The National Cancer Institute (NCI) plans to procure services to provide regulatory support to recipients of National Cancer Institute (NCI) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) phase II grants (regular and transitioned FastTracks) and contracts. REGULATORY SUPPORT FOR SBIR/STTR PHASE II AWARDEES - MEDICAL DEVICES This acquisition will be conducted under the procedures for acquiring commercial buys as authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.500. The North American Industry Classification System code is 541990 and the business size standard is $7M. Period of Performance shall be from the effective date of the award through twelve months, with two 12 month options. Only one award will be made as a result of this solicitation. This will be FIRM FIXED PRICE (FFP), Indefinite Delivery Indefinite Quantity (IDIQ) contract. MINIMUM CONTRACTOR QUALIFICATIONS – Medical Devices Contractor Requirements: The Contractor shall be responsible for providing approximately 30 hours regulatory support to approximately 25 to 30 NCI phase II SBIR/STTR awardees each year as well as other activities. Regulatory contractors shall have a background and expertise in the topics under the purview of the FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER) as evidenced by the number (greater than 50 in total, with a minimum of 10 each for drugs (IND/NDA), biologics (BLA) and devices (IDE/510(k)/PMA) of successful applications filed and approved. Senior members of the team must each have a minimum of 15 successful filings to the FDA for devices (IDE/510(k)/PMA), in any combination. Junior members, on the other hand, must each have a minimum of 5 successful filings to the FDA for devices (IDE/510(k)/PMA), in any combination. Potential offerors may request a copy of the solicitation from Malinda Holdcraft, Contract Specialist via electronic mail at [email protected] or fax (301) 402-4513. Interested parties shall include the name of company; complete mailing address; point of contacts, phone, fax numbers, and email address; company DUNS number and business size. Offerors who received a copy of the solicitation under RFQ-NCI-90160-NG will automatically receive a copy of this solicitation (RFQ-NCI-100055-NG-Devices). However, if an offeror is NOT interested in receiving the new solicitation, please notify the contract specialist. All questions shall be in writing and may be addressed to the contract specialist. Estimated issue date of the solicitation is March 26, 2010 with an estimated due date of April 9, 2010. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Reference: RFQ-NCI-100055-NG-Devices on all correspondence.

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