Vaxicool Replacement RFQ 28 June 2023.pdf

NOTE: Due to the length of this combined synopsis/solicitation, a pdf copy to help provide easier readability is attached to this posting.

COMBINED SYNOPSIS SOLICITATION

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 document will not be issued.

ii. The solicitation number is 75A50323Q00008 which is being issued as a Request for Proposal (RFQ).

Contract Type will be Firm Fixed Price.

iii. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-04, effective June 2, 2023.

iv. This acquisition is being posted as Full and Open and is not set aside for small businesses. NAICS 333415 Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing. The size standard is 1,250 (number of employees).

v. a. The Strategic National Stockpile (SNS), of the U.S. Department of Health and Human Services (HHS)

Administration for Strategic Preparedness and Response (ASPR), has a requirement for up to 800 Portable pharmaceutical grade refrigerator and freezer units that are 100% domestically manufactured as is required by the Infrastructure and Investment Jobs Act (IIJA)/Make PPE in America. See Section B-

SUPPLIES OR SERVICES AND PRICES/COSTS.

b. The Government intends to evaluate offers and award a contract without discussions. However, the

Government may, at its sole discretion, elect to conduct discussions if determined to be in the best interest of the Government.

vi. See Sections B and C below for description of requirements.

vii. The period of performance is anticipated to be 12 months, September 1, 2023 through September 30, 2024.

viii. The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (MAR 2023), applies to this acquisition. The Government intends, but is not obligated, to award multiple contracts.

ix. The provision FAR 52.212-2, Evaluation-Commercial Products and Commercial Services (MAR 2023), applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria.

x. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications-

Commercial Products and Commercial Services (DEC 2022), with its offer. (Note, if offerors are registered within the System for Award Management (SAM) and certs and reps are up to date, make a statement to that affect in accordance with this clause).

xi. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (DEC 2022), applies to this acquisition.

xii. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (JUN 2023), applies to this acquisition and FAR clauses applicable are 52.219-9, 52.219-16, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-

36, 52.222-37, 52.222-40, 52.225-5, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition Regulation (HHSAR) clauses. See below for details.

xiii. There are no special contract requirements or terms and conditions related to contract financing arrangements.

xiv. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

xv. Offers are due no later than 28 July 2023, 3:00 PM Eastern Standard Time (EST). Officers must submit and electronic copy of the Technical Quote and Price/Business Quote via email to dsnssolications@cdc.gov with the Subject Line RFQ 75A50323Q00008, and by email to Lawrence McCoy at gwg8@cdc.gov and Mattie Washington at qva7@cdc.gov. The offeror’s complete quote (including all information required to be submitted as part of the offeror’s Volume I -Technical Quote, and Volume II - Price/Business Quote) must be received by the date and time specified for receipt of offers. See Section l for additional details for the content of proposals.

Electronics submissions only will be accepted and shall be submitted via email to the email addresses specified above. Email submissions are limited to 10 MB. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

o All questions regarding this RFQ of contractual or technical nature, must be submitted electronically by email to with subject line “ QUESTIONS RFQ 75A50323Q00008”, to Lawrence McCoy at gwg8@cdc.gov and Mattie Washington at qva7@cdc.gov. no later than 1:00 p.m. Eastern Standard Time (EST) 21 July 2023. The Government’s responses to questions will be posted as an attachment to the combined synopsis/solicitation posting. Unless the Government otherwise determines that it is in its best interest to provide a response, questions received after the deadline will not be answered.

xvi. The point of contact for information regarding this Combined Synopsis/Solicitation is:

Contracting Officer Lawrence McCoy Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: gwg8@cdc.gov| Office: 770-488-2087 mailto:dsnssolications@cdc.gov mailto:gwg8@cdc.gov mailto:qva7@cdc.gov mailto:gwg8@cdc.gov mailto:qva7@cdc.gov mailto:gwg8@cdc.gov%7C

RFQ-75A5323Q00008

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Contract Line Items

ITEM Supplies/Services Quantity Unit Unit Price Total Price 1 Portable Pharmaceutical Grade

Refrigerator Unit

Firm Fixed Price (FFP)

600 Unit

2 Portable Pharmaceutical Grade Freezer Unit

Firm Fixed Price (FFP)

200 Unit

Note: Shipping and packing will be provided by the contractor and is included in the Firm Fixed Price (FFP) of the contract in Section B.1 Contract Line-Items.

B.2 Delivery Schedule Milestones

The Offeror shall provide a delivery schedule for the refrigerator (600) and freezer (200) units for the period of twelve

(12) months. The Government will determine the actual delivery schedule prior to contract award. Offerors shall provide the following information:

B.2.A - Below is a delivery schedule template for CLIN’s 1 and 2. Offerors shall update this table with the delivery schedule and locations identified in Section C.5 at a rate of no less than 33 units per month.

Refrigerator Unit (600) or Freezer Unit (200): Delivery Period: 1 October 2023 – 30 September 2024 CLIN Product Type Oct 23 Nov 23 Dec 23 Jan 24 Feb 24 Mar 24 Apr 24 May 24 Jun 24 Jul 24 Aug 24 Sep 24

1 Refrigerator 2 Freezer

B.2.B- Alternate Delivery Schedule per Offerors Production Schedule and Capabilities: Below is a delivery schedule template for CLIN’s 1 and 2. Offerors shall update this table with their estimated minimum and/or maximum quantities and delivery schedule for the period of twelve months.

Refrigerator Unit (600) or Freezer Unit (200): Delivery Period: 1 October 2023 – 30 September 2024 CLIN Product Type Oct 23 Nov 23 Dec 23 Jan 24 Feb 24 Mar 24 Apr 24 May 24 Jun 24 Jul 24 Aug 24 Sep 24

1 Refrigerator 2 Freezer

B.3 Type of Contract- This is a Firm Fixed Price (FFP) contract.

STATEMENT OF WORK (SOW)

Title of Project: Portable pharmaceutical grade refrigerator and freezer units

C.1 Background

The mission of the Strategic National Stockpile (SNS), of the United States (U.S.) Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) is to ensure the availability and rapid deployment of life-savings pharmaceuticals, antidotes, other medical supplies and equipment necessary to counter the effects of nerve agents, biological pathogens, and chemical agents. When state, local, tribe and territorial public health and medical systems request federal assistance to support their response efforts, SNS ensures that the right medicine and supplies get to those who need them most during emergency.

The Strategic National Stockpile (SNS) is a national repository of medicines, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. The assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that causes local supplies to run out.

For the SNS to accomplish its mission of supporting the US and US territories, it will need to have durable medical grade quality active mobile refrigeration units to support the vaccine mission. These mobile refrigeration units will have to be quality tested specifically for vaccines to ensure the distribution of air inside of the unit is even and constant throughout transport. The device must maintain an even temperature consistently and keep vaccines at their cold temperature for several days without needing electricity.

The cold chain is a temperature-controlled environment used to maintain and distribute temperature sensitive medical products like vaccines in optimal condition. The cold chain begins at the manufacturer, continues in shipment to medical logistics, then to the vaccination site, and ends at administration of the vaccine to the patient. Failure to adhere to required specifications for shipping, storing, and handling vaccines in the manufacturer’s packaging insert may reduce the vaccines potency resulting in inadequate protection against disease. A single shipment of vaccine can immunize thousands of patients but could become compromised if that shipment is exposed to temperature fluctuations or direct sunlight.

C.2 – Purpose

The purpose of this requirement is to provide the Strategic National Stockpile (SNS), Pharmaceutical-grade active refrigerator and freezer units ship temperature-controlled products in support of SNS mission providing national repository of medicines, vaccines, to support "emergency responses". Specifically, SNS has the need for significant quantities of refrigerator and freezer units due to the last procurement for the units were 20 years ago. The units are failing, and replacement parts have been discontinued. The biologics being deployed by SNS cannot be shipped via common refrigerator and freezer units. The refrigerators/ freezers required to ship biologics must be purpose-built units using a temperature data logger with an uncertainty of ±.05°C or less. The refrigerator and freezer units shall be compliant with the domestic sourcing requirements established in the Make PPE in America and the Infrastructure Investment and Job Acts. See, Public Law 117-58, Subtitle C, 135 Stat. 429 (2021) and meet International Safe Transit Association standards.

C.3 – Scope of Work

The Government expectation is to receive a delivery of 600 custom-built or pharmaceutical-grade active refrigerator and 200 custom-built or pharmaceutical-grade active freezer units by September 30, 2024, to be shipped to SNS locations within the United States identified in the deliverables section. These units would ensure temperature consistency, provide ease of serviceability, integrate with temperature monitoring systems, and have compressors that are more efficient and able to cool more quickly. The minimum warranty period for the unit shall be one year, however, longer warranty periods would be more beneficial to the United States Government (USG).

Pharmaceutical-grade active refrigerator and freezer unit that are 100% domestically manufactured as is required by the Infrastructure and Investment Jobs Act (IIJA)/Make PPE in America is a MANDATORY REQUIREMENT.

C.3.1 The proposed pharmaceutical grade mobile active refrigerator unit shall maintain the following temperature ranges:

• Maintains a temperature range from 2°C to 8°C (36°F to 46°F). Set thermostat midrange to achieve a temperature of about 4°C (39°F). Have the ability to set a low and a high alarm at desired temperature.

• Calibration report/certificate for each unit shall include the following calibration points: unit’s upper and lower operating range and 2°C to 8°C. The certificate must also contain the unit’s serial number and confirmation that the unit passed testing using NIST certified test instrument or equivalent.

C.3.2 The proposed pharmaceutical grade mobile active freezer unit shall maintain the following temperature ranges:

• Maintains a temperature range between -30°C and +30°C (-22°F to 86°F). Set thermostat midrange to achieve of about -20°C (-4°F). Have the ability to set a low and a high alarm at desired temperature

• Calibration report/certificate for each unit shall include the following calibration points: unit’s upper and lower operating range and -30°C and +30°C. The certificate must also contain the unit’s serial number and confirmation that the unit passed testing using NIST certified test instrument or equivalent.

C.3.3 The pharmaceutical grade mobile active refrigerator and freezer unit shall meet the minimally requirements:

• Temperature Monitoring Equipment. An accurate temperature history that reflects actual vaccine temperatures is critical for protecting vaccines. Each unit must have its own integrated certified and calibrated temperature monitoring device (TMD).

• Digital Data Logger (DDL) shall provide accurate and detailed temperature data including details of how long a unit has been operating outside the required temperature range.

• Temperature sensor/data logger must be accurate within ±0.5°C between 2°C and 8°C and is National Institute of Science and Technology (NIST) certified or equivalent

• The units shall have a liquid crystal display (LCD)/light emitting diode (LED) panel screen for o Temperature readout of extreme high/low temperature during operation o Current temperature o Temperature history during operation o Battery level indicator when not connected to AC power o Low battery condition alarm- visible and audible, high and low

• Once internal battery is fully charged the unit will have a least 60 hours of operation time while in refrigeration mode 2°C to 8°C. If the unit is able to exceed 60 hours of operational time using battery power, then this would be more beneficial to the USG.

• Once internal battery for the freezer is fully charged, the unit will have at least 12 hours of operation time while in freezer mode -30°C and +30°C. If the unit is able to exceed 12 hours of operational time using battery power, then this would be more beneficial to the USG.

• Pay load volume: between 27 to 56 Liters

• Microprocessor-based temperature control with a digital temperature sensor (thermocouple, resistance temperature detector [RTD], or thermistor)

• The units shall have a consistent temperature throughout the refrigerator and freezer unit.

• The unit must display out of time excursion defined in days, hours, minutes for both high and low temperature settings

• The device weight should be no more than 120 lbs. with internal batteries included

• Have at least 100 VAC to 240 VAC and 50 to 60 HZ input capability, USA standards.

• Unit must come with wheels, handles, or device for a 2-person lift and transport

• Unit must come with all necessary auxiliary components required for the unit operation including charging cables.

• The offeror shall have Model number/device name and serial number affixed on each unit.

• The offeror shall have a Quick operation guide and operator’s manual attached to each unit.

• The offeror shall have the date of manufactured affixed on each unit.

• Data recorded on temperature monitor device shall be tamper proof

• The units shall have a Battery Shelf Life ≥ 2 years (from time of receipt)

• The offeror shall have a Calibration date indicated on each unit (defined by end of Month and Year).

Calibration date of the unit must be within 30 days from date of receipt.

• The offeror shall have the calibration due date shall be indicated each unit

• The refrigerator and freezer units shall have visual and audible display of an out of temperature notification (or an icon symbol) if the temperature exceeded the programmed parameters such as an “Ok” and/or an “Alarm”

• The refrigerator and freezer units shall display “out-of-time” excursion defined in days, hours, minutes for both high and low settings

• The offeror shall provide the website and telephone numbers (non-emergency and emergency) of its representatives (primary and alternate), who should be contacted for help assistance.

• The offeror shall include statement or end user directions for safe disposal and any associated material risks

• The offeror shall provide their Quality Assurance (QA)/ Quality Control (QC) Validation Approach per industry standard and traceable to NIST standards

• The offeror shall provide General Qualification Acceptance Criteria

• The offeror shall provide their testing approach and methodology (Software and Hardware, Factory Acceptance Testing)

• The offeror shall provide qualification/validation study for the refrigerator units demonstrating that the unit meets the storage requirement of 2°C to 8°C for at least 60 hours. The qualification/validation study must include temperature mapping study to determine probe placement within the unit. Study must document how long the units are able to maintain temper with no power (power loss study). Also include battery charge time from 0 to 100%.

• The offeror shall provide qualification/validation study for the freezer unit demonstrating that the unit meets the storage requirement of -30°C and +30°C for at least 12 hours. The qualification/validation study must include temperature mapping study to determine probe placement within the unit. Study must document how long the unit is able to maintain temper with no power (power loss study). Also include battery charge time from 0 to 100%.

• The offeror shall provide Qualification verification letter for all units sold.

• The Units must be serialized or Lot # controlled (defined on Quality Acceptance Verification letter).

• The pharmaceutical grade mobile active refrigerator and freezer unit must be capable of air transportation.

• The pharmaceutical grade mobile active refrigerator and freezer unit comply with cold-chain protocols.

C.4 – Contract Period of Performance:

The period of performance shall be for twelve (12) months from the effective date of contract award which is anticipated 1 September 2023 with the delivery period of 1 October 2023 thru 30 September 2024. The government anticipates delivery will be on a monthly basis over the 12 months period. However, the delivery schedule is subject to change to meet the government requirements.

C.5 – Delivery Location and Shipping Requirements:

The warehouse exact delivery address (es) shall be provided at the time of award and the vendor shall distribute the active refrigerator and/or freezer units to the designated locations at a rate of no less than 33 units per month. If the vendor would like to distribute more, this amount would have to be agreed upon with the COR or designated project manager. Shipping locations are subject to change within the contracted time period.

Six Hundred (600) pharmaceutical grade refrigerator units shall be delivered by September 30, 2024, or sooner.

• Refrigerator units will be delivered to: Olive Branch, MS

• Refrigerator units will be delivered to: TBD, MD

• Refrigerator units will be delivered to: Salt Lake City, UT

• Refrigerator units will be delivered to: Dallas, TX

Two Hundred (200) pharmaceutical grade freezer units shall be delivered by September 30, 2024, or sooner.

• Freezer units will be delivered to: Olive Branch, MS

• Freezer units will be delivered to: Salt Lake City, UT

• Freezer units will be delivered to: DFW Airport, TX

• Freezer units will be delivered to: TBD, MD

The contractor shall ship the pharmaceutical grade refrigerator and freezer units FOB Destination using traceable means. For the unit shipment, contractor shall provide the following information to the COR within 48 hours after shipment:

• All shipments will include packing slip sand contract number.

• Storage Requirements shall be on all packing lists.

• Item description shall include Model Number, Device Name and Serial Number.

• All pallets are to have the identical Ty-Hi stack pattern except for the final pallet.

• All product to be delivered on-standard 48" by 40" pallet, not to exceed 60"in height, stretch wrapped and secured to pallet for safe transport.

• Contractor shall contact the COR or designated point of contact (POC) to schedule delivery appointments.

C.6 Deliverables

Deliverable Description Form Delivery Date 001 Kick-off Meeting CO/COR/POC 2 Business Days after Award 002 Delivery Documents Scan and email to COR/POC 2 Business Days Prior to Delivery 003 Packing Slips Scan and email to COR/POC 48 hours after shipping 004 Monthly Report Email to COR/POC Within 2 business days from the beginning of each month 005 Delivery Schedules Email to COR/POC 5 Business days prior to the beginning of each month 006 Final Report Email to COR/POC Within 5 business days from end of contract, or the final delivery whichever comes first.

Monthly Report – The monthly report shall be in excel format and contain at a minimum, the following information for each delivery that occurred in the previous month:

1. Date of Delivery

2. Location of Delivery

3. Freight Carrier

4. Quantity of unit and number of pallets,

5. Manufacturer

6. Model and Serial Number

Delivery Schedules – The delivery schedules for the upcoming month shall be provided to the COR/POC 5 business days prior to the beginning of each month and include the anticipated dates, quantities, location, and truck loads for delivery of the upcoming month.

Final Report – The final report shall be a detailed summary of all deliveries under the performance of this contract.

SECTION D-PACKAGING, MARKING AND SHIPPING

D.1 PACKING

All postage and fees related to submission of information, including forms, and reports, etc., to the Contracting Officer or Contracting Officer’s Representative (COR) or other persons designated to receive shall be paid by the Contractor.

D.2 MARKINGS

All product delivered under this contract shall be packaged, marked and shipped in accordance with Government specifications and FDA regulations. This requirement intends to require vendors to adhere to the FDA’s Unique Device Identification (UDI) Policy requirements, effective as of September 24, 2022, for any product delivered under this contract. At a minimum, deliverable shall include the following information at time of delivery:

1. Packing Slip with Contract number

2. Contractor Name and Address

3. Storage Requirements shall be on all packing’s lists

4. Product Name, Model Number, Serial Number and Manufacturer

D.3 DELIVERY LOCATION & SHIPPING REQUIREMENTS

Products shall be shipped FOB Destination. The address(es) will be provided by the COR after award and will be to a Government designated location within the continental United States (CONUS). The contractor shall adhere to the following shipping requirements:

a. Contractor shall contact designated COR/POC (for the respective address items are being delivered to) to schedule delivery appointments NLT 48 hours prior to shipping any product but as far in advance as possible (delivery times are Mon – Fri 8:00 AM – 3:30PM).

b. All pallets are to have the identical TI-HI stack pattern for all deliveries throughout this contract except for the final pallet.

c. The product/case packaging configuration shall be identical for all deliveries throughout this contract.

d. All product to be delivered on 48" by 40" pallet, not to exceed 60” in height, stretch wrapped, and secured to pallet for safe transport.

e. Product is to be stacked in such a way that no portion of the cased materials may exceed the dimensions of pallet.

f. All cases must be positioned on the pallet in a way that allows for labels to be viewable.

g. The exact delivery locations shall be provided by the COR; Delivery will be within the CONUS.

SECTION E- INSPECTION AND ACCEPTANCE

52.252-2 Clauses Incorporated by Reference (Feb 1998)

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

(End of Clause)

FAR SOURCE TITLE AND DATE

52.212-4 Contract Terms and Conditions-Commercial Services (DEC 2022) 52.246-2 Inspection of Supplies-Fixed Prices (Aug 1996)

E.1 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or a duly authorized representative (who for the purposes of this contract shall be the Project Officer or COR) at the destination of the articles, services or documentation.

Final acceptance shall be based on the completion of each delivery.

“Notwithstanding the clause at FAR 52.212-4(a), inspection and acceptance shall be governed in accordance with FAR 52.246-2”.

http://farsite.hill.af.mil/

SECTION F- DELIVERIES AND PERFORMANCE

52.252-2 Clauses Incorporated by Reference (Feb 1998)

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

52.246-16 Responsibility for Supplies (Apr 1984) 52.247-34 F.O.B. Destination (Nov 1991) https://www.acquisition.gov/

SECTION G- CONTRACT ADMINSTRATION DATA

G.1 ADMINISTRATION

This contract will be administered by the following ASPR/DSNS personnel:

Contract Specialist Lawrence McCoy, Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: gwg8@cdc.gov| Office: 770-488-2087

Contracting Officer, Team Lead Annette Wright, Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: owf8@cdc.gov| Office: 404-273- 3127

Contracting Officer’s Representative (COR)/Technical Point of Contact (POC) Bruce Lee, Strategic National Stockpile (SNS) Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: bjl9@cdc.gov Office: 770-488-2517

G.2 HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 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) mailto:gwg8@cdc.gov%7C mailto:owf8@cdc.gov%7C mailto:Lsf7@cdc.gov

G.3 Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP)

a. All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP):

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 the applicable Prompt Payment clause included in the contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

c. 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.

o 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.

1) 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.

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

e. If the Contractor is unable to comply with the requirement to use IPP for submitting I 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.

G.4 Invoice Elements.

In accordance with FAR 32.905 Payment documentation and process, Contractor shall submit an electronic invoice to the email addresses designated in the contract to receive invoices. Payment will be based on receipt of a proper invoice and satisfactory contract performance.

(a) Content of invoices.

(1) A proper invoice must include the following items (except for interim payments on cost reimbursement contracts for services):

(i) Name and address of the contractor.

(ii) Invoice date and invoice number. (Contractors should date invoices as close as possible to the date of mailing or transmission.)

(iii) Contract number or other authorization for supplies delivered or services performed (including order number and line-item number).

(iv) Description, quantity, unit of measure, unit price, and extended price of supplies delivered, or services performed.

(v) Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms).

Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading.

https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

(vi) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment).

(vii) Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.

viii) Taxpayer Identification Number (TIN). The contractor must include its TIN on the invoice only if required by agency procedures. (See 4.9 TIN requirements.)

(ix) Electronic funds transfer (EFT) banking information.

(A) The contractor must include EFT banking information on the invoice only if required by agency procedures.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the contractor must have submitted correct EFT banking information in accordance with the applicable solicitation provision (e.g., 52.232-38, Submission of Electronic Funds Transfer Information with Offer), contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(x) Any other information or documentation required by the contract (e.g., evidence of shipment).

(2) An interim payment request under a cost-reimbursement contract for services constitutes a proper invoice for purposes of this subsection if it includes all of the information required by the contract.

(3) If the invoice does not comply with these requirements, the designated billing office must return it within 7 days after receipt (3 days on contracts for meat, meat food products, or fish; 5 days on contracts for perishable agricultural commodities, dairy products, edible fats or oils, and food products prepared from edible fats or oils), with the reasons why it is not a proper invoice. If such notice is not timely, then the designated billing office must adjust the due date for the purpose of determining an interest penalty, if any.

(b) Authorization to pay. All invoice payments, with the exception of interim payments on cost-reimbursement contracts for services, must be supported by a receiving report or other Government documentation authorizing payment (e.g., Government certified voucher). The agency receiving official should forward the receiving report or other Government documentation to the designated payment office by the 5th working day after Government acceptance or approval, unless other arrangements have been made. This period of time does not extend the due dates prescribed in this section. Acceptance should be completed as expeditiously as possible. The receiving report or other Government documentation authorizing payment must, as a minimum, include the following:

(1) Contract number or other authorization for supplies delivered or services performed.

(2) Description of supplies delivered, or services performed.

(3) Quantities of supplies received and accepted, or services performed, if applicable.

(4) Date supplies delivered, or services performed.

(5) Date that the designated Government official-

(i) Accepted the supplies or services; or

(ii) Approved the progress payment request, if the request is being made under the clause at 52.232-5, Payments Under Fixed-Price Construction Contracts, or the clause at 52.232-10, Payments Under Fixed-Price Architect-Engineer Contracts.

(6) Signature, printed name, title, mailing address, and telephone number of the designated Government official responsible for acceptance or approval functions.

(c) Billing office. The designated billing office must immediately annotate each invoice with the actual date it receives the invoice.

https://www.acquisition.gov/far/subpart-4.9#FAR_Subpart_4_9 https://www.acquisition.gov/far/52.232-38#FAR_52_232_38 https://www.acquisition.gov/far/52.232-33#FAR_52_232_33 https://www.acquisition.gov/far/52.232-34#FAR_52_232_34 https://www.acquisition.gov/far/52.232-5#FAR_52_232_5 https://www.acquisition.gov/far/52.232-10#FAR_52_232_10

(d) Payment office. The designated payment office will annotate each invoice and receiving report with the actual date it receives the invoice.

The Administration for Strategic Preparedness and Response (ASPR) additional requirements:

(i) The contractor shall submit monthly invoices under this contract unless otherwise agreed upon by all parties. For indefinite delivery and blanket purchase agreement vehicles, separate invoices must be submitted for each order.

(ii) Invoices must break-out price/cost by contract line-item number (CLIN) as specified in the pricing section of the contract.

SECTION H—SPECIAL CONTRACT REQUIREMENTS

H.1– CONTRACTING OFFICER

The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

H.2 – CONTRACTING OFFICER’S REPRESENTATIVE

Performance of work under this contract is subject to the technical direction of the COR identified in Section G.1, or a representative designated by the contracting officer in writing. The term “technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, and/or fills in details and otherwise serves to ensure that tasks outlined in the contract are accomplished satisfactorily. Technical direction must be within the scope of the contract specification(s)/work statement. The COR does not have authority to issue technical direction that:

i. Constitutes additional work outside the contract specification(s)/work statement;

ii. Constitutes a change as defined in the “Changes” clause of this contract;

iii. Causes an increase or decrease in the contract price, or the time required for contract performance;

iv. Interferes with the contractor’s right to perform under the terms and conditions of the contract; or

v. Directs, supervises or otherwise controls the actions of the contractor’s employees.

Technical direction may be oral or in writing. The COR must confirm oral direction in writing within five workdays, with a copy to the contracting officer. The contractor shall proceed promptly with performance resulting from the technical direction issued by the COR. If, in the opinion of the contractor, any direction of the COR or the designated representative falls within the limitations above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government workday. Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subjected the terms of the “Disputes” clause of this contract.

H.3 – CONTRACTOR PUBLICITY

The Contractor, or any entity or representative acting on behalf of the Contractor, may not refer to the equipment or services furnished pursuant to the provisions of this contract in any news release or commercial advertising, or in connection with any news release or commercial advertising, without first obtaining explicit written consent to do so from the Contracting Officer. Should any reference to such equipment or services appear in any news release or commercial advertising issued by or on behalf of the Contractor without the required consent, the Government will consider institution of all remedies available under the contract and applicable law.

H.4 – NON-DISCLOSURE AGREEMENT

All Contractor’s employees that will have access to non-public and procurement-sensitive information (photos, drawings, specifications, statements of work requirements, location data, etc.) or access to non-public ASPR facilities must sign a Non-Disclosure Agreement (NDA). The NDA will be made part of the contract file. The NDA requires contractor’s employees properly identify themselves as employees of a contractor when communicating or interacting with ASPR employees, employees of other governmental entities (when communication or interaction relates to the contractor’s work with ASPR/SNS), and members of the public. The Federal Acquisition Regulation (FAR) 37.114(c), states “All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

1) The Contractor shall inform employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

2) During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractors’ employees sign a NDA and it is submitted to the Contracting Officer prior to commencement of their work with ASPR/SNS.

3) Contractor employees in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meeting where sensitive information may be discussed.

4) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum: contract number, employee’s name, position, date of hire and NDA requirement.

SECTION I- CONTRACT CLAUSES

I.1 FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer shall make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.204-7 System for Award Management (Oct 2018) 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 (Aug 2020) 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance

Services or Equipment (Nov 2021) 52.209-7 Information Regarding Responsibility Matters (Oct 2018) 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services (DEC

2022) 52.212-4 Alt. I Contract Terms and Conditions-Commercial Products and Commercial Services (Nov

2021) 52.222-56 Certification Regarding Trafficking in Person Compliance Plan (Oct 2020) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023)

52.242-15 Stop-Work Order (Aug 1989) 52.246-16 Responsibility for Supplies (April 1984)

HHSAR

352.203-70 Anti-Lobbying (Dec 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.223-70 Safety and Health (Dec 2015) 352.227-70 Publications and Publicity (Dec 2015) 352.233-71 Litigation and Claims (Dec 2015) 352.237-74 Non-Discrimination in Service Delivery (Dec 2015) 352.239-74 Electronic and Information Technology (EIT) Acquisitions (Dec 2015) http://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Clauses Incorporated in Full Text

I.2 FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services. (JUN 2023)

(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 products and commercial services:

(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)(l)(A) of Pub. L. 115-232).

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

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) (31 U.S.C.

3903) and 10.U.S.C. 3801)

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 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 products and commercial services:

[Contracting Officer check as appropriate.]

_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I

(Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

X (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509)).

_ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020)

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

_ (5) [Reserved].

_ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (8) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117-328).

X (9) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) (31 U.S.C. 6101 note).

_ (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.2313).

_ (11) [Reserved].

_ (12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C. 657a).

_ (13) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct

2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

_ (14) [Reserved]

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

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

_ (16) (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.

_ (17) 52.219-8, Utilization of Small Business Concerns (Oct 2022) (15 U.S.C. 637(d)(2) and (3)).

_ (18) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) (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.

__ (19) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

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

_ (20) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637s).

__ (21) 52.219-16, Liquidated Damages-Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

(22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Oct 2022) (15

U.S.C 657 https://www.acquisition.gov/far/part-52#FAR_52_204_27

X (23) (i) 52.219-28, Post Award Small Business Program Representation (MAR 2023) (15 U.S.C.

632(a)(2)).

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

_ (24) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

_ (25) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business

Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) (15 U.S.C. 637(m)).

_ (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

_ (27) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15U.S.C. 637(a)(l 7)).

X (28) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

X (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (DEC 2022) (E.O.13126).

X (30) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (31) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

_ (ii) Alternate I (Feb 1999) of 52.222-26.

X (32) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

_ (ii) Alternate I (Jul 2014) of 52.222-35.

X (33) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

_ (ii) Alternate I (Jul 2014) of 52.222-36.

X (34) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

X (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)

(E.O. 13496).

X (36) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) (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).

_ (37) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

_(38) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)).