25RMidazolam_Sources Sought Notice.docx

Sources Sought Notice for Midazolam Injection CIV, 10MG/0.7mL Autoinjector

NSN: 6505-31-019-0519

Item Identification: Midazolam Injection CIV, 10MG/0.7mL Autoinjector Medical Procurement Item Description: MPID #1 dated January 31, 2025 The Defense Logistics Agency Troop Support is seeking sources capable of providing the Midazolam Injection CIV, 10mg/0.7mL Autoinjector. The subject item is a consumable Midazolam autoinjector for treatment of seizures, including those caused by nerve agent. Midazolam treats traditional nerve agent and non-traditional nerve agent-induced seizures and prevents subsequent brain damage. The Midazolam autoinjector replaces the currently fielded Convulsant Antidote Nerve Agent (CANA), a diazepam autoinjector.

DISCLAIMER:

Data obtained from this Sources Sought Notice/Request For Information (RFI) will be used by DLA Troop Support in making recommendations and decisions on the development of an appropriate planning and procurement strategy for the subject item. All information submitted shall remain with the U.S. Government and will not be returned. It will be kept confidential as allowed by relevant Federal law and will be eligible for additional special protections under the conditions of the Protected Critical Infrastructure Information (PCII) Program outlined in the Critical Infrastructure Information Act of 2002.

This Sources Sought Notice/RFI does not commit the U.S. Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement.

GOVERNMENT REQUIREMENT:

DLA Troop Support is contemplating awarding an indefinite delivery, indefinite quantity type contract with a one-year base term and four one-year option terms.

Midazolam Injection CIV, 10MG/0.7mL Autoinjector shall meet the individual requirements for the drug solution as set forth in the NDA. The volume range of the solution shall be 10MG/0.7 per mL. The delivered volume shall be the total drug delivered during the injection process. Shall be suitable for intramuscular administration. The formula shall meet the minimum formula for Midazolam Injection as determined by the FDA and Related Biological Products Advisory Committee. The Midazolam autoinjector shall be licensed by the Food and Drug Administration (FDA).

Please see MPID #1 dated January 31, 2025 for requirements for the manufacture, packaging, marking, and labeling of the Midazolam Autoinjector. MPID #1 dated January 31, 2025 is attached to the Sources Sought Notice.

The quantities provided below are estimates and may change at the time of solicitation based on changes in customer demand and supply position.

Notes:

1. The Guaranteed Minimum Quantity for the base term and each option term is 135,000 each.

2. The Annual Estimated Quantity (AEQ) for the base term and each option term is 234,240 each. AEQ refers to the Government's good faith estimate of the requirements during a specified contract tier. The AEQ does not obligate the government to order a specific quantity, it is provided for informational purposes only.

3. The Maximum Quantity for the base term and each option term is 732,480 each (the contract maximum quantity is 3,662,440 each and accounts for fluctuations in customer demand). The Government is proposing a 30-day not-to-exceed quantity of 60,960 each.

4. Ordering period: One-year base term and four one-year option terms

5. Delivery Destination: DLA Distribution Susquehanna in New Cumberland, PA DoDAAC: SV3100 DLA Distribution Susquehanna U Avenue, Bldg. 89, Door 6 New Cumberland, PA 17070 Attn: Jim Earp 717-770-3128

6. FOB Destination

7. Inspection/Acceptance at Destination

8. Awardee shall have FDA approval to manufacturer/sell the Midazolam Injection CIV, 10MG/0.7mL Autoinjector prior to the solicitation closing date and time.

NEW PRODUCTS UNDER DEVELOPMENT

For products under development, describe the current stage of development and whether the product has undergone independent laboratory testing or FDA testing/trials etc. Firms and organizations that currently develop or manufacture the subject item or that have technologies, pharmaceuticals, or manufacturing capabilities under development are invited to submit information to Jessica De La Hoz at Jessica.DeLaHoz@dla.mil by May 28, 2025.

CURRENT MANUFACTURERS/AUTHORIZED DEALERS

If your firm currently manufactures or distributes the Midazolam Autoinjector, please complete the following market research survey and return it with your response to the Sources Sought Notice/RFI to Jessica De La Hoz at Jessica.DeLaHoz@dla.mil by May 28, 2025:

Company Identification and Contact Information Company Name:

Company Address:

Company Main Phone Number:

Company CAGE:

Point of Contact #1 Name:

Title/Position:

Phone:

Email:

Point of Contact #2 Name:

Title/Position:

Phone:

Email:

Company Description:

1. Business size (Large or Small)?

NOTES:

· NAICS Code is 325414 – Biological Product (except Diagnostic) Manufacturing

· Small business for NAICS listed above is defined as a firm that employs less than 1250 people

2. Manufacturing address / Place of Performance:

3. If you are not a manufacturer, are you an authorized dealer/distributor? (Y/N) __________

Product:

Please provide the product name and description including description of any special features you are proposing to supply in response to this Sources Sought Notice/RFI.

FDA Registration:

1. If you are a manufacturer, please submit a copy of your company’s FDA registration for manufacturing Midazolam Injection CIV, 10MG/0.7mL Autoinjector with your response to this Sources Sought Notice/RFI.

2. If you are an authorized dealer/distributor, please submit a letter of commitment from the manufacturer with your response to this Sources Sought Notice/RFI.

Commerciality:

1. Is the item commercial or modified commercial in accordance with Federal Acquisition Regulation (FAR) 2.101 (see below for FAR 2.101 definition)? (Y/N) __________

a. For example: is the item of a type used by the general public; sold or offered for sale to the general public?

b. Is the modification of a type available in the commercial marketplace?

Production:

1. What is the minimum quantity (number of doses) your company must manufacture per month to remain sustainable? ___________________________ per month

2. What is the optimal quantity (number of doses) your company would like to manufacture per month? ____________________________ per month

3. What is the maximum quantity (number of doses) your company can manufacture per month (assuming materials and components are available) without incurring additional costs / additional shifts?

____________________________ per month

4. What is the quantity (number of doses) per box? ________________

5. What is the quantity (number of doses) per pallet? ________________

6. What is the quantity (number of doses) per truckload/container? __________________

7. What is the smallest preferred ordering increment? (Ex: one master carton, which is 480 each) ________________________________________________________________

8. What is the lead time (in days) from the time an order is placed and delivered to the Government? _____________ days

9. Will the lead time be shorter for follow-on delivery orders? (Y/N) ____________

a. If yes, what is the lead time for follow-on delivery orders? ____________ days Storage Requirements:

Are there any special storage requirements?

Current Unit Sale Price:

1. What is the current unit sale price for the proposed Midazolam Autoinjector? $___________________

a. NOTE: if unit prices are different depending on global regions/countries/customers (Government vs. Civilian, please provide current pricing for the Government of the United States.

b. NOTE: if the item is listed in the National Acquisition Center Contract Catalog Search Tool, please provide the Big 4 Price.

Estimated (future) Prices:

For market research purposes, this is not a Request for Quote.

1. Are you able to provide unit prices for up to five years? (Y/N)

a. If the answer is yes, please provide estimated prices for the next five (5) years:

Unit Price

b. If the answer is no, please enter the unit price for as many years as is possible in the table under question 1.a. (above)

c. If the answer is no, what is the reason(s) for not being able to provide estimated prices for the next five years? (ex: price of xyz component is too volatile)

IMPORTANT NOTICE: AVAILABILITY OF SOLICITATIONS

Availability of solicitations, FAR 5.102(d) applies, as our office no longer issues solicitations or amendments in paper form. Offeror should register to receive notification of this solicitation or solicitation amendments. The solicitation will be posted on https://www.dibbs.bsm.dla.mil//.

POINT OF CONTACT INFORMATION

Jessica De La Hoz Contracting Officer Phone: 445-737-3623 Email: jessica.delahoz@dla.mil