R -- IMPLANT SETS

The U. S. Agency for International Development (USAID) intends to issue a request for proposal (RFP) in anticipation of an award of contract(s) to acquire U.S. Food and Drug Administration (USFDA) or other stringent regulatory body (defined below) approved contraceptive implant along with the insertion device to USAID. The base quantity is 72,000 sets. A stringent regulatory authority (SRA) is a drug regulatory body that closely resembles FDA in standards utilized in its operations. Currently, countries that participate in the International Conference on Harmonization (ICH) are considered to have stringent regulatory authorities. The ICH regulatory bodies include: the U.S. FDA; the Japanese Ministry of Health, Labor, and Welfare; the European Agency for the Evaluation of Medicinal Products (EMEA) centralized procedure; and the European Free Trade Area (represented by the Swiss Medic). The Canadian drug regulatory authority, the Therapeutic Products Directorate, Health Canada, is an observer to the ICH and is also considered a stringent regulatory authority. Other countries may be considered to have a stringent regulatory body if they have implemented ICH guidelines and resemble the U.S. FDA in operation, but would be considered by USAID on a case-by-case basis. The implants supplied to USAID under this contract shall have the expiration dating approved by the U.S. Food and Drug Administration (USFDA) or other stringent regulatory body of 60 months (5 years). The Government contemplates award of a Firm Fixed Price contract(s) resulting from this solicitation. The Offeror must supply the following documentation to USAID: (1) Complete product description, (2) evidence that the implants offered in response to this solicitation are manufactured in an ISO 9000 approved facility, (3) evidence that the product and production/manufacturing facility have been approved by U.S. FDA or other stringent regulatory body, (4) evidence that the product shelf life approved by U.S. FDA or stringent regulatory body is 5 years, (5) long term stability data, (6) any data to support that the product does not require climate controlled transport and storage, and (7) documented proof of any current registrations and in-process registrations. Products purchased under this contract are for developing countries for use in family planning programs supported by USAID and in a full range of service delivery programs. The authorized geographic code for procurement of goods and services under this contract is 935. Performance under the basic contract shall be from the award date on the face of the contract through December 31, 2007. Four additional option years of performance will be from January 1, 2008 through December 31, 2011. The RFP is expected to be issued on or about late March 2006 and will be distributed through the Federal Business Opportunities website of the General Services Administration. The publication of this notice or the RFP does not obligate the U.S. Government to make an award.