SOLICITATION NOTICE
R -- Consultant Biomedical Statistical Review Services
- Notice Date
- 2/2/2009
- 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
- 09-223-SOL-00004
- Archive Date
- 2/28/2009
- Point of Contact
- Mrs. London L Johnson, Phone: 301-827-7041, London L Johnson,, Phone: 301-827-7041
- E-Mail Address
-
london.johnson@fda.hhs.gov, london.johnson@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) is seeking offers for consultant biomedical statistical review services. This is a combined-synopsis/solicitation for commercial items (as defined by FAR 2.101) prepared in accordance with the format in FAR Subpart 12.6, as a supplemented with additional information included in this notice. This announcement constitutes the only solicitation. A written request for quotations will not be issued. This acquisition is subject to FAR Subpart 13.5 regarding the application of simplified acquisition procedures. This acquisition is issued as Request for Quotation (RFQ) 09-223-SOL-00004. All responsible business sources may submit an offer that may be considered. The NAICS code is 541690. The small business standard is $7 million. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-30. Offers in response to this RFQ shall be submitted by 3:00 pm EST, Friday, February 13, 2009. I.OBJECTIVE: The objective of this purchase order is to obtain the services of a consultant biomedical statistical review services. II.SCOPE OF WORK: (a) 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 of Drug Evaluation and Research (CDER) at FDA. 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 (b) 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. (c) The Contractor shall also have a thorough knowledge of survival analyses and meta-analytic techniques as well as Agency expertise in clinical trial design and statistical methods. (d) The Contractor shall define and develop new formulas, tests, procedures and refine existing procedures as necessary to evaluate new, novel or complex problems. (e) The Contractor shall attend and participate in meetings with drug sponsors to discuss their drug development programs. It is estimated there will be two to three such meetings per week. (f) 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 cardiovascular risk in drugs for the treatment of type 2 diabetes. (g) The Contractor shall have the ability to communicate findings and statistical information verbally and in writing. (h) The Contractor shall keep the Project Officer informed of progress on IND and NDA written reviews. III. PERIOD OF PERFORMANCE: The period of performance for this purchase order is the date of award through one year from the date of award. IV. PLACE OF PERFORMANCE: U.S Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 21, Silver Spring, Maryland 20993. V. INSTRUCTIONS FOR SUBMITTING QUOTES: The provisions at FAR 52.212-1 Instructions to Offerors-Commercial Items (JUNE 2008) are incorporated by reference. Offerors shall follow these instructions. Special attention is directed to the following paragraphs: (b)(4) does not apply; (b)(6) pricing is fixed price; (b)(10) All information required by this paragraph shall be submitted. Experience shall be limited to current projects and/or projects completed within the last 3 years; (d)(e)(h) and (i) do not apply. The provisions at FAR 52.212-3 Offeror Representations and Certifications—Commercial Items (June 2008) is incorporated by reference. It must be completed as well. Offerors shall submit their quotes via email to London.Johnson@fda.hhs.gov. VI. EVALUATION CRITERIA: Award will be made on a best value basis taking into account the following factors: experience, past performance, and price, respectively. The Government may award to other than the lowest priced offer based on a trade-off among these factors. VII. AWARD: A written purchase order will be e-mailed, faxed, or mailed to the successful offeror, within the timeframe for acceptance of offers. This shall result in a binding purchase order without further action by either party.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=f638e42773db4417a673c8d832479422&tab=core&_cview=1)
- Place of Performance
- Address: US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 21, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01742669-W 20090204/090202220052-f638e42773db4417a673c8d832479422 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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