SOLICITATION NOTICE
B -- Review/Study of Premarket Product Review and Policy Development for Point Care and Rapid Drugs of Abuse/Toxicology Diagnostic Devices
- Notice Date
- 10/29/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857
- ZIP Code
- 20857
- Solicitation Number
- Reference-Number-E066592
- Archive Date
- 11/29/2002
- Point of Contact
- Tracy O'Neill, Contract Specialist, Phone 301-827-7175, Fax 301-827-7101, - Ida Cofield, Contract Specialist, Phone (301) 827-7156, Fax (301) 827-7151,
- E-Mail Address
-
toneill@oc.fda.gov, icofield@oc.fda.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items or services prepared in accordance with the format in FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ) No. E066592. These solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The Standard Industrial Classification (SIC) Code for this acquisition is 7389 and the North American Classification System (NAICS) Code is 541990. The FDA intends to issue a purchase order on a sole source basis to Nancy A. Moore for the following service: Review/Study of Premarket Product Review & Policy Development for Point Care & Rapid Drugs of Abuse/Toxicology Diagnostic Devices. (1) The contractor will review complex toxicology and general chemistry submissions including submissions with point of care application and using alternative matrices. Some of these will be first of a kind and require extensive background in FDA regulatory and review policy as well as in forensic science; (2) The contractor will author, provide quality control, and provide edit guidance documents for documents dealing with toxicology and chemistry submissions including scientific performance, labeling, and appropriate strategies for maximizing likelihood of proper testing protocols. These include highly visible products such as drug testing OTC, which poses unique use and information issues; (3) The contractor will participate in the formulation of policy and procedures for dealing with toxicology and chemistry submissions, in particular in the areas of drugs of abuse. This area is currently under review by senior management in both FDA and HHS and requires historical perspective, review experience, and strong scientific and writing skills; and (4) The contractor will interact with SAMHSA, CMS, or other government agencies to discuss and develop FDA review policies and to address problem review issues. The contractor will have knowledge with both premarket review and compliance issues and have an understanding of the premarket notification program. The contractor needs to be conversant with IVD study design, labeling and quality control. The period of performance will be the date of the award through six months. The following FAR Clauses shall apply to this solicitation: 52.212 Instructions to Offerors-Commercial; 52.214-4 Contract Terms and Conditions-Commercial Items; and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. The award is being issued on a sole source basis because Nancy Moore has a unique knowledge of both premarket review and compliance issues in regards to the Center for Devices and Radiological Health/Office of Device Evaluation Program. FAR provisions can be found at the following website: http://www/arnet.gov.
- Place of Performance
- Address: Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
- Zip Code: 20850
- Country: USA
- Zip Code: 20850
- Record
- SN00195509-W 20021031/021029213215 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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