SPECIAL NOTICE
99 -- Notice of Intent to use Other than Full and Open Competition
- Notice Date
- 12/8/2016
- Notice Type
- Special Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), 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
- ZIP Code
- 20201
- Solicitation Number
- Intent-2017-1-AVAX
- Point of Contact
- Brooke Bernold, Phone: 2027202823, Christine Jihae Park, Phone: 2024015550
- E-Mail Address
-
brooke.bernold@hhs.gov, christine.park@hhs.gov
(brooke.bernold@hhs.gov, christine.park@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent to Use Other than Full and Open Competition Action Code : Intent 2017-1 AVAX 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 Emergent BioSolutions, Inc. for procurement of BioThrax, the only US licensed vaccine against anthrax. 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 December 23, 2016 at 5:00 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 Emergent BioSolutions, 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 anthrax 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 is able to deliver a US licensed anthrax vaccine to the Centers for Disease Control and Prevention Strategic National Stockpile (CDC/SNS). All capability statements, proposals, or quotes received prior to December 23, 2016 at 5:00 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 second quarter FY2017. The estimated period of performance is a 24-month base period from date of award for delivery of doses to the CDC/SNS. Delivery Schedule : The delivery schedule of the anthrax vaccine doses to the CDC/SNS will be established during contract negotiations. The first delivery of anthrax vaccine to the CDC/SNS is expected to occur in calendar year 2017 of the 24 month base period. Contract type : The Government proposes the award of a firm-fixed price contract for the purchase and delivery of anthrax vaccine. Estimated award amount : The total estimated dollar value for the 24-month base period contract is approximately $100M. Background : Bacillus anthracis causes severe, often fatal, infection following inhalation of spores. During the 2001 B. anthracis letter attacks, 45% (5/11) of the persons with inhalational anthrax died despite intensive treatment with antibiotics and aggressive supportive care. A terrorist attack will also have a long-term impact on the ability to re-populate an area that has been contaminated with anthrax spores. In fact, spores can persist in the environment for decades, and current decontamination procedures cannot even accurately define "safe" levels. Several medical interventions contribute to mitigating the high morbidity and mortality from inhalational anthrax, including vaccines, antibiotics, and antitoxins - all part of the HHS anthrax medical countermeasures (MCM) strategy. The only FDA-approved vaccine (BioThrax®) for anthrax is manufactured in the United States by Emergent BioSolutions. BioThrax is the only vaccine currently available that is actively procured and stockpiled within the CDC/SNS by the Government. It is licensed in the US for general use prophylaxis (GUP) in individuals who are at high risk of infection (e.g. military, lab workers); the current regimen calls for a three dose priming series (0, 1, 6 months) with boosters at 12 and 18 months after initial priming series, and annual boosters thereafter. More importantly, the vaccine was recently approved by the FDA for post-exposure prophylaxis (PEP). The protocol calls for a series of 3 immunizations (0, 2, 4 wks) co- administered with a 60-day supply of antibiotics. The use of anthrax vaccines, in conjunction with antibiotics, has the following advantages: potentially provides additional protection in a post-exposure setting, when used in combination with antibiotics, and provides longer-term protection than antibiotics alone; thus, enhancing safety for individuals entering into areas that have been contaminated with anthrax spores. The Government currently has a requirement for anthrax vaccine. Emergent BioSolutions has the only US licensed anthrax vaccine and capacity to meet the needs of the United States Government (USG) for replacement of expiring BioThrax doses in the SNS with licensed vaccine. 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 prior to procurement and FDA approval. In addition, this duplication of efforts would significantly delay the time to approval as well as readiness of the product for procurement and stockpiling.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/Intent-2017-1-AVAX/listing.html)
- Place of Performance
- Address: Emergent BioSolutions, 3500 N. Martin Luther King Jr. Blvd., Lansing, Michigan, 48906-9910, United States
- Zip Code: 48906-9910
- Zip Code: 48906-9910
- Record
- SN04346504-W 20161210/161208233952-81103eef20f243e35d97d02bc3655a8a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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