FDA Approved Pharmaceuticals_DuoDote - ASPR/SNS

SMALL BUSIENSS SOURCES SOUGHT NOTICE

Deparement of Health and Human Sercices (HHS), Administration for Strategic Preparedness and Response (ASPR), Division of Strategic National Stockpile (SNS)

1.0       INTRODUCTION

The Government is seeking qualified small business concerns and seeks to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUB Zone, service-disabled, veteran-owned, 8(a), woman-owned small businesses, or small disadvantaged businesses; and (3) size classification relative to the North American Industry Classification System (NAICS) code 325412 Pharmaceutical Preparation Manufacturing.  Your response to the information requested will assist the Government in determining the appropriate acquisition strategy, including whether a small business set-aside is a possibility.

This Small Business Sources Sought Notice (SBSSN) is not a Request for Proposal (RFP) and does not constitute a commitment by the United States Government (USG). The USG is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10, to identify potential small business sources to fulfill the requirement and gather information on current capabilities within the market. All information submitted in response to notice is voluntary and the USG will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the USG. Proprietary information submitted should be marked appropriately.

2.0       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-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters, or other emerging infectious disease agents. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, SNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event.

The Strategic National Stockpile (SNS) is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation.

These 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. Pharmaceuticals and Medical Supplies are strategically stored in a network of warehouses across the country for rapid deployment to protect the U.S. population against 21st century health security threats, such as anthrax, botulism, smallpox, plague, tularemia and viral hemorrhagic fevers, as well as emerging infectious diseases, pandemic influenza, natural disasters, and other chemical, biological, radiological, and nuclear incidents.

The SNS intends to use responses to this Small Business Sources Sought Notice (SBSSN) for planning purposes towards the procurement of a variety of FDA approved pharmaceuticals to maintain minimum stockpiling capabilities for responding to public health events.

3.0       REQUIREMENT

The SNS has a need to procure DuoDote Single Dose Autoinjector due to unexpected FDA testing failures of Antidote Nerve Agent Autoinjector (ATNAA) which has caused and inventory shortage and denial to State and local agencies that depend on SNS medical countermeasures used for medical and national emergencies. 

This acquisition is essential to keep the agency in a readiness state to be able to respond to national emergencies.

The contractor, as an independent organization and not as an agent of the Government, shall procure and furnish all labor, materials, supplies, facilities, equipment, transportation and travel necessary to deliver the acceptable pharmaceuticals.

The contractor shall provide brand name or equal product for the pharmaceuticals listed in table in the attachment listed below.  

Attached:  Sources Sought Notice_SNS Pharm DuoDote 

3.1         Special Requirements:

1. Shelf-life Requirements: At time of delivery, product shall have no less than 80% of total FDA approved shelf-life remaining.
2. 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 pharmaceuticals.  
3. The Contractor shall be an authorized manufacturer, distributor, or reseller with a current FDA license for such. If proposing on a controlled substance pharmaceutical, the contractor shall also have the appropriate DEA licenses to procure, store, and distribute such drugs.

3.2       Packaging and Shipping Requirements

1. All contracts for delivery to a DSNS location shall have the following shipping requirements:
2. No partial case or package quantities will be accepted.
3. No mixed lot numbers per case or per packages will be accepted.
4. No mixed sizes (e.g., smalls, mediums, or larges mixed in on one pallet) will be accepted.
5. No mixed product per pallet will be accepted.
6. One lot number will be used per pallet. The final delivery may contain one pallet with multiple lot numbers. Lots must be clearly identified.
7. Duplicate lots should only have one expiration date (i.e., the same two lot numbers should not have different expiry dates).
8. All shipments will include packing slips which should list the contract number, item description, NDC or part number, lot numbers, quantities, and storage requirements.
9. Contractor shall contact designated 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 – 3:00 PM).
10. For products with an issued NSN, product cases shall have applicable NSN annotated on case and inner packages' labels. NDC numbers (National Drug Code numbers must also be annotated on case and inner package labels.  NDCs must use the 5+4+2 standard digit methodology (xxxxx-yyyy-zz). Leading zeros may be utilized on the 5-digit section and/or the 4-digit section and/or the 2-digit section within the NDC methodology.
11. All pallets are to have the identical TI-HI stack pattern except for the final pallet.
12. 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.

    3.3   Contract Period of Performance

The anticipated start of the Contract Period of Performance: 9/30/2023 - 10/29/2024.

This is an emergency procurement and product will be needed upon receipt of contract.

   3.4      Delivery & Transportation

1. Delivery location and schedule will be provided by the Contracting Officer’s Representative after award. Note: Contractor should inform delivery personnel they will have to submit identification and have vehicle inspected before entry into facility.
2. The offeror shall have and maintain all capabilities required to safely pack, ship, and deliver the product throughout the performance of this requirement.
3. Labels used on pharmaceuticals should indicate the name or identifying code, batch number, and storage conditions when such information is critical to ensure the quality of Pharmaceuticals.

4.0       INFORMATION SOUGHT

Interested respondents must respond to all of the following questions:

1. What is your core business?
2. Are you considered to be a manufacturer or a distributor of medica\pharmaceutical products?
3. Is your company currently registered in System for Award Management (SAM)?
4. Does your company currently have any contract(s) with other commercial or government activities that require storage and distribution of material?
5. Is your company capable or interested in providing an offer with the requirements listed above?
6. Describe any risk or obstacle you foresee with this emergency requirement and how you would mitigate those risk?
7. Does your company maintain a published commercial price catalog for your pharmaceutical prices?
8. What is your company’s normal shipping time after receipt of an order for material?
9. What are your capabilities for shipping material OCONUS (Outside Contiguous United States) if the USG requested you to arrange a direct shipment?
10. Shipping term for this requirement is free on board (f.o.b.) origin, inspection and acceptance of the material accomplished at source by the FDA.  Would your company be able to comply with these transportation and inspection terms?
11. Is your company authorized to distribute pharmaceutical items, drugs, and biologicals?
12. Describe your company’s procedures for managing and recording the product’s shelf-life.

*Please note that potential offerors are expected to be an independent organization capable to provide brand name or equal product for the pharmaceuticals in all areas mentioned above.

5.0       RESPONSE INFORMATION

Respondents to this SBSSN may identify their interest by submitting a capability statement, including primary contact information at the organization (name, email, address, and telephone number) handling this SBSSN, in the event HHS has additional questions or requires clarification of the submitted information.

Responses are limited to 15 pages including appendices and attachments. All respondents and comments to this SBSSN shall reference 23-ASPR-SNS_DuoDote.

5.1       Response Due Date

Respondents shall provide capability statements and all information and data in Microsoft Office ®, or Adobe® Acrobat® format, no later than:

 2:00 PM EST on Friday, September 1, 2023

Capability packages shall be submitted electronically with Subject Line, Sources Sought Notice 23-ASPR-SNS_DuoDote to the following:

Dsnssolicitations@cdc.gov and Sherica Teshome, Contracting Officer, Sherica.Teshome@hhs.gov.

6.0       OTHER INFORMATION

ASPR/SNS will not award any contracts under this notice, but rather seeking availabilities, capabilities, and other pertinent marketplace data to strengthen SNS’s understanding of the current and future marketplace, enhance its ability to obtain pharmaceuticals economically, efficiently, and lawfully to establish potential vendor source files and listings.

ASPR/SNS encourages respondents to submit currently available marketing or existing information to the maximum extent consistent with this notice’s requirements and limitations.

Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. ASPR/SNS will presume that any unmarked information, data, and materials were furnished with an “unlimited rights” license, as FAR subpart 27.4 defines that term, and ASPR/SNS assumes no liability for the disclosure, use, or reproduction of the information, data, and materials.

DISCLAIMER AND IMPORTANT NOTES

This notice does not obligate the USG to award a contract or otherwise pay for information provided in response.  The USG reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. 

Any provided organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform.  Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

Capability statements will NOT be accepted after the due date mentioned above.  The Government will not return capability statements received.  Submit all communications to dsnssolicitations@cdc.gov.  No phone calls will be accepted.

ATTACHMENT:  Sources Sought Notice_SNS Pharm DuoDote