.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

The 21st Century Cures Act which was enacted in December 2016 also contains provisions for the FDA to increase surveillance and monitoring of certain medications such as opioids which aligns with CDER’s mission. This section of the Act encourages the use of real-world evidence in the analysis of post market surveillance data to enable the Agency to respond promptly to serious public health issues.

https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf

In addition, Title IX of the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007) contains numerous provisions related to post-marketing safety and communication of safety information. A subset of those provisions calls for enhanced authorities for accessing disparate data sources and establishing and improving procedures to identify drug use data trends on a national level.

CDER has previously used pharmaceutical sales data to support many of its regulatory and public health initiatives. These data provide important context for understanding adverse event reports;

for instance, by allowing for modeling drug risks based on usage patterns and for calculating patient-based, adverse event reporting rates for drugs. CDER has also used these data to support several public presentations and reports, including FDA’s 2019 report, Drug Shortages: Root Causes, and Potential Solutions. 1

FDA is not interested in developing this database and expects any qualified organization to own the data as well as the means to access the data.

1 https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions htts://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions

FDA's authority to fund research projects is set out in section 301 of the Public Health Service Act (PHSA 42 U.S.C. 241).

3.2 Statement of Work: See Attachment 1: Statement of Work

PART 4: INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the delivery location. The Project Officer will perform inspection and acceptance of the materials delivered. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer or the Contracting Officer’s Representative (COR) within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within fifteen (15) days from the time the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within three (3) business days.

PART 5 – DELIVERIES OR PERFORMANCE

Deliveries and Place of Performance Satisfactory performance of this contract shall be deemed to occur upon delivery of services described above and/or upon acceptance by the Contracting Officer or the Contracting Officer’s Representative (COR) of these services. All work will take place at the contractor’s location (Please note that training may be performed at the FDA’s facility.)

The Contractor shall contact the Government POC at least 24 hours prior to delivery or service. Deliveries, technical support, and trainings shall occur at the place of performance specified above during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM, excluding holidays, in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

Period of Performance The anticipated period of performance is for a base period of 12 months and four 12-month option years.

Each option period has the same tasks as the base period.

PART 6 – CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government for the purpose of this contract:

Contracting Officer’s Representative (COR):

TBD

The Contracting Officer’s Representative (COR) is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

Contracting Officer (CO): Contract Specialist (CS):

Kimberly Delong Howard S. Yablon 4041 Powder Mill Road 4041 Powder Mill Road Beltsville, MD 20705 Beltsville, MD 20705 kimberly.delong@fda.hhs.gov howard.yablon@fda.hhs.gov Tel: (240) 402-8639 Tel: (240) 402-7630

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to (1) Direct or negotiate any changes in the RFQ; (2) Modify or extend the period of performance; (3) Change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract.

Payment Schedule:

The Contractor shall submit invoices subsequent to the delivery of deliverables as stated in the Statement of Work.

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, 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, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

mailto:kimberly.delong@fda.hhs.gov http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)-show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. 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.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA 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.

PART 7 – CONTRACT PROVISIONS AND CLAUSES

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) mailto:ERIC@fda.hhs.gov

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://acquisition.gov/far/

52.202-1 – Definitions (June 2020) 52.203-3- Gratuities (Apr 1984) 52.203-11 – Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sept 2007) 52.203-12 – Limitation on Payments to Influence Certain Federal Transactions (June 2020) 52.203-13 – Contractor Code of Business Ethics and Conduct (Nov 2021) 52.204-13 – System for Award Management Maintenance (Oct 2018) 52.204-16 – Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016) 52.204-19 – Incorporation by Reference of Representations and Certifications (Dec 2014) 52.204-22 – Alternative Line Item Proposal (Jan 2017) 52.204-25 - Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 52.209-10 – Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) 52.209-11 – Representations by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (Feb 2016) 52.209-12 – Certification Regarding Tax Matters (Oct 2020) 52.212-4 – Contract Terms and Conditions – Commercial Items (Oct 2018) 52.212-7 - Option for Increased Quantity – Separately Priced Line Item (Mar 1989) 52.232-7 – Payments Under Time and Materials and Labor Hour Contracts (Nov 2021)

FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 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 the provision at 52.204-26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items.

(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— https://acquisition.gov/far/ https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#id19CAC0P0ESS https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1060550 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#unique_1605198408

(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.

(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.

(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 https://www.sam.gov/

(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.

FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)

(a) Definitions. As used in this provision, “covered telecommunications equipment or services” has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) 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”.

(c) Representation. The Offeror represents that it □ does, □ 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.

FAR 52.212.-3 Offeror’s Representations and Certifications-Commercial Products and Commercial Services (May 2022)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v)) of this provision.

(a) Definitions. As used in this provision— https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#unique_1605198408

"Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174).

Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended."Sensitive technology"—

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and https://www.acquisition.gov/far/52.204-25#FAR_52_204_25

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3)of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business concern—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veteransor, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service connected, as defined in 38 U.S.C. 101(16).

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships.

SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim

(2) Through another subsidiary of a parent corporation

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C.

101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned business concern means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women

Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

(b)

(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM.

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

http://www.sam.gov/ https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/4.1201#FAR_4_1201

[Offeror to identify the applicable paragraphs at (c) through (v) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii). Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it □ is, □ is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it □ is, □ is not a small disadvantaged business concern as defined in 13 CFR124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is, □ is not a women-owned small business concern.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that-

(i) It □ is, □ is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: __________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

https://www.acquisition.gov/far/part-19#FAR_Part_19 https://www.acquisition.gov/far/19.000#FAR_19_000

(7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that-

(i) It □ is, □ is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: __________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:____________________________________

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that–

(i) It □ is, □ is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR Part 126;

and

(ii) It □ is, □ is not a HUBZone joint venture that complies with the requirements of 13 CFR Part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: __________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

(d) Representations required to implement provisions of Executive Order11246-

(1) Previous contracts and compliance. The offeror represents that-

(i) It □ has, □ has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and

(ii) It □ has, □ has not…