ACTION Initiative

The purpose of Modification Number 000001, provided on the SF-30, dated August 3, 2010, is to provide answers to questions received. No changes have been made to the subject solicitation. ___________________________________________________________________________ (Solicitation Information) This updated notice hereby represents an ACTIVE Solicitation in furtherance and support of the U.S. Food & Drug Administration's Analgesia Clinical Trails, Innovations, Opportunities, and Networks (ACTION) Initiative. The Subject Solicitation Number is: 10-223-SOL-00263. Please see RFP Section L.1.6, Pages 66-67 for question submittal instructions. All questions regarding this solicitation shall be submitted to the designated FDA Point of Contacts no later than July 28, 2010. Offerors are hereby reminded that you must be registered in the Central Contract Registration (CCR) database in order to be eligible for award. You may register in CCR at: http://www.ccr.gov. Registration may take a few weeks. Therefore, you are strongly encouraged to begin the CCR registration process immediately. ___________________________________________________________________________ (Pre-Solicitation Notification Information) This Pre-Solicitation Notice Amendment in its entirety hereby takes precedence over all prior pre-solicitation notices regarding the FDA's Analgesia Clinical Trials Innovations, Opportunities, and Networks (ACTION) Initiative. Due to the results of numerous upper management reviews, and in an effort to maximize the probability of program success, FDA has amended its acquisition strategy for the subject requirement, as provided below. The FDA intends to issue an RFP to develop and manage an administrative and scientific infrastructure to support non-clinical and clinical research in the areas of analgesic trial design and drug development in furtherance of the FDA's ACTION Initiative within the framework of a Public Private Partnership (PPP). The ACTION Initiative is being designed as a PPP for two key purposes. First, to initiate and foster strategic collaboration amongst a broad spectrum of stakeholders, including, but not limited to, industry, academia, professional organizations, patient advocacy groups, and other Government agencies with the well-defined goal of sharing data, best practices, and innovative thinking. Second, under the auspices of the ACTION Initiative, it is anticipated that these stakeholders will leverage their resources (e.g. data, scientific expertise, infrastructure, and financial resources) to foster dialog and develop specific projects that will add to the body of information so that analgesic drug development can be moved forward in an expedited and efficient manner. The ACTION PPP overarching objectives have been defined, as follows: (1) Identify scientific gaps in the design, implementation, and interpretation of clinical trials of drug products intended for the treatment of acute and/or chronic pain; (2) Develop scientific projects that will bridge the identified gaps and facilitate the development of novel, safe, and effective analgesic drug products; and, (3) Disseminate project findings to the analgesic community at large. More specifically, in follow-up to this Presolicitation Notice and in furtherance and support of the ACTION Initiative, FDA intends to solicit proposals to aid in the development and execution of the following 6 inter-related activities as a single, comprehensive effort: ADMINISTRATIVE FUNCTIONS [Items 1-3]: (1) Develop a Scientific Advisory Board to develop, manage, and implement a series of projects under the ACTION PPP [Responsibilities will include soliciting, reviewing, evaluating, prioritizing, and selecting projects for review and approval by the Executive Committee of the ACTION PPP.]; (2) Develop a strategic plan for the establishment of an administrative and scientific infrastructure to support a series of scientific projects under the ACTION PPP; (3) Coordinate a scientific workshop with key experts in the field of analgesia and pain management, as well as all potential partners of the ACTION PPP, including stakeholders from industry, professional organizations, patient advocacy groups, and other Government agencies; SCIENTIFIC STUDIES [Items 4-6]: (4) Assess FDA's clinical trial databases and develop novel and alternative means of analyzing various pain scores in a manner that effectively considers variables, such as bias and inter-individual variance, as guided by the FDA and the ACTION PPP; (5) Establish and assess both group and individual analgesic clinical trials databases for relationships between assay sensitivity and metrics, including, but not limited to, specific research designs and methodological features so as to guide the future design of analgesic clinical trials, as guided by the FDA and the ACTION PPP; and (6) Develop methodologies for the execution and transformation of pooled trial data from relevant analgesic trials for treatment of acute and chronic pain. FDA anticipates competing the requirement on a 100% "Full and Open" basis, utilizing the procurement methods set forth at Federal Acquisition Regulation (FAR) Part 15, Contracting by Negotiation, and making a single award to the responsive offeror whose proposal provides the greatest overall benefit in response to the prospective solicitation. Successful execution of the aforementioned activities will involve enormous challenges in terms of the broad array of skills, abilities, knowledge, and resources required to complete all activities in a timely, efficient, and effective manner. Therefore, because it is unlikely that any one entity will possess all of the expertise and resources necessary to accomplish all work required under this requirement, ALL INTERESTED ENTITIES ARE ENCOURAGED TO BEGIN FORMING SUB-CONTRACTING AND/OR TEAMING RELATIONSHIPS WITH OTHER ORGANIZATIONS IN ORDER TO SUBMIT THORUGH AND COMPETITIVE RESPONSES TO THE PROSPECTIVE ACTION INITIATIVE SOLICITATION. The prospective contract award type and respective period of performance is anticipated to be Firm-Fixed-Price and/or Labor Hour and approximately 12 months from date of award, respectively. The anticipated performance location is the responsive offeror's preferred location; however, the awardee will be required to travel to the Washington, DC Metropolitan Area, including the state of Maryland. The designated North American Industry Classification System (NAICS) code is anticipated to be: 813920 - Professional Organizations. This industry comprises establishments primarily engaged in promoting the professional interests of their members and the profession as a whole. These establishments may conduct research; develop statistics; sponsor quality and certification standards; lobby public officials; or publish newsletters, books, or periodicals, for distribution to their members. This announcement is NOT a Request for Proposal (RFP). The FDA anticipates release of the prospective RFP on or around July 14, 2010, to be posted on the Federal Business Opportunities Web Site. The anticipated proposal due date and award date for this effort is expected to be on or around August 16, 2010, and September 15, 2010, respectively. Interested parties must respond to the prospective RFP in order to be considered for award of any resultant contract. Individual notifications will NOT be sent to potential offerors regarding the issuance of the solicitation, nor any of its amendments. It is the offeror's responsibility to monitor FBO for release of this acquisition and any associated amendments. **NO QUESTIONS WILL BE ENTERTAINED AT THIS TIME** Offerors will be provided an opportunity to submit questions via e-mail after the solicitation is released. All respective answers will be posted to www.FBO.gov via solicitation amendment.