Management Consultant Services

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12 Commercial Items acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-36. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code, 541618 is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. This is a total small business set-aside. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Food and Drug Administration (FDA) intends to award a purchase order for Management Consulting Services. This solicitation is issued as Request for Quote (RFQ) No. FDA-09-1061416. 1. STATEMENT OF WORK Objective The primary objective of this procurement is to acquire the expertise needed to provide assistance with overall regulatory, biomedical engineering and toxicology support. Background The ophthalmic devices field in the Division of Ophthalmic, Neurological and ENT Devices (DONED) is a very active device area at the present time and includes recognized risk factors associated particularly with contact lenses and intraocular lenses (IOLs). The devices present serious issues to be resolved prior to and after their being marketed. Specifically, in the last three years there have been several microbiological outbreaks with potentially sight-threatening consequences for millions of end users of these devices, resulting in device recalls associated with some contact lens care products and IOLs. The IOL outbreak involved toxic anterior segment syndrome (TASS). The contact lens outbreaks involved the Acanthamoeba organism and fusarium keratitis. CDRH and DONED have been awarded funds from HHS to study some of the possible device-related causes behind these outbreaks and to develop methods and guidances for appropriate testing of the devices in order to lower the current risk of another outbreak. For contact lens outbreaks, it is believed that the disinfection efficacy of the contact lens care products may have been compromised by interactions between the lens and the care products. Finding the precise etiology of a TASS outbreak is challenging due to the myriad of potential causes and lack of standardized methodology. Utilizing the expertise of research scientists such as a microbiologist and chemist, DONED will develop methods with sufficient detection levels to evaluate levels of endotoxins, metal contaminants, organic contaminants, foreign protein/ nucleic acids, etc. associated with major ophthalmic products. In addition, DONED will undertake intraocular studies, utilizing the expertise and assistance of an ophthalmologist and research scientists, to assess the intraocular test methods and determine the dose response of organic and inorganic contaminants to cause inflammation. Scope of Work The FDA requires a Contractor to work with Division management to develop more robust analytical procedures to characterize the various components (preservatives, surfactants, additives) of the care product solutions utilizing the expertise of a microbiologist and chemist. The Contractor shall assist in categorizing the numerous silicone hydrogels lens materials into fundamental groups based on how these materials interact with the components of the care product solutions. The Contractor shall assist with measuring the relative tendency of various lens materials to cause adherence of bacteria in conjunction with various types of care products additives (moisture retention, comfort, lubrication). These efforts will result in test methods that predict the tendency of products to fail in disinfection performance under real world conditions. The Contractor shall serve as the coordinator for the “High Throughput Methods for Detection and Identification of Contaminants and Emerging Disease: Assuring the Safety of Ophthalmic Medical Devices” research projects for IOLs and contact lens care products. In this capacity, the Contractor shall provide oversight for the research on IOLs and contact lens care products, manage budget oversight for the projects, and provide summary details of the projects to higher management. The Contractor shall also participate in the development of studies and guidance documents for ophthalmic devices as it relates to the aforementioned research projects. The Contractor shall be given assignments to: (1) provide oversight for the Division and tracking information to DONED & upper management on the IOL and contact lens care solutions studies; (2) provide opinions on the regulatory appropriateness of submissions that are received for ophthalmic devices; and (3) assist at meetings with upper management, industry and professional organizations concerning these studies and devices. The Contractor shall be required to participate in and/or provide: (1) tracking of overall budget in summary form, with input from the ODE budget officer and others; (2) summary narratives of study progress for the projects; (3) written formal consultative memoranda with the time constraints dictated by regulations; (4) telephonic and in person consultations with the staff of DONED on an ad-hoc basis; (5) commit to regularly scheduled weekly telephone interaction with DONED staff; (6) participate telephonically at meetings and conferences as necessary; (7) assist management in preparing various guidance document reviews. 3. PERIOD OF PERFORMANCE One Year: anticipated period of performance is from September 25, 2009 through September 24, 2010. 4. PRICING It is estimated that the level of effort will be 1266 hours for one year. Proposed pricing should be the entire period of performance, and detail the number of hours proposed and proposed price per hour. Labor hours should be fully loaded. 5. EVALUATION FACTORS FOR AWARD A. BEST VALUE CRITERIA - BASIS FOR AWARD The Offeror should demonstrate the statement of work is understood and offer a logical approach to its 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, FDA will evaluate the offerors proposal submission based on Technical Elements, Price, and Past Performance as described below. Technical, Past Performance, and Price are of equal importance. 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 a task order 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. B. 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 Statement of Work as set forth in the RFQ. Each proposal must document the feasibility of successful implementation of the requirements of the RFQ. Offerors must submit information sufficient to evaluate their proposals based on the criteria listed below. Technical Evaluation Offerors should provide information on all of the following criteria. 1) experience with all ophthalmic devices 2) knowledge of the FDA’s regulatory review process of ophthalmic device submissions 3) expertise in biomedical engineering and toxicology 4) professional licensing in both biomedical engineering and toxicology 5) familiarity with the FDA management structure Past Performance Evaluation FDA will evaluate the offeror's past performance in the conduct of similar tasks and their relevance to this acquisition. Price FDA will evaluate the offeror's submission/proposal on their ability to provide support at a reasonable and realistic price (to include any discounts offered). 7. PAYMENT SCHEDULE Payment will be made in equal monthly installments. 8. CCR Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. 9. QUESTIONS DEADLINE: All questions are to be submitted via email to [email protected] no later than 2:00 P.M. on September 10, 2009 4:00 P.M. 10. OFFERS DUE: Proposals must be delivered no later than 2:00 p.m. local time on September 14th, 2009. Proposal submissions are restricted to a limit of ten (10) pages. Proposal must be submitted via e-mail to [email protected] 11. PROVISIONS AND CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.217-9, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. No telephone calls will be accepted.