SOLICITATION NOTICE
R -- Bio-Medical Statistician Consultant/Review Services
- Notice Date
- 3/12/2010
- 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 Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1070755
- Archive Date
- 4/13/2010
- Point of Contact
- Phillip K. Frame, Phone: 301-827-7169, Patricia M Pemberton, Phone: 301-827-1022
- E-Mail Address
-
Phillip.Frame@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
(Phillip.Frame@fda.hhs.gov, patricia.pemberton@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- DESCRIPTION THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION, A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. The associated North American Industrial Classification System (NAICS) code for this procurement is 541690 for full and open competition. The FDA intends to issue a firm fixed-price purchase order for the tasks identified below: Services and Prices/Costs Labor/Cost CategoryRateU/IQuantityTotal Price Background The Office of Biostatistics needs a biomedical statistician to review routine submissions but also complex submissions that require a high level of statistical expertise and experience. There are several current areas of critical importance to the Division that require significant statistical expertise. Two of the most important areas are adaptive clinical trial designs and the assessment of cardiovascular (CV) risk in drugs for the treatment of type 2 diabetes. Statement of Work Tasks •The Contractor shall write statistical reviews and evaluations of clinical data contained in New Drug Applications (NDAs), Investigational New Drug (IND) submissions, and related documents. Data to be reviewed are those submitted from drug sponsors primarily to the Division of Metabolic and Endocrine Products (DMEP) within the Center for Drug Evaluation and Research (CDER) at FDA. •The Contractor will define and develop new formulas, tests, procedures and refine existing procedures as necessary to evaluate new, novel or complex problems. •Responsibilities include attending and participating in internal meetings with FDA staff and industry meetings with drug sponsors to discuss their drug development programs. To enhance interaction between the Contractor, FDA staff and industry, it is required that attendance at both internal and industry meetings be on-site (FDA headquarters at White Oak, Maryland) and not off-site via telecom. It is estimated there will be two to three such meetings per week. •The Contractor shall study the statistical literature to maintain proficiency in statistical expertise with particular attention to statistical methods related to adaptive clinical trial designs, non-inferiority designs and trial designs for the assessment of CV risk in drugs for the treatment of type 2 diabetes. •The Contractor shall keep the Project Officer informed of progress on IND and NDA written reviews. Knowledge/Skills •The Contractor shall have extensive knowledge of statistical theory and methods as applied to adaptive clinical trial designs, non-inferiority designs and clinical trials for the assessment of CV risk. The Contractor shall also have a thorough knowledge of survival analyses and meta-analytic techniques as well as expertise in clinical trial design and statistical methods. •The Contractor must be able to immediately begin and satisfactorily complete work assignments without formal training. As such, the Contractor must have experience as a statistical reviewer of IND and NDA submissions containing clinical trials involving the assessment of CV risk in drugs for the treatment of metabolic disorders, including type 2 diabetes or hyperlipidemia. •The Contractor should be able to interact frequently with medical officers and project officers at FDA and with other technical disciplines as needed (clinical pharmacology, pre-clinical pharmacology and toxicology, chemistry) in order to be a fully functioning member of the project team assigned to a specific IND or NDA. •The Contractor shall have the ability to communicate findings and statistical information verbally and in writing at an exceptional level. •The Contractor shall be free of financial conflicts of interest with the regulated industry. Specifically, the Contractor may not hold financial interests in companies which are significantly regulated by the FDA consistent with current policies by the FDA Ethics Program that prohibit certain financial interests for FDA employees. •The contractor is entitled to paid leave corresponding to Federal holidays. Evaluation Criteria Award will be made to the party whose proposal offers the best value to the Government; technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable. The Government will evaluate information based on the following evaluation criteria: 1) Qualifications & Availability of Proposed Personnel 2) Understanding the Requirements & Technical Approach and 3) Price. Qualifications/Availability of Proposed Personnel is more important than Understanding the Requirements/Technical Approach and each of these factors are significantly more important than price. 1. Qualifications & Availability of Proposed Personnel Each contractor will be evaluated on the capability, qualifications, and availability of staff for the performance of tasks listed in the Statement of Work. Offerors must 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 must be provided. 2. Understanding the Requirements & Technical Approach Provide a comprehensive statement of the scope and purpose of the project to demonstrate complete understanding of the intent and requirements. This understanding indicates a clear comprehension and awareness of the contract objectives. Proposal will be evaluated on the following: a. Understanding of the purpose and scope of work to be accomplished such as experience providing statistical consultation. b. Describe in detail the methodologies that would be used for the project, indicating level of experience with each. The technical proposal shall be submitted electronically via e-mail to the Contracting Officer. The technical proposal described above shall be limited to 10 pages double-spaced not including resumes or bibliographies, with no less than an 11 point font. The price proposal shall not be included in the technical proposal. It shall be sent via email to the Contracting Officer as a separate document. The Offeror’s proposal should 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 must 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. FAR Provisions/Clauses FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.212-2 Evaluation – Commercial Items; 52.212-3 Offeror Representations and Certifications – Commercial Items; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-3, Buy American Act—Free Trade Agreements – Israeli Trade Act 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. 52.217-8 Option to Extend Services; 52.219-1 Small Business Program Representations; 52.225-2 Buy American Certificate; 52.244-6 Subcontracts for Commercial Items Additional Information This is a Combined Synopsis/Solicitation for professional and scientific services as defined herein. The Government intends to award a Firm Fixed-Price Purchase Order as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. 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. Additionally, all proposals shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541690; business size; and payment terms. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 3:00 PM (1500) EST on 29 March 2010 to the attention of Phillip Frame, Phillip.Frame@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. QUESTIONS DEADLINE: all questions must be received by email (Phillip.Frame@fda.hhs.gov) before 3:00 pm (1500) EST on 22 March 2010. FAXED PROPOSALS SHALL NOT BE ACCEPTED.
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