68 -- EMERGENCY RESPONDER ANTHRAX ANTIMICROBIAL KITS

THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL. This notice does not constitute a commitment by the Government. The Government is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10 to identify potential sources to provide the requirement and to gather information on current capabilities within the market. All information submitted in response to this sources sought notice is voluntary and the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Proprietary information submitted should be marked appropriately SUMMARY The United States Department of Health and Human Services (HHS) seeks to identify organizations that are capable of preparing and commercializing individualized packets of antibacterial drugs for use by HHS Emergency Responders. This will be the first phase of a program that will eventually lead to licensed kits for first responders (called a First Responder MedKit) and finally for the general public (called a Household MedKit). Under this program, individualized packets of antibacterial drugs will be provided to HHS emergency responders and critical personnel. The first steps toward a kit for use by the general public will be in parallel to this program and include the RFP discussed below (palatability studies). The oral antibacterial drugs included in the kit must already be approved by the Food and Drug Administration (FDA) for treatment or prophylaxis of anthrax. In the first stage of this program, emergency response organizations at HHS will provide these kits, in accordance with applicable pharmaceutical prescribing requirements, to their employees as part of normal operational and occupational safety equipment. The objective of this pilot program will be to develop and evaluate control systems for shipping and dispensing, expiration management, recovery and destruction, reconciliation, replenishment. This pre-event provisioning will enable HHS emergency medical service staff and critical staff to have immediate access to potentially lifesaving chemoprophylaxis when dealing with incidents for which prompt use of such medical countermeasures is an essential part of personal protection - such as a bioterrorism attack involving the bacterium that causes anthrax. HHS will issue a solicitation for competitive proposals for First-Responder MedKits, including options for the preparation and commercialization of the kit for use by first responders and the general public. Approximately 100,000 kits will be acquired by HHS. At this time, HHS is gathering information on the capabilities of the market to meet the following requirements: (1) design and prepare a prototype kit and any associated instructions for its use by HHS Emergency Responders, (2) prepare a strategy seeking approval of the kit by the FDA, for use by First Responders and the general public, (3) manufacture and furnish to the USG a predefined quantity of kits that will be provided to HHS Emergency Responders and critical staff, (4) design and implement a system for the control of distribution, recovery, destruction, replenishment, and reconciliation, and (5) describe the organization's experience in preparing and administering an Investigational New Drug (IND) application and other regulatory documents required by the Food and Drug Administration (FDA). In addition, having gained premarket approval for a First-Responder kit, and depending on the ultimate approved indication and labeling, the contractor could be allowed to market the product to State, local and tribal governments and private-sector entities for use in their preparedness efforts against bioterrorism. Awardees will be required to file an Investigational New Drug (IND) application with FDA during the design and conduct labeling comprehension studies to support the commercialization of the kit. ADDITIONAL INFORMATION Whenever an emergency incident involves biological threats, time is of the essence. Exposure to bacteria that cause life-threatening diseases, such as anthrax, plague, tularemia, and typhus, can have catastrophic medical consequences if not countered promptly with antibacterial drugs and other prophylactic measures. For first responders in particular, prompt peri-incident administration of certain FDA-approved antibacterial drugs (primarily doxycycline and ciprofloxacin) can provide prophylaxis against biological threats encountered during their efforts to help others in the wake of the incident. Initial studies were conducted by the CDC in 2006 using a prototype kit to determine if emergency home preparation instructions for storage and use of the kit could be followed. Participants were asked to return the kit intact at specific times. The study, conducted in St. Louis, used both doxycycline and ciprofloxacin kits and enrolled over 13,000 people from more than 4000 households. Additional studies are likely to be required before the kit can be made available to the general public. The immediate objective of this announcement is to meet the preparedness needs of HHS Emergency Responders. This initial objective assumes that the users will be healthy adults who are capable of swallowing a tablet or capsule. Subsequent objectives (First Responder MedKit or Household MedKit) will target user groups that will include individuals who may be unwilling or unable to swallow pills, such as infants and young children, and those with a medical condition that makes swallowing pills difficult or impossible. In parallel with the current focus on an Emergency Responder kit, HHS in considering a separate acquisition initiative to develop the knowledge base needed for private-sector entities to prepare and commercialize a kit for use by the general public. A Request for Proposals (RFP-BARDA-08-12, http://www2.fbo.gov/spg/HHS/OOS/OASPHEP/RFP-BARDA-08-12/listing.html) was published on 8 FEB 2008. The purpose of that RFP is to identify commercial entities capable of designing and performing food palatability studies to mask the bitter taste of doxycycline and ciprofloxacin, and capable of evaluating home preparation instructions acceptability of these drugs, in terms of delivery of dose. INFORMATION TO INCLUDE IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT Interested organizations should provide the following information: 1) The most recent Annual Report or a summary of your corporate history, current business activities, and near-term objectives. 2) A summary describing your organization's resources, expertise, and experience in the manufacture or repackaging FDA-approved pharmaceuticals for the commercial market. 3) Descriptive information on the following areas: experience in managing, preparing and submitting Investigational New Drug (IND) applications or other regulatory documents required by the FDA and experience in the preparation of clinical protocols, the management of clinical trials, and the subsequent submission of a New Drug Application (NDA). 4) A summary of experience with systems for the control of distribution, recovery, destruction, and reconciliation, such as barcodes and RFID software or hardware. DUE DATE Interested parties may identify their interest by submitting a capability statement including the information requested above, an anticipated product delivery schedule, primary contact information at the organization (name, email, address, and telephone number) for this Sources Sought Notice in the event that HHS has additional questions or requires clarification on the submitted information. Responses are limited to 10 pages. Data sets (e.g., tables, charts, graphs) and documents which are pertinent to the response can be submitted as appendices to the primary submission. Respondents are also requested to specify whether they are a large business or small business under the North American Industry Classification System (NAICS) code 325412, which has a small business size standard of 750 employees. All respondents and comments to this announcement shall reference DHHS-Sources Sought - First Responder MedKit and be submitted to Brenda Brooks, Contracting Officer, at brenda.brooks@hhs.gov by 5:00 PM EST on March 21, 2008. All submitted information shall remain with the U.S. Government and will not be returned.