*****SCOPE: This is a Sources Sought Notice requesting information from industry that will be used for internal Government planning purposes only. This Sources Sought Notice does not constitute a Request for Proposal, Request for Quote, an Invitation for Bid, or any other commitment to procure these services now or in the future. HHS will not directly reimburse any costs incurred for preparation or submission of information in response to this Notice. HHS reserves the right to share all information received in response to this Notice throughout HHS and its components, and to use all such information in the formulation of one or more solicitations seeking competitive offers on contracts for, or related to, the requirements described herein. Any proprietary, confidential, and sensitive data should be clearly marked as such. HHS will protect information submitted as allowed by relevant Federal law. All information submitted shall remain with the Government and will not be returned.

*****PURPOSE: The HHS/ASPR/BARDA seeks to identify qualified contract manufacturers in the United States for the formulation, filling, labeling, packaging, shipping, and/or testing of inactivated, monovalent H5N1 influenza vaccines, placebo buffers, diluents, and adjuvants for preclinical studies and human clinical trials. Data obtained hereunder will be used by HHS/ASPR/BARDA in making recommendations and decisions on the development of an appropriate planning and procurement strategy for National Pandemic Preparedness.



*****BACKGROUND: Preparing to address the challenges of an influenza pandemic is a priority for the U.S. Government. Prophylactic immunization is a primary means to reduce influenza mortality and disease severity. HHS/ASPR/BARDA has undertaken a portfolio matrix approach to modernize and diversify influenza vaccines including the implementation of specific measures that support (1) stockpiling of pre-pandemic influenza vaccines (2) antigen optimization approaches for pandemic influenza vaccines and (3) building of domestic influenza vaccine manufacturing infrastructure. HHS/ASPR/BARDA now plans to leverage adjuvant antigen-sparing technologies to increase the number of vaccine doses in the national pre-pandemic vaccine stockpile by assessing the feasibility and value of combining vaccine antigens with the adjuvants of different manufacturers.



*****SPECIFICATIONS: The North American Industry Classification System (NAICS) Code is 325414, Biological Product (except Diagnostic) Manufacturing. The small business size standard is 500 employees. The Government requests that firms provide information concerning the following four (4) capabilities:



**(1)** Manufacturing facilities-

(a) Name(s) of manufacturing facilities;

(b) Address(es);

(c) A brief description of the manufacturing facilities used for equipment cleaning, materials preparation, formulation and filling of sterile products, labeling, packaging, and cold (2-8 oC) and room temperature storage capacity for in process and finished products;

(d) A brief description of quality control testing facilities.



**(2)** Manufacturing and laboratory testing capabilities and availability-

(a) Experience with sterile product manufacturing using stainless steel, glass and disposable vessels/equipment;

(b) Capabilities for sterile filling, including fill level control, stoppering, capping, labeling and inspection of 5 ml and 10 ml vials including the types of equipment used;

(c) Experience with influenza vaccine potency testing using the single radial immunodiffusion assay. Laboratory capabilities and experience (including subcontracting) for sterility, general safety, pH, osmolality, particle size, SDS-PAGE and antimicrobial effectiveness testing;

(d) A brief description of the resource availability for filling November, 2007- July, 2008.



**(3)** Compliance History of Manufacturing Location(s)-

(a) A brief summary of all regulatory inspections and results during the last five years from national regulatory authorities such as the FDA, USDA and/or EMEA, and State pharmaceutical regulatory authorities, as applicable.



**(4)** List Prices-

(a) Established catalog or market prices for formulation, filling, labeling, packaging, shipping, storage and testing.



*****CAPABILITY STATEMENT: Interested firms shall only submit the information specifically requested in the SPECIFICATIONS section that addresses the capabilities of the firm. Information shall be submitted by electronic mail in .pdf or MS Office format to Schuyler.Eldridge@hhs.gov by 3:00 p.m., (EDT) on October 26, 2007.



Primary responses are limited to TWO (2) PAGES. Data sets (e.g., tables, charts, graphs) and documents which are pertinent to the response can also be submitted as appendices to the primary submission.



In your submission, please provide a company point of contact, telephone number, e-mail address, firm's DUNs number, and web page URL. Additionally, indicate if the product or service meets the Federal Acquisition Regulations (FAR) definition of a "Commercial item" as specified in FAR 2.101; the type of business submitting the response (i.e., small business, large business, hub-zone, small and disadvantaged business, etc.); and if the product can be acquired on a GSA schedule, VA schedule, or other Government-wide acquisition vehicle (if so, please supply the contract title and number, contract point of contact information and the name of the awarding agency).