SOLICITATION NOTICE
B -- Cytokines as Therapeutic Agents-Workshop
- Notice Date
- 8/22/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- FDA-SOL-08-000895
- Archive Date
- 9/20/2008
- Point of Contact
- Nicholas E Sartain,, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in 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. This requirement is being issued in conjunction with FAR part 13 Simplified Acquisition Procedures, as applicable. The solicitation number is FDA-SOL-08-000895. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-26. The associated North American Industry Classification System (NAICS) Code is-541690- Other Scientific and Technical Consulting Services; Small Business Size Standard is $6.5 million. The Food and Drug Administration has a requirement for the following: I. Background: The mission of the FDA Center for Drug Evaluation and Research (CDER) is to assure that safe and effective drugs are available to the American people. CDER promotes, protects and enhances the health of the public through drug development, evaluation and continued safety monitoring throughout the drug life cycle. To accomplish its mission CDER must contend with many important challenges. Failure rates in clinical development have remained largely unchanged over the past two decades. FDA’s Critical Path Initiative (CPI) seeks to identify and address scientific and technical obstacles to optimize the development of safe and therapeutically important medical products. Under the Critical Path Initiative (CPI), FDA is trying to identify innovative ways to enhance drug development and reduce the time it takes to bring therapeutically important and safer medical products to the market by leveraging prior knowledge. To date, recombinant and purified cytokines have fallen short of their promise as therapies. Despite outstanding therapeutic promise and sound scientific rationale, most cytokine therapies have failed to establish clinical utility. The FDA seeks to establish a forum for joint discussions with the biopharmaceutical industry to facilitate product development for unmet medical needs in the context of the agency’s Critical Path Initiative. The purpose of this workshop is to provide a forum to discuss the successes and failures of recombinant cytokines as therapeutic agents for treating human diseases, including cancer and autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. This conference will provide a forum to review the scientific and clinical basis of both successful and unsuccessful attempts to develop cytokines as therapeutic agents. It will also provide a forum to develop strategies to increase the probability of clinical success of recombinant cytokines as therapeutic agent’s in future clinical trials. The meeting is designed as a forum to critically assess the factors that are limiting the clinical development of cytokines as therapeutic agents. The FDA anticipates participation by scientists and clinicians from other federal agencies (e.g., NIH, NIST), the biopharmaceutical industry, academic institutions, consortia that may contribute to future clinical trials (e.g., Biomarker/Genomic Consortia) and others to actively participate in this unique conference. The overall goal of the workshop is to identify areas for improvement and to coordinate, develop and disseminate novel approaches to current scientific hurdles that are impairing the development of cytokine products. II. Objective: FDA wishes to collaborate on the development of a scientific workshop to address the role of cytokines as therapeutic agents. III. Scope of Work: The Contractor shall work within and/or develop any necessary elements to produce the following two (2) deliverables within a twelve month (12) period. Should it be necessary to extend the period over which this work is to be completed, a no-cost extension may be requested in writing. Such a request must be reviewed and approved by the FDA Project Officer with concurrence from the FDA Contracting Officer. All data and outcomes associated with this scope of work shall be provided through the Program Officer, to the FDA on both electronic format and in hard copy. A final report shall be prepared by the Contractor, summarizing the deliverables of this award. This report must be submitted to the FDA Project Officer electronically and in hard copy. Any public disclosure of the aforementioned report and outcomes must be reviewed by the FDA Program Officer and designated staff, and cleared for dissemination. Deliverable #1 The contractor shall conduct a forum, in collaboration with the FDA and in the context of Sections 1 and 2 of this Statement of Work. Such a workshop shall include input and participation from multiple stakeholders including Federal and State bodies, industry, academia and other potential partners in the field. The details of logistics, agenda, attendees and workshop objectives shall be developed with the FDA Project Officer and designated FDA staff, and shall be outlined in separate documents between the Contractor and FDA. Deliverable #2 The Contractor shall, with input from meeting participants, other stakeholders and FDA staff, lead the development and publication of a workshop. Such a workshop may contain, but may not be limited to discussion of the following elements: •improved methods for identifying disease targets, •alternative methods for enhancing and targeting cytokine delivery, and •physicochemical modification of cytokines to prolong their bioavailability Deliverables and Timeline The activities and deliverables under this Scope of Work must be completed during a twelve (12) month period from the date of award. Contract Type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized. Period of performance will be 12 months after receipt of order. The primary location of performance is anticipated to be at the contractor’s location. Payment terms net 30 days. FOB Point of Delivery for reports and deliverables shall be provided to: Food and Drug Administration, CDER, N29A RM3B13 HFD-122 8800 Rockville Pike, Bethesda, MD 20892. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The Government will award a purchase order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: (i) Technical capability of the service offered to meet the Government’s requirement. (ii) Past Performance (iii) Price. Technical and Past Performance when combined are significantly more important when compared to price. Technical acceptability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the contractor can meet the Government's requirement. The following technical evaluation criteria will be used: Technical Evaluation Criteria: A.Technical Evaluation - This evaluation will be based upon the thoroughness of the proposal submitted. The offeror should show an understanding of the objectives and offer a logical program for their achievement. The following factors will be weighted as indicated in establishing a numerical rating for all technical proposals submitted. Area 1—Key Personnel (30 points) Factors to be considered include: •Skills and experience of the proposed staff with respect to the tasks delineated in the Statement of Work •Availability of proposed resources to commit to the contract Area 2—Qualifications and Experience (40 points) The Offeror shall describe their past performance in related efforts, identifying other organizations with which they have participated in similar efforts. This description should include degree of involvement, organization size and type. Offerors will be evaluated on their performance under existing and prior contracts for similar services and products. Area 3—Management Plan and Approach (30 points) Factors to be considered in this area include the: •Degree to which the Offeror’s organization is able to support the efforts proposed •Approach to managing the project, including supervisory responsibility and accessibility to qualified staff Past Performance information to include recent and relevant contracts for the same or similar service including: contract numbers, points of contact with telephone numbers and other relevant information. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the product and/or service meets the technical requirements. Offerors shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The government reserves the right to make an award without discussions. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. Offerors shall complete and return a copy of the provision at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items with their offer. If the end product(s) offered is other than domestic end product(s) as defined in the clause entitled "Buy American Act-Supplies," the offeror shall so state and shall list the country of origin. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The following addenda have 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 additional FAR clauses cited in this clause are applicable: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.222-50, 52.225-3 Alt 2, 52.225-13, and 52.232-33. The following additional provisions and/or clauses apply: 52.204-7. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov/far/ CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) system before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit an offer, which shall be considered. The offer must reference solicitation number FDA-SOL-08-000895. The Offers are due in person, by postal mail, fax or email to the point of contact listed below on or before September 5, 2008 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OSS/OFFAS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov.
- Web Link
-
FedBizOpps Complete View
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- Place of Performance
- Address: FDA/CDER, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01648605-W 20080824/080822222343-0d2a4f4f8daf3782e1a0c8b7cc5293a1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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