Notice of Intent to use Other than Full and Open Competition
Notice of Intent to Use Other than Full and Open Competition
Action Code: Intent 2017-2 SPX
Agency: Department of Health and Human Services
Office: Office of the Secretary
Location: Acquisitions Management, Contracts, & Grants (AMCG) Contracting Office
Address: Office of the Assistant Secretary for Preparedness & Response (ASPR) Department of Health and Human Services 330 Independence Ave. SW G640 Washington, District of Columbia 20024 United States.
The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and Acquisition Contracts Management and Grants (AMCG) intend to use other than full and open competition to award a sole source contract to Bavarian Nordic, A/S. for procurement of lyophilized IMVAMUNE®, a lyophilized smallpox vaccine. This notice of intent to award a sole source contract will be posted for 15 calendar days to verify that no other sources can meet this requirement given only one responsible source and no other supplies or services will satisfy the Government requirements. The Government seeks to avoid substantial duplication of cost that is not expected to be recovered through competition. This 15 calendar day notice shall expire on June 30th, 2017at 4:00 PM Eastern Standard Time. If no credible responses to the intent to sole source are received by the Government, a request for proposal will be forwarded to Bavarian Noridic, Inc. Following, the Government will amend the intent to sole source by posting the redacted Justification and Approval (J&A) for 30 days. The proposed contract action will support services for which the Government intends to solicit and negotiate with only one source under the authority of the Federal Acquisition Regulation (FAR) 6.302-1.
This notice of intent is not a request for competitive proposals. Interested individuals may identify their interest and capability to respond to the requirement by submitting in writing their name, address, telephone number, email, and a statement regarding capability to provide the specified lyophilized smallpox vaccine. Responses shall be limited to three (3) pages or less, including all attachments. Interested parties will be considered only if they respond to this notice with clear and convincing evidence that competition would be advantageous to the Government, would not be cost or time prohibitive, and that they can provide a lyophilized smallpox vaccine that has completed Phase 2 with data supporting use of the vaccine in immunocompromised populations. All capability statements, proposals, or quotes received prior to June 30, 2017 at 4:00 PM Eastern Standard Time will be considered by the Government. The Government will not be responsible for any costs incurred by responding to this notice. The Government will notify parties of the outcome of any capability statement, proposals, or quotes submitted in response. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
Anticipated Award Date and Period of Performance:
The Government anticipates an award date of in FY2017. The estimated period of performance is a 60-month base period from date of award.
Delivery Schedule:
The delivery schedule of the lyophilized smallpox vaccine will be established during contract negotiations.
Contract type:
The Government proposes the award of a mixed contract consisting of both firm-fixed price and cost-reimbursable CLINs for the procurement of smallpox vaccine.
Estimated award amount:
The total estimated dollar value for the 60-month base period contract is approximately $100M.
Background:
Smallpox is arguably the greatest threat to public health since the causative agent, variola virus, is spread person to person, the disease has a high mortality rate, and the virus can readily be prepared in large quantities. Fortunately, vaccination with a related, live, replicating, attenuated Orthopoxvirus (vaccinia virus) led to the global eradication of this disease in 1979. Routine vaccination was halted shortly thereafter because the risks associated with vaccination outweighed the threat of the disease. Given that a large majority of the population has not been vaccinated and remains vulnerable to a smallpox outbreak, BARDA has invested in the development and procurement of medical countermeasures to ameliorate the impact of a potential smallpox emergency. These products include vaccines to prevent disease and antivirals designed to treat patients after the onset of symptoms.
The only licensed smallpox vaccine, ACAM2000TM, is a live virus vaccine that is presently employed to vaccinate U.S. military, lab workers, and first response personnel. ACAM2000TM has been in use for many years and has been shown to be highly effective in preventing smallpox infection; however there is a black box warning on this product as its use has been associated with significantly higher rates of local and/or systemic reactions among individuals receiving vaccine, especially those who are immunocompromised.
To achieve the stated Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) smallpox preparedness requirement to address medical countermeasure gaps for all sectors of the American civilian population, BARDA has procured a third generation MVA based smallpox vaccine (trade-name IMVAMUNE®). IMVAMUNE® does not replicate in mammalian cells and has been safely tested in over 7,500 people, including individuals infected with Human Immunodeficiency Virus (HIV), those diagnosed with skin disorders such as atopic dermatitis (AD), and the elderly.
The current formulation of IMVAMUNE® stored in the Centers for Disease Control and Prevention Strategic National Stockpile (CDC/SNS) is a liquid frozen vaccine with a limited shelf-life. The US Government currently has a requirement for a lyophilized formulation of IMVAMUNE® with a longer shelf-life, as a more sustainable option for maintaining preparedness of the IMVAMUNE® stockpile. The US Government has been supporting the development of the lyophilized formulation of IMVAMUNE® through advanced research and development contracts. The lyophilized vaccine has completed Phase 2 stage of development. The Government considers that an award to any other Offeror would be a duplication of effort and require funding to complete animal model studies and clinical trials to assess safety and efficacy of the product. In addition, this duplication of efforts would significantly delay the time to approval as well as readiness of the product for procurement and stockpiling.
Contracting Office Address:
Office of the Assistant Secretary for Preparedness & Response (ASPR)
Department of Health and Human Services
330 Independence Ave. SW
G640
Washington, District of Columbia 20201
United States
Matthew A. Rose, Contracting Officer, Phone 2022052901, Email Matthew.Rose@hhs.gov - Brooke Bernold , Contracting Officer , Phone 2022600690, Email brooke.bernold@hhs.gov
