Fellowship Academic Program

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation, FDA-SOL-09-1061707, is issued as a Request for Proposal (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 05-35. The associated NAICS code is 611310 and small business size standard is $ 7.0 Millions. The Food and Drug Administration (FDA) is seeking for an Academic Institution to provide a fellowship program that will train fellows for the challenges of drug information and risk communication. I. Background The purpose of the fellowship program is to develop a cohort of trained fellows who will be especially prepared to take up the challenges of drug information and risk communication. This program is being undertaken to introduce participants to the various medical and regulatory aspects of drug development. It will serve to maintain and enhance a scientific like between Government personnel and university scientists; and it will aid not only the drug information and safety process throughout the industry. Graduates of the program will have important roles to play not only in the Government, but also in a university-based PharmD. program, or in the pharmaceutical industry. This agreement is to establish a jointly sponsored academic based fellowship program in pharmaceutical drug development between the following institutions: - Government Site - Academic Site - Pharmaceutical Company Site II. Objectives: - The primary objective of the program is to introduce participants to various medical and regulatory aspects of drug development. - Train health care professionals for a career in the drug development industry by allowing them - hands on experience. - Understand regulations regarding human drug products. - Understand the value of drug information to heath care providers and to consumers. III. Structure and Content of Program: The Fellowship requires two years of on-site participation administered through an accredited College of Pharmacy. The fellow will be a PharmD. graduate and will have rotational experiences at an academic institution, the Agency's Research Center, and either pharmaceutical company. The fellow is expected to complete a project that incorporates viewpoints and aspects of the rotational experience. IV. Training Tracks Within the Pharmaceuticals Drug Development Fellowship Program: Although certain training elements are common to all fellows the three distinct training tracks identified within the program will allow tailoring of training to the career goals of the individual trainee. The training tracks are as follows: 1) Drug Information Track - Utilize drug information references to facilitate communication through dissemination of timely and clinically significant information for drug products, and Center's role, etc. - Respond to inquiries regarding approved drugs - Become familiar with drug products, regulations, guidance documents and timely issues 2)Prescription Drug Advertising Track: - Reviews and evaluates promotional materials for compliance with regulations. These include materials from the Internet and exhibit halls of medical meetings and materials used by pharmaceutical sales representatives. - Reviews and evaluates promotional claims to determine if they are substantiated by the labeling and/or medical journal articles. V. Candidate Qualifications: Candidates must be a PharmD. Graduate from an accredited institution. Highly Qualified candidates will possess the following competencies and skills: - Knowledge of the drug development and review process - Knowledge of the risk management framework - Knowledge of Post-marketing epidemiological assessment - Knowledge of basic health promotion-health education concepts - Knowledge of basic social marketing perspective and strategies - Excellent oral and verbal communication skills - Excellent written communication skills - PowerPoint presentation skills - Interest in computer and web-based communication tools VI. Selection and Approval of Candidates: A Committee comprised of representatives from each of the organizational components participating in the fellowship interviews and agreed on the selection of the candidate. The applicant selected for the Division of Drug Information (DDI), is TBD, PharmD. The fellowship timeline is as follows: - Academic Site: 07/01/08-12/31/08 - Industry Site: 01/01/09-08/31/09 - Academic Site: 09/01/09-12/31/09 - Government Site: 01/01/10-06/30/10 The applicant selected for the Division of Drug Marketing, Advertising, and Communication (DDMAC) is TBD, PharmD. The fellowship timeline is as follows: - Academic Site: 07-01-08 - 01-31-09 - Industry Site: 02-01-09 - 11-30-09 - Government Site: 12-01-09 - 06-30-10 VII. Roles and Responsibilities: The Government will: - Appoint a Coordinator for the Joint Academic/Government/Industry fellowship Program in Pharmaceutical Drug Development. - Appoint mentor(s) who will guide the fellow during their stay at the Government Site - Jointly with the participating organizations periodically review and revise the objectives and programmatic assignments of the fellows. - Authorize the Coordinator to serve as a liaison between the Government's Research Center and the Academic institution. - Accept one fellow per programmatic area per fellowship cycle. Additional fellows will be accepted at the Government's sole discretion. - Inform the academic institution when the Government recommends withdrawal of any fellow from the Fellowship Program whose performance is unsatisfactory. - Provide to the participating academic institution a sum of $X.XX (I thought this was more - but I don't remember the numbers) for administrative and management cost associated with the fellowship. Academic Institution will: - Provide a stipend to the fellow. - Maintain completion of records and reports necessary for the conduct and verification of student participation. - Monitor the progress of the fellow and establish criteria for the successful completion of the fellowship. - Designate a faculty member to coordinate with a designee from the specific programmatic area the fellow is assigned. - Coordinate the educational experience. - Serves as central resource for fellow regarding their development. - Coordinates recruitment and candidate selection. VIII. At no time during the course of the fellowship will the participant be considered an employee of the Agency's Research Center. Fellows will, however, adhere to the rules, regulations, procedures, and policies of the Agency's Research Center while of the premises and during that portion of the fellowship, including but not limited to completion of a Confidentiality and Nondisclosure Acknowledgement. The Agency's Research Center has the right to terminate the use of its facilities and its resources by any Fellow for violation of its rules, regulations, procedures and policies. IX. This agreement may be amended by mutual consent by the officials executing this agreement or their successor after giving written notice to the other party at least 30 days prior to the proposed amendment date. This agreement shall become effective upon execution by the signatories. Either party may terminate this Agreement upon sixty- (60) days written notice to the other. Subject to mutual agreement of the parties, such termination may not prevent those students already participating in the Fellowship program from completing their assignment at the Agency's Research Center. Evaluation Criteria: The Offeror should demonstrate in its proposal that the objectives in the statement of work are understood and offer a logical approach to their achievement. Award will be made to the Offeror who is deemed most responsive, whose proposal conforms to all requirements, and is judged to represent the best value. To conduct a best value assessment, the FDA will evaluate the Offeror's proposal submission based on criteria described below. As this is a best-value selection, the government may make tradeoffs in the factors below to arrive at a best value decision. The Government may award the contract on the basis of initial offers received, without discussions. Therefore, each initial offer should contain the Offeror's best terms from a cost and technical standpoint. EVALUATION CRITERIA: The evaluation will be based on the completeness, thoroughness and demonstrated capabilities of the prospective Offeror in relation to the needs of the project as set forth in the SOW. Each proposal must document the feasibility of success implementation of the requirements. The Offeror should show that the objectives stated in the proposal are understood and offer a logical program for their achievement. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. THE GOVERNMENT WILL EVEALUATE INFORMATION BASED ON THE EVALUATION CRITERIA DESCRIBED BELOW: CAPABILITY FACTOR DESCRIBED TO - EXCEEDS, MEETS, OR FAILS TO MEET THE REQUIREMENT. Technical: Demonstrated understanding of the requirement and capability to be responsive to the requirement Past Performance: Approach and demonstrated experience and qualified personnel to fulfill the requirement. This criterion will be used to rate the acceptability of a plan of action with details on how the proposed work will be accomplished. Include a timeline; lists of key individuals who will work on the project with a short description about their effort or contribution. Assure the adequacy of time devoted to the project by key staff. The key staff should be qualified and knowledgeable. A premium is placed on skilled writing and editing of features on food and medical product safety topics, and adherence to a tight production schedule. Provide resumes that include a description of the experience and capability for each of the key personnel, including documentation of their previous experience researching and writing on health and medicine for a daily newspaper, wire service or magazine distributed nationally. Descriptions shall address such items as the individual's background, education, work experience and accomplishments. Show the knowledge that key personnel have gained through completed and ongoing efforts that are similar in nature to this effort and include five related writing samples for each individual proposed to perform editorial activities. While number of resumes supplied by the bidder is not limited, only resumes for key personnel working under this contract shall be provided. Price: The extent to which the project's costs are reasonable based on the activities to be carried out and the anticipated outcomes. OFFEROR MUST COMPLETE AND SUBMIT WITH ITS QUOTE, FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS - COMMERCIAL ITEMS (JUL 2009), WHICH ARE AVAILABLE ELECTRONICALLY AT: http://www.arnet.gov/far/current/html/52_212_213.html. The clause at FAR 52.212-4 (Mar. 2009), Contract Terms and Conditions - Commercial Items and FAR 52.212-5 (Jun. 2009), Contract Terms and Conditions required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. The additional FAR clauses cited in the clause are applicable to the acquisition: (1) 52.203-6 Restrictions on Subcontractor Sales to the Government, with Alternate I (Sep. 2006), (2) 52.219-8, Utilization of Small Business Concerns (May 2004), (3) 52.219-14, Limitations on Subcontracting (DEC 1996), (4) 52.222-21 Prohibition of Segregated Facilities (FEB 1999), (5) 52.222-26 Equal Opportunity (MAR 2007), (6) 52.222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006), (7) 52.222-36 Affirmative Action for Workers and Disabilities (JUN 1998), (8) 52.222-37 Employment Reports on Special Disabled Veterans, Veterans on the Vietnam Era, and Other Eligible Veterans (Sept 2006) (9) 52.222-19 Child Labor-Cooperation with Authorities and Remedies (Feb 2008) (10) 52.225-13 Restrictions on Certain Foreign Purchases (June 2008) (11) 52.232-33 Payment by Electronic Funds Transfer (Oct 2003). (12) 52.204-7 Central Contractor Registration (Apr 2008). (13) 52.217-7 Option for Increased Quantity'Separately Priced Line Item (Mar 1989) (14) 52.217-8 Option to Extend Services (Nov 1999). (15) 52.217-9 Option to Extend the Term of the Contract (Mar 2000). Technical Proposal shall be no more than 25 pages. Award will be made to the offeror providing best value to the Government in consideration of cost and technical proposal. The Contract Specialist must receive any questions no later than 10:00 AM local time, September 16, 2009. Electronic submission is acceptable. If you wish to send hard copy, an original and 3 copies of the offerors cost and technical proposal shall be received on or before 12:00 P.M. local time, September 17, 2009 at Food and Drug Administration 5630 Fishers Lane Rockville, MD 20857. For information regarding this solicitation, please contact Jeankite Joseph, at 301-827-5095, Fax 301-827-7106, or email: jeankite.joseph@fda.hhhs.gov