SOLICITATION NOTICE
B -- Statistical Evaluation of Design, Conduct and Analysis of Pre-clinical and Clinical Studies
- Notice Date
- 12/28/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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, MD, 20857-0001, UNITED STATES
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-07-00148
- Response Due
- 1/12/2006
- Point of Contact
- Roberta Richardson, Contract Specialist , Phone 301-827-7175, Fax 301-827-7106, - Patricia Pemberton, Contracting Officer, Phone 301-827-1022, Fax 301-827-7106,
- E-Mail Address
-
roberta.richardson@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 12.6., supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals/quotes are being requested. No other solicitation will be issued. This acquisition is a small business set aside and is being issued as a Request for Quote (RFQ). This synopsis, identified as FDA-SOL-07-00148, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following full-time services as defined below under commercial item procedures. Work to be Performed: NAICS CODE : 541990 All Other Professional, Scientific, and Technical Services Background: The Division of Biostatistics in the Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) provides statistical expertise in the evaluation of materials and documents submitted to and generated by the Center to assure statistical validity and consistency. This contract is intended to provide additional statistical expertise to supplement current staff. Scope of Work: Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel and services, and otherwise do all things necessary for or incident to the performance of the work as described below: 1. Conduct comprehensive statistical review of pre-market submissions from manufacturers. This includes reviewing study protocols to determine whether data collected are (or will be) scientifically and statistically valid; evaluating manufacturer?s data to determine whether claims made are supported by valid statistical analyses; identifying deficiencies in the submissions and providing written reviews and specific language for regulatory letters that conveys statistical concerns and requests to non-statisticians. This activity includes collaboration with Center clinicians, scientists and engineers. 2. Perform, when appropriate, statistical analyses of submitted data to validate analytical results and answer specific questions arising during statistical review. 3. Provide backup support for statistical consultation/analysis activities in the Division. Deliverables: Written statistical reviews of individual submissions. Quarterly summary reports providing status of submissions and progress on projects. Monthly reports showing time expended on reviews and projects. Period of Performance: Period of Performance: 7 mo Base with 2 option years Base period: March 1, 2007 - September 30, 2007 Option year 1: October 1, 2007 - September 30, 2008 Option year 2: October 1, 2008 - September 30, 2009 Payment schedule: Payment will be made in monthly installments based on level of effort (hours worked). Invoices are to be submitted to the assigned FDA Project Manager, for approval. Qualifications: ? Advanced degree in Statistics or Biostatistics. ? Experience in medical product clinical trial design, analysis and/or evaluation. ? Experience in laboratory experiment design and analysis. ? Ability to communicate clearly orally and in writing. ? Current and Active Clearance to see confidential and proprietary information. Where Work will be Done: The contractor will operate from an office in the FDA space located at: FDA/CDRH PI50 RM140L HFZ-550 1350 Piccard Dr Rockville, MD 20850 Additionally, some of the work may be done off site. Equipment Use: The contractor will use a personal computer provided by FDA/CDRH. Award Date: The anticipated award date is 01 Feb 2007; however, all dates in this announcement are subject to change. 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.. The solicitation and incorporated clauses and provisions are those in effect through Federal Acquisition Circular 05-12, dtd Aug. 4, 2006) 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 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 52.219-6;FAR 52.222-3; FAR 52.222-19; FAR 52.222-21; FAR 52.222-26; FAR 52.222-35; FAR 52.222-36 FAR 52.222-37; FAR 52.225-3; FAR 52.225-15 ;FAR 52.232-33 The following clauses are incorporated by reference and apply to this acquisition. FAR 52-232-18 AVAILABILITY OF FUNDS (APR 1984) FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995) FAR 52.217-09 OPTION TO EXTEND THE TERM OF THE CONTRACT (Mar 2000) FAR 52.217-8 OPTION TO EXTEND SERVICE (Nov 99) The government reserves the right to make an award without discussions. THE GOVERNMENT WILL NOT PAY FOR COSTS INCURRED IN THE PREPARATION AND SUBMISSION OF DATA OR OTHER COSTS INCURRED IN RESPONSE TO THIS ANNOUNCEMENT Deadlines for Responding: ? All questions must be submitted via email to the Contract Specialist named below. No telephone call inquires. ? Late date / time to submit questions: Jan 9, 2007 3:00pm EST Points of Contact Roberta Richardson, Contract Specialist, Phone 301-827-7175, Fax 301-827-7106, Email Roberta.richardson@fda.hhs.gov - Patricia Pemberton, Contracting Officer, Phone 301-827-1022, Fax 301-827-7106, Email patricia.pemberton NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (28-DEC-2006). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 08-JAN-2007, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-07-00148/listing.html)
- Place of Performance
- Address: FDA/CDRH PI50 RM140L HFZ-550 1350 Piccard Dr Rockville, MD
- Zip Code: 20850
- Country: UNITED STATES
- Zip Code: 20850
- Record
- SN01207639-F 20070110/070108222849 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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