Oct 10, 2019 12:46 pm REQUEST FOR INFORMATION
BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY/INFLUENZA AND EMERGING INFECTIOUS DISEASES DIVISION (BARDA/IEIDD)
DATE: October 10, 2019
TITLE: DRUG PRODUCT MANUFACTURING DURING A PANDEMIC - METHODS OF REPLACING STOCKPILED ANTIVIRALS IN A SHORT TIMELINE
RFI No: RFI-20-10022019 Oseltamivir Replacement -0001
1.1 The Influenza and Emerging Infectious Diseases Division (IEIDD), in support of the Biomedical Advanced Research and Development Authority (BARDA), is seeking information regarding methods of drug product manufacturing that could allow replenishment of the antiviral stockpile in one year. The intent is to ensure antivirals will be available for a possible second wave of an influenza pandemic.
1.2 THIS IS A REQUEST FOR INFORMATION (RFI) ONLY
IEIDD is issuing this RFI solely for information and planning purposes - it does NOT constitute a Request for Proposal (RFP), a promise to issue a RFP, or a commitment to issue any type of solicitation in the future. This RFI does not commit the United States Government (USG) to contract any supply or service whatsoever. At this time, IEIDD is not seeking development proposals and will not accept or review unsolicited proposals received.
The USG will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the interested party's expense. Submission is voluntary and is not required to propose to a subsequent solicitation on this topic (if any).
If IEIDD chooses to release a solicitation in the future, it will be summarized on the Federal Business Opportunities (FedBizOpps) website and the Office of the Assistant Secretary for Preparedness & Response (ASPR) website at https://www.medicalcountermeasures.gov/.
It is the responsibility of the potential responder to monitor these sites for additional information pertaining to any potential requirement.
Within the USG, the Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR), the Biomedical Advanced Research and Development Authority (BARDA) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, and natural exposure(s) to pandemic influenza and emerging infectious diseases.
Prevention and treatment of disease caused by seasonal and novel influenza strains of pandemic potential continue to be a public health challenge. To prepare for a potential influenza pandemic, ASPR maintains the Strategic National Stockpile (SNS) to provide antivirals and other medical countermeasures during an influenza pandemic. The antiviral stockpile has enough antivirals for a severe pandemic. In the event of a second wave of an influenza pandemic, the depleted stockpile inventory will need replacement. The USG is seeking to gather information from manufacturers on alternative drug product images/formulations with the goal of supplying up to 50 million treatment courses of antivirals to the SNS within one year. Creative drug product presentations are encouraged. For the purpose of this request, assume that the USG will provide enough active pharmaceutical ingredient (oseltamivir) to replenish all 50 million treatment courses. Dosing schemes to be considered include 75mg, 30mg and pediatric weight-based formulations at twice per day for 5 days. The drug product must be easily stored, distributed and administered.
The goal is to have the manufacturing technical readiness, plant capacity and capability readily available for oseltamivir drug product production in the event of a pandemic. In addition, should the emergency capability be used, there should be no or minimal impact on other products produced at the facilities destined for the US market.
3.0 Requested Information
In the event of a pandemic, the USG may want to rapidly replace 50 million treatment courses of antivirals in the Strategic National Stockpile. The USG will provide active pharmaceutical ingredient oseltamivir. The USG is seeking information and recommendations from developers/manufacturers on how best to collaborate with the USG to address the points identified below:
1. A proposal and innovative solution for the drug product image and justification for the solution
2. Major assumptions used for the innovative solution
3. The high level drug product research and development plan, including analytical development
4. Timeline for completion of development and the state of readiness
5. Raw material procurement lead time, assume only US-sourced material or material that is foreign sourced must stockpiled and maintained in the US
6. A United States only manufacturing plan using US based manufacturing sites
a. Fill/Finish should include package and labeling for the finished goods and US sourced material
7. An estimate of potential capital expenditures, solutions that require a new facility are not sought in this request
8. Readiness timing from USG notification of the need for antiviral production to complete readiness to manufacturing start
9. Discuss potential impacts to other products manufactured using the same bulk drug product and fill/finish facilities should the capabilities need to be used
10. A high level cost estimate including research and development, engineering, potential capital expenditures and manufacturing campaign. Details should be limited in scope.
11. Warm base readiness requirements - once tech transfer is complete, what would be needed to sustain the capability through the years when there is no need for manufacturing and the cost associated with the warm base capability
12. A brief company overview (expertise and experience with approved products, cGMPs, etc.) and previous experience with manufacture of oseltamivir or similar drugs
4.1 Interested parties are requested to respond to this RFI with a white paper.
4.2 White papers shall adhere to the following:
• 8.5 by 11 inch paper in a format compatible with either the Microsoft Office software package or Adobe Acrobat; and
• Response shall be limited to 15 pages for Section 2 and submitted via email only to the individual(s) identified in Section 6.0 below
Proprietary information, in any form, should be minimized and MUST BE CLEARLY MARKED. To aid the USG, please segregate proprietary information. Please be advised that all submissions become USG property and will not be returned.
Information marked as "Proprietary" obtained in response to this RFI will be protected from unauthorized disclosure in accordance with FAR Subpart 15.207, applicable law and HHS regulations.
4.3 Section 1 of the white paper shall provide administrative information, and shall include the following at a minimum:
4.3.1 Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number and e-mail of designated point of contact.
4.3.2 Recommended contracting strategy
4.3.3 Business type (large business, small business, small disadvantaged business, 8(a)-certified small disadvantaged business, HUBZone small business, woman-owned small business, very small business, veteran-owned small business, service-disabled veteran-owned small business.)
The North American Industry Classification System (NAICS) Code(s) are as follows:
325412 - Pharmaceutical Preparation Manufacturing; and
325414 - Biological Product (except Diagnostic Manufacturing.)
4.3.5 The facility security clearance of the responder (if applicable.)
The number of pages in Section 1 of the white paper shall not be included in the 15-page limitation, i.e., the 15-page limitation applies only to Section 2 of the white paper.
4.4 Section 2 of the white paper shall answer the issues addressed in Section 3.0 of this RFI and shall be limited to 15 pages.
5.0 Industry Discussions
BARDA representatives may or may not choose to meet with potential responders. Such discussions would only be intended to get further clarification or possible capability to meet the potential USG need.
Electronic responses to this RFI are due no later than:
12:00 PM EDT on December 19, 2019
Your white paper shall be submitted to the following individual.
Wendell Conyers, Supervisory Contracting Officer
Division of Contracts Management and Acquisition (DCMA)
Biomedical Advanced Research and Development Authority (BARDA)
Please include RFI No RFI-20-10022019 Oseltamivir Replacement -0001 in the subject line of all correspondence.
All technical and administrative correspondence and questions regarding this announcement shall also be submitted to the above email address.
BARDA intends to use electronic mail for all correspondence regarding this RFI.
THIS IS A REQUEST FOR INFORMATION (RFI) ONLY to identify sources that can provide feedback on DRUG PRODUCT MANUFACTURING DURING A PANDEMIC. The information provided in the RFI is subject to change and is not binding on the USG.
BARDA has not made a commitment to procure any items or services, and release of this RFI should not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submission become USG property and will not be returned.
This RFI is in accordance with FAR 52.215-3 Request for information or Solicitation for Planning Purposes (Oct 1997), as such, any information received will be for the purpose of planning only.
Allow Vendors to Add/Remove From Interested Vendors:
Allow Vendors to View Interested Vendors List: