SOLICITATION NOTICE
Y -- Centers for Innovation in Advanced Development and Manufacturing
- Notice Date
- 3/2/2011
- Notice Type
- Presolicitation
- NAICS
- 236210
— Industrial Building Construction
- 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
- 11-100-SOL-00011
- Point of Contact
- Kyle Roberts, Phone: 202-260-0747, Linda I Luczak, Phone: 202-260-0271
- E-Mail Address
-
kyle.roberts@hhs.gov, linda.luczak@hhs.gov
(kyle.roberts@hhs.gov, linda.luczak@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- TITLE: Centers for Innovation in Advanced Development and Manufacturing SOLICITATION NO: 11-100-SOL-00011 NAICS Code: 236210 Description: THIS IS A FORMAL SYNOPSIS OF A PROPOSED CONTRACT ACTION NOTICE IN ACCORDANCE WITH FAR 5.2. THIS COMPETITIVE ACTION IS BEING PROCURED UNDER FULL AND OPEN COMPETITION. The Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) and the Office of Acquisitions Management, Contracts & Grants (AMCG) seek to establish U.S.-based Centers for Innovation in Advanced Development and Manufacturing (the ‘Centers') as public-private partnerships that share facility construction costs, facilitate development and manufacture of medical countermeasure (MCM) product candidates, ensure domestic vaccine and other biopharmaceutical manufacturing surge capacity in an emergency, and provide workforce development training programs. These U.S.-based Centers are expected primarily to provide, on a routine basis, core services that include advanced development and manufacturing capabilities of USG-supported developers of medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) MCMs to address national preparedness and response priorities and needs. Additionally, HHS/BARDA requires Contractor(s) to provide new or renovated domestic facilities that utilize state-of-the art flexible and innovative manufacturing processes and platform technologies to produce CBRN biopharmaceutical MCMs under routine conditions or vaccines or other biopharmaceuticals in an emergency for outbreaks of emerging infectious pathogens including pandemic influenza or other threats. Further, HHS/BARDA requires Contractor(s) to provide a workforce development training program to enhance and maintain the nation's ability to produce these MCMs. The work performed at these Centers will be coordinated and integrated by HHS/BARDA with programs from other USG agencies to provide long-term solutions that address the medical consequences of currently known or unknown threats. The Contractor and/or subcontractors or other affiliates must be experienced in vaccine and biopharmaceutical advanced development, manufacturing, quality systems, and regulatory affairs for FDA-approved products, in addition to maintaining a facility with adequate manufacturing surge capacity in a state of readiness for an extended period of time under the contract. The solicitation will include a Statement of Objectives, not a Statement of Work. The Offerors however will be required to submit a detailed Statement of Work to address these Objectives as part of their submission. There are five (5) Minimum Mandatory Eligibility Criteria for this solicitation. [1] FDA Licensure of a Biopharmaceutical Product within the Last Ten (10) Years: The Offeror or it's subcontractor thereof shall have proficiency in biopharmaceutical product licensure and/or the manufacture of licensed biopharmaceuticals (i.e. vaccines, monoclonal antibodies, well-characterized biological products). This shall be demonstrated by the Offeror or a subcontract thereof having successfully sponsored a Biologics License Agreement (BLA) or New Drug Application (NDA) leading to production of a licensed biopharmaceutical product in the United States in the past ten (10) years. [2] U.S. Biopharmaceutical Manufacturing: The Offeror shall provide in the proposal written evidence of a firm commitment that the Offeror shall establish and maintain the necessary facilities in the U.S. or its territories for core advanced development and multi-purpose manufacturing services throughout the amortized lifetime of the facility(s). [3] Cost Sharing: The Offeror shall be required to propose cost sharing for this requirement. At a minimum, the Offeror shall commit to fund fifty-one percent (51%) of the total cost of the project for the new construction of biopharmaceutical facility(s), or twenty-five percent (25%) of the total cost for the retrofit of existing pharmaceutical facility(s). [4] Surge Manufacturing Capacity of Vaccines for Pandemic Influenza & Other Threats: Efforts funded as a result of this solicitation shall lead to U.S.-based manufacturing facility(s) that can be used, in an emergency, to produce, next- generation cell-, recombinant-, or molecular-based pandemic influenza vaccine to protect the U.S. population. These facilities may also be used, in an emergency, to produce vaccine or bother biopharmaceutical products against emerging infectious diseases and others threats of known and unknown origin. Therefore, the Offeror shall provide written evidence of a firm commitment to supply regulatory, quality, and production plans that will achieve a minimum of 50 million finished pandemic influenza vaccine doses within four (4) months of receipt of a Delivery Order for pandemic influenza vaccine. An Offeror that cannot identify a specific pandemic influenza vaccine candidate at the time of proposal submission shall be paired by HHS/BARDA with an appropriate vaccine candidate at the time of contract award or afterwards. [5] Training: The Offeror shall provide written evidence of a firm commitment to supply biopharmaceutical-oriented workforce development program that is aligned with current regulatory guidelines with U.S.-based, accredited academic institutions or other USG-recognized U.S.-based organizations that specialize in this area. Additional technical evaluation criteria will be identified in the RFP. It is anticipated that two (2) pre-proposal conferences will be held during the solicitation period. Potential Offerors and any subcontractors are encouraged to attend. Teaming or partnering agreements (inclusive of small businesses) are highly encouraged. Small Businesses interested in subcontracting opportunites can contact the Contracting Officer or Offerors identified on http://www.FedBizOpps.gov. Multiple contract awards may be awarded as a result of this solicitation. Contract(s) awarded under this solicitation will have a base period between 2 to 8 years and option periods between 17 to 23 years depending on the successful Offeror(s) best overall approach. Option periods will not be further synopsized. Therefore, base and all option periods (if exercised) shall not exceed a maximum of 25 years. Please note that a draft RFP of this requirement was previous posted in FEDBIZOPPS under reference number DRAFT-RFP-AMCG-10-39 with subsequent questions and answers posted. Potential Offerors may review the previous posted information. However, this previous draft RFP does not represent the Government's official requirement and is no longer applicable. This final RFP, when released, is the official Request for Proposal for HHS's requirements. Information regarding the Centers for Innovation in Advanced Development and Manufacturing can be found online at www.medicalcountermeasures.gov. HHS/BARDA will be hosting a web-based session during the term of this Synopsis to provide an overview of HHS's requirements and provide additional responses to previous comments and questions; details regarding this meeting, pre-proposal conferences dates and other public information will be posted on www.medicalcountermeasures.gov. The RFP Number 11-100-SOL-00011, Centers for Innovation in Advanced Development and Manufacturing solicitation will be issued for this requirement on or about 15 to 30 days after the release of this synopsis. The solicitation, all related documents and amendments, if any, will only be released and available electronically through the FedBizOpps. As such, no written, telephonic, facsimile or email requests for the solicitation package will be honored. Interested parties can register at the aforementioned site to receive procurement announcements by email. Since this solicitation will only be available electronically, it is solely the responsibility of interested parties to monitor http://www.FedBizOpps.gov for any solicitation amendments. Any responsive and responsible Offeror may submit a proposal to be considered by the USG. This notice does not commit the USG to the award of a contract. No collect calls or facsimile transmissions will be accepted. All responses should be identified with the respective solicitation number 11-100-SOL00011, name of company, business size, name of requestor, mailing address, telephone number, fax number, and email address of Point of Contact (POC), should be submitted to the Contracting Officer address identified in this notice.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/11-100-SOL-00011/listing.html)
- Record
- SN02391864-W 20110304/110302234752-549bbcb2f3b05c494c39a8c175876ca9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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