Pralidoxime_Buy_SOW.pdf

Pralidoxime (Protopam), 1GM Powder Vial for Injection

Purpose

Division of Strategic National Stockpile (DSNS) has a requirement and a need to purchase

Pralidoxime (Protopam) 1GM Powder Vial for Injection. The Pralidoxime Product will be used during emergency and national emergency situations.

Background

The mission of the Division of Strategic National Stockpile (DSNS) is to deliver critical medical assets to the site of a national emergency. DSNS achieves this mission by operating and maintaining ASPR Strategic National Stockpile (SNS).

The DSNS provides technical assistance through guidance and training to state and local public health departments on how to receive, distribute, and dispense medical supplies. When SNS assets are combined with federal, state, and local technical expertise to manage and distribute assets efficiently, DSNS ensures that key medical supplies are available during emergencies.

Requirements

The contractor must be able to provide all item (s) listed below:

NATIONAL

DRUG CODE

DESCRIPTION UOM ESTIMATED

QUANTITY

NDC

60977-0141-01

Pralidoxime

(Protopam), 1GM

Powder Vial for

Injection

PKG

23,000

Shipping Requirements:

At time of delivery to the Government, the Contractor is required to provide no less than

36 months of shelf life dating

Full case quantities only

No partial case or package quantities will be accepted

No mixed lot #'s per Case or per Packages will be accepted

One lot number per pallet. The last pallet will be able to contain multiple lot numbers per

PO; Lots must be clearly identified

Item description, NDC/Part number, lot numbers and quantities shall be included on the packing list

All pallets are to have the identical TyHi stack pattern except for the last pallet

All product to be delivered on standard 48" by 40" heat treated pallets, not to exceed 60” in height, (clear) stretch wrapped and secured to pallet for safe transport

Contractor shall contact designated COR to schedule delivery appointments

Contractor shall maintain communication with the COR and Contracting Officer on any shipping changes or updates

Contractor will provide an estimated Shipping Schedule upon receipt of award to the

Contracting Officer.

PLACE STORAGE REQUIREMENTS ON ALL PACKING LISTS****

Delivery Schedule:

Distribution Plan will be provided to contractor after contract award.

Ship 23,000 PKG to GA:

Life Science Logistics

4475 South Fulton Parkway, Bldg 5, North Suite C

Atlanta GA 30349

POC: Geawyna Epps

TELE: 404-304-1756

Pricing Requirements:

The Contractor’s proposed unit price shall include all costs associated with labor, material, transportation, and all other costs required to provide the product in the quantities and timeframes specified by the Government.

Packing and Marking Requirements:

All pallets are to have the identical TyHi stack pattern except for the final pallet

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

All shipments will include packing slips and contract number

Special Requirements:

The products produced and stored under this contract must be FDA approved and shall be manufactured in accordance with the conditions approved by the Food and Drug Administration under appropriate patents for the medication. The current Good Manufacturing Practice regulations (cGMP's) (21CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packing of drugs.

Government Furnished Information/Material: N/A

Period of Performance

Project Estimated Completion Date: Date of award through 12 months

Project Officer: Dale Clark