Attachment 1-Statement of Work_COVID Needles and Syringes-Final-Amendment 1.docx

Amendment 1: This document has been modified. Changes shown below in red font text.

STATEMENT OF WORK

PROCUREMENT OF SAFETY NEEDLES AND SYRINGES FOR COVID-19

1.0 SCOPE: The Contractor, as an independent Contractor and not as an agent of the Government, shall furnish the necessary resources as specified in this Statement of Work (SOW), to manufacture and/or supply Safety Needles and Syringes.

2.0 BACKGROUND:

On Friday, March 13, 2020, the President declared a national emergency concerning the novel coronavirus disease (COVID-19) under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the “Stafford Act).

The mission of the Division of Strategic National Stockpile (DSNS), of the United States (U.S.) Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of nerve agents, biological pathogens, and chemical agents. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, DSNS ensures the right medicines and supplies get to those who need them most during an emergency. When the vaccine becomes available the Government will have an immediate need to begin vaccinating the entire U.S. population. To administer the vaccine the Government will require needles and syringes to be available.

There is an insufficient domestic supply of safety needles and syringes to meet the projected needs to vaccinate the nation’s entire population against COVID-19. Should vaccine programs be accelerated, demand could outpace available devices to administer a vaccine.

3.0 OBJECTIVE: The HHS currently has contracts in place with three (3) major manufacturers to provide needles and syringes supplies to support the initial preparedness needs at the onset of a pandemic outbreak. The objective of this acquisition is to supplement the current supply and establish contracts with additional manufacturers and suppliers to provide a quantity of up to 500 million safety needles and syringes supplies.

4.0 REQUIREMENTS:

4.1. General:

4.1.1. The Contractor shall “host” a Kick-Off Meeting within one (1) calendar day after contract award via teleconference. The Contractor shall provide Meeting Minutes containing a detailed overview of the meeting discussions in accordance with (IAW) Contract Data Requirements List (CDRL) A001.

4.1.1.1. The Contractor shall provide a Certificate of Analysis with each shipment per the DD Form 1423, Contract Data Requirements List (CDRL) A002, confirming the supplies described below meet the Performance Specifications in paragraph 4.2 below.

4.1.2. The Contractor shall provide copies of 510(k) Approval Letters for ALL supplies (dispensing syringes or needles) to demonstrate compliance with Section 510(k) of the Food, Drug and Cosmetic Act as part of their proposal. The Contractor shall provide, if necessary, 510(k) Approval Letters Updates if any information from the initial 510(k) Approval Letters is changed/needs to be updated.

4.1.2.1.1. The Contractor shall ensure all supplies have a “Shelf-Life” with expiration dates of no less than five (5) years from the date of sterilization, and must have at least four (4) years of remaining expiry from the time of shipment.

4.1.2.1.2. The Contractor shall only use Current Good Manufacturing Practice (cGMP) processes to manufacture the needles and syringes.

4.1.2.1.3. Period of Performance/Delivery Dates. Due to the current COVID-19 response ongoing at the time of solicitation and the unknowns during a pandemic and vaccine development, the Government desires the total quantity awarded to be delivered by December 31, 2020, unless the Contractor is unable to provide the full quantity. However, the Government may make awards through one (1) year after award if needed to meet the total quantity requirement. Proposed delivery schedules shall be finalized at time of contract award in effort to reach 500 Million needles and syringes through potential multiple companies.

4.2. Technical Requirements:

4.2.1. The Contractor shall provide sterile needle (with Luer hub connection) and syringe (with Luer lock connection) units approved by the Food and Drug Administration (FDA) and comply with Occupational Safety and Health Administration (OSHA) Needlestick Safety and Prevention Act requirements as a “safety-engineered product.” Safety-engineered supplies include needles preventing sharp injuries by either; being completely enclosed after use by an attached shield, or be fully retracted within the syringe. The Contractor may provide individual syringes and individual needles as long as there is a one-to-one (1:1) ratio. In order to meet the specified quantities upon contract award and comply with the specifications in this SOW, the following may be provided: (1) individually wrapped sterile syringes with individually wrapped sterile needles in a one-to-one (1:1) ratio, (2) sterile needle/syringe combination unit, or (3) a mixture of sterile combination units and individually wrapped sterile syringes with equal number of individually wrapped sterile needles.

4.2.2. The Contractor shall only provide acceptable product sizes as described below:

Individual Syringe:

Syringe

1mL

3mL

Individual Needle:

Combination Unit:

4.2.3. Dispensing Syringe: Description: A dispensing syringe allows for the controlled and precise flow of liquid. The dispensing syringe is used to inject medications or other liquids into body tissues. Manual syringes consist of a barrel, stopper, and plunger.

4.2.3.1. The Contractor shall ensure dispensing syringes comply with Title 21 Code of Federal Regulations (CFR) 880.5860 and follow International Standards Organization (ISO) 7886-1:2017 and the following material specifications:

4.2.3.1.1. A device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle;

4.2.3.1.2. Heavy duty barrel - The barrel has a scale showing the capacity of the syringe.

4.2.3.1.3. Stopper - The stopper maintains the fluid in the barrel between the syringe nozzle and the plunger;

4.2.3.1.4. Plunger - The plunger is used to aspirate and inject fluids into and out of the syringe;

4.2.3.1.5. Disposable;

4.2.3.1.6. Luer lock to accept luer hub applicator (e.g. needle);

4.2.3.1.7. Sizes as specified in Section 4.2.2 above; and

4.2.3.1.8. Sterile individually wrapped packaging.

4.2.4. Hypodermic Needle: Description: A Hypodermic needle is a slender, hollow instrument for introducing material into the body parenterally.

4.2.4.1. The Contractor shall ensure hypodermic needles comply with 21 CFR 880.5570, OSHA Needlestick Safety and Prevention Act, and follow International Standards Organization (ISO) 7864, and the following specifications:

4.2.4.1.1. Disposable;

4.2.4.1.2. Luer hub to attach to luer lock syringe;

4.2.4.1.3. See Tables in Sections 4.2.2 above for acceptable needle length and gauges;

4.2.4.1.4. Sterile individually wrapped packaging; and

4.2.4.1.5. Safety-engineered.

4.3. Delivery Location and Shipping Requirements: The shipping destinations [approximately seven (7)] are considered Sensitive; therefore, the Government will provide the address(es) and delivery Points of Contact (POC) at the Kick-Off Meeting.

4.3.1. The Contractor shall provide Packing Slips with all shipments per CDRL A003. The Packing Slips shall include the following: (1) Contract number, (2) Storage Instructions for the product, (3) Item description, (4) Part number, (5) Lot numbers; and (6) Quantities. The Packing Slips shall include BOTH: (1) a Packing Slip Paper Copy with the shipment; and (2) a Packing Slip Paper Emailed Copy to the Designated Government Representative.

4.3.2. No Partial Case or Packages quantities will be accepted unless approved by the Contracting Officer prior to shipping.

4.3.3. The Contractor shall NOT Mixed Lot #'s per Case or per Packages. The Contractor shall only provide full case quantities only, unless approved by the Designated Government Representative in advance via email.

4.3.4. The Contractor shall ensure all pallets have the identical TyHi stack pattern, except for the final pallet; which would be a partial pallet or individual boxes.

4.3.5. All supplies shall be delivered on a standard 48" by 40" pallet, not to exceed 60” in height, stretch wrapped, clear-wrapped is preferred, and secured to the pallet for safe transport.

4.3.6. The Contractor shall contact the Designated Government Representative to schedule delivery appointments. The Government will provide the Designated Government Representative(s)’ information at the Kick-Off Meeting.

4.3.7. Contractor shall contact the Designated Government Representative to schedule delivery appointments.