SOURCES SOUGHT
Q -- HHS Egg Supply Sources Sought
- Notice Date
- 3/3/2010
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, 330 Independence Avenue, SW, Rm G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- HHS-BARDA-Sources_Sought_Egg_Supply-Mar-2010
- Archive Date
- 3/27/2010
- Point of Contact
- S. Kyle Roberts, Phone: 202-260-0747, RoseMary T Mann, Phone: 202-260-1572
- E-Mail Address
-
kyle.roberts@hhs.gov, rosemary.mann@hhs.gov
(kyle.roberts@hhs.gov, rosemary.mann@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- PROPOSED REQUIREMENT TITLE: HHS-BARDA-Sources Sought Egg Supply-Mar 2010: Continuous Supply of Embryonated Eggs and Clinical Batch Production for National Pandemic Influenza Preparedness Efforts ------------------------- THIS IS A SOURCES SOUGHT NOTICE ONLY. This Sources Sought Notice (SSN) is not a Request for Proposal (RFP) and does not constitute a commitment by the United States Government (USG). The USG is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10, to identify potential sources to provide the requirement and gather information on current capabilities within the market. All information submitted in response to this sources sought notice is voluntary and the USG will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the USG. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the USG and will not be returned. The Department of Health & Human Services (HHS) has a future requirement to support the program’s mission of, A Nation Prepared, to rapidly respond and produce a strain-matched pandemic influenza vaccine in the event of a declared pandemic. Assuring this early availability of a sufficient quantity of vaccine for the U.S. population in the setting of a pandemic will potentially prevent thousands of deaths and save billions of dollars. In 2004, the USG awarded a sole source contract to normalize the supply of embryonated eggs throughout the year and stockpile other critical materials for rapid pandemic influenza vaccine production, if required. This contract also supported work to produce small clinical lots of inter-pandemic influenza vaccine for potential clinical testing. This contract is to expire in March 2010. The purpose of this SSN is to identify potential sources (large or small businesses) that may be capable of performing this new revised requirement. This proposed requirement would support these services as well as reagent production and management of potential clinical testing programs. Therefore, this new requirement would be a continuation of the existing requirements with a broadening of the scope of work (SOW) to incorporate materials and activities newly identified as essential to the mission of assuring the expedient supply of strain-matched influenza vaccine to the U.S. population during a pandemic. Specifically, the USG contemplates a requirement that includes the following services: 1. Maintain a continuous (year-round) domestic-based supply of embryonated eggs commensurate with the output of identified domestic-based commercial scale influenza manufacturing capabilities for the rapid production of matched-strain, monovalent pandemic influenza vaccine candidate, if required by the USG. USG contemplates the pricing by a potential offeror will be on an eggs per production day basis. The price will incorporate costs for overall flock management to supply the necessary laying hens to support daily egg production targets that match the current commercial scale capabilities on a continuous basis. In addition, the price will incorporate the maintenance of a +20% egg production contingency (not to exceed 90,000 eggs per production day). USG will support the costs of eggs produced and not used by commercial manufacturing activities. 2. Manufacture, formulate, characterize, test, fill and finish 3,000 investigational doses of monovalent inter-pandemic influenza vaccine (at pilot manufacturing scale). Strain selection will be at the direction of HHS. 3. Manage to completion Phase 1 -or- Phase 1/2 clinical studies of investigation monovalent inter-pandemic influenza vaccine candidates. Pricing to include all costs associated with necessary regulatory filings (i.e. IND). 4. Create/ produce one (1) or two (2) reference strain reagents each year for shipment to FDA/CBER for appropriate calibration testing. Pricing to include all necessary lab work required to establish a reference strain per regulatory guidelines. Pricing to include the appropriate storage costs to maintain a reference strain library in which the contents are accessible to and retrievable by HHS upon request. To be evaluated and considered for award of this requirement, a potential offeror must meet the following mandatory qualification criteria: 1.The potential offeror shall demonstrate they currently maintain and have unlimited access to a U.S. based, FDA licensed, cGMP manufacturing facility that is currently, or has recently, been engaged with egg-based influenza vaccine production at commercial scale. 2.The potential offeror shall demonstrate they currently maintain and have access to a FDA licensed, cGMP pilot scale manufacturing facility that is capable of egg-based inactivated influenza vaccine production. 3.The potential offeror’s bulk manufacturing facilities are in compliance with current WHO guidelines for pandemic vaccine manufacturing including BSL2+ enhanced biocontainment facilities and procedures 4.The potential offeror shall demonstrate they possess the appropriate facilities and skills to produce, calibrate and maintain reference strain-specific reagents for influenza antigens. 5.The potential offeror shall provide proof that their facility(s) and subcomponent contractors/ suppliers/ vendors have pandemic influenza plans in place to ensure USG contracts will be honored during a pandemic influenza outbreak. It is anticipated that a Request for Proposal (RFP) will be announced approximately March 2010 with proposals due in April 2010. While the mandatory qualification criteria do not have to currently be met for this sources sought notice, all of the mandatory qualification criteria shall be met by proposal submission. It is requested that respondents to this sources sought notice may identify their interest by submitting the following information: 1.An anticipated delivery schedule of the services outlined in the contemplated by the USG in the scope of work (SOW) outlined above. 2.A brief capability statement, including how a potential offeror plans to meet the mandatory qualification criteria outlined above. 3.Primary contact information at the organization (name, email, address and telephone number) handling this sources sought notice, in the event HHS has additional questions or requires clarification of the submitted information. The Government is seeking qualified small business concerns and seeks to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUB Zone small businesses, service-disabled, veteran-owned small business, 8(a) small businesses, woman-owned small businesses, or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code 325412. The small business size standard is 500 employees. Your response to the information requested will assist the Government in determining the appropriate acquisition strategy, including whether a set-aside is a possibility. Teaming arrangements are encouraged. Any organization, especially small business concerns that can perform the work are encouraged to apply. Responses are limited to fifteen (15) pages. Data sets (i.e., tables, charts, graphs) and documents that are pertinent to the response can be submitted in excess of the fifteen (15) pages, as appendices to the primary submission. Potential respondents are also requested to include whether or not they are a large or small business. Small businesses are highly encouraged to respond. All respondents and comments to this sources sought notice shall reference HHS-BARDA Sources Sought-Egg Supply-Mar 2010 and be submitted to Kyle Roberts, Contract Specialist, at kyle.roberts@hhs.gov by 1:00 PM EST, March 12, 2010. Contracting Office Address: Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Room G640 Washington, District of Columbia, 20201 Primary Point of Contact: Mr. S. Kyle Roberts, Contract Specialist Kyle.roberts@hhs.gov Phone: 202-260-0747 Fax: 202-205-6061 Secondary Point of Contact: Ms. Rosemary Mann, Contracting Officer Rosemary.Mann@hhs.gov Phone: 202-260-1572 Fax: 202-205-6061
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