THIS IS A REQUEST FOR INFORMATION ONLY for market research and planning purposes only, as defined in FAR 15.201(e). This is not a solicitation or request for competitive proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this Notice. 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, and the Government will not reimburse respondents for preparation of the response. Response to this Notice is strictly voluntary and will not affect future ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement.

BACKGROUND:

The U.S. Army Medical Research Acquisition Activity (USAMRAA) is conducting market research to obtain information regarding services to manufacture a new lot of the Hantaan DNA Plasmid Bulk Drug Substance, according to current Good Manufacturing Practice (cGMP) regulations, to produce a new Drug Product (DP) for possible use under an Emergency Use Authorization (EUA).

The primary objective of this requirement is to manufacture a new lot of the Hantaan DNA Plasmid Bulk Drug Substance, according to current Good Manufacturing Practice (cGMP) regulations, to produce a new Drug Product (DP) for use under an Emergency Use Authorization (EUA).

SPECIFICATIONS:

The Contractor shall provide DNA Manufacturing Services necessary to complete all tasks listed below.

TASK #1: The contractor shall manufacture and formulate 20 grams of the Hantaan DP at a concentration of 2.0 mg/mL and release the DP in accordance with 21 CFR 210/211/610 for phase II current Good Manufacturing Practice (cGMP) regulations (Deliverables 6-7). Product release tests and specifications are provided in Appendix A.

TASK #2: The contractor shall aseptically fill the formulated Hantaan DP into a minimum of 7000 vials containing 1.4 mL of product (1.0 mL extractable volume using PharmaJet Stratis disposable syringes), label and release the final products according to cGMP regulations.

TASK #3: The contractor shall coordinate with the Contract Officer's Representative (COR) the shipment of final products using validated shippers and templates to the Government's storage facility, so that a Government representative is available for acceptance of products.

TASK #4: The contractor shall initiate a stability program at -20°C ± 10 °C for the new Hantaan final product, and conduct stability testing at FDA required time points beginning in the base year period and continuing through the life of the contract.

TASK #5-9: The contractor shall continue stability testing of the Hantaan final product at
-20°C ± 10 °C.

SUBMITTALS:

Interested parties shall respond by specifying if they have the capability to manufacture a new lot of the Hantaan DNA Plasmid Bulk Drug Substance, according to current Good Manufacturing Practice (cGMP) regulations, to produce a new Drug Product (DP) for possible use under an Emergency Use Authorization (EUA).

Summaries of the services as listed above shall be no more than Ten (10) pages in length, and shall describe service capabilities in each of these areas.

Interested Parties shall provide business size status based upon NAICS code 541380, Small Business Size Standard of $15 million, CAGE code as registered at SAM.gov. Interested Parties may include item brochure information with the summary package by the Government's requested date of submittal of June 24TH, 2019. Interested parties shall submit information in response to this RFI to: [email protected].

Responses shall be submitted and received via Email no later than 11:00AM EST Thursday, June 24TH, 2019. Documents shall be electronic in Microsoft Word, Excel, Power Point, and/or Adobe Portable Document Format (PDF) and provided as attachments to the Email. No telephonic responses to this RFI will be considered.

Questions concerning this RFI may be addressed by contacting: [email protected]. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers for contract and will not be used by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Vendors having the services that they believe would be suitable for military operations as described herein shall submit all supporting documentation requested by this RFI to the POC noted above.

Please provide information on your organization in the following areas;

1. Company Name, Address and Single Point of Contact with Name, Title, Telephone Number and E-mail Address.

2. DUNS Number and Cage Code

3. Confirmation of Current Active Registration in System for Award Management (SAM)

4. Primary NAICS Code(s) and Business Size (i.e., small/large)

5. GSA Schedule, If Available

6. Commercial Price List, if GSA schedule is Not Available

7. Product Specific Brochures Literature

PROVISIONS AND CLAUSES:

52.215-3 -- Request for Information or Solicitation for Planning Purposes.

Request for Information or Solicitation for Planning Purposes (Oct 1997)

(a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation.

(b) Although "proposal" and "offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal.

(c) This solicitation is issued for the purpose of Market Research and Planning Purposes Only.

(End of Provision)