SOLICITATION NOTICE
A -- Systems Biology Approach for Predicting Complex Drug Interactions - FDA1077950 Pricing Table - FDA1077950 Statement of Work
- Notice Date
- 8/13/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1077950ss
- Archive Date
- 9/4/2010
- Point of Contact
- Emily Hunt,
- E-Mail Address
-
emily.hunt@fda.hhs.gov
(emily.hunt@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Statement of Work Pricing Table This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541712, identified as FDA1077950, 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. 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. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. 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. This requirement is being solicited on an unrestricted basis. Statement of Work See Attachment Pricing Table See Attachment EVALUATION FACTORS FOR AWARD/TECHNICAL EVALUATION CRITERIA Evaluation Criteria for Competitive Proposals The Government shall award a simplified purchase order to the responsive contractor/vendor who offers the "best value" to the Government in accordance with the requirements of the Statement of Work. The anticipated procurement procedures are those prescribed by FAR Part 13 for Simplified Acquisition Procedures. Written quotations shall be evaluated against the following evaluation factors listed in descending order of importance: Technical and Scientific Understanding and Approach, Past Performance/Experience, Qualifications and Availability of Proposed Personnel, Price. Evaluation Criteria This evaluation shall be based upon the completeness and thoroughness of the proposal submitted. The offeror shall demonstrate that the objectives stated in the proposal are understood and offer a logical program for their achievement. The technical proposal shall be submitted electronically via e-mail to the Contracting Officer. The technical proposal shall be limited to twenty-five (25) pages double-spaced not including CVs, resumes or bibliographies, with no less than an eleven (11) point font. The price quotes shall not be included in the technical proposal. They shall be sent via email to the Contracting Officer as a separate document. The offeror's proposal shall present sufficient information to reflect a thorough understanding of the work requirements and a detailed plan for achieving the objectives of the scope of work. Technical proposals shall not merely paraphrase the requirements of the Agency's scope of work or parts thereof, or use of phrases such as "will comply" or "standard techniques will be employed." The technical proposal shall include a detailed description of the techniques and procedures to be used in achieving the proposed end results in compliance with the requirements of the Agency's scope of work. Evaluation Factors Factor 1: Technical and Scientific Understanding and Approach (Maximum possible score = 40) Factor 2: Past Performance/Experience (Maximum possible score = 40) Factor 3: Qualifications and Availability of Proposed Personnel (Maximum possible score = 20) Factor 4: Price Factor 1: Technical and Scientific Understanding and Approach The quotation shall demonstrate a thorough understanding of the requirements of the Statement of Work and describe an approach which shall demonstrate the achievement of timely and acceptable performance as described in the Statement of Work and the Specifications therein. The quotation shall present a comprehensive statement of the problem, scope, and purpose of the project to demonstrate an understanding of the requirements from a management and technical standpoint. Detailed plan of work, complete with quality control and detailed time line. Quotation shall be evaluated on the following: (a) Strong knowledge in design, study conduct, data analyses, and data interpretations of contemporary in vitro and in vivo metabolism and drug interaction studies (b) In depth knowledge in construct of physiologically based pharmacokinetic models to predict drug drug interactions (c) Familiarity with reputable, commercial software for physiologically based pharmacokinetic modeling (d) Established scientific reputation within the field of drug-drug interaction predictions utilizing physiologically based pharmacokinetic modeling Factor 2: Past Performance/Experience The offeror shall describe their past performance, identifying other organizations with which they have participated in similar efforts including the degree of their involvement, the size and complexity of the organization and other information describing their experience. Offerors shall submit a list of three (3) references. Contracts listed may include those entered into by the Federal Government, agencies of State and local governments and commercial customers. Offerors that are newly formed entities without prior contracts should list contracts and subcontracts as required for all key personnel. The reference list of the three (3) references shall include the following information for each contract and subcontract: (a) Name of contracting activity (b) Contract type (c) Contract work (d) Contracting officer and telephone (e) Program manager and telephone Each offeror shall be evaluated on their performance under existing and prior contracts for similar products or services. Performance information shall be used as an evaluation factor against which offeror's relative rankings shall be compared to assure best value to the government. The government shall focus on information that demonstrates quality of performance relative to the size and complexity of the procurement under consideration. (a) Prior experience in design, study conduct, data analysis and result interpretation of in vitro metabolism and drug interaction studies using human liver microsomes and recombinant cytochrome P450 enzymes (b) Prior experience of using reputable, commercial software for physiologically based pharmacokinetic modeling to assess drug drug interactions which incorporate among other data in vitro and/or in vivo metabolizing enzyme kinetics and enzyme inhibition/induction parameters (c) Demonstrated capabilities in chemical synthesis or acquisition of non commercially available stereoisomers Factor 3: Qualifications and Availability of Proposed Personnel Each offeror shall be evaluated on the capability, qualifications, and availability of staff for the performance of tasks listed in the Statement of Work. Each offeror shall identify staff and describe their capabilities and expertise in substantive areas related to activities described in the Statement of Work. Personnel proposed to be assigned and available for work under the project shall be evaluated on their demonstrated, documented, and relevant expertise, education, availability, and experience as it relates to the requirement described in the Statement of Work. Supporting documentation about the experience, training, and education (e.g., CVs) of proposed personnel shall be provided by offeror. (a) PhD degree or equivalent degree and experience in pharmaceutical sciences, biological sciences or other related subjects Price Evaluation The Government plans to award a purchase order to the offeror whose quote represents the best value solution. The Contracting Officer may reasonably determine that the superior solution/approach merits a higher price, and therefore represents the best value to the Government. INSTRUCTIONS TO OFFERORS 1. All submitted quotations shall not exceed 25 pages in their final submission. 2. All questions must be emailed no later than 5:00 PM Eastern Time August 17, 2010 to Emily.Hunt@fda.hhs.gov. No phone calls will be accepted or returned. 3. Quotations shall be submitted electronically to Emily.Hunt@fda.hhs.gov on or before August 20, 2010 at 5:00 PM Eastern Time. No late quotations will be accepted. The Offeror assumes full responsibility for ensuring that offers are received at the place as delineated herein. 4. Quotations must contain documentation that addresses all technical factors stated within the Statement of Work. 5. 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 and Bradstreet number and banking information. 6. The anticipated award date is 09/03/2010. 7. The following FAR clauses apply to this combined synopsis/solicitation. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items,52.217-8 Option to Extend Services (Nov 1999)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1077950ss/listing.html)
- Place of Performance
- Address: Silver Spring, Maryland, United States
- Record
- SN02240440-W 20100815/100814000016-7129c0168ad38560dfa2c36393032ce3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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