Maintenance and Operation of a Chemical Synthesis Facility

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Contraception and Reproductive Health Branch (CRHB) of the National Institute of Child Health and Human Development (NICHD) is recompeting its contract for a Chemical Synthesis Facility (CSF) capable of synthesizing potential anti-fertility agents on a laboratory gram scale to a relatively larger kilogram scale. The kilogram scale chemical agents are manufactured under current Good Manufacturing Practices (cGMP) for comprehensive contraceptive evaluation, including toxicology studies, primate testing and preclinical safety studies before entering human clinical studies. This is a 100% Small Business Set-Aside, NAICS Code 54172 with a size standard of 500 employees or less. NICHD seeks a Small Business contractor capable of: 1) rapidly synthesizing laboratory scale gram quantities of specific chemical compounds required for in vitro and initial contraceptive investigation in small animals, 2) synthesize and purify relatively larger quantities of up to 10 kilograms of drug candidates for comprehensive anti-fertility testing by the Government, including toxicology studies, primate testing and preclinical and clinical studies under current Good Manufacturing Practices (cGMP), 3) synthesizing chemicals and/or chemical intermediates of up to 10 kg for use in other ongoing chemical, peptide and related contracts and other contract programs, 4) stable isotope and radiolabeled synthesis of compounds for pharmacokinetic and metabolism studies and 5) peptide synthesis on a laboratory milligram scale to a larger scale of up to 1 kg that may require manufacture under cGMP. Radiolabeled and peptide synthesis may be sub-contracted out with the approval of the Program Officer. This RFP (NIH-NICHD-CPR-2012-07) will be electronically available on or about April 16, 2012. Proposals will be due by 4:00 P.M. EST on June 5, 2012. The RFP may be accessed through the FedBizOpps website, https://www.fbo.gov. All responsible sources may submit proposals. However, in order to be considered for evaluation the following mandatory requirements must be met at the time of proposal submission: (1) Documented capabilities for achieving relatively large-scale synthesis (10 kg); (2) Facilities which meet requirements for cGMP as prescribed by the Food and Drug Administration (see 21 CFR Parts 201, 207, 210, 211 and 229; and (3) nuclear license to handle radioisotopes if chemistry is carried out in-house. All correspondence must cite the above RFP number. No phone calls will be accepted. This notice does not commit the Government to award a contract.

Contracting Office Address:
Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510, UNITED STATES.