Long-Term Study, Safety & Effectiveness of Artificial Joint Replacement Devices

THIS ANNOUNCEMENT IS AMENDED TO EXTEND THE DATE AND TIME FOR RESPONDES FROM AUGUST 13, 2008, 12:00 P.M. CDT TO SEPTEMBER 8, 2008; 2:00 P.M. CDT. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, in conjunction with Far 13.5 as applicable and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. This is a Request for Quotations (RFQ); a written solicitation will not be issued. The Food and Drug Administration has a requirement for the following: Collaboration with entities that are collecting extensive information on artificial joint replacements and have at least 300 participants included in their registry that have been followed for at least one (1) year. The proposed study would produce valid and precise estimates of device performance following the implantation of the device that would benefit decision-making of patients, clinicians and CDHR. Crucial variables include device survival and device related adverse events. OBJECTIVES: 1) Evaluate long-term safety and effectiveness of artificial joints. 2) Development of a de-identified dataset that includes demographics, device and outcome information. 3) Data analysis. 4) Development and dissemination of manuscripts. METHODS: Specific information necessary to be included in the registry - 1) All artificial joint replacements, 2) Demographic characteristics, 3) Device characteristics, 4) Survival information, 5) Revision rates, 6) Adverse Events, and 7) Short and long term outcomes. Additional Methods - Survival analysis of length of the duration of implant, Evaluation of adverse events and relatedness to device, evaluation of revision rates. Reporting Requirements and Deliverables - The successful contractor will be required to submit the following items: o A de-identified dataset or memorandum regarding how data will be analyzed o Data cleaning methods, or analysis procedures o Results of data analysis, and o Participation in manuscript preparation. The results of this study will be disseminated to all interested parties in the FDA and in the participating institutions within the registry. Theses data will also be presented at National and international orthopedic meetings and prepared for publication in peer-reviewed journals. Period of Performance: September 1, 2008 through August 31, 2009. The solicitation number is FDA-SOL-08-00835. Proposals/Quotations are due August 13, 2008, by 2:00 p.m. Central Daylight Time in Jefferson, AR; at Food and Drug Administration, OC/OSS/OFFAS, Attention: Sandra Davis, 3900 NCTR Rd., Jefferson AR 72079-9502. The North American Industry Classification System (NAICS) Code is 541990 and the size standard is $6.5 million. The award will be made on the basis of full and open competition from among all responsible business concerns submitting offers. All responsible sources may submit a quotation, which if received timely, shall be considered by the Agency. Offers must be submitted on SF1449, attached, or can be located at http://www.gsa.gov/Portal/gsa/ep/formslibrary.doformType=SF and reference solicitation number FDA-SOL-08-00835. Contract Type: Commercial-Item Firm Fixed Price. FOB Point of Delivery reports and deliverables shall be provided to: Food and Drug Administration, CDRH, PI50 RM 320JJ, HFZ-541, 1350 Piccard Dr, Rockville MD 20850. Offerors must include a completed copy of the provisions at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. Applicability of FAR Provisions: the following Federal Acquisition Regulation (FAR) provisions and clauses apply to this request for quotes and are incorporated by references. The solicitation document and incorporated provisions and clauses are those through Federal Acquisition Circular (FAC) 2005-26 dated June 12, 2008. - 52.203-6 (SEPT 2006) Restrictions on Subcontracting Sales to the Government - 52.212-1 (NOV 2007) Instructions to Offerors - Commercial - 52.212-2 (JAN 1999) Evaluation - Commercial Items - (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Technical, Price and Past Performance. Technical and past performances, when combined, are equal to cost. The technical quotations will receive paramount consideration over cost and past performance; however, cost will be evaluated for price reasonableness. Each offeror must (1) submit written information that pertains to their capability to supply the required equipment, (2) identify two sources for which the offeror has provided the same or similar items that are required herein (include contracts within the past two years, Points of contact and telephone numbers). The Government may make its decision on the basis of initial quotations received and not have discussions. Therefore, each initial quotation should contain the offeror's best terms from both a price and technical standpoint. Offerors shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Government is not responsible for locating or securing any information, which is not identified in the proposal. Before the offer's specified expiration time, the Government may accept the offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. - 52.212-3 (NOV 2007) Offeror Representations and Certifications-Commercial Items (Offerors must include a completed copy of 52.212-3 with their offeror). The full text of this clause can be located at: www.arnet.gov/FAR. - 52.212-4 (FEB 2007) Contract Terms and Conditions Commercial Items. - 52.212-5 (JUNE 2008) Contract Terms and Conditions Required to Implement Status or Executive Order - Commercial Item. (The following clauses are applicable to this requirement: 52.222-3; 52.222-19; 52.222-21; 52.222-26; 52.222-35; 52.222-36; 52.222-37; 52.222-50; 52.225-1; 52.225-3; 52.225-4; 52.225-13; 52.225-20 and 52.232-33) - 52.215-5 (OCT 1997) Facsimile Quotations. - 52.204-7 (JULY 2006) Central Contractor Registration - 52.219-4 (JULY 205) Notice of Price Evaluation for HUBZone Small Business Concerns - 52.219-8 (MAY 2004) Utilization of Small Business Concerns - 52.219-39 (DEC 2004) Notification of Employee Rights Concerning Payment of Union Dues or Fees Clause and provisions can be obtained at http://www.acquisition.gov. CCR Requirement - Offeror's must be registered in the Central Contractor Registration (CCR) before an award can be made. If offeror's are not registered in CCR, they may do so by accessing the CCR web site at: http://www.ccr.gov. A standard commercial warranty on parts and workmanship is required. The Defense Priorities and Allocation System (DPAS) and assigned rating are not applicable to this solicitation notice.